NORTH KANSAS CITY, Mo. Jim Neely is running a tight-knit, community focused campaign; for the Cameron, Missouri, physician and decades-experienced public servant, there isnt any other way to do it.

Hes pursuing a run for governor, the first from rural Northwest Missouri to seek the states top job in some time, with a message designed to advance conservative principles while hoping to leverage popular frustrations with what he labels typical Jefferson City politics. He took a moment at a campaign meet-and-greet event on Thursday to elaborate on this.

Weve got challenges and, you know what, the citizens see this, he said. Theres a relationship problem between taxpayers and government.

Mike Larkin of Plattsburg, Missouri, a retired airline pilot for TWA, attended the Neely event on Thursday at Repeal the 18th Bar and Bistro in North Kansas City, Missouri, after following Neelys career in public service for some time. Larkin said it is one of his most important values that the Show Me State be run by working professionals from rural America, preferably Northwest Missouri.

It means everything, Larkin said. Everything. I have watched what goes on in Jeff City for 40 years, and none of us can be very happy with our state government. Bad politics seem to permeate, no matter what side youre on.

Beyond his service in the state legislature since his first election in 2012, Neely still practices medicine, serving assisted living facilities in local communities in association with the Cameron Regional Medical Center; hes practiced medicine there since 1987.

He originally hails from Tarkio, Missouri, and moved at a young age to Forest City, Missouri. In his young adult life, Neely served in the U.S. Army as an infantry officer from 1974 to 1976, separating with the grade of first lieutenant. Neely was on the Cameron R-I school board from 1996 to 2005.

So, my ties to Northwest Missouri are significant, he said. I love Northwest Missouri.

Theres no way to run a Republican campaign for governor these days without acknowledging the elephant in the room of COVID-19, and Neely is in a particular position to do that as a practicing medical doctor. He described himself as a skeptic of mandatory requirements for masks, of the like that apply in Jackson County where the Thursday event took place.

At the end of the day, Neely believes that rural leaders should push back on broad mandates. Those who feel compelled to wear masks to protect themselves and others should do so, he said, but this is not the governments role to enforce.

We need to be all going right back, back to the normal we had in January and February, back to work, he said. People will be happier and healthier.

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Neely offers Northwest Missouri medicine in governor run - News-Press Now

Peter DimitrionCaleb Sokolowski

Wayne State University School of Medicine students Peter Dimitrion and Caleb Sokolowski have jumped into the popular world of podcasting as the creators and hosts of Leading the Rounds: A Medical Leadership Podcast.

We began this podcast because we are both passionate about leadership development, which is its own field and needs to be studied like pathology, biology and more, said Dimitrion, a second-year M.D./Ph.D. student. There are few resources for medical trainees that are accessible and affordable. Leadership development is overlooked in contemporary medical education, yet medical students and physicians find themselves in leadership roles from the beginning of their training. Other industries, such as the military and business, have formal leadership development courses, but physicians receive no formal leadership training as a part of their medical curriculum. We want to meet this need and improve our comprehension and understanding of leadership principles.

His co-host is also in his second year of the M.D. program. Dimitrion and Sokolowski published seven episodes so far, with guests including Army Maj. Cal Walters and Paul Thomas, M.D., a Class of 2013 alumnus and founder of the direct primary care clinic Plum Health in Detroit.

The show will focus on three facets they believe are critical to their development as future medical leaders: leadership development, personal development and health systems literacy.

Leading the Rounds is available on Apple Podcasts or Spotify.

We also have a website,www.leadingtherounds.com, which we are constantly updating with links to our episodes and resources for anyone who isinterestedin following up on the ideas that we talk about in our podcast. People can also connect with us on Instagram @Leadingtherounds, Dimitrion added.

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Medical students launch 'Leading the Rounds,' to explore leadership development in medicine podcast - The South End

Until the color of a mans skin is of no more significance than the color of his eyes. Bob Marley, War

Racial inequity in the U.S. health system is, in many ways, far deadlier than police violence.

The failures of the health care industry to appropriately care for Black patients are well-documented, resulting in the lowest life expectancy of any major group in the U.S. In addition to poverty, lack of access to care, and inadequate treatment, people of color are also dying due to bias in medical education, clinicians insufficient exam skills, and lack of appropriate information tools. The medical community needs to wake up and start fixing the way we recruit, train, and equip clinicians to reverse the trend of Black Americans dying too early and too often.

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My specialty, dermatology, is a prime example of the kinds of changes we need.

The skin is considered a window into health. But clinicians who havent been properly trained often fail to see some conditions in patients with Black skin. Reggae pioneer Bob Marley died of melanoma, a treatable skin cancer that is often missed and misdiagnosed in Black people. It becomes fatal if left untreated.

