Categories
- Global News Feed
- Uncategorized
- Alabama Stem Cells
- Alaska Stem Cells
- Arkansas Stem Cells
- Arizona Stem Cells
- California Stem Cells
- Colorado Stem Cells
- Connecticut Stem Cells
- Delaware Stem Cells
- Florida Stem Cells
- Georgia Stem Cells
- Hawaii Stem Cells
- Idaho Stem Cells
- Illinois Stem Cells
- Indiana Stem Cells
- Iowa Stem Cells
- Kansas Stem Cells
- Kentucky Stem Cells
- Louisiana Stem Cells
- Maine Stem Cells
- Maryland Stem Cells
- Massachusetts Stem Cells
- Michigan Stem Cells
- Minnesota Stem Cells
- Mississippi Stem Cells
- Missouri Stem Cells
- Montana Stem Cells
- Nebraska Stem Cells
- New Hampshire Stem Cells
- New Jersey Stem Cells
- New Mexico Stem Cells
- New York Stem Cells
- Nevada Stem Cells
- North Carolina Stem Cells
- North Dakota Stem Cells
- Oklahoma Stem Cells
- Ohio Stem Cells
- Oregon Stem Cells
- Pennsylvania Stem Cells
- Rhode Island Stem Cells
- South Carolina Stem Cells
- South Dakota Stem Cells
- Tennessee Stem Cells
- Texas Stem Cells
- Utah Stem Cells
- Vermont Stem Cells
- Virginia Stem Cells
- Washington Stem Cells
- West Virginia Stem Cells
- Wisconsin Stem Cells
- Wyoming Stem Cells
- Biotechnology
- Cell Medicine
- Cell Therapy
- Diabetes
- Epigenetics
- Gene therapy
- Genetics
- Genetic Engineering
- Genetic medicine
- HCG Diet
- Hormone Replacement Therapy
- Human Genetics
- Integrative Medicine
- Molecular Genetics
- Molecular Medicine
- Nano medicine
- Preventative Medicine
- Regenerative Medicine
- Stem Cells
- Stell Cell Genetics
- Stem Cell Research
- Stem Cell Treatments
- Stem Cell Therapy
- Stem Cell Videos
- Testosterone Replacement Therapy
- Testosterone Shots
- Transhumanism
- Transhumanist
Archives
Recommended Sites
Monthly Archives: July 2021
LGBTQ patients face bias at the doctor’s office. Here’s how a first-of-its-kind fellowship at UW medical school aims to change that. – Appleton Post…
Posted: July 21, 2021 at 2:02 am
The University of Wisconsin School of Medicine and Public Health will be the first site to host a new national fellowship that aims to makethe doctor's office more supportive ofLGBTQ patients.
The school will receive $750,000 over four years from the American Medical Association Foundation to launch a training program for early-career primary care physicians to ensureLGBTQ people have access to a high standard of health care.
Research has shown that discrimination against LGBTQ people is associated with higher rates of depression, increased suicide risk and reduced access to preventive health caresuch as cancer screenings.
In the past year, 15% of LGBTQ Americans postponed needed medical care for fear of discriminationfrom their health care provider, according to an October 2020 study from the Center for American Progress, a progressive think tank based in Washington, D.C.
Many LGBTQ respondents have had other negative experiences with health care, the study found, including a provider being visibly uncomfortable with their sexual orientation (14% of respondents), harsh or abusive language (8%) or unwanted physical contact (7%).
The outlook is worse for transgender people a third of whom in the same study reported having to teach their provider about transgender people to receive appropriate care and LGBTQ people of color, who often experience intersecting discrimination.
These results track locally: A 2019 study using data from the Survey of the Health of Wisconsin found lesbian, gay and bisexual Wisconsinites were twice as likely as their heterosexual counterparts to delay obtaining health care, and transgender residents were nearly three times more likely to report poor quality of care and unfair treatment by the medical profession.
RELATED:New UW clinic to use latest genetic technology to help patients with unknown diseases
RELATED:Pride across a century: A look at the LGBTQ history of Wisconsin
UW-Madison's fellowship program aims to turn those outcomes around. And while it's first, the foundation'swebsite says it plans to support fellows at dozens of institutions over the next decade.
Dr. Elizabeth Petty, senior associate dean for academic affairs at the School of Medicine and Public Health, will serve as program director.
As a lesbian woman, Petty said she hashad some negative encounters with the health care system.
"I've had some things that were said that were offensive or humiliating, things that were wrong in terms of making assumptions about my sexual activity ... not offering the kind of care I knew I needed as a physician," she said.
She's also part of Facebook groups for LGBTQ people in Madison to share which doctors will provide affirming care and which to avoid. It upsets her that affirmingcare isn't a given.
The fellows who take part in this program are expected to help changethat landscape. Petty said they plan to recruit nationally for early-career primary care providers who have a track record of health equity work.
The first year of the program, which will kick off in July 2022, will serve as a pilot year, with the goal of adding three fellows per year as its reputation grows.
It will be housed within the school's Department of Family Medicine and Community Health, andfellows will do both clinical and classroom training in LGBTQ health topics and participate in research, teaching, mentoring and community engagement.
Research in particular will be critical to improving health outcomes for LGBTQ people, Petty said, because there's so much left to be explored: the unique needs in rural communities, across intersections of race and ethnicity, and across a person's lifespan, to name a few.
When fellowships conclude, doctors will have a variety of options at their fingertips, she said. They could stay on to do research or teach at UW, join a practice elsewhere in Wisconsin or even go on to be a "change agent" at the national level.
Petty said it's exciting to be the first school chosen for the fellowship program, but that it's even more exciting to picture a few years down the road, when theremight be a strong network of programs improving the health care experiencefor LGBTQ patients across the country.
In Wisconsin, she feels the work will tie directly to the Wisconsin Idea the notion that what's learned at the university should be applied to solve problems throughout the state.
"We can change the shape of health care for LGBTQ people," she said. "We're here to serve."
Contact reporter Madeline Heim at 920-996-7266 or mheim@gannett.com. Follow her on Twitter at @madeline_heim.
The rest is here:
LGBTQ patients face bias at the doctor's office. Here's how a first-of-its-kind fellowship at UW medical school aims to change that. - Appleton Post...
Posted in Genetic medicine
Comments Off on LGBTQ patients face bias at the doctor’s office. Here’s how a first-of-its-kind fellowship at UW medical school aims to change that. – Appleton Post…
Movers & Shakers, July 16 | BioSpace – BioSpace
Posted: July 21, 2021 at 2:02 am
Tessara Therapeutics Cambridge, Mass.-based Tessara Therapeutics tapped Howard Liang as president and chief executive officer. Additionally, the company also expanded its leadership team with multiple appointments. Madhusudan Peshwa was named Chief Technology Officer for Cell Therapy;Bill Querbes was tapped as Senior Vice President of Therapeutic Discovery & Translational Sciences; Cecilia Cotta-Ramusino was promoted to Senior Vice President of Platform Development; Vikram Ranade was named Senior Vice President of Corporate Development; David Pollard was named Head of Bioprocess, and Steve Garbacz was tapped as Head of Finance. Prior to joining Tessara, Liang was Chief Financial Officer and Chief Strategy Officer at BeiGene for six years.
