Monthly Archives: February 2022

I get up in the morning and I read the obits. If Im not in them, I have breakfast.Carl Reiner

When were young, we say hello to our friends and share our daily highs and lows. When were old(er), we read the obits to say goodbye and remember.

So recently, before my breakfast, I saw a familiar name in the paper. The wife of a friend had died. After more than 50 years of marriage, there would be no more Hi honey, Im home or How was your day? No more conversations, deep or frivolous. No more shared worries about the state of our planet, economy, or children. No more date nights on the couch with a bowl of popcorn and a movie on demand. No more hugs and kisses. No more. No more. Such is the stuff of heart-rending grief.

As it so happens, a few years earlier the same friend described his wife with the following: She is my heart and soul. She has vastly broadened my world view, changed me for the better, and I am indebted to her in endless ways. Without her, I am nothing.

The combination of his loss and his tribute got me thinking about the notion of immortality. Carl Reiner hit on one level of immortality: The ability to eat breakfast cheats death for at least for one more day. On the other end of the spectrum, billions of people around the world believe that when their time for breakfast runs out, they will be united for all eternity with their family and friends, and their God, in heaven. Bookends to the notion of immortality. But what else lies on the shelf of our lives between those bookends?

After thinking about it, there are in fact other forms of immortality between breakfast and the belief of billions. The pharaohs have their pyramids, Shakespeare his plays, and every family their scrapbooks (or, today, iPhones) filled with hundreds if not thousands of photos of us full color immortality.

On a more serious note, psychologists debate how much of who we are is due to nature (genetics) or nurture (family, cultural, and environmental factors). While they debate the percentages of those two factors, the real point lies in the continuation (or immortality) of their effects.

So I went back to my friends tribute to his wife: She has vastly broadened my world view, changed me for the better. On the nurture side of the argument, we enter relationships as blind dates, looking for commonalities, ways we can connect, future roads we might travel together. After any long-term relationship, each partner has transformed, contributed to, and changed each other in ways both significant and subtle. And those changes endure even after the death of a spouse or friend. We are not human etch-a-sketches instantly reverting to blank slates upon the loss of the artist. In this way, the best traits of the people important to us, the traits that change us for the better, are immortal.

On the nature side of the equation, half (more or less) of our childrens DNA is me; the other half, my wife. I look at our grandchildren and realize that the half in each parent is now a quarter in them, and yet to be an eighth in a great-grandchild. Just as I am half of each of my parents and an eighth of each great-grandparent. This genetic immortality is something we share only with our immediate family, something of a seed bank to continue the lineage of a family.

The quest for immortality is a strictly human pursuit. We search for the fountain of youth, have our bodies frozen to near absolute zero waiting for a cure to the disease that put us on ice, have countless amazing life-extending surgeries, and take billions of dollars of life-extending medications. We resist death at all costs, and continually look forward to a tomorrow. Its the human condition.

So when someone changes us for the better, changes how we behave because of their influence be they spouse, child, parent, friend, mentor, or personal hero do they not live on in that sense? And when we inherit the DNA of our parents, and their parents, and pass that on to our children, and grandchildren, do they, and we, not also live on in that way? After all, without these influences, none of us would be who we are.

Without her, I am nothing. No. You were you until you met her and then the two of you created personalities entwined like two strands of psychological DNA, built around the molecular DNA you each inherited, and which, along with psychological traits, you pass on to your children. Is that not a way in which partners find immortality in others lives, and in the lives of all who will follow them?

Mexicos annual celebration of Die de los Muertos (captured so beautifully in the movie Coco), reminds people to remember their ancestors and to thank them for their lives and contributions. In reality, they live on not for just one day, but every day through the genetic and psychological contributions each of us exhibits every day of the year.

More than breakfast, less than heaven; not as enduring as a pyramid nor as fleeting as a digital photograph. Immortality lies in the play we write with each other with a debt to the past and hope for the future. I am enjoying writing that play and looking forward to fewer goodbyes and a lot more breakfasts.

Its the human condition.

See the article here:
On immortality and the human condition - Wednesday Journal

A recent study conducted by researchers at Baylor College of Medicine and Texas Childrens Hospital is the first to identify an underlying mechanism and possible drug targets for a new severe neurological disorder in children called NEDAMSS.

The disorder, called NEDAMSS for neurodevelopmental disorder with regression, abnormal movements, loss of speech and seizures, is caused by spontaneous mutations in the Interferon Regulatory Factor 2 Binding Protein Like (IRF2BPL) gene. In this study, the team led by Drs. Hugo Bellen, Paul Marcogliese and Debdeep Dutta at Baylor and the Jan and Dan Duncan Neurological Research Institute (Duncan NRI) at Texas Childrens employed fruit flies to dissect the biological function of IRF2BPL.

In 2018, Marcogliese and Bellen, along with a team of researchers affiliated with the Undiagnosed Diseases Network a National Institutes of Health-funded network whose goal is to find genetic variants responsible for previously unidentified disorders discovered the NEDAMSS disorder. In collaboration with Drs. Shinya Yamamoto, Michael Wangler and others at the Duncan NRI and Baylor, as well as Drs. Loren Pena and Vandana Shashi at the UDNs Duke clinical site, they identified mutations in IRF2BPL as the cause of severe steady regression of motor and language skills in the initial cohort of five patients.

Today, there are 31 patients identified with mutations in IRF2BPL, said Marcogliese, co-corresponding author of the study and postdoctoral associate in the Bellen lab. IRF2BPL has been named as one of the top 100 autism candidate genes and its variants have been implicated in early-onset Parkinsonism. However, until now, very little was known about the biological function of this gene and how its loss results in neuronal dysfunction.

