CBER

San Francisco Witnesses the Voice of GCT Titans GenScript Biotech Global Forum Outlines the Future of the Industry

Retrieved on: 
Friday, January 12, 2024
Stanford University, DSM-IV codes, Overalls, Gene therapy, Flagship Pioneering, Biotechnology, Artificial intelligence, Neogene, CBER, Gene editing, Genome editing, Assistant professor, Therapy, Biological engineering, SAN, Humour, Harvard University, GenScript Biotech, Optimism, Safety, Patient, J. P. Morgan, AstraZeneca, Hope, GCT, Broad Institute, CBO, Process, Animal, Gene, ARCH Venture Partners, Multiple myeloma, Speech, Intellia Therapeutics, Development, Associate, Health, CRISPR, Intelligence, Courage, Research and development, Division, Conference, T cell, FDA, Eli Lilly and Company, SVP, Pharmaceutical industry

On January 10 this year, GenScript Biotech hosted the "Satellite Session" of the J.P. Morgan annual conference—the 2024 GenScript Biotech Global Forum in San Francisco.

Key Points: 
  • On January 10 this year, GenScript Biotech hosted the "Satellite Session" of the J.P. Morgan annual conference—the 2024 GenScript Biotech Global Forum in San Francisco.
  • GenScript Biotech is committed to building a high-quality platform for exchange and cooperation for global peers, driving the advancement of the cell and gene industry.
  • since the first global forum was held in 2020, GenScript Biotech has created numerous valuable opportunities for industry peers.
  • This grand event brought together the wisdom and strength of global elites in the biopharmaceutical industry, sparking a profound discourse on the future of GCT.

SeaStar Medical Reports Third Quarter 2023 Financial Results and Provides a Business Update

Retrieved on: 
Tuesday, November 14, 2023
Chronic kidney disease, Neutrophil, Acute respiratory distress syndrome, STEC-HUS, Cardiorenal syndrome, Safety, Food, Hepatorenal syndrome, University, AKI, HDE, Risk, ICU, Clinical trial, Monocyte, Mortality, CBER, Sepsis, Patient, Nephrology, Insurance, Research, Letter, Dialysis, Approvable letter, FDA, G&A, Child, Standard of care, Acute kidney injury, Partnership, Nephron, Clinical study design, R, Hospital, SCD, Physician, CKRT, Karger Publishers, PMA, HIV disease progression rates, Pharmaceutical industry, Nursing, Dietary supplement, Cryptocurrency

DENVER, Nov. 14, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, reports financial results for the three and nine months ended September 30, 2023 and provides a business update.

Key Points: 
  • DENVER, Nov. 14, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, reports financial results for the three and nine months ended September 30, 2023 and provides a business update.
  • “Recent clinical and regulatory successes have significantly improved and strengthened our company’s prospects,” said Eric Schlorff, SeaStar Medical CEO.
  • SeaStar Medical expects regulatory approval for the SCD-ADULT in the first half of 2025 and commercial launch in the second half of 2025.
  • The Company issued two convertible notes each for $0.5 million in August 2023 and a third convertible note for $0.5 million in September 2023.

Limb-Girdle Muscular Dystrophy Scientific Leaders - Together With the FDA - Will Come Together for a Drug Development Workshop on February 8, 2024

Retrieved on: 
Wednesday, December 13, 2023
Food, OND, Therapy, Hospital, CBER, Patient, Nationwide Children's Hospital, Virginia Commonwealth University, FDA, CDER, Caregiver, Limb–girdle muscular dystrophy, University, Muscular dystrophy, Drug development, Pharmaceutical industry, Medical device, LGMD, Research

ROCKVILLE, Md., Dec. 13, 2023 /PRNewswire/ -- On February 8, 2024, The Speak Foundation, a patient-led 501(c)(3) organization for Limb-Girdle Muscular Dystrophy (LGMD), will be convening a multi-stakeholder LGMD Scientific Drug Development Workshop in Rockville, Maryland.

Key Points: 
  • ROCKVILLE, Md., Dec. 13, 2023 /PRNewswire/ -- On February 8, 2024, The Speak Foundation, a patient-led 501(c)(3) organization for Limb-Girdle Muscular Dystrophy (LGMD), will be convening a multi-stakeholder LGMD Scientific Drug Development Workshop in Rockville, Maryland.
  • The workshop will continue to drive the momentum for the sense of urgency needed by the patient community to accelerate LGMD drug development.
  • "This workshop is a continuing step to work with the FDA and LGMD scientific leaders on pushing critical drug development forward.
  • The LGMD Scientific Workshop will be a focused discussion with clinicians, scientific researchers, drug developers, regulators, patients and patient advocates on the characteristics of LGMD that drive drug development programs.

MCRA Announces the Hiring of Former FDA Leadership to Advance its Regenerative Medicine Expertise

Retrieved on: 
Wednesday, November 15, 2023
Regenerative medicine, Associate, Regulatory affairs, Device, Quality assurance, OTP, Clinical trial, Plasma, Tissue, CBER, Patient, CDRH, FDA, Biomedical engineering, Advanced manufacturing, Combination, SVP, Knowledge, Health, MCRA, Medical device, Research, Computer security, Iris, Policy

Dr. Yong and Dr. Marklein bring nearly two decades of FDA regulatory experience to MCRA – making them predominant leaders in this rapidly expanding area of medicine.

