Optimizing Biologics Formulation Development
Hanns-Christian Mahler, Ph.D., Head Pharmaceutical Development & Supplies, Biologics EU, F. Hoffmann-La Roche, Switzerland
Since 2010, Dr. Mahler is leading the department Pharmaceutical Development & Supplies, Biologics EU at Roche, Base, Switzerland. His responsibilities include early- and late-stage/commercial formulation development, primary packaging development, drug delivery, Drug Product process development, process characterization and validation, transfer to commercial production and production support and preclinical and clinical (phase 1-3) Drug Product supplies of parenteral dosage forms including biologics. He joined Roche in 2005 as Group Leader Formulation Development Biologics. From 2000-2005, Dr. Mahler was working at Merck KGaA, Darmstadt, Germany as Principal Formulation Scientist, Lab Manager for Protein Formulation Development and Clinical Trial Manufacturing and CMC Team leader for Erbitux during its submission and launch phase. Dr. Mahler studied Pharmacy at the University of Mainz, Germany, holds in Ph.D. in Toxicology from the Institute of Pharmacy, University of Mainz and Pharmacist specialization degrees in Toxicology & Ecology and Pharmaceutical Technology. He was further trained in Economy and Marketing. Dr. Mahler obtained his venia legendi (german Habilitation) from the University of Frankfurt/Germany in 2010 and is adjunct faculty and lecturer at the universities of Frankfurt (Germany), Kansas (Lawrence, US) and Basel (Switzerland). He was elected an AAPS Fellow in November 2013.
David Volkin, Ph.D., Takeru and Aya Higuchi Distinguished Professor, The University of Kansas
Dr. Volkin is the Takeru and Aya Higuchi Distinguished Professor of Pharmaceutical Chemistry at the University of Kansas. He is also 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 biopharmaceutical industry, including senior director positions at Merck Research Laboratories and Centocor R&D. He led formulation and analytical R&D groups developing dosage forms and analytical methods for dozens of vaccine and therapeutic protein candidates used in clinical trials, including five vaccines and two monoclonal antibodies approved for commercial use. He is co-author of over 90 scientific publications and co-inventor on 14 U.S. patents. Dr. Volkin graduated with B.A. in Chemistry from the University of California-San Diego and earned a Ph.D. in Biochemical Engineering from the Massachusetts Institute of Technology.
Vladimir Razinkov, Ph.D., Principal Scientist, Amgen
2006-current: Amgen Inc., Seattle, WA Principal Scientist, Department of Drug Product Development Formulation and pre-formulation development. High throughput screening, candidate selection and characterization of biopharmaceuticals. Previously worked in pharmaceutical and biopharmaceutical industry for companies including MedImmune and Wyeth. Ph.D. in Biophysics, Institute of Bioorganic Chemistry, Moscow, Russia M.S. Applied Physics and Mathematics, Moscow Institute of Physics and Technology
Hong Liu, Ph.D., Senior Research Associate, Early Stage Pharmaceutical Development, Genentech
Current Position: Early Stage Pharmaceutical Development in Genentech, Inc 2003-present Role and Responsibility: Serve as a formulation lead in multiple projects from research stages to Phase II clinical trial of protein therapeutics for immunology and oncology indications EDUCATION China Agricultural University Beijing, PR. China Bachelor of Science in Plant Physiology and Biochemistry July 1998 University of Rhode Island Kingston, Rhode Island Master of Science in Chemistry May 2002 University of Rhode Island Kingston, Rhode Island Ph.D in Chemistry May 2013
Russell G. Burge, Ph.D., Application Scientist, Freeslate, Inc.
Russell Burge is an Application Scientist at Freeslate, Inc. He earned a Bachelor of Science degree in biochemistry from Arizona State University in Tempe. Russell obtained a Ph.D. in molecular biology and biochemistry from the Scripps Research Institute in La Jolla, California. After graduation, Russell received post-doctoral training at the University of Colorado in Boulder. During post-doctoral training, Russell worked on the biophysical characterization of RNA and DNA aptamers relevant to the biopharmaceutical industry. Russell’s industry experience includes working as a Scientist I at KBI Biopharma Inc., where he worked on more than a dozen biopharmaceutical development projects.
