(Located in the INTERPHEXConnects Area: Booth #3477)
Open to all badgeholders
Join the editors of BioPharm International and Pharmaceutical Technology for in-depth conversations with INTERPHEX speakers, FDA representatives, industry stakeholders and thought leaders. The Main Stage will host approximately 10-15 sessions per day including.
Tuesday, March 29
1:30 PM - 3:30 PM
The Year of Continuous Processing
How close is the pharma industry to having a fully automated, continuous manufacturing line from API synthesis to fill/finish? This panel brings together industry experts, scientists, and FDA regulators to assess the current state of the art and remaining challenges before continuous processing is a reality for small molecule manufacturing. Follow-on interviews address additional topics in continuous processing, including how feasible it is for biopharmaceutical manufacturing.
1:30-2:30: Challenges for Continuous Processing
Panelists:
- Moheb Nasr, Director, Office of new Drug Quality Assessment, CDER, FDA
- Alex Cheuh, Director/Team Leader of the Technology, Science and Operations Group, Pfizer Global Supply Division, Pfizer Inc.
- Fernando Muzzio, Professor Chemical Engineering, Rutgers University and President, Mixing Consultants, Inc.
- Moderator: Michelle Hoffman, Editorial Director, Pharmaceutical Technology
2:30-3:30: Interviews
- The Future for a Fully Integrated Platform
- James Evans, Associate Director Novartis-MIT Center for Continuous Manufacturing
- Automating Stem-Cell Manufacturing
Wednesday, March 30
10:30 AM - 11:30 AM
China: The New Pharma Frontier
(Presented by Interphex and Pharmaceