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WEBINAR SPEAKERS

Dr. Ketan Patel

St. John’s University – Assistant Professor of Pharmaceutical Sciences

Presentation: Development of self-medicated formulations of Remdesivir for COVID-19: Extended release in-situ depot and pulmonary liposome

Date: April 6th

Dr. Patel is working as an assistant professor of pharmaceutical sciences at St. John’s University, NY. He holds a Ph.D. in Pharmaceutics from the Institute of Chemical Technology, Mumbai, India. The major focus of his research group at St. John’s University is to develop a translational drug delivery system/formulations for improving the efficacy and/or patient compliance. Dr. Patel has authored more than 50 research publications in prestigious, peer-reviewed journals in the area of pharmaceutics, 3D printing, opioid abuse deterrent formulation, pre-exposure prophylaxis of HIV, investigating novel class of anticancer molecules and development of tumor targeted nanoparticles. He has five US patents on innovative formulation technologies. Dr. Patel received a Melanoma Research Scholar Award from Outrun the Sun, Inc. and a National Institutes of Health grant for his research on development of nanomedicine of Proteolysis Targeting Chimera (PROTAC) for the treatment of metastatic melanoma.

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Dr. Sean McMahon

Ashland – Business and Technical Manager

Presentation: Extended Release Injectables: ViatelTM Bioresorbable Polymer Design for Success

Date: Feb 23rd, 2021

Dr. Seán McMahon is the Business and Technical Manager for the ViatelTM bioresorbable polymer portfolio at Ashland, supporting customers with key excipients/materials and technical solutions in the development of extended release parenteral drug delivery formulations, medical devices, tissue engineering scaffolds and cosmetics.

He joined Ashland as part of the Vornia Ltd. acquisition in 2018 where he previously held responsibility for the company’s major business functions in his role as CEO. During his time at Vornia Ltd., he led development of the company’s major intellectual property platform for production of bioresorbable polymers. He has extensive knowledge of bioresorbable polymer design, chemistry and processing technologies used in medical applications. This experience comes from working on large research and commercial projects delivering bioresorbable polymer-based solutions for orthopedic, cardiovascular, neurological, oncology, wound-care, dental, ophthalmic, regenerative medicine and wider drug delivery technologies.

Dr. McMahon has published several research/review papers on polymer design for medical applications. He obtained his B.Eng. and M.Sc. from the National University of Ireland, Galway (NUIG) and his Ph.D. from the School of Medicine and Medical Sciences at the University College Dublin (UCD), Ireland.

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Tim Smith

Freund-Vector Corporation – Senior Process Development Scientist

Presentation: Bottom Spray (Wurster) Coating: Understanding the Challenges, Processing & Scale-Up Considerations

Date: March 16th

Tim has been involved in the design and development of equipment and processes for the pharmaceutical, food, and confectionary industries for over 35 years. Currently serving as a Senior Process Development Scientist with Freund-Vector Corporation. Previously served as a Research Associate, Application Engineer, R&D engineer, R&D project manager, and Laboratory Manager.

Presentations have included seminars at University of Tennessee, University of Mississippi, University of Maryland, Colorcon, E&G, Evonik, FDA, Interphex, Lubrizol, TechSource, AAPS annual meetings, Freund-Vector’s technical courses and numerous domestic/international customer facilities.

Lead author of “Development, Scale-up, and Optimization of Process Parameters: Roller Compaction”, Chapter 31 in Developing Solid Oral Dosage Forms edited by Yihong Qiu, Yisheng Chen, Geoff G.Z. Zhang, Lirong Liu, and William R. Porter, 2008.

Educational background is in Chemical Engineering (B.S.) and Food Science (M.S.) – Iowa State University.

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Charles Vesey

Colorcon, Inc. – Formulation Technology Manager

Presentation: Formulation Strategies and Tools for Accelerated Development of Solid Oral Dosage Forms

Date: March 9th

Charles Vesey has more than 20 years of experience in solid oral dosage form development and is currently a Formulation Technology Manager in the Market Development group at Colorcon, Inc., located in Harleysville, Pennsylvania. Charles received both his Bachelors in Pharmacy and Masters in Pharmaceutics from the Philadelphia College of Pharmacy at the University of the Sciences in Philadelphia. Charles began his career at Colorcon as a Research Associate in the Global Technology Development group where he focused on film-coating formulation, raw material qualification, process optimization, and scale-up. His current work is in the area of drug product design to make better tasting medicines for pediatric and geriatric populations to help positively impact patient compliance. More broadly, Charles interests include formulation and process troubleshooting of solid oral dosage forms with emphasis on multiparticulate controlled-release products. Charles has contributed numerous research publications and conference presentations in the area of modified release technologies. He is a member of the American Pharmacists Association (APhA), a licensed pharmacist in the Commonwealth of Pennsylvania, and a United States Pharmacopeia (USP) Expert Committee Member (volunteer).