Steven LaBrenz, Ph.D., Scientific Director, Drug Product Development, Janssen R&D
Steven LaBrenz is a Scientific Director with Janssen R&D, LLC in the Drug Product Development division. He has been a member of the Parenterals and Liquids group since 2008, leading the areas of assay development, formulation development, product troubleshooting and high throughput screening. Steve earned his Ph.D. from Texas A&M University in Organic Chemistry and was both an NIH and ASEE post-doctoral fellow.
Nicolas Moniotte, Ph.D., Technology Development Leader, R&D Formulation Development, GlaxoSmithKline Vaccines, Belgium
Nicolas recieved his PhD from the University of Namur, Belgium and joined GSK Vaccines 6 years ago, as a formulation scientist. He is currenlty leading the evaluation and implementation of new formulation technologies for vaccine products. He is also the head of the High-Throughput Formulation Screening Platform at GSK Vaccines.
Meera Agarkhed, Formulation Scientist, ImClone Systems, a Wholly-Owned Subsidiary of Eli Lilly & Co.
After receiving Masters in Biochemistry and Biotechnology, Meera has been working in formulation development of biologics for over 12 years. Her experience mainly includes formulation and analytical method development.
Henrik Rajesh Kumar Parshad, Principal Scientist, Biopharmaceutical Formulation Development, Novo Nordisk A/S, Denmark
Completed Masters in Pharmaceutical sciences at UNiversity of Copenhagen, Faculty of pharmaceutical sciences in 1999 and PhD same place in 2003. Has worked in formulation and process development for 10+ years: 5 years within diabetes area (2003-2008), and 5 years within inflammation (2008-current).
Murali Bilikallahalli, Ph.D., Associate Director, Formulation Sciences, Proteins, Vaccines & Oligos, MedImmune, LLC (a subsidiary of AstraZeneca)
Murali has a PhD in Biophysical Chemistry and is currently a Associate Director at MedImmune leading Formulation of Proteins, Oligos and Vaccines. He is an SME in the biophysical area over 20 years, and has been developing formulations and Drug products for variety of biologic modalities such a mAbs, conjugated proteins, VLPs, sub-unit vaccines, live attenuated viral vaccines, CPGs, SiRNA, and DNA plasmids. Two approved products in the market (Elilyso & Xiapex). He has won three young investigator awards (ASBMB-USA, ASPET-USA & JSPS- Japan) and published over 40 original research papers, expert reviews and book chapters. Currently, he serves on the Editorial boards of Drug Discovery Today and mAbs.
Jamie Moore, Ph.D., Director, Early Stage Pharmaceutical Development, Genentech
Dr. Jamie Moore is a Director leading the Early Stage Pharmaceutical Development at Genentech, responsible for developing formulations to support preclinical and Phase I/II clinical studies for biologics. Dr. Jamie Moore has a B.S. in Chemistry and obtained a Ph.D. from UCSF in the department of Chemistry and Chemical Biology.
Jianxin Guo, Ph.D., Principal Scientist, Pharmaceutical Sciences, Pfizer
Jianxin Guo is a principal scientist in biotherapeutics pharmaceutical sciences group at Pfizer Inc. She obtained her PhD in pharmaceutics in 2003 from China Pharmaceutical University, Nanjing, China. She joined Pfizer in 2010 and her formulation experiences include antibody drug conjugates, vaccines and high concentration mAbs.
Angelica Olcott, Ph.D, MFI Product Manager, ProteinSimple
My career in product marketing has focused on analytical systems to support the biopharmaceutical industry as well as large academic centers. During the past 10 years, I specialized in laboratory automation and personal flow cytometry, and recently combined these two interests as the lead product manager for Micro-Flow Imaging at ProteinSimple. I am interested in how this technology can be used to evaluate particle contaminants across a variety of protein formulations and biological samples. Prior to joining industry, I completed doctoral research in molecular pharmacology, involving peptide-based and anti-oxidant strategies for autoimmune disorders.
Michele Pallaoro, Ph.D., Unit Head, Formulation Analytics, Novartis Vaccines & Diagnostics, Italy
Michele Pallaoro first graduated in Biology at the University of Rome La Sapienza then obtained a PhD in Biochemistry. After two years at the University of California were he grew his interest for Biochemistry and protein engineering he came back to Italy to take a junior research position at IRBM (Merck & Co). Here he made relevant contributions in several projects ranging from anti HCV to anti-tumoral programs. After ten years he moved to Novartis Vaccines and Diagnostics were he is currently leading the Formulation Analytical Unit. Michele Pallaoro is author or co-author several research papers and reviews in peer reviewed journals and holds several patents.