Mail Voting Litigation in 2020, Part II: Submission of Mail-In Ballots – Lawfare

This post is the second of a five-part series on litigation about mail voting during the 2020 general election. This series is part of Lawfare's collaboration with the Stanford-MIT Healthy Elections Project.

As the coronavirus pandemic has wrought unprecedented change on the U.S. election system in general and on mail voting in particular, voters and advocates have challenged nearly every aspect of the vote-by-mail process. This post surveys litigation brought since March 2020, challenging vote-by-mail ballot submission rules and procedures that voting rights advocates argue burden the right to vote.

Specifically, this post discusses four types of legal battles playing out across the country aimed at removing barriers for voters who cast their ballots by mail. The lawsuits challenge Election Day ballot receipt deadlines for mail-in ballots, the requirement that ballots be returned in a secrecy sleeve, the cost of postage required to mail ballots, and the lack of accommodations for voters with disabilities who seek to send ballots by mail. The claims are largely constitutional, but plaintiffs have also employed statutory arguments. Plaintiffs have had little success on ballot postage and voter assistance claims, as well as in Pennsylvanias highly publicized secrecy sleeve litigation, but have seen mixed results in Election Day receipt deadline and accessibility challenges.

Ballot Receipt Deadlines

A central category of vote-by-mail litigation concerns ballot receipt deadlines. Some states, such as Florida, Oklahoma, Georgia, Maine and Texas, mandate that mail ballots be received by election officials no later than Election Day in order to be counted. Other states require that mail ballots be postmarked no later than Election Day and received by election officials within some specified number of days after, typically two to seven days. In practice, Election Day ballot receipt deadlines result in tens of thousands of rejected ballots. In the 2020 primaries, more than 50,000 ballots were rejected for arriving late, including more than 20,000 in Florida alone. According to data from the 2018 and 2016 Election Administration and Voting Survey, late receipt is the number one cause of rejected mail ballots.

Plaintiffs have brought four main types of federal law challenges to Election Day mail ballot deadlines, three under the U.S. Constitution and one under the Voting Rights Act. The constitutional claims are that Election Day deadlines constitute an undue burden on the right to vote under the Anderson-Burdick test, violate the Fourteenth Amendment by denying procedural due process and violate the Equal Protection Clause of the Fourteenth Amendment. Plaintiffs initially saw some success on the constitutional claims, with district courts granting plaintiffs requests for preliminary injunctions in Georgia and Wisconsin. However, appellate courts subsequently stayed these injunctions. As shown in the discussion of DNC v. Wisconsin State Legislature below, the Supreme Court has so far largely supported these appellate court stays.

The New Georgia Project case, filed in May, illustrates the undue burden and procedural due process arguments in operation. For their undue burden claims, plaintiffs relied on what is known as the Anderson-Burdick test. Developed out of two separate U.S. Supreme Court rulings, the test calls for balancing the burden imposed on the electorate by a voting regulation against the states interests in relying on that regulation. Plaintiffs argued that Georgias requirement that all mail-in ballots be received on or before Election Day posed a severe burden on the right to vote by requiring voters to learn the deadline, receive their ballots with enough time to complete and return them, and guess how many days it would take their ballots to reach election officials through the mail service. Plaintiffs further argued that even those voters who meet the deadline suffer a burden on their right to vote because they are deprived of the ability to consider their choice of candidate until Election Day due to the requirement that their ballot be in the mail soon enough to reach election officials by the Election Day ballot receipt deadline.

In addition, plaintiffs argued that Georgias Election Day ballot receipt deadline violates the Due Process Clause under the Mathews test. The Mathews test calls for balancing an individuals interest in not being deprived of a right without certain procedural protections against the governments interest. Plaintiffs argued that Georgias failure to count ballots received after Election Day and its requirement that mail voters cast their votes early deprived the voters of their protected interests to vote and have that vote count and to cast a meaningful and informed vote, since they would have incomplete information when they had to mail it. Plaintiffs also argued that additional or substitute procedural safeguards were available by counting mail-in votes postmarked by Election Day and received within five business days of the election, which would be allowed under Georgia law.

In other cases, plaintiffs have argued that Election Day ballot receipt deadlines violate a third constitutional provision: the Fourteenth Amendments Equal Protection Clause. Plaintiffs in Lewis, for example, argued that Texass Election Day receipt deadline resulted in disparate treatment of voters because different counties enforce the deadline with differing degrees of strictness.

Some federal district courts have been receptive to plaintiffs constitutional claims, but federal appellate courts have subsequently stayed district courts injunctions. For instance, the court in New Georgia Project granted the relevant part of a preliminary injunction on Aug. 31, effectively extending Georgias receipt deadline. But in early October, the U.S. Court of Appeals for the Eleventh Circuit stayed the injunction. The appeals panel found that the district court erred on two analytical fronts: first, in finding that Georgias Election Day deadline severely burdened the right to vote; and second, in improperly weighing the States interests against this burden. The Eleventh Circuit also criticized the district court for accepting the plaintiffs novel procedural due process argument, noting that, even if we could choose to innovate a new approach (which we cannot), we would see no reason to do so.

Similarly, in DNC v. Bostelmann, in response to a challenge to Wisconsins Election Day ballot receipt deadline during the states primary elections, a federal district court ordered the state to accept all ballots postmarked within six days of the election. However, the U.S. Supreme Court stayed this order, reasoning that it was issued too close to the election and was, therefore, likely to cause confusion among voters. Five months later, in late September, the district court granted a preliminary injunction in four consolidated lawsuits, including DNC v. Bostelmann. The injunction extended the deadline for the receipt of absentee ballots until Nov. 9, provided the ballots were postmarked by Election Day, Nov. 3. But the U.S. Court of Appeals for the Seventh Circuit stayed the district courts injunction in early October, agreeing with the Wisconsin legislatures contentions that a federal court should not change rules so close to an election and that political, not judicial, officials should decide when a pandemic justifies changes to otherwise valid rules.

On Oct. 26, the U.S. Supreme Court, in a 5-3 vote, rejected Democrats and voting rights groups request to strike down the Seventh Circuits stay. The court did not issue a majority opinion, but in multiple concurrences, Chief Justice John Roberts and Justices Neil Gorsuch and Brett Kavanaugh criticized the federal courts intervention in state election procedures. Roberts leveled criticism not only at the federal district court that ordered an extension of Wisconsins receipt deadline but also at district courts more broadly. In describing the courts deadline extension as improper, Roberts noted that [i]n this case, as in several this Court has recently addressed, a District Court intervened in the thick of election season to enjoin enforcement of a States laws. Gorsuch similarly found the district courts order inappropriate on the basis of both separation of powers and voter confusion concerns. Under the Constitution, according to Gorsuch, judges cannot improvise with their own election rules in place of those the peoples representatives have adopted. He stressed the measures already taken by the Wisconsin legislature to respond to the pandemic and argued that the district court was simply complaining that the state hasnt done enough. Here, Gorsuch voiced concern that there were no clear rules for a judge to use in determining exactly when a ballot receipt deadline would be acceptable. Additionally, Gorsuch raised the possibility that [l]ast-minute changes to election procedures run the risk of confusion and chaos and eroding public confidence in electoral outcomes.

Concurring, Kavanaugh articulated three reasons why the district courts injunction was unwarranted. First, the injunction violated the Purcell principle by altering state election laws close to an election. Kavanaugh explained that the Purcell principle serves to ensure that the rules of the road are clear leading up to the election, reducing voter and election official confusion, promoting efficiency, and giving citizens confidence in the election result. He noted further that it would turn Purcell on its head to interpret the principle as stated that a federal appellate court should not overturn a district court order close to the election. Instead, he saw the federal circuit courts intervention here as correcting the district courts violation of Purcell. Second, Kavanaugh stated that the district courts injunction misapprehended the limited role of the federal courts in COVID-19 cases, because it is the role of the state legislature to address the health and safety of the people. While asserting that federal courts lack the expertise needed to make changes to election laws due to the pandemic, he listed cases in which the Supreme Court has recently stayed federal court injunctions that second-guessed state legislative judgments about whether to keep or make changes to election rules during the pandemic.

Third and finally, Kavanaugh wrote that the District Court did not sufficiently appreciate the significance of election deadlines. Under the Anderson-Burdick test, he said, a states reasonable deadlines for election processes do not raise constitutional issues because a State cannot conduct an election without deadlines. In particular, he claimed that states with Election Day receipt deadlines want to avoid the chaos and suspicions of impropriety that can ensue if thousands of absentee ballots flow in after election day and potentially flop the result of an election. He further stated that quick election results help to preserve the stability of elections. Kavanaugh endorsed in a footnote Chief Justice William Rehnquists view in Bush v. Gore that state courts are limited in their ability to rewrite state election laws for federal elections because Article II states that rules in presidential elections are to be established by state legislatures.

Justice Elena Kagan, in dissent, took issue with what she deemed Kavanaughs and the Seventh Circuits misunderstanding of Purcells message. Purcell instructs courts to consider all relevant factors, not just the calendar. While an autumn injunction could confuse voters, there is not a moratorium on the Constitution as the cold weather approaches. The federal district court was correct in issuing its order, Kagan argued, since an extension of the ballot receipt deadline would not confuse voters about how to cast their ballots or discourage Wisconsinites from exercising their right to vote. Kagan also emphasized what she viewed as the detrimental effects of the courts decision on Wisconsin voters enfranchisement. Tens of thousands of Wisconsinites, through no fault of their own, may receive their mail ballots too late to return them by Election Day, Kagan wrote. Without the district courts order, they must opt between brav[ing] the polls, with all the risk that entails, and los[ing] their right to vote.

In addition to claims arising under federal constitutional law, plaintiffs have challenged ballot receipt deadlines under Section 2 of the Voting Rights Act. For example, plaintiffs in Middleton v. Andino asserted that South Carolinas ballot receipt deadline abridge[s] and in some cases entirely den[ies] the rights of African American voters, due in part to socioeconomic differences between racial groups in South Carolina that exacerbate the coronaviruss effects. The district court denied plaintiffs motion for a preliminary injunction extending the receipt deadline. Plaintiffs in Yazzie v. Hobbs were also unsuccessful in bringing a challenge under the Voting Rights Act. On appeal, the U.S. Court of Appeals for the Ninth Circuit ruled that plaintiffssix members of the Navajo Nation who reside on the reservation in Apache County, Arizonalacked standing because they failed to plead a concrete and particularized injury. The Ninth Circuit also found that a favorable decision would not redress plaintiffs alleged injury because it would be infeasible for election officials to identify and separate mailed ballots cast by on-reservation Navajo Nation members from those cast by other voters.

In two somewhat unusual cases from the 2020 primaries, county boards of elections in Pennsylvania petitioned state courts to allow them to extend their own receipt deadlines. In one instance, the sheer volume of mail-in ballots that had to be sent to voters resulted in some voters receiving their ballots too late to return them by the deadline. In the other case, a design flaw for a website to request a mail-in ballot in another Pennsylvania county resulted in apartment numbers being left off of voters addresses, preventing mail-in ballots from reaching them in time to be returned by the receipt deadline. A state court granted the first petition, while another state court denied the latter.

For the general election, plaintiffs in Pennsylvania have secured a vote-by-mail ballot deadline extension. In Pennsylvania Democratic Party v. Boockvar, the Pennsylvania Supreme Court extended the states receipt deadline and adopt[ed] the Secretarys informed recommendation of a three-day extension of the absentee and mail-in ballot received-by deadline to allow for the tabulation of ballots mailed by voters via the USPS and postmarked by 8:00 p.m. on Election Day to reduce voter disenfranchisement. In late September, Republican state legislators, as well as the Republican Party of Pennsylvania, filed applications for a stay of the Pennsylvania Supreme Courts order at the U.S. Supreme Court. But in mid-October, the Supreme Court denied Republicans request, permitting Pennsylvania officials to count ballots received up to three days after the election. It takes five votes to issue a stay, but the court was tied on whether to grant Republicans request. Neither side of the court explained its position.

At the U.S. Supreme Court, Republican state legislators had argued that the receipt deadline extension granted by the Pennsylvania Supreme Court violates federal law that requires holding all elections for Congress and the Presidency on a single day throughout the Union and violates the Elections Clause of the U.S. Constitution by seizing the authority to set the times, places, and manner of federal elections from the state legislature. The legislators argued that the Elections Clause grants direct authority to Pennsylvanias General Assembly to regulate federal elections in Pennsylvania and that only Congress, not the Supreme Court of Pennsylvania, can alter the General Assemblys election regulations. While the legislators request for review acknowledged the coronavirus context of the Pennsylvania Supreme Courts decision, it noted that the Supreme Court of Pennsylvanias own special master found that COVID-19 is not likely to disrupt the November General Election ballot receipt deadline.

In early October, Secretary Kathy Boockvar and Pennsylvania Democrats filed briefs in response to legislators and Republicans requests for review. Boockvar argued that the legislators stay request raised concerns of federalism. This Court should not second-guess the Pennsylvania Supreme Courts straightforward construction of the Commonwealths constitution, Boockvar stated in her brief. The secretary urged that state courts be left free and unfettered by [this Court] in interpreting their state constitutions. In addition to federalism implications, a decision by the U.S. Supreme Court to grant legislators stay request could have resulted in the rejection of thousands of ballots. Such an outcome could have had an outsize impact on the results of the 2020 presidential election, since at least 3 million votes are expected to be cast by mail alone in Pennsylvania this year and because President Trump won Pennsylvania by a narrow margin of 44,000 votes in 2016. However, as previously noted, the U.S. Supreme Court has allowed the Pennsylvania Supreme Courts decision to stand.

Plaintiffs have also brought state law claims mirroring federal undue burden claims, and the results have been mixed. For instance, plaintiffs in Alliance for Retired Americans challenged Maines ballot receipt deadline as an undue burden under both the U.S. Constitution and the Maine Constitution. The court, in denying plaintiffs motion for a preliminary injunction, found this argument unavailing, stating that even in 2020, [the ballot deadline] imposes only a modest burden on the right to vote.

Michigan state courts have been all over the place on this issue. Plaintiffs in League of Women Voters of Michigan v. Benson unsuccessfully petitioned the Michigan Court of Appeals for a writ of mandamus ordering the secretary of state to accept ballots postmarked by the election date, with claims under the Michigan Constitution. The Michigan Supreme Court denied plaintiffs leave to appeal. In Michigan Alliance for Retired Americans v. Benson, plaintiffs initially saw a better outcome, as a Michigan state court granted plaintiffs preliminary injunction enjoining enforcement of Michigans Election Day ballot receipt deadline. The court held that, as applied to plaintiffs under the facts and evidence presented in this case, the ballot receipt deadline violates plaintiffs constitutional rights under Article II, Section 4, of the Michigan Constitution. It ruled that an absent voter ballot that is postmarked by no later than November 2, 2020, and received within 14 days after the election, is eligible to be counted. However, in mid-October, a state appellate court reversed that ruling, holding that under League of Women Voters of Michigan v. Benson, it is constitutional to require that ballots be received by the close of polls on Election Day to be counted.

