Desk Book of Pharmaceutical Dissolution Science and Applications

Dr. Schwendeman’s long-term research goal is to design highly potent and safe synthetic high-density lipoprotein (HDL) nanomedicines for treatment of atherosclerosis. These 10 nm size particles mimic the natural HDL function of cholesterol removal from arterial plaques and subsequent cholesterol transport to the liver for elimination. Dr. Schwendeman spent 12 years in pharmaceutical industry at Cerenis Therapeutics (Fierce 15 biotech, www.cerenis.com), Pfizer, and Esperion Therapeutics. She was involved in discovery and translation of several HDL therapies to Phase II clinical trials. Her efforts led to development of a kilo-scale recombinant Apolipoprotein A-I process and highly homogeneous and safe HDL particles for the largest-to-date Phase II sHDL clinical trial (>500 patients). She successfully submitted FDA INDs for six different products including nanoparticles, liposome, proteins, peptides and small molecules.

Ajay Pydah is the Lead for Software and Data Management Solutions at SOTAX in the Americas. Prior to taking on his current customer facing role, Ajay led a software development group at Caliper Life Sciences and later all of Product Development and Production at SOTAX Corporation in Westborough, MA. He holds a Master of Science in Engineering from Northeastern University in Boston and a Bachelor of Science in Mechanical Engineering from India.

Ajay is the Treasurer for SPDS US and currently serves on the Board of the organization.

Vivek Purohit, Ph.D. has over 17 years of experience in clinical pharmacology/pharmacometrics in various disease areas such as infectious diseases, cardiovascular, rare diseases and inflammation/immunology. He is deeply committed to the application of quantitative approaches to decision making and answer key development questions for efficient drug development. He joined the Clinical Pharmacology group at Pfizer in 2007 and has extensive experience in the areas of Inflammation & Immunology with a special focus on dermatology indications. He has consistently applied Model Informed Drug Development (MIDD) principles in areas of infectious diseases, inflammation and topical dermatological agents with high impact on development decisions.

Vivek has authored/co-authored several peer-reviewed publications, book chapters and holds 4 patents.

He received his Ph.D. degree in Pharmaceutical Sciences from the University at Buffalo, State University of New York, Buffalo in 2005.

Stephen D. Stamatis is a director in Synthetic Molecule Design & Development at Eli Lilly and Company. He completed his B.S.E. in Chemical Engineering at the University of Michigan and Ph.D. in Chemical Engineering from Purdue University in 2010. His thesis work focused on Bayesian approaches to parameter uncertainty assessment in microkinetic models of catalysis. Dr. Stamatis completed a postdoctoral fellowship at the University of Iowa in pharmaceutics where he developed whole body physiologically based pharmacokinetic models to asses drug product stability risk. He joined Eli Lilly and Company in 2013 developing oral absorption models for several assets. His current work focuses on the application and development of biopharmaceutics models in drug discovery through late phase commercialization with an emphasis on drug product performance.

Dr. Prasad Panzade is an executive with a broad vision and strategic entrepreneurial mind set personality with over 24 years of experience in the multidimensional chemical industries including the Pharmaceutical and biopharmaceuticals. Dr. Panzade holds a Ph.D. degree in pharmaceutical sciences with specialization in the field of Pharmaceutical Analytical Sciences and Technology. He has been an active member of several professional organizations and a mentor who believes in developing more future leaders.

Dr. Panzade is currently working with ProtaGene Inc. as a Head of Analytical operations and Lab platforms. In the past he has worked with Apotex Inc. Canada’s number one generic pharmaceutical company as a Senior director of Analytical R&D and Quality Control for Global R&D, prior to this he worked as a senior vice president for a multibillion-dollar conglomerate Aditya Birla Group. He has held several levels of positions in the API, specialty chemicals, polymer and generic drug formulation industries. Dr. Panzade is a speaker who provides active insights on the latest in the fields of analytical sciences world. He has several peer reviewed journal publications, articles published and patents to his credits.

