Speakers

Timothy G. Rothwell is currently the Chairman of Emisphere Technologies Inc. (OTC: EMIS. Mr. Rothwell is also the Chairman of Speracura LLC, a healthcare consulting company from 2009 and the President of the SDHB PHEOPARA Coalition from 2016.

Mr. Rothwell was formerly Chairman of Sanofi from 2007 to 2009 in the U.S. He also served as Chief Executive Officer and President of Sanofi-Aventis from September 2004 to February 2007. Mr. Rothwell oversaw all domestic commercial operations as well as the coordination of Industrial Affairs and Research and Development activities in the U.S. From May 2003 to September 2004, Mr. Rothwell was President and Chief Executive Officer of Sanofi-Synthelabo, Inc. and was instrumental in the formation of Sanofi-Aventis U.S. in 2004. Mr. Rothwell holds a Bachelor of Arts from Drew University and earned his J.D. from Seton Hall University.

Daniel O. Blackwood is currently a Research Fellow in the Drug Product Design group of Pharmaceutical Sciences-Small Molecule at Pfizer. He is based in Groton, Connecticut, USA. He received his BS in Mechanical Engineering from Cornell University in Ithaca, NY and his MS in Industrial Engineering from Columbia University in New York City. During his ~25 years at Pfizer, Daniel’s research has focused on the co-development and technology transfer of late stage drug product programs and the development of robust process scale-up models supporting these activities. Currently, he is a technical lead for Pfizer’s Portable, Continuous, Miniature, and Modular (PCM&M) development and manufacturing initiative for Oral Solid Dosage (OSD) forms. In addition, he is a subject matter expert in drug product continuous processing technologies including gravimetric feeders, in-line powder mixers, and tablet compression equipment.

Adam Procopio is currently part of Device Development at Merck & Co., Inc and is leading an effort in the field of additive manufacturing (3D Printing) of oral and non-oral dosage forms. Before this role and a major part of his 18-year career at Merck, Adam led the Compaction Research Laboratory where his group was responsible for all aspects of compaction and mechanical property characterization of drug substance and product from Phase I to Commercial Launch. His research interests are in both experimental and computational predictive technologies. He holds numerous publications and patents in his name and has given several invited presentations. He holds MS (1999) and PhD (2005) degrees in Materials Science and Engineering from Drexel University, Philadelphia, PA where he also moonlights as an Adjunct Professor.

Dr. Frank L. Douglas is an award-winning industry veteran with three decades of experience in healthcare, pharmaceuticals and entrepreneurship. He currently serves as CEO of THEVAXGenetics USA Inc., Member of the Board of TheVaxGenetics Vaccine Co. and Co-Founder of Douglas Ahmed Consulting (DAC). Some of his past experiences include: President and CEO of the Austen BioInnovation Institute in Akron, Executive Vice President, Chief Scientific Officer and Member of the Board of Management of Aventis AG, Chief Scientific Advisor of Bayer Healthcare, AG, Founder and First Executive Director of the MIT Center for Biomedical Innovation, Professor of the Practice in the Massachusetts Institute of Technology (MIT) Sloan School of Management, MIT Departments of Chemistry, Biomedical Engineering and the Harvard-MIT Division of Health Science and Technology. Dr. Douglas holds a Ph.D. in physical chemistry and a M.D. from Cornell University. He did his internship and residency in internal medicine at the Johns Hopkins Medical Institute and a fellowship in neuroendocrinology at the National Institutes of Health.

Karen Sheffler graduated from the University of Wisconsin-Madison in 1995 with master’s degree in Speech-Language Pathology. There, she was influenced by great mentors in the field of swallowing and swallowing disorders (dysphagia) like Jay Rosenbek, JoAnne Robbins, and James Coyle. Once the “dysphagia-bug” bit, she has never looked back. Initially, Karen worked in skilled nursing facilities and rehabilitation centers, but since 1999 she has been in acute care. She obtained her Board Certification as a Specialist in Swallowing and Swallowing Disorders (BCS-S) in August of 2012. Karen was awarded her 5th ASHA Award for Continuing Education (ACE) in May 2017. She is currently a member of the Dysphagia Research Society (DRS), the American Speech-Language Hearing Association’s Special Interest Group 13: Swallowing and Swallowing Disorders, and the National Foundation of Swallowing Disorders (NFOSD).

She began SwallowStudy.com in May 2014 to create a valuable evidence-based dysphagia resource for professionals and patients.

Dr. Robert Goldberg is co-founder and vice president of the Center for Medicine in the Public Interest. (CMPI) He also hosts the popular and controversial blog on the pharmaceutical industry and healthcare, www.drugwonks.com. Prior to founding CMPI, Goldberg was Director of the Manhattan Institute’s Center for Medical Progress and Chairman of its 21st Century FDA Task Force that examined the impact of the FDA’s Critical Path Initiative on drug development and personalized medicine. Having written for The Wall Street Journal, The Washington Post, the Los Angeles Times, among many others, Dr. Goldberg is considered an expert on Medicare reform, comparative effectiveness and the FDA’s Critical Path Initiative

Dr. Tracy is an expert in clinical pharmacology and a Fellow with the American Association of Pharmaceutical Scientists. He holds two patents related to drug delivery systems and has published over 100 scientific manuscripts. His areas of research include drug metabolism, pharmacogenetics and the larger field of clinical pharmacology. Dr. Tracy has held numerous key positions at state universities including Head of the Department of Experimental and Clinical Pharmacology at the University of Minnesota, Dean of the College of Pharmacy and Provost at the University of Kentucky. Dr. Tracy serves as the Chief Executive Officer of Aprecia Pharmaceuticals.