Interestingly, overexpression of Pits (the fly version of IRF2BPL) or human IRF2BPL in flies resulted in serrated wings and bristle loss, both of which are common when the Wnt/Wingless signaling pathway is perturbed during development. Reducing Pits in neurons, however, led to an age-dependent neurological defect in flies, which the team later found was associated with an increase in the activity of the Wnt/Wingless pathway.

In collaboration with Dr. Nan Cher Yeo at the University of Alabama Birmingham and Dr. Kathrin Meyer at Nationwide Childrens Hospital, they confirmed these findings in zebrafish and in patient-derived cells as well.

Numerous experimental observations led the researchers to conclude that Pits and Wnt/Wg act in an antagonistic manner. In agreement with these observations in animal models, they found that Wnt signaling is increased in NEDAMSS patients, whose cells are known to have reduced levels of IRF2BPL.

To understand how Pits/IRF2BPL regulates Wg/Wnt pathway, the researchers conducted biochemical and mass spectrometry assays, which revealed a Wnt antagonist, Casein kinaseI (CkI), as one of the top binding partners of Pits. Further, they also confirmed genetic interactions between IRF2BPL and CkI.

In summary, the study shows an antagonistic relationship between IRF2BPL/Pits and the Wnt/Wg pathway in the fruit fly model. It also shows that under normal circumstances, IRF2BPL/Pits regulates neural function by inhibiting the Wnt/Wg pathway.

In NEDAMSS patients, loss of IRF2BPL is accompanied by increased levels of Wnt in astrocytes a prominent type of cell in the brain. The Wnt pathway, the human counterpart of the Wingless pathway in flies, is known to be important for the proper development and function of neurons and other organs, and its disruption results in several types of cancers. The researchers also showed that they can suppress characteristics associated with the loss of IRF2BPL/Pits using Wnt inhibitors, which have proven to be safe and effective in treating many cancers.

It used to take decades from the initial discovery of a novel gene to dissecting its biological mechanism to finding a therapy, said Bellen, Distinguished Service Professor of Molecular and Human Genetics at Baylor and the corresponding author of the work. However, with the UDNs unique approach that fosters close collaborations between clinicians and researchers working on various model systems, we were able to move from the initial identification of this mutation to a potential therapy in just three years.

Furthermore, we were able to progress rapidly thanks to the continued support from the iDREAM For a Cure, as well as supplemental support from the NIH for which we are truly grateful. We hope to translate these promising discoveries into a viable therapy in the future.

The researchers report their findings in the journal Science Advances.

Other researchers involved in the study include Shrestha Sinha, Nghi Dang, Zhongyuan Zuo, Yuchun Wang, Di Lu, Fatima Fazal, Thomas Ravenscroft, Hyunglok Chung, Oguz Kanca, JiJuWan, Emilie Douine, Stanley Nelson, Matthew Might, Kathrin Meyer and Nan Cher Yeo. They are affiliated with one or more of the following institutions: Baylor College of Medicine, Texas Childrens Hospital, the Research Institute at Nationwide Childrens Hospital, University of Alabama, David Geffen School of Medicine, Cincinnati Childrens Hospital and Ohio State University.

Read more.

Continued here:
Wnt signaling is identified as a target in NEDAMSS disorder - Baylor College of Medicine News

Pfizer: William Pao

William Pao, M.D., Ph.D., will join Pfizer as executive vice president and chief development officer as of March 21.

Dr. Pao will become a member of Pfizer's executive leadership team, reporting to chairman and CEO Albert Bourla. Hesucceeds Rod MacKenzie, who is retiring after 35 years at Pfizer.

At Pfizer, Dr. Pao will oversee the Companys Global Product Development organization, which is responsible for the clinical development and advancement of Pfizers pipeline of innovative medicines in inflammation and immunology, internal medicine, hospital, oncology and rare disease, as well as regulatory affairs in support of Pfizers R&D pipeline and portfolio of marketed therapies.

Dr. Pao joins Pfizer from Roche,where he most recently served as the Head of Pharma Research and Early Development (pRED) and oversaw the discovery and early development of a portfolio of new molecular entities to treat diseases related to cancer, neuroscience, ophthalmology, rare diseases, immunology, infectious diseases, and rare blood disorders, across seven global sites.

Before joining Roche, Dr. Pao simultaneously held key positions as Professor of Medicine and Director of the Division of Hematology/Oncology at Vanderbilt University, and Director of Personalized Cancer Medicine at Vanderbilt-Ingram Cancer Center.

During this time, he was co-corresponding author on the first paper to describe osimertinib (Tagrisso), a medication used to treat non-small-cell lung carcinomas with specific mutations. He also co-founded MyCancerGenome, a pioneering cancer medicine knowledge resource for physicians, patients, caregivers, and researchers.

GlaxoSmithKline plc has appointed Tony Wood as Chief Scientific Officer (CSO) designate: who will assume full accountability for R&D across GSKs portfolio and pipeline as of August.

One of the worlds pre-eminent chemists, Wood has more than 30 years of experience working across diverse disciplines of R&D to deliver innovative medicines. He joined GSK from Pfizer in 2017, as Senior Vice President, Medicinal Science and Technology, and is responsible for all science and technology platforms supporting the discovery, clinical development and delivery of new medicines across GSK.

Over his career, Wood has led large-scale global organisations in drug discovery and development in multiple therapeutic areas, including immunology, oncology and infectious diseases. He has been involved in the launch of many new medicines at GSK, includingNucala,Blenrep,Jemperli,Cabenuvaand most recentlyXevudy. Wood has also been integral to delivering the recent improvements in GSKs R&D productivity and central to developing its R&D approach focusing on science of the immune system, human genetics and advanced technologies, notably building capabilities in functional genomics, artificial intelligence and machine learning.

In his earlier career at Pfizer, Wood created and led its first global Medicinal Chemistry organisation, supporting all small molecule discovery output from Pfizers research units. Among many achievements, this group designed the antiviral molecules that led to the development of the SARS-CoV-2 medicine Paxlovid.

Wood also created and led Pfizers first Medicinal Sciences organisation. In this role he was accountable for the design and development of medicines including the JAK1 inhibitor abrocitinib, JAK3 inhibitor ritlecitinib, and tofacitinib follow-on medicines. He was also responsible for the structure-based design of the Pfizer RSV vaccine, which is currently in phase III development. Prior to this, Tony co-led Pfizers research for the antiviral therapeutic area. He invented maraviroc, a CCR5 antagonist for the treatment of HIV and Pfizers first successful drug derived from high-throughput screening.

Wood will take over from current CSO, Dr Hal Barron. After this, Dr Barron will remain a member of GSKs Board transitioning to serve as a Non-Executive Director and a member of the Boards Science Committee for an initial period of three years. In addition to his Non-Executive responsibilities, Barron will also provide advice and support on scientific and asset development matters and will attend key R&D executive investment and advisory committees. He will also continue to engage with the scientific community, R&D partners and other companies, as required, in support of R&D and on behalf of GSK.

Barron will assume the position of CEO and Board Co-Chair of Altos Labs effective 1 August 2022. Altos Labs is a new, private biotechnology company based in the San Francisco Bay Area, with multiple global sites, and is focused on the biology of cellular rejuvenation programming with the goal of reversing disease.

Biopharma CDMO AGC Biologics has appointed Regina Choi-Rivera as the new General Manager of the companys large-scale biopharmaceutical mammalian production facility in Boulder, Colorado.

AGC Biologics acquired the Boulder Facility in June 2020, giving the company additional capacity and a significantly larger production scale for mammalian-based projects in the US. The Boulder site houses two 20,000-liter stainless steel cell bioreactors and has more than twenty acres of undeveloped land, creating opportunities for future expansion, including space for up to four more 20,000-liter bioreactors. The facilitys automation and cost-effective capabilities make it well-suited for high volume commercial production and high titer antibody processes.

In her new role, Choi-Tivera assumes executive oversight and leadership and will manage strategic development and facility operations. She brings more than 25 years of experience in the biotech industry with her and joins AGC Biologics after working for Samsung Biologics for eight years. While at Samsung Biologics she most recently served as vice president, Head of Drug Product Business Unit. Prior to that Ms. Choi-Rivera was vice president, Head of the Drug Substance Contract Manufacturing Business unit. Before her time at Samsung, she spent nearly a decade with Janssen Pharmaceuticals research and development division, supporting pilot plant operations and managing outsourcing activities.

CurevacsChief Technology Officer, Dr. Mariola Fotin-Mleczek, will resign from CureVac at the end of this month: after nearly 16 years of scientific leadership at the company. She leaves to pursue a family business outside the biotech industry in her home country of Poland.

Fotin-Mleczek joined CureVac in May 2006 and became a member of the management board in 2013, first as Chief Scientific Officer and as Chief Technology Officer in 2018. As a scientist trained in immunology and cell biology, Mariola was responsible for the development and preclinical testing of CureVacs mRNA technology platform across the therapeutic areas of prophylactic vaccines, oncology and molecular therapy. She is co-inventor of multiple key mRNA technology-related patents and has authored more than 30 scientific publications with a focus on mRNA technology.

Further development of CureVacs mRNA technology platform will be led by Dr. Igor Splawski, Chief Scientific Officer of CureVac, and spearheaded by Dr. Patrick Baumhof, Senior Vice President Technology, who has a 15-year scientific tenure with the company. The consolidated scientific frontend will seamlessly integrate with the subsequent clinical development of new mRNA-based vaccines and therapeutics.

Ajinomoto Bio-Pharma Services, a global provider of bio-pharmaceutical contract development and manufacturing services, has appointed Tony ONeill as vice president of compliance, US Operations.

ONeill brings extensive experience leading quality, manufacturing, and operational excellence teams in the pharmaceutical and bio-pharmaceutical industry. He joins Aji Bio-Pharma after 25 years at Allergan, where he held a number of quality and operational leadership positions in biologics manufacturing and development with responsibility both in Ireland and US operations. His most recent roles include Executive Director Quality Operations and Executive Director Risk Management and Compliance, where he was responsible for leading a team in developing standard policies and processes for data management and controls across a network of 14 sites.

As we continue to expand our capacity and service offerings, including the addition of our new multi-purpose fill/finish suite, Tonys expertise will be integral in ensuring the required sterility and regulatory standards are met for both cGMP clinical and commercial manufacturing, said Nobu Shimba, President and CEO of Aji Bio-Pharma, US

Genezen, Inc., a cell and gene therapy CDMO focused on early-phase process development, GMP vector production and analytical testing services, has appointed Laura Jacanin as Senior Director of Business Development.

Previouslywith similar roles at Wuxi, Lonza, and Cytovance, Laura has over 20 years experience in the life science sector and has extensive cell and gene therapies (C>s) and biologics expertise.

Jacanin will be responsible for developing and expanding Genezens offering oflentiviral and retroviral vectors to meet the growing demands of the C> market and supporting the development and production of therapies.

Jacanin is the latest in a series of appointments at Genezen which has included: Natasha Rivas as Vice President of Quality Assurance and Regulatory Affairs; Raymond Kaczmarek as CEO; and Brok Weichbrodt as Vice President of Operations.

The appointments have been made to help drive the business growth alongside a new 75,000+ square foot cGMP-compliant lentiviral and retroviral vector production facility. The first phase, a process development and analytical lab, officially opened in late 2021. The next phase, with cGMP production suites, is currently underway and due to complete in early 2022.

