Formulation Approaches

Tuesday, February 26, 2013, 8:30am-10:40am PST

Talks in this session will discuss approaches for accelerating clinical and commercial development by quickly developing phase appropriate formulations. Tools and approaches for rapid formulation development capable of predicting long-term stability should be emphasized. Other example topics include: the relationship of formulation to molecule selection/optimization, approaches for achieving high concentration formulations, and strategies to gain acceptable expiry by filing.

Session Co-Chairs:

  • John Carpenter, University of Colorado

  • Ping Yeh, Amgen

Confirmed Speakers

  • Vladimir Razinkov, Amgen: High Throughput Formulation Development of Therapeutic Proteins

  • David Volkin, University of Kansas: Utility of High-Throughput Biophysical Analysis of Protein Stability during Formulation Development and Comparability Assessments

  • Robert Mueller, Roche: Phase appropriate approach for formulation development

David Volkin

Dr. Volkin is Takeru and Aya Higuchi Distinguished Professor of Pharmaceutical Chemistry at the University of Kansas. He is also co-Director of KU’s Macromolecular and Vaccine Stabilization Center.  His research interests include characterization, stabilization, formulation and delivery of protein drugs and vaccines.  In 2010, Dr. Volkin joined the KU faculty after 20 years in the pharmaceutical industry, including senior director positions at Merck Research Laboratories and Centocor R&D.  He led formulation and analytical R&D groups responsible for developing dosage forms and...

Mark Brader

Dr. Brader is a Principal Scientist and formulation technology group leader in the Protein Pharmaceutical Development department at Biogen Idec.  His protein formulation experience spans the full breadth of pharmaceutical protein product development, from candidate selection to BLA filing.  He has held leadership roles supporting drug product development to submission readiness and rapid formulation strategies supporting early phase clinical evaluation.  Previous roles include senior technical positions in the Pharmaceutics Department at Novo Nordisk, Denmark and Biopharmaceutical R&D...

Robert Mueller

Since 2010, Dr. Müller leads a technical development group in the Late-Stage Pharmaceutical and Processing Development at F. Hoffmann-La Roche Ltd (Basel, Switzerland) with the main focus based on commercial protein formulation and process development.

2008, Dr. Müller took over a formulation research lab in the group of Formulation R&D Biologics at F. Hoffmann-La Roche Ltd (Basel, Switzerland) working on early-stage biotech R&D projects.

From 2005-2008, he was working as formulation scientist in the group of Formulation R&D Biologics at F. Hoffmann-La Roche Ltd (...

Vladimir Razinkov

Amgen Inc., Seattle, WA. Principal Scientist, Department of Drug Product Development working in formulation and pre-formulation development. High throughput screening, candidate selection and characterization of biopharmaceuticals.