Dr. Ajaz S Hussain, PhD, President, NIPTE
Opening remarks
Pharmaceutical Quality System, Professional Development & Continual Improvement
Dr. James DiNunzio, Senior Principal Scientist, Merck
Early Development Considerations for Continuous Manufacturing
Dr. James DiNunzio is currently a Senior Principal Scientist at Merck & Co., Inc. in Rahway, NJ where he heads the Hot-Melt Extrusion Subject Matter Expert Network Team and co-leads the Continuous Processing Technology Development Team. Since joining Merck in 2013 he has contributed to multiple programs in the disease areas of oncology, virology and CNS disorders. Prior to Merck, he served as a Senior Scientist in the Pharmaceutical & Analytical R&D group at Roche where he was responsible for the formulation design of poorly soluble compounds using enabled technologies. He has also held positions of increasing responsibility at PharmaForm and Forest Laboratories.
Dr. DiNunzio received his Ph.D. in Pharmacy (Pharmaceutics) from The University of Texas in 2009 specializing in thermal manufacturing of amorphous dispersions. He also holds M.S. and B.S. degrees in Chemical Engineering from Columbia University and The State University of New York at Buffalo. He currently serves on the Editorial Advisory Boards of AAPS PharmSciTech and the Journal of Pharmaceutical Sciences. He has authored over 25 research papers and book chapters in the field of hot-melt extrusion and formulation design for bioavailability enhancement. His current research interests include: formulation design for bioavailability enhancement, melt extrusion process design for challenging systems and the development of continuous manufacturing technologies.
Ravi Harapanhalli, VP Global Regulatory Affairs, Amneal Pharmaceuticals
Development and Approval of Generic Complex Products- An FDA and Industry Tango
Dr. Ravi Harapanhalli is serving as Senior Vice President of Global Regulatory Affairs at Amneal Pharmaceuticals for the last three years. In this capacity he oversees all regulatory activities including submission and approval of ANDAs, 505b2 NDAs, and regulatory meetings with Health authorities. He provides regulatory strategies and advises scientific teams on complex regulatory and technical issues facing high-barrier generics including combination products and complex drug substances. Earlier, he was Vice President of Technical Affairs at Parexel International, and provided high level consultations to pharmaceutical/biopharmaceutical industry. Prior to that, he was at US FDA for over 11 years in the Office of New Drug Quality Assessment and worked through the ranks from being a CMC Reviewer to finally serving as Branch Chief until July 2008. During his tenure at FDA he supervised and reviewed various dosage forms and complex drug substances and combination products including modified-release dosage forms, implants, transdermals, MDIs/DPIs, liposomes, suspensions/dispersed systems, synthetic APIs, therapeutic proteins/peptides/MAbs/biosimilars, oligonucleotides, iron complexes, radiopharmaceuticals, etc. Prior to FDA, he was in academics and industry for several years including Harvard, Rutgars-UMDNJ, and Hoechst Marion Russell. He holds Ph.D. in Medicinal Organic Chemistry from IIT Bombay and is a diplomat of the American Board of Science in Nuclear Medicine.
Dr. Charlie Martin, Leistritz Extrusion North America
Continuous mixing via twin screw extrusion: past, present and future
As President/General Manager of Leistritz Extrusion, Charlie is responsible for the management of a company that provides manufacturing equipment and engineering services to the plastics, medical and pharmaceutical industries in the USA and around the world.Extensively published in trade publications, textbooks and journals, Charlie has delivered 200+ technical presentations at wide-ranging international events, and is the co-editor of the textbook Pharmaceutical Extrusion Technology. He has also been awarded 2 extrusion related patents.Charlie currently serves on the Board of Directors for the Society of Plastics Engineers (SPE) Extrusion Division, the Polymer Processing Institute @ New Jersey Institute of Technology, and also on the Technical Advisory Board for Teel Plastics in Baraboo, WI. Previously he has held the Technical Program Chairman and Chairman positions for the SPE Extrusion Division.
Charlie earned his undergraduate degree from Gettysburg College and an MBA from Rutgers University.
Dr. Salvatore Mascia, CONTINUUS Pharmaceuticals
Integrated Continuous Manufacturing with Novel Technologies
Salvatore Mascia is the Founder & CEO of CONTINUUS Pharmaceuticals. He was the former Strategic Project Manager at the Novartis-MIT Center for Continuous Manufacturing, where he led the integration of the first end-to-end continuous manufacturing process for pharmaceuticals. At the end of the project, he was presented with the “Leadership Award” that recognized his leadership role at the Center. Salvatore has gained experience in strategic management and fund raising in addition to leadership skills via various roles of responsibility within the entrepreneurial ecosystem. Among those, he co-founded “Professionisti Italiani a Boston” in 2009, and served as President of the “Cambridge University Technology and Enterprise Club” in 2006/07. He also ran a pharmacy business for 2 years. Salvatore completed a post-doc at MIT in Chemical Engineering and holds a PhD in Chemical Engineering from the University of Cambridge, UK and a BS and MS in Pharmacy (summa cum laude) from University of Perugia, Italy.
Dr. Douglas Hausner, Associate Director Industrial Liaison, Rutgers University
Recent advances in continuous solid dose pharmaceutical manufacturing from Industrial and FDA sponsored research
Doug is currently the Associate Director of the Engineering Research Center for Structured Organic Particulate Systems (C-SOPS) based at Rutgers University in New Jersey, USA. C-SOPS focuses on the science based development of pharmaceutical products and processes. C-SOPS has been directly involved in working with major pharmaceutical companies and the FDA on the first processes for continuous manufacturing of pharmaceutical solid dose products.
Dr. Michael Repka, University of Mississippi
Conjugation of melt extrusion and additive manufacturing as a continuous process for patient-focused dosage formulation development
Dr. Michael A. Repka has significantly contributed to the advancement of hot melt extrusion (HME) technology and has established himself as an expert in this field. Polymeric and lipid drug delivery design, stabilization and formulation/process development for poorly soluble drugs are important aspects of his research. Dr. Repka has more than 160 publications, the majority on HME, and is regularly invited nationally and internationally as a speaker for symposia and workshops. He has licensed numerous patents and has been an entrepreneur for almost 4 decades, founding several companies to promote a variety of pharma and device technologies. Dr. Repka is Chair and Professor of the Department of Pharmaceutics and Drug Delivery and Director of the Pii Center for Pharmaceutical Technology at The University of Mississippi’s School of Pharmacy. He serves as an Editor for both AAPS PharmSciTech and the Journal of Drug Delivery Science and Technology. Dr. Repka is a thought leader for pharmaceutical HME technology, as most articles focusing on hot melt extrusion cite his work.
Dr. Feng Zhang, University of Texas at Austin
Session Chair
Feng Zhang is an assistant professor at the University of Texas at Austin. He received his Ph.D. in pharmaceutics from the University of Texas at Austin. He has been working in the industry for 14 years prior to joining the department of pharmaceutics at the University of Texas at Austin in 2014. He was the Director of Product Development at PharmaForm from 2007 to 2010 and Senior Scientist in the Formulation and Process development department at Gilead from 2011 to 2013. Zhang has been conducting research and product development using twin-screw extrusion process since 1994.
His principal research interest at UT Austin is in twin-screw extrusion processing for continuous granulation, bioavailability enhancement, abuse deterrent opioid delivery, and controlled release drug delivery. He is the editor of 2nd edition of “Pharmaceutical Extrusion Technology”, published in 2018. He has authored four book chapters on twin-screw extrusion process. He has published 40 peer-reviewed papers articles. He is also inventor on 12 issued patents covering a wide range of drug delivery systems. He serves on the editorial board of AAPS PharmSci Tech.
Dr. Robert Bellantone, President and CSO, Physical Pharmaceutica LLC
In Vitro Release Test Design for Complex Formulations
Robert Bellantone is the President of Physical Pharmaceutica LLC and Professor Emeritus at Long Island University (LIU).
Dr. Bellantone received a B.S. in Pharmacy from the University of Connecticut. After four years as a doctoral student in pharmaceutics, he changed his field of study and earned a Ph.D. in theoretical/computational physics, also from UConn. He was a member of the LIU Pharmacy faculty from 1996 through 2015 and served as the major adviser to 29 Ph.D. graduates.
