The Bioprocessing Summit
The Bioprocessing Summit

Stream 2 - Speaker Bios

Speaker Bios

Overcoming Formulation Challenges for Biopharmaceutical Development
August 3-4, 2015

Vincent Corvari, Ph.D., Senior Research Advisor, Bioproduct Research & Development, Eli Lilly & Company

Dr. Corvari received a B.S. degree in Pharmacy from Philadelphia College of Pharmacy & Science and a Ph.D. degree in Industrial Pharmacy from the University of Maryland. He held various positions at Cephalon and Biogen before taking his present position at Eli Lilly & Company.  Dr. Corvari’s area of technical expertise is focused on drug product development of protein therapeutics spanning early phase candidate selection through late phase clinical development and commercialization.  Over the past 22 years, much of Dr. Corvari’s work has centered on physico-chemical characterization of candidates, formulation design, manufacturing process development and technology transfer to commercial manufacturing sites.

Michael T. Jones, Ph.D, Research Fellow, Biotherapeutics Pharmaceutical Sciences, Analytical R&D, Pfizer, Inc.

I received my B.S. in Chemistry from Nebraska Wesleyan University and my Ph.D. in Organic Chemistry from Kansas State University. I have worked in the Pharmaceutical industry for over 25 years as an analytical chemist for both small molecules and biologics and as a formulations chemist developing formulations for early stage compounds.  I currently work for Pfizer, Inc where I supervise a group of analytical scientists developing the analytical strategy for biopharmaceuticals.

Sandeep Yadav, Ph.D., Scientist, Late Stage Pharmaceutical Development, Genentech, Inc.

Sandeep Yadav is a Scientist at Late Stage Product Development, Genentech Inc. with responsibility for devising novel strategies to address viscosity and stability issues associated with high concentration formulation development, and has authored and co-authored several publications concerning viscosity, self-association/aggregation and stabilization techniques in peer-reviewed journals. Sandeep holds a PhD degree in Pharmaceutics from University of Connecticut, MS in Pharmaceutics (Drug Delivery) and BS in Pharmaceutical Sciences from University of Delhi.

Shuai Shi, Ph.D., Associate Principal Scientist, Sterile Product and Analytical Development, Merck

Dr. Shi received his PhD. degree in pharmaceutical sciences from the University of North Carolina at Chapel Hillin 2010. In a short period of three years, Dr. Shi has six publications in leading, peer-reviewed international reputed pharmaceutical journals. Several of these manuscripts are also firsts in their field. Two describe, for the first time, the delivery of mycafungin intended for treatment of fungal infections following lung transplants and support the clinical work of collaborators at Duke University. Additionally, two of these manuscripts illuminate a conundrum in pharmaceutical analysis that of cascade impactor profile comparisons to demonstrate particle size equivalence. Dr. Shi creatively developed an alternative method which has gained a wide interest from the pharmaceutical aerosol field. Dr. Shi was also a recipient of the MOPH graduate scholar award for his outstanding PhD research in developing respirable tuberculosis vaccines. In 2010-2011, Dr. Shi completed a post-doctoral fellowship with one of the most distinguished scientists in the field of biotechnology, Professor Russell Middaugh, at the University of Kansas, where he was the project leader for multiple industry sponsored projects on protein and vaccine formulation and characterization. Dr. Shi has also published several exceptional research articles during this period. In one publication, he successfully discovered the aggregation mechanism of a recombinant protein sEphB4-HSA, a therapeutic candidate for the treatment of vascular proliferative diseases and cancer such as Kaposi sarcoma (KS). This article was ranked one of the ten most downloaded papers published in 2012 and thus being featured on the journal’s website. In 2011, Dr. Shi took up a position as a Senior Scientist in the Sterile Product Development group at Merck. Since then he has made significant contributions to the biophysical characterization and formulation development of Merck biosimilar, biobetter and novel programs. This includes leading a high-performance team to develop new technologies for protein characterization; supervising junior-level scientists on their research activities and serving as functional representatives on multiple protein characterization and formulation projects. Dr. Shi’s excellent work in Merck has won him several times Merck Award of Excellence, one provisional formulation patent on a biosimilar, and several publications. Dr. Shi is a member of multiple scientific societies such as AAPS, ACS and Sigma Xi. He is also a peer reviewer for a number of international journals.