Before BeiGene, Liang spent 10 years at Leerink Partners, where he was Managing Director and Head of Biotechnology Equity Research. Peshwa joined Tessara in May 2021 after serving as CTO at Mana Therapeutics Peshwa is responsible for developing the strategy and executing the operating plan encompassing the design, development, and manufacture of Tessaras proprietary mobile gene element engineered cell therapy product portfolio. Bill Querbes joined Tessara in April of 2021 as Senior Vice President of Therapeutic Discovery and Translational Sciences. Before that, he held the position of Vice President and Fabry Program Lead at AVROBIO. Cecilia Cotta-Ramusino joined Tessara in 2019 as the Head of Platform Development. Cotta-Ramusino was the first employee at insitro where she was the Head of Functional Genomics. Prior to insitro, she was one of the first scientists hired at Editas.Ranade joined Tessara in 2020 as the Head of Corporate Development.
In this role, he drives corporate strategy, business development, and investor relations for Tessara. He was previously at McKinsey & Company, where he was an Associate Partner in the healthcare practice. Pollard, the head of Bioprocess, has over 25 years of bioprocess development. He has held roles at Merck & Co. and Sartorius. Pollard will help Tessara drive digital workflows and high throughput automation to accelerate sustainable gene therapy process development. Steve Garbacz joined Tessara in 2021 as the Head of Finance. He has more than 25 years of experience in financial management for a range of companies, including Biogen, Epizyme, Spero, and Anika.
AbCellera Neil Berkley has been named Chief Business Officer of AbCellera. Berkleys role will include leading the strategy and continued growth of AbCelleras partnership business, which currently includes a diverse portfolio of more than 100 programs with drug developers of all sizes. He joins AbCellera from Halozyme Therapeutics, where he served as Vice President, Head of Business Development. Berkley held leadership roles at Axerovision, COI Pharmaceuticals, Acadia Pharmaceuticals, Cadence Pharmaceuticals, and GSK. He also cofounded Mpex Pharmaceuticals, which was acquired by Aptalis, and Vaxiion, a clinical stage bladder cancer company.
Pierre Fabre Francesco Hofmann was appointed Head of R&D at Pierre Fabre Medical Care. Hofmannwilloversee theGroup's innovation strategy for pharmaceuticals (oncology, dermatology, rare diseases, health care). Before joining the Pierre Fabre Group, Hofmann had been workingas Global Head of Oncology Drug Discoveryfor Novartis. In this leadership role, hecoordinatedthe discovery andprogression intoclinical development of no less than twelve new cancer drugs. Hofmann'sprimarymission will be toaccelerate the delivery of new therapeuticstodevelop the Group's R&D portfolio in pharmaceuticals, through a combination of in-house projects and external partnership opportunities.
Sherlock Biosciences Bryan Dechairo was named president and CEO of Cambridge, Mass.-based Sherlock. He succeeds co-founder Rahul Dhanda, who willcontinue to serve as a board member until the end of 2021 and then as strategic adviser in 2022.Dechairo joins Sherlock from Myriad Genetics, where he was executive vice president of clinical development. Before joining Myriad, he was CMO, chief scientific officer and senior vice president of research and development at Assurex Health, which was acquired by Myriad in 2016. Prior to Assurex Health, Dechairo held roles of increasing responsibility at Medco Health Solutions, Pfizer and other diagnostic and therapeutics companies.
Atsena Therapeutics Jennifer Wellman was appointed to the board of directors of N.C.-based Atsena Therapeutics. Wellman is the Chief Operating Officer of Akouos, Inc., a precision genetic medicine company. Prior to Akouos, Wellman was Head of Product Development Strategy at Spark Therapeutics, Inc., now a subsidiary of Roche Holding AG, where she was also a co-founder. Previously, Wellman was the Director of Regulatory Affairs for the Center for Cellular and Molecular Therapeutics at Childrens Hospital of Philadelphia.
Eleusis London-based Eleusis tapped four members for its board of directors. David Socks, former CEO of Phathom Pharmaceuticals, joined as chairman of the board. Robert Hershberg, former CBO and CSO of Celgene; John Tucker, CEO of SC Pharmaceuticals; and Esther van den Boom, Managing Partner at van den Boom & Associates also joined.
H1 New York-based H1 announced Mohak Shah has joined the company as SVP of Data Science and Learning. Before joining H1, he was the Vice President of AI and ML at LG Electronics, and prior to that was the Head of Data Science at Bosch.
Renovacor Jiwen Zhang was named senior vice president of regulatory affairs and quality assurance at Philadelphia-based Renovacor, Inc. She most recently served as vice president, head of regulatory affairs at Passage Bio, Inc., an AAV-based gene therapy company. Prior to her time at Passage Bio, Zhang worked as executive director, head of regulatory affairs at Tmunity Therapeutics, Inc. Zhang also previously worked at GE Healthcare and was responsible for building a regulatory affairs function to support the companys newly formed cell technology and regenerative medicine business. Before joining GE Healthcare, Zhang held roles of increasing responsibility at several companies including Merck and Co. Inc., Wyeth Pharmaceuticals (now Pfizer) and Sanofi.
Opiant Pharmaceuticals Matthew Ruth was named Chief Commercial Officer of Opiant Pharmaceuticals. From 2015 until 2019,Ruthwas responsible for building out theU.S.Operational, Commercial, Government Affairs and Medical Affairs team in preparation for the launch and commercialization of Opiants branded nasal naloxone spray. Prior to his work in the opioid overdose space,Ruthwas Chief Operating Officer for RightCare Solutions, a medical technology company. Earlier in his career,Ruthwas Vice President of Azur Pharma. From 2006 to 2007, he was Vice President forAvanir Pharmaceuticals. Prior to that, he held positions of increasing responsibility at Allergan.
Glytec Jordan Messler was named CMO of Waltham, Mass.-based Glytec. In this new role, Messler will be responsible for spearheading continuous improvement initiatives for Glytecs clinical strategy and product development while supporting the delivery, customer, quality and regulatory teams to ensure ethical and safe glycemic management best practices. Messler joined Glytec in October 2018 as the Executive Director of Clinical Practice. Before Glytec, he was the Medical Director for the Morton Plant Hospitalist group.
T-knife Therapeutics Megan Baierlein was named COO of Bay Area-based T-knife. Baierlein was most recently the senior vice president and COO at Audentes Therapeutics, overseeing program management, clinical operations, and general and administrative functions. Prior to Audentes, Baierlein served as executive director of program management at Ultragenyx Pharmaceutical, Inc. Before that, she held management positions at BioMarin in both program management and clinical operations. Earlier in her career, Baierlein held roles of increasing responsibility at Genentech and Elan Pharmaceuticals.