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Ive seen patients of color misdiagnosed because clinicians could not recognize their rashes. Ive seen immunologic diseases such as lupus, life-threatening drug reactions, and other conditions that manifest themselves on the skin get missed for the same reasons. I recall one very ill patient who was transferred to our hospital two weeks after a life-threatening drug reaction began from a sulfa-based antibiotic used to treat a urinary tract infection. She had body-wide blistering and ended up in the burn unit because the nurse and physician who initially evaluated her did not recognize the early skin clues and missed the diagnosis entirely. It was a miracle that she survived.

What went wrong in that case is a sadly common occurrence.

Inflammation caused by increased blood flow appears red or pink on white skin. Thats what clinicians are trained to recognize. In brown or Black skin, though, inflammation often appears brown or violaceous. Most medical and nursing students, and even many experienced clinicians, dont know that because most medical textbooks severely underrepresent disease manifestations on pigmented skin. This failure to train clinicians to effectively diagnose disease in people with pigmented skin contributes to lopsidedly negative outcomes for Black patients.

But unlike many of the pervasive economic, historic, and cultural factors driving poor health in the Black community, we can fix this problem today by having health systems and medical and nursing schools teach the skin exam in people of color to reduce error and bias; train clinicians about specific treatments for diseases that occur more often in patients of color; and advance tools and education that position clinicians to provide excellent care for every patient.

Racial bias in medicine is also tied to the images clinicians use to communicate with their patients. Showing patients one or more pictures of their condition is highly effective for communicating a diagnosis, educating them, and building trust. This is especially true in the current environment of Covid-19 when telemedicine is increasingly being used. But when people of color have their clinicians explain a disease process with images that do not look like them or their condition, it creates confusion, undermines trust, and ultimately affects patient behavior and outcomes.

Early on in my career, I recognized that showing reference images to patients that represent not only their condition but also their skin type can transform the conversation. It takes less than a minute to show a patient a comparable image to explain his or her diagnosis, but it makes a monumental difference and it shows you took the time to care.

Practices, clinics, and hospitals need to diversify their patient education materials to start dissolving these barriers to better patient-doctor relationships and optimal patient health. Medical image databases, books, and decision support tools must showcase the entire spectrum of skin colors to better represent the diverse patient populations we care for. By teaching clinicians-to-be using a range of skin types, and increasing access to diverse images that build patient knowledge and trust, we can start bringing equity to the practice of medicine, diagnosis, and patient education.

The horrific death of George Floyd has led many white Americans like me to reexamine our personal biases and the structural racism that has plagued our country since its founding. Medical professionals must address racial disparities in care immediately and start taking the life-expectancy gap for Black Americans as seriously as any other factor contributing to the deaths of thousands of people every year. To do this, we all need to acknowledge that racism in medicine is not simply about poor access, inequitable care, or hiring bias it is also at the core of how we teach and practice medicine with people of color. We can, and must, do better.

Art Papier is a physician and CEO of VisualDx, a medical informatics company affiliated with the University of Rochester.

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To begin addressing racial bias in medicine, start with the skin - STAT - STAT

Jarret Glasscock, CEO of Cofactor Genomics, recently spoke with Patrick Hurban, Senior Director and Global Head, Translational Genomics at Q2 Solutions on the topic of onboarding novel technologies for clinical studies. Dr. Hurban leads a team of laboratory-based and bioinformatics scientists who evaluate, develop, validate, and implement all of the genomic capabilities offered throughout the Q2 global laboratory locations. Dr. Hurban also serves as Laboratory Director for their CAP/CLIA Genomics Center of Excellence laboratory in the Research Triangle Park, North Carolina.

Jarret: How do you see novel technologies making an impact in precision medicine?

Pat: Precision medicine is critically reliant on biomarkers. While contemporary technologies have done a good job of identifying potential biomarkers and translating them to diagnostics, its sobering to realize that as of today in the U.S. there are only 38 approved companion diagnostics, and that doesnt represent 38 distinct targets, many of those are overlapping. The field often thinks of the therapeutic first, with the companion diagnostic then added on. But the paradigm is shifting. Personally, Im really excited by diagnostics that can be tied to multiple therapieswhat some have termed a companion therapeutics strategy. Genomics is particularly relevant in this framework, and weve already seen approvals of NGS-based tests covering multiple therapeutics and multiple indications, as well as tissue-agnostic markers like microsatellite instability-high. I look forward to technology advances that enable cost-effective and rapid integrative multi-omic testing.

Jarret: How does your team onboard new technologies into your laboratory?

Pat: We use a phased approach. We strongly prefer forging technology partnerships, as opposed to simply purchasing things through a customer/vendor relationship. Our technology portfolio must remain current and relevant to our clinical development clients, so we take every client interaction as an opportunity to understand their evolving needs and identify ways of working together to identify and evaluate potentially interesting technologies. Our clients rely on our objectivity, so we conduct evaluations that are designed to pressure-test the claimed capabilities of a technology, but also to determine whether its feasible to deploy the technology as part of clinical trialswe must always be mindful that no matter how interesting a technology is, if we cant collect, store, transport, and process the sample within stability, its not a workable solution for trials. And solutions that work in trials conducted in an academic medical center setting may not work in a community care setting. Once weve identified something of interest, our implementation will include a validation commensurate with the intended use of the technology, and we will work closely with our colleagues in our production laboratory to engineer an operationalized, scalable, and sustainable workflow.

Jarret: Why is immune profiling important to your clients and partners?

Pat: Immuno-oncology approaches have revolutionized cancer research and treatment. Despite the tremendous advances we have made to date, no one would deny that we have only scratched the surface of the vast complexity of the immune response to tumors. Clearly, new therapeutic avenues and biomarker possibilities are opened with each incremental advance of our understanding. In clinical development theres always a tension between having a narrow focus that enables strong, definitive findings, and casting a wider net using broader profiling solutions. We have need of both, since so many trials seek to confirm biomarker hypotheses as well as generate new hypotheses.

Jarret: When do you believe well see the next generation of technologies transition into clinical practice?

Pat: Sooner than any of us are ready for. So many of the newer technologies are showing such promise, with the possibility of illuminating our understanding of tumor biology in fundamentally new ways, so there is a huge push from our clinical development partners to find ways to incorporate nascent technologies. All of this is aimed at ultimately finding biomarkers that can be translated into routine use.

Jarret: What differentiates Q2 Solutions from other CROs?

Pat: Leading with science. We have the most effective combination of operational excellence and scientific acumen available today. We offer outstanding science and a breadth and depth of technical knowledge that is unrivaled in the industry. We take the long view and have a track record of investing in people and technology to propel clinical trials forward. We engage early and understand that the success of our partners is the best measure of our own success..

The rest is here:

RNA, Data Science, and the Future of Precision Medicine - Clinical OMICs News

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LAS VEGAS, NV (KVVU) UNLV Medicine allows patients with confirmed cases of COVID-19 to attend some in-person medical appointments, officials confirmed to FOX5 on Wednesday.

A staff member who spoke to FOX5 said that they previously scheduled patients with COVID-19 for telehealth appointments only. The staff member, who requested anonymity in speaking to FOX5, said the organizations scheduling department informed staff that they could now schedule people who have tested positive for COVID-19 for in-person medical appointments.

In a statement provided to FOX5, UNLV Medicine confirmed that they will see patients who have knowingly tested positive for COVID-19 if the patient is not sick enough for the ER, but for whom its important to be seen by their doctor for appointments such as high risk pregnancies, etc.

UNLV Medicine provided the below statement:

We strongly advise patients who are COVID-19 positive to isolate themselves and manage their illness at home. If they need to speak to, or be seen by a doctor, we offer telehealth appointments.

Only if they are very sick do we recommend a patient go to the ER, as it is important during the pandemic not to overcrowd hospital emergency departments with those not requiring emergent care.

For patients not sick enough for the ER, but for whom its important to be seen by their doctor for appointments such as high risk pregnancies, etc, during those rare occasions we will see them, as it would be irresponsible for us as healthcare providers not to.

All our patients should feel confident that as frontline healthcare providers we have world- class safety protocols in place to protect all patients and employees during this pandemic. Those same protocols have been successfully used to keep our patients, doctors and medical assistants safe while conducting COVID-19 tests on more than 17,000 Nevadans since March 23rd.

UNLV Medicine

Please note: This content carries a strict local market embargo. If you share the same market as the contributor of this article, you may not use it on any platform.

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UNLV Medicine allows patients with COVID-19 to attend some in-person appointments - ABC17News.com

If you're a lover of prairie music--and who isn't? We do live in the prairie afterall--then you are going to love this weekend's Levitt in Your Living Room guest. Levitt at the Falls Executive Director, Nancy Halverson, joined us in the studio to tell us more about the upcoming Levitt in your Living Room virtual concert on July 25th. And we were also being joined by the next Levitt in Your Living Room musical guest, Carrie Newcomer, who joined us through Zoom. They joined us to tell us what we can expect when we tune into this weekend's virtual event.

This weekend's Levitt in your Living room guest lives in the woods of Southern Indiana with her husband and two shaggy dogs. Yet, it only takes one listen to her music to know that Carrie Newcomer has a deep love for this country and it's rich heritage. Take a listen for yourself.

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Preventing injuries and treatment for women with Avera Orthopedics and Sports Medicine - KELOLAND.com

On Wednesday, 40 physicians, including a Portland OBGYN, will hand over their social media accounts to 40 Black female physicians.

PORTLAND, Ore A Portland doctor is lending her social media presence to an effort that highlights the voices of Black women in medicine.

This week OBGYN Dr. Jennifer Lincoln will turn over her Twitter and TikTok accounts as part of a national campaign called #ShareTheMedicalMic.

"Maybe that seems silly and you might say, 'Well, its just social media,'" Dr. Jennifer Lincoln said. "Well, your thoughts are what you see. So, make your feed what this world looks like which is not just people who look like you and people who believe the same things as you but diversify it and learn from that."

In June, celebrities started a new initiative on social media called #ShareTheMicNow to amplify Black voices in Hollywood, handing their accounts over to them for a day. Now, two physicians are bringing that effort to their field.

Dr. Renee Paro and Dr. Lauren Powell created the campaign for Black voices in medicine as we still see disproportionate numbers of health conditions and deaths that affect the Black community, according to Dr. Lincoln.

On Wednesday, July 22, Dr. Lincoln will join dozens of colleagues across the country to encourage that conversation and call attention to Black female voices in medicine. 40 female physicians, including Dr. Lincoln, will hand over their social media accounts to 40 Black female physicians.

"These women we are featuring are amazing," said Dr. Lincoln. "They are leaders in their communities, leaders in their field. A lot of them are mothers and are juggling so many things and I think that they deserve this recognition."

A few years ago, Dr. Lincoln saw the positive impact female physicians could make by connecting with people online. Now, with more than 45,000 Instagram followers and 780,000 followers on TikTok, she uses her social media presence to talk about important issues of women's health and racism.

"In this day and age, we are realizing how siloed we are and if anything in the past two weeks has shown us it's that we need to be listening to all voices. This is not a new narrative, but it's a narrative that we need to bring into the mainstream, and we need to get out there," she said. "And so, we're giving them the mic. We're giving them the accounts and saying, 'Okay, get your voice out there. Say what you need to be heard' so that they can expand their audiences and speak to what they want to."

Only about 5% of doctors in the United States are Black and about 2% are Black women, according to the Association of American Medical Colleges.

"That's just a ridiculous disparity," Dr. Lincoln said.

Dr. Lincoln hopes the #ShareTheMedicalMic initiative will shed light on this disparity and others. She knows the world of social media can be a divisive place but says it can also be a force for good.

"The positives, when it comes to these communities of underrepresented groups [is] the ability to connect and see that you're not alone and amplify that is amazing," she said.

This Wednesday,Dr. Jessica Shepherdwill take over Dr. Lincolns Instagram page.

"When I look at her, I'm like, 'That's what I want to be when I grow up,'" Dr. Lincoln said.

A fellow OBGYN, mom and media personality, Dr. Shepherd and Dr. Lincoln have a lot in common. They hope to soon share a wider audience as well.

"We get to, kind of, expose each other's audiences to both of us because we both have so many similarities, but the differences too are important, and I love that because it makes us unique," said Dr. Lincoln.

Follow #ShareTheMedicalMic all day Wednesday and check out @DrJenniferLincoln on Instagram to see Dr. Shepherd's message.

You can also follow Dr. Shepard on Instagram at @jessicashepherdmd

Dr. Shepherd also plans to hold a live Instagram conversation at 6 p.m. PST Wednesday.

Read the rest here:

#ShareTheMedicalMic campaign aims to amplify the voices of Black women in medicine - KGW.com

ST. LOUIS The historic effort to find a coronavirus vaccine comes to St. Louis.

Both the St. Louis University (SLU) Center Vaccine Development and the Washington University School of Medicine are looking for thousands of volunteers for Phase 3 efficacy trials for potential vaccines.

This is the last phase before FDA approval.

These are the trials that will tell us whether or not the vaccine actually works or does not work, said Dr. Sharon Frey, clinical director of SLUs Center for Vaccine Development and principal investigator of the trial at SLU.

The trials will involve at least two of five vaccines on the verge of making it this far: through initial vaccine development and the first two phases of smaller group clinical trials.

The Phase 3 efficacy trials will study tens of thousands of people across the country.St. Louis researchers are looking for about 3,000 volunteers from this area who have not already tested positive for COVID-19.

They must be at least 18 but theres no upper age limit. Those over age 65 are encouraged to participate.