Mark Bolgar, Ph.D., Senior Research Fellow, Analytical and Bioanalytical Development, Bristol-Myers Squibb Co.

Dr. Mark Bolgar is a Senior Research Fellow in the Analytical and Bioanalytical Development Department of Bristol-Myers Squibb in New Brunswick, New Jersey.  Mark currently leads the New Modalities and Biologics Team which supports formulation development of biologics and acts as a center of excellence for the analytical development of new drug modalities such as peptides, ADCs, and oligonucleotides.  Mark also has extensive experience in the CMC development of small molecules and has held the role of Analytical Project Team leader and he was the Integrated Development team lead for Baraclude. 

Mark began his career at the then E.R Squibb and Sons in Analytical R&D in Lawrenceville in 1986 following the completion of a B.S. in chemistry at the University of Florida.  After completing a M.S. degree in chemistry at Rutgers in 1993, he earned his doctorate in chemistry from the University of Manchester (U.K.) in 1996 while on a BMS Doctoral Fellowship. 

Kevin Constable, Director, Technology Development, Terumo- Global Pharmaceutical Solutions.

Sachin Dubey, Ph.D., Head of Formulation Development, Process Development, Glenmark Pharmaceuticals SA

Sachin Dubey is presently working with Glenmark Pharmaceuticals, Switzerland, where he is responsible for formulation development and clinical trial preparations. Sachin earned his PhD from the University of Geneva, Switzerland and has previously worked with Novozymes Biopharma, Denmark. His principal research interests are protein/mAb/bispecific formulation formulation, stabilization, downstream processing, chromatography, DOE and QbD. He also has a keen interest in practicing lean principles. He has received multiple research and industry awards and has several publications and presentations to his credit.

Hardeep Samra, Ph.D., Senior Scientist, Formulation Sciences, MedImmune, Inc.

Hardeep Samra is a Senior Scientist in the Department of Formulation Sciences at MedImmune, and currently is responsible for leading and supporting formulation development activities for multiple late-stage biologics.   Since joining MedImmune in 2008, Hardeep has led and supported formulation development activities on multiple early stage programs, as well being actively involved in leading several technology development, strategic initiatives, and academic collaborations aimed at optimizing early formulation development through the implementation of high-throughput screening and formulation platforms, as well as the development of predictive tools for common formulation and protein instability challenges.  He has over 8 years of experience in formulation development and characterization of live-attenuated and subunit vaccines, monoclonal antibodies, and multiple other novel molecule therapeutics.  He completed his doctorate in 2007 in Biochemistry and Biophysics from the University of Kansas, and also received bachelor’s degrees in both Genetics and Cellular Biology from the same institution.   Hardeep serves as an ad hoc reviewer for multiple scientific journals, including the Journal of Pharmaceutical Chemistry, Biochemistry, and Molecular Pharmaceutics.  He is an author on over a dozen scientific publications, and presents regularly at scientific conferences on topics involved with formulation development and protein characterization.

Mark Yang, Ph.D., Director, Fill Finish Development, Genzyme - a Sanofi Company

Dr. Yang is the Director of Fill Finish Development in Genzyme, where he leads a team responsible for Commercial formulation and lyophilization process development and technology transfer.  Prior to Genzyme, Dr. Yang was Associate Director at Acceleron Pharma, where he built the formulation lab/team and oversaw CTM product manufacturing in US and EU. Dr. Yang also worked for many years in drug delivery and high concentration formulation. He is the recipient of VP Award from Genzyme, Outstanding Technology Achievement Award from Baxter, Fellows Award for Research Excellence from NIH. Besides numerous patents, he published over 20 peer-reviewed research papers.

Yuh-Fun Maa, Ph.D., Principal Engineer, Pharmaceutical Processing and Technology Development, Genentech, Inc.