Ji Xing Pharmaceuticals Shanghai-based Ji Xing tapped Joseph Romanelli as CEO. Romanelli has more than 25 years of biopharmaceutical and biotechnology experience, nearly all with Merck & Co., Inc. Most recently, he served as the President of MSD China for more than four years, where he oversaw over 20 product launches, including Keytruda and Gardasil. From an industry and organizational perspective, he was named a Top Ten Pharma Leader of the Year in 2019 by the National Healthy China Forum and managed the companys more than 5,000 employees in the market. He also briefly served as President of U.S. Human Health at Merck overseeing the companys largest market by revenue. Previously, Romanelli held senior roles, including Vice President of Investor Relations.
Hillstream BioPharma Scott J. Dixon, Associate Professor of Biology at Stanford University and Faculty Fellow of Stanfords ChEM-H initiative and Member at Stanford Cancer Institute, joined the Scientific Advisory Board of Hillstream BioPharma.
Certara Nicolette D. Sherman was named Chief Human Resources Officer at Certara. Most recently, Sherman was CHRO at Oyster Point Pharma. Prior to that, she served in multiple roles at Sanofi for 12 years, including Vice President of North American Human Resources Operations and Vice President of Global Leadership Development.
BeyondSpring Brendan Delaney, the Chief Commercial Officer of Constellation Pharma, was appointed to the BeyondSpring Board of Directors. Prior to joining Constellation, Delaney was the CCO at Immunomedics, where he led the buildout of the marketing, sales, market access and commercial operations teams. Previously, he served as Vice President of U.S. Hematology-Oncology at Celgene Corporation. Prior to joining Celgene, he held various commercial roles at both Novartis Oncology and Genentech, where he led several successful product launches for blockbuster brands.
Cygnal Therapeutics Timothy Zheng joined Cygnal Therapeutics as Senior Vice President ofBiology. Zheng joins Cygnal from Boehringer Ingelheim, where he was a Highly Distinguished Research Fellow. He also served as a Member of the U.S. Research Site Leadership Committee and as Executive Director, Immune Modulation. Prior to Boehringer Ingelheim, he held a number of roles at Biogen and Biogen Idec over a 17-year period with increasing responsibilities, most recently as Director of Immunology and then Director of Neuroimmunology.
Byondis Timo van den Berg was named Senior Director of Immuno-Oncology R&D at Netherlands-based Byondis BV. Most recently he serves as head and principal investigator, Immunotherapy Laboratory, Department of Molecular Hematology at Sanquin Research, a non-profit organization responsible for the blood supply in the Netherlands. Since 2017, Van den Berg has been professor of Immunotherapy at Vrije Universiteit. Van den Berg is a member of many boards, including Amsterdam Infection and Immunity Institute and Cancer Center Amsterdam.
FINN Partners Kristie Kuhl was promoted to managing partner, Global Health Practice Leader for FINN Partners, an industry media organization. Kuhl joined Finn Partners in 2015 as U.S. Pharma and NY Health Head. She came to FINN after serving as an executive vice president at agencies Cohn & Wolfe and Makovsky, where she drew on her knowledge of pharma marketing, regulatory law, patient advocacy and the U.S. reimbursement system to advance breakthrough therapies.
Visit link:
Movers & Shakers, July 16 | BioSpace - BioSpace
Posted in Genetic medicine
Comments Off on Movers & Shakers, July 16 | BioSpace – BioSpace
Esoteric Testing Market: Chemiluminescence segment is expected to witness strong growth – BioSpace
Posted: July 21, 2021 at 2:02 am
Esoteric testing is the analysis of 'rare' molecules or substances. It is not performed in a routine clinical laboratory. These test are performed when there is requirement of additional information external routine lab testing, for proper diagnosis of disease, establish a prognosis or select and supervise a therapeutic treatment. Esoteric testing requires skilled personnel to perform the test and analyze the results due to usage of sophisticated chemicals and instruments. The tests are performed by specialized and independent clinical reference laboratories owing to high cost. It is not feasible for physician office laboratories and hospitals to perform these tests in-house. The test are regulated by regulatory stringent regulatory framework. These tests are not performed regularly.
Request Brochure of Report @
https://www.transparencymarketresearch.com/sample/sample.php?flag=B&rep_id=30377
Based on test type, the global esoteric testing market has been segmented into genetics, endocrinology, immunology, molecular diagnostics, microbiology, oncology, serology, and toxicology. Molecular diagnostics is the fastest growing segment of the market, followed by the immunology and oncology segments, owing to increased prevalence of rare and genetic diseases and high demand for personalized medicine treatment. In terms of technology, the esoteric testing market has been segmented into chemiluminescence, ELISA, mass spectrometry, real time PCR, and flow cytometry. The chemiluminescence segment is expected to witness strong growth, followed by ELISA, because it is the most widely used technology in esoteric testing due to high efficiency and small sample required for testing. The real time PCR segment is expected to be driven by rise in prevalence of genetic disease and increase in demand for genetic testing. Growing use of information technology has allowed instant and efficient data transfer. These developments will provide more efficient results and improved patient care creates huge demand for esoteric testing market. Complex diseases difficult to diagnose and treat through conventional methods are diagnosed using esoteric testing. Rising prevalence of such complex and rare medical diseases is expected to contribute to the growth of the esoteric testing market. Additionally, high investments in proteomics, increasing demand for personalized medicine, and genomics boost the growth of the esoteric testing market. However, stringent government regulations and dearth of qualified and trained professionals are likely to restrain the esoteric testing market.
Request for Analysis of COVID-19 Impact on Esoteric Testing Market @
https://www.transparencymarketresearch.com/sample/sample.php?flag=covid19&rep_id=30377
In terms of region, the global esoteric testing market can be classified into North America, Latin America, Europe, Asia Pacific, and Middle East & Africa. North America dominates the esoteric testing market, followed by Europe, due to higher incidence and prevalence rate, growing awareness about early disease detection, and quick adoption of sophisticated instruments. Asia Pacific is an emerging market for esoteric testing due to increasing prevalence of disease, gradual development of medical infrastructure, rising awareness, and significant patient pool with unmet medical needs. However, high cost, lack of availability of trained personnel, and poor patient awareness are factors restraining the esoteric testing market in regions such as Middle East & Africa and Latin America.
Pre Book Esoteric Testing Market Report at @
https://www.transparencymarketresearch.com/checkout.php?rep_id=30377<ype=S
Major players operating in the esoteric testing market include Laboratory Corporation of America Holdings, OPKO Health, Inc., ARUP Laboratories, Genomic Health, Inc., Quest Diagnostics, American Medical Laboratories, Gold Standard Diagnostics Corp, and ZeptoMetrix Corporation.
About Us
Transparency Market Research is a next-generation market intelligence provider, offering fact-based solutions to business leaders, consultants, and strategy professionals.
Our reports are single-point solutions for businesses to grow, evolve, and mature. Our real-time data collection methods along with ability to track more than one million high growth niche products are aligned with your aims. The detailed and proprietary statistical models used by our analysts offer insights for making right decision in the shortest span of time. For organizations that require specific but comprehensive information we offer customized solutions through ad hoc reports. These requests are delivered with the perfect combination of right sense of fact-oriented problem solving methodologies and leveraging existing data repositories.