Finally, a notable case arising out of New Yorks June 23 primary, Gallagher v. N.Y. State Board of Elections, illustrates the interplay between ballot deadlines and postal service operations. In response to the coronavirus pandemic, the New York State Legislature modified existing law to require that absentee ballots postmarked on or before Election Day be counted. Ballots were to be counted if they arrived before the close of polls on June 23 or were postmarked by June 23 and arrived by June 30. For some reason, thousands of absentee ballots for the June 23 Primary were not postmarked, even though they were mailed in. Evidence reviewed by the court indicated that a large number of ballots, especially in New York City, were invalidated because they lacked a postmark. Plaintiffs brought suit in the Southern District of New York, claiming violations of their First and Fourteenth Amendment rights, as well as corresponding rights under the New York Constitution.

Applying Anderson-Burdick, the U.S. District Court for the Southern District of New York found the burden on plaintiffs right to vote to be exceptionally severe because a large number of ballots will be invalidated ... based on circumstances entirely out of voters control. Having found a severe burden, the court applied strict scrutiny, finding that the states interest in ensuring ballots were cast before polls closed on Election Day was valid but that the postmark requirement was grossly overinclusive, covering ballots that cannot possibly have been put in the mail later than June 23.

In assessing plaintiffs Equal Protection Clause claim, the court also examined whether the postmark requirement created a voting process where the state by later arbitrary and disparate treatment, value[s] one persons vote over that of another. The court found that votes were valued differently in two ways. First, the U.S. Postal Service handled the postmark issue for ballots differently across the state. Second, because ballots travel through the mail at different speeds, ballots mailed at the same time on the same day might, by chance, be treated differentlyone might be counted and the other might not.

Having found a substantial likelihood of success on the merits, as well as a strong public interest in granting an injunction, the court determined that the equities tipped in plaintiffs favor. In early August, the court granted a preliminary injunction requiring local elections boards to count otherwise valid absentee ballots which were (1) received by June 24, 2020 without regard to whether such ballots are postmarked by June 23, 2020 and (2) received by June 25, 2020, so long as such ballots are not postmarked later than June 23, 2020.

Ballot Secrecy Sleeve Requirements

Another salient category of vote-by-mail litigation concerns ballot secrecy sleeve rules, which require voters to place completed ballots in paper envelopes before enclosing those envelopes in outer, or return, envelopes. The purpose of secrecy sleeves is to separate the voters identifying information from the ballot itself in order to protect the voters privacy. At least 15 states have laws requiring election officials to provide absentee voters with secrecy sleeves but, in many of those states, use of the secrecy sleeve is optional, and failure to use it is not grounds to reject the ballot.

In a high-profile case in Pennsylvania, Pennsylvania Democratic Party v. Boockvar, plaintiffs argued that failure to use the secrecy sleeve should not result in rejection of the ballot. In fact, most Pennsylvania counties accepted naked ballots, those not placed in secrecy envelopes, during the states June 2020 primary. Plaintiffs argued that the language of Pennsylvanias secrecy sleeve statute did not require rejection of naked ballots. On Sept. 17, the Pennsylvania Supreme Court held that naked ballots must be rejected in the November general election. After determining that the language of the statutory secrecy sleeve requirement is neither ambiguous nor unreasonable, the court came to the inescapable conclusion that a mail-in ballot that is not enclosed in the statutorily-mandated secrecy envelope must be disqualified.

According to Philadelphias city commissioner, Lisa M. Deeley, more than 100,000 ballots across the state could be rejected for missing secrecy sleeves. The Pennsylvania Supreme Courts decision has sparked a flurry of voter education efforts from nonprofit organizations and political campaigns to highlight the now-required secrecy envelope.

Cost of Postage for Mailing Ballots

Another set of legal challenges targets states failure to cover the costs of mailing completed mail-in ballots. While about a dozen statesincluding Hawaii, Oregon, and Washington, which regularly conduct all elections by maildo provide voters with prepaid ballot return envelopes, most states do not.

Plaintiffs have brought suit in several states, including Georgia, Florida, Oklahoma, Maine, South Carolina, North Carolina, Texas and Pennsylvania, alleging two constitutional violations. First, plaintiffs argue that requiring voters to pay for postage to cast their votes or apply for ballots constitutes a poll tax in violation of the Fourteenth and Twenty-Fourth Amendments. Second, plaintiffs assert that forcing voters to pay for stamps is an impermissible burden under the Anderson-Burdick test. As of mid-October, plaintiffs have had little success in ballot postage litigation. Courts have largely denied plaintiffs motions for preliminary injunctions on both their poll tax and Anderson-Burdick ballot postage claims, generally finding that paying for postage is not a poll tax and that burdens on voters do not outweigh state interests.

The case of Black Voters Matter Fund v. Raffensperger provides an illustrative example of the postage-as-poll-tax argument. Georgia law allows voters to vote absentee for any reason after applying for an absentee ballot. Plaintiffs sued Georgias secretary of state because voters must provide postage to apply for absentee ballots via mail and to return completed ballots. Plaintiffs contend the cost of stamps is tantamount to a poll tax, even though there are no statutes or regulations that require government officials to charge voters postage on absentee ballot applications. The federal district court dismissed plaintiffs poll tax claim in early August. Although the court recognized that in-person voting is potentially a difficult option for many voters, particularly during a pandemic, the court held that because in-person voting theoretically remains an option, stamps are not poll taxes under the Twenty-Fourth Amendment prism. In September, plaintiffs appealed the district courts poll tax ruling to the U.S. Court of Appeals for the Eleventh Circuit.

Other plaintiffs challenging postage requirements as poll taxes have seen mixed, but largely negative, results. For instance, in Nielsen v. DeSantis, the court summarily dismissed plaintiffs claim that a Florida statute requiring voters to pay postage for mail ballots constituted a poll tax, simply stating that [r]equiring a voter to pay for postage to mail a registration form or ballot to a Supervisor of Elections is not unconstitutional or otherwise unlawful. In Alliance for Retired Americans, the Supreme Judicial Court of Maine denied plaintiffs motion for a preliminary injunction in late September, and similarly concluded that requiring postage on a mail-in ballot is not a poll tax. A federal district court in Oklahoma reached the same conclusion in DCCC v. Ziriax. While plaintiffs have seen minimal success on poll tax claims, the U.S. District Court for the Western District of Texas declined in Lewis v. Hughs to dismiss plaintiffs challenge to a Texas law requiring voters to pay for ballot postage. The court held that it was sufficient at the motion-to-dismiss stage for plaintiffs to have alleged that postage constituted a fee that must be paid if voters wished to avoid risking harming their health to vote in person. The Fifth Circuit summarily affirmed the district courts opinion in early September and then withdrew its opinion in early October.

Plaintiffs have also brought claims that postage requirements are an impermissible burden under the Anderson-Burdick test. Parties allege a variety of burdens, many of which are exacerbated by the coronavirus. Plaintiffs in Black Voters Matter Fund, for instance, alleged that a failure to provide prepaid postage burdened the right to vote by requiring those least able to afford stamps to pay, those who lack internet access or credit cards to risk their safety by going to the post office during a pandemic, and those who have no means to do so to travel to the post office. Plaintiffs in Lewis, Alliance for Retired Americans and New Georgia Project made similar arguments, asserting that government interests are insufficient to justify these burdens.

As with poll tax claims, plaintiffs have generally seen negative results for their Anderson-Burdick claims. In denying plaintiffs motion for a preliminary injunction in Black Voters Matter Fund, the federal district court in Atlanta noted that plaintiffs failed to demonstrate a substantial likelihood of success on their argument that the burden of the postage requirement outweighs the cost to the state of the requested relief. While plaintiffs appealed the courts poll tax ruling to the Eleventh Circuit, they declined to appeal the courts Anderson-Burdick holding. The federal district court in Oklahoma, ruling in DCCC v. Ziriax and denying plaintiffs motion for injunctive relief, stated that paying for postage is a light burden on voters and that the states fiscal interests are sufficient to justify its not allocating funds to prepay for postage for absentee ballots. Similarly, in Alliance for Retired Americans, a superior court in Maine denied a preliminary injunction finding that paying for postage to return an absentee ballot by mail represents, at most, a moderate burden and, more likely, only a slight burden that is outweighed by the States interest.

Finally, in addition to federal constitutional law claims, plaintiffs have brought postage requirement suits grounded in state constitutional law. For example, plaintiffs in Stringer v. North Carolina alleged that a postage requirement for mail ballots violates the Free Elections Clause of the North Carolina Constitution, which states that [a]ll elections ought to be free. As of mid-October, the case has not progressed significantly.

Failure to Provide Accomodations for Voters With Disabilities

Plaintiffs in some states have challenged the lack of accessibility of mail voting procedures, alleging that absentee voters with disabilities face unnecessary obstacles. Generally, these cases are brought by or on behalf of visually or manually impaired individuals who are unable to transmit, mark and/or return mail-in ballots in accordance with state procedures.

Voting by mail typically entails filling out a paper ballot by hand and placing the completed ballot in the mail. While existing mail voting processes may allow nondisabled individuals to vote secretly and independently, voters with visual or manual disabilities are likely to need assistance to read and mark their paper absentee ballots, stripping them of the privacy available to nondisabled voters. Thus, plaintiffs describe their dilemma as having to make the unconscionable choice of either leaving their homes in order to receive in-person assistance with voting at the closest polling placethereby facing the threat of severe illness or death [during the pandemic]or staying home and foregoing the right to vote privately and independently (if third-party assistance is available), or the right to vote entirely (if it is not).

These cases have largely been brought in federal court, asserting violations of Title II of the Americans with Disabilities Act (ADA) or Section 504 of the Rehabilitation Act. Both claims center on the failure of states to offer reasonable accommodations to voters with disabilities in the provision of public services and federally funded programs. Plaintiffs assert the existence of a variety of logistically and financially feasible accommodations that would enable disabled voters to request, receive, complete and even return their absentee ballots electronically. For instance, Maryland has designed, implemented and made freely available to other states its ballot marking system that allows a disabled voter to receive and complete an online ballot. For voters who are blind or deaf-blind, electronic ballots permit the use of text-to-speech or braille translation software that obviates the need for assistance. In August, Pennsylvania implemented an online ballot tool, OmniBallot, which allows for the electronic delivery and marking of ballots via a link sent to eligible voters. Pennsylvania expanded accessibility after a state court ruled that its mail-in ballot process violated the ADA and Rehabilitation Act. After the ruling, the federal district court in a case challenging Pennsylvanias accessibility limitationsDrenth v. Boockvargranted defendants motion for summary judgment, agreeing with defendants argument that because a remote ballot marking system will be in place for the November 2020 general election and all future elections, there is no longer a case or controversy for the court to resolve. The court further granted defendants motion for summary judgment with respect to any claim arising from the return or submission of mailed ballots because Plaintiffs complaint did not raise such a claim.

Some plaintiffs have sought a different accommodation for blind voters: an electronic ballot delivery system that some states have created to comply with Uniformed and Overseas Citizens Absentee Voting Act (UOCAVA) obligations. Michigan, for example, voluntarily entered into a consent decree to make its UOCAVA PDF ballots available to blind voters for the states May primary election. Although Michigan does not currently permit the electronic transmission of completed ballots, voters with disabilities benefit from the increased technological accessibility to electronic ballots.

Conclusion

In recent months, voters have brought a wave of challenges to mail-in ballot submission deadlines and restrictions that they believe infringe on the publics right to vote. Plaintiffs have, thus far, seen largely negative results. Even where plaintiffs have won preliminary injunctions at the lower court level, the appellate courtsin both state and federal contextshave typically reversed rulings that would have extended ballot deadlines and relaxed limitations on voter assistance.

It remains to be seen whether additional rulings on vote-by-mail cases will be issued and implemented before November. As the coronavirus pandemic rages on, vote-by-mail will remain a crucial method of electoral participation, and voters are likely to continue to challenge state rules that they view as burdening their right to vote.

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Mail Voting Litigation in 2020, Part II: Submission of Mail-In Ballots - Lawfare

Chilly mornings in the forecast – Brownsville Herald

The cool front that arrived in the Valley brought with it chilly mornings and nice afternoons.

The National Weather Service in Brownsville says temperatures each morning for the rest of the week will range from the mid 40s to low 60s.

The afternoons will be sunny and cool with temperatures from the upper 60s to low 80s through Friday. The weekend calls for great weather lows in the upper 40s and highs in the mid 80s.

Forecasters say surface high pressure will build in the Valley and the northern ranchlands, so that is bringing the mostly cool and dry conditions across deep south Texas through the rest of the week and into the weekend.

Wednesday: Lows in the upper 40s, highs around 70; northwest winds 15 to 20 mph.Thursday: Lows in the lower 50s, highs in the upper 70s; north winds 10 to 15 mph.Friday: Lows in the lower 50s, highs in the upper 70sSaturday through Tuesday: Lows in the mid 50s, highs in the upper 70s.

On the coast, there is a moderate risk of rip currents on the beaches of South Padre Island and at Boca Chica Beach.

Diana Eva Maldonado is the Digital Editor for the Brownsville Herald, Valley Morning Star and Coastal Current. She can be reached at dmaldonado@valleystar.com or (956) 421-9872 or (956) 982-6618.

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Chilly mornings in the forecast - Brownsville Herald

Should the FDA Have Approved Remdesivir to Treat COVID-19 Patients? – Healthline

Last week, the Food and Drug Administration (FDA) approved the antiviral remdesivir as a treatment for COVID-19 in adults and children 12 years and older, paving the way for wider use of the drug.

Dr. Lanny Hsieh, clinical professor of infectious diseases at UCI Health, said the FDAs move is very exciting.

Putting together all of the scientific evidence we have on remdesivir to date, it remains the standard of care for hospitalized patients with COVID-19, she said. Ultimately, it is our patients who would benefit from this FDA approval.

However, research so far on remdesivir is mixed, and the drug is far from a cure for COVID-19.

In May, the FDA issued an emergency use authorization (EUA) for remdesivir, marketed in the United States under the brand name Veklury. This allowed the drug to be used to treat those with severe COVID-19.

The agency broadened the EUA in August to allow for its use on all hospitalized patients with COVID-19, regardless of how severe their illness.

President Trump took remdesivir along with several other treatments when he was hospitalized for COVID-19 in early October.

The FDA based its decision on three randomized controlled trials.

One study of 1,062 participants with mild, moderate, or severe COVID-19 was published earlier in October in the New England Journal of Medicine.

Results from this trial show that remdesivir reduced the length of hospital stay by about 5 days from 15 down to 10.

Patients taking remdesivir also had a lower chance of dying after 28 days 11.4 percent compared with 15.2 percent in patients receiving an inactive placebo.

This [study], along with other trials reviewed by the FDA, has led to remdesivirs approval, Hsieh said, who is the principal investigator on the remdesivir clinical trial at UCI Medical Center.

The two other trials reviewed by the FDA had similar results. One of these also showed that a 5-day course of remdesivir worked just as well as taking the drug for 10 days.

However, preliminary results from the World Health Organization (WHO) Solidarity trial of more than 11,000 participants found that remdesivir had little effect on how long they stayed in the hospital and no effect on death.

This study was published as a preprint on medRxiv and hasnt yet been peer-reviewed, so the results should be viewed with some caution. The WHO plans to publish it in the New England Journal of Medicine.

Given the results of the WHO study, Dr. Eric Topol, a professor of molecular medicine at the Scripps Research Translational Institute, questioned whether the FDA should have granted remdesivir a full approval.

How can Remdesivir get a full [FDA] approval when there are such mixed data? Not supportive of this decision at all, he wrote on Twitter. Does it work early? Does it work late? Does it work anytime? So much unresolved.

