The 6th Annual Charles I.
Jarowski Industrial Pharmacy Symposium
Drug Product Value Enhancement
Strategies
David R. Taft, Ph.D.
Professor and Dean
Arnold & Marie Schwartz College of Pharmacy and Health
Sciences, Long Island University
David R. Taft is Professor of Pharmaceutics and Dean of the
Arnold & Marie Schwartz College of Pharmacy and Health Sciences
of Long Island University. He received his undergraduate degree in
Pharmacy from the University of Rhode Island and his Ph.D. in
Pharmaceutical Science from the University of Connecticut. He
joined the faculty of Long Island University in 1994 after
completing a post-doctoral fellowship at the University of North
Carolina School of Pharmacy.
Dr. Taft’s research interests are in the area of
pharmacokinetics with a focus on drug disposition mechanisms. His
laboratory has collaborated with numerous companies in preclinical
evaluation of novel therapeutic entities. Dr. Taft has published
more than 90 manuscripts, research abstracts and book chapters, and
he co-edited two books. He serves on the editorial advisory boards
of Journal of Pharmaceutical Sciences and Drug Development and
Industrial Pharmacy. Dr. Taft is a past recipient of the American
Association of Pharmaceutical Scientists (AAPS) New Investigator
Grant in Pharmacokinetics, Pharmacodynamics, and Drug
Metabolism.
Kenneth V. Phelps
President and CEO
Camargo Pharmaceutical Services
Ken Phelps relied on more than three decades of experience in
the health science and services industry to found Camargo
Pharmaceutical Services in 2003. As an expert in end-to-end drug
development, specifically the 505(b)(2) regulatory approval
pathway, Phelps and his team attain two to five pre-IND meetings
before the FDA per month. Aiding companies across more than 25
countries, Camargo provides successful FDA approval of numerous
drug products each year.
Prior to founding Camargo, his broad background in drug
development had led to a number of executive-level assignments in
the areas of quality control, project management and regulatory,
clinical and medical affairs at Duramed Pharmaceuticals (now Teva
Pharmaceuticals).
Prior to his work for Duramed, Phelps held a number of positions
at Merrell National Labs, which merged to become Merrell Dow and
eventually evolved into Sanofi-Aventis. At Merrell he had global
responsibility for quality assurance, quality control and
processing technology with an assignment based in Milan, Italy, and
later directed IT for multinational manufacturing operations,
leading to technical improvements in R&D, accounting and
manufacturing operations.
Mahendra G. Shah, `77GP, `85Ph.D.
Partner, Vivo Ventures
Former Chairman and CEO, Nextwave Pharmaceuticals
As of 2010, Mahendra G. Shah, Ph.D. is a venture partner at Vivo
Ventures a health care focused venture fund. From 2005 to 2009 he
was the founder, chairman and CEO of Nextwave pharmaceuticals
pediatric focused specialty pharmaceutical company. From 1993 to
2003 he was the chairman and CEO of First Horizon Pharmaceuticals a
publicly traded specialty pharmaceutical company where he raised
over $200 million dollars in public market and build a very
profitable company with sales over $150 million. The company was
sold to Shinogi pharmaceuticals for $ 1.4B.
From 1991 to 1999 he was the vice president of E. J. Financial
enterprises, inc., which manages a fund that invests in health care
companies. He previously served on the board of Unimed
Pharmaceuticals (UMED),Introgen Therapeutics
Inc.(INGN),Inpharmakon, inc., Protomed Inc., Structural
Bioinformatics Inc., and Zarix Inc. From 1987 to 1991 he was the
senior director of new business development with Fujisawa USA
(Astellas). Prior to that time he worked in various scientific and
management positions with Schering-Plough and Bristol Myers-Squibb
company.
Dr. Shah received his Ph.D. in industrial pharmacy from
St.John’s University and his Bachelors and Masters Degree in
Pharmacy from L.M. College of Pharmacy in Gujarat, India
Sesha Neervannan, PhD
Vice President, Pharmaceutical Development
Allergan
Dr. Sesha Neervannan is currently Vice President of
Pharmaceutical Development at Allergan. In his current role, he
oversees the CMC activities related to developing the drug product
from Discovery to Commercialization that includes material
characterization, formulation, process engineering, device &
packaging engineering, analytical development, and drug delivery
research and development efforts.
Prior to joining Allergan, Sesha held senior positions at
Bristol-Myers Squibb and Amgen, in both a functional and team
leadership role. Sesha has several research publications and
patents and is a well recognized invited speaker at several
national and international conferences. He serves on the several
advisory Boards including the Scientific Advisory Board for CHDI, a
non-profit organization, Customer Advisory Board for NineSigma and
the Editorial Advisory Board for the journal, Expert Opinion on
Drug Delivery.