TMR believes that unison of solutions for clients-specific problems with right methodology of research is the key to help enterprises reach right decision.
ContactMr. Rohit BhiseyTransparency Market ResearchState Tower,90 State Street,Suite 700,Albany NY - 12207United StatesUSA - Canada Toll Free: 866-552-3453Email: sales@transparencymarketresearch.comWebsite: https://www.transparencymarketresearch.com/
Original post:
Esoteric Testing Market: Chemiluminescence segment is expected to witness strong growth - BioSpace
Posted in Genetic medicine
Comments Off on Esoteric Testing Market: Chemiluminescence segment is expected to witness strong growth – BioSpace
Pacific Biosciences and Invitae Announce Intent to Expand Collaboration – BioSpace
Posted: July 21, 2021 at 2:02 am
MENLO PARK, Calif., July 20, 2021 (GLOBE NEWSWIRE) -- Pacific Biosciences of California, Inc. (Nasdaq: PACB)(Pacific Biosciences or PacBio), a leading provider of high-quality, long-read sequencing platforms, and Invitae Corporation (NYSE: NVTA), a leading medical genetics company, today announced an intent to expand their multi-year collaboration to develop a production-scale high-throughput HiFi sequencing platform to include the sequencing technology developed by Omniome, Inc.
The expansion of the collaboration is expected to add the short read sequencing technology enabled by Sequencing by Binding (SBB) chemistry upon close of PacBios proposed acquisition of Omniome, and contingent upon PacBios and Invitaes agreement of associated terms. Omniomes novel and highly differentiated sequencing technology promises significant improvement in raw base accuracy over traditional next generation sequencing products enabling the potential for more precise and sensitive molecular diagnostics. PacBio and Invitae intend to work together to leverage the improved accuracy and sensitivity of SBB chemistry to further advance cancer diagnostics and pathogen detection. Additionally, the parties intend to work together to explore novel methods of integrating SBB chemistry with PacBios HiFi genomes.
We believe access to both of these technologies will accelerate the adoption of long read sequencing techniques in clinical whole genome applications, providing deeper insight into the genome and lower the overall cost of analysis, said Christian Henry, CEO and President at PacBio. Scientists and clinicians rely on accurate short reads and accurate long reads to conduct their science and answer their specific questions. We seek to deliver the most advanced sequencing solutions and are excited that we might expand our development collaboration with Invitae to broadly enable their clinical NGS sequencing.
In partnering with the PacBio team, we are pleased with our progress toward a new generation of innovative whole genome-based offerings, and look forward to expanding that effort to include the highly differentiated SBB chemistry, said Sean George, Co-Founder, President and Chief Executive Officer of Invitae. By combining SBB with PacBios HiFi Sequencing, the opportunity and utility of next generation sequencing technologies can be expanded for patients in the clinical setting with improvement in accuracy and reduction in costs.
The expansion of the collaboration is expected to begin in the second half of 2021 once PacBios acquisition of Omniome, Inc. is complete.
About Pacific BiosciencesPacific Biosciences of California, Inc. (NASDAQ: PACB) is empowering life scientists with highly accurate long-read sequencing. The companys innovative instruments are based on Single Molecule, Real-Time (SMRT) Sequencing technology, which delivers a comprehensive view of genomes, transcriptomes, and epigenomes, enabling access to the full spectrum of genetic variation in any organism. Cited in thousands of peer-reviewed publications, PacBio sequencing systems are in use by scientists around the world to drive discovery in human biomedical research, plant and animal sciences, and microbiology. For more information, please visit http://www.pacb.com and follow @PacBio.
About InvitaeInvitae Corporation (NYSE: NVTA) is a leading medical genetics company whose mission is to bring comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Invitaes goal is to aggregate the worlds genetic tests into a single service with higher quality, faster turnaround time, and lower prices. For more information, visit the companys website at invitae.com.
PacBio products are provided for Research Use Only. Not for use in diagnostic procedures.
Forward-Looking Statements This press release may contain forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the U.S. Private Securities Litigation Reform Act of 1995, including statements relating to the intended expansion of the collaboration between PacBio and Invitae to include Omniomes short read sequencing technology, including the expected timing of such expansion; the potential for PacBio to enable Invitaes clinical NGS sequencing capabilities; PacBio and Invitae agreeing to associated terms of such collaboration expansion; the potential cost reductions, and potential increases in accuracy and sensitivity, associated with the use of SBB technology; the potential use of SBB technology for more precise and sensitive molecular diagnostics, including cancer diagnostics and pathogen detection; potential novel methods of integrating SBB chemistry with PacBios HiFi genomes; expectations that access to both SBB and HiFi sequencing technologies may accelerate adoption of long read sequencing techniques in clinical whole genome applications; expectations regarding the timing of the closing of PacBios proposed acquisition of Omniome, and increase the rate of identification of, potential disease-causing genetic variants in rare disease the potential of HiFi data, the applications, insights, and attributes of SMRT sequencing technology, and the benefits of PacBio sequencing. Readers are cautioned not to place undue reliance on these forward-looking statements and any such forward-looking statements are qualified in their entirety by reference to the following cautionary statements. All forward-looking statements speak only as of the date of this press release and are based on current expectations and involve a number of assumptions, risks and uncertainties that could cause the actual results to differ materially from such forward-looking statements. Readers are strongly encouraged to read the full cautionary statements contained in the Companys filings with the Securities and Exchange Commission, including the risks set forth in the companys Forms 8-K, 10-K, and 10-Q. The Company disclaims any obligation to update or revise any forward-looking statements.
Contacts
Investors:Todd Friedman+1 (650) 521-8450ir@pacificbiosciences.com
Media:Jen Carroll+1 (858) 449-8082pr@pacificbiosciences.com
Read more:
Pacific Biosciences and Invitae Announce Intent to Expand Collaboration - BioSpace
Posted in Genetic medicine
Comments Off on Pacific Biosciences and Invitae Announce Intent to Expand Collaboration – BioSpace
Arbor Strengthens Focus on Therapeutics with Key Additions to Leadership Team – Yahoo Finance
Posted: July 21, 2021 at 2:02 am
- Pam Stetkiewicz, Ph.D., Appointed Chief Operating Officer - Kathryn McCabe, Ph.D., Named SVP, Head of Business Development
CAMBRIDGE, Mass., July 20, 2021 (GLOBE NEWSWIRE) -- Arbor Biotechnologies, an early-stage life sciences company discovering and developing the next generation of genetic medicines, announced today the appointments of Pam Stetkiewicz, Ph.D., as Chief Operating Officer, and Kathryn McCabe, Ph.D., as SVP, Head of Business Development. These appointments further expand Arbors leadership team and strengthen its focus on therapeutics.
