DissoAmerica 2020 – Online

Speakers

• 

  David Sperry
  

  David Sperry

  Dr. Sperry is a Sr. Research Advisor in Small Molecule Drug 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.

• 

  Deanna Mudie
  

  Deanna Mudie

  Dr. Deanna Mudie is a leader in oral drug formulation and PBPK modeling with over 20 years of experience across academia, pharmaceutical companies, and CDMOs. She is a recognized expert in the development of amorphous solid dispersion (ASD) formulations for improving the performance of poorly soluble compounds. As a Senior Principal Scientist at Simulations Plus, Dr. Mudie develops modeling solutions that enhance drug innovation and streamline regulatory approvals. With a PhD in Pharmaceutical Sciences and a BSE in Chemical Engineering from the University of Michigan, she combines her background in formulation design with simulation technology to advance pharmaceutical research.

• Gregory E. Amidon University of Michigan, Ann Arbor, MI USA 48109
  Gregory E. Amidon

  University of Michigan, Ann Arbor, MI USA 48109

  Dr. Amidon received his Bachelor of Science degree in Medicinal Chemistry (1974) and his Ph.D. in Pharmaceutical Chemistry (1979) from the University of Michigan at Ann Arbor, MI. He joined the University of Michigan, College of Pharmacy as Research Professor of Pharmaceutical Sciences in 2007 after 28 years in the pharmaceutical industry. Prior to joining the University of Michigan, Dr. Amidon held research positions in pharmaceutical R&D for Pfizer, Pharmacia, Pharmacia & Upjohn, and The Upjohn Company. His current research interests focus on oral bioperformance assessment and in vivo predictive dissolution as well as pharmaceutical materials science. Dr. Amidon is a member, Fellow, and past President of AAPS. He is the recipient of the 2014 AAPS Research Achievement Award in Physical Pharmacy and Biopharmaceutics, the 2015 Champion of Quality award from USP, and is a past recipient of the Ebert Prize from the American Pharmacists Association.

• 

  James Polli Professor of Pharmaceutical Sciences and Ralph F. Shangraw/Noxell Endowed Professor in Industrial Pharmacy and Pharmaceutics at U of Maryland
  

  James Polli

  Professor of Pharmaceutical Sciences and Ralph F. Shangraw/Noxell Endowed Professor in Industrial Pharmacy and Pharmaceutics at U of Maryland

  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.

• 

  Joseph W. Polli Director, Medical Information and Scientific Communications, ViiV Healthcare
  

  Joseph W. Polli

  Director, Medical Information and Scientific Communications, ViiV Healthcare

  Dr. Polli received his B.Sc. in Molecular and Cellular Biology in 1986 from The Pennsylvania State University, and his Ph.D. in Pharmacology from the Milton S. Hershey Medical Center-The Pennsylvania State University in 1990. From 1990-1993, he was a Pharmacological Research Associate (PRAT) Fellow at the National Institutes of Health. In 1993, he joined GlaxoSmithKline, plc where he was a Senior Director and Senior Fellow in the Mechanistic Safety and Disposition Department for over 25 years. His group provided in vitro support for the discovery and registration of clinical drug candidates, which included mechanistic studies on absorption, distribution, metabolism, elimination, safety and drug interactions. In 2018, Joe joined ViiV Healthcare (a subsidiary of GSK) as a Director Medical Information and Scientific Communications working on cabotegravir, a long-acting HIV integrase inhibitor. His research interests include membrane transporters that influence drug disposition, understanding drug interaction mechanisms related to drug metabolism/transport, and processes to enhance the development of drug candidates. He has published more than 70 original research papers and was inducted as an AAPS Fellow in 2004. He was named to the 2014, 2015, 2016, 2017 and 2018 Clarivate Analytics Thomson Reuters Highly Cited Researchers, and received the 2014 AAPS Research Achievement Award in Pharmacokinetics, Pharmacodynamics, and Drug Metabolism, which recognizes an outstanding scientist who has demonstrated significant impact in their respective field. Joe is currently the 2020 AAPS President and has served the association as a Member-at-Large on the AAPS Board of Directors, Annual Meeting Chair and Chair of the PPDM Section.

