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WEBINAR SPEAKERS

Michael Thompson

McMaster University – Associate Dean and Professor of Chemical Engineering

Presentation: Developments in Twin-Screw Granulation

Date: May 26th

Dr. Michael Thompson is a Professor of Chemical Engineering and Associate Dean of Engineering at
McMaster University in Canada. His research group looks at processes related to polymers or particulate
production, to develop new manufacturing solutions for the industries of polymer, food,
pharmaceutical, and energy.  The group at McMaster is one of the earliest research contributors to the
field, beginning back in 2008, and has been responsible for much of the screw design and wetting
practices used today.  The group enjoys close collaborations with a range of experts in the drug and
excipient community and remains committed to seeing broader deployment of twin-screw granulation
within the industry.

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Dr. Chad Brown

Merck – Executive Director and Global Head, Pharmaceutical Sciences

Presentation: Hot Melt Extrusion as a Key Enabler of Developing Products of
Low Solubility Compounds

Date: June 2nd

Chad Brown is the Executive Director and Global Head of the Merck Animal Health Pharmaceutical Sciences group located in Rahway, NJ, USA. His responsibilities include oversight of Formulation, Analytical and Packaging R&D from early discovery to commercial launch. Chad has 17 years of drug product development experience. He joined Merck in 2007 in the Merck Research Laboratories in Human Health and led the Oral Formulation Sciences and Technology group in Human Health. During this tenure, he became a subject matter expert in solid dispersion manufacturing, specifically hot melt extrusion and served on the board of The Society of Plastic Engineers Extrusion Division. He has been fortunate to be involved with several publications, patents and product launches using this technology. Chad holds a PhD from the University of Washington in Bioengineering and a BS degree from Colorado State University in Chemical Engineering.

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Andy Birkmire

GEA – Process Development Manager

Presentation: Successful Strategies for Developing a Continuous Manufacturing Process

Date: June 9th

Andrew Birkmire is the Process Development Manager for GEA Process Engineering, Inc., a world leader in Pharmaceutical manufacturing technology. He has more than 20 years of experience with Pharmaceutical Batch and Continuous processes, including feeding, blending, granulation, drying, and coating. He currently runs the Pharmaceutical Technology Center in Columbia, MD.

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Dr. John Vrettos

Enteris BioPharma – Principal Scientist in Formulation Development

Presentation: Breaking Through the Barriers of Oral Biologics

Date: June 16th

Dr. John Vrettos joined Enteris BioPharma in July 2013 as a Principal Scientist in Formulation Development. He is responsible for development programs for the oral delivery of peptides and poorly-permeable small molecules from feasibility through clinical trials. Previously, Dr. Vrettos was with Unigene Laboratories, advancing formulations to enable the oral delivery of peptides. Dr. Vrettos gained much experience with solid oral formulation development while a Principal Scientist in Technical R&D at Novartis Pharmaceuticals from 2008 to 2012. Prior to that, he was a Senior Scientist in the Pharmaceutical Sciences department at Human Genome Sciences. Dr. Vrettos received his Ph.D. in biophysical chemistry from Yale University in 2001 and was a National Research Council Postdoctoral Fellow at NIST in the Biomolecular Materials group from 2002-2003.

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Dr. Harsh Chauhan

Creighton University – Associate Professor, Pharmacy

Presentation: Formulation Considerations for development of Ternary Solid Dispersions

Date: June 23rd

Dr. Chauhan is an Associate Professor in Pharmaceutical Sciences at Creighton University, NE, USA; with a research lab working in the area of developing novel drug delivery systems for poorly soluble compounds. He completed his PhD from MCPHS University, Boston, MA. He had published more than 25 peer reviewed article, five book chapters and presented around 50 posters in national and international conferences. He serves as reviewer and editorial board in many reputed pharmacy journals. He is a member of American Association of Pharmaceutical Scientist (AAPS) and American Chemical Society (ACS). His profile can be found here.

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Dr. Daniel Treffer

Melt Prep – CEO and Founder

Presentation: Rapid and lossless prototyping of HME formulations in the milligram to gram scale via Vacuum Compression Molding

Date: June 30th

Daniel Treffer is the founder and CEO of MeltPrep GmbH. A start-up company founded in 2016 which develops equipment for sample preparation. The company is based on his findings, which he obtained during his PhD in the field of pharmaceutical engineering. His work was supervised by Professor Khinast at the RCPE in Graz, where he faced several challenges in hot-melt extrusion development projects and recognised the strong need for novel tools for faster and lossless drug formulation developments. He patented the innovative vacuum compression molding (VCM) technology in 2014.
He also established two new product lines within his company. First, the VChamber, which turns any hot plate into a vacuum oven, and second ExtruVis, a technology for straight-forward and precise residence time distribution measurement.

During his career, Daniel has authored & published several scientific papers, contributed to the scientific textbook “Melt Extrusion by Dr. Repka” and is a coveted speaker at different conference talks all over the world.

His mission is to simplify drug development processes in order to enable pharma companies to bring much-needed drugs to the market as fast as possible.

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Jim Marjeram

O’Hara Tech – Technology Director

Presentation: Advantages of Continuous Tablet Coating

Date: September 8th

Jim Marjeram is a graduate of Humber College with a specialty in Electro-Mechanical Engineering Technology. Jim has worked in the pharmaceutical industry for more than 30 years, concentrating on solid dosage solutions. Most of Jim’s career has been with O’Hara Technologies Inc. which has grown from local engineering firm to world class supplier of engineered pharmaceutical tablet coating and process systems during Jim’s tenure with the organization. Jim has served the company in diverse roles from product development to his current role as Sales Director. Throughout that time Jim has developed several patents and patents-pending in the area of continuous tablet coating. Jim can be contacted at jim.marjeram@oharatech.com.