View post:
New appointments in the biopharma industry - BioPharma-Reporter.com

GAINESVILLE, Fla.--(BUSINESS WIRE)--Cyclo Therapeutics, Inc. (Nasdaq: CYTH) (Cyclo Therapeutics or the Company), a clinical stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and families living with diseases, today announced the formation of a Global Steering Committee (GSC) to guide the pivotal Phase 3 global clinical development program of Trappsol Cyclo for the treatment of Niemann-Pick Disease Type C (NPC). As the Global Principal Investigator for the TransportNPC study, Caroline Hastings, MD serves as the senior scientific and clinical expert for the trial and will also chair the GSC.

Dr. Caroline Hastings, global principal investigator for TransportNPC and chair of the GSC, has been instrumental in assembling this high caliber Global Steering Committee with representation of renowned Key Opinion Leaders and clinical experts in NPC. It is another testimony of our commitment to serve the NPC community and deliver on the unmet medical needs. I feel humbled and privileged to be working with this outstanding group of professionals who are committed to advance science and clinical trials that can bring hope and treatment benefits to so many patients and their families, commented Lise Kjems, MD, PhD, Chief Medical Officer of Cyclo Therapeutics.

The Companys ongoing pivotal Phase 3 study, TransportNPC, is a randomized, double-blind, placebo-controlled, parallel group, multicenter study designed to evaluate the safety, tolerability, and efficacy of 2,000 mg/kg doses of Trappsol Cyclo administered intravenously and standard of care (SOC), compared to placebo administered intravenously and SOC alone, in patients with NPC1. The Phase 3 study intends to enroll at least 93 pediatric (age 3 years and older) and adult patients with NPC1 in at least 23 study centers in 9 countries. Eligible patients will be randomized 2:1 to receive either Trappsol Cyclo or a placebo. Randomization will not be constrained based on patient age, nor will patient enrollment be gated by patient age. The study duration is 96 weeks and includes an interim analysis at 48 weeks.

Dr. Hastings, Global Principal Investigator for the TransportNPC trial and member of Cyclo Therapeutics Scientific Advisory Board added, I am very grateful by the overwhelmingly positive responses as I reached out to fellow scientists and physicians to invite them to join the Global Steering Committee. I am honored to be working alongside these wonderful colleagues with outstanding knowledge and expertise and who represent the excellent investigators taking part in the TransportNPC trial. Together, we have a very unique opportunity to further refine the scientific strategy for Trappsol Cyclo and help drive this important program toward potential approval.

NPC is a devastating neurodegenerative disease that needs more effective therapies. Given the clinical course and progressive nature of this disease, novel therapeutic strategies with the potential for disease modifying effects are necessary. The TransportNPC trial is unique as it is designed to demonstrate the long-term clinical benefits and potential for disease modification, commented Professor Roberto Giugliani, MD, PhD.

I have been caring for patients with NPC for more than 25 years. These patients urgently need better treatment options that will better halt the cruel, neurodegenerative course that this disease takes. In this study with cyclodextrin intravenously, I see an opportunity to improve the therapeutic offer, added Dr. Eugen Mengel.

The members of the TransportNPC Global Steering Committee are:

For more information about the Companys TransportNPC pivotal Phase 3 study, visit http://www.ClinicalTrials.gov and reference identifier NCT04860960.

Cyclo Therapeutics received Orphan Drug Designation for Trappsol Cyclo to treat NPC1 in both the U.S. and EU and Fast Track and Rare Pediatric Disease Designations in the U.S. The Rare Pediatric Disease Designation is one of the chief requirements for sponsors to receive a Priority Review Voucher in the U.S. upon marketing authorization.

About Cyclo Therapeutics

Cyclo Therapeutics, Inc. is a clinical-stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and families suffering from disease. The Companys Trappsol Cyclo, an orphan drug designated product in the United States and Europe, is the subject of four formal clinical trials for Niemann-Pick Disease Type C, a rare and fatal genetic disease, (www.ClinicalTrials.gov NCT02939547, NCT02912793, NCT03893071 and NCT04860960). The Company is planning an early phase clinical trial using Trappsol Cyclo intravenously in Alzheimers Disease based on encouraging data from an Expanded Access program for late-onset Alzheimers Disease (NCT03624842). Additional indications for the active ingredient in Trappsol Cyclo are in development. For additional information, visit the Companys website: http://www.cyclotherapeutics.com.

Safe Harbor Statement

This press release contains forward-looking statements about the companys current expectations about future results, performance, prospects and opportunities, including, without limitation, statements regarding the satisfaction of closing conditions relating to the offering and the anticipated use of proceeds from the offering. Statements that are not historical facts, such as anticipates, believes and expects or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual results in future periods to differ materially from what is expressed in, or implied by, these statements. The factors which may influence the companys future performance include the companys ability to obtain additional capital to expand operations as planned, success in achieving regulatory approval for clinical protocols, enrollment of adequate numbers of patients in clinical trials, unforeseen difficulties in showing efficacy of the companys biopharmaceutical products, success in attracting additional customers and profitable contracts, and regulatory risks associated with producing pharmaceutical grade and food products. These and other risk factors are described from time to time in the companys filings with the Securities and Exchange Commission, including, but not limited to, the companys reports on Forms 10-K and 10-Q. Unless required by law, the company assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

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Cyclo Therapeutics Announces Formation of Global Steering Committee Comprised of Leading Experts to Advise on the Global Phase 3 Clinical Development...

The research report Monoclonal Antibodies Market includes qualitative and quantitative insights into the major drivers, restraints, opportunities, and challenges impacting worldwide market growth. The analysis contains detailed statistical market data on the major companies, as well as revenue forecasts. The Monoclonal Antibodies market study also includes information on the sales growth of many regional and country-level markets, as well as the competitive landscape and specific company analysis for the forecast period. The Market Report examines future growth factors as well as the existing status of market share, penetration of various types, technologies, applications, and geographies through 2027.