Bringing Pam and Katy on at this time represents a significant milestone for Arbor as we drive our genetic medicines portfolio to the clinic and partner with leading companies to bring engineered cell therapies to patients, said Devyn Smith, Ph.D., CEO, Arbor Biotechnologies. Their scientific expertise, business acumen, and extensive experience in cell therapy and gene editing will help us execute on this strategy to develop therapeutics with our tailored library of CRISPR-based genetic editors and modifiers.
Pam Stetkiewicz is joining Arbor from Flagship Pioneering, where she was Senior Vice President, Global Program Leader at Flagship Pioneering Medicines. Dr. Stetkiewicz brings more than 20 years of extensive life-sciences pharmaceutical experience with recent experience at Editas Medicine as Vice President, Program and Alliance Management. At Editas, she led the team that filed the first IND for an in vivo CRISPR therapeutic (EDIT-101 for LCA10). Prior to Editas, Dr. Stetkiewicz worked at Novartis Institute of Biomedical Research for 13 years, in a variety of roles across science, alliance, project and portfolio management. Her last role at Novartis was as Executive Director, in Strategic Alliances which involved early business development and collaborations with external companies. She received her Ph.D. from Johns Hopkins University and a B.S. from the University of Rhode Island.
Story continues
Im thrilled to be joining Arbor at this exciting time, said Dr. Stetkiewicz. The company has made significant progress in the discovery and development of innovative therapies, particularly in the genetic medicines space, and I am looking forward to helping fulfill the therapeutic promise of Arbors already impressive discoveries.
Kathryn (Katy) McCabe is joining Arbor from Roche where she was Senior Director of Business Development based in Cambridge, MA. Over the last 20 years, she has combined her scientific knowledge, entrepreneurial spirit, and business experience to help transform novel modalities into new medicines at Roche, Lilly, Baxalta and GSK. Dr. McCabe has focused much of her attention on cell and gene therapy and has closed deals for CAR-T, diabetes cell therapy, in vivo gene editing, and gene therapy as well as led large strategic initiatives in these areas. In addition, she has had close interactions with a number of venture funds as the scientific lead for Lillys limited partnerships. Early in her career, Dr. McCabe led a team of senior scientists to develop stem cells for retina and corneal transplantation. She was a Postdoctoral Fellow in Dr. Marianne Bronners lab at Caltech, received her Ph.D. in Neuroscience and Behavior from the University of Washington, and her B.A from the University of Pennsylvania.
I look forward to finding partners that share our vision of bringing curative therapies to patients, said Dr. McCabe.
About Arbor BiotechnologiesArbor Biotechnologies is an early-stage life sciences company discovering and developing the next generation of genetic medicines. Co-founded by Feng Zhang and David Walt, Arbor uses its proprietary discovery engine to uncover unique CRISPR-based genetic modifiers with differentiated genetic editing and delivery capabilities. Following its strategic partnership with Vertex Pharmaceuticals to accelerate the path to the clinic for Arbors technologies, Arbor recently announced an agreement with Lonza. These partnerships further validate the breadth of applications of Arbors gene editing platform that can be custom tailored to address the underlying pathology of each genetic disease. Arbors pipeline of genetic medicines is focused on bringing curative therapies to all patients with genetic disease.
Media Contact:Kelly Friendlypress@arbor.bio
Follow this link:
Arbor Strengthens Focus on Therapeutics with Key Additions to Leadership Team - Yahoo Finance
Posted in Rhode Island Stem Cells
Comments Off on Arbor Strengthens Focus on Therapeutics with Key Additions to Leadership Team – Yahoo Finance
Missouri S&T hosts first in series of national critical minerals workshops – Missouri S&T News and Research
Posted: July 21, 2021 at 2:00 am
What are critical minerals, where do we find them, and why are they considered critical? Leading critical-minerals experts from across the country will answer these questions and more during a virtual workshop hosted by Missouri S&T Aug. 2-3. The workshop will provide insight and answers to issues surrounding materials such as cobalt for lithium-ion batteries in electric vehicles, germanium for transistors, tellurium for solar cells and rare earth elements for magnets and electronics.
The term critical minerals describes commodities whose unreliable supply threatens our nations economy and defense, says workshop organizer Dr. Marek Locmelis, assistant professor of geology and geophysics at Missouri S&T. The critical-minerals discussion cuts across a variety of disciplines, from mining and geosciences to public policy to environmental considerations. Important concerns are sustainability, ethical and responsible sourcing, and research for compounds that could replace critical minerals.
Missouri S&T will host eight keynote presenters:
Keynote presentations will address several topics: supply chains, global politics, domestic sourcing and production, recycling, and reprocessing. The workshop will also address the illicit critical-mineral economy, a topic of increasing urgency as critical minerals are sometimes unethically mined for example, using child labor and human trafficking and illegally marketed, similar to issues associated with conflict diamonds.
The workshop will also feature breakout sessions where participants will discuss research needs in areas related to the keynote presentations. The discussions can be used to inform Congress and develop federal funding initiatives.
The workshop is funded through a grant from the National Science Foundation and is the first in a planned series of national conversations about critical minerals. The workshops will bring together representatives from higher education, industry and government to help spur action and disseminate research on critical minerals.
We are grateful for the NSFs support for this crucial topic, says Locmelis. We will continue the discussions during an in-person workshop on the Missouri S&T campus in mid-2022. Because the critical-mineral challenge will stay with us for decades, we look forward to developing the workshop into a regular series of meetings in the future.
In addition to Locmelis, workshop organizers include Dr. Michael Moats, professor and interim chair of materials science and engineering; Dr. Kwame Awuah-Offei, interim director of mining and explosives engineering; Dr. Lana Alagha, associate professor of mining engineering; Dr. Mark Fitch, assistant chair and associate professor of civil, environmental and architectural engineering; Dr. Alanna Krolikowski, assistant professor of history and political science; and Dr. Angela Lueking, associate dean for research in the College of Engineering and Computing at Missouri S&T.
The workshop is open to anyone who is interested in critical minerals. For more information or to register, visit criticalminerals.mst.edu/.
About Missouri University of Science and Technology
Missouri University of Science and Technology (Missouri S&T) is a STEM-focused research university of over 7,600 students and part of the four-campus University of Missouri System. Located in Rolla, Missouri, Missouri S&T offers 101 different degree programs in 40 areas of study and is ranked by CollegeFactual as the best public university to study engineering. For more information about Missouri S&T, visit http://www.mst.edu.
Follow this link:
Missouri S&T hosts first in series of national critical minerals workshops - Missouri S&T News and Research
Posted in Missouri Stem Cells
Comments Off on Missouri S&T hosts first in series of national critical minerals workshops – Missouri S&T News and Research
In Brief This Week: DiaSorin, Cue Health, Avacta, Pandemic Response Lab, TruDiagnostic, and More – 360Dx
Posted: July 21, 2021 at 1:59 am
NEW YORK In a filing with the US Securities and Exchange Commission this week, Luminex said it became a wholly owned, indirect subsidiary of DiaSorin,and the previously announced merger of the companies has been completed.
DiaSorin announced in a separate statement thatit completed the acquisition for a price of $37 per share, or a total equity value of approximately $1.8 billion. The acquisition gives it access to Luminexs multiplexing technology, a portfolio that will strengthen its current offeringand expand its presence in the US, DiaSorin said.
