GETTING FROM R&D TO IND:
HOW DISCOVERY AND BIOANALYTICAL STRATEGY INFLUENCE NONCLINICAL PROGRAM DESIGN
Webinar Recorded On:
Wednesday, May 26th, 2021
4:00pm BST | 11:00am EDT | 8:00am PDT
Learn how your discovery and bioanalytical strategies impact IND-enabling program design!
For large molecule lead candidates, your discovery and bioanalytical strategies can either accelerate your time to the clinic or create hurdles along the way. These strategies are critical in identifying optimal lead candidates early, streamlining CMC testing assays, and developing bioanalytical methods that are robust and can be validated. Discovery and bioanalytical strategies also influence your nonclinical development program and support your IND-enabling studies to ensure your study findings translate to Phase I and beyond.
On May 26th, Eurofins and Sinclair Research teamed up for our live webinar “Getting from R&D to IND: How discovery and bioanalytical strategy influence nonclinical development program design” presented by:
- Francisca Neethling, Business Line Leader, Biotherapeutics, Eurofins Discovery
- Stanley Prince, Senior Scientific Advisor, Biologics, Eurofins BioPharma Product Testing
- Bo Kowalczyk, Senior Vice President, Eurofins Pharma BioAnalytics Services US Inc
- Tina Rogers, Senior Scientific Advisor, Sinclair Research
This webinar will cover discovery and bioanalytical strategy considerations and how they influence your nonclinical development program and support your IND-enabling studies.
In our webinar, Sinclair and Eurofins will help you learn about:
- Discovery considerations to identify lead candidates, characterization and advantages of use for antibody generation
- Biopharmaceutical product testing considerations to include GMP cell banking and downstream antibody development testing
- Considerations for your bioanalytical large molecule program to include attributes of PK and ADA assays, the pros and cons of commercial vs custom reagents and approaches for ADA assays in preclinical vs clinical development
- IND-enabling program design considerations for large molecules
About the Presenters:
Francisca Neethling recently joined Eurofins as Head of Biotherapeutics Discovery to address the limitations biotech and pharmaceutical face in early discovery and development of antibodies and biologic therapeutics. She brings 20+ years experience in antibody discovery, most notably at Boehringer Ingelheim where she was a Senior Principal Scientist managing CRO relationships and a discovery team that contributed to antibody candidates in clinic and beyond.
As a Senior Scientific Advisor for Eurofins BioPharma Product Testing, Stanley Prince provides technical and commercial support for GMP Biosafety services helping clients navigate specialized testing needs. Spanning a 17 year career in the CRO and Biotech industries, Mr. Prince brings a depth of understanding and scientific expertise in the development of large molecule and cell and gene therapy projects. He received his B.S. in Life Sciences from Penn State and earned an M.B.A. from Alvernia University.
As Senior Vice President, Bo Kowalczyk is responsible for business unit oversight supporting the staff to ensure client’s/study’s needs are met. Mr. Kowalczyk brings 25 years of drug development CRO experience to Eurofins in both small and large molecule platforms supporting Bioanalysis, CM&C Analytical, Medicinal Chemistry, and ADME services. He received his MS Organic Chemistry from Illinois Institute of Technology and an MBA from University of Illinois.
Tina Rogers, PhD, MBA, DABT, is a life sciences executive with 25 years of experience in the CRO industry providing preclinical drug development services to biopharma, NIH and DoD. In her role as Senior Scientific Advisor, Dr. Rogers leads the expansion of Sinclair Research’s nonclinical development services and provides scientific and regulatory guidance to support customer programs. Dr. Rogers holds a PhD in Molecular & Cellular Biology and Pathobiology from the Medical University of South Carolina, an MBA from Auburn University and is a diplomate of the American Board of Toxicology.