John Hornick was a partner in the Washington, D.C. office of the Finnegan IP law firm (one of the largest IP firms in the world) for 25 years. John founded Finnegan’s 3D Printing Working Group, frequently speaks and writes on 3D printing, and is recognized as a thought leader in this space. He is the author of the book, 3D Printing Will Rock the World, which won a Silver Award from the Nonfiction Authors Association, has been called a “must-read” offering “rare insight into how 3D printing is redefining what can be designed and manufactured,” and was selected for the U.S. Special Operations Command's 2017 Reading List (think Delta Force and Navy Seals) in the Disruptive Technology Category https://jsou.libguides.com/readinglists. His articles and videos have been widely published. He was the only IP attorney selected by the U.S. Comptroller General Forum on Additive Manufacturing (which was the basis of a report to Congress). John has served as a juror for the International Additive Manufacturing Award. John also educates the law enforcement community on 3D printing-related risks and benefits.

Bob Tufts is a Clinical Assistant Professor at the Sy Syms School of Business at Yeshiva University, where he teaches courses in the Business Strategy and Entrepreneurship Department. He has a degree in Economics from Princeton University, an MBA in Finance from Columbia University School of Business and worked on Wall Street for over twenty years in futures and foreign exchange and in domestic equities sales and trading. His first job upon graduation from college was as a professional baseball player. He pitched in the major leagues during parts of the 1981-1983 seasons for San Francisco Giants and the Kansas City Royals. A cancer survivor, he advocates on behalf of patients at medical conventions, seminars, via social media and in columns in various traditional media outlets.

TEACHING AND RESEARCH INTERESTS:
Entrepreneurship Management Sports Marketing Baseball Labor and Social History Health Care

HONORS AND AWARDS:
Yeshiva University Sy Syms School of Business Lilian F. and William L. Silber Professor of the Year Award, 2017-2018 academic year American Association All Star, 1982 AAA Rolaids Relief Award, 1982 Pacific Coast League all Star, 1981 Texas League All Star, 1979 Silver Glove Award, 1979

Xiaoling Li, Ph.D. is a Professor of Pharmaceutics and Associate Dean of Graduate Education and Research in Thomas J. Long School of Pharmacy and Health Sciences at the University of the Pacific. Dr. Li is a Fellow of American Association of Pharmaceutical Scientists and a Fellow of American Institute for Medical and Biological Engineering. He received BS in Pharmacy and MS in Nuclear Pharmacy from Shanghai Medical University in 1982 and 1985, respectively. Under the guidance of Dr. Sung Wan Kim, Dr. Li obtained his Ph.D. in Pharmaceutics from the University of Utah in 1991. Prior to his academic career, he was a postdoctoral research fellow at Ciba-Geigy Corp (now Novartis). Dr. Li’s research interest areas include oral mucosal drug delivery, novel polymers for pharmaceutical and medical application, targeting drug delivery, antibody mimics, drug transport across biological membranes, and application of physicochemical concepts to novel dosage form design. His research projects are funded by both NIH and pharmaceutical industry. He holds 6 patents with 42 patent applications pending and has published more than 90 papers/book chapters, over 160 abstracts/presentations, and two books entitled “Design of Controlled Release Drug Delivery Systems” and “Oral Bioavailability”. Dr. Li received CRS Outstanding Paper Award for the Journal of Controlled Release in 1992. He is a Thomas J. Long Fellow, recognized as a Distinguished Faculty Research Lecturer (2003), and received Distinguished Faculty Award (2012) at the University of the Pacific. Dr. Li is the recipient of AAPS Outstanding Educator Award in 2015. He is a member of the Association of American Pharmaceutical Scientists, Controlled Release Society, and a convention member of USP. Dr. Li has mentored and trained 24 Ph.D., 3 MS, 15 post doctoral research fellows, and 18 visiting scientists. He co-founded two companies, Formurex, Inc., a formulation development company in 2006 and Triastek, a 3D printing pharmaceutical company in 2015. Dr. Li works closely with the pharmaceutical industry and provides consultation for product development to various pharmaceutical companies.

Jae is a co-founder of Aprecia and served as Vice President of Research and Engineering from 2003-2013. His leadership was key to Aprecia’s development and the commercialization of Spritam®. From 2013 – 2014, he was the Founding Member and Managing Partner of Fluent Consulting. He joined GlaxoSmithKline in 2014 as Senior Scientific Investigator for Advanced Manufacturing Technology and PTS Automation. In that role, he formulated the 3DP strategy across a wide range of applications from discovery through manufacturing. Jae received his B.S. in Metallurgical Engineering and Materials Science from Carnegie Mellon University and his Ph.D. in Materials Science Engineering from M.I.T. He also holds an M.B.A. from The Wharton School at the University of Pennsylvania.

Peter Pitts is President and co-founder of the Center for Medicine in the Public Interest. Prior to founding CMPI, Pitts was a Senior Fellow for healthcare studies at the Pacific Research Institute. From 2002-2004, Peter was the FDA’s Associate Commissioner for External Relations, serving as senior communications and policy adviser to the Commissioner. He supervised FDA's Office of Public Affairs, Office of the Ombudsman, Office of Special Health Issues, Office of Executive Secretariat, and Advisory Committee Oversight and Management. He served on the agency’s obesity working group and counterfeit drug taskforce.

Michael S. Smith co-founded the Gastroparesis Patient Association for Cures and Treatments, Inc. (g-pact.org) and has had Chronic Intestinal Pseudo-Obstruction and related Autonomic Neuropathy since 1987. He is currently establishing a patient-driven research consortium to accelerate the development of new therapies for people with gastroparesis. Michael is Associate Counsel of Starr Insurance Holdings, Inc., a multinational corporation. He was a 1994 honors graduate of Hofstra University and a 1997 graduate of Hofstra Law School.