However, Hsieh said the WHOs study had several limitations, including not comparing remdesivirs effects to a placebo, and looking at several potential treatments in the same study.

Although interesting, Solidaritys findings do not take away from the results of [the NEJM trial], she said, which is a study that is conducted with the most scientific rigor to date.

Without a COVID-19 vaccine approved in the United States, doctors are anxious for an effective treatment for COVID-19. Remdesivirs approval finally gives them something to work with.

Given the limited arsenal of effective or even marginally effective treatments for COVID-19, and the fact that we dont have a fully curative therapy or a vaccine, it is good to have more options, said Dr. Matthew G. Heinz, a hospital physician and internist in Tucson, Arizona.

But he said remdesivir is still difficult to get in some parts of the country, especially in rural areas.

And its expensive. A 5-day course of treatment can cost $3,120 for people with private insurance, reports Vox.

Remdesivir is also not without risks. In some people, it can cause elevated liver enzymes, which could be a sign of liver damage. The most common side effect, though, is nausea.

In specific situations for certain patients, I do think [remdesivir] is reasonable to use, Heinz said, because it can inhibit viral replication if given at the right time point.

Remdesivir blocks the coronavirus from replicating, so it works best if given early.

Remdesivir is likely going to be more useful for stopping serious progression of the disease, Heinz said. But to give it to someone whos already critical getting intubated or who has already been intubated may not work.

The drug is less effective in later stages of severe COVID-19, when the damage is caused more by an overactive immune response than by the virus itself.

At this point, doctors turn to other treatments that target the immune system. One of these is the corticosteroid dexamethasone, which dampens the immune response and has been shown to reduce deaths from COVID-19.

Although remdesivir isnt completely effective against COVID-19, many doctors on the front line are glad to have it as an option.

Given that its not shown to have significant safety concerns, and at least one good study does show some benefit, it is reasonable to have remdesivir as an available treatment while we wait for better ones, Heinz said.

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Should the FDA Have Approved Remdesivir to Treat COVID-19 Patients? - Healthline

Ross Prize Ceremony and Webinar on the Genetics of Neurological Disorders – The New York Academy of Sciences

New York, October 26, 2020 The Ross Prizein Molecular Medicine will be awarded to Adrian R. Krainer, PhD, St. Giles Foundation Professor at Cold Spring Harbor Laboratory, in a virtual ceremony and webinar hosted by the New York Academy of Sciences, Feinstein Institutes for Medical Research, and the journal Molecular Medicine on October 30. The webinar will be held 1 PM to 4:50 PM EDT.

The Feinstein Institutes for Medical Research has selected Dr. Krainer as the eighth recipient of the Ross Prize, which is awarded annually through the Feinstein Institutes peer-reviewed, open-access journal, Molecular Medicine.

The Ross Prize recognizes Dr. Krainer for his pioneering work in introducing anti-sense therapy in clinical use, and for its successful application to spinal muscular atrophy (SMA). The Ross Prize includes a $50,000 award.

After a brief award presentation at the start of the October 30 webinar, Dr. Krainer will discuss his work. This will be followed by a session on topics in the genetics of neurological disorders. Speakers for this session will include: Edward M. Kaye, MD, Stoke Therapeutics; Michelle L. Hastings, PhD, Rosalind Franklin University of Medicine and Science; and Timothy Yu, MD, PhD, Boston Children's Hospital, Harvard Medical School. The webinar will be held 1 PM 4:50 PM EDT.

The Ross Prize is made possible by the generosity of Feinstein Institutes board members Robin and Jack Ross. The Ross Prize recognizes biomedical scientists whose discoveries have transformed the way medicine is practiced. The awardees are midcareer researchers who have made a significant impact in the understanding of human disease pathogenesis and/or treatment. Moreover, it is anticipated that they will continue to make profound advances in the general field of molecular medicine.

The Ross Prize is a worthy tribute to the significance and impact of the fundamental and applied research conducted by my lab and our collaborators, which culminated in a disease-modifying therapy for spinal muscular atrophy, Dr. Krainer said. I greatly admire the seven previous Prize recipients, so I am humbled to join this distinguished group of scientists and clinicians.

Dr Krainer is the eighthrecipient of the Ross Prizein Molecular Medicinebecause his discoveries are revolutionizing treatment of a devastating, crippling pediatric illness, saidKevin J. Tracey, MD, president and CEO of the Feinstein Institutes and editor emeritus ofMolecular Medicine.His work enables children with spinal muscular atrophy to crawl, walk, and live a full life.

Dr. Krainer explained his work in more detail:

"My labs research has a long-standing focus on understanding RNA splicing, a fundamental cellular process. In addition, we are interested in how alterations in this key step in gene expression cause or contribute to disease. This basic research eventually led us to the development of mechanism-based therapies. Our main goals are to continue gaining novel insights into RNA-splicing mechanisms and regulation, and to translate these findings into new drugs or clinically useful methods. These are important goals, because they differ from the traditional path for drug development, and so they have the potential to yield effective solutions to intractable medical problems."

In addition to studying the mechanisms of RNA splicing, Dr. Krainer uses multidisciplinary approaches to examine the ways in which they go awry in disease, and the means by which faulty splicing can be corrected. He co-developed the first FDA-approved therapy for the genetic disorder SMA an illness that has been the leading genetic cause of infant death based on the biological process of RNA splicing. This life-saving drug is also the first approved splicing-corrective therapy.

To learn more about the Ross Prize celebration and symposium, and to register for the event, please visit http://www.nyas.org/RossPrize2020.

Past recipients of the Ross Prize are: Daniel Kastner, MD, PhD, scientific director of the National Institutes of Healths (NIH) National Human Genome Research Institute (NHGRI); Huda Y. Zoghbi, MD, professor, Departments of Pediatrics, Molecular and Human Genetics, Neurology and Neuroscience at Baylor College of Medicine; Jeffrey V.Ravetch, MD, PhD,the Theresa and Eugene M. Lang Professor and head of the Leonard Wagner Laboratory of Molecular Genetics and Immunology at The Rockefeller University; Charles N.Serhan, PhD, DSc, director of the Center for Experimental Therapeutics and Reperfusion Injury at Brigham and Womens Hospital, the SimonGelmanProfessor ofAnaesthesiaat Harvard Medical School and professor at Harvard School of Dental Medicine; Lewis C.Cantley, PhD, the Meyer Director of the Sandra and Edward Meyer Cancer Center at Weill Cornell Medical College andNew York-Presbyterian Hospital; John J. OShea, MD, scientific director at the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); and Dan R. Littman, MD, PhD, the Helen L. and Martin S. Kimmel Professor of Molecular Immunology in theSkirballInstitute ofBiomolecularMedicine at New York University School of Medicine.

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Ross Prize Ceremony and Webinar on the Genetics of Neurological Disorders - The New York Academy of Sciences

UArizona researchers have breakthrough related to stomach cancer – Eastern Arizona Courier

TUCSON A promising new biomarker that appears in patients before stomach cancer develops may help with early detection of the disease and improve patient response to therapy, according to findings in a study led by University of Arizona Health Sciences researchers.

The biomarker can be detected through a simple blood test, saving time and lowering costs. Currently, stomach cancer diagnosis requires endoscopic collection of stomach tissue through a biopsy procedure, and then analysis by pathology.

Published in Gut, the journal of the British Society of Gastroenterology, the study was led by Juanita L. Merchant, MD, PhD, chief of the Division of Gastroenterology and Hepatology at the UArizona College of Medicine Tucson, a cancer biology program researcher at the UArizona Cancer Center and an elected member of the National Academy of Medicine.

See a video of how Drs. Juanita Merchant and Yana Zavros found a new biomarker to help diagnose stomach cancer.

The biomarker, MiR130b, is a microRNA or small non-coding RNA molecule that can play an important role in regulating gene expression, affecting disease development and progression. MiR130b can be produced by a group of immune cells called myeloid-derived suppressor cells (MDSCs), commonly associated with infections caused by Helicobacter pylori (H. pylori), a bacteria associated with ulcers. These particular cell types in the stomach correlate with early, preneoplastic changes (before a tumor develops) that can lead to gastric cancer long after an H. pylori infection has passed.

The study included collaboration with Yana Zavros, PhD, associate head for research in the College of Medicine Tucsons Department of Cellular and Molecular Medicine and the Cancer Centers shared resource director for Tissue Acquisition Cellular and Molecular Analysis.

Even though you get can get rid of the bacteria, oftentimes the infection itself already has initiated a cascade of events that inevitably may lead to cancer, Dr. Zavros said. That is why early detection is so important.

A Blood Test Instead of a Procedure

The study arose out of basic science mouse models that simulated changes in the stomach similar to that caused by H. pylori. This led the researchers to identify MiR130b in the mouse models, and they also detected the same microRNA in the plasma of human patients that either had precancerous changes or those that already had progressed to cancer.

This was a retrospective study, said Dr. Merchant, who is a member of the universitys BIO5 Institute. It is very exciting because now we can begin looking at this biomarker more prospectively in different patient populations.

Although less common in the United States, the National Cancer Institute reports gastric (stomach) cancer is the third most common cause of cancer-related deaths in the world. The findings, however, could have major implications for Arizonas rural areas and Hispanic and Native American populations, which are at greater risk for developing gastric and other gastrointestinal (GI) cancers, because these diseases often are caused by dietary and environmental factors and may go undetected for long periods.

Dr. Merchants lab has a sub-project in the Cancer Centers U54 grant (Partnership for Native American Cancer Prevention) to study detection of the microRNA described in the Gut paper in members of Native American populations with H. pylori.

This molecular signature (the microRNA MiR130b) that we discovered may help us see if patients have changes in their mucosa (the membrane that lines the stomach) related to having H. pylori, Dr. Merchant said. And a blood sample would be less invasive and then could be a way to make the decision whether we need to bring a patient in for an endoscopy.

Broader Implications for Treatment

Once diagnosed, gastric cancer can be difficult to treat. Immunotherapies with proven effectiveness in treating other types of cancer are not as successful against most GI cancers, including stomach cancer. The researchers believe these new findings in gastric cancer may help to address why other GI cancers also are resistant to therapy.

The underlying mechanism by which a patient may not respond well in gastric cancer may be applicable in other organs as well Dr. Zavros said. The way the cells interact with each other to render that patient resistant to therapy may be quite similar between gastric, pancreatic and colon cancers.

Dr. Merchant added: There may be dual-purposes. We can look at it as a biomarker to help us from a diagnostic perspective, but we also can look at therapies that can be developed based on what this microRNA itself is targeting.

Another project funded by the Cancer Centers Sparking Bench-to-Bedside Team Science Project award is building from results of this study to explore therapies for pancreatic and gastric cancer. The investigators are exploring the tumor microenvironment, in particular the immune cell MDSCs, referred to previously, that appears to dampen the chemotherapeutic response to immunotherapies.

The project relies heavily on Dr. Zavros BioDroid program, which develops miniature organs in the lab with a realistic microanatomy, also known as organoids. These are used in collaboration with the Tissue Acquisition Repository for Gastrointestinal and HEpaTic Systems (TARGHETS), created by Dr. Merchant. TARGHETS is a GI/Hepatology biorepository that collects samples from patients who undergo endoscopy.

Both Drs. Zavros and Merchant are looking to the BioDroid and TARGHETS efforts to reveal additional information that will allow them to develop new approaches to address resistance of gastric cancer to immunotherapies.

We want to find a way to reprogram the cancer cells or the immune cells within that patients tumor environment to make the patient more responsive to the therapy, Dr. Zavros said. A biomarker gives us a place to start.

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UArizona researchers have breakthrough related to stomach cancer - Eastern Arizona Courier

Aviceda Therapeutics Announces Formation of Scientific Advisory Board – BioSpace

Oct. 27, 2020 12:00 UTC

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Aviceda Therapeutics, a late-stage, pre-clinical biotech company focused on developing the next generation of immuno-modulators by harnessing the power of glycobiology to manipulate the innate immune system and chronic, non-resolving inflammation, is announcing the members of its Scientific Advisory Board who will help shape ongoing development efforts.

The Aviceda Scientific Advisory Board includes Pamela Stanley, PhD; Ajit Varki, MD; Christopher Scott, PhD; Geert-Jan Boons, PhD; Salem Chouaib, PhD; and Peng Wu, PhD.

Aviceda has assembled an extraordinary multi-disciplinary team of world-class scientists and renowned researchers to join our efforts in developing the next generation of glyco-immune therapeutics for the treatment of immune-dysfunction conditions, said Mohamed A. Genead, MD, Founder, CEO & President of Aviceda Therapeutics. Each individual offers a fresh perspective and unique strategic acumen that complements and strengthens the insights of our in-house leadership development team.

Prof. Scott, Aviceda Scientific Co-Founder, is Director of the Patrick G Johnston Centre for Cancer Research and Cell Biology at Queens University Belfast. He is internationally renowned for his work in development of novel approaches in the field of antibody and nanomedicine-based therapies for the treatment of cancer and other conditions. Prof. Scott has a background in both the pharmaceutical industry and academia and was a founding scientist of Fusion Antibodies Plc. Research in his laboratory is funded by agencies such as Medical Research Council, UK charities and various industrial sources. He also held a Royal Society Industrial Fellowship with GSK from 2012 to 2015 and won the Vice Chancellors Prize for Innovation in 2015 with his groups work on developing a novel Siglec targeting nanomedicine for the treatment of sepsis and other inflammatory conditions.

The novelty of Avicedas platform technology is its potential to affect immune responses associated with a wide range of disease states, many of which are currently unmet or underserved needs. I look forward to the continued development of Avicedas core technology and moving forward to clinical trials that will pave the way for truly disruptive therapeutic strategies to enter the clinic that will significantly impact and improve patients lives in the not-too-distant future, said Prof. Scott.

Avicedas Scientific advisory chairwoman, Prof. Stanley, is the Horace W. Goldsmith Foundation Chair; Professor, Department of Cell Biology; and Associate Director for Laboratory Research of the Albert Einstein Cancer Center, Albert Einstein College of Medicine, New York. She obtained a doctorate degree from the University of Melbourne, Australia, for studies of influenza virus, and was subsequently a postdoctoral fellow of the Medical Research Council of Canada in the laboratory of Louis Siminovitch, University of Toronto, where she studied somatic cell genetics. Prof. Stanleys laboratory is focused on identifying roles for mammalian glycans in development, cancer and Notch signaling. Among her many varied contributions, Prof. Stanleys laboratory has isolated a large panel of Chinese hamster ovary (CHO) glycosylation mutants; characterized them at the biochemical, structural and genetic levels; and used them to identify new aspects of glycan synthesis and functions. She serves on the editorial boards of Scientific Reports, Glycobiology and FASEB Bio Advances; she is an editor of the textbook Essentials of Glycobiology; and her laboratory is the recipient of grants from the National Institutes of Health. Prof. Stanley has received numerous awards, including a MERIT award from the National Institutes of Health, an American Cancer Society Faculty Research Award, the Karl Meyer Award from the Society for Glycobiology (2003) and the International Glycoconjugate Organization (IGO) Award (2003).

Working with Aviceda represents a unique opportunity to contribute to science at the cutting edge. Its pipeline contains a broad range of candidates that represents numerous first-in-class opportunities, said Prof. Stanley.