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Seth Forster

Merck – Associate Principal Scientist

Presentation: Long-Acting Implants: Design for Durable Drug Delivery

Date: August 4th

Seth Forster is an Associate Principal Scientist in the Pharmaceutical Commercialization Technology department of Merck Manufacturing Division, based in West Point, PA. He is focused on development and scale-up of novel pharmaceutical dosage forms and process technology, especially for long-acting drug-eluting implants and dry powder inhalers. Seth has a BS in Chemical Engineering from Purdue University and an MS in Pharmaceutics from Temple University. He has been developing pharmaceutical products since 2006.

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Dr. John Shelley

Schrodinger – Schrodinger Fellow

Presentation: Formulation Development for Small Molecules and Biologics Enhancements with Molecular Modeling

Date: July 28th

John Shelley, PhD, has been a software developer and product manager at Schrödinger for approximately 20 years. John was promoted to Fellow based upon his work on software products for small-molecule drug design. Over the last 6 years his work has shifted to modeling related to drug formulation particularly structured solutions including liposomes, polymersomes and protein solutions.

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Dr. Andrea Browning

Schrodinger – Product Manager

Presentation: Formulation Development for Small Molecules and Biologics Enhancements with Molecular Modeling

Date: July 28th

Andrea Browning is responsible for leading efforts related to polymeric materials simulation in Schrödinger Materials Science and joined Schrödinger in 2017. Prior to joining Schrödinger, she was a lead research engineer and project manager at The Boeing Company. She brings a decade of experience in connecting industrial, engineering problems to root materials issues and how simulations can be used to inform industrial decisions.

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Dr. Dedong Wu

AstraZeneca – Senior Scientist

Presentation: Improving Bioavailability by Prodrug Approach

Date: September 1st

Dedong Wu is a senior scientist in AstraZeneca Pharmaceutical Science to provide expertise in the areas of predictive pharmaceutics, drug substance form selection, preformulation, enabling formulation and drug delivery for both early-stage drug candidate design/assessment and commercial drug product development. He had worked in Bristol-Myers Squibb for 5 years before he joined Astrazeneca in 2005. Dedong Wu received his Ph.D. in physical chemistry and has published more than 80 scientific manuscripts.

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Chandra Kelley

Pfanstiehl – Director of Business Development

Presentation: Key Considerations in Accelerating Biopharma Formulation Development

Date: August 11th

Chandra Kelley has been the Director of Business Development at Pfanstiehl, Inc. since 2016, has more than twenty years of experience in the Biopharma industry and a BS in Biology from PLNU in San Diego.

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Dr. Feng Zhang

UT Austin – Assistant Professor in Pharmaceutics

Presentation: Hot-melt extrusion to prepare amorphous solid dispersions: key concepts and common misperceptions

Date: July 7th

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 worked 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 (now part of BioDuro) 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, 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 60 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 and North American editor for Journal of Drug Delivery Science and Technology.

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Dr. Xiaohu Deng

Viracta – Sr. Vice President of Product Development

Presentation: Phase-appropriate CMC Strategies in Drug Product Development

Date: July 14th

Dr. Deng is a Sr. Vice President of Product Development at Viracta Therapeutics, overseeing the overall product development strategy and execution. Prior to Viracta, Dr. Deng was Senior Director, Head of CMC at Kura Oncology, Inc. and Wellspring Biosciences, leading the CMC function – including development, manufacture, quality control, and clinical supply – of multiple programs through various phases of development (I, II and III and registrational).   Dr. Deng started his industry career at Janssen Pharmaceutical Companies of Johnson & Johnson in various roles of increasing responsibility associated with process chemistry R&D, CRO management, and project management of discovery/preclinical development.  He has more than 60 peer-reviewed journal publications, book chapter, abstracts and patents to his credit.  Dr. Deng holds a Ph.D. in organic chemistry from Emory University and MS and BS in chemistry from Fudan University.

 

Dr. Yi-Ling Hsieh

AbbVie – Senior Scientist

Presentation: Lipid-Based Formulation – The Impact on Biopharmaceutics and Patient Centricity

Date: July 21st

Dr. Yi-Ling Hsieh is a Senior Scientist in Early Development in AbbVie. She has extensive experience in formulation development for early and late stage projects. She currently leads the lipid-based formulation platform development in AbbVie (Legacy Allergan) and investigates the impact of formulation design on biopharmaceutics. Prior to her current position, she led the solid-state characterization effort for the small and large molecule inhalation formulation in Novartis to support the development activities from pre-clinical stage to NDA submission. She also gained wide-ranging industry experience, including material characterization, novel enabling formulations, and regulatory quality compliance from her prior experience in Pfizer, Schering-Plough and Bristol-Myers Squibb. She authored several peer-reviewed publications with the focus of salt stability and the precipitation and supersaturation behavior of drug molecules. Dr. Hsieh earned her Ph.D. degree in Pharmaceutics and B.S. degree in Pharmaceutical Sciences from Purdue University – West Lafayette.

Dr. Abu Serajuddin

St. John’s University – Professor of Industrial Pharmacy

Presentation: Development of HPMCAS-based amorphous solid dispersions by melt extrusion

Date: August 18th

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.

Sean Mcmahon

Ashland – Professor of Industrial Pharmacy

Presentation: Business Development and Technical Manager

Date: TBD

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.