Volunteers would not be exposed to COVID-19 as part of the trials, researchers said.Theyd get either an actual dose of vaccine or a placebo.

The studies are not going to expose anybody to the virus, said Dr. Rachel Presti, director of Washington Universitys Infectious Disease Clinical Research Unit. Were just going to see if getting the vaccine protects you from getting infected more than getting a placebo or saline injection. We want to see if it protects people from getting infected. We also want to see if it protects people from getting really, really, sick People are afraid to touch each other and hug each other and do the things they normally do. Really, were thinking might be our best shot to getting past that.

Phase 3 trials are expected to begin in the US next month. Theres still hope for having a safe, effective, vaccine by the end of the year.

This is an opportunity for St. Louis to be in the forefront of making history with these vaccine studies. It is everybodys chance to help make a difference, Dr. Frey said.

For more information about vaccine trials at Saint Louis Universitys Center for Vaccine Development, please visit http://vaccine.slu.edu or call 314-977-6333 or 1-866-410-6333; or email vaccine@slu.edu. Contact Washington University School of Medicine at 314-454-0058 or by email at Idcru@wustl.edu.

You can also check http://www.CoronavirusPreventionNetwork.org.

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SLU, Washington University School of Medicine to host COVID vaccine trials in the coming weeks - KTVI Fox 2 St. Louis

The quest for developing a vaccine and finding a definitive treatment for COVID-19 treatment is reportedly making good progress. However, with the number of infections around the globe having crossed 14.7 million, there is no easy containment of this pandemic. Clinical trials with re-purposed antivirals and biologicals have been approved in different geographical settings. These medicines are believed to have some potential in shortening the recovery time in COVID-19 patients. Recently, the Drugs Controller General of India (DCGI) issued approval to Glenmark Pharma to manufacture and market Favipiravir tablets for restricted emergency use. It also issued approvals to Hetero and Cipla to manufacture and market injectable formulations of Remdesivir, and to Biocon Limited to market injectable formulations of Itolizumab.

Also read: Glenmark Pharma cuts price of COVID-19 drug by 27% to 75/tablet

Remdesivir is an antiviral originally developed by Gilead to treat the Ebola virus infection. Favipiravir is a generic version of an anti-influenza medicine developed by Toyama Chemical in Japan. Gilead has entered into royalty-free voluntary licensing agreement with companies including Hetero and Cipla to provide technology transfer to manufacture Remdesivir for distribution in 127 countries. The free royalty period is valid until the World Health Organization (WHO) declares the end of the pandemic or until another medicine or vaccine is approved to treat or prevent COVID-19. Hetero has priced Remdesivir at 5,400 for a 100 mg injection vial, and Cipla at 4,000 per vial. A five-day treatment course with Remdesivir would work out to 24,000-32,000 per patient. Glenmark claims to have developed the active pharmaceutical ingredient and formulation of Favipiravir through its in-house research team and has priced Favipiravir 200 mg tablet at 103, with a course of treatment costing 12,566 per patient. Both these medicines inhibit viral RNA-dependent RNA polymerase, thereby retarding viral replication in host cells. Itolizumab, incidentally used in the treatment of psoriasis, reportedly shows therapeutic effects in severe COVID-19 infections progressing to acute respiratory distress syndrome. Treatment with Itolizumab is also not inexpensive by any means with the medical costs amounting to 32,000 per patient. The critical question is whether the above pricing would exclude a majority of the patients from the benefits of these re-purposed medicines.

The updated clinical management protocol of the Ministry of Health and Family Welfare (MHFW) lists Remdesivir as a potential medicine for investigational therapy in moderate COVID-19 infections without underlying contra-indications. The protocol does not mention Favipiravir, which nevertheless finds a place in the WHO Clinical Management Protocol. Itolizumab figures neither in the MHFW nor in the WHO protocol.

The question that begs an answer from pharmaceutical companies marketing re-purposed medicines for restricted emergency use is whether these medicines can be made available at affordable prices to patients. The current pricing does not indicate this. Andrew Hill et al in their study published in the Journal of Virus Eradication determined the price of final finished product (FFP) or medicine ready for use, by adding the costs of the active pharmaceutical ingredient, excipients, formulation, packaging and a reasonable profit margin. Their calculations have estimated the cost for a treatment course with Remdesivir to be $9 and the estimated production cost for a course with Favipiravir to be $20 per patient. Itolizumab has not been subjected to a costing analysis in their study.

Affordability of medicines is a matter of particular concern. When companies attempt to recover the fixed costs or sunk costs that went into the investment and development of the medicine, the final price becomes unreasonable. This is distressing for the patient, especially when the therapeutic results or clinical benefits have not been fully established.

