Lynne Peterson is the Senior Writer for Trends-in-Medicine.

Here is the medical news to watch for Oct. 4-10, 2021.

Drug development: The Drug Information Association (DIA) is sponsoring a virtual Biosimilars Conference Oct. 5-6 to bring together manufacturers, regulators, payors, prescribers, and patients to discuss factors that influence biosimilar development and access and to share perspectives on what success and equilibrium will look like. The goal is to build global strategies to continue the growth of the biosimilars market. Peter Stein, MD, director of the FDA’s Office of New Drugs, will be a keynote speaker, and several other FDA officials also will speak, along with experts from Amgen, Parexel, Pfizer, Sandoz, and others.

Endocrinology: The hybrid American Society for Bone and Mineral Research (ASBMR) meeting in San Diego and virtually is winding up on Oct. 4.

Endovascular: The hybrid VEINS and VIVA meeting is continuing in Las Vegas and virtually through Oct. 7.

ENT: The hybrid American Academy of Otolaryngology – Head and Neck Surgery (AAO-HNS) meeting is continuing in Los Angeles and virtually through Oct. 6.

Gastroenterology: The virtual United European Gastroenterology (UEG) Week is continuing through Oct. 5. Among the data to watch: Phase II results for Landos Biopharma’s Omilancor (BT-11), a LANCL2 agonist, in ulcerative colitis.

Gene therapy: The Advanced Therapies Congress is taking place in person Oct. 5-6 at ExCeL in London. The meeting will explore, define, and attempt to tackle the challenges to development of patient access to advanced therapy medicinal products (ATMPs) – medicines for human use that are based on genes, tissues, or cells. There will be discussions about the impact of Covid-19 on the field, the latest developments, and ways to move forward. Topics will include cell therapy, immunotherapy, pricing and market access, manufacturing, clinical trials, rare diseases, gene editing, regenerative medicine, and, of course, gene therapy. Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research – and the new acting director of the FDA’s Office of Vaccines Research and Review – will be the keynote speaker. Other speakers include senior officials from Bone Therapeutics, Novartis, Orchard Therapeutics, Pluristem Therapeutics, Quell Therapeutics, and others.

Infectious diseases: The FDA’s Antimicrobial Drugs Advisory Committee will meet virtually on October 7 to consider Takeda’s maribavir for post-transplant cytomegalovirus (CMV).

Neurology

  • The virtual World Congress of Neurology is continuing through Oct. 7. Topics will include: evaluating treatment response in multiple sclerosis, advances in migraine treatment, chronic facial pain, preclinical Alzheimer’s disease, stroke prevention, and more.
  • The Northeast Amyotrophic Lateral Sclerosis (NEALS) meeting will be held virtually Oct. 6-7. Among the data to watch: Phase I results for Denali Therapeutics’ DNL-343, a brain-penetrant EIF2B activator.

Oncology: The American Association for Cancer Research (AACR), the National Cancer Institute (NCI), and the European Organisation for Research and Treatment of Cancer (EORTC) International Conference on Molecular Targets and Cancer Therapeutics (what’s known as the Triple meeting) will take place virtually Oct. 7-10. Among the data to watch:

  • Phase I results for Prelude Therapeutics’ PRT-811, an oral PRMT5 inhibitor, in solid tumors and recurrent high-grade gliomas.
  • The results of the Phase II TRIDENT-1 trial of Turning Point Therapeutics’ repotrectinib (TPX-0005), a ROS1/TRK/ALK inhibitor, in non-small cell lung cancer (NSCLC).
  • The results of the SHIELD-1 trial of Turning Point Therapeutics and Zai Lab’s TPX-0022, a MET/CSF1R/SRC inhibitor, in solid tumors.
  • Phase I results with Relay Therapeutics’ RLY-4008 (an FGFR2 inhibitor) in solid tumors.

Ophthalmology: Two ophthalmology meetings are taking place this week — one in Europe and the other in the U.S. — but both are hybrid, so you can join one or both of the meetings virtually if you aren’t vaccinated to travel.

  • The European Society of Cataract and Refractive Surgeons (ESCRS) is in Amsterdam, the Netherlands, and virtually Oct. 8-11. This is the place to learn about the latest developments in cataract and refractive surgery.
  • The American Society of Retina Specialists (ASRS) is in San Antonio and virtually Oct. 8-12. Look for data on 4D Molecular Therapeutics’ 4D-125, a gene replacement therapy for X-linked retinitis pigmentosa (XLRP).

Pediatrics: The American Academy of Pediatrics (AAP) annual meeting will take place virtually Oct. 8-11. The meeting is a good way to stay abreast of the latest best practices in pediatrics, with a large selection of pediatric educational opportunities.

Rare diseases: The FDA is expected to make a decision by October 7 on a treatment for anti-neutrophil cytoplasmic antibody-associated vasculitis – ChemoCentryx’s avacopan, a C5a receptor inhibitor. Remember, the FDA decision was delayed from July 7 due to new data submitted to the FDA.

Regulatory

  • The FDA’s National Center for Toxicological Research is co-hosting with the Global Coalition for Regulatory Science Research a virtual Global Summit on Regulatory Science: food/drug safety with real-world data and artificial intelligence on Oct. 4-6.
  • The FDA is hosting a webinar on Oct. 5 on enhanced drug distribution security in 2023.
  • The FDA’s Patient Engagement Advisory Committee is meeting virtually on Oct. 6 on factors the FDA and industry should consider to effectively communicate medical device recall information to patients and the public.
  • On Oct. 6 the FDA is hosting a webinar in its series on “Conversation on Cancer,” focused on disparities faced by patients living with cancer in the Latinx LGBTQ+ community.

Lynne Peterson, Senior Writer for Trends-in-Medicine

Cat ID: 165

Topic ID: 98,165,497,730,543,188,121,190,130,138,214,192,725,925,240,165,213,427,542