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Dr. Larry Ereshefsky

Hassman Research Institute and CNS Research – CSO, Early Phase Development

Presentation: Optimizing Formulations in Early Phase Development: The view from the ‘clinical’ side

Date: Title to be announced

Dr. Ereshefsky is an internationally recognized thought leader in clinical translational central nervous system research with a proven track record in designing Phase I/IIA and clinical pharmacology studies. He is a leader in the application of translational drug development tools, and in the use of signal detection strategies to minimize placebo response. He is a retired Regents Professor of Pharmacy, Psychiatry, and Pharmacology from The University of Texas/UT Health Science Center. Subsequently, he was the VP, Principal Clinical Pharmacologist, and Global CNS Leader for Early Phase at PAREXEL.

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Dr. Changquan Calvin Sun

University of Minnesota (UMN) – Professor of Pharmaceutics and Director of Graduate Studies

Presentation: Material-sparing and expedited development of tablets for early clinical testing

Date: April 13th

Dr. Sun is Professor of Pharmaceutics and Director of Graduate Studies at the Department of Pharmaceutics, University of Minnesota (UMN). After receiving his Ph.D. in Pharmaceutics from UMN, he worked in the pharmaceutical industry for 8 years before joining the UMN in 2008. Dr. Sun’s research focuses on formulation development of tablet products through appropriate application of materials science and engineering principles, including 1) crystal and particle engineering for superior powder flow and compaction properties; 2) solid state chemistry and engineering, and 3) pharmaceutical unit operations, e.g., blending, granulation, and tableting.
Dr. Sun is an expert in the areas of solid-state science, tablet formulation design, and powder technology. He has published over 200 peer-reviewed papers in these areas with more than 7,800 citations (H-index of 46). Dr. Sun currently serves on the editorial advisory boards for J. Pharm. Sci., Int. J. Pharm., Mol. Pharmaceutics, and Pharm. Res. He has served on the Expert Committee in Physical Analysis of the United States Pharmacopeia since 2010. Dr. Sun is an AAPS Fellow and a Fellow of Royal Society of Chemistry. He has received a number of awards, including the 2019 Ralph Shangraw Memorial Award by International Pharmaceutical Excipient Council (IPEC) for his outstanding research contributions in the study of excipients or excipient-related technology over a number of years.

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Dr. Tom Tice

Evonik Corporation – Senior Director, Technical Global Marketing

Presentation: Lactide/Glycolide Parenteral Excipients for Successful Drug Delivery Solutions

Date: March 23rd, 2021

Thomas R. Tice, PhD, Senior Director, Technical Global Marketing, Evonik Corporation, provides scientific support to Evonik’s product development, sales, M&A, and intellectual property teams. Dr. Tice is internationally recognized for research in drug delivery and has lectured on the topic throughout the world. His specialties include complex parenteral dosage forms and bioabsorbable polymers. He has over 40 years’ experience developing injectable, extended-release microparticles and implants made with bioabsorbable lactide/glycolide polymers. He led the team and is one of the inventors that developed the first commercial, injectable, extended-release microparticle product. This product is Decapeptyl® SR, a one-month LHRH formulation indicated for the treatment of prostate cancer. Dr. Tice earned his PhD in Biophysics from Syracuse University, New York. He holds 48 US patents with many foreign equivalents and has more than 180 publications, presentations and invited lectures to his credit. He currently serves on the Board of McWhorter School of Pharmacy at Samford University. He has served on United States Pharmacopeia expert committees for 15 years dedicated to improving global health through setting pharmaceutical standards; presently serving on the General Chapters-Dosage Forms Expert Committee and Excipient Joint Committee.

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Abu Serajuddin

St. John’s University – Professor of Industrial Pharmacy

Presentation: Title to be announced

Date: March 2nd, 2021

Abu Serajuddin, PhD, is Professor of Industrial Pharmacy at St. John’s University, Queens, New York, USA. Prior to joining academia in 2008, he worked in the pharmaceutical industry for 32 years in scientific and managerial positions. In his latest positions in the industry, he served as Executive Director and the US Head of Pharmaceutical R&D at Novartis Pharmaceutical Corp. Currently, at St. John’s University, he has built a world-class teaching and research program dedicated to the development of drug delivery systems and pharmaceutical processing technologies, including melt extrusion. He has published over 120 papers and book chapters, and he is a coinventor in 13 patents. He also made 145 invited presentations in national and international conferences. In recognition of his scientific and professional achievements, he was elected Fellow of American Pharmacists Association (APhA) and American Association of Pharmaceutical Scientists (AAPS). AAPS also recognized him with 3 of its highest awards, namely, AAPS Research Achievement Award in Formulation Design and Development in 2010, AAPS Research Achievement Award in Manufacturing Science & Engineering in 2014, and the AAPS Lipid-based Drug Delivery Outstanding Research Award in 2015. For his academic and research excellence as a member of the faculty, St. John’s University bestowed him the University Medal for Outstanding Achievement in 2019.