Before moving into the full-time positions in industries Dr. Panzade has worked as lecturer in the pharmaceutical college and Dr. Panzade spends his time in providing consulting services to various industries for analytical, quality and compliance related issues and market insights.

John Middleton began synthesizing and characterizing biodegradable polymers for drug delivery applications in the 1980’s as a chemist at Southern Research Institute.   After receiving his Ph.D. in polymer science from the University of Southern Mississippi he has worked for several biomaterials companies synthesizing biodegradable polymers for customer applications.  He has served in senior management roles at Birmingham Polymers, Durect Corporation, Atrix Laboratories, Lakeshore Biomaterials, Brookwood Pharmaceuticals and Surmodics.  He joined Tolmar in 2012 and is the Vice President of Polymer Development.  He is the coauthor on 18 publications and has approximately 15 US patents.

Zachery Custer is a Senior Scientist at Merck & Co. Inc. based in West Point, PA. He received a B.S. in Chemistry from Eastern University before joining Merck in 2016. During his time at Merck, Zach has contributed to the control strategy for several small molecule products in capacities such as analytical method development and authoring, method validation, specification setting, authoring of new drug application sections, and method transfers/ quality risk assessments. One of Zach’s key areas of focus has been the automation of analytical methods, especially disolution methods, for both pipeline and commercial products. Zach took on a role as the automation strategy lead in Merck’s Analytical Chemistry in Development and Supply organization in 1Q2022.

Dr. Ramaswamy, a graduate in chemistry (1973-78), Double post graduate in management (Marketing & HR from NMIMS, Mumbai)  and a doctorate in pharmaceutical Business Administration.  A Professional having nearly 4 decades of successful experience in various capacities in Indian Pharmaceutical Industry. He is currently the Managing Director of Sotax India Pvt. Ltd., a company head quartered in Switzerland, pioneer Pharmaceutical testing.

Prior to Sotax India he worked for Sarabhai Chemicals as a full time Director and CEO, Managing Director of Stiefel India Pvt. Ltd. (Which is merged with GSK later), Unichem Laboratories. He represented the Biotechnology Delegation organized by Govt of India to Canada in 2007. Dr. Ramaswamy has been a visiting faculty in reputed management Institutes in Mumbai and given many guest lectures including at IIM (Bangalore), Madurai Kamaraj University, NMIMS, etc. He has published many articles on Management and Human Resources Development and Brand Building.

He has also been instrumental in conceiving the idea and need for a Society For Pharmaceutical Dissolution science. and initiated the movement by bringing the Pharma Industry Scientists and Pharmaceutics Faculties from various pharmacy colleges, & Regulators under one roof and registered this Society as SPDS.

Nominated as a member in the International Scientific Advisory Board and session chair of 3rd International Symposium on Scientific and Regulatory Advances in Biological and Non-Biological Complex Drugs in Budapest, Hungary.

Andre Hermans is a Director in the Small Molecule Analytical Research and Development (SMAR&D) Division at Merck and Co. in Rahway, NJ. He received his PhD in Analytical Chemistry from the University of North Carolina in Chapel Hill before joining Merck in 2007. During his time at Merck, Andre supported analytical method development and process development in the small molecule solid oral dosage area throughout all phases of drug development. Additionally, he is co-leading Merck’s efforts around in-vivo predictive technologies, dissolution innovations, and clinically relevant dissolution specifications. Andre is a member of the IQ dissolution and ICH Q3D working groups, member of the USP expert panel for “New Advancements in Performance Testing”, and chair of the AAPS In-vitro release and dissolution testing community. He is author of several publications in the field of dissolution testing and clinical relevance.