Prof. Varki is currently a distinguished professor of medicine and cellular and molecular medicine, Co-director of the Glycobiology Research and Training Center and Executive Co-director for the UCSD/Salk Center for Academic Research and Training in Anthropogeny at the University of California, San Diego; and an Adjunct Professor at the Salk Institute for Biological Studies. Dr. Varki is also the executive editor of the textbook Essentials of Glycobiology. He received basic training in physiology, medicine, biology and biochemistry at the Christian Medical College, Vellore, The University of Nebraska, and Washington University in St. Louis, as well as formal training and certification in internal medicine, hematology and oncology. Dr. Varki is the recipient of numerous awards and recognitions, including election to the American Academy of Arts and Sciences and the US National Academy of Medicine, a MERIT award from the National Institutes of Health, an American Cancer Society Faculty Research Award, the Karl Meyer Award from the Society for Glycobiology and the International Glycoconjugate Organization (IGO) Award (2007).

The Aviceda team is already building on the foundational work in the emerging field of glycobiology to develop potential therapeutics and interventional strategies. Their work could be critically important for growing the understanding of how glycobiology and glycochemistry are applicable to immunology, and more broadly, to the field of drug and therapeutic development, said Prof. Varki.

Prof. Boons is a Distinguished Professor in Biochemical Sciences at the Department of Chemistry and the Complex Carbohydrate Research Center (CCRC) of the University of Georgia (USA) and Professor and Chair of the Department of Medicinal and Biological Chemistry of Utrecht University (The Netherlands). Prof. Boons directs a research program focused on the synthesis and biological functions of carbohydrates and glycoconjugates. The diversity of topics to which his group has significantly contributed includes the development of new and better methods for synthesizing exceptionally complex carbohydrates and glycoconjugates. Highlights of his research include contributions to the understanding of immunological properties of complex oligosaccharides and glycoconjugates at the molecular level, which is being used in the development of three-component vaccine candidates for many types of epithelial cancer; development of convergent strategies for complex oligosaccharide assembly, which make it possible to synthesize large collections of compounds with a minimal effort for structure activity relationship studies; and creation of a next generation glycan microarray that can probe the importance of glycan complexity for biological recognition, which in turn led to identification of glycan ligands for various glycan binding proteins that are being further developed as glycomimetics for drug development for various diseases. Among others, Prof. Boons has received the Creativity in Carbohydrate Science Award by the European Carbohydrate Association (2003), the Horace Isbell Award by the American Chemical Society (ACS) (2004), the Roy L. Whistler International Award in Carbohydrate

Chemistry by the International Carbohydrate Organization (2014), the Hudson Award (2015) and the Cope Mid-Career Scholar Award from ACS (2016).

Aviceda is leading the field of glycoimmunology in exciting new directions. I look forward to working with the company as it pursues multiple lines of development efforts that will someday transform the way immune-inflammatory conditions are treated in the clinic, said Prof. Boons.

Prof. Chouaib is the Director of Research, Institute Gustave Roussy, Paris, where he is active in research in tumor biology. Previously, Prof. Chouaib worked at the French National Institute of Health and Biomedical Research (INSERM) where he led a research unit focused on the investigation of the functional cross talk between cytotoxic cells and tumor targets in the context of tumor microenvironment complexity and plasticity. His research was directed at the transfer of fundamental concepts in clinical application in the field of cancer vaccines and cancer immunotherapy. Prof. Chouaib is a member of the American Association of Immunologists, New York Academy of Sciences, French Society of Immunologists, International Cytokine Society, American Association for Cancer Research, International Society for Biological Therapy of Cancer and American Association of Biological Chemistry. He was awarded the cancer research prize of the French ligue against cancer in 1992 and in 2004 the presidential prize in biotechnology. He was awarded for translational research and scientific excellency by INSERM. His research has resulted in more than 310 scientific articles and several reviews in the field of human immunology, tumor biology and cancer immunotherapy; he has also been an editor for several textbooks.

Dr. Wu is an Associate Professor in the Department of Molecular Medicine at Scripps Research. The current research in the Wu laboratory integrates synthetic chemistry with glycobiology to explore the relevance of protein glycosylation in human disease and cancer immunotherapy. In 2018, Dr. Wu developed a platform to construct antibody-cell conjugates for cancer immunotherapy, which does not require genetic engineering. Previously, while working as a postdoctoral fellow in the group of Professor Carolyn R. Bertozzi at the University of California, Berkeley, Dr. Wu developed an aldehyde-tag (SMARTag) based technology for site-specific labeling of monoclonal antibodies, which served as the foundation for Redwood Biosciences Inc., a biotech company co-founded by Bertozzi. In 2014, Redwood Bioscience Inc. and the SMARTag Antibody-Drug Conjugate technology platform was acquired by Catalent Pharma Solutions.

About Aviceda Therapeutics

Founded in 2018 and based in Cambridge, Massachusetts, Aviceda Therapeutics is a late-stage, pre-clinical biotechnology company with a mission to develop the next generation of glyco-immune therapeutics (GITs) utilizing a proprietary technology platform to modulate the innate immune system and chronic, non-resolving inflammation. Aviceda has assembled a world-class, cross-disciplinary team of recognized scientists, clinicians and drug developers to tackle devastating ocular and systemic degenerative, fibrotic, oncologic and immuno-inflammatory diseases. At Aviceda, we exploit a unique family of receptors found expressed on all innate immune cells and their associated glycobiological interactions to develop transformative medicines. Combining the power of our biology with our innovative cell-based high-throughput screening platform and proprietary nanoparticle technology, we can modulate the innate immune response specifically and profoundly. Aviceda is developing a pipeline of GITs that are delivered via biodegradable nanoparticles and which safely and effectively target numerous immune-inflammatory conditions. Avicedas lead ophthalmic optimized nanoparticle, as an intravitreal formulation, AVD-104, is being developed to target various immune system responses that contribute to pathology associated with age-related macular degeneration (AMD).

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Aviceda Therapeutics Announces Formation of Scientific Advisory Board - BioSpace

Remdesivir approved by FDA to treat Covid-19, but the evidence is mixed – Vox.com

The Food and Drug Administration on Thursday gave its first full approval for a drug to treat Covid-19 to the antiviral remdesivir. But some researchers say the FDA is once again promoting a Covid-19 therapy based on shaky evidence.

Developed by Gilead Sciences and marketed under the brand name Veklury, remdesivir previously received emergency use authorization (EUA) from the FDA in May, which allowed it to be used to treat patients with severe Covid-19. In August, the FDA relaxed its guidelines to allow the drug to be used in less serious cases. President Donald Trump also took the drug as part of his treatment when he was diagnosed with Covid-19 earlier in October.

Full FDA approval promotes remdesivir to the standard of care for hospitalized patients, and other potential treatments for Covid-19 will now have to be compared to it during clinical research.

Todays approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the Covid-19 pandemic, FDA commissioner Stephen Hahn in a statement Thursday. The FDA based its decision on three randomized controlled trials. (The largest of those looked at 1,062 hospitalized patients.) The trials results showed that remdesivir reduced the length of hospital stays in some Covid-19 patients.

However, shortly before the approval was granted, a study from the World Health Organization announced preliminary results that found the drug had no effect on mortality and unlike the FDAs findings negligible effects on how long patients were in hospitals. The study, known as the Solidarity Trial, recruited almost 12,000 patients, making it the largest Covid-19 treatment study in the world thus far. Researchers say the findings should have given the FDA pause.

I think its really inappropriate to give this a full approval because the data dont support it, said Eric Topol, a professor of molecular medicine at the Scripps Research Translational Institute. What [the FDA] should have done instead of issuing the approval was put on the brakes.

Absent a vaccine, doctors are desperate for an effective treatment for Covid-19, and the FDAs approval of remdesivir finally gives them an option. In the United States, Covid-19 case counts are rising again, with states like Wisconsin opening field hospitals to deal with a looming surge.

But the approval of remdesivir has raised concerns, not only because of the results of the WHOs trial but also because it follows a number of questionable FDA authorizations for other Covid-19 therapies that appear to have been influenced by political pressure from the White House.

Now some researchers and doctors are concerned that remdesivir could not only be less effective than promised, but that its approval could also undermine other efforts to develop better Covid-19 therapies.

Remdesivir seems to be most effective relatively early on for hospitalized patients with severe Covid-19. To help beat back the illness, it interferes with how SARS-CoV-2, the virus that causes Covid-19, makes copies of itself. The virus uses genetic instructions in the form of RNA, written in a code made of molecules represented by the letters A, U, G, and C. The drug mimics the molecule represented by A, adenosine. The fake adenosine blocks the virus from copying itself but doesnt fool human cells. The result is the virus cant reproduce as much within a patients body.

The antiviral drug was originally developed to treat the Ebola virus, and it has received a hefty investment from the US government over almost two decades, as Ekaterina Cleary, lead data analyst and research associate at the Center for Integration of Science and Industry, wrote in a piece for Stat News:

Research from the Center for Integration of Science and Industry, with which I am affiliated, determined that between gathering knowledge behind remdesivirs chemical structure and molecular target, the NIH invested as much as $6.5 billion between 2000 and 2019.

Remdesivir treatment is not without risks. It has been shown to cause some side effects in some people, such as elevated liver enzymes, which could indicate liver damage. The drug can also trigger allergic reactions, resulting in fever, shortness of breath, wheezing, swelling, low blood oxygen, and changes in blood pressure.

For a patient with private insurance, the intravenous drug can cost $3,120 for a five-day course of treatment.

Antivirals like remdesivir are most effective early on during the progression of Covid-19, when most of the damage is being done by the virus itself. Its less effective in later stages, when the problem isnt just the virus. The severe manifestations of the disease are caused by an out-of-control immune response to the infection, said Angela Rasmussen, a virologist at the Columbia University Mailman School of Public Health.

If the immune system gets riled up, it can cause a lot more destruction than SARS-CoV-2 and require more-drastic interventions like intubation, at which point another approach is needed. Thats a big reason why corticosteroids like dexamethasone, which tamp down on the immune system, are the only drugs so far reliably demonstrated to actually reduce Covid-19 mortality.

But giving a patient steroids too early in an infection could prevent the immune system from mounting an effective response against SARS-CoV-2.

Coming up with an effective treatment regimen requires delicately balancing where a patient is in the course of their coronavirus infection and how severe their illness has become. But given how murky it is to identify an infection to begin with let alone confirming the diagnosis and starting the correct treatment during the appropriate window researchers have a hard time teasing out what interventions work best.

Thats why carefully controlled, large-scale clinical trials are so important. And with mixed results coming from the studies conducted to date, some scientists dont think the evidence for remdesivirs effectiveness is enough for the FDA to grant approval.

I was really surprised when I saw that news, Rasmussen said.

The FDA has already made some controversial decisions around Covid-19 drug treatments. The agency granted an EUA for the anti-malaria drug hydroxychloroquine in March, after Trump called it a game changer. The FDA revoked the EUA in June, saying hydroxychloroquine was unlikely to be effective and could cause lead to heart problems.

Then in August, the agency granted an EUA for convalescent plasma to treat Covid-19. But the National Institutes of Health said the evidence used by the FDA was insufficient.

There is more evidence that remdesivir works compared with that of convalescent plasma, but thats not saying much. Its not as weak as the case for plasma, but thats no standard. The case for plasma is nonexistent, said Jeremy Faust, attending physician in emergency medicine at Brigham and Womens Hospital in Boston and an instructor at Harvard Medical School. There is actually randomized controlled trial data that suggests [that] for a subset of patients, remdesivir can decrease hospital length of stay.

The strongest results in favor of remdesivir show that patients who received it had a median recovery time of 10 days, compared to 15 days for those who took the placebo. Its a significant effect, but its not huge, and its certainly not a cure for Covid-19, nor a way to guarantee fewer deaths.

Faust said one of his concerns with the FDAs remdesivir approval is a phenomenon known as indication creep, in which a treatment shown to work in only a limited set of circumstances gets prescribed to more and more people. The worry here is that remdesivir, which is approved only for Covid-19 patients over 12 years old who required hospitalization, could start being used in patients with milder Covid-19 illness, or in more severe cases past the point where it could be effective.

What will happen, I guarantee, is people will start to use the medication more than they need it, Faust said. Since the course of treatment is five days, it could also extend the length of hospital stays in patients who would otherwise be discharged earlier, saddling them with unnecessary costs.

Another concern is that the approval of remdesivir, especially with such mixed evidence for its effectiveness, could undermine further research.

Topol noted that with remdesivir now as the only fully approved drug, it becomes much more difficult to conduct studies on other therapies because they now have to be compared against remdesivir, the new standard treatment, as well as a a placebo.

That raises the cost and complexity of trials, delaying results. Such comparisons are worthwhile if the standard of care is effective, but it adds unnecessary complications if its not.

It also makes it harder to recruit people for subsequent clinical trials of the drug to better validate its effectiveness. People may be more reluctant to sign up for a trial where they could get a placebo when they know they could get the actual drug.

The biggest, most serious problem is that we wont get to the truth, Topol said.

Its worth noting that remdesivir could still be a viable treatment for Covid-19, but the evidence presented so far is contradictory and more investigation is needed to clarify its effectiveness. So why did the FDA go ahead with its approval, then?

Its hard to say, but Herschel Nachlis, a research assistant professor of government at Dartmouth College, suggested the approval might be a strategic move by the agency to deflect political pressure away from the all-important Covid-19 vaccination campaign. Trump has linked a vaccine to his election prospects and blamed the FDA for holding it back. The appearance that a Covid-19 vaccine was rushed to meet political needs could make people reluctant to get vaccinated, so regulators are keen to distance themselves from the 2020 election campaign.

If, in the short term, approving remdesivir gives the President a win and alleviates some pressure on the agency from the President about vaccines, that helps buy the FDA important time, Nachlis told Vox in an email. It might be another case, like convalescent plasma, of giving up some ground in a battle to put yourself in the position to be able to win the broader war.

Whether Nachliss hypothesis is correct isnt yet known. But what is clear is that the evidence on remdesivirs effectiveness appears to be mixed, which is why it would have been helpful for the FDA to have held a public advisory committee meeting to discuss the evidence, a step it typically takes for full pharmaceutical approvals.

Since it may be months before a vaccine for Covid-19 is available, treatments are still urgently needed and other approaches are being studied. Trump, for example, also underwent a course of an experimental monoclonal antibody therapy from the company Regeneron when he was treated for Covid-19. There are multiple clinical trials of these drugs underway, but now they have competition.

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Remdesivir approved by FDA to treat Covid-19, but the evidence is mixed - Vox.com

FDA Approves New FoundationOneLiquid CDx Companion Diagnostic Indications for Three Targeted Therapies That Treat Advanced Ovarian, Breast and…

FoundationOne Liquid CDx analyzes the largest genomic region of any FDA-approved comprehensive liquid biopsy test and was approved in August to provide tumor mutation profiling in accordance with professional guidelines for patients with any solid tumor. Concurrently, it was approved as a companion diagnostic for a poly (ADP-ribose) polymerase (PARP) inhibitor approved by the FDA for the treatment of metastatic castration-resistant prostate cancer patients with qualifying BRCA1/2 alterations, and for three first-line EGFR tyrosine kinase inhibitors (TKIs) for the treatment of non-small cell lung cancer patients.

FoundationOne Liquid CDx offers oncologists an important and minimally invasive tool to consider when making treatment decisions for their patients, regardless of the type of cancer they have, said Brian Alexander, M.D., M.P.H., chief medical officer at Foundation Medicine. These three additional companion diagnostic claims expand the tests clinical utility into breast and ovarian cancer, demonstrating our commitment to bringing precision medicine to more patients, and we plan to continue working with our biopharma partners to increase that reach.