Akin to the flexibilities in the TRIPS agreement which helped in making antiretrovirals affordable during the AIDS crisis, some countries are resorting to enabling legislation and procedural modifications of existing regulations to address affordability of anti-COVID-19 medicines. Israel issued a compulsory licence to Hetero for production and import of the Lopinavir-Ritonavir combination from India, following which the innovator AbbVie decided not to enforce its patent right. Canada passed the COVID-19 Emergency Response Act and Germany, The Prevention and Control of Infectious Diseases in Humans Act. Chiles Lower House of Parliament and Ecuadors National Assembly passed resolutions allowing TRIPS flexibilities in the pandemic. Prompted by Costa Rica, WHO opened a voluntary patents pool, for compiling and sharing information and technological know-how for the development of medicines, vaccines and diagnostics for COVID-19.

Indian patent laws too are armed with sufficient powers to ensure reasonable pricing for pharmaceutical products. India has used compulsory licensing only once in 2012 for Sorafenib. Section 92 of the Act enables grant of compulsory licensing in circumstances of national emergency or extreme urgency. Compulsory licences may not be the solution in all such situations. Nevertheless, the pricing will have to reflect the magnitude of the crisis and the socioeconomic realities in individual countries.

Many innovator companies, perhaps to escape or avoid any coercive move or legal action by governments, agree upon voluntary licences with generic companies. Such tie-ups can cause substantial reduction of medicine prices, as was seen in the case of Sofosbuvir, the $1,000 anti-hepatitis C medicine. Its price went down to approximately $10 per tablet in India, subsequent to the innovators voluntary licences with Indian generic companies in 2014. The terms and conditions of such agreements are generally wrapped in secrecy and may have clauses detrimental to public interest. Besides, as allegations of cartelisation between innovators and generic companies were raised in the case of antidiabetics Sitagliptin and Vildagliptin in the past, such arrangements are generally viewed with suspicion.

The prices announced for the re-purposed medicines appear to be high, especially given the rate of spread and the public health crisis in India. Economies of scale will ensure that the companies recoup their investment costs, and still generate profits. The burden of a global pandemic will have to be borne by governments and pharmaceutical companies alike. Unprecedented public health crises call for situation-specific decisions from pharmaceutical companies and profit maximisation should take a back seat. At least there is a strong case for reconfiguring the pricing strategies of the re-purposed medicines for COVID-19 treatment.

Sharmila Mary Joseph is Secretary, Department of Ayush, Government of Kerala, and James J. Nedumpara is Professor and Head, Centre for Trade and Investment Law, Indian Institute of Foreign Trade, New Delhi. Views are personal

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Why are re-purposed medicines expensive? - The Hindu

SEATTLE, July 21, 2020 /PRNewswire/ --Today, the Washington State Department of Health, UW Medicine and the Paul G. Allen Family Foundation announced the launch of a major study to determine the percentage of Washingtonians who have been infected by COVID-19. UW Medicine's Virology Laboratory will conduct the study in close partnership with state and local public health agencies, sampling across rural and urban populations throughout the state and within racially, ethnically and socioeconomically diverse communities.

"Data is a crucial tool in helping us fight this pandemic and safely reopening our economy," Gov. Jay Inslee said. "This study and partnershipwillprovide vital insightsabout the trajectory of COVID-19 in Washington,informing our response and allowing usto betterprotect Washingtonians."

All 7,000 study participants will receive a diagnostic COVID-19 test followed by three antibody tests over the course of eight months. By including 7,000 participants, the study will provide statistically valid information about the distribution of COVID-19 in communities within our state. The results of the first antibody tests will indicate the baseline prevalence of infection to date. In addition to infection rates, the study will examine how long COVID-19 antibodies persist. This will inform the Department of Health's assessments and safety guidelines to control COVID-19 infections in communities across the state.

"As one of the first in the country to develop a COVID-19 test, UW Medicine has invested millions of dollars to build significant capacity for both COVID-19 and antibody testing at scale," said Dr. Keith Jerome, head of the Virology Division at UW Medicine. Jerome is the principal investigator of the study and directs multiple virology labs. Dr. Mark Wener, who directs the Immunology Division, will serve as the co-investigator and assist in the implementation.

The antibody tests will be processed at the UW Medicine Virology Lab, using the Abbott Architect SARS-CoV-2 IgG assay, which has been shown to have an extremely high degree of accuracy, to ensure that the resulting data is valid for use in statewide policy decisions. UW Medicine scientists were involved in evaluating the specificity of the test and are confident of its accuracy.

