Strategic Considerations for Successful Biosimilars Development

Siân Estdale BSc, MPhil, PhD, Head of Science and Innovation, Clinical Trials Testing Solutions, Covance

Siân Estdale is the head of science and innovation within clinical trials testing solutions at Covance where she has worked since 2002. Her expertise is in methodologies to support drug development of molecules, especially biologics from R & D to market in CMC and BioA and now patient care analysis. She has worked with biosimilars for over 12 years and worked with the CMC team to develop biosimilar master files for key targets. Previous to Covance, Estdale was an academic, lecturing in Biomedical Sciences at Bradford and Sheffield Hallam Universities with 14 years research experience in diverse areas: recurrent miscarriage, ischemia-reperfusion and skin research. She has a PhD in organic chemistry.

Joan Meyer, MS, PhD, Executive Director, Strategy & Planning Inflammation, Infectious Disease and General Medicine, Covance

Dr. Joan Meyer is the executive director, inflammation, infectious disease & general medicine at Covance. She has more than 30 years of experience in basic research and clinical development, which includes more than 20 years at Procter & Gamble and spans both consumer products and pharmaceuticals. She has taken two compounds from the bench through Phase III clinical development and designed and/or led clinical studies in a variety of indications across many therapeutic areas as well has launched new products, developed Phase IV studies and led an FDA Advisory Committee presentation. Dr. Meyer received her PhD in Neuroscience from the University of Illinois.

Alicia M. Baker McDowell, DRSc, MS, Executive Strategist, Head of Biosimilars Center of Excellence, Strategic Product Development Consulting, Covance

Alicia Baker McDowell is an executive strategist and the head of the Biosimilars Center of Excellence based in Princeton, NJ. Baker has over 24 years of drug development experience including over 21 years in global regulatory strategy. Baker has registered products across the globe in over 90 countries and is experienced in direct agency interactions including FDA, EMA, MHRA, NMPA, PMDA, KFDA, TGA and others. Her experience spans small molecules and biologics from both the innovator and biosimilar side of development.

Baker has a BS in Biology from St. Joseph’s University, a MS in Regulatory Affairs/Quality Assurance from Temple University, a MS in Regulatory Science from the University of Southern California and a Doctorate in Regulatory Science from the University of Southern California.