In accordance with the Monoclonal Antibodies market is set to grow at a CAGR of 10.2% over a forecast period (2022-2027).

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https://marketintelligencedata.com/reports/1537656/global-monoclonal-antibodies-market-growth-2022-2028/inquiry?Mode=Vaishnavi

Top Players Analysed in the Report are:

, AbbVie, Roche, Johnson & Johnson, Amgen, Merck, BMS, Eli Lilly, Formation Biologics, Genmab, GlaxoSmithKline, Human Genome Sciences, mmunogen, MedImmune, Novartis, Pfizer, Seattle Genetics, Stemcentrx, Synthon Biopharmaceuticals, Takeda, Teva,

Monoclonal Antibodies Market Segmentation, By Type:

Cancer

Autoimmune Diseases

Infection

Hematological Diseases

Others

Monoclonal Antibodies Market Segmentation, By Application:

Cancer

Autoimmune Diseases

Infection

Hematological Diseases

Others

Segmentation by application: breakdown data from 2016 to 2021, in Section 2.4; and forecast to 2026 in section 11.8.

Oncology

Autoimmune and inflammatory diseases

Respiratory diseases

Ophthalmology

Regional Analysis:

Global Monoclonal Antibodies Market is further classified on the basis of region as follows:

North America (USA, Canada, Mexico)

Europe (Great Britain, France, Germany, Spain, Italy, Central and Eastern Europe, CIS)

Asia Pacific (China, Japan, South Korea, ASEAN, India, rest of Asia Pacific)

Latin America (Brazil, rest of LA)

Middle East and Africa (Turkey, CCG, rest of the Middle East)

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Chapter 1: Overview of Monoclonal Antibodies Market

Chapter 2: Global Market Status and Forecast by Regions and Typed

Chapter 3: Company Profiles, recent developments, and investments

Chapter 4: Market Competition Status by Major Manufacturers

Chapter 5: Major Manufacturers Introduction and Market Data

Chapter 6: Upstream and Downstream Market Analysis

Chapter 7: Cost and Gross Margin Analysis

Chapter 8: Marketing Status Analysis

Chapter 9: Market Report Conclusion

Chapter 10: Research Methodology and Reference.

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Monoclonal Antibodies Market Profitability and Leading Players To 2027 | North America, Europe, Asia and Pacific The Grundy Register - The Grundy...

Deer graze along the dunes at Robert Moses State Park in Babylon, NY.Photo: Thomas A. Ferrara/Newsday RM (Getty Images)

The Omicron variant of the coronavirus has found its way into white-tailed deer living in New York, new research released this week has found. The results are the latest to show that deer in the U.S. have become frequent carriers of SARS-CoV-2a phenomenon that could have important implications for the future of the virus and our vulnerability to new variants.

Numerous studies have found that deer can readily contract the coronavirus. Last November, for instance, researchers from Penn State University and elsewhere reported that up to a third of free-living and captive deer in Iowa carried traces of the virus from late 2020 to early 2021. Some of these same researchers from Penn State and others, including those with the New York City Department of Parks & Recreation, have released their latest findings this week on the preprint website bioRxiv.

The team tested blood and nasal samples from wild deer living on Staten Island that were temporarily captured as part of a sterilization program to keep the population in check. The samples were collected between December 2021 and January 2022, and the scientists performed antibody and RNA tests on them.

Overall, 14.5% of 131 deer that had their blood taken tested positive for antibodies to the coronavirus, indicating a prior infection. About 10% of the 68 deer that had nasal swabs taken tested positive for an acute infection. And when the researchers sequenced the genetics of these positive samples, they found that some had caught the Omicron variant, the most transmissible version of the coronavirus to emerge yet.

The Omicron found in these deer bore a close genetic resemblance to Omicron strains found in human residents of the city, all but confirming that humans had somehow been the source of the deer infections. Its unclear how this is happening, but direct contact via hand-feeding or through exposure to contaminated wastewater or trash are possibilities. Interestingly, at least one infected deer had both an active infection and very high antibody levels, possibly indicating that it had been reinfected.

This work, the researchers say in their paper, clearly shows that Omicron can infect white-tailed deer and highlights an urgent need for comprehensive surveillance of susceptible animal species to identify ecological transmission networks and better assess the potential risks of spillback to humans.

Deer, at least in the lab with older strains of the virus, dont appear to experience much if any illness from their infections, unlike other animals such as minks. But the widespread transmission of the virus seen in these animals doesnt bode well for several reasons. The virus could mutate to become a serious health problem for deer in the U.S., which would only add to the list of infectious diseases circulating in these animals. The virus could also mutate in unpredictable ways or recombine with other coronaviruses in deer that would allow it to become more immune-evading or virulent once its transmitted back to humans.

None of this is certain, of course, and theres plenty of coronavirus already circulating and mutating in humans. But one reason why diseases like influenza are considered a pandemic threat is that flu viruses are constantly being spread back and forth between different species. Every once in a while, the genetic shuffling that this process produces can spit out a version of the flu thats both highly contagious in humans and much more deadly than the typical seasonal flu. So if the same thing can happen with SARS-CoV-2, its a risk that we have to keep an eye on as much as possible, the researcherssay.

The circulation of the virus in deer provides opportunities for it to adapt and evolve, study author Vivek Kapur, a veterinary microbiologist at Penn State University, told the New York Times. And its likely to come back and haunt us in the future.

Read the rest here:
Deer in New York Test Positive for Omicron, Researchers Warn of Future 'Spillback to Humans' - Gizmodo

Food that is organic or not organic? Grown from genetically modified (engineered) seeds or not?

How about neither genetically modifiednor organic?What aboutboth organic and genetically modified??