• 

  Lynne S. Taylor
  

  Lynne S. Taylor

  Lynne S. Taylor, Ph.D. is the Retter Professor of Pharmacy in the Department of Industrial and Physical Pharmacy, Purdue University. Prior to moving to academia, she spent several years working at AstraZeneca in Sweden developing new drugs. Lynne received a Bachelor of Pharmacy degree with First Class Honors from the University of Bath in the UK. Her PhD was undertaken at the University of Bradford, UK, in the area of Pharmaceutical Technology. After her PhD, Lynne was a postdoctoral researcher at the University of Wisconsin-Madison. Research in Lynne’s group is directed toward exploring the science underlying the preformulation, formulation and manufacturing of drugs and other bioactive substances, in particular poorly water soluble compounds. She has published more than 300 peer reviewed articles. Lynne has received a number of awards including the Coblentz Society Craver Award in Applied Vibrational Spectroscopy (2014), the Journal of Pharmaceutical and Biomedical Analysis Outstanding Manuscript award (2007), the Ebert prize for the best manuscript in the Journal of Pharmaceutical Sciences (2012) and the Pharmaceutical Research meritorious manuscript award (2012). Lynne is a Fellow of the Royal Society of Chemistry and the American Association of Pharmaceutical Scientists, and is editor-in-chief of the ACS journal, Molecular Pharmaceutics.

• 

  Patrick Ballmer Vice President and Deputy of the CEO of the Aesch, BL, Switzerland headquartered SOTAX Group
  

  Patrick Ballmer

  Vice President and Deputy of the CEO of the Aesch, BL, Switzerland headquartered SOTAX Group

  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.

• 

  Sanjaykumar Patel
  

  Sanjaykumar Patel

  Sanjaykumar Patel is Sr. Principal Scientist at Merck & Co., Inc. in Rahway, NJ. He has more than 22 years of experience in the pharmaceutical industry. His experience includes working on novel drug delivery formulations such as self-emulsifying drug delivery systems, amorphous solid dispersion, controlled release and gastroretentive, and parental formulation. His research interest is focused on developing predictive bio-relevant in-vitro methodologies to understand the in-vivo performance of oral and parental formulations. He has co-authored 18 scientific papers. He is an active member of AAPS and an immediate past Chair of the IVRDT (In Vitro Release and Dissolution Testing) community. He is a board member of the Society of Pharmaceutical Sciences-US Chapter in the area focusing on dissolution.

• 

  Vatsala Naageshwaran
  

  Vatsala Naageshwaran

  A novel in vitro combined dissolution and absorption system to support formulation development and predict clinical outcomes

  For an orally administered drug to be absorbed, two upfront processes must occur. The formulated product must dissolve, and the released drug must go into solution. At that point, drug permeation/flux comes into play and becomes the final determining factor in how much of the dose will be absorbed. In this presentation I am going to showcase a unique tool that we have developed and validated called IDAS (In Vitro Dissolution Absorption System) which combines traditional dissolution testing with permeability assessments across a bio-relevant barrier. The presentation will include case studies that highlight the utility of IDAS and its physiological relevance to accelerate the selection of formulations for pre-clinical and clinical studies and help predict clinical outcomes. Absorption Systems has received a two-year grant from the USFDA to study BCS class 3 compounds and the impact of excipients using the IDAS system.

  A novel in vitro combined dissolution and absorption system to support formulation development and predict clinical outcomes

  For an orally administered drug to be absorbed, two upfront processes must occur. The formulated product must dissolve, and the released drug must go into solution. At that point, drug permeation/flux comes into play and becomes the final determining factor in how much of the dose will be absorbed. In this presentation I am going to showcase a unique tool that we have developed and validated called IDAS (In Vitro Dissolution Absorption System) which combines traditional dissolution testing with permeability assessments across a bio-relevant barrier. The presentation will include case studies that highlight the utility of IDAS and its physiological relevance to accelerate the selection of formulations for pre-clinical and clinical studies and help predict clinical outcomes. Absorption Systems has received a two-year grant from the USFDA to study BCS class 3 compounds and the impact of excipients using the IDAS system.