Cue Health said this week that its Cue COVID-19 Test Kit has received regulatory approval from the Central Drugs Standard Control Organisation for professional point-of-care use in India. The molecular test provides results within 20 minutes and connects to smartphones to report results. The test can also detect emerging variants, Cue said in a statement.
Avacta Life Sciences said this week that its diagnostics division has obtained ISO 13485 certification for the quality management system for the manufacture and distribution of its Affimer reagents for use in lateral flow, ELISA, and immunodiagnostic in vitro diagnostic devices. The ISO standard defines the requirements for quality management for a developer and legal manufacturer of diagnostic products and medical devices. Avacta said the certification provides a practical foundation for addressing regulatory requirements and ensures the safety of its products. The certification also means that a CE mark for the AffiDx SARS-CoV-2 antigen lateral flow test can be transferred to Avacta from its partner Mologic, Avacta added.
The Pandemic Response Lab and Brio this week announced they are partnering to offer COVID-19 testing and variant surveillance for the entertainment industry. Brio will provide sample collection services, logistics, reporting, advanced software, and support to entertainment facilities. PRL, operated by Opentrons Labworks, will conduct PCR testing and genome sequencing of positive results to track variants. PRL can provide results from PCR testing in six hours or less, the firms said in a statement. Financial and other terms of the deal were not disclosed.
Ott Scientific said this week it is merging its four legacy organizations into one business called Ethos Biosciences. Ethos will operate four product lines and service brands American Bionostica for lateral flow products; Astral Diagnostics for histology and hematology stains and reagents; Exocell for research and clinical nephrology assays; and Astral Rx for pharmaceutical formulations. Ethos will serve the diagnostics market, including healthcare, biotechnology, veterinary, and food and environmental testing. It will operate in Newtown Square, Pennsylvania, and Logan Township, New Jersey.
The Access to Comprehensive Genomic Profiling Coalition, a group working to expand insurance coverage of broad genomic testing panels for advanced cancer patients, this week announced Strata Oncology as its newest member. Strata offers comprehensive genomic profiling using its StrataNGS panel, and combines patients genomic information with real-world data to provide information doctors can use to make personalized treatment plans. The company also operates a clinical trial platform.
TruDiagnosticsaid this week it has licensed mitotic clock technology from the Van Andel Institute and Cedars-Sinai Medical Center. Developed by epigenetics researchers at those institutions, the mitotic clock examines how many times a cell has undergone replication, and could be useful in clinical research and personalized medicine applications, TruDiagnosticsaid. For instance, the technology may be able to detect cell senescence, a biomarker for aging; unusually high levels of cell division, which may be a biomarker for cancer or other disease; and stem cell depletion. TruDiagnostic said that it will work with researchers at the Van Andel Institute to further develop the technology.
MedMira, a developer and manufacturer of rapid diagnostic tests, said this week that it has closed a C$500,000 ($396,648) equity investment with a Canadian investor to increase its operational capacity. The equity investment, fully diluted, represents less than 1 percent of its total shareholding. Under the terms of the deal, the investor will acquire 2,711,496 equity units at $0.18444 per unit.
ACT Genomics Holdings said this week that its next generation sequencing-focused operation and laboratory at the Hong Kong Science Park has received accreditation from the College of American Pathologists. The new accreditation significantly strengthens the NGS testing services and R&D capacity for the company, which already has CAP-accredited laboratories in Taipei, Taiwan, and Kanagawa, Japan. The 3,500-square-foot Hong Kong laboratory has a dual NGS testing platform from Illumina and Thermo Fisherand is run by a team of eight qualified laboratory technicians, ACT said. Apart from boosting the group's capacity for providing services and support, the three laboratories will continue to pursue research projects, helping ACT develop new products.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on 360Dx.
Go here to see the original:
In Brief This Week: DiaSorin, Cue Health, Avacta, Pandemic Response Lab, TruDiagnostic, and More - 360Dx
Posted in Epigenetics
Comments Off on In Brief This Week: DiaSorin, Cue Health, Avacta, Pandemic Response Lab, TruDiagnostic, and More – 360Dx
The University of Vermont: Impactful research, healthier world – Study International News
Posted: July 21, 2021 at 1:56 am
At the University of Vermont, researchers are focusing on what matters. Here, in Burlington, Vermont, surrounded by majestic vistas, some of the brightest minds in the world are harnessing the power of research to achieve no small feat: supporting the health of our environment and our societies. They are striving for sustainable solutions with local, national, and global applications and impact.
Part of UVMs success lies in its cross-disciplinary research and collaboration made possible by a public research university of its size and scale. At the Larner College of Medicine, an innovative research model is shedding light on immune response in dengue infection, with the potential of saving hundreds of millions of lives per year. Another breakthrough is fast-tracking promising discoveries in the fight against cancer.
Over at the College of Education and Social Services (CESS), PhD students are unleashing human potential and in the process of making education accessible to people of all abilities.
To create a better future for all will take the entire might of nations and individuals working together. UVM has the unique strengths to lead this charge. Below are four stories that offer a window on a sliver of the work that UVM is doing to create new knowledge and build new practices to help societies thrive today and for generations to come.
What happens when grit is paired with opportunities
Hans Cabra
Hans Cabra, a Fulbright Scholar from Bogot, Colombia, knows what true courage is. The PhD in Educational Leadership and Policy Studies candidate grew up in a sketchy neighbourhood with a mother who only completed elementary school and a father who barely made it beyond middle school. Where other marginalised children from impoverished backgrounds dont see a way out of the trap, he dared to dream. He applied for a scholarship to Norway and got it.
Education gave me an opportunity to escape poverty and ignited a passion for helping young people to pursue their dreams, he shares. As a PhD scholar at UVM, hes doing just that.
Cabra is pursuing research on after-school programmes and how to cultivate grit and perseverance. I believe that grit is the main ingredient in achieving success, but it has to be paired with the right opportunities, he explains. These opportunities completely changed my life and the lives of my family members. I want to bring this transformative power of education to all the kids in my community and in my country.
Access for all abilities
Sefakor Komabu-Pomeyie grew up in a village in Ghana, marginalised because of her disability and gender. When she was eight years old, she was diagnosed with polio after being administered an expired vaccination. The virus left her unable to walk on her own. Stigma followed.
Sefakor Grateful Komabu-Pomeyie
The power of education helped Komabu-Pomeyie beat the odds of life. In 2011, she was selected as a Ford International Education Fellow, which enabled her to come to Vermont and earn a masters degree in sustainable development, with a concentration in policy analysis and advocacy, from the School for International Training.
Today, Komabu-Pomeyie is taking her education to new heights as she works toward a PhD in Educational Leadership and Policy Studies. She is also building an accessible and inclusive school in Ghana for students of all abilities. The odds may have been stacked against her, but armed with a UVM degree, shes ready to take her seat at the policy table when she returns to Ghana.