Navnit H. Shah is SVP and scientific advisor at Amneal. Prior to joining Amneal he was President and CSO of Kashiv Pharma, in Bridgewater, NJ. Navnit was a Distinguished Scientist in the Pharmaceutical R&D Department at Hoffmann-La Roche Inc. Nutley, N.J. and was heading dosage form development group prior to joining Kashiv Pharma in 2012. He received his Ph.D from St John’s university , New York, has over 40- years of experience and published and presented over 100 papers and 120 abstracts in drug delivery area covering improving dissolution and bioavailability of poorly water soluble molecules, Lipid delivery and controlled release. He is an inventor and co-inventor of 35 issued patents and 20 patent applications and has recently published extensively on Amorphous Solid Dispersion Technologies for poorly soluble drugs. He has received numerous awards: AAPS fellow in 1998, Thomas Alva Edison Patent Award in 2005, distinguished Alumni award in 2008, Research Leadership award from New Jersey Bio Medical Research in 2010, and New Jersey Inventor of the year award by New Jersey Inventor Hall of fame (NJIHoF) for the drug delivery technologies in October 2011. He was adjunct professor at University of Rhode Island , responsible for mentoring many graduate students for their thesis.

Mei Ou earned her M.D./B.S. and M.S. degrees from the Shanghai Medical College of Fudan University, China, and a Ph.D. degree in Pharmaceutics and Pharmaceutical Chemistry from the University of Utah in 2009.  After that, she joined the Drug Metabolism and Pharmacokinetics group in Merck & Co. Inc., where her work involved RNAi Therapeutics.  In 2015, Mei joined the FDA as a Biopharmaceutics Reviewer and currently she is a Senior Pharmacologist in the Office of New Drug Products, where she performs primary/secondary regulatory and scientific review work for IND/NDA/ANDA/SUPPL submissions, supporting multiple clinical therapeutic areas such as oncology, hematology, neurology, anti-infective, anti-viral, psychiatry, cardiovascular, and renal, metabolism and endocrinology, etc.  Also, she has served as the Application Technical Lead and Cross Discipline Team Leader for several NDA submission under the Office of Oncology Diseases, and has contributed to multiple working groups at FDA, such as the CDER Nanotechnology working group, ONDP Breakthrough Therapy Designation working group, and KASA for NDAs initiative working group.

Dr. Heimbach is a Director at Merck in the Biopharmaceutics & Specialty Dosage Group where he serves as a biopharmaceutics expert in oral and parenteral drug development.  Prior to that Tycho was at Novartis where he led a global PBPK modeling group in DMPK and served as PBPK/PBBM and biopharmaceutics expert.  He served on the working groups for the PBPK renal and hepatic impairment WG and the PBBM WG for the Innovation and Quality in Pharmaceutical Development (IQ) consortium. Since 2021 Tycho is an AAPS Fellow and he is an author/co-author of more than 50 publications in ADME, PBPK and formulation sciences.

Tessa Carducci is an associate principal scientist at Merck & Co. based in Rahway, NJ working in the Analytical Commercialization Technology department. She graduated with a BS in Chemistry and minor in Psychology from Duke University and a PhD in Analytical Chemistry from UNC-Chapel Hill. At Merck, Tessa has worked on real time release strategy development and pioneered predictive dissolution modeling for release for a new drug product. Her primary areas of focus at Merck include subject matter expertise in dissolution and global filing requirements. She also enjoys implementation of novel analytical techniques, strategies for commercialization and world class supply, problem solving, and navigating new regulatory requirements. Outside of work Tessa enjoys taking care of her dog, skiing and snowboarding, traveling, and trying new foods.

Dr (Ms) Padma V. Devarajan, President Society for Pharmaceutical Dissolution Science (SPDS) is 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 Targeted 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 and   the Outstanding Woman Scientist Award of ICAR, Government of India.

B.Sc. Pharmacy, University of Strathclyde (1979) and Ph.D. Pharmaceutics, University of London (1984). Fellow of AAPS, CRS, APSTJ, and AIMBE. 2010 CRS President; 2002 AAPS President. Editor of International Journal of Pharmaceutics (2009 – 2018). Editorial board member of 13 international journals. Recipient of: 2018 AAPS Wurster Award in Pharmaceutics; 2014 AAPS Research Achievement Award; 2014 AAPS Outstanding Educator Award; 2014 CRS Distinguished Service Award; 2013 AAPS IPEC Ralph Shangraw Award; 2010 CRSI Fellowship, 2011 APSTJ Nagai International Woman Scientist Award. Over 240 refereed publications, over 640 research presentations, over 305 invited presentations, 22 keynote and plenary addresses.