Yuh-Fun Maa is a Principal Engineer at Genentech (SSF, US) focusing on pre-filled syringe process development, API bulk storage development, and drug delivery technology assessment. Yuh-Fun rejoined Genentech in February 2010 and has over 20-year industrial experience in pharmaceutical/biopharmaceutical development and drug delivery. Prior to Genentech, he joined ALZA, a Johnson & Johnson Company, in 2002 to work on Macroflux Transdermal Technology, which was spun out to become Zosano Pharma in 2006, with responsibilities in developing stable solid-state formulations tip-coated on microprojections of the transdermal patch. Before ALZA, Dr. Maa accumulated extensive experience in developing protein/vaccine powder formulations for various drug delivery technologies during his employment with Genentech (1992-1998) and PowderJect Technologies/Vaccines (1998-2001). He holds a Ph.D. in Chemical Engineering from the University of Rochester in Rochester, NY (1989) and has also completed postdoctoral training at SRI International (1990). Dr. Maa has authored >50 peer-reviewed scientific articles and patents/patent applications.

Russell Burge, Ph.D., Applications 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.

Jan Stracke, Ph.D., Principal Scientist, Pharmaceutical Development & Supplies, ​PTD Biologics Europe, F. Hoffmann-La Roche Ltd.

Jan Stracke joined Roche in 2001 working on chemical modification and purification methods for protein therapeutics. Later, he took a position in Protein Analytics, specializing in the physico-chemical analysis, characterisation and stability assessment of therapeutic proteins. Recently, he joined Roche Early-Stage Pharmaceutical Development & Supplies in Basel as Principal Scientist, responsible for the formulation and pharmaceutical development of biotherapeutics. His main interests are the evaluation of chemical and physical degradation pathways and the elucidation of the structure-function relationships for the new therapeutic entities.

Richard K. Brown, Ph.D., President, AVIA Biosystems

Ranajoy Majumdar, Ph.D., Research Scientist, Biophysical Characterization, Biopharmaceutical Research and Development, Eli Lilly and Company

Ranajoy is a research scientist in the biopharmaceutical R&D department of Eli Lilly and Company. He is a member of the biophysical characterization group and leads characterization efforts for several molecules in internal CM&C teams. His research interests include high throughput structural characterization and application of biophysical techniques in formulation and process development of biomolecules. Prior to joining Lilly, Ranajoy obtained a Ph.D. in Pharmaceutical Chemistry from the University of Kansas.

Geetha Thiagarajan, Ph.D., Senior Scientist, Sterile Product and Analytical Development, Merck & Co.

After obtaining my Ph.D. in Biochemistry from India on the biophysical aspects of protein aggregation related to cataract of the eye lens, I continued to pursue my interest in protein unfolding and aggregation leading to disease. This included my studies of A aggregation in Alzheimer’s and Polyglutamine aggregation in Huntington’s disease with Prof Ronald Wetzeland collagen-based disorders with Prof Barbara Brodsky. I worked in the area of Human Genetics with Prof Robert Desnick at Mount Sinai School of Medicine, NY identifying Single Nucleotide Polymorphisms (SNPs) in receptor proteins which could impact the uptake of lysosomal proteins. I joined Merck in 2011 and have been associated with the Biophysical and Analytical Characterization group in the Sterile Product and Analytical Development Department.

Rachael Lewus, Ph.D., Scientist II, Formulation Sciences, MedImmune, Inc.

Rachael Lewus is a formulation scientist working with MedImmune (Gaithersburg, MD) in the area of Biopharmaceutical Development.  She has been working with MedImmune for four years, serving as the lead formulation representative on clinical programs focusing on late stage development and commercialization.  Rachael received her Ph.D. in Chemical Engineering from the University of Delaware in 2011, where she focused on prediction of protein phase behavior.  Her current scientific interests also include mechanistic understanding of protein particle formation pathways and formulation process characterization.

Speaker Bios

High-Concentration Protein Formulations
August 5-6, 2015

Thomas Laue, Ph.D., Professor, Biochemistry and Molecular Biology; Director, Biomolecular Interaction Technologies Center (BITC), University of New Hampshire

Tom Laue is the Carpenter Professor of Molecular, Cellular and Biomedical Sciences, and professor of Material Sciences at the University of New Hampshire. He is the Director of both the Center to Advance Molecular Interaction Science and the Biomolecular Interaction Technologies Center. He received his bachelor's degree in Natural Sciences from the Johns Hopkins University in 1971 and his Ph.D. in Biophysics and Biochemistry from the University of Connecticut in 1981. His post-doctoral studies were conducted at the University of Oklahoma. Between 1969 and 1975, he worked as a technician in the deep space program of NASA. He joined the University of New Hampshire in 1984 as an Assistant Professor, and teaches both undergraduate and graduate courses in biochemistry and biophysics. His research focuses on the development of instrumentation and methods that use the fundamental properties of mass and charge for examining macromolecular interactions. These instruments provide unique insights into these interactions, and have resulted in extensive collaborations with both academic and industrial labs. Tom has over 120 publications, serves on several editorial boards, and gives over one hundred lectures, seminars and workshops a year.

