Speakers


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    Doug Ball Research Fellow Pfizer Doug obtained his BS and MS in Biology from St. John’s University, Jamaica, NY in 1977 and 1980, respectively and is board certified in general toxicology (DABT).

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    Stephen Barat Senior Director, Toxicology Operations Forest Laboratories Stephen has been with Forest Research Institute since 2009, providing senior leadership and direction for preclinical safety assessments for drug development and registration programs.

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    Edwin Chan Site Manager, External Manufacturing Collaboration Genentech Edwin has over ten years of experience supporting pharmaceutical processing development, where he authored and co-authored numerous journals related to manufacturing considerations of prefilled syringe for biologics.

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    Ella Cozmi Director, Human Factors, Engineering Hospira Ella Cozmi is the Director of Human Factors Engineering at Hospira, Inc. She is a seasoned medical device developer with a background in nursing, physics and engineering.

  • Jason Fernandez Scientist, Protein Pharmaceutical Development Biogen Idec Jason Fernandez is a Scientist at Biogen Idec, where he has worked in the Protein Pharmaceutical Development group for the past three years. He has 13 years of experience in the field of protein formulation and process development, with a focus on combination product development.

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    David Grote Site Quality Head cGMP Teva Pharmaceuticals David is a QA leader with years of development, technology transfer, manufacturing and validation experience of both biologics drug product and drug substance, David is currently responsible for cGMP QA for multiple clinical products at Teva Biopharmaceuticals.

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    Mike Hrytsak Manager, Device Development Regeneron Pharmaceuticals Mike has over 5 years engineering and management experience in medical device and pharmaceuticals industry.

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    Catherine Kang Senior Associate, Global Regulatory Affairs Hospira Catherine provides regulatory support to cross-functional teams for development and on-market support of pre-filled syringes and other medical devices at Hospira.

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    Nan Yung Lin Consultant Engineer Eli Lilly

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    Daniel Norwood Distinguished Research Fellow in Analytical Development Boehringer Ingelheim Dr. Norwood chaired the PQRI working group on Leachables and Extractables in Orally Inhaled and Nasal Drug Products, and is currently a member of the PQRI working group for Parenteral and Opthalmic Drug Products.

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    Swaroopa Paratkar Research Investigator Bristol-Myers Squibb Swaroopa Paratkar, Research Investigator, Bristol-Myers Squibb got her PhD in Biochemistry; Expertise in biologics parenterals formulation development, biophysical/analytical characterization; development of pre-filled syringes, vials, lyophilized drug products; Lead cross-functional teams to execute CMC development of parenterals drug products; Tech transfer of drug product manufacturing processes.

  • Gretchen Vandal Senior Manager, Regulatory-CMC, Combination Products Biogen Idec Gretchen Vandal is a Senior Manager in the Regulatory Affairs, CMC Combination Products organization at Biogen Idec. Read more...

  • Russell Watt Senior Research Associate, Pharmaceutical Development Isis Pharmaceuticals Russell has a background in chemistry and physics, and supports the Pharmaceutical Development department at Isis Pharmaceuticals. Read more...

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    John Zowtiak Director, Device Development Johnson & Johnson Expertise in development & commercialization of drug delivery systems for pharmaceuticals.

  • Jared Bee Senior Scientist, Biophysics MedImmune Dr. Jared S. Bee has interests in using biophysics to understand links between protein structure, function and solution behavior. His formulation experience includes overcoming challenges with stability and functionality for prefilled syringe presentations of ultra-high concentration biopharmaceuticals.

  • Tage Carlson Director, Medical Products Research and Development Baxter Tage is currently the director of Baxter’s toxicology division, responsible for assessing the safety of our materials and drug solutions. He is a board-certified toxicologist dedicating the majority of his career to the nonclinical development of small molecules.