The first two are pretty common questions, while the latter two are almost never asked. Some people believe that within thecontinuum of macro and micro phenomenaof the natural world, deliberate and precise crop modifications at the genomic level should be prohibited, must be linked to pesticide use, and are distinctly different than the relatively random modifications achieved via traditional breeding techniques. They are virulently anti-biotechnology. A whole industry developed around these beliefs.

This limited thinking comes at a cost: We spend a greater proportion of income on food; we omit some foods out of the diet due to cost, possibly reducing nutrient quality intake. In Canada, where I live, we risk becoming a laggard nation by signaling to the pubic and businesses that we are not willing to keep up with technology; and inadvertently or note we perpetuate fear mongering agendas to result in an ignorant population.

Heres a question Ive struggled with for a long time: why are those that are pro-organic and concerned around pesticide use also not embracing GMO technology, which in some cases dramatically reduces the amount and toxicity of crop chemicals?

I believe organic GMOs should be not only accepted but actively pursued and especially by those who embrace the goal of organics to reduce the environmental impact of farming.

I know that assertion seems absurd to most people but Im going to try to explain my perspective. Keep in mind there are many layers to this topic, some outside the scope here, but Im going to try to clearly break it down step-by-step.

Almost all of the plant food you eat was processed from commercial crop varieties. Of the dozens of varieties registered and available in any given year, a farmer must then assess performance of that variety (either from past experience, or from accumulated field trial data provided by researchers), consider if the data is relevant for the farms geography/soil/latitude, as well as seed availability, production economics, and other production implications, while staying aware of what market demands are while usually trying to predict what prices will be in the coming year. For example (and assuming prices arent contractually locked-in with a buyer prior to producing it), does the buyer of his grain wantcertified organicgrain or not? This question in particular is relevant since production practices of the crop in the field are largely determined by those intended markets, especially in terms of the land being used as well as pesticides used.

Think about the chronological order of everything described so far. The way the crop is grown in the field determines whether or not the food made from it can be labelled as organic or not. Non-GMO is dependent upon the way the genetics came together prior to variety registration, years before the variety is grown in the field. Yet, the terms organic and non-GMO are used interchangeably and inseparably.

Why?

Heres an analogy. Lets say youre shopping for a new sports car, and your only must-have is that it must be powered by a BMW engine. Logically, it would make sense to start looking at BMW cars, but actually you can get other brands with BMW engines: Morgan (brand) out of the UK is a distinct brand but actually uses BMW engines:

Morgans also happen to be mostly hand-built, use wooden body panels, and their factories are mostly old brick buildings. BMW uses much automation/robotics and their factories are more modern and constructed differently. If your only must-have is the BMW engine, do you really care how the car around it was produced? Probably not.

This analogy can help us understand the controversy over growing GMO seeds organically. A widely-held but inaccurate perception of agricultural practices / food production is that they must be either one or the other of these two categories:

But this is a more accurate way of viewing it:

In other words and in most cases the method of production (growing the crop) used in the field is independent of the method used to establish the genetics of that plant (from which the food or ingredients are sourced). What is more, the way that the genetics were assembled in the crop must always precede production of the crop commodity that later becomes food.

Because the genome all genes of the plant is the blueprint for the plant, genetic changes can influence a huge diversity of traits, including (but not strictly or limited to) things like herbicide (such as glyphosate) tolerance. Conversely, not all herbicide tolerance is the result of genetic modification techniques either.

One disclaimer. I have worked for one of the big companies and I have also worked in government alongside incredibly smart people that were not secretly funded by an agricultural biotechnology company contrary to what some camps ceaselessly believe. Neither of those groups have any interest in talking about this topic. Guess why? Because theres no money in it. Thats only half an answer though, because profit in a capitalist market is the by-product of supplying a demand with a desired and affordable producta product that consumers you and me are willing to pay for.

So to ask the question again: Why dont private companies or government have an interest in talking about organic GMOs? Its because theres zero demand. But why is there zero demand? I think its because consumers are completely unaware that its even a theoretical option and thus nobody is asking for such products. In my opinion, organic GMOs have massive potential: to improve nutrition, minimize pesticide use, quickly mitigate production challenges related to climate change, increase carbon sequestration and minimize environmental damage of climate change, reduce costs along the value chain (thus reducing cost of groceries), open up an entire new branch of research, and employ highly-skilled people.

Im going to use a weird-looking square version of a Venn diagram to avoid awkward gaps between boundaries of overlapping circular borders of a normal Venn. Im going to start broad, then increasingly narrow down the details, adding layer upon layer in the diagram. There will be 3 major layers to this process as well:

Unlessan entire genome has been synthetically assembledde novo(by manually connecting millions of independent nucleotides and inserting it into an empty cell resulting in a viable life form) or, by manually editing codons of an existing genomewith alternative sequences with the same function or, unless a living organism has somehow spontaneously manifested itself out of the aether, any organism plant or animal, organic or not must be derived from existing genetics. In other words, in plants, parent genetics have to come together and produce the next generation. For the sake of this post, Im going to represent this starting pool of genetics using a giant grey square:

This is the first major layer to this discussion. So again, this grey square blob contains all the compatible genetics in nature that could possibly be combined and recombined to produce the baby plants of the next generation. (The label at the top refers to two differing and naturally-occurring plant reproductive systems, but regardless, this square still represents all available genetics). In the case of GMOs, cisgenic sources would be grouped into this pool. I didnt show it here because this illustration will become really busy as it is already, but transgenic would be a small, different shade of grey square off to the side (since those genetic modifications do become compatible but technically come from a non-compatible source organism, and make up a very small proportion of all genetic material available.