Dr. Bellantone’s areas of expertise include the material science of dosage forms and biopharmaceutics. His interests include drug solubilization, complex dosage forms, and developing biorelevant in vitro release tests. He has published 27 peer-reviewed papers in a variety of fields and has authored or co-authored over 90 research posters at national scientific meetings. He has been awarded six U.S. patents, including five for pulsatile microdialysis (PMD). He has also consulted for numerous drug companies and collaborated with the FDA on three projects, using PMD to study drug release from ophthalmic emulsions, nanoparticle dissolution, and food-drug interactions.
Dr. Bellantone is thought to be the world’s only registered pharmacist with a Ph.D. in physics. While he finds this amusing, he is a serious fan of sports history and a formidable player at sports bar trivia contests.
Dr. Hugh D. Smyth, University of Texas at Austin
Challenges in Quantification of Orally Inhaled Products
Dr. Tony Zhou, Purdue University
Session chair
Dr. Qi (Tony) Zhou is an Assistant Professor in the College of Pharmacy of Purdue University. Dr. Zhou’s research focuses on particle engineering and characterization for oral dosage forms and inhalation formulations. He has published 60 journal articles and secured >$5M research funding including NIH R01 and Bill & Melinda Gates Foundation and industrial projects. Dr. Zhou’s significant contribution has been recognized by many awards including 2016 IPEC Excipient Emerging Researcher Award and 2017 New Investigator Award in Aerosol Medicine. Dr. Zhou is an Editor of AAPS PharmSciTech and Editorial Board Member of Journal of Pharmaceutical Sciences, Current Pharmaceutical Design and Drug Development and Industrial Pharmacy.
Dr. Akm Khairuzzaman, Senior Reviewer, Office of New Drug Product, FDA
Scientific and Regulatory Challenges with Complex Generics
Dr. Khairuzzaman is a senior reviewer at FDA’s Office of New Drug Product under the Office of Pharmaceutical Quality, CDER. For the last 10 years, he has been overseeing quality section of investigational new drug application (IND), new drug application (NDA), and abbreviated new drug application (ANDA) at various level. Prior joining to FDA in the year of 2008, Dr. Khairuzzaman worked for Barr Pharmaceuticals Inc., New York (currently owned by TEVA), for seven (7) years as a scientist and research investigator in its research and development group. Dr. Khairuzzaman earned a bachelor degree in Pharmacy. His graduate degrees, M.S. in Industrial Pharmacy and Ph.D. in Pharmaceutics are from Arnold and Marie Schwartz College of Pharmacy, Long Island University, New York.
Dr. Priyanka Ghosh, Office of Generic Drugs, FDA
Understanding the complexity of topical dermatological formulations
Dr. Priyanka Ghosh is a pharmacologist within the Division of Therapeutic Performance, Office of Research and Standards, OGD. Her specialization is drug products in the topical and transdermal drug delivery area. In her current role, Dr. Ghosh is responsible for the development of product-specific guidance for generic drug development, reviewing and responding to controlled correspondences, citizen petitions and Pre-ANDA meeting packages. Dr. Ghosh is also the project officer on multiple regulatory science research initiatives related to topical and transdermal drug products, under the GDUFA regulatory science research program.
Prior to joining the FDA, Dr. Ghosh completed her B.Tech in Biotechnology from West Bengal University of Technology (India) and a Ph.D. in Pharmaceutics and Drug design from the University of Kentucky. Dr. Ghosh is the author on numerous research manuscripts and review articles in the topical and transdermal area.
Lakshmi Raghavan, Founder and President, Solaris Pharma
Design considerations of transdermal delivery systems
Dr. Raghavan is a successful entrepreneur with more than 25 years of technical and business development expertise. Lakshmi Raghavan, PhD is currently the Founder and President of Solaris Pharma Corporation, leading its Research & Development, Business Development and overall corporate strategy. Prior to Solaris Pharma Corporation, Dr. Raghavan founded DermPathe Pharmaceuticals in 2010, a contract research organization providing contract research & development services in topical product development and pre-clinical services.
Dr. Raghavan is the Chairman of the In vitro Committee that is part of the Q3 Microstructure Steering Committee. He is also the Community Leader of the AAPS Topical & Transdermal Group.
Dr. Raghavan holds a Bachelor of Science and Master of Science in Physics from the University of Madras, Chennai, India and a Doctor of Philosophy degree in Physics from Indian Institute of Technology, Chennai, India. He has more than 40 research publications and several book chapters.