This study is funded by a $3.4 million grant from the Paul G. Allen Family Foundation and builds on the Foundation's previous support of UW Medicine's COVID-19 Emergency Response Fund, which has raised more than $30 million to date.

"Comprehensive, high-quality data that statistically represents Washington's diverse communities and populations is critical to support the state's healthcare response and reopening," said Jody Allen, co-founder and chair of the Paul G. Allen Family Foundation. "This statewide study will provide a necessary baseline understanding of COVID-19 presence in communities to inform smart policy decisions as we all move forward with Washington's economic and health recovery."

To learn more about this state-wide study, please visit UW Medicine Virology Lab.

Additional quotes from representatives of the Washington State Legislature

"This important study will help us better understand the prevalence of COVID-19 across Washington State, as well as make significant contributions to larger scientific questions that will benefit global efforts to address the pandemic," said Senator Mike Braun.

"I'm encouraged that this study will help provide additional context to understand the disparate impact of COVID-19 on populations outside of those that currently have greatest access to testing," said Senator Mark Mullet.

About UW Medicine

UW Medicine is one of the top-rated academic medical systems in the world. With a mission to improve the health of the public, UW Medicine educates the next generation of physicians and scientists, leads one of the world's largest and most comprehensive biomedical research programs, and provides outstanding care to patients from across the globe. The School of Medicine faculty is second in the nation in federal research grants and contracts with $923.1 million in total revenue (fiscal year 2018) according to the Association of American Medical Colleges.

About the Paul G. Allen Family Foundation

For more than four decades the Paul G. Allen Family Foundation has focused on changing the trajectory of some of the world's toughest problems. Founded by philanthropists Jody Allen and the late Paul G. Allen, co-founder of Microsoft, the Foundation initially invested in community needs across the Pacific Northwest with a focus on regional arts, under-served populations, and the environment. Today, the Foundation supports a global portfolio of frontline partners working to preserve ocean health, protect wildlife, combat climate change, and strengthen communities. The Foundation invests in grantees to leverage technology, fill data and science gaps, and drive positive public policy to advance knowledge and enable lasting change.

Media Contacts

UW Medicine: Susan Gregg, sghanson@uw.edu, (206) 616-6730

Paul G. Allen Family Foundation: press@pgafamilyfoundation.com, (206) 342-2230

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UW Medicine and the Paul G. Allen Family Foundation Announce Study to Determine Prevalence of COVID-19 Infection Across Washington State - NBC Right...

BEDFORD, Mass., July 20, 2020 (GLOBE NEWSWIRE) Anika Therapeutics, Inc.(NASDAQ: ANIK), a global, integrated joint preservation, restoration and regenerative solutions company with products across the orthopedic early intervention continuum of care, today announced U.S. Food and Drug Administration (FDA) clearance and the planned launch of multiple new product innovations that address the needs of orthopedic and sports medicine surgeons and their patients seeking to stay active by overcoming soft tissue damage. Six minimally invasive surgical devices and instruments have been cleared by the FDA to repair rotator cuffs, perform arthroscopic knee repairs and treat arthritis damage in the hand and wrist. The products will be commercialized through Anikas recently expanded sales and marketing team throughout the third quarter of 2020 and mark the first products launched from the acquisitions of Parcus Medical and Arthrosurface, which were completed earlier this year.

Anika has rapidly pivoted to become a dynamic, customer facing enterprise. The introduction of these innovative technologies is evidence that the Company is listening to its physician customers to identify surgeon and patient needs, and has the ability to develop, gain approvals for and launch a series of new devices and instruments, even during pandemic conditions, said Cheryl R. Blanchard, Ph.D., President and Chief Executive Officer of Anika. Commercial success and growth in the sports medicine and joint preservation and restoration market demands an evolving understanding of unmet patient needs and the ability to translate surgeon feedback into designs that are both meaningful and practical for todays minimally invasive surgical ecosystem. Anika is well positioned to launch these exciting innovations, and we look forward to introducing these new products to our growing customer base as COVID restrictions ease and elective procedures resume in the U.S.

The new products include:

Consistent incremental improvements to techniques, tools and materials are critical in joint preservation surgery, allowing surgeons to continually refine ways to keep their patients active and comfortable, said Anil S. Ranawat, M.D., Hospital for Special Surgery. Having worked closely with the Anika team in recent years, I am impressed with their ability to identify clinical problems and provide real time solutions for us as practitioners. Their growing armamentarium of new tools is the most recent example of this commitment, and I look forward to putting them into practice.

