Peck Symposium Speakers
Dr. Steve Nail, Ph.D.
Principal Scientist, Baxter Pharmaceutical Solutions, Bloomington, IN
Steven L. Nail is currently a Principal Scientist in the Pharmaceutical Development 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 was formerly Chairman of the USP Committee of Experts in Parenteral Products. He is a Fellow of the American Association of Pharmaceutical Scientists, and received the Research Achievement Award in Pharmaceutical Technology from AAPS in 2007. In 2013, he was recognized as a Distinguished Alumnus by the School of Pharmacy, Purdue University. In 2017, he received the Honored Baxter Career Award from Baxter Healthcare, Inc.
Some Thoughts on the Need for Graduate Education in Pharmaceutical Biotechnology
Large-molecule therapeutic agents, often monoclonal antibodies, antibody-drug conjugates, and fusion proteins, have assumed a higher profile in pharmaceutical research and development in recent years, and there is no reason to think that this trend will end any time soon. The discussion comes from the point of view of a scientist from a contract R&D/contract manufacturing organization that handles both large and small molecules at various stages of development, with responsibilities ranging from analytical method development and validation to formulation and process development of injectable dosage forms. We encourage our scientists to develop both deep expertise in a particular area of interest to them, but also to develop a broad understanding and the ability to converse intelligently with scientists and engineers involved in such areas as biophysical characterization of proteins, physical and chemical stability assessment, unit operations in manufacture of injectable products, as well as unit operations in the production of a large molecule bulk drug substance. Scientists should be encouraged to view the development process as a continuum, with no sharp dividing lines. We view university faculty as critical partners, both in the development of deep and relatively narrow expertise, as well as developing a “big view” of our scientific and technical world.
Dr. Nathaniel Milton
Research Advisor in Biopharmaceutical Product Development, Retired from Eli Lilly
Nathaniel (Nate) Milton Ph.D., RPh received his B.S. in Pharmacy (’89) and Ph.D. in Industrial and Physical Pharmacy (’95) from Purdue University. He retired from Eli Lilly and Company after 28 years of service where his last role was as a Research Advisor in Biopharmaceutical Product Development. In this role, Dr. Milton led formulation development teams responsible for developing small and large molecule (proteins, peptides, and insulins) parenteral formulations, supporting technology transfer to clinical trial and commercial manufacturing facilities, and establishing processes for sterile extemporaneous compounding to enable early phase clinical trials.
Dr. Milton recently joined Exelead Biopharmaceuticals as a Senior Scientist providing technical support to manufacturing, quality control, and product development. His memberships and professional affiliations include Purdue’s College of Pharmacy Diversity and Inclusion Committee, the Dean’s Advisory Council, and he is an Adjunct Faculty member. Dr. Milton also volunteers at the Rophe Free Clinic in Indianapolis where he practices community pharmacy and mentors pharmacy interns.
The Influence of Biotechnology on Industrial Pharmacy and Health Outcomes
The presentation is a broad review of trends in the health care industry, the development of new drug products, and changes in the pharmaceutical business. The influence of biotechnology, personalized medicine, advances in drug delivery technology, and parenteral manufacturing and their impact on the practice of industrial and physical pharmacy will be discussed.
Dr. Chetan Pujara
Vice President in Global R&D, Allergan
Dr. Chetan Pujara is Vice President in Global R&D at Allergan plc, Irvine, CA. His organization designs and develops dosage forms and drug-device combination products intended for clinical trials and commercialization. In this role, he oversees formulation & manufacturing process development, analytical & microbiology development, packaging development, clinical supplies manufacture and GMP lab systems operations departments.
Prior to joining Allergan, Chetan was employed by Abbott Laboratories (Abbvie) in Illinois, where he held various positions in Global Pharmaceutical R&D gaining experience in development of solid oral dosage forms and pediatric oral suspensions.
Chetan contributes to the pharmaceutical sciences community by volunteering for several non-profit organizations. He is a member of the USP Dosage Forms Expert Committee and USP <771> Ophthalmic Preparation Expert Panel. He serves on the Industrial Advisory Board of Dane O. Kildsig Center for Pharmaceutical Processing Research and is an Adjunct Professor in the Department of Industrial and Physical Pharmacy, Purdue University, IN. He is also a Scientific Advisor to the Editors of J. Pharm Sci and served on PQRI’s physical properties working group.
Chetan received his B.S. degree in Pharmacy from BITS, Pilani, India and PhD in Pharmaceutics from Purdue University, West Lafayette, IN.
Evolving trends in patient-centric dosage form design and development
Dr. William Randolph
Vice President, Global Technology Services, Johnson & Johnson
Thirty-two years Pharmaceutical Industry experience in R/D formulation development, Solids and Parenteral Drug Product Technical Operations as well as large and small API Technical Operations. Marion- Merrell Dow Senior Formulation Scientist 1/88-12/92. Hoffman-La Roche 1/93 to 12/98 in increasing levels of responsibility for Process Development, and Drug Product Technical Operations. Currently Vice President of Global Technical Operations for Janssen – Pharmaceutical Companies of Johnson and Johnson responsible for new product process development and transfer, platform definition and development, complex incident resolution, and continuous process improvement. Driving the change to continuous manufacturing platforms for both large and small molecule manufacturing.
