7th Drug Formulation, Solubility & Bioavailability -

7th Drug Formulation, Solubility & Bioavailability
March 26 - 28, 2018
Boston, MA

The Modeling and Enabled Formulation Expertise You need to Maximize Developability, Avoid Particle Formation, and Maintain Stability and Bioavailability

Faculty – 7th Drug Formulation, Solubility & Bioavailability

Rossitza Alargova

Gail Dempsey
EOC and Director, Manufacturing Technologies, PIEDMONT ANIMAL HEALTH

Rakesh Dixit
Vice President, R&D, Global Head, Biologics Safety, MEDIMMUNE

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Dr. Dixit conducted extensive graduate and post-graduate training in Toxicology–Biochemistry with both Indian and US Institutions (Case Western Reserve University, Medical College of Ohio, University of Nebraska) and is board certified in Toxicology from the American Board of Toxicology, Inc. since 1992. Rakesh served as a Senior Toxicologist with Midwest Research Institute between 1987 and 1992.

In December 1992, Rakesh joined the Department of Safety Assessment, Merck and Co., Inc, West Point, PA where he served in various management positions. During his about 14 years with Merck, Rakesh contributed to the successful filings of many blockbuster drugs. For about a year, Rakesh was associated with Johnson and Johnson PRD, La Jolla/Alza as Senior Director of Toxicology.

In Aug 2006, Rakesh joined MedImmune, Inc. (an AstraZeneca Biologics company) as Senior Director (R &D) & Global Head of Biologics Safety Assessment, Experimental Pathology, and Laboratory Animal Medicine. In his current position as a Vice President of R &D, Rakesh is responsible for providing guidance on research and development of biological products; including nonclinical toxicology/safety support for all AstraZeneca-MedImmune biologics products, including monoclonal antibodies and vaccines. Rakesh has published more than 60 papers in renowned international journals and has given over 100 invited lectures/presentations/workshops in national and international meetings.

Rakesh’s areas of expertise are mainly in the area of pharmaceuticals and biologics drug development, safety assessment of small molecule drugs, biologics, vaccines and in exploring mechanisms of toxicity and biologics pharmacological activity. Rakesh has helped to bring several blockbuster pharmaceuticals to the market while working at Merck. Rakesh a recognized expert in safety and pharmacology biomarkers and their applications.. Rakesh is the Editor-in-chief of Toxicology Mechanisms and Methods and Associate Editor for Toxicology Applied Pharmacology, and Journal of Toxicology and Environmental Health. Rakesh also serves as an expert reviewer and in appointed committee for many programs managed by the prestigious U.S. National Academy of Sciences and US National Institutes of Health, including National Cancer Institute.

Emilija Fredro-Kumbaradzi
Manager, Biowaivers and Biocorrelations, APOTEX

Ruchi Gupta
Scientist, MEDIMMUNE

Ghazal Hariri
Senior Scientist, Global R&D, PFIZER

Joachim Hoechel
Head, Clinical Pharmacology, BAYER

Keith Horspool
Vice President, Pharmaceutics, BOEHRINGER INGELHEIM

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Keith Horspool is Vice President of Pharmaceutical Development at Boehringer Ingelheim, Ridgefield, CT. His department encompasses predevelopment support; physical pharmaceutics; formulation development; and process technology to support API selection, solid dosage form design and process development for technology transfer. The group has a strong interest in the evaluation and implementation of new technology — including advanced materials profiling, predictive methods for pharmaceutical development and drug delivery systems — to facilitate new products to patients.

Prior to joining BI, Dr. Horspool worked at Pfizer (UK and US) and AstraZeneca. He has more than 20 years of experience, during which he has managed pre-formulation, formulation development and materials science. He has a B.Sc. in pharmacy, and a Ph.D in pharmaceutical chemistry.

James Huckle
Scientist, Basic Pharmaceutics, Oral Delivery Product and Process Development, AMGEN

Fady Ibrahim
Principal Scientist, Biopharmaceutics, PFIZER

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Fady Ibrahim is a Principal Scientist in Pharmaceutical Sciences at Pfizer Worldwide R&D in Groton, CT. Fady has a BSc in pharmacy and a Ph.D. in pharmaceutical sciences from the University of Houston, TX. His Ph.D. started to develop his core research interests of formulation, pharmacokinetics and biopharmaceutics. He moved to The University of British Columbia, Vancouver, Canada, as a postdoc to work on developing an oral lipid-based formulation for amphotericin B. Then, he moved to Pfizer in Groton to join the Biopharmaceutics Group. His role in the Biopharmaceutics Group is focused on translational biopharmaceutics. His research focuses on understanding oral absorption and the effect of physicochemical properties of drug substance and drug product on oral absorption. He is interested in studying the intestinal precipitation of weakly basic compounds from various dosage forms. His main areas of expertise are dissolution, formulation, PK modeling and simulation, and IVIVC.

Neera Jain

Wen Lin
Senior Investigator, NOVARTIS

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Dr. Wen Lin is a Senior Investigator I at the Novartis Institutes for BioMedical Research in East Hanover, NJ. Dr. Lin has extensive experience in both Gastroplus and Simcyp PBPK models, modeling preclinical and clinical data through all phases of drug development. Her key responsibilities include PK/PD, formulation and ADME studies needed for regulatory submission in all major disease areas, including application of pediatric PBPK models. Dr. Lin has been involved with the IQ Preclinical Workgroup for Polymorphism since 2013. Currently she serves as the Novartis representative to the Simcyp Paediatric Discussion Group. Dr. Lin received her B.S. in pharmacy and M.S. in pharmacology from the Second Military Medical University, China. She received her Ph.D. in pharmaceutics from Rutgers, the State University of New Jersey. Dr. Lin has authored/coauthored more than 20 publications.

Eric Munson
Professor, Pharmaceutical Technology, UNIVERSITY OF KENTUCKY

Karthik Nagapudi
Senior Scientist, GENENTECH

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Karthik Nagapudi got his Ph.D. degree in polymer science from Georgia Institute of Technology in Atlanta in 1999. He did his postdoctoral work on biomimetic polymers for tissue engineering applications in the lab of Dr. Elliot Chaikof in Emory University. After his postdoctoral work, he joined Merck Research Labs in the physical measurements group in January of 2003. In June of 2006, he moved to the preformulation group in Amgen Inc. In 2011 he became the head of the solid-state group in Amgen. He moved to Genentech in July of 2014, where he is a group head leading formulation and solid-state development group. His primary research interests are applying advanced solid state NMR methods in pharmaceutical analysis, understanding thermodynamics of phase behavior in pharmaceuticals, understanding stability of high energy solids and mechanochemistry.

Robert Prud’homme
Professor, Chemical and Biological Engineering, PRINCETON UNIVERSITY

Fenghe Qiu
Senior Research Fellow, BOEHRINGER INGELHEIM

Robert Saklatvala
Director, Basic Pharmaceutical Sciences, MERCK

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Rob joined the Analytical Sciences group at Merck in Hoddesdon, UK, in 1993 and provided support for a number of Merck products — including Zocor, Propecia, Maxalt and Vytorin — and was made Director of the UK Analytical Sciences group in 2009. In 2007, Rob also completed a number of global process improvement projects to successfully obtain his Merck Six Sigma Black Belt.

In 2012, Rob moved from the UK to take up a new position at Merck as a Director of the Discovery Pharmaceutical Sciences group, initially based in Rahway, NJ, and more recently in Boston, MA. In this new role, Rob and his team support Discovery programs aiming to optimize properties of drug candidates for drug delivery and providing formulation support for pre-clinical in vivo studies through a wide range of drug delivery techniques.

Manuel Sanchez-Felix
Senior Fellow, Formulations, NOVARTIS

Jaymin Shah
Research Fellow, Pharmaceutical Sciences, Parenteral Development Centre of Emphasis, PFIZER

Pavithra Sundararajan
Assistant Principal Scientist, Preclinical Development, MERCK

Meena Venugopal
Vice President, Biopharmaceutics, ALVOGEN

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Meena Venugopal, Ph.D., is Vice President for Biopharmaceutics at Alvogen, an international pharmaceutical company. Dr. Venugopal has more than 22 years of experience in the pharmaceutical industry in the area of biopharmaceutics, pharmacokinetics, and generic submissions for US and international markets such as TPD, EMEA, TFDA, ANVISA, COFEPRIS and DCGI. She is also familiar with FTFs, 505(b)(2)s, in vitro models for drug delivery, skin permeation studies, BCS Biowaivers, IVRT studies, IVIVC and bio relevant dissolution. In her current role at Alvogen, she provides leadership and clinical strategies from product selection through development for all dosage forms for execution of ANDAs for Paragraph IV, First to File and First to Market applications. She has overall responsibility for clinical programs to support product development in several therapeutic areas in a fast-growing international pharmaceutical company for U.S. and international markets.

Dr. Venugopal has held various positions of increasing responsibility over the last few years at companies including Actavis, Forest Labs and Sandoz. She has a B.S. in chemistry from the University of Mumbai and an M.S. in biochemistry from the University of Mumbai, and a Ph.D. in cell biology from Kent State University. She is a member of the American Association of Pharmaceutical Sciences (AAPS) and the Generic Pharmaceutical Association (GPhA).

Dedong Wu
Senior Scientist, ASTRAZENECA

Liping Zhou
Head, Formulation Development, RA PHARMACEUTICALS

Andy Zhu
Head, Preclinical Oncology Modeling and Simulations, TAKEDA

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