Dr. Robin H. Bogner, University of Connecticut
Natural Variation in Freeze-Drying at Lab and Manufacturing Scales – Implications for Scale-Up
Dr. Bogner is Professor of Pharmaceutics in the Department of Pharmaceutical Science at the University of Connecticut where she is also a member of the Institute of Materials Science. She received her B.S. in Pharmacy from Rutgers University, M.S. from the University of Iowa, and Ph.D. from Rutgers University after which she joined the faculty of the University of Connecticut. Dr. Bogner’s research interests are focused on the characterization and dissolution of pharmaceutical solids, both freeze-dried parenterals and oral dosage forms. The amorphous form of drugs and the implications of partially crystalline systems are a more recent interest. Dr. Bogner has a patent and many publications. She has served on several editorial boards, a USP committee, an FDA advisory committee and in various leadership roles in the American Association of Pharmaceutical Scientists (AAPS). Dr. Bogner is a Teaching Fellow at the University of Connecticut, and Fellow of the AAPS.
Dr. Steven L. Nail, Baxter Pharmaceutical Solutions
My Friend Mike Pikal: Some Personal and Professional Reflections
Steven L. Nail is currently a Principal Scientist in the R&D organization of Baxter Pharmaceutical Solutions, Bloomington, IN. His undergraduate training is in chemical engineering at Purdue University, and his Ph.D. is in pharmaceutics, also from Purdue. From 1975-1991 he worked for The Upjohn Company, Kalamazoo, MI in various capacities, all related to development and manufacture of parenteral products, with a special interest in the science and technology of freeze-drying. In 1991, he became Associate Professor in the School of Pharmacy at Purdue, and was promoted to Professor in 1999. His research interests at Purdue focused on the physical chemistry of freezing and freeze-drying, characterization of frozen systems and freeze-dried solids, stability of proteins as freeze-dried products, pharmaceutical thermal analysis, and pharmaceutical applications of supercritical fluid technology. His teaching responsibilities have included undergraduate pharmacy courses in parenteral pharmaceutical products and graduate courses in pharmaceutical processing. From 2002 until 2006, he was Research Fellow in the Pharmaceutical Sciences R&D organization at Eli Lilly & Co., Indianapolis, IN. He is Chairman of the USP Committee of Experts in Parenteral Products, and is a member of the Executive Committee of the Council of Experts at USP. He is a Fellow of the American Association of Pharmaceutical Scientists. In 2007, he received the AAPS Research Achievement Award in Pharmaceutical Technology. In 2013, he was recognized as a Distinguished Alumnus by the School of Pharmacy, Purdue University.
Dr. Serguei Techessalov, Pfizer Bio Therapeutics
Application of QbD principles for lyophilized protein parenteral manufacturing processes: Pfizer-NIPTE collaboration
Dr. Serguei Tchessalov is a Research Fellow at Pfizer Bio Therapeutics R&D (Andover, MA). He received his Ph.D. from Institute of Applied Biochemistry (Moscow) on development of novel methods for formulation and process control during lyophilization. He completed his Post-Doctoral training with prof. Pikal (UCONN). For the past 30 years (both, in Russia and US) Dr. Tchessalov is working on formulation and lyophilization process development of bacterial and viral vaccines, proteins and different biological materials. His current research is focused on lyophilization process scale up and transfer as well as processing of parenteral dosage forms (filtration, filling, freezing/thawing, etc.)
Dr. Sajal Patel, MedImmune
Dosage Form Design and Development, Biopharmaceutical Development
Dr. Sajal M. Patel is currently working as a Senior Scientist at MedImmune in Dosage Form Design and Development within Biopharmaceutical Development. In his current role, Dr. Patel is responsible for formulation, process and device development of liquid and lyophilized biologics with a focus in freeze-drying, freeze-thawing and inhaled biologics technology development. He is also in charge of developing early and late stage strategy for lyophilized drug product development and manufacturing. He received his M.S. in Chemical Engineering from the University of Southern California and Ph.D. in Pharmaceutical Sciences from the University of Connecticut. His publications have focused on lyophilization process design and control. Dr. Patel’s research interest remains in this area and include application of QbD to the development and manufacturing of lyophilized drug product.