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Dr. Dave A. Miller

Vice President  – Research and Development at DisperSol Technologies

Presentation: The Importance of Particle Properties on the Biopharmaceutical Performance of Amorphous Solid Dispersions

Date: March 30th, 2021

Dave A. Miller, Ph.D. has served as Vice President of Research and Development at DisperSol Technologies since 2011. Prior to joining DisperSol, he was a Senior Principal Scientist at Hoffmann-La Roche, Inc. in Nutley, NJ. Dr. Miller specializes in formulation and processing technologies for improving oral bioavailability of insoluble small molecules. He has applied his expertise toward advancing numerous drug candidates through various stages of development from early discovery to commercial-ready stages. Dr. Miller was an original inventor of the pharmaceutical applications of the KinetiSol technology and continues to be a primary innovative driver for application and expansion of the platform. He has published 35 research articles in peer-reviewed journals, authored 7 book chapters, and is co-editor of the First and Second Editions of the textbook, Formulating Poorly Water-Soluble Drugs. He has 8 granted patents in the United State and numerous pending applications. Dr. Miller holds a B.S. in Chemical Engineering and a Ph.D. in Pharmaceutics from the University of Texas at Austin.

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Dr. Dana E. Moseson

Purdue University – Postdoctoral Research Scientist

Presentation: Crystallinity: A Complex Critical Quality Attribute of Amorphous Solid Dispersion

Date: May 11th, 2021

Dana Moseson joined the Department of Industrial and Physical Pharmacy in the fall of 2016. Prior to coming to Purdue, she received her bachelors from Penn State University and then spent 10 years at Emerson Resources in Norristown, PA specializing in formulation development and clinical supplies manufacturing. Under the direction of Professor Lynne Taylor, Dana’s dissertation work has investigated the processing and performance of hot melt extruded amorphous solid dispersions, in particular seeking mechanistic insight into the performance impacts of residual crystallinity. Her research has won several prestigious awards, including the National Science Foundation Graduate Research Fellowship (NSF GRFP 2018-2021), International Pharmaceutical Excipients Council of the Americas (IPEC-Americas) Graduate Student Award (2019), and National Institute for Pharmaceutical Technology and Education (NIPTE) Outstanding Student Research Scholarship (2020). She is currently a postdoctoral researcher at Purdue University.

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Dr. Mark A. Tracy

Tracy BioConsulting, LLC. – Founder and President

Presentation: Lessons Learned in Advancing Sustained Release Polymer Microparticle Products into the Clinic

Date: May 4th, 2021

Dr. Tracy is Founder and President, Tracy BioConsulting, LLC. Tracy BioConsulting (www.tracybioconsulting.com) is a specialty biopharmaceutical consulting firm dedicated to helping clients successfully advance their scientific research into and through the clinic. Dr. Tracy is known internationally for developing innovative first-in class complex injectable and nucleic acid therapeutics. Dr. Tracy played a key role in developing Onpattro®, the first RNAi therapeutic approved by the FDA, EMA and other regulatory agencies worldwide. He also developed several complex injectable sustained release products that have been commercialized including Vivitrol®, Bydureon®, and Nutropin® Depot, which was the first long acting protein product approved by the FDA. Dr. Tracy has extensive experience in the development of nano and microparticle-based products and other sterile injectable formulations from research through IND filing and commercialization. He has been recognized by peers internationally for accomplishments and leadership in the pharmaceutical product development, bioengineering, and delivery fields. Dr. Tracy is a Past-President and Fellow of the Controlled Release Society (CRS) and a Fellow of the American Institute for Medical and Biological Engineering (AIMBE).

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Wenzhan Yang

AstraZeneca – Associated Principal Scientist

Presentation: Small Molecule Drug Delivery Approaches to Modulate Target Engagement in Drug Discovery

Date: TBD

Wenzhan Yang is an associated principal scientist in the department of Advanced Drug Delivery in Pharmaceutical Sciences at AstraZeneca. She has extensive experience in clinical drug candidate selection, development risk assessment and formulation development for preclinical and clinical studies. She also had six years of teaching experience at Shenyang Pharmaceutical University in China. She has authored and coauthored over 30 peer-reviewed publications and several book chapters and patent applications.

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Dr. Jeffrey Leyton

Université de Sherbrooke, – Associate Professor

Presentation: Journey to the Center of the Cell: Reprogramming Intracellular Transport to the Nucleus Enhances Tumor Killing for Antibodies Conjugated to Nuclear-Active Payloads

Date: TBD

Dr. Leyton is a scientist in the field of antibody-based medicines with a focus on the improvement of tumor targeting and accumulation. His successful projects range from the development of methods and algorithms to discover novel transport pathways and signal sequences to improve nuclear localization, the development of novel antibody-drug conjugates with nuclear-active payloads, antibody engineering.  Dr. Leyton earned his PhD in Molecular and Medical Pharmacology from the University of California, Los Angeles and trained as a postdoctoral fellow in the department of pharmaceutical sciences at the University of Toronto prior to joining the Université de Sherbrooke.

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