Dr. James E. Polli is Professor of Pharmaceutical Sciences and Ralph F. Shangraw/Noxell Endowed Professor in Industrial Pharmacy and Pharmaceutics at U of Maryland.  He received a B.S. in Pharmacy (Philadelphia College of Pharmacy and Science) and a Ph.D. in pharmaceutics (U of Michigan). His research interest is oral drug absorption. His two main research interests are 1) maximizing oral bioavailability through formulation and chemical approaches and 2) developing public quality standards for oral dosage forms. Dr. Polli has an active laboratory and clinical research program, with clinical pharmacokinetic studies in patients and healthy volunteers. He has served as advisor to 20 Ph.D. graduates. He is co-Director of the U of Maryland Center of Excellence in Regulatory Science and Innovation (CERSI), and FDA-funded collaborative agreement with the Agency. He is Director of the online MS in Regulatory Science program (www.pharmacy.umaryland.edu/regulatoryscience). He is an Editor of Pharmaceutical Research. He is a member of the University of Maryland General Clinical Research Center Advisory Committee.  Dr. Polli is a member of the University of Maryland institutional review board (IRB). He is a member of the Scientific Advisory Board of Simulations Plus.

Sanjaykumar Patel is Principal Scientist at Merck & Co., Inc. in Rahway, NJ. He has 18 years of experience in pharmaceuticals industry. His experience includes working on novel drug delivery formulations such as self-emulsifying drug delivery systems, amorphous solid dispersion, controlled release and gastro retentive, and parental formulation. His research interest is focused on developing predictive bio-relevant in-vitro methodologies to understand in-vivo performance of oral and parental formulations. He has co-authored several scientific papers. He is an active member of AAPS and a part of the IVRDT (In Vitro Release and Dissolution Testing) focus group steering committee. He is involved in cross-organization consortium, OrBiTo, in the area focusing on a development and improvement of in-vitro analytical tools.

Dr. Xujin Lu is a Research Fellow at Bristol-Myers Squibb Company in the department of Drug Product Development, Global Product Development and Supply. With 30 years of experience in research and development in pharmaceutical industry, Dr. Lu currently focuses on in-vitro biopharmaceutics drug release and biorelevant dissolution for product development. Dr. Lu is active members of AAPS, ACS, and SAS, and a past Chair of the In Vitro Release and Dissolution Testing (IVRDT) Focus Group of AAPS. Dr. Lu also serves on the USP Expert Panel on New Advancements in Product Performance Testing, USP Expert Committee of Dosage Forms, and the Editorial Advisory Board of Dissolution Technologies journal.

Deanna Mudie, Ph.D., is a Principal Scientist in Research and Development at Lonza. Her focus is on enabling bioavailability enhancing amorphous solid dispersions by developing dosage form platforms and in vitro dissolution methodologies to predict bioperformance. Deanna earned her Ph.D. in Pharmaceutical Sciences and B.S.E. in Chemical Engineering from the University of Michigan. She has seven years of pre-doctoral experience at two large pharmaceutical companies developing and manufacturing oral dosage forms from pre-clinical to commercial scale.

Dr. Sperry is an Executive Director in Synthetic Molecule Design & Development at Lilly Research Laboratories. He obtained a B.S. degree in chemistry from Indiana University, Bloomington, IN and a Ph.D. degree in chemistry from the University of Rochester, Rochester, NY. After receiving his degree, he took a postdoctoral research scientist position at Pharmacia & Upjohn where he developed an Artificial Stomach Duodenum model and studied its utility in drug development. Shortly thereafter, he accepted a research scientist position at Pharmacia (later Pfizer), working in the area of in vitro methods and biopharmaceutics. He then moved to Bausch and Lomb where he developed commercial ophthalmic formulations for late stage molecules.  In 2007, Dr. Sperry joined Lilly Research Laboratories, where he created a group focusing on in vitro drug product performance techniques and predictions of in vivo performance.  In 2013, Dr. Sperry joined a computational modeling group at Lilly.  He now supports product development by using existing and creating new models to predict product performance and oral absorption of small molecule drug formulations.