Todays approval expands FoundationOne Liquid CDxs companion diagnostic indications to include the following targeted therapies:

PIK3CA is the most commonly mutated gene in HR+/HER2- breast cancer; approximately 40% of patients living with HR+/HER2- breast cancer have this mutation.1

An estimated one in four women with epithelial ovarian cancer have a mutation of the BRCA1 or BRCA2 gene.2

Using a blood sample, FoundationOne Liquid CDx analyzes over 300 cancer-related genes for genomic alterations. FoundationOne Liquid CDx results are delivered in an integrated report that identifies alterations matched to FDA-approved therapies. It also enables accelerated companion diagnostic development for biopharma companies developing precision therapeutics.

As a laboratory professional service which has not been reviewed or approved by the FDA, the FoundationOne Liquid CDx report delivers information about the genomic signatures microsatellite instability (MSI) and blood tumor mutational burden (bTMB), as well as single gene alterations, including NTRK fusions, to help inform the use of other therapies including immunotherapies. Also, as a laboratory professional service, the report provides relevant clinical trial information and includes interpretive content developed in accordance with professional guidelines in oncology for patients with any solid tumor.

About FoundationOne Liquid CDx

FoundationOne Liquid CDx is a qualitative next generation sequencing based in vitro diagnostic test for prescription use only that uses targeted high throughput hybridization-based capture technology to analyze 324 genes utilizing circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of advanced cancer patients. The test is FDA-approved to report short variants in over 300 genes and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies (listed in Table 1 of the Intended Use) in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Patients who are negative for companion diagnostic mutations should be reflexed to tumor tissue testing and mutation status confirmed using an FDA-approved tumor tissue test, if feasible. For the complete label, including companion diagnostic indications and complete risk information, please visit http://www.F1LCDxLabel.com.

About Foundation Medicine

Foundation Medicine is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient's unique cancer. The company offers a full suite of comprehensive genomic profiling assays to identify the molecular alterations in a patients cancer and match them with relevant targeted therapies, immunotherapies and clinical trials. Foundation Medicines molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in cancer. For more information, please visit http://www.FoundationMedicine.com or follow Foundation Medicine on Twitter (@FoundationATCG).

Foundation Medicine and FoundationOne are registered trademarks of Foundation Medicine, Inc.

PIQRAY is a registered trademark of Novartis AG.

RUBRACA is a registered trademark of Clovis Oncology, Inc.

ALECENSA is a registered trademark of Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.

Source: Foundation Medicine

1 The Cancer Genome Atlas Network. Comprehensive molecular portraits of human breast tumours. Nature. 2012;490(7418):61-70.2 Pennington et al, Clin Cancer Res. 2014; 20(3):764-7753 Dearden et al. Ann Oncol. 2013 Sep; 24(9): 23712376.

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FDA Approves New FoundationOneLiquid CDx Companion Diagnostic Indications for Three Targeted Therapies That Treat Advanced Ovarian, Breast and...

How Many Have Recovered From Covid-19 Cases? No One Knows. – msnNOW

Gabriela Bhaskar for The Wall Street Journal Coronavirus recoveries are undercounted in public-health statistics.

Health researchers collect various pieces of Covid-19 data to get a handle on the spread of the new coronavirus, but one metric has proven tough to pin down: how many infected people have recovered.

Among the 8.8 million coronavirus cases reported in the U.S. so far, some 3.5 million have recovered, according to Johns Hopkins University, which tracks the pandemic.

Yet the tally of recovered Covid-19 patients misses the mark, health experts say, while also failing to capture the many people who are struggling with lingering medical issues from their cases.

The data are so spotty, public-health authorities say they dont know what the true count is. The national figure displayed on trackers likely misses the true count by millions, estimates Ashish Jha, dean of the Brown University School of Public Health.

The spottiness stems from the absence of both an agreed-upon definition for a coronavirus recovery and a standardized way to track the numbers of patients, the health experts say. What constitutes recovery is so nebulous that some states dont even track it, and those that do probably undercount the true number.

Im not aware of anyone using the recovery figures, said Marcus Plescia, chief medical officer of the Association of State and Territorial Health Officials. Ive seen that data, and Ive not paid attention to them.

The lack of clarity means the popular picture of Covid-19s toll misses a datapoint indicating that most infected people have overcome the illness. And it highlights the challenges in assembling data that would help health authorities track the virus and help people fight it.

Like a lot of these issues with data reporting for Covid, theres really not a clear standard for how to do it, said Lauren Gardner, a Johns Hopkins University associate engineering professor who leads the team that built the schools widely cited Covid-19 dashboard.

Both the general public and many health professionals tend to consider patients recovered if they feel the way they did before they became ill. Yet many states define coronavirus recovery differently.

These states count a Covid-19 case as a recovery simply because time has passed since a person developed symptoms or was discharged from the hospital.

Michigan defines recovered cases as the number of people with a confirmed Covid-19 diagnosis who are alive 30 days after getting symptoms. Texas estimates recoveries under a complex formula that subtracts deaths and certain other cases, and assumes it takes 32 days for hospitalized patients to recover and 14 days for nonhospitalized patients.

Such measurements might indicate how many people who tested positive for the coronavirus didnt die, but might miss those who never displayed symptoms and didnt undergo testing.

The metrics also miss the viruss individual impact, according to health experts. While some patients bounce back quickly, others can struggle with side effects for weeks or even months.

There is a variable path after people get sick, said Eric Topol, a cardiologist and professor of molecular medicine at the Scripps Research Institute. There are people who are still ill months after they get sick. We know those symptoms can be very severe, and people can be debilitated.

Given the complexities, some states dont try to count how many have recovered from Covid-19.

The California Department of Public Health said assessing who is recovered is too subjective, and the persistence of side effects in a subset of Covid-19 patients known as long-haulers makes it hard to get a good count.

The Florida Department of Health also doesnt provide a specific recovery metric. It said relying on hospital discharges or estimating length of illness doesnt capture recovery.

Without data from every state and accurate figures from states reporting data, the recovery numbers given by Covid-19 trackers available online are useless for assessing how many people have recovered, said Jennifer Nuzzo, an epidemiologist and senior scholar at the Johns Hopkins Center for Health Security.

Dr. Nuzzo said she doesnt know what the true number of recovered patients is.

Covid-19 trackers get their recovery figures from states that are reporting the numbers. Alexis Madrigal, a founder of the widely cited Covid Tracking Project, said he has sometimes wanted to stop recording recoveries because of too much imprecision in what constitutes a recovery and in tallying them.

Most recovery definitions are not what they purport to be or what people expect, said Mr. Madrigal, who is also a staff writer at The Atlantic magazine.

Donna Bourne, of Shelby, Ohio, got sick and tested positive for Covid-19 in late March. Seven months later, she said, she still struggles with fatigue and severe shortness of breath climbing the stairs in her home. She uses her asthma inhaler every day, as opposed to once a week before getting Covid-19. She now also has an irregular heartbeat, recall problems and sometimes drools because the lower part of her face is partially paralyzed.

Despite her continued health issues, she fits the description of presumed recovered in Ohio, because she is still alive more than 21 days since she first developed symptoms.

Your body just does not recover from Covid the way it would from the flu, said Ms. Bourne, 55 years old, who was recently furloughed from her job assisting workers with disabilities. Its really, really hard on you.

Many state and local health departments ignore recovery tallies in gauging the progress of the pandemic.

Without a standard definition of Covid-19 recovery, there isnt a way to compare data between counties or cities, or to tell how well people living in these places are recovering, said Oscar Alleyne, chief of programs and services for the National Association of County and City Health Officials.

What health authorities could use is a figure capturing how people infected with Covid-19 are faring over time, Dr. Alleyne said. Armed with such data, public-health departments would be better equipped to write guidelines for treatment and allocate the resources that doctors and patients need, he said.

Write to Sarah Toy at sarah.toy@wsj.com

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How Many Have Recovered From Covid-19 Cases? No One Knows. - msnNOW

COVID-19 in the continent’s children: UK award supports new research – University of Cape Town News

Professor Heather Zar, the chair of the Department of Paediatrics and Child Health and the director of the South African Medical Research Council Unit on Child and Adolescent Health at the University of Cape Towns(UCT) Faculty of Health Sciences, is spearheading a research project that is one of 12 globally to receive a recent COVID-19 grant.

The National Institute for Health Research / United Kingdom Research and Innovation Global Effort on COVID-19(NIHR/UKRI GECO) grant is a collaborative funding opportunity. Under Professor Zar as the project leader, the study will offer a unique opportunity to understand the determinants of severe acute respiratory syndrome coronavirus2(SARS-CoV-2) infection and coronavirus disease(COVID-19) in children in Africa in a low-middle-income country(LMIC) context. The award will enable Zar and her team to undertake a study titled Spectrum, determinants and long-term outcome of SARS-CoV-2 infection and disease in African children.

The reasons children typically develop mild illness or have asymptomatic infection are poorly understood. In LMICs, where children make up a large proportion of the population, risk factors such as malnutrition, HIV exposure, tuberculosis or prior infection with endemic coronaviruses may have an impact on the risk of infection and development of COVID-19.

This project aims to investigate the spectrum of illness in African children, the risk factors for infection or disease, and the immune or inflammatory factors protecting children against SARS-CoV-2 infection or severe COVID-19 disease.

Zar is collaborating with partners at the universities of Western Australia and Southampton in the United Kingdom for this research.

COVID-19 infection in African children

This funding provides a wonderful opportunity to better understand COVID-19 in African children in an LMIC context, she said.

This is particularly relevant because of the high burden of pneumonia, which continues to be the major single killer of children under five years of age, due to factors such as malnutrition, smoke exposure and the high burden of infectious disease in these settings.

Understanding why children are only mildly affected may be key to developing new strategies to prevent or ameliorate illness.

However, this hasnt occurred with COVID-19, said Zar, who is an affiliate member of the Institute of Infectious Disease and Molecular Medicine(IDM) at UCT. Surprisingly, children in LMICs and globally are predominantly only mildly affected by COVID-19, with relatively few severe cases or deaths occurring in young children. The current project will investigate whether prior infection with other organisms (including seasonal coronaviruses) protects children against severe disease through development of immunity.

Understanding why children are only mildly affected may be key to developing new strategies to prevent or ameliorate illness, said Zar.

Drakenstein Child Health Study

Whitney Barnett, the projects programme manager, said that this funding will offer researchers the additional focus of investigating COVID-19 across different settings, ranging from communities to hospitals. SARS-CoV-2 infection will be investigated in children who are hospitalised with pneumonia as well as in children who are part of the population-based Drakenstein Child Health Study(DCHS), anovel African birth cohort study, which is led by Zar.

The DCHS has comprehensively investigated the early-life determinants of child health, and developmental pathways to health or disease from pregnancy through childhood so it provides a unique platform to study COVID-19 in children, and the impact of the pandemic on child health.

It is especially important to be able to do this study here because children make up a high proportion of the population.

The DCHS also bridges the intersection of infectious diseases and the emergence of non-communicable diseases, Zar said.

It is especially important to be able to do this study here because children make up a high proportion of the population, and risk factors such as malnutrition, pollution, poverty and a high burden of infections may contribute to their vulnerability to developing illness.

She added that the context of the DCHS offers further understanding of COVID-19-related childhood illness, including the protective or risk factors for infection or disease that have been carefully measured from the antenatal period through childhood, and the role of inflammation.

As a child health specialist in respiratory illness, Zar said that this will inform future research and healthcare approaches and provide a unique opportunity to generate new knowledge, identify risk factors for illness and develop novel strategies for prevention and treatment.

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COVID-19 in the continent's children: UK award supports new research - University of Cape Town News

FoundationOneCDx Receives FDA-Approval as a Companion Diagnostic for VITRAKVI(larotrectinib) to Identify Patients with NTRK Fusions Across All Solid…

Foundation Medicine, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOneCDx to be used as a companion diagnostic for VITRAKVI (larotrectinib), which is currently FDA-approved for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. FoundationOne CDx, the only FDA-approved tissue-based comprehensive genomic profiling (CGP) test, is now approved to detect NTRK1/2/3 fusions across all solid tumor types and identify patients who may be appropriate for treatment with VITRAKVI.

NTRK fusion positive cancer occurs when a piece of the chromosome containing the NTRK gene breaks off and binds to another chromosome. These NTRK gene fusions produce TRK fusion proteins, which may cause cancer cells to grow.1 NTRK fusions are more commonly found in rare cancer types, such as secretory carcinoma of the breast or salivary gland and infantile fibrosarcoma, but they can also occur across many more common cancer types including glioma, melanoma and carcinomas of the lung, thyroid and colon.2

"Taking a comprehensive and validated approach to genomic testing is critical for all advanced cancer patients, but especially for those harboring rare mutations that can be missed with alternative testing methods," said Brian Alexander, M.D., M.P.H., chief medical officer at Foundation Medicine. "Not only will this approval improve access to genomic testing and reinforce the role it plays in rare cancers, but it also confirms the incredible progress made toward tumor-agnostic cancer care. We're proud of the impact this will have on NTRK fusion positive cancer patients."

FoundationOne CDx is the first FDA-approved broad companion diagnostic that is clinically and analytically validated for solid tumors. The tissue-based comprehensive genomic profiling test is currently approved as a companion diagnostic for more than 20 targeted therapies.

"Many patients with rare conditions, like NTRK fusion positive cancer have limited treatment options and poor access to targeted therapies," said Susan Spinosa, co-chair and patient founder of the NTRKers. "This companion diagnostic approval is a critical step forward in addressing this challenge as it provides this patient population with broader access to comprehensive genomic testing and appropriate treatment options."

The approval of VITRAKVI was based on data from three multicenter, open-label, single-arm clinical trials: LOXO-TRK-14001 (NCT02122913), SCOUT (NCT02637687), and NAVIGATE (NCT02576431). Identification of positive NTRK gene fusion status was prospectively determined in local laboratories using next generation sequencing (NGS) or fluorescence in situ hybridization (FISH). NTRK gene fusions were inferred in three pediatric patients with infantile fibrosarcoma who had a documented ETV6 translocation by FISH. The major efficacy outcome measures were overall response rate (ORR) and response duration, as determined by a blinded independent review committee according to RECIST 1.1. The clinical validation to support the FoundationOne CDx NTRK companion diagnostic approval was then achieved through a clinical bridging study between the local clinical trial assays and FoundationOne CDx.

About FoundationOne CDx

FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens. FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit http://www.foundationmedicine.com/genomic-testing/foundation-one-cdx.

About Foundation Medicine

Foundation Medicine is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient's unique cancer. The company offers a full suite of comprehensive genomic profiling assays to identify the molecular alterations in a patient's cancer and match them with relevant targeted therapies, immunotherapies and clinical trials. Foundation Medicine's molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in cancer. For more information, please visit http://www.FoundationMedicine.com or follow Foundation Medicine on Twitter (@FoundationATCG).

Foundation Medicine and FoundationOne are registered trademarks of Foundation Medicine, Inc.