About Anika Therapeutics

Anika Therapeutics, Inc.(NASDAQ: ANIK), is a global, integrated joint preservation, restoration and regenerative solutions company based in Bedford, Massachusetts. Anika is committed to delivering a diverse array of products to improve the lives of patients, with a focus on osteoarthritis pain management, sports medicine and joint preservation, restoration and regeneration. The Company has close to three decades of global expertise commercializing innovative products across the orthopedic early intervention continuum of care. For more information about Anika, please visitwww.anikatherapeutics.com.

Forward-Looking Statements

The statements made in the first and third sentence of the first paragraph, which are not statements of historical fact, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, those relating to the Companys planned product launches. These statements are based upon the current beliefs and expectations of the Companys management and are subject to significant risks, uncertainties, and other factors, especially in light of the evolving landscape around the COVID-19 pandemic. The Companys actual results could differ materially from any anticipated future results, performance, or achievements described in the forward-looking statements as a result of a number of factors including, but not limited to, (i) the Companys failure to realize the anticipated benefits of its recently completed acquisitions; (ii) unexpected expenditures or assumed liabilities that may be incurred as a result of these acquisitions; (iii) loss of key employees or customers following the acquisitions or otherwise; (iv) unanticipated difficulties in conforming business practices, including accounting policies, procedures, internal controls, and financial records of the recently acquired companies; (v) inability to accurately forecast the performance of the recently acquired companies resulting in unforeseen adverse effects on the Companys operating results; (vi) synergies between the recently acquired companies and the Company being estimates which may be materially different from actual results; (vii) the Companys ability to obtain pre-clinical or clinical data to support domestic and international pre-market approval applications, 510(k) applications, or new drug applications, or to timely file and receive FDA or other regulatory approvals or clearances of its products; (viii) that such approvals will not be obtained in a timely manner or without the need for additional clinical trials, other testing or regulatory submissions, as applicable; (ix) the cost effectiveness and efficiency of the Companys clinical studies, manufacturing operations, and production planning; (x) the Companys ability to successfully commercialize its products, in the U.S. and abroad; (xi) the Companys ability to provide an adequate and timely supply of its products to its customers; and (xii) the Companys ability to achieve its growth targets.Additional factors and risks are described in the Companys periodic reports filed with the Securities and Exchange Commission, and they are available on the SECs website at http://www.sec.gov. Forward-looking statements are made based on information available to the Company on the date of this press release, and the Company assumes no obligation to update the information contained in this press release.

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Anika To Launch Six FDA-Cleared Sports Medicine and Extremities Products in Third Quarter of 2020 - OrthoSpineNews

Understanding chirality twists within nanoparticles can help several industries, including pharma

The accurate measurement and characterisation of a single, twistednanoparticle in a laboratory for the first time has broughtthe pharmaceutical sector a step closer to produce and blend medicines on a microscopic scale.

The groundbreaking observations were made by physicists at the University of Bath, United Kingdom who measure molecules at the nanoscale, 10,000 times smaller than a pinhead.

The physicists studied the structure of gold and other materials, using a technique called the hyper-Rayleigh scattering optical activity, according to a July 20, 2020 press release from the university.

The technique allowed scientists to see a clear image of a screw thread twist in the gold nanoparticles shape.

Understanding the chirality twists within a material is critical for several industries, including the pharma sector, food additives, perfumes and pesticides.

This is because the direction in which a molecule twists determines some of its properties, said the press release, citing examples.

A molecule that twisted clockwise can produce the smell of lemons, while an anti-clockwise twist or a mirror-image of the lemon-smelling molecule produces the smell of oranges.

Chirality is one of the most fundamental properties of nature, said Ventsislav Valev, who headed the project and is a professor at Bath University.

It exists in sub-atomic particles, in molecules (DNA, proteins), in organs (the heart, the brain), in bio-materials (such as seashells), in storm clouds (tornadoes) and in the shape of galaxies (spirals hurling through space), he added.

There is immense potential for the practical applications of ultra-sensitive chiral sensing. Local pharmacists will now be able to mix substances in a new manner, using minute droplets of active ingredients instead of large beakers.

The ordinary consumer may, in the future, receive medicine in pills that are mini-labs rather than receiving them in bottles to be refrigerated, said Valev.

A precise number of micro-droplets will flow through micro-channels upon cracking the pill. This will mix and produce the needed medicine, explained Valev.

We can now aim to produce microdroplets containing a single chiral nanoparticle, to use as catalysts in chemical reactions, said PhD student Lukas Ohnoutek, the first author on the paper.

Chiral materials, including machines, can be built up one nanoparticle at a time from the microdroplets in the future, said Valev.

This is both a record and a milestone in nanotechnology, he added.

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Single nanoparticle twists pave the way for medicines on demand: Study - Down To Earth Magazine