Thomas Palm, Ph.D., Senior Research Investigator II, Drug Product Science and Technology, Bristol-Myers Squibb Co.

Yun Liu, Ph.D., Research Associate Professor/Instrument Scientist, Chemical & Biomolecualr Engineering/Center for Neutron Research, University of Delaware/National Institute of Standards and Technology

Dr. Yun Liu is a research associate professor at the Chemical and Biomolecular Engineering Department of University of Delaware, and a staff scientist at the Center for Neutron Research in National Institute of Standards and Technology. Dr. Liu’s research interests cover biophysics, colloidal science, and gas adsorption/desorption problems. He has successfully applied colloidal theories to investigate the structure and dynamics of dense protein solutions using different techniques including neutron/x-ray/light scattering.

Randall Mauldin, Ph.D., Scientist II, Protein Formulation and Process Development, Biogen Idec

Thomas Hey, Ph.D., Director, Biochemistry, Innovation Center Complex Formulations, Fresenius Kabi Deutschland GmbH

Thomas Hey is Director Biochemistry at the Innovation Center Complex Formulations at Fresenius Kabi. He received his Ph.D. in biochemistry from the University of Bayreuth, Germany. After working for Scil Proteins (Halle/Germany) on alternative scaffold proteins he joined Fresenius Kabi, where he is now responsible for the bioconjugation activities within the HESylation® Technology platform.

Kevin Constable, Director, Technology Development, Terumo- Global Pharmaceutical Solutions

Bruce Kerwin, Ph.D., Head, Drug Product Design, Just Biotherapeutics, Inc.

Bruce Kerwin is Head of Drug Product Design at Just. Biotherapeutics, Inc. Dr. Kerwin has worked in the biotechnology industry for more than 20 years and is a recognized expert in protein formulation and drug product development. Dr. Kerwin received his Ph.D. from the University of California at Davis followed by a postdoctoral fellowship at Washington State University.  Dr. Kerwin worked for 5 years in the formulation development department for Baxter Hemoglobin Therapeutics and for 16 years at Amgen as research scientist and scientific director in Drug Product Development. In prior roles at Amgen Dr. Kerwin led numerous project teams developing novel solutions to formulation problems such as high viscosity, high concentration and protein aggregation while successfully bringing drug candidates through development from pre-IND to commercialization. His work on large and small volume parenteral formulations included monoclonal antibodies, antibody drug conjugates, PEGylated proteins, glycosylated and non-glycosylated proteins and viruses. Dr. Kerwin was also intimately involved with alternative drug delivery systems at Amgen such as slow release and nanoparticle formulations by developing productive relationships with both internal and external industrial partners. He has over 50 research publications in a wide array of areas relating to protein science and formulation development, is an inventor on multiple patents and holds an adjunct appointment as an Adjunct Professor on the faculty of the School of Pharmaceutical Chemistry at the University of Kansas.

Jamie Tsung, Ph.D., Principal Scientist, Momenta Pharmaceuticals, Inc.

Dr. Jamie Tsung received her Ph.D. in pharmaceutical sciences from the University of Connecticut.  Currently, she is a Principal Scientist at Momenta Pharmaceuticals.  Prior to Momenta, she worked for Shire, Baxter, and UCB. Her biopharmaceutical experience spans preclinical to marketed products, integrating formulation, characterization, processing technology, regulatory, and quality control providing a valuable perspective and creative approach to product development.