Next, lets look at the 2nd major layer to this process (As we move inwards towards the centre of this diagram, were moving further along the breeding process, step by step, until we reach the new plant variety. (The letters A, B, C and D refer to various routes to get to that end point, which Ill summarize at the end, but for now just ignore them). Note that sizes of any category are not necessarily proportional to the real amount of material established through either method, its just to illustrate the relationships.):

Since the grey represents any and all possible genetic resources from which the genetics of a new plant variety can be established, any technique, whether itstraditional breeding, or GMO, must be derived from those resources. Those genetic resources used, regardless of the methods, are thus a sub-set of that whole pool of resources available. During this process, tools to enhance the breeding process, such as MAS described earlier, may be used. (Another example might the general category of gene-editing, including techniques such as CRISPR, which are not consistently considered GMO across all regulatory jurisdictions at this time.)

Even though a plant may be the recipient of novel genes, or of engineered changes within its existing genome, these still make up a very small percentage of the entire genome of the plant. Therefore, selection must still be carried out in the field as it would be with traditional breeding. A GMO is not a completely unnatural, 100% fabricated or synthetic thing; it is actually a mostly-the-same variant of the non-GMO counterpart.

Lets look atBrassica napus, for example. This oilseed crop has848,200,303 total nucleotide base pairs(the subunit of genes, and the level at which modifications can be engineered) and a large proportion of varieties in North America are GMO. Now lets compare a GMO version ofBrassica napus,anInVigor variety: one transgene enables it to be unaffected by a herbicide called glufosinate, and a second one that influences fertility in the plant. The former is comprised of171 base pairs, the latter of90 base pairs. In total, these GMO alterations relative to the wild type progenitor account for 0.00003077% difference. Id argue the proteins expressed by the genes should be the focus of any opponent to such technologies, but even those products of the modifications are a minuscule proportion oftotal expression in the plant.

The lighter shading here represents the breeder selection for traits, such as that glufosinate tolerance, or something as straightforward as the height of the plant. Since any breeding program has multiple generations of populations at any given time, theres a lot of back and forth as far as activities go, but this depicts the progress further towards the end goal of establishing a variety:

These activities will be pretty much the same regardless of whether or not GMO techniques have been used, since as mentioned, GMO is not an entirely new thing, it is mostly the same as a non-GMO variant and must still be grown in the field like any other plant. Aside from the new trait(s) of a GMO that result from novel genes introduced, the GMO variant will respond to environmental pressures the same as any other version of it will. A few common traits selected for are highlighted below (the dotted outlines represent particulars that may be regulated differently in different jurisdictions, can cant be considered definitely a traditional or a GMO tool/process, technically speaking):

This part is super interesting, because herbicide tolerance (HT) traits are commonly assumed to always be GMO, but actually they can be established in plants via either traditional breeding, or applying GMO techniques (genetic engineering). HT gives the crop the ability to go unaffected after being sprayed by a specific herbicide which would otherwise kill it.

Ill use canola as an example again here. There are three main categories of HT canola: glufosinate-resistant (GF), glyphosate-resistant (GP), andimidazolinone-resistant(IMI). All are HT, all have functional differences relative to the wild type progenitor, however GF and GP are GMO while IMI isnotGMO since it was established via traditional breeding. In other words, a couple transgenes were deliberately introduced into parent plants chosen from the starting pool (the grey square) giving the GF and GP varieties this HT ability; in contrast, mutagenesis was used for the starting material in preceding generations for the IMI non-GMO varieties. Mutagenesis involves exposing the population to a mutagen that deliberately induces random mutations (genetic disruptions, resulting in new or different traits) in individuals of the population, from which those with ideal traits (including HT) are selected and further generations are derived from those ones. The mutagen agent is of course not carried forward in subsequent generations, but the resulting mutations (and thus resulting traits) are.

This next part is the third major phase of this concept: field production. This is the part where you see farm equipment operating in the field each year. There are two production methods that farmers can choose: conventional, or organic (but the decision will have been made months before planting and/or before acquiring seed). Conventional is a general category referring to the most modern technology (in crop production, or with field equipment), whereas organic is a technical term described in theOrganic Products Regulationswithin the Canada Agricultural Products Act.

Now keep in mind this is technically speaking: put viable seeds in the ground, and they will grow; the field conditions dont really care about whether generations previous to that seed were bred using traditional or genetic modification techniques. This is why the green representing field production practices overlaps with both breeding approaches. Heres that section outlined in the line-dash:

But, because this is regulation (i.e. power of law), this is the part where the value chain becomes somewhat incongruent with technical realities. Remember the chronological order in which these events must all happen. Up to this point, everything follows a logical flow, but suddenly one of them (the dark green, outlined shaded area) is backwards.

Why isorganic a distinct and regulated term.

In Canada, section 1.4 of Organic production systems: General principles and management standardsclearly prohibits materials or techniques in organic production and preparationall products of and materials from genetic engineering (GE), as defined in this standard, and as specified in 4.1.3, 5.1.2 and 6.2.1 of CAN/CGSB-32.311;. This is currentas of March 2021.It defines genetic engineering to produce GMOs as artificial manipulation of living cells for the purpose of altering its genome constitutes genetic engineering and refers to a set of techniques from modern biotechnology by which the genetic material of an organism is changed in a way that does not occur other than through traditional breeding by multiplication or natural recombination. The genome is considered an indivisible entity; artificial technical/physical insertions, deletions, or rearrangements of elementsof the genome constitute genetic engineering.

Lastly, lets address pesticides. This is the final square overlay.

Neither contemporary systems are perfect in this context, since there are a plethora of pesticides approved for bothconventionalandorganic systems. Of course, toxicology will differ for each but regardless, for registration and use in Canada, they are all subject to the same extensiveregulatoryprocessof the Pest Management Regulatory Agency (PMRA) of Health Canada.

