This September, join an expert panel including biotech consultant and journalist Luke Timmerman, clinical experts from biotech, Jenny Gordon, Amanda Moore, and Kanya Rajangam, and Debra Schaumberg (Global Head of Strategic Development Consulting, Thermo Fisher), as they explore common early-phase trial pitfalls that disproportionately impact emerging biotechs – such as protocol missteps, regulatory delays, and recruitment challenges.
Topics the panel will explore include the unique risk landscape for emerging biotechs, top risk areas in early-phase trials, and opportunities for de-risking through strategic partnership.
Learn to recognize and avoid common pitfalls that often derail Phase I/II studies for emerging biotech companies. Gain clarity on regulatory, operational, and strategic hurdles specific to early-stage drug development. Understand how limited internal resources can lead to risk accumulation - and how to avoid it.
Attend this webinar for insights and advice on:
- Implementing a risk assessment framework early in trial planning
- How strategic partnership and leveraging external expertise can de-risk trial design and execution
- Key lessons learned from real-world experience to improve trial execution
Jenny Gordon
VP, Head of Clinical Operations at City Therapeutics
Jenny Gordon is currently the VP, Head of Clinical Operations at City Therapeutics. She has worked in clinical operations in academic and industry settings for 23 years, in large pharma, mid-sized and small biotech, including Abbott, Vertex, Biogen, Bioverativ, Sanofi, Freeline and Editas. Jenny brings a wealth of experience leading and empowering teams to reach a cross functional, partnership-oriented approach to clinical development program strategy, trial execution and stakeholder engagement. She holds a BA in art from the University of Iowa and a Master of Science in Health Science from the George Washington University.
Luke Timmerman
Biotech Journalist & Founder of the Timmerman Report
Luke Timmerman is the founder of Timmerman Report, a leading biotech industry newsletter, and author of “Hood: Trailblazer of the Genomics Age,” a biography of automated DNA sequencing pioneer Leroy Hood. Luke was named one of the 100 most influential people in biotech in 2015 by Scientific American. He has a bachelor’s in journalism from the University of Wisconsin and was awarded a Knight Science Journalism Fellowship at MIT. Since 2017, his mountaineering campaigns have catalyzed the biotech community to give back more than $12 million to alleviate suffering from cancer, poverty, and sickle cell disease.
Debra Schaumberg
Vice President & Global Head, Strategic Development and Global Head of Strategic Scientific Solutions for Ophthalmology at Thermo Fisher Scientific
Dr. Debra Schaumberg is an internationally recognized expert in ophthalmology clinical research with over 25 years of experience in clinical development, regulatory and medical affairs strategy. She leads medical science and strategy for ophthalmology at PPD and oversees a team of senior scientists supporting biotech and biopharma clients across all therapeutic areas. Dr. Schaumberg has led R&D programs from early development through medical affairs for drugs, biologics, devices, and diagnostics. Previously, she held faculty positions at Harvard Medical School and the University of Utah, and served as Global Medical Director and Head of Medical Evidence at Shire. She has authored hundreds of scientific publications and holds degrees from Harvard, Johns Hopkins, and the Illinois College of Optometry.
Kanya Rajangam
President, Head of R&D and Chief Medical Officer at Senti Bio
Dr. Rajangam is President, Head of Research and Development and Chief Medical Officer at Senti Bio. She is responsible for leading research and development strategy to rapidly advance Senti Bio’s logic gated pipeline programs through clinical development. Dr. Rajangam currently serves on the board of directors of Turnstone Biologics, a clinical-stage biotechnology company developing next-generation tumor infiltrating lymphocyte cell therapies and on the scientific advisory board of Vibe Bio, a privately held company developing AI aided asset diligence. Prior to the current role, Dr. Rajangam served in leadership roles at various biotech companies, most recently Nkarta Therapeutics where, as Chief Medical Officer, she was responsible for clinical development of CAR-NK cell therapies for oncology. Prior to Nkarta, she was Chief Medical Officer at Atara Biotherapeutics where she led the development of T-cell therapies for oncology, neurology and infectious diseases. Prior to that, Dr. Rajangam was Chief Medical Officer of Cleave Biosciences, where she led oncology clinical development programs. Dr. Rajangam gained relevant experience at Onyx and Exelixis, while contributing to the clinical development and global approval of several marketed oncology products including Kyprolis®, Cotellic® and Cometriq®/Cabometyx®. Dr. Rajangam received a medical degree from St. Johns’ Medical College and completed her surgical residency with a focus on oncology at the Postgraduate Institute of Medical Education and Research (PGIMER), both in India. She received a Ph.D. in biomedical cell and tissue engineering from Northwestern University.
Amanda Moore
VP, Program Leadership & Clinical Operations at Abeona Therapeutics
Amanda Moore has over 20 years of clinical operations and development experience in the biotechnology and pharmaceutical industry with a track record of leading innovation in clinical trials, pioneering operating committee relationships, and oversight of global development programs. Ms. Moore joined Abeona in October 2020 and holds responsibility for Program Leadership, Clinical Development and Operations, Patient Advocacy, and Medical Writing. Previously, she has served in clinical operations and development roles with Biogen, Reckitt Benckiser, Sage Therapeutics and Intercell after her early career working at a research site and at a CRO. Ms. Moore holds a Master’s degree in Health Science from the George Washington University.