Vitrakvi is a registered trademark of Bayer

Source: Foundation Medicine

1 National Cancer Institute. "NTRK Gene Fusion." https://www.cancer.gov/publications/dictionaries/cancer-terms/def/ntrk-gene-fusion

2 "Annals of Oncology. "Identifying patients with NTRK fusion cancer" https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6859817/

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FoundationOneCDx Receives FDA-Approval as a Companion Diagnostic for VITRAKVI(larotrectinib) to Identify Patients with NTRK Fusions Across All Solid...

SAIS students from around the world travel to Italy for in-person instruction – The Hub at Johns Hopkins

ByMike Broida

As the coronavirus pandemic has forced many schools and universities around the world, including Johns Hopkins, to conduct classes remotely, one Johns Hopkins campus has opened its doors to students and faculty this fall: SAIS Europe, the School of Advanced International Studies' campus in Bologna, Italy.

One of two overseas SAIS campuses, SAIS Europe has the distinction of not only being the sole Johns Hopkins division holding in-person instruction this semester, but also hosting students from the school's Washington, D.C., and Nanjing campuses as well.

"Our students, faculty, and staff are happy to be here," says Michael Plummer, director of SAIS Europe and a professor of international economics. "We're all very grateful to have an in-person experienceand after last spring it's not one we're taking for granted."

Last spring, Italy was one of the countries hardest hit by the COVID-19 pandemic. In March, as the country locked down to limit the spread of the virus, SAIS Europe swiftly switched to online instruction for the rest of the semester.

With the pivot to remote instruction, many students returned to their home countries, with some choosing to remain in Bologna. In May, after the end of the semester, SAIS Europe worked with school and university leaders to plan for a safe reopening in the fall. Over the summer, SAIS Europe transformed the Bologna Center to reflect best health and safety practices due to COVID-19 and to upgrade its existing remote learning infrastructure to accommodate students who were unable to take classes in person.

As the fall semester approached, another issue became a greater concern for the SAIS Europe staff: securing visas for international students. Administrators worked with incoming students from around the world to help them navigate the new and uncertain visa requirements due to the coronavirus pandemic. But as the visa scenario gradually became clearer for SAIS Europe, the same was not the case for SAIS' other overseas campus, the HopkinsNanjing Center.

Though coronavirus infections remained relatively low in China, HNC faculty and staff soon realized that many international studentsincluding Americanswould not be able to attain visas to enter the country. As HNC moved toward a remote fall semester, faculty and staff were conscious of a significant number of students who still wanted an in-person academic experience.

Image caption: A student works in the library at SAIS Bologna, where social distancing measures have been put in place to protect students, faculty, and staff

Image credit: Anna Fantuzzi / Johns Hopkins University

"In July, we started asking the question of whether we could be 'in exile' away from Nanjing," says Adam Webb, American co-director of the HNC and resident professor of political science. "Before COVID, we'd talked generally about fostering some type of exchange with our sister campuses in D.C. and Bologna, but once it was clear that we weren't going to open in person in Nanjing, we worked with SAIS Europe and leaders at SAIS to set a plan in motion."

In August, when SAIS Europe began its fall semester, it not only welcomed its own students but also 19 HNC students and 5 HNC faculty members, who joined "in exile" for the fall semester after quarantining for two weeks. In addition, SAIS Europe was also able to welcome 16 students who had planned to start their academic year in Washington. Students that are "in exile" take most of their classes remotely through their home campus, though they are able to make full use of the Bologna Center's resources this semester, including taking one or two courses from the SAIS Europe curriculum.

"We were planning on having a full house this fall," Plummer says. "And we certainly do have one nowjust not quite how we expected."

Michael Plummer

Director, SAIS Europe

In response to this unanticipated hybrid community, students and faculty are hoping to take advantage of the opportunity to forge new collaborations, relationships, and learning opportunities, while also maintaining health and safety measures. This semester, registration at SAIS has been expanded to allow students from HNC, SAIS Europe, or Washington to register for at least one class listed at another campus. HNC faculty are also planning to hold events in both Mandarin and English for students at the Bologna Center, some of which will also have online participation.

For SAIS, the integration at SAIS Europe this fall is emblematic of a future marked by greater collaboration and exchange among its three campuses. Plans are already underway to ensure that these continent-spanning partnerships remain in place beyond this semester.

"The coronavirus pandemic struck while SAIS was already in a time of major transformation," says SAIS Dean Eliot Cohen. "I couldn't be prouder of the way our team pulled together to unsnarl all the complications involved with having HNC and D.C. students taking classes in Bologna. Johns Hopkins is a place that really fosters this ability to make something good come out of awful circumstances. Folks here are always asking how can we use this moment to make ourselves better? This is a great example of that."

One of the HNC students "in exile" this fall is Nick Kaufman, who was previously a Fulbright grantee in the Chinese province of Anhui. When it was clear that HNC classes would be online, with a special option to temporarily join SAIS Europe in Bologna, Kaufman immediately warmed to the idea of starting his year in Italy. He was also excited by the opportunity to see China from a new, unconsidered perspective.

"At times, China studies can feel like tunnel vision, and very focused on China and the U.S.," he says. "Coming to SAIS Europe has been a great way to see how China interacts with Italy and Europe, and the way Europe interacts with China. It's a good opportunity to see China writ large, and I'm already learning a lot about how the EU relates to China. It's a unique perspective I wouldn't have received anywhere else."

Image caption: Natalie Smith

Image credit: Anna Fantuzzi / Johns Hopkins University

Joining Kaufman at SAIS Europe is Natalie Smith, a second-year SAIS master's student who spent her first year in Bologna. After the SAIS campus in Washington turned to remote instruction in August, Smith reached out about returning to Bologna for the fall semester, adding in-person instruction at SAIS Europe to the classes she was taking remotely.

"I'm a hands-on, interactive learner, and for me so much of the draw of SAIS and SAIS Europe has been the in-person engagementespecially in my coursework," Smith says. "I wasn't sure I would get as much out of my SAIS experience from taking classes online. I'm really grateful for the way SAIS and SAIS Europe has gone above and beyond to make in-person instruction happen and also to welcome in so many HNC or D.C. students to Bologna."

While classes are in session at SAIS Europe, many of the hallmarks and traditions of past years in Bologna look radically differentfrom classrooms rearranged to allow for social distancing to much more limited offerings at the on-campus caf. Some changes, however, represent a more permanent change, like new smartboards and cameras that have helped improve remote instruction. Despite the challenges and setbacks from the coronavirus pandemic, for SAIS, the potential for greater collaboration, both in person and online, is only just beginning.

"We are currently facing a world in extraordinary turmoil from a number of serious issues, not just the coronavirus," Cohen says. "There isand will bea tremendous need in every sector for the skills that our graduates possess. SAIS will be one of the institutions adapting to meet this need as we add more opportunities for students to learn in a time and mode that works for them. Even in this challenging moment, it's exciting to see this potential come to fruition."

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SAIS students from around the world travel to Italy for in-person instruction - The Hub at Johns Hopkins

New World, New Duties: Creating Tomorrows Travel, Today – Worth

When confidence reemerges, and travel comes back to a life we recognize, and incontrovertibly it shall, the full experienceincluding travel safetywill be viewed through a different prism.

The best business partnerships are those that have a shared mission and vision at the heart of it all. GeoSures partnership with the travel community is connected to the soul of what motivates online travel agencies (OTAs), travel management companies (TMCs), travel managers, industry platforms, destination marketers and others in our ecosystemwhich is a calling to help people find and afford opportunities to expand their personal horizons.

We are all driven by a fundamental urge to experience diverse places and cultures and make more of the world our own. GeoSure shares that goal, and our role in this mission is one we take seriously.

This goal of widened experiences extends broadly and powerfully, which is why a statement by Kim Albrecht earlier this year was so meaningful. As the visionary CMO of SAP Concur, Albrecht recognizes that the power of new technologies designed for women and LGBTQ+ travel safety is necessary and long overdue. She wrote: In 2020, these kinds of features wont be considered added; they will become an expected and common part of the traveler experience.

Just a year before that statement, Albrecht articulated an enlightened vision for the role of safety in the wider realm of corporate responsibility, predicting: safety will go hand-in-hand with employee satisfactionand female traveler safety, in particular, will rise to the top of corporate agendas.

The prescience of leaders like Albrecht, as well as trendsetting organizations, is even more consequential in todays world. The pandemic, and the consequent economic shockwaves it created, has inspired a searchat the highest levels of global corporate leadershipto identify new ways to engender trust and reassurance, improving both the leisure and business travel experience.

I have continually been impressed by the way that leaders have embraced new and more expansive obligations to their stakeholders in the wake of COVID-19. They have recognized that there is an unprecedented need for investment in the science and technology that can lead to a new culture of safety. The travel ecosystem has conceptualized and launched new ways to tackle the current insatiable demands for timely information as the world has become increasingly unpredictable. This data appetite is for usable and actionable statistics relating to the current spread, pervasiveness and manifestations of the coronavirus on the most localized levels possible.

These investments in travel safety correspond with what we have seen in the health care industry, including pharma, as unprecedented resources and efforts have been unleashed to treat COVID-19 and develop vaccines.

In short, there are many ways to address the existential challenges of this virus.

As noted above, the healthiest business partnerships emerge from common brand roots and shared values. We launched GeoSure into the world seven years ago, with a mission to open global horizons in parallel with what travel actors and others were focused on.

Long before COVID, we built a platform designed to use artificial intelligence, machine learning and the latest in information technology to capture and distribute travel safety insights in the form of proprietary GeoSafeScores. These scores are a confidence-driving set of metrics that benefit everyone in our industry.

The nature of society and our world has changed, and as a result, companies of all sizes are rethinking their obligations through a new lens. This widening of responsibility does not have a single source. Its predicated on a confluence of circumstances that call for new safety transparency and standards: the extraordinary data demands of COVID-19 transmission; societal demands for greater diversity, equality and inclusion; and awakening of the need to give the LGBTQ+community and other at-risk groups tools to help them stay safe.

We call that a #newdutyofcare.

Conventional duty of care was previously limited to a narrow scope of the risks of physical harm pertaining to business travelers on the road, those whom had access to precautions and risk mitigation measures provided through their employers.

The #newdutyofcare goes far beyond those responsibilities. It now includes the use of innovative technology to assure employee and associate well-being, confidence and empowerment across multiple dimensions of travel, including the safety and security of women and members of at-risk groups.

GeoSures vision of the #newdutyofcare for business travel has further widened the aperture to include leisure travelers.

As many of us now work from home, the lines between our business and personal lives have forever blurred. Corporations are recognizing they need be attentive to, and supportive of, the entirety of their employees lives, including areas that were outside the roles that employers traditionally played.

Self-care and respect for individual and family wellness are essential parts of a full and healthy life. Companies are starting to pay for stress-reduction and mindfulness programs, expanded child care and other enlightened programs that were unheard of just a few years ago.

We see the implications of those changes in the world of travel as an expansion of the traditional corporate duty of care to a new duty of self-caremaking safety a part of not just business and leisure travel, but indeed everyday life in ones own community.

Imagine searching for a hotel or destination, filtered by characteristics such as whether you are a solo female traveler, whether you are Black, white, Latinx, Caucasian or of Asian descent, straight, gay, transgender or otherwise. Imagine specific searches for your journey, and relevant safety results, as a function of your preferences and personal experience, returned by location. You select accordant safetyyou now have agency, youre in control. Not the other way around.

There is no doubt how empowering that experience would be. Contemplate how much travel will be boosted based on the self-confidence and trust that can be surfaced and made easily accessible. For everyone, anywhere. And thats only one element of GeoSures vision of the future of travel. And as Albrecht added, there is more to come. Much more, especially looking at enhanced individualization.

When confidence reemerges, and travel comes back to a life we recognize, and incontrovertibly it shall, the full experienceincluding travel safetywill be viewed through a different prism. Risk management and active travel safety will become embedded across the entire planning and booking process, along with the users itinerary, and perhaps even after we return home. Rich capabilities will be developed, costs will decline dramatically, usage will spike and organizations will deliver the most expansive definition of travel safety possible.

Fueled by this new dimension of expanded safety, paired with intelligent technologies, travel will arise stronger and smarter than ever before. The heretofore $8+ trillion global industry juggernaut will reach new economic heights and traveler fulfillment.

Our partners across the travel ecosystem will join us in reopening the world to joyful and unencumbered participation.

Together with destinations, organizations, travel platforms and communities, the shared missions of GeoSure and our partners will forever change the travel experience and well-being of the world, for the bettera safer, more predictableworld indeed.

Michael Becker is the cofounder ofGeoSure, a data science startup which aggregates thousands of data sources and signals through its proprietary predictive analytics and risk modeling platform.

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New World, New Duties: Creating Tomorrows Travel, Today - Worth

These destinations were overwhelmed by tourists. Here’s how they’re doing now – CNN

(CNN) Overtourism was the travel buzzword of 2019, as destinations around the globe, from the hiking trails of Machu Picchu to the canals of Venice, battled the impact of throngs of visitors.

Amid all the planning, predicting and projecting, there's one thing these destinations couldn't envisage: the travel industry grinding to a screeching halt as Covid-19 spread across the world.

Travel bans, quarantines and nationwide lockdowns have forced most travelers to stay home, and destinations that previously struggled with too many tourists have been left reeling.

Dubrovnik, Croatia

Tourists in Dubrovnik in July 2020.

IVAN VUKOVIC/AFP via Getty Images

A sea of terracotta red roofs, a fortress-like Old Town and an association with one of the most popular TV series of the 2010s led the Croatian city of Dubrovnik to witness a surge in tourism numbers in recent years.

Alongside travelers who flew in for long weekends, Dubrovnik also saw footfall from thousands of cruise ship passengers who disembarked for the day, flooding the city's Old Town and leaving by nightfall.

Over the past couple of years, mayor Mato Frankovi and other city officials vowed to get the situation under control, as the city featured in "Game of Thrones" became increasingly packed.

New regulations came into place in 2019 to restrict the number of cruise ships in the city's old port to just two at a time, the result of a partnership with the Cruise Line International Association (CLIA).

As 2020 began, officials questioned whether such new rules would make an impact.

Then in March, the pandemic hit Europe. Croatia closed its borders and the tourists stopped coming.

When Dubrovnik left lockdown in early summer and tourism tentatively restarted, the tourists returning to Dubrovnik were mostly Croatians on staycations. It wasn't until flights started up again in the summer that international visitors began to return.

But it wasn't to last -- Covid numbers began to rise again and tourism declined once more.

"The UK put us on the red list, and then it went all down again. The airlines just one by one cut the number of flights," Dubrovnik's deputy mayor Jelka Tepi tells CNN Travel. "Without flights and without the UK market, Dubrovnik has very low tourist figures."

"The atmosphere this summer is the atmosphere like in the 90s, when the war was going on, only the grenades were not flying all over our heads," he tells CNN Travel.

The city may have grown from the ashes of war into a thriving tourism destination -- perhaps too thriving, in many locals' eyes -- but now the question is whether it can use the catastrophe of Covid-19 as a chance to reset.

Ivan Vukovic, Dubrovnik tour guide

Tepi says the cruise rules -- and Dubrovnik's other overtourism restrictions -- will not be relaxed when international flights recommence and the city encourages visitors to return.

Dubrovnik wants to make it clear to future visitors that the city takes both overtourism -- and the virus -- seriously.

"At the entrance of the Old City, we have a big banner warning people to wear masks, to keep distance, to wash hands, use the sanitizers etc. and beside those rules, we have the Respect the City program rules as well," says Tepi.