Yu Tang, Ph.D, Principal Scientist, Integrated Biologics Profiling, Novartis

I am currently holding a Principal Scientist position in Integrated Biologics Profiling of Novartis. I obtained my Ph.D in 2008 in the field of Pharmaceutical Sciences. My research is focusing on development of protein formulation and advanced protein delivery systems. My recent research interests are in resolving challenges in protein formulation, such as solubility, viscosity, and aggregation.

Michael S. Marlow, Ph.D., Senior Staff Scientist, Protein Biochemistry, Regeneron Pharmaceuticals, Inc.

Michael S. Marlow, Ph.D. has been with Regeneron Pharmaceuticals, Inc. in the department of Protein Biochemistry since 2010.  Michael is responsible for the biochemical and biophysical characterization of IND-track biotherapeutics and has played a role in the research and development of Eylea®, one of the most successful biotherapeutic launches in recent history. Prior to joining Regeneron, Dr. Marlow worked at OSI Pharmaceuticals for 2 years, where he assembled and ran a gene-to-protein suite in support of small molecule discovery.  In addition, he instituted a number of biophysical assays for confirming and ranking small molecule leads emerging from high throughput screens. Dr. Marlow received his Bachelor of Science from Rensselaer Polytechnic Institute, a Ph.D. in molecular biophysics from Vanderbilt University, and post-doctoral training at the University of Pennsylvania.

Shiranthi Jayawickreme, Ph.D., Associate Director, Analytical Development, Biogen Idec

Shiranthi received her Bachelors degree in Chemistry from the University of Colombo, Sri Lanka.  Then she received her Masters degree in Analytical chemistry from Dalhousie University, Canada and her Ph.D. degree in Biological Sciences from Yale University.

She has worked in the Biopharmaceutical industry during the last 17 years in Analytical Development organizations at Bayer Corporation, Wyeth-Pfizer, and Biogen.  Her experience has been in method development, qualification, validation and testing of Plasma-derived proteins, Vaccines, and recombinant Mabs.

Ronald Maurer, Ph.D., Scientist, Process Development – Downstream, Bristol-Myers Squibb Co.

Jan Jezek, Ph.D., CSO, Development, Arecor Ltd.

Jan Jezek, the principal inventor of the core protein stabilisation technologies, is a biochemist with a strong background in physical chemistry. Currently responsible for R&D activities, platform development and technical IP support in the field of stabilisation of biologics. He played a crucial role in the development of stabilising technologies for commercially important proteins that allow preservation of protein structure and biological activity during sterilisation by gamma radiation and during long-term storage at ambient temperature. Lead successful grant funded projects with TSB funding. Previously, a Principal Scientist at Insense Limited, he was responsible for development of novel medical devices from concept to market. Dr. Jezek holds a joint Doctorate from the University of Bedfordshire and the University of Chemical technology, Prague. He is a member of the Scientific Advisory Board of the Centre of Excellence in Biopharmaceuticals (University of Manchester). He is also a committee member of the Formulation Science & Technology Group (FSTG) at the Royal Society of Chemistry.

Bakul Bhatnagar, Ph.D., Principal Scientist, Formulation & Process Development, Pfizer, Inc.

Bakul Bhatnagar is a Principal Scientist in BioTherapeutics Pharmaceutical Sciences at Pfizer located in Andover, MA.  He obtained a Ph.D in Pharmaceutical Science from the University of Connecticut and performed post-doctoral work in the department of Pharmaceutics at the University of Minnesota.  He is experienced in formulation and process development of freeze-dried therapeutics and in frozen- and solid-state characterization of pharmaceuticals.

Emmanuel Dauty, Ph.D., Head of the Physico-Chemistry Department, Department: Physico-Chemistry, Adocia

Emmanuel Dauty secured a PhD in chemistry at the University Louis Pasteur (Strasbourg, France), under the supervision of JP. Behr. In 2002, he moved to a postdoctoral position with Prof. AS. Verkman at UCSF (California, USA) to study macromolecule diffusion in complex living system. He then moved back to France to join The Theoretical Modeling of Cellular Biology Group where he worked on particle transport in cells.

He joined Adocia in 2009 as a Senior Scientist. In 2011, he becomes Project Leader Monoclonal Antibodies and develop the AVR platforms for mAb. Since December 2014, he is the Head of the Physico-Chemistry Department. He is the co-author of 3 patents and 12 scientific publications.