Talia is currently Head of Product Design and Performance at UCB Pharma in Belgium. She is accountable for the design, development and manufacture of drug products from preclinical and clinical development through to commercial, and leads a multi-skilled department including biopharmaceutics, formulation, manufacturing, materials science and solid state experts. Her previous roles at UCB include Head of Biopharmaceutics, where she was accountable for biopharmaceutics strategies on projects across the portfolio from preclinical to commercial phases, and Principal Scientist, with a focus on strengthening collaboration between the Pharma Sciences, Clinical Pharmacology and DMPK functions to drive integrated risk assessment and cross-functional product development strategies.  Before joining UCB in 2019, Talia worked at AstraZeneca in the UK for 12 years, most recently as an Associate Principal Scientist in Biopharmaceutics. She has extensive and diverse experience of developing and overseeing biopharmaceutics and clinically relevant dissolution strategies on drug projects, with particular focus on oral products Phase 2 to post-launch.  Her research interests include clinically relevant dissolution tests and specifications, IVIVC/IVIVR, biowaivers, and biopharmaceutics in patients and special populations. Talia is active in several cross-industry collaborations and consortia, including EFPIA and IQ working groups. Talia was EFPIA Deputy Topic Lead on the ICH M9 (BCS-based biowaivers) Expert Working Group, and is currently representing EFPIA as Deputy Topic Lead on the ICH M13 (bioequivalence studies) Expert Working Group. She has been an invited speaker at several national and international conferences/workshops in the field of biopharmaceutics and clinically relevant specifications, and has authored/co-authored mor than 40 manuscripts and 3 book chapters in these fields. Talia received a Master of Pharmacy with honours (2002) and Doctor of Philosophy (2007) degrees from the Welsh School of Pharmacy, Cardiff University.

Mr. Pankaj Patel is the Chairman of Zydus Lifesciences, a discovery-driven, global Lifesciences company with operations in 55 countries worldwide. A stalwart and a visionary, Mr. Pankaj Patel combines both research and techno-commercial expertise.  Mr. Patel has been nominated as a Member of the Mission Steering Group (MSG), the highest policy making and steering body constituted under National Health Mission (NHM) and of the Drug Technical Advisory Board by Ministry of Health & Family Welfare, Govt. of India, New Delhi. Mr. Patel is a Past President of the Federation of Indian Chamber of Commerce & Industry (FICCI). Mr. Patel is Chairman of IIM, Udaipur and Member of the Board of Governors of IIM Ahmedabad, Invest India, IIFT and other education institutes and universities. He is the Vice President and Trustee of the Gujarat Cancer Society and Chairman of the Gujarat Cancer and Research Institute, a Regional Cancer Centre. In recognition of his contributions to the healthcare industry in India, Mr. Pankaj Patel is conferred several awards.

Dr. Morris is the Executive Director of the American Association of Pharmaceutical Scientists (AAPS). She leads the staff team that supports all operational aspects of the Association and works with the AAPS Board of Directors and other Volunteer Leadership Committees on the strategic and direction-setting activities that guide the work of the scientific society. Prior to that, she was Vice President of Scientific and Regulatory Affairs at the Parenteral Drug Association (PDA). Until 2018, Dr. Morris held several scientific senior leadership positions at the United States Pharmacopeia (USP), including as the Global Head of Biologics and Senior Vice President of Compendial Science. Before joining USP in 2003, Dr. Morris worked in the biopharmaceutical industry, with an expertise focus on analytical development and product characterization. She completed her postdoctoral research at the National Institutes of Health. She holds a Ph.D. in molecular virology from the Medical University of Luebeck, Germany, and a master’s degree in biology from the Carl von Ossietzky University of Oldenburg, Germany.