• 

  Vinod P. Shah
  

  Vinod P. Shah

  Dr Shah is a Pharmaceutical Consultant. He is International Chairman of Society of Pharmaceutical Dissolution Science (SPDS) (2012 – Present) and founder President of SPDS-US chapter. He received his Pharmacy degree with Gold Medal distinction from Madras University, India and Ph.D. in Pharmaceutical Chemistry from University of California, San Francisco (UCSF).
  Dr Shah served US Food and Drug Administration (FDA) in different capacities in the Centre for Drug Evaluation and Research. His regulatory research interest was to develop in vitro and in vivo methodology for various pharmaceutical dosage forms. He has developed many Regulatory Guidances for the Industry. He is a recipient of several FDA Awards, including Award of Merit. He retired from FDA as a Senior Research Scientist after over 30 years of service. He is author/co-author of over 340 scientific papers and is a 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 of International Pharmaceutical Federation (FIP). Dr Shah is a recipient of AAPS Distinguished Service Award; IDMA Eminent Pharmaceutical Analyst Award; FIP Lifetime Achievement Award in Pharmaceutical Sciences; Honorary Doctorate from Semmelweis University, Budapest, Hungary and from University of Medicine and Pharmacy Carol Davila Bucharest, Romania; SPDS Award of Excellence; American Association of Indian Pharmaceutical Scientists (AAiPS) Lifetime achievement award; AAPS Distinguished Pharmaceutical Scientist Award; AAPS Global Leader Award and FIP Host Madsen Medal Award.

• 

  Vivek Shah
  

  Vivek Shah

  Vivek Shah is a highly accomplished scientist with an academic background in pharmaceutical sciences and chemistry. He received his Bachelor’s degree in Pharmaceutical Sciences from Ohio State University and then pursued a Master’s degree in Chemistry from Long Island University.

  After completing his studies, Vivek began his professional career at Merck. He contributed to the development of new techniques, Direct Drug Analysis in Polymeric Implants DESI-MSI Imaging and using Mixed Reality in Pharmaceutical Development. His expertise with the Apparatus 4 helped drive dissolution studies for many different programs including a program that used an in-line NMR cryoprobe with the Apparatus 4.

  Vivek’s expertise and contributions to the pharmaceutical industry have not gone unnoticed. He currently serves on the USP expert panel for In Vitro Product Performance and is an Executive Board member for the US Society of Pharmaceutical Dissolution Science, demonstrating his commitment to advancing the field of pharmaceutical sciences and his deep understanding of in vitro testing methodologies.

  Currently, Vivek is leading the Pharma Services team for SOTAX in Massachusetts, where he continues to demonstrate his leadership and scientific acumen. In his current role, he has helped develop and validate groundbreaking in-vitro methods for complicated drug release programs.

• 

  Xujin Lu
  

  Xujin Lu

  Dr. Xujin Lu is a pharmaceutical consultant. With 30+ years of experience in pharmaceutical industry spanning analytical sciences, CMC, and formulation development across early‑ and late‑stage drug products, his career includes major contributions to the research, development, regulatory approval, and commercial launch of multiple innovative drug products in diverse dosage forms. His latest focus before retiring from Bristol Myers Squibb Company was in charge of the in‑vitro biopharmaceutics function, overseeing multi‑site and multi‑national teams responsible for evaluating drug release and predicting bioperformance of novel formulations, with dedication in advancing the scientific validity and strategic application of in‑vitro methodologies to support product development pipelines.
  Dr. Lu is an active member of AAPS and a past Chair of the In Vitro Release and Dissolution Testing (IVRDT) Focus Group. He serves on the USP Expert Panel on New Advancements in Product Performance Testing, the USP Expert Committee on Dosage Forms, and the Editorial Advisory Board of Dissolution Technologies. He is also a member of the Scientific Advisory Board of the Society for Pharmaceutical Dissolution Science – US Chapter.