Recently, for her work as an education and disabilities advocate, she was honoured with the prestigious International Service Award from the Association of University Centres on Disabilities at a ceremony in Washington, DC.
Its a life-changing moment. Its a huge award. It means the work I have been doing from my village has been recognised internationally, she says, adding her gratitude for UVM professor Maria Mercedes Avila, PhD, for nominating her for the award.
Saving hundreds of millions of lives
The Aedes mosquito-borne dengue virus is a pathogen that plagues the tropical regions of the world. In 2019, it caused a record number of over 400 million cases. Its effects range from asymptomatic to severe diseases many times, it can be fatal.
Vaccines have been hard to develop, as there are four strains to protect equally against. Only one vaccine, Dengvaxia, has been approved for a subset of at-risk individuals in endemic areas.
A study by UVM is offering hope. Led by Associate Professor of Microbiology and Molecular Genetics (MMG) Sean Diehl, PhD, it set out to determine biomarker candidates and predictors for clinical and immunological responses resulting from dengue infection.
Associate Professor of Microbiology and Molecular Genetics Sean Diehl
These data offer new potential biomarkers for characterising dengue virus infection and novel pathways that could be leveraged to combat viral replication, explains Diehl. Our results also gave us some clues about how we might be able to boost protective immune responses, which is the goal of developing effective vaccines.
Diehl adds that for some of the genes identified in this study, little is known about their role in the response against dengue virus. This is very exciting, because it could lead to new ways to fight dengue, so we are now investigating these in the lab, shares Diehl.
A potential target for new cancer treatments
For two decades, UVM Cancer Centre researcher Jason Stumpff, PhD, has studied how cells divide and how mistakes in this process contribute to diseases, such as cancer. Every killer has a weak spot, and Stumpffs latest work has unearthed a vulnerability that could be a potential target for interrupting cancer cell growth.
Stumpffs recent work focuses on the role of a protein called KIF18A in driving cell division. In these new studies, his lab found that cancer cells are more dependent on KIF18A for growth than normal cells. Target KIF18A and its possible to stem or stop cancer.
This promising discovery was made possible by UVMs wide-ranging collaboration with national and international partners. Stumpffs findings mark a milestone in a long research journey that began with support from an American Cancer Society Institutional Research Grant pilot award through the UVM Cancer Centre, and then led to Susan G. Komen and National Institutes of Health (NIH) funding.
The collective impact of this research collaboration exemplifies the importance of sharing data and enhancing rigour of scientific studies to move fundamental science discovery effectively toward important progress in the fight against cancer, says Stumpff.
Follow UVM on Facebook, Twitter, YouTube, Instagram and LinkedIn
Original post:
The University of Vermont: Impactful research, healthier world - Study International News
Posted in Vermont Stem Cells
Comments Off on The University of Vermont: Impactful research, healthier world – Study International News
Times really up! FDA authority to crack down on regenerative medicines upheld as grace period ends – JD Supra
Posted: July 21, 2021 at 1:54 am
Following the courts decision in US Stem Cell Clinic, CBER Director Peter Marks, M.D., stated in an FDA Voices blog post that the agency will continue cracking down on unapproved products marketed as regenerative medicine therapies, citing how the US Stem Cell decision is a victory for public health and an endorsement of the FDAs work to stop stem cell clinics that place patients at risk by marketing products that violate the law. Dr. Marks also referred to a second injunction case, United States v. Cell Surgical Network et al., which is currently being litigated in the U.S. District Court for the Central District of California, and a third enforcement action pursued by the FDA involving the seizure of vials of Vaccinia Virus Vaccine, Live, which was resolved in March 2018.
Since 2015, FDA has been documenting violations of current Good Manufacturing Practice (cGMP) requirements for tissue products by US Stem Cell Clinic. The agency issued aWarning Letterto the clinic in August 2017, which weanalyzed here. The clinic claimed that FDAs cGMP regulations were not applicable because the treatment falls under FDAs same surgical procedure and 361 HCT/P exceptions to regulation under the Federal Food, Drug, and Cosmetic Act (FDCA) and the Public Health Service Act (PHSA). In June 2019, a Florida district court ruled in favor of FDA, and enjoined the clinic from offering its stem cell therapy to patients.
As we summarized (here), the district courtfoundthat the population of stromal and vascular cells in US Stem Cell Clinics therapy, known as stromal-vascular fraction (SVF), requires FDA approval of a New Drug Application (NDA) or a Biologics License Application (BLA) before it can be commercially marketed. The court also found that the therapy was adulterated and misbranded because of the clinics manufacturing procedures and that its promotion violated statutory requirements.
On appeal with the Eleventh Circuit, US Stem Cell Clinic again argued it is exempt from regulation under the FDCA because the procedure falls into the same surgical procedure exception at 21 C.F.R. 1271.15(b). This provision states that FDAs regulation does not apply if you are an establishment that removes HCT/Ps from an individual and implants such HCT/Ps into the same individual during the same surgical procedure. Arguing before the District Court, FDA had successfullyassertedthat the SVF implanted into the clinics patients does not constitute such HCT/P removed from the patient due to the processing steps applied to the SVF in this case, meaning US Stem Cell Clinic was not covered by this exception.
In prefacing its analysis, the Eleventh Circuit notably explained that it was not merely offering judicial deference to FDA, saying it was giving the agencys view no special weight. The court said that although [t]here was a time when a court faced with a regulation that seemed impenetrable on first read might simply wave the ambiguity flag and defer to the agencys interpretation, this is the case [n]o longer. Rather, the court carefully consider[ed] the text, structure, history, and purpose of [the] regulation, and resolved the apparent ambiguity in FDAs favor.
First, the court considered the clinics argument that cells or tissues can be HCT/Ps only if they are intended for implantation into a patient, and it is the SVF and not the adipose tissue that is intended for implantation. The court rejected this defense, explaining that because adipose tissue contains the SVF, and because HCT/Ps are articles containing or consisting of human cells or tissues that are intended for implantation into a patient, both the adipose tissue and the SVF are HCT/Ps subject to regulation.
Second, US Stem Cell Clinic argued that an HCT/P re-implanted into a patient meets the regulatory definition of such HCT/P if it is like or similar to the HCT/P removed from the patient. The Eleventh Circuit disagreed. Instead, the court adopted FDAs interpretation that such HCT/P refers to the antecedent HCT/P removed from the patient in its original form. The Eleventh Circuit agreed with FDA and the District Court that the SVF procedure does not fall within the same surgical procedure exception because the biological material implanted into the patient is not the same as that removed. The court cited a history of FDA treating such HCT/Ps as meaning HCT/Ps in their original form that have not been subjected to significant processing.
The clinic also argued on appeal that it is exempt from regulation under the FDCA and PHSA because the procedure falls into the 361 HCT/P exception, whereby an HCT/P meeting four criteria (set forth in 21 C.F.R. 1271.10(a)) is deemed a 361 HCT/P, meaning that it is regulated solely under Section 361 of the Public Health Service Act (PHSA) and its implementing regulations in 21 C.F.R. Part 1271. Being deemed a 361 HCT/P subjects a therapy to a lighter regulatory burden. However, the Eleventh Circuit ruled that the 361 HCT/P exception does not apply because the HCT/P in this case is not intended for homologous use only.