Key Points: 
  • Dr. Yong and Dr. Marklein bring nearly two decades of FDA regulatory experience to MCRA – making them predominant leaders in this rapidly expanding area of medicine.
  • Dr. Yong states, "I am thrilled to be joining MCRA at such a critical time for Regenerative Medicine.
  • Dr. Marklein states, "By joining MCRA, I can leverage my regulatory expertise in regenerative medicine to support our clients and drive meaningful change.
  • We are excited to welcome Carolyn and Iris to the MCRA team to foster the expansion of MCRA's focus in the regenerative medicine space."

Sarah McGarry, M.D., Senior FDA Official in CDER and CBER, Joins Greenleaf Health

Retrieved on: 
Wednesday, November 8, 2023
FDA, COVID-19, Public Policy, Consulting, Pharmaceutical, Professional Services, Medical Devices, Infectious Diseases, Government, Science, Biotechnology, AIDS, Other Science, Health, Research, Georgetown University School of Medicine, Bioinformatics, CBER, Center for Biologics Evaluation and Research, Policy, Food, Infection, Duke University, SARS-CoV-2, Center for Drug Evaluation and Research, OND, HIV, CDER, Ritonavir, Senior, Marketing, Internal medicine, China Biologic Products, Associate, Food and Drug Administration, Pharmaceutical industry

Greenleaf Health, Inc. (Greenleaf), a leading consulting firm for companies regulated by the Food and Drug Administration (FDA), is pleased to announce that Sarah McGarry, M.D., has joined as Senior Vice President, Drug and Biological Products.

Key Points: 
  • Greenleaf Health, Inc. (Greenleaf), a leading consulting firm for companies regulated by the Food and Drug Administration (FDA), is pleased to announce that Sarah McGarry, M.D., has joined as Senior Vice President, Drug and Biological Products.
  • Throughout her 18-year FDA service, Sarah held multiple leadership, review, and advisory positions within the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).
  • Her knowledge of the FDA review process and regulatory policy will enrich the strategic and scientific guidance that Greenleaf provides to clients.
  • from Georgetown University Medical School and completed a residency in internal medicine and a fellowship in infectious diseases at Duke University.

FDA Launches Pilot Program to Help Further Accelerate Development of Rare Disease Therapies

Retrieved on: 
Friday, September 29, 2023
Well, China Biologic Products, CDER, Communication, Drug development, START, Life, Register, CBER, Marketing, Center for Drug Evaluation and Research, New Drug Application, Disability, Center for Biologics Evaluation and Research, ARC, Rare, Adequate Yearly Progress, Federal, Biologics license application, Request for information, Investigational New Drug, Federal Register, Patient, Learning, Effectiveness, FDA, Death, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, Support, Education, Food, Safety, Disease, Pharmaceutical industry, Medical device, Research

"These are complex products and we recognize the importance of sponsor communication with the FDA to facilitate development of products for patients with unmet medical needs."

Key Points: 
  • "These are complex products and we recognize the importance of sponsor communication with the FDA to facilitate development of products for patients with unmet medical needs."
  • The FDA has undertaken additional efforts to further enhance and expedite the availability of therapies intended to treat rare diseases.
  • The agency additionally published a docket for stakeholder feedback as part of the Learning and Education to Advance and Empower Rare Disease Drug Developers (LEADER 3D) program under the CDER Accelerating Rare disease Cures (ARC) program .
  • Feedback will be used for the identification of knowledge gaps in rare disease drug development and the development of publicly available resources to inform stakeholders who design and conduct rare disease drug development programs on regulatory considerations surrounding clinical trial design.

Wilson Bryan, M.D., Former Director of FDA CBER’s Office of Tissues and Advanced Therapies, Joins Greenleaf

Retrieved on: 
Wednesday, July 19, 2023
Consulting, Biotechnology, FDA, Professional Services, Other Health, Health, General Health, Public Policy, Pharmaceutical, Medical Devices, Government, CDER, University, Therapy, Gene, ALS, CBER, Antibody, Cerebrovascular disease, Center for Biologics Evaluation and Research, Food and Drug Administration, Multimedia, Wilson, China Biologic Products, Division, Center for Drug Evaluation and Research, Medical school, UTSW, Faculty, Neurology, Rare, Food, Pharmaceutical industry, Research, Tissue

Greenleaf Health, Inc. (Greenleaf), a leading Food and Drug Administration (FDA) regulatory consulting firm, today announces that Wilson Bryan, M.D., has joined as Executive Vice President, Drug and Biological Products.

Key Points: 
  • Greenleaf Health, Inc. (Greenleaf), a leading Food and Drug Administration (FDA) regulatory consulting firm, today announces that Wilson Bryan, M.D., has joined as Executive Vice President, Drug and Biological Products.
  • His experience enhances Greenleaf’s cell and gene therapy capabilities and brings added perspective to the firm’s strategic advising on drug, biologic, and medical device regulation more broadly.
  • As a neurologist and neuromuscular specialist, Wilson deepens Greenleaf’s expertise in those fields as well.
  • Wilson received his medical degree from the University of Chicago Pritzker School of Medicine.