He received his Ph.D. in Pharmaceutical Chemistry at The
University of Kansas.
Salah U. Ahmed, `85GP, `90Ph.D.
President and CEO
Abon Pharmaceuticals
Dr. Salah U. Ahmed is the Founder, President & CEO of Abon
Pharmaceuticals, LLC., established in 2009. Prior to the
establishment of Abon, he was the Executive Vice President of
Global Research and Development and Chief Scientific Officer at
Barr Pharmaceuticals, Inc. Dr. Ahmed led diverse R&D operations
in the USA and several countries in Europe involving the
development of generic pharmaceuticals, proprietary
pharmaceuticals, API and biotechnology products. He managed a
product portfolio with a broad range of Drug Delivery Systems (DDS)
including parenteral, nasal, ocular, oral, transmucosal,
transdermal, and intrauterine routes of administration.
Dr. Ahmed received his MS in Industrial Pharmacy and PhD in
Pharmaceutical Sciences from St. Johns University, New York. He has
more than a quarter century of pharmaceutical experience, of which
16 years were at Barr Pharmaceuticals, Inc. His leadership role in
product development significantly contributed to Barr’s
transformation to a specialty pharmaceutical company and a world
leader in the generic pharmaceuticals industry.
Dr. Ahmed has a notable track record in pharmaceutical research
involving special DDS, solid-state interactions, statistical design
and mathematical modeling in product development research, and
in-vitro/in-vivo performance of dosage forms. His research work in
these areas originated more than 40 patents. He authored or
co-authored more than 60 research papers, abstracts and book
chapters. He has been a distinguished speaker in many
pharmaceutical conferences/workshops in the USA and in
Europe.
Gary Liversidge, Ph.D.
Chief Technology Officer and Vice President
Alkermes, Inc.
Dr. Liversidge is Chief Technology Officer and Vice President,
Research and Development for Alkermes. He received his B. Pharm.
from the University of Bradford, England in 1978, and a Ph.D. in
1981 from the University of Nottingham, England with Dr. David
Grant. From 1981 to 1983, he completed a postdoctoral fellowship in
Pharmaceutical Chemistry at the University of Kansas with Dr.
Takeru Higuchi. He then joined the faculty at the School of
Pharmacy, University of North Carolina through 1985. Since then he
has held various positions in the Pharmaceutical industry. Dr.
Liversidge is the inventor of NanoCrystal® technology. He holds 22
US patents and over 80 patent applications and has over 50
publications and several monographs and book chapters. Dr.
Liversidge’s inventions are incorporated in six licensed products
that help almost 2 million patients in the USA every day.
J. D. Pipkin, Ph.D.
Sr. Director, New Product Development
Ligand Pharmaceuticals
James D. (J.D.) Pipkin, Ph.D., is Sr. Director, New Product
Development at Ligand Pharmaceuticals, Inc. In 2001, J.D. joined
CyDex Pharmaceuticals, which was acquired in early 2011 by Ligand.
His responsibilities are to support development of new
applications, intellectual property and products utilizing
CAPTISOL, whether the application involves new molecular entities
(NMEs) or reformulations of existing drugs for life cycle
management. Prior to joining the Company, he was Executive Director
for CMC Services and Director of Formulation Development at Oread
Laboratories from 1995 to 2001. From 1986 through 1995, he was a
Research Fellow with Merck Research Laboratories in the INTERx
Research and West Point PR&D facilities; his area of research
interest was in the design and evaluation of controlled release
devices to enhance therapeutic efficacy and lower systemic burden.
He was at The Squibb Institute for Medical Research from 1980
through 1985, where he directed the preformulation activities for
new chemical entities. He has contributed to numerous
presentations, publications and patents and holds a M.S. and Ph.D.
from the University of Kansas in Pharmaceutical Chemistry, and B.A.
in Mathematics and Chemistry from KU.
Tapan Sanghvi, Ph.D.
Scientific Fellow
Vertex Pharmaceuticals
Tapan Sanghvi is a Scientific Fellow I of Formulation
Development at Vertex Pharmaceuticals Inc., Cambridge, MA. He leads
a team of dedicated scientists focused on preformulation
characterization, formulation design, process scale-up and
technology transfer for solid dosage forms. Dr. Sanghvi is a leader
in the development of drug delivery technologies with a special
focus on spray dry dispersions, making significant advancements in
this area as the pharmaceutical development leader of telaprevir.
Dr. Sanghvi is a strong advocate for Quality by Design and
biopharmaceutical modeling. He has a M.B.A. and Ph.D. in
Pharmaceutical Sciences, and has delivered many publications and
presentations during his career in the pharmaceutical
industry.