Script/Panellists
Brief:
As you are completing your Phase 1 healthy volunteer study in Australia or New Zealand, it’s critically important to revisit your clinical development strategy as you continue your journey towards commercialization of your asset in the US.
In this webinar, you’ll hear firsthand from a sponsor, a PI and an experienced CRO team who have helped numerous biotech companies to navigate through these decisions.
The panel will discuss the key elements for your clinical development strategy when transitioning from healthy volunteers to patients. These include:
- Optimal timing of the IND and other regulatory considerations
- Study design and selection of endpoints
- When is best to move into a patient population, including the possibility and feasibility of a Proof of Concept study
- KOL engagement and key success factors
Speakers:
Nancy Shulman
Chief Medical Officer, Bluejay Therapeutics, Inc
Dr. Shulman has 25 years of clinical development experience spanning academia and industry. Her experience spans preclinical translational research, early development, all the way through late clinical development, and includes small molecules, monoclonal antibodies, ADCs and cell and gene therapies. She has background in infectious diseases/virology, but also has clinical development experience in hepatology, immunology, oncology, and oncology. She has worked in Roche, Genentech, AbbVie, Ambys Medicines, and is currently the CMO at Bluejay Therapeutics, a startup focusing on viral hepatitis and other liver diseases.
Dr. Chris Wynne, MBChB, FRACR, DPharm Med
Chief Scientific Officer, Consultant Oncologist, and Principal Investigator, New Zealand Clinical Research
With over 20 years of experience in clinical research, Dr. Wynne has led over 90 trials spanning SAD, MAD, food effect, biosimilar, and device studies. He is a member of the National Trials Committee and has published over 60 publications. Dr. Wynne's key research interests are early phase trials and innovative trial design. His contributions and leadership in the medical community make him a highly regarded figure in the field of clinical research.
Dr. Michael Strauss
Senior Director of Scientific Affairs, Novotech Drug Development Consulting
Dr. Strauss leads a team of scientists in Novotech Drug Developing Consulting (DDC) group. DDC provides full-service global regulatory services including scientific review and strategic program development. His consulting specialties focus on CMC/Regulatory. Dr. Strauss has led teams in drafting INDs, NDAs and BLAs, facilitated numerous meetings with regulatory agencies, and served as regulatory representative to FDA for many client products during his 20 years developing biotech products.
David Ng
Global Vice President of Biometrics and Data Management, Novotech
With a career spanning more than thirty years in biostatistics and data management, Dr. David Ng provides guidance in study design and statistical strategy. He oversees a team of over 350 biometrics professionals to assist sponsors in the planning and conduct of their studies. Dr. Ng has extensive experience in many indications, especially in rare diseases, and has assisted sponsors in study design, defining endpoints and goals, and interactions with regulatory agencies in the US, EU, China and Japan.
Shawnna Barrett
Senior Therapeutic Strategy Manager, Novotech
With eight years of experience at Novotech, Shawnna's expertise spans clinical operations, medical writing, data management, and statistics. She specializes in business development, working as the lead early phase subject matter expert collaborating closely with biotech companies across all therapeutic areas. She guides companies through the intricacies of first-in-human studies, helping them to assess readiness, select suitable regions, and develop effective study strategies to meet their corporate goals.
Registration link: Transitioning from Healthy Volunteers to Patients: Navigating the Clinical Development Journey (on24.com)