Stream 2 - Speaker Bios
Overcoming Formulation Challenges for Biopharmaceutical Development
August 3-4, 2015
Vincent Corvari, Ph.D., Senior
Research Advisor, Bioproduct Research & Development, Eli Lilly &
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,
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
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
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
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
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
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
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
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
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,
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
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
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.