Homologous use is the repair, reconstruction, replacement, or supplementation of a recipients cells or tissues with an HCT/P that performs the same basic function or functions in the recipient as in the donor. 21 C.F.R. 1271.3(c). US Stem Cell Clinic argued that SVF meets the homologous use criterion of a 361 HCT/P because SVF was intended to perform the same basic regenerative function both before and after the procedure. However, the District Court determined that the Clinic intended that the SVF treat a litany of illnesses in the recipient, which is not the same basic function that the SVF performed prior to the procedure.
The Eleventh Circuit agreed with the District Court that the clinic intends the stem cells to perform functions after the procedure that are beyond the basic functions the stem cells performed prior to the procedure. The court said that promotion of an HCT/P for an unproven therapeutic use, such as curing cancer, would be a nonhomologous use, and thus the 361 HCT/P exception does not apply in this case. In making this determination, the court said it relied upon the labeling, advertising, and other indications of the manufacturers objective intent. Because the defendants had marketed their SVF therapy to treat an array of diseases, the court found the clinic could not argue the pre-procedure SVF cells were intended to have performed the same function as the re-implanted SVF cells.
In issuing its opinion, the court permanently enjoined US Stem Cell Clinic from offering its adipose stem cell therapy unless and until several conditions were met, including FDA approval of a new drug application or biologics license application for the SVF solution.
In 2017, FDA published a new regenerative medicine policyframeworkconsisting of four guidance documents, which provided for a grace period of risk-based enforcement discretion for certain HCT/Ps, which ended on May 31, 2021. This grace period was meant to give certain manufacturers time to assess whether they need to file an IND or marketing application with FDA, or whether they met the four regulatory criteria for continuing to market their products solely under the authority of section 361 of the PHSA, which does not require pre-market review and approval.
Following up on the governments victory in this legal battle, CBER Director Peter Marks, M.D., published a blog on June 3 warning that FDA will be cracking down on unapproved products marketed as regenerative medicine therapies, citing how the Eleventh Circuit affirmed the lower courts judgment in US Stem Cell as cause for the renewed admonition. Marks wrote that the US Stem Cell decision is a victory for public health and an endorsement of the FDAs work to stop stem cell clinics that place patients at risk by marketing products that violate the law.
More recently, on July 9, CBER added a Q&A page on its website about the end of the HCT/P enforcement discretion period, drawing a clear line in the sand to convey that FDA is serious about the end of enforcement discretion period. Notably, the Q&A page directs physicians not to administer an HCT/P that does not qualify for 361 HCT/P status, until that HCT/P has a BLA, unless that physician is studying the HCT/P as a clinical investigator in a clinical trial under an IND. It also appears to say that there is no grace period for products that were introduced into interstate commerce before May 31, 2021 and are still on the market.
This was the not the first time that CBER has warned of impending enforcement of its regenerative medicine policy framework; in an FDA Voices blog post on April 21, Marks had written that the agency will not again extend the grace period for HCT/P companies to come into compliance with its regenerative medicine policy framework. In both that article and the June 3 publication, Marks emphasized that FDA has taken and will continue to take action regarding unlawfully marketed HCT/Ps. Most recently Marks wrote that, since December 2018, the FDA has issued 400 letters to manufacturers and health care providers who may be offering violative stem cell or related products. In addition, since 2017, FDA has issued 14 Warning Letters and 24 Untitled Letters involving violative HCT/Ps, Marks wrote.
We recently analyzed (online here) the significance that these warnings carry for companies in the regenerative medicine space, and outlined the potential risks of noncompliance. These risks go well beyond FDA enforcement, and include the possibility of FTC action, False Claims Act liability, product liability claims, and susceptibility to private lawsuits.
[View source.]
Continued here:
Times really up! FDA authority to crack down on regenerative medicines upheld as grace period ends - JD Supra
Posted in Florida Stem Cells
Comments Off on Times really up! FDA authority to crack down on regenerative medicines upheld as grace period ends – JD Supra
How Innovative AI Trends Can Reshape the Biotechnology Industry – CIOReview
Posted: July 21, 2021 at 1:51 am
The biotechnology industry has advanced significantly due to artificial intelligence and other computerized tools.
FREMONT, CA: Biotechnology companies and various health organizations worldwide maintain massive databases. Drug manufacturing, chemical analysis of multiple compounds, RNA and DNA sequencing, enzyme studies, and other similar biological processes require the strong support of computerized tools and applications to increase efficiency and reduce manual errors.
Today, the world is confronted with an unprecedented public health crisis in the form of a Coronavirus pandemic. Economies are collapsing, countries are being placed on lockdown, and all hope is being placed in the biotechnology industry to develop a safe, effective vaccine in the shortest amount of time possible. Artificial intelligence is critical in biotechnology and related applications for managing biological processes, increasing drug production, managing supply chains, and overlooking the industry's data pool.
Increased and improved predictability for both structured and unstructured data enables businesses to plan their operations more efficiently and effectively, resulting in increased productivity and a faster pace of work.
The following are some significant AI trends that will reshape the biotechnology industry.
Advancing Innovations: From the Laboratory to the Market
The demand for drugs, industrial chemicals, food-grade chemicals, and other biochemistry-related raw materials has increased over the last decade. Artificial intelligence in biotechnology is critical for accelerating drug discovery and development (right to the point where it reaches the market). AI-based tools and apps help develop molecule structures based on target markets. It uses machine learning to calculate permutations and combinations of various chemicals to find the best variety without manual experimentation in the lab. Predictive analysis can forecast market demand for a particular drug or chemical using artificial intelligence in biotechnology. AI in biotech can also help manage the intelligent distribution of raw materials required by the biotechnology industry.
Open-Source Artificial Intelligence Platforms: Accelerate Data Analysis
Scientists around the world are researching AI programs that can automate data maintenance and analysis. Using open-source AI programs such as CRISPR libraries and H2O.ai frees lab assistants from repetitive data entry and analysis tasks. Other critical informatics tasks are also systematically analyzed to produce more accurate and timely results. Removing manual functions from healthcare providers and scientists can focus on innovation-driven processes enabled by biotechnology AI.
Expanding Agricultural Biotechnology's Boundaries: Improving Quality and Quantity
Biotechnology is crucial in the development of more and better crops. AI-based tools are required to study crop features, note and compare qualities, and forecast plausible yield. Aside from these tools, the agricultural biotechnology industry uses robotics for packaging, harvesting, and other essential tasks. By combining weather forecasts, farmland data, and the availability of seeds, manure, and pesticides, AI in biotech helps plan future patterns in material movement.
See Also:Top 10 EAM Solution Companies
Visit link:
How Innovative AI Trends Can Reshape the Biotechnology Industry - CIOReview
Posted in Biotechnology
Comments Off on How Innovative AI Trends Can Reshape the Biotechnology Industry – CIOReview