Unlike most European destinations, Croatia is permitting Americans to visit -- as long as they present a negative Covid-19 PCR test that's no older than 48 hours. A lack of flights makes this difficult for the average American to take advantage of, but some elite travelers with access to private jets are making the most of it.

Luxury tourism, says Tepi, is something the city will continue to focus on going forward.

That said, city officials and those in the private sector are keen for all kinds of visitors to return -- they just want a more sustainable, focused future.

The aim, says tour guide Vukovic, isn't a return to overtourism -- it's "some kind of 'normal' tourism, if possible."

Barcelona, Spain

A Barcelona restaurant sits empty on July 27, 2020.

Cesc Maymo/Getty Images Europe/Getty Images

The Catalan city of Barcelona, with its soaring Gaudi spires, sandy beach and al fresco bars, has been a tourism hotspot since the 1992 Olympic diving competition showcased the city's beauty to international audiences.

Today, tourism generates between 12 to 14% of the city's GDP and 9% of overall employment, says Xavier Marc, Barcelona City Council's councilor for Tourism and Creative Industries.

But in recent years, city officials and locals, worn down by overtourism, have started re-examining this reliance on holiday business.

The pandemic has served to further reinforce the importance of creating spaces in the city center that can be enjoyed by locals as well as tourists, Marc tells CNN Travel.

The restaurants and businesses in Barcelona's Ciutat Vella have been disproportionately impacted by the pandemic, he explains.

Prior to Covid-19, Barcelona had introduced a series of measures designed to combat some of the throes of overtourism.

The city clamped down on vacation rentals, introduced a tourism tax and encouraged travelers to visit neighborhoods outside the overcrowded old town.

Marc says Barcelona will "maintain its firmness intact" when it comes to these management strategies.

There are no plans to change the way the city clamps down on illegal rentals or tourist behavior -- "although logically, the decrease in activity has led to a reduction in incidents in these areas," adds the councilor.

Following the end of its strict lockdown, Barcelona only had a brief window in which international travelers could easily visit, before Spain found itself on other countries' quarantine lists.

By September, international tourism was down by 77%.

Today, the city, like others in Europe, is struggling to quash a fresh surge of Covid-19 cases, and a nighttime curfew is in place to try to stop rising figures.

Marc says he isn't worried about tourism failing to recover in the future, but he emphasizes the importance of avoiding the pitfalls of the past.

Machu Picchu, Peru

Machu Picchu has been largely off limits to visitors since the beginning of the pandemic.

PERCY HURTADO/AFP via Getty Images

The famous Inca citadel of Machu Picchu is atop many travelers' bucket lists, thanks to those soaring views of archaeological wonders framed by verdant mountains.

But for much of 2020, Peru's most famous landmark was out of bounds.

The South American country went into a strict lockdown on March 15, which lasted through June.

In the summer, it was announced that Machu Picchu would open to domestic tourism, but this failed to materialize as Covid cases in Peru rose.

Sarah Miginiac, general manager for South America at adventure company G Adventures, who lives in Peru, tells CNN Travel that tourism operators have been working closely with Peru's Ministry of Culture and the Ministry of Environment to establish new protocols to keep visitors to Machu Picchu Covid-secure -- and ensure tourist numbers remain under control.

Since then, tourists must pre-book tickets that are valid for up to four hours. Under this system 5,000 people can complete the trek per day.

When Machu Picchu reopens, this number will be cut further in order to ensure social distancing.

"The new rule is that there's going to be only 75 persons allowed in Machu Picchu at a time," says Miginiac. "The size of the group is going to be a maximum of seven people, plus a guide -- we're going from over 5,000 to only 675 per day."

Ensuring travelers return to Machu Picchu in a more sustainable way is also key, with Miginiac suggesting that the current restrictions on visitor numbers could provide an opportunity to promote other beautiful, lesser known destinations within Peru.

Venice, Italy

A couple takes a selfie in Venice's normally bustling St. Mark's Square on October 3, 2020.

MIGUEL MEDINA/AFP/AFP via Getty Images

A visit to the Italian city has long been a popular city break, but as tourist numbers have soared over the past decade, locals have increasingly fought back -- protesting the cruise ships in the city's lagoon and vocalizing worries that Venice could become a theme-park-version of itself.

Various regulations and new rules designed to handle the influx of visitors have been introduced over the years -- including bans on new hotels and city center fast food spots. A steep access fee for day-trippers on popular dates was set to launch in July 2020, but ultimately postponed.

On top of its overtourism woes, last year the Italian city battled catastrophic floods.

Northern Italy became one of the first European regions to feel the brunt of Covid-19 in late February.

Venice went into lockdown and so began months with no tourists.

When international borders reopened in the summer, visitor numbers were nowhere near comparable to previous years.

For some locals, it was the bizarre culmination of what they'd been dreaming of for years -- just in terrible circumstances.

Jane da Mosto, Venice resident

"Everyday life is a lot more pleasant without the congestion created by the crowds of tourists that came in large groups," says Venetian Jane da Mosto, co-founder and executive director at We Are Here Venice, a non-profit association that's been campaigning for several years to reclaim Venice for locals.

As in Dubrovnik, cruise ships became a moot point as the industry shut down.

Pre-Covid, an estimated 32,000 cruise ship passengers visited Venice per day and many campaigners were actively discussing their impact on the city.

Fewer tourists means "the beauty of the city, it's architecture, water and views is much more evident," da Mosto tells CNN Travel.

"But it has come at an enormous cost - a lot of people are out of work, shops aren't selling much and the cultural sector has been drastically affected," she adds.

Expert view: Tourism will bounce back

A woman walks along Kuta Beach on the Indonesian resort island of Bali on August 15, 2020.

SONNY TUMBELAKA/AFP/AFP via Getty Images

Many other destinations around the word -- from historic cities like Amsterdam and Prague to beauty spots like Thailand's Maya Bay and the beaches of Bali, Indonesia -- have also suffered the consequences of too many tourists in recent years.

Now, they too are suffering the consequences of a lack of visitors.

And while overtourism might have wreaked havoc on destinations, the phenomenon also followed some predictable patterns: a destination became popular, people flocked there, the destination struggled to cope, solutions -- some effective, some less so -- were proposed.

Covid-19, however, is not particularly predictable, at least not in the long term.

This, says Tony Johnston, head of tourism at the Althone Institute of Technology in Ireland, makes planning for the future difficult.

"The [tourism] industry is an industry which has traditionally relied on very stable and very predictable models of growth," he tells CNN Travel. "And that's just been completely removed.

"Nobody knows how the next six months, 12 months or even longer-term future is going to look -- so it's very difficult for policymakers to plan, and very difficult for the commercial side of the industry to plan."

Johnston posits that no matter a destination's intentions now, when and if the Covid threat is mitigated, it'll be difficult for planners and policy makers to juggle pressure from industry lobby to bring tourists back quickly, while avoiding a return to the overtouristed problems of the past.

That said, there will be some travelers who will remain unwilling or unable to travel again, whether due to health concerns or considerations of their carbon footprint.

Still, there's a reason these destinations were overtouristed to begin with -- a lot of people want to visit them.

That's not likely to change irrevocably, even if numbers take a while to stabilize. After all, if you've never visited Venice, living through a global pandemic might make you wonder why you never got around to it.

"Bucket list travel locations are going to be one of the things that stimulate the recovery, for sure, people will want to do things immediately, once they have an opportunity to do so," suggests Johnston.

The tourism industry is "very volatile, but very, very resilient, and very adaptable," he adds.

Correction: An earlier version of this story incorrectly referred to Dubrovnik as the Croatian capital.

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These destinations were overwhelmed by tourists. Here's how they're doing now - CNN

Villas of Distinction Recognized with Cond Nast Traveler’s 2020 Readers’ Choice Award in Villas Category – Benzinga

WILMINGTON, Mass., Oct. 29, 2020 /PRNewswire-PRWeb/ -- Cond Nast Traveler announced this month the results of its annual Readers' Choice Awards, with Villas of Distinction recognized in the Villas category. Villas of Distinction is the world's premier full-service luxury villa rental company and creates one-of-a-kind getaways at the world's top villas for its guests.

More than 715,000 Cond Nast Traveler readers submitted an incredible number of responses rating their travel experiences across the globe.

"The results of this year's survey, conducted at the start of the COVID-19 pandemic, are a testament to the lasting power of a meaningful travel experience," said Jesse Ashlock, U.S. Editor of Cond Nast Traveler. "The winners represent the best of the best for our audience and offer plenty of trip-planning inspiration for all the adventures we can't wait to have next."

The Cond Nast Traveler Readers' Choice Awards are the longest-running and most prestigious recognition of excellence in the travel industry. The full list of winners can be found here.

"It is a distinct honor to be named one of the best-of-the-best by the readers of Cond Nast Traveler," said Willie Fernandez, general manager and vice president of Villas of Distinction. "We couldn't have received this honor without the loyalty of our guests, as well as the dedication of our travel advisor partners, and our Villas Specialists and Concierges, who as a team, not only book villa stays but create truly unique vacation experiences."

Villas of Distinction provides a better solution for consumers and agents looking for trustworthiness and effortless vacation planning. Each guest is assigned a personal Concierge to tailor the perfect travel experience down to the last detail. The luxury provider may not boast the largest number of villas, but it is known for having the highest quality because it ensures every villa meets strict standards so that each home exceeds expectations. Pair that with expertise, Villa Specialists average 14 years of experience, and that is how Villas of Distinction has gained its guests' trust.

The 2020 Readers' Choice Awards are published on Cond Nast Traveler's website at http://www.cntraveler.com/rca and celebrated in the November issue of Cond Nast Traveler US and UK print editions.

About Villas of Distinction Villas of Distinction, as part of World Travel Holdings, is an award-winning, full-service premier luxury villa experience creator with an extensive portfolio of thousands of privately-owned villas in more than 50 luxurious destinations worldwide including the Caribbean, Mexico, Hawaii, Europe, Central America, the United States and many private islands. Many villas feature private pools, butlers, maids and chefs. The luxury villa provider has gained its guests' trust by ensuring every villa meets strict standards so that each home exceeds expectations. Since 1989, Villas of Distinction's team of experts have made vacation planning effortless by helping travelers find their perfect vacation home and creating one-of-a-kind getaways and lasting memories at the world's top villas. http://www.VillasofDistinction.com.

About Cond Nast Traveler Cond Nast Traveler is the world's most distinguished travel title providing inspiration and advice for discerning travelers. Authoritative and influential, Cond Nast Traveler is a multi-platform, transatlantic brand. Publishing US and UK print editions under Editor-in-Chief Melinda Stevens, Cond Nast Traveler offers award-winning expertise in luxury travel from around the world. For more, visit http://www.cntraveler.com. For press inquiries, please contact: awards@condenasttraveler.com

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Villas of Distinction Recognized with Cond Nast Traveler's 2020 Readers' Choice Award in Villas Category - Benzinga

Where Wes Anderson films ‘accidentally’ come to life – The Guardian

Theres something about director Wes Andersons style thats instantly recognisable. Immaculate composition, symmetrical lines, pastel colours, idiosyncratic and strangely alluring sets are trademarks in films from The Darjeeling Limited to The Grand Budapest Hotel.

But a new photography travel book, Accidentally Wes Anderson, is full of places in the real world that look as though they are from one of his films (but arent). Its the latest offering from the man behind the @accidentallywesanderson Instagram account, Brooklyn-based Wally Koval.

It started as a travel bucket list for me and my wife Amanda in 2017, inspired by images of places around the world that reminded me of a Wes movie, said Koval. We posted pictures from our travels, people started following, conversations began, ideas were swapped the response was phenomenal.

Today, the Instagram account has more than 1.2 million followers sharing discoveries across the globe.

Kovals love of Andersons style started young. I remember my dad was watching [1998 Anderson comedy] Rushmore and I was intrigued. I love his aesthetic, the symmetry theres something oddly soothing about it. Everything fits together like a puzzle, but theres always something darker beneath, a chaos within the characters ...

The book features 200 colourful images (whittled down from about 15,000 photos with a lot of arguments and tears), along with the stories behind them researched by Koval and his team.

From the Crawley Edge Boatshed on Australias Swan River, once threatened with demolition by the government and now the most-photographed spot in Perth, to Marfa Central Fire Station in Texas, founded as a water stop to replenish steam engines running trains between San Antonia and El Paso, and today run by 17 volunteers, each building has a tale to tell.

Other images from the Americas include the interior of the Post Office in Wrangell, Alaska, built as part of Roosevelts New Deal public works project and decorated with paintings of the American scene to soften the austerity of the architecture.

In Europe, theres pink Hotel Opera in Prague: nationalised by the Communist regime, the building then sat unused for decades but today is a family-run hotel once again. In Lisbon, the bright yellow Ascensor da Bica, a funicular railway built in 1892, is pleasingly framed in a gap between buildings. In Asia, striking pictures include 16th-century Amer Fort, overlooking Maota Lake in Rajasthan, with guards in white tunics a contrast against the ochre wall.

Its impossible for me to choose a favourite, said Koval. It changes all the time. There are so many layers to each one something might fascinate you about a photo and then you delve further into the stories behind them and theres always more to discover. We had to dig deep to gather the information we joined a local historical society, infiltrated private Facebook groups, and spent hours phoning and faxing far-flung places!

As well as being a perfect armchair travel read and an unusual guide, Koval hopes AccidentallyWes Anderson will inspire people to open their eyes and see the world differently.

We have travelled a lot, but we have always held that you dont need to go far to find interesting places. The pandemic has proven this. We couldnt go to Scotland or Spain as planned, but went to Delaware, where Amanda and I are from, and were blown away by things we found.

The ultimate stamp of approval came from Wes Anderson himself, who wrote the foreword to the book. The photographs in this book were taken by people I have never met, of places and things I have, almost without exception, never seen but I must say, I intend to. I now understand what it means to be accidentally myself. I am still confused about what it means to be deliberately me, if that is even what I am, but that is not important.

Accidentally Wes Anderson by Wally Koval is published on 29 October (Trapeze, 25). To order a copy for 21.75, including UK p&p, visit The Guardian Bookshop

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Where Wes Anderson films 'accidentally' come to life - The Guardian

Trending Now: Sports Tourism Market Share, Growth, Demand, Trends, Region Wise Analysis of Top Players and Forecasts – Aerospace Journal

Final Report will add the analysis of the impact of COVID-19 on this industry

The report titled Global Sports Tourism Market is one of the most comprehensive and important additions to Alexareports archive of market research studies. It offers detailed research and analysis of key aspects of the global Sports Tourism market. The market analysts authoring this report have provided in-depth information on leading growth drivers, restraints, challenges, trends, and opportunities to offer a complete analysis of the global Sports Tourism market. Market participants can use the analysis on market dynamics to plan effective growth strategies and prepare for future challenges beforehand. Each trend of the global Sports Tourism market is carefully analyzed and researched about by the market analysts.

TheTop Manufacturers/playersincluding- Expedia Group, Priceline Group, China Travel, China CYTS Tours Holding, American Express Global Business Travel, Carlson Wagonlit Travel, BCD Travel, HRG North America, Travel Leaders Group, Fareportal/Travelong, AAA Travel, Corporate Travel Management, Travel and Transport, Altour, Direct Travel, World Travel Inc., Omega World Travel, Frosch, JTB Americas Group, Ovation Travel Group

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If you are involved in the Sports Tourism industry or intend to be, then this study will provide you a comprehensive outlook. You must keep your market knowledge up-to-date segmented by Applications, Product Types, and some major players in the industry. If you wish to customize study with different players/manufacturers according to target geography or needs regional or country segmented reports we can avail customization according to your requirement.