Dr Arvind Kumar Bansal is currently Professor and Head, department of Pharmaceutics at National Institute of Pharmaceutical Education and Research (NIPER) – SAS Nagar, Punjab, India. He earned his M Pharm (Pharmaceutics) (1988) and Ph.D. (1993) from University of Delhi, India. Prof Bansal worked as Senior Scientist and Group Leader in JK Pharmaceuticals and Ranbaxy Research Laboratories, for 8 years. Therein he conceptualized, evolved formulation strategies, developed and transferred the technology to production shop floor, for NCEs and generic drug products. Prof Bansal joined NIPER in 2000 and developed expertise in areas of pre-formulation and formulation development encompassing characterization and stabilization of the amorphous form, polymorphism, pseudo-polymorphism, particle engineering, screening salt forms, improvement of oral bioavailability and lyophilization. His research group works with the mission statement – ‘developing science based industrially viable pharmaceutical technologies’ and works closely with pharmaceutical industry to create opportunities for commercial exploitation of the products. Dr Bansal was conferred prestigious Fellow of American Association of Pharmaceutical Sciences in 2016. He is the only Indian, working in India, to be awarded this Fellow status. He has won prestigious awards like AAiPS Distinguished Educator and Researcher Award, Innocentive Award, OPPI Award and IPA-ACG Scitech Innovation Award 2018 for Best Innovative Development of Solid Dosage Form. Prof Bansal’s research group has completed more than 550 industry-sponsored projects, granted 11 patents, filed 27 patents, and published 170 research articles and 27 review articles. He has total citations of 8011, with h-index of 47, in Google Scholar. He is an editorial board member of ‘Journal of Excipients and Food Chemicals’, ‘Drug Development Research’ and ‘Pharmaceutics’. He is also an Advisor to the editorial board of ‘Journal of Pharmaceutical Science’ and ‘Molecular Pharmaceutics’. Recently his lab has out-licensed a platform technology on “Nano crystalline solid dispersions – NanoCrySP”.

Patrick serves as Vice President and Deputy of the CEO of the Aesch, BL, Switzerland headquartered SOTAX Group. Raised in Switzerland and educated at ETH Zurich, he moved to Pennsylvania in 2005 and Massachusetts in 2009 to develop the presence of SOTAX in the United States. Today he oversees all activities of SOTAX in North- and South America, including Production, Product Development and Application Laboratories at SOTAX in Westborough, MA. A Chemist by training, his research interests prior to joying SOTAX were in the areas of Medicinal and Computational Chemistry.
The SOTAX Group exclusively works with scientists in AR&D, QC and Production of the pharmaceutical industry worldwide. We seek to assist them in their work with cutting edge solutions in the areas of data management, automation, dissolution testing, automated sample preparation, and at-line testing solutions.

Dr. Shah is a pharmaceutical consultant. He retired from the US FDA (Food and Drug Administration) after serving for 30 years. While at the FDA, he developed several Regulatory Guidance for the Pharmaceutical Industry in the area of biopharmaceutics, including a guidance on the dissolution of IR and ER products. He is the author/co-author of over 330 scientific papers and co-editor of four books.

Dr Shah was the President of American Association of Pharmaceutical Scientists (AAPS) in 2003. He is a Fellow of AAPS and FIP. Dr Shah is a recipient of FDA Award of Merit, FIP Lifetime Achievement Award in Pharmaceutical Sciences; IDMA Eminent Pharmaceutical Analyst Award (India); Honorary Doctorate from Semmelweis University, Budapest, Hungary; Honorary Doctorate from University of Medicine and Pharmacy Carol Davila Bucharest, Romania; SPDS Award of Excellence; AAPS Distinguished Pharmaceutical Scientist Award and AAPS Global Leader Award.