Dr. Peter Marks of FDA to Keynote 2023 Bio Innovation Conference Hosted by Maryland Life Sciences

Retrieved on: 
Monday, April 17, 2023
Stem Cells, Biotechnology, Technology, FDA, Health, Pharmaceutical, Oncology, Other Science, Other Technology, Genetics, Science, Vaccine, Molecular biology, Wuhan Institute of Biological Products, Yale University, Internal medicine, CBER, Physician, Brigham and Women's Hospital, Center for Biologics Evaluation and Research, Convention center, Medicine, Food and Drug Administration, Marks, National academy, National Academy of Medicine, Patient, Blood, Hospital, American College, Conference, Food, Safety, Pharmaceutical industry, Medical device, Nursing, Hematology, New York University, Research

Maryland Life Sciences, a division of the Maryland Tech Council, is pleased to announce that Peter Marks, Ph.D., Director of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA), will serve as keynote speaker at the 2023 Bio Innovation Conference on Monday, October 30, 2023 at the Bethesda North Marriot and Conference Center.

Key Points: 
  • Maryland Life Sciences, a division of the Maryland Tech Council, is pleased to announce that Peter Marks, Ph.D., Director of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA), will serve as keynote speaker at the 2023 Bio Innovation Conference on Monday, October 30, 2023 at the Bethesda North Marriot and Conference Center.
  • He joined the FDA in 2012 as Deputy Center Director for CBER and became Center Director in 2016.
  • Dr. Marks received his graduate degree in cell and molecular biology and his medical degree at New York University.
  • Dr. Marks is board certified in internal medicine, hematology and medical oncology, and is a Fellow of the American College of Physicians.

Vector BioMed Appoints Jakob Reiser, Ph.D., as Senior Director of Regulatory Affairs

Retrieved on: 
Tuesday, April 11, 2023
Vector, GMP, Doctor of Philosophy, CBER, Center for Biologics Evaluation and Research, Gene, Louisiana State University Agricultural Center, MBA, Associate, Bangladesh Technical Education Board, CAR, LSU, Investigational New Drug, University of Texas Health Science Center at San Antonio, Regulatory affairs, Miltenyi Biotec, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, BLA, NIH, Food, Safety, Vaccine, Research

GAITHERSBURG, Md., April 11, 2023 /PRNewswire/ -- Vector BioMed, a biomanufacturing company specializing in the manufacture of lentiviral vectors, today announced the appointment of Jakob Reiser, Ph.D., to the position of Senior Director, Regulatory Affairs, as the Company expands its team to offer a best-in-class lentiviral vector platform to aid in the development of innovative gene therapies.  Dr. Reiser brings more than 45 years of scientific and regulatory experience to Vector BioMed including nearly 15 years as a principal investigator at the Center for Biologics Evaluation and Research (CBER), part of the U.S. Food and Drug Administration (FDA).

Key Points: 
  • "Dr. Reiser is a key addition to Vector BioMed's senior leadership team, bringing to the company a world-renowned scientist and leading expert in the field of lentiviral vector research and development," said Boro Dropulić, Ph.D., MBA, CEO of Vector Biomed.
  • As Senior Director of Regulatory Affairs at Vector BioMed, Dr. Reiser will apply his expertise to support partners in their regulatory strategy and submissions in order to advance their clinical-stage programs."
  • Prior to joining Vector BioMed, Dr. Reiser spent nearly 15 years as a principal investigator at CBER where he led a laboratory focused on the safety and manufacture of lentiviral vectors.
  • We have developed an efficient lentiviral vector manufacturing process that yields very high vector titer and quality.

Circle Kicks off 10-Year Anniversary in 2023 and 5 Years of USDC with Release of First Annual "State of the USDC Economy" Report and More

Retrieved on: 
Tuesday, January 17, 2023
USD Coin, Crypto, Ecosystem, Digital currency, CBER, Student, USDC, Partnership, Growth, Research, Cryptocurrency, Circle

DAVOS, Switzerland and BOSTON, Jan. 17, 2023 /PRNewswire/ -- Circle, a global digital financial technology firm and the issuer of USD Coin (USDC) and Euro Coin, celebrates its 10 year anniversary in 2023 and five years since the launch of USDC. As part of the kick-off to mark the occasions, Circle is releasing the first-ever comprehensive report about the state of the USDC economy: "State of the USDC Economy — Welcome to the Utility Value Phase of Digital Currency."

Key Points: 
  • As part of the kick-off to mark the occasions, Circle is releasing the first-ever comprehensive report about the state of the USDC economy: " State of the USDC Economy — Welcome to the Utility Value Phase of Digital Currency ."
  • "Developers are essential to the success of USDC and the entire Web3 ecosystem," said Allaire.
  • Program details, including the opening of the application process this Spring, will be available in the coming weeks.
  • The awards range from $5,000 to $10,000 and will be announced in May at CBER's annual conference.