The Future of the Pharmaceutical Supply Chain: Janssen’s view on what it means for the Pharmaceutical Scientist of 2035?
In this discussion I will attempt to provide insights into what Janssen Pharmaceuticals currently sees as the future of the Pharmaceutical business. We see this future as a combination of not only the amazing new age technologies and therapies we are currently developing or investing in, but also the mega trends that we see impacting our business and what these together mean to our supply chain but more specifically to our pharmaceutical technical organization and its resources. We will discuss our thoughts on the direction of the industry and how we plan to cope with those changes. Our intent is to provoke thought of what the overall future of the industry is looking like therefore laying the ground work, so we can debate how best to prepare the Pharmaceutical Scientists of 2035 and beyond.
Dr. James Fort
Senior Vice President, Product Development, Aprecia
Dr. Fort is currently the Senior Vice President of Product Development at Aprecia, a 3DP pharmaceutical company. With his 29 years in the pharmaceutical technology, consumer healthcare and prescription pharmaceutical industries, he has gained considerable scientific and technical experience. His areas of emphasis have been preformulation, solid state characterization, formulation development/product design and development, and drug delivery. Dr. Fort’s contributions have been instrumental with several successful NDA applications, consumer product introductions, and an Rx to OTC switch. His work has impacted multiple consumer healthcare businesses such as Pain Management, Upper Respiratory, Personal Care and GI, as well as several therapeutic classes of new chemical entities in Pharma during his tenure in the Pharmaceutics department at Abbott Laboratories.
While at Wyeth/Pfizer Consumer Healthcare, Dr. Fort has led high profile cross-functional project teams and launched numerous products with iconic brands of Advil, Robitussin, Chapstick, Preparation H, and the Rx to OTC switch of Nexium 24HR. The line extensions of Nexium 24HR resulted from the innovation pipeline he helped design. His product experience spans various solid and liquid dosage forms, drug delivery systems, and regulatory classes.
Dr. Fort has authored multiple publications and patents. He earned a Ph.D. in Industrial and Physical Pharmacy from Purdue University and a B.S. in Pharmacy cum laude from Duquesne University.
3D Printing of Pharmaceuticals: Manufacturing unique dosage forms and accelerating drug development
Dr. Dale Wurster
Professor, College of Pharmacy, The University of Iowa
Dale Eric Wurster received his B.S. Degree (Chemistry) from the University of Wisconsin-Madison in 1974. The Ph.D. Degree (Industrial and Physical Pharmacy) was granted in 1979 by Purdue University. Upon graduation, Wurster joined the faculty of the University of North Carolina-Chapel Hill. Since 1982 he has been on the faculty of the University of Iowa College of Pharmacy, where he holds the rank of Professor. In addition to his faculty responsibilities, he has been the Associate Dean/Senior Associate Dean for Academic Affairs of the University of Iowa Graduate College (Jan. 1, 2002 – June 30, 2015).
Wurster’s research has largely focused on interactions occurring across interfaces. He is the author or co-author of over 200 peer-reviewed abstracts and research articles, and he has served as major professor for 34 past and current Ph.D. students.
Wurster is currently serving a three-year term as President Elect (2018), President (2019), and Past President (2020) of the American Association of Pharmaceutical Scientists (AAPS). He is an AAPS Fellow (1998) and the recipient of an AAPS Research Achievement Award in Manufacturing Science and Engineering (2009). He was named a Distinguished Alumnus of the Purdue University College of Pharmacy in 2015, and, in 2017, he was presented with the Ralph Shangraw Memorial Award by the IPEC Foundation. In 2018, he received the David J. W. Grant NIPTE Distinguished Scholar Award in Basic Pharmaceutics.
Dr. David Engers
Director at Purdue GMP Center (PGC)
David A. Engers, Ph.D. is currently a director at the Purdue GMP Center (PGC). Dr. Engers has over 20 years of technical and leadership experience including development and innovation of technologies to improve oral bioavailability of poorly water-soluble compounds, technology transfer, scale-up, qualification of products and processes, high-potency formulations, and leading initiatives to accelerate the delivery of Phase I clinical supplies.
Dr. Engers has presented and / or published on topics in solid state chemistry, evergreening strategies, pharmaceutical unit operations, triboelectrification, and intellectual property strategies, including invited lectures at the United States Patent and Trademark Office and the Canadian Intellectual Property Office. He is an inventor on 14 issued patents in crystalline forms, amorphous solid dispersions, and nanocrystalline technology. Dr. Engers currently serves as an adjunct professor in the Department of Industrial and Physical Pharmacy at Purdue University and as a scientific advisor to the Editors for the Journal of Pharmaceutical Sciences.
Dr. Engers received his BSE in chemical engineering from the University of Michigan, Ann Arbor and his PhD in pharmaceutics from Purdue University, where he worked with Professor Kenneth R. Morris to advance the understanding of molecular anisotropy in the maintenance of local structure in amorphous materials.
Moderator of Panel Discussions