Major types covers, Very Motivated, Partially Motivated, Accessory, Accidental, Not Motivated

Major applications covers, Below 30 Years, 30-40 Years, 40-50 Years, Above 50 Years

Report highlights: Report provides a broad understanding of customer behavior and growth patterns in the global Sports Tourism market report sheds light on lucrative business prospects for the global Sports Tourism market Readers will gain insight into upcoming products and related innovations in the global market of Sports Tourism The report provides details on the main strategic initiatives adopted by the main players in the global Sports Tourism industry The authors of the report examined the segments taking into account their profitability, market demand, turnover, production and growth potential In the geographic analysis, the report examines current market developments in various regions and countries.

Key Questions Answered in ROY Sports Tourism Market Report:

The Global Sports Tourism market report gives an uncommon and satisfactory investigation of the market size, examples, division, and post in the creation and supply of Sports Tourism with Global Scenario. It likewise talks about the market size of various fragments that are rising and their advancement includes alongside development patterns. Different partners like speculators, brokers, providers, CEOs, Research and media, Global Director, Manager, and President were associated with the essential information determination to think of bits of knowledge on Strength, Weakness, Opportunities, and Threat to the business or rivalry.

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Also, the report serves the important statistical data points gathered from the administrative foundations and other key sources, investigating the development of the business for the assessed period (2020-2025). As far as utilization, this report centers on the utilization of Sports Tourism by locales and applications. The exploration incorporates different factors about the market, its prominence in the worldwide market, division, current patterns that are being followed, innovative progressions, and future figures.

Table of ContentsSection 1 Sports Tourism Product DefinitionSection 2 Global Sports Tourism Market Manufacturer Share and Market Overview2.1 Global Manufacturer Sports Tourism Shipments2.2 Global Manufacturer Sports Tourism Business Revenue2.3 Global Sports Tourism Market Overview2.4 COVID-19 Impact on Sports Tourism IndustrySection 3 Manufacturer Sports Tourism Business Introduction3.1 Expedia Group Sports Tourism Business Introduction3.1.1 Expedia Group Sports Tourism Shipments, Price, Revenue and Gross profit 2015-20203.1.2 Expedia Group Sports Tourism Business Distribution by Region3.1.3 Expedia Group Interview Record3.1.4 Expedia Group Sports Tourism Business Profile3.1.5 Expedia Group Sports Tourism Product Specification3.2 Priceline Group Sports Tourism Business Introduction3.2.1 Priceline Group Sports Tourism Shipments, Price, Revenue and Gross profit 2015-20203.2.2 Priceline Group Sports Tourism Business Distribution by Region3.2.3 Interview Record3.2.4 Priceline Group Sports Tourism Business Overview3.2.5 Priceline Group Sports Tourism Product Specification3.3 China Travel Sports Tourism Business Introduction3.3.1 China Travel Sports Tourism Shipments, Price, Revenue and Gross profit 2015-20203.3.2 China Travel Sports Tourism Business Distribution by Region3.3.3 Interview Record3.3.4 China Travel Sports Tourism Business Overview3.3.5 China Travel Sports Tourism Product Specification3.4 China CYTS Tours Holding Sports Tourism Business Introduction3.5 American Express Global Business Travel Sports Tourism Business Introduction3.6 Carlson Wagonlit Travel Sports Tourism Business IntroductionSection 4 Global Sports Tourism Market Segmentation (Region Level)4.1 North America Country4.1.1 United States Sports Tourism Market Size and Price Analysis 2015-20204.1.2 Canada Sports Tourism Market Size and Price Analysis 2015-20204.2 South America Country4.2.1 South America Sports Tourism Market Size and Price Analysis 2015-20204.3 Asia Country4.3.1 China Sports Tourism Market Size and Price Analysis 2015-20204.3.2 Japan Sports Tourism Market Size and Price Analysis 2015-20204.3.3 India Sports Tourism Market Size and Price Analysis 2015-20204.3.4 Korea Sports Tourism Market Size and Price Analysis 2015-20204.4 Europe Country4.4.1 Germany Sports Tourism Market Size and Price Analysis 2015-20204.4.2 UK Sports Tourism Market Size and Price Analysis 2015-20204.4.3 France Sports Tourism Market Size and Price Analysis 2015-20204.4.4 Italy Sports Tourism Market Size and Price Analysis 2015-20204.4.5 Europe Sports Tourism Market Size and Price Analysis 2015-20204.5 Other Country and Region4.5.1 Middle East Sports Tourism Market Size and Price Analysis 2015-20204.5.2 Africa Sports Tourism Market Size and Price Analysis 2015-20204.5.3 GCC Sports Tourism Market Size and Price Analysis 2015-20204.6 Global Sports Tourism Market Segmentation (Region Level) Analysis 2015-20204.7 Global Sports Tourism Market Segmentation (Region Level) AnalysisSection 5 Global Sports Tourism Market Segmentation (Product Type Level)5.1 Global Sports Tourism Market Segmentation (Product Type Level) Market Size 2015-20205.2 Different Sports Tourism Product Type Price 2015-20205.3 Global Sports Tourism Market Segmentation (Product Type Level) AnalysisSection 6 Global Sports Tourism Market Segmentation (Industry Level)6.1 Global Sports Tourism Market Segmentation (Industry Level) Market Size 2015-20206.2 Different Industry Price 2015-20206.3 Global Sports Tourism Market Segmentation (Industry Level) AnalysisSection 7 Global Sports Tourism Market Segmentation (Channel Level)7.1 Global Sports Tourism Market Segmentation (Channel Level) Sales Volume and Share 2015-20207.2 Global Sports Tourism Market Segmentation (Channel Level) AnalysisSection 8 Sports Tourism Market Forecast 2020-20258.1 Sports Tourism Segmentation Market Forecast (Region Level)8.2 Sports Tourism Segmentation Market Forecast (Product Type Level)8.3 Sports Tourism Segmentation Market Forecast (Industry Level)8.4 Sports Tourism Segmentation Market Forecast (Channel Level)Section 9 Sports Tourism Segmentation Product Type9.1 Very Motivated Product Introduction9.2 Partially Motivated Product Introduction9.3 Accessory Product Introduction9.4 Accidental Product Introduction9.5 Not Motivated Product IntroductionSection 10 Sports Tourism Segmentation Industry10.1 Below 30 Years Clients10.2 30-40 Years Clients10.3 40-50 Years Clients10.4 Above 50 Years ClientsSection 11 Sports Tourism Cost of Production Analysis11.1 Raw Material Cost Analysis11.2 Technology Cost Analysis11.3 Labor Cost Analysis11.4 Cost OverviewSection 12 Conclusion

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Trending Now: Sports Tourism Market Share, Growth, Demand, Trends, Region Wise Analysis of Top Players and Forecasts - Aerospace Journal

Beachfront Residences at The St. Regis Bahia Beach Resort Open November 1 – Luxury Travel Advisor

The St. Regis Bahia Beach Resort in Puerto Rico has announced the debut of the Ocean Drive Beachfront Residences, the propertys $85 million luxury residential development.The first penthouse is currently available for reservations from November 1to February 28.

Located just steps away from The St. Regis Bahia Beach Resort, guests of the newly debuted Ocean Drive Beachfront Residences will enjoy hotel services and amenities, views of the Atlantic Ocean and a two-mile stretch of crescent beach. Compromising 30 condominium residences in three beachfront buildings, The Ocean Drive Beachfront Residences offers three- and four-bedroom residences and penthouse models ranging in size from 3,379 to 4,048 square feet of interior space. Designed by SB Architects Miami, the residences have expansive indoor and outdoor living spaces, beachfront terraces, en-suite bedrooms and more.

The first available penthouse unit has four bedrooms and five-and-a-half bathrooms with a total of 7,694 square feet. The residence boasts a kitchen with Wolf and Sub-Zero appliances, an oceanfront king master suite, an ocean front king bedroom, two double bedrooms, walk-in closets, soaking tubs, two terraces overlooking the Atlantic Ocean, and a private rooftop terrace with an outdoor kitchen, BBQ, plunge pool and bathroom. Guests will also enjoy private elevator access, St. Regis Butler service, housekeeping and private dining service. There is a minimum night stay of five nights.

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About the hotel:Located on a former coconut plantation and situated between the El Yunque National Forest and Espritu Santo River State Preserve, The St. Regis Bahia Beach Resort is set on 483 acres and is the only Gold-certified Audubon Signature Sanctuary in Puerto Rico. The St. Regis Bahia Beach Resort has private bird sanctuaries; an on-site green team led by a marine biologist; multiple dining outlets; an ocean-front golf course designed by Robert Trent Jones Jr.; and an Iridium Spa.

Good to know: Puerto Rico was the first U.S. destination to receive the "Safe Travels" stamp designation from the World Travel and Tourism Council (WTTC).Currently, visitors to the Island must complete a Puerto Rico Health Department form, which can be found on the departments online portal, and provide proof of a negative PCR COVID test from no more than 72 hours prior to arrival.

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Beachfront Residences at The St. Regis Bahia Beach Resort Open November 1 - Luxury Travel Advisor

Tourism and Agriculture Market 2020 Trends, Market Share, Industry Size, Growth, Sales, Opportunities, Analysis and Forecast To 2025 – TechnoWeekly

The Tourism and Agriculture Market study added by Reports web, exhibits a comprehensive analysis of the growth trends present in the global business scenario. The study further presents conclusive data referring to the commercialization aspects, industry size and profit estimation of the market.

The trends affecting the Industry in emerging regional sectors have additionally been explained in this study. The current findings and recommendations the analysts suggest for the future growth of the market have also been evaluated in this Tourism and Agriculture report.

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Key Vendors are Involved in Industry:

Expedia Group, Corporate Travel Management, Booking Holdings (Priceline Group), China CYTS Tours Holding, American Express Global Business Travel (GBT), China Travel, Fareportal, BCD Group, AAA Travel, Travel Leaders Group, Frosch, Ovation Travel Group, JTB Corporation, Travel and Transport, World Travel Inc., Direct Travel, TUI Group, Omega World Travel, AlTour International, World Travel Holdings, Abercrombie & Kent Group, InnerAsia Travels, Natural Habitat Adventures, Butterfield & Robinson

Segmentation by type: breakdown data from 2015 to 2020 in Section 2.3; and forecast to 2025 in section 10.7.Direct-market AgritourismExperience and Education AgritourismEvent and Recreation Agritourism

Segmentation by application: breakdown data from 2015 to 2020, in Section 2.4; and forecast to 2025 in section 10.8.Below 30 Years Old30-40 Years Old40-50 Years OldAbove 50 Years Old

The following part of the report explains the detailed segmentation of the Tourism and Agriculture Market. Valuable data and information related to the key segments have been established via this market research report. The revenue share coupled with insightful forecasts for the major segments and the other significant sub-segments have been detailed via this report.

The key industry players that have contributed to the Tourism and Agriculture Market have also been detailed in this report.

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Due to increase in competition in this market, a number of companies are entering into strategic partnerships with software companies to increase the overall product benefit and sustain their Tourism and Agriculture Market position.

The Tourism and Agriculture Market report focuses on the requirements of the clients from several global Market regions such as North America, Latin America, Asia-Pacific, Europe, and India.

Research objectivesTo study and analyze the global Tourism and Agriculture market size by key regions/countries, type and application, history data from 2015 to 2019, and forecast to 2025.To understand the structure of Tourism and Agriculture market by identifying its various subsegments.Focuses on the key global Tourism and Agriculture players, to define, describe and analyze the value, market share, market competition landscape, SWOT analysis and development plans in next few years.To analyze the Tourism and Agriculture with respect to individual growth trends, future prospects, and their contribution to the total market.To share detailed information about the key factors influencing the growth of the market (growth potential, opportunities, drivers, industry-specific challenges and risks).To project the size of Tourism and Agriculture submarkets, with respect to key regions (along with their respective key countries).To analyze competitive developments such as expansions, agreements, new product launches and acquisitions in the market.To strategically profile the key players and comprehensively analyze their growth strategies.

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Tourism and Agriculture Market 2020 Trends, Market Share, Industry Size, Growth, Sales, Opportunities, Analysis and Forecast To 2025 - TechnoWeekly

Impact of Covid-19 on the Hospitality, Travel, and Leisure Sector – Programming Insider

The Covid-19 pandemic has made a deep and lasting impression on the lives of millions of people, endangering not only their health but their livelihoods as well. As the world begins to contract and borders are closed, whole industry sectors have been devasated to an extent unimaginable even at the start of the year.

Arguably no part of the economy has been more devastated by the hospitality, travel and leisure sector due to international travel restrictions, laws on social distancing and rapidly changing government responses to a rapidly evolving health situation, Support packages and furlough schemes have helped cushion some of the blows, but many smaller, and even such larger companies, will not survive, and many who work in this sector face a very uncertain future.

Of course, the picture is not unremittingly black. Some businesses have actually thrived during the lockdown, particularly those in the digital space. Amazon, for example, reported its biggest profits in its history at the end of July, with third-quarter earnings and sales exceeding all analysts expectations.

People forced to spend more time at home or by themselves are turning to the internet, which means for example that an online casino in Ireland can expect 2020 to be a bumper year. That is not necessarily a good thing. A UK survey has recently revealed that 52% of online gamblers increased the amount they spent during national lockdown as a way of reliving the boredom. And that includes one in five problem gamblers, and a 12% increase from those who identified themselves as moderate gamblers.

This switch to online consumption is likely to continue. Already the health minister in Scotland has advised people there to prepare for a digital Christmas, with family celebrations likely to be conducted on Zoom.

Nor is there likely to be any upside soon. French President Emmanuel Macron has warned his citizens that they will be fighting the virus at least until the middle of next year, whilst the US has just recorded a record daily high of Covid-19 cases.

Globally, the economic impact of the pandemic on the hospitality, travel and leisure sectors is likely to be truly staggering.

Take tourism, which currently accounts for 10% of global GDP. The World Travel and Tourism Council (WT&TC) has estimated that the pandemic could cost nearly 50 million jobs world-wide, in the travel and tourism industry, with Asia likely to suffer the greatest impact with 30 million jobs at risk.

Meanwhile, another study has suggested the loss of travel related economic output in 2020 will be US $910 billion that is seven times greater than the post 9/11 impact.

All this means that, when the world finally emerges on the other side of the pandemic, and people are able to travel once more, they are likely to face a reduced choice. Their favourite airline might not exist anymore, their preferred hotel will remain shuttered, and many of the pubs, bars, cafes and restaurants they liked to visit will just be historical memories.

And it may also extend into the sporting arena, where hundreds of clubs and sporting associations which have been bedrocks of local communities for years may simply disappear.

In September FIFA predicted that the pandemic will cost the sport of football US $14 billion this year that is a third of the games global economic value. When those losses are projected on to all the other sports and leisure activities, then the numbers become truly mind-boggling.

In summary, apart from the immense cost to peoples physical and mental health, the pandemic is likely to cause almost incalculable damage to the hospitality, travel and leisure sector. There will be some winners, but there will be hundreds of thousands of losers.

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Impact of Covid-19 on the Hospitality, Travel, and Leisure Sector - Programming Insider