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.

Dr.L.Ramaswamy, A Graduate in Chemistry with post graduation in Marketing and Human resource Management  and a doctorate  in Pharmaceutical Business Administration, has been working with Indian Pharmaceutical Industry in various positions for more than four 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 Founder and Chairman of Sotax India Pvt Ltd, a fully owned Subsidiary of Sotax AG, Switzerland and is on the board of directors at Ortiv-Q3, a joint venture CRO subsidiary of Sotax AG. He is also the Secretary General of SPDS – Society for Pharmaceutical Dissolution Science, Head of pharma vertical, USIIC under economic affairs of  US consulate, Mumbai (usiic.in), India Ambassador for AAiPS – American Association of Indian Pharmaceutical Scientists (aaips.org), Founder and National Convenor of AIPAC – All India Pharmaceutical Association Consortium, Governing body member FPQL – Forum of Pharma Quality leaders (fpql.in), Life member IPA – Indian Pharmaceutical Association (ipapharma.org), Associate member of IDMA – Indian Drug Manufacturer’s Association (idma-assn.org) and Member of Indo-Swiss Chamber of Commerce.

Email: drlrama@spds.in | drlrama19@hotmail.com

Dr. Mangal Nagarsenkar is Professor Emeritus and former Head, Department of Pharmaceutics, Bombay College of Pharmacy, Mumbai, India. She is also associated as Research Adviser at Vivekanand Education Society’s college of pharmacy.

Prof. Nagarsenkar 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. She has authored 118 research articles in national and international journals, 9 review articles, 7 book chapters and 2 books. She is a member of the editorial advisory board of IJPS, editorial advisory board of Drug Delivery Letters, Bentham Publication and has served as a reviewer for various national and international journals. Her research collaborations include University of Jena, Germany, University of Helsinki, Finland, G S medical college, Mumbai, ACTREC, Navi Mumbai, IICT, Hyderabad and CDRI, Lucknow. She has 2 US patents, 5 Indian patents and 3 trademarks to her credit.

She has been a recipient of awards and recognition including Prof. (Mrs.) M. R. Baichwal Visiting fellow in Pharmaceutical Sciences and Technology in UICT (2005-2006), Amrut Mody Research Fund, Distinguished Researcher National Award (2012), Association of Pharmaceutical Teachers of India (APTI) Dr. (Mrs.) Manjushree Pal Best Researcher National Award (2013), IPA MSB Student forum- Life Time Achievement Award (2021), APTI- MSB and Karyakaushalam, Mumbai -Certificate of honour for excellence in  education(2024)  .

Prof. Nagarsenker’s research interests  include lipid nanocarriers for improved and targeted drug delivery,  Solubilisation and dissolution  and design  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 Principal in Charge, Professor of Pharmaceutical Analysis and Chairperson-Industrial Collaborations and Resource Mobilization at Bombay College of Pharmacy (BCP), a premier Pharmacy institute. She is former Coordinator- AICTE Quality Improvement Program and President, Institute Innovation Council at BCP. She is Global Chair- Dissolution Research Presentations International, a competition conducted by SPDS.
• Passionate educator, motivating and training students, analysts, chemists and faculty in the nuances of pharmaceutical analysis and medicinal chemistry; and a researcher developing novel and cost-effective techniques useful for the industry, with more than 30 years’ experience.
• M Pharm and PhD (Tech) from Institute of Chemical Technology (formerly UDCT) Mumbai,
• Experience of more than 30 years handling several academic and administrative positions
• Research funding of more than INR 8 crores from various agencies like Department of Science and Technology, Department of Biotechnology, AYUSH, All India Council of Technical Education, University Grants Commission, University of Mumbai, Amrut Mody Research Fund and from several industries based in India and abroad including sanction of Rs 5.87 crores for co-establishment of National Facility of Research and Training in Integrated Analytical Strategies for Discovery, Development and Testing of Drugs, Pharmaceuticals and Nutraceuticals at Bombay College of Pharmacy under the Drugs and Pharmaceuticals Research Promotion Scheme of the Department of Science and Technology with high end instruments like LC-MS/MS, ICP-MS and HPTLC-MS.
• One patent and one Technology Transfer, many publications and presentations, 6 of which have won awards.
• Consultancy: worth more than INR 2 crores with organizations like Shogun Organics, Aarti Industries, Sanofi Aventis, Analytical Solutions, Glaxo Smith Kline, Ambernath Organics, Sandu Pharma, Nerlikar Hospital, SG Pharma, Loba Chemie, Nature Pure, Hi Media, ACG Worldwide, Dharmayug Biosciences, Alpha MD, Micro-Tracers Inc (USA), Ajanta Pharma, Macleods Pharma, Glenmark, Anshul Life Sciences, GS Medical College and KEM Hospital, Abbott, Nature Pure, Teledyne Hanson (USA), Aristo Pharma and Rubicon Research.
• Expertise in LC-MS-MS, HPLC, chiral HPLC, HPTLC, HPTLC-MS, and ICP-MS analysis, Quantitative LC-MS/MS Analysis of Nitrosamine Drug Related Substance Impurities (NDSRIs), Bioanalytical Method development and validation; Therapeutic Drug Monitoring and pharmacokinetic analysis, Herbal Analysis and Nutraceutical Analysis.
• Member, CII Education Council Task Force for Industry Academia Partnership and Member, CII Education Council Task Force Entrepreneurship & Start-ups Ecosystem (2022-23) and Member of PHD Chamber of Commerce and Industry – National Education Committee, 2023.
• Recipient of the UKIERI Indo UK Staff Exchange Program 2011-12 Award by the British Council, Fabulous Global Healthcare Leader Award, Most Iconic Healthcare Leaders (Global) Award.

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.

Dean Research and Innovation, Professor in Pharmacy and former Head, Department of Pharmaceutical Sciences and Technology at the Institute of Chemical Technology, Mumbai, India. She is also a member of the Board of Governors and Head of the Incubator at the Institute of Chemical Technology.

She has many granted patents, has licensed technologies to industry and products commercialized in India and Europe.  She is author of two books on Targetted Drug Delivery, published by Springer. She was actively associated with Controlled Release Society Inc., USA as Board Member, Member on the Board of Scientific Advisors, Chair of the Young Scientist Mentor Protégé Committee and Chair of the Outstanding Paper Award Committee of the Journal Drug Development and Translational Research. She is a Member on the Editorial board of the Asian Journal of Pharmaceutical Sciences and the European Journal of Drug Metabolism and Pharmacokinetics.

Prof. Devarajan is a nominated Fellow of the Maharashtra Academy of Sciences, and Life Fellow of the Indian Chemical Society. She is  a recipient of several awards and recognitions for Research and Innovation,  including the American Association of Indian Pharmaceutical Scientists Distinguished Educator and Researcher Award, the VASVIK award for Industrial Research, the APTI Award for Research in Pharmaceutical Sciences,  OPPI Scientist Award the Bengaluru Nano Innovation Award and  the Outstanding Woman Scientist Award of ICAR, Government of India.

Dr. Srinivasan holds a Ph.D in Chemical Engineering from University of Missouri – Rolla. In his decade long industrial career, he has held R&D leadership position at Dr. Reddy’s Laboratories and Amneal Pharmaceuticals.