Now, look at the four letters labelling the pathways around the sides (A, B, C & D). All three, A, B, and D are technically possible, and allowed. But look at path C: plants are bred from the starting pool using genetic engineering techniques, and could very well be grown in the field with organic production methods, since production occurs after the genetics are established in a variety. Sure, you could argue there would be no point to doing that, if the assumption was that all GMO traits are herbicide tolerance, and thus to benefit from the modifications, the appropriate herbicide must be applied. However, HT is only one of many real and theoretical traits that can be conferred to an oRgaNiSm.

One last layer: A sub-category of conventionally-produced crops are those with a herbicide tolerant (HT) trait and thus a specific herbicide is to be used in the field with them.

This concept was already introduced earlier at the trait selection step in the 2nd phase of this process. To date, there are only HT varieties compatible with conventional production of GMO varieties + application of conventional herbicides (path D), and conventional production of non-GMO varieties + application of conventional herbicides (path A). Technically, path B could be possibleandpermitted under current regulation, assuming there were an organically-approved herbicide to which the crop variety were tolerant, but Im unaware of any. And HT under path C of course can never be reached within current regulation.

Its a bit tricky to depict in an illustration. to select for a trait that confers herbicide tolerance, the plants at that step of the breeding process have to be exposed to a specific herbicide (when the herbicide to be used is already defined) or to be exposed to a spectrum of different herbicides (different chemistries)

Lets put it all together. Heres the full illustration with all the details added:

And guess what: the fundamental genetic building blocks are identical whether the plant is GMO or not. Whether youre eating the plants carbohydrates, proteins or fats, the body therefore isnt concerned about how they were assembled. Either the material is digested / broken down and used in the body, or dissembled and excreted and eventually becomes fertilizer for more things to grow, thus adding to the

Considering the information presented on the Canada Organic Trade Association (COTA), the national association which protects, promotes and builds information on Canadas organic sector, it isvehemently opposedto anything GMO, stating that Genetically engineered products (GMOs) are prohibited in organic production. This means an organic farmer cant plant GMO seeds Actually, I can get on board with most ofwhat they actively promote, lets take a look:

While these are mostly noble goals, the opposition to GMOs is over-reaching and not well founded, as it rejects genetically engineered solutions with identical goals. I suppose it makes sense for an organics association to dictate what/what type of pesticides can be used to establish a specific production environment, but for the same association to take any stance on GMOs is inappropriate.I am not saying safety/practicality/feasibility of genetic engineering should not be assessed; rather, I am saying that should be an independent association/effort rather than distorting interest via the lens of a specific production system.

Genetic engineering is already used to significantly reduce the use of toxic and persistent synthetic pesticides and fertilizers while encouraging biodiversity. Consider Bt crops In this case, one gene from a bacteria (Bacillus thuringiensis, Bt for short originally registered in the USA60 years agoas a biopesticide) that is naturally found in soil was genetically engineered into a corn varietys genome (and subsequently into other crops including soybeans, cotton and eggplant). Why? That gene enabled the bacteria to produce a protein that was naturally (and selectively) an insecticide to a particular insect that happens to be a pest to the corn. Instead of spending time, money, and fuel to spray a synthetic insecticide across entire fields, this modification gave the corn inherent ability to repel that insect.Bt crops eliminate the need to spray to kill insect pests, minimize pest-related crop losses and reduce the financial risksall by using tools already in that environment.

Bt corn was the first insect resistant crop rolled out, in 1995 in the United States. The seeds are now grown in many countries around the world.

Bt cropswhether corn grown in the Canada or South Africa or Brazil, or Bt eggplants grown in Bangladesh have led to a dramatic drop in the use of chemical pesticides.

Organic GMOs will become increasingly relevant in the next few years, not only to comply withglobal effortsto reduce pesticide use, but for reasons unrelated to pesticides.

Here are a few intriguing non-human-nutrition-focused benefits that GMOs could offer, assuming their progress isnt further impeded. Over the past couple decades, they havehelped to reduce pesticide (herbicide and insecticide) and indirectly reduced greenhouse gas emissions. Recent efforts are investigating the ability tomodify plants(trees, maybe field crops soon) to reduce carbon emissions by increasing their capacity to store carbon in their root systems. They hint at other modifications to improve their amenability to processing for biofuel use as well, further adding to efforts to reduce GHG emissions.Other groupsbelieve GMOs are essential to quickly adapting commercial crop varieties for extreme environmental changes, such as drought, or even to produce no-carbon fuel. Check out SingaporesGardens by the Bay, one of many futures that agriculture could take.

Such technologies to combat field pests isnt perfect; some populations of the target pest can eventuallyovercomethe crops inherent insecticidal ability note that this is not unique to insects nor to genetic engineering solutions to pests. There are greater implications beyond the scope here, but briefly, implies how crucial crop rotations are (in other words, removing continuous availability of hosts), as well as taking an integrated approach to production (switching up the tools used to combat pests, and/or using 2 or more tools at once).

Another valid concern raised is that crops modified to endogenously produce pesticides means that it is dispersed throughout the plant & thus the parts that are processed for food. If prohibition of this area of research were to end, I would anticipate that the end-products would be subject to the same extensive Health Canadaregulationsas food additives currently are.

To reiterate: Im not saying this is an all-or-nothing scenario, or that GMOs offer all the answers. But these technologies and systems should be more integrated and be given more consideration as complementary rather than viewed as competition. The rapidity with which environments have changed in recent history I would think is even more reason to put all options on the table. When has prohibition of anything ever been effective?

The purpose of this article is not to declare anything as right or wrong, good or bad, best or worst; rather, it is to help non-specialists understand technical nuances and offer some new information to ponder, or cause some progressive discussion among industry. Hopefully in some way, it might help guide a more progressive, rational, sustainable and/or profitable industry. Nothing here is sponsored; it is simply my own view on current and future directions that agriculture may take.

A version of this article was originally posted at the Former Farmboy and is reposted here with permission.

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