SPDS International Committee

Dr. Shah was Scientific Secretary (2003 – 2011) of  International Pharmaceutical Federation (FIP), and is now Chair of Regulatory Sciences Special Interest Group of FIP. Dr. Shah retired from US FDA (Food and Drug Administration) as a Senior Research Scientist after 30 years of service in July 2005. At FDA, he has developed several Regulatory Guidances for Pharmaceutical Industry in the area of dissolution, SUPAC, bioequivalence and biopharmaceutics. He has received several FDA Awards including Award of Merit, Scientifi c Achievement Award and Distinguished Career Service Award. Dr. Shah is an Honorary Member of Indian Pharmaceutical Association (2003), and arecipient of IDMA Award (India, 2009) and SPDS Excellence Award (India, 2014). Dr.Shah is author/co-author of over 300 scientific papers and is a co-editor of four books. Dr.Shah was the President of American Association of Pharmaceutical Scientist(AAPS) in 2003. He is a Fellow of AAPS and FIP. Dr. Shah is a recipient of AAPS Distinguished Service Award, Pharmaceutical

Sciences World Congress (PSWC) Research Achieve m ent Award, FIP Lifetime Achievement Award in Pharmaceutical Sciences, Honorary Doctorate from Semmelweis University, Hungary and from University of Medicine and Pharmacy Carol Davila Bucharest, Romania.

He has also received the Distinguished Scientist award from AAPS,USA

Dr. Banakar is Professor of Pharmaceutics and an Independent Consultant/Advisor to Pharmaceutical Industry and Academia worldwide with extensive contribution in drug product development and evaluation (in vitro and clinical).

He is on the International Scientific Advisory Board of several pharmaceutical corporations worldwide. Of date, he has successfully completed several Pharmaceutical Product Development Technology Transfer through education assignments sponsored by the UN/IESC and other pharmaceutical corporations worldwide. Additionally, he has planned and executed the development, both in vitro and clinical, of several NDAs [including 505(b)(2)] and ANDAs (both IR and MR products). Furthermore, he has served as testifying/non-testifying expert in over 50 patent litigations in the disciplines of pharmaceutical formulations/technology, clinical investigations and dissolution testing. He is the Founding Chairperson of 2 International CROs and has executed over 400 clinical trials (Phase I-IV including BE studies).  Additionally, he is the founding Board Member and Principal Scientific Adviser of Society for Pharmaceutical Dissolution Science [SPDS].

He has authored over 100 publications, over 100 published abstracts and presentations, numerous specialized workshop manuals, several chapters and monographs, over 45 expert book reviews and 5 guest editorials. The texts that he has authored include: Pharmaceutical Dissolution Testing, Drug Development Process: Increasing efficiency and cost effectiveness, and co-edited include: NanoBioMedicine (6 volume; 91 chapters series), Desk Book of Pharmaceutical Dissolution Science and Applications, among others. He is the co-author of an electronic text: Basic Pharmacokinetics. He is on the roster of experts with WHO, United Nations – TOKTEN program and International Executive Service Corps (IESC). He is listed in Who’s Who in Biotechnology, Who’s Who Among Asian Americans, and American Men and Women of Science. He has received numerous awards for excellence in teaching, research/scholarly activity, two Service to Country Awards from the UN and nomination for the distinguished Fulbright Scholar Award for Teaching. He is the founding Editor-in-Chief and on Editorial Boards of several scientific journals.

Vijay is an accomplished Quality, Regulatory & Analytical professional with about 40 years of rich experience of working for highly reputed Indian & Multinational Pharma firms like Unichem, Ranbaxy, Sun Pharma , Lupin, IPCA, German Remedies  in  Sr positions like EVP, Director & GM- Quality & Regulatory. He has led from front for several successful regulatory inspections including US FDA, MHRA, WHO, EDQM, ANVISA, TGA both for Drug Products & API’s.

Since 2013, he is running his own Pharma Consultancy called TRAC offering specialized services globally, for cGMP Training, Regulatory Filings, Auditing & Compliance. His current clients include reputed pharma companies based in India, China, Bangladesh, Turkey, US, Europe, Malaysia etc..  He is a frequent international trainer on several cGMP related topics.

He is the founder President of ‘Society for Pharmaceutical Dissolution Science’. He is currently working on the board of Directors of ISPE-India. IDMA has conferred upon him an ‘Outstanding Analyst Award 2011’ for his contribution towards pharmaceutical analysis. He has also published articles on cGMP related topics like CAPA, OOS, QbD & cGMP in reputed journals/books. He is M.Sc. by Research in Organoanalytical Chemistry from Mumbai University. He has a good Microbiological background too.

A Graduate in Chemistry with post graduation in Marketing and Human resource Management  and a doctorate  in Business Administration, has been working with Indian Pharmaceutical Industry in various positions for more than three decades. During the tenure he had the opportunity to represent his organization in many platforms and one of which was representing the India Delegation to Canada organized by Government of India during 2007. Currently he works as the Managing Director of Sotax India Pvt Ltd, a fully owned Subsidiary of Sotax AG, Switzerland and also is the General Secretary of Society for Pharmaceutical Dissolution Science.

Email: Lakshmanan.ramaswamy@sotax.com

Dr. (Mrs.) Mangal Nagarsenker is Retired Professor and Head, Department of Pharmaceutics, Bombay College of Pharmacy, Mumbai, India. She received her B.Pharm.Sc and  M.Pharm.Sc. at Institute of Chemical Technology, Mumbai and Ph.D (Tech) at Bombay College of Pharmacy, Mumbai.

Prof. Nagarsenker has more than 3 decades of research experience in the field of novel drug delivery systems. She has successfully guided many M.Pharm and Ph.D students and  has served as a reviewer for various national and international journals.

Prof. Nagarsenker’s research interests are 1) polymeric and lipid nanocarriers for improved drug delivery, 2) Drug nanocrystals for improved oral and topical delivery, 3) pulmonary drug delivery and 4) synthesis of novel ligands for targeted drug delivery.

Email: mangal.nagarsenker@gmail.com

Dr. Diane Burgess received her B.Sc. degree in Pharmacy from the University of Strathclyde, U.K. (1979) and her Ph.D. in Pharmaceutics from the University of London, U.K. (1984). She was a postdoctoral fellow at the Universities of Nottingham, U.K. (1984-1985) and North Carolina (1985).

Dr. Burgess has been active in teaching, research and service throughout her career. Her students have recognized her with the Outstanding Teacher of the Year Award (2005 and 1992). She received the 2009 Distinguished Service award from the University of Connecticut, School of Pharmacy. In 2010, she became the first recipient of the CRSI (Controlled Release Society, India Chapter) fellowship award for outstanding contributions in drug delivery research. Dr. Burgess is the 2011 recipient of the Nagai APSJ International Women Scientist Research Achievement Award. Dr. Burgess also received the 2013 AAPS IPEC Ralph Shangraw Memorial Award for her outstanding research in the area of pharmaceutical excipients. In 2014, Dr. Burgess was recogized for her exceptional commitment in CRS, and was selected as the recipient of the Distinguished Service Award.

Dr. Burgess is a fellow of AAPS (American Association of Pharmaceutical Scientists) and of AIMBE (American Institute for Medical Biological Engineering). She served as elected President of AAPS in 2002 and CRS (Controlled Release Society) in 2009. She is a member of the USP Biopharmaceutics Expert committee and the USP Advisory Panel on Injectables. Dr. Burgess is editor of the International Journal of Pharmaceutics (2009 – to date). She was an editor for AAPSPharmSci (1999 – 2005) and editor of the Journal of Drug Delivery Science and Technology (2003 – 2008). Dr. Burgess serves on the editorial boards of seven international journals. Dr. Burgess has severed on NIH study sections on Drug Delivery and Biomedical engineering, Drug Delivery and Drug Discovery, Gene and Drug Delivery, and Nanomedicene as well as many special study sections for NIDA, NIDDK and NCI (2001- to date). In 2001 she undertook a sabbatical at the Office of Testing and Research at CDER, FDA. She consults for pharmaceutical, food, cosmetic and other industries.

J-M. Cardot is pharmacist (D Pharm), he got Masters in Biopharmaceutical, Statistical sciences and Pharmacokinetics and has a Ph. D. in pharmaceutical sciences Auvergne University. He is professor and head of the Department of Biopharmaceutics and Pharmaceutical Technology from the Auvergne University, France.

J-M. Cardot was from 1987 to 1999 in Ciba-Geigy and Novartis in development departments in Basel and in Paris. He created in 1999 a company dedicated to the production of technical and clinical batches of high potent activity drugs.

From 1992 to 2002 J-M. Cardot was also associated professor in Auvergne University in Biopharmaceutics. He enters in University in 2002 as Professor and head of Department.

His research fields are Biopharmaceutical development of drugs, in vitro dissolution and in vivo bioequivalence and in vitro-in vivo correlation

Prof. Krishnapriya Mohanraj is Professor and Head, Department of Pharmaceutical Analysis, at Bombay College of Pharmacy. She completed her M Pharm and PhD (Tech) in Pharmaceutical Chemistry at Institute of Chemical Technology (formerly UDCT), Mumbai. She was selected for the UKIERI Indo UK Staff Exchange Program at Kingston University by the British Council (2011-12 award).

Her expertise includes Computer aided drug design, synthesis and pharmacological evaluation, Enzymatic resolution, Bioassay guided fractionation of herbal extracts, Chiral chromatography, Bioanalysis, In vitro analysis, LC-MS/MS studies, Structural Elucidation, Impurity profiling and development of stability indicating methods.She has undertaken many research projects and industrial collaborations.

Email: krishnapriyamohanraj@gmail.com

Samir Haddouchi Managing Director, SPS Pharma Services, France

Prior to joining SPS Pharma Services in 2005, Samir spent more than 10 years in the pharmaceutical industry. As a chemist, he started working on the analytical development of agrochemical compounds at Sandoz Agro in the region of Basel (Switzerland).During the Novartis merger, he movedto Orléans (France) in 1998 to join the analytical group in the technical development department where he became responsible for dissolution.

In 2005, he resigned from Novartis to create SPS Pharma Services in Clermont Ferrand which is the first and only CRO specialized in Dissolution and Release Testing. Since then, Samir manages SPS facility and is in charge of projects management. In April 2013, SPS Pharma Services moved to a new larger facility in Orleans (France) in order to ensure better efficiency and provide a broader range of services to its clients, including cGMP routine testing. Fields of interest and expertise: analytical development (HPLC), in vitro dissolution and release testing (all techniques from USP1 to USP7), in vitro-in vivo correlations (IVIVC), formulation development, laboratory automation. Samir is regularly invited as speaker in international conferences as well as expert for various organizations (scientific societies and Health Authorities).

Vatsala Naageshwaran is the Senior Vice President of Operations at Absorption Systems. She has worked on numerous projects in support of NDA submissions that have received FDA and EMA approvals as well as with several leading generic companies to support successful ANDA submissions and market approvals of generic drugs since 2009 to date. She manages the ocular, medical device and PK services which are based in San Diego while continuing to support business development worldwide.

Prior to joining Absorption Systems, she has worked for several biotechnology / pharmaceutical companies as a research scientist with experience in drug discovery, assay validation, and product development. Her research has been featured at national conferences such as AAPS, SOT, AACR and EORTC and she has authored publications submitted to peer-reviewed journals. She has spoken at numerous forums and conducted workshops on clinically relevant drug transporters and non-clinical methods for establishing bioequivalence of oral and complex drug products. Vatsala has a Master’s degree in Biochemistry from Mt Holyoke College, MA and she is currently pursuing a Master’s degree in Pharmacometrics at the University of Maryland Baltimore and a PhD in Ocular Modelling at the University of Eastern Finland. Her research interests are in the areas of ophthalmology, pharmacokinetics and bioequivalence.

Dr. Kailas Thakker is a Pharmacy graduate from Department of Technology Mumbai ,Masters degree in Pharmacy from Columbia University in New York and Doctor of Philosophy from University of Kansas She worked at United States Pharmacopeia for over 12 years and then went on to head Analytical departments at small venture backed virtual pharmaceutical companies. About 19 years ago, Kailas founded Analytical Solutions with a vision to provide quality analytical services to the pharmaceutical industry. Working with regulatory, compendia and industry leaders, she started working towards developing and improving in vitro release test using Franz diffusion cells. About 18 months ago, Analytical Solutions expanded the service base to offer product development services. With the change of the service platform, came the change of name, Tergus Pharma. Today, Tergus Pharma offers comprehensive product development service to pharmaceutical industry with emphasis on topical products from concept commercialization.

Dr (Ms) Padma V. Devarajan is Professor in Pharmacy and ex-Head, Coordinator  M.Tech Pharmaceutical Biotechnology Department of Pharmaceutical Sciences and Technology and and Coordinator of the World bank TEQIP programme,  at the Institute of Chemical Technology, Mumbai, India. The Institute of Chemical Technology is the only ELITE University and Centre of Excellence in the state of Maharashtra in India.   Her research interests include colloidal carriers for targeted delivery in cancer and infectious diseases, Veterinary Drug delivery, Bioenhancement strategies, and Mucosal DDS as alternative to parenteral administration and QbD in drug development. She has over 100 publications and presentations in cited journals and  national/international conferences,  and five book chapters in the area of drug delivery and a  book on  “Targetted Drug Delivery- Concepts and Strategies ” published by Springer.

She has filed over twenty patents international/ national, has seven patents granted and four patents licensed. Her research is funded through a number of Grants from the Government of and the industry including companies from Japan, Germany and USA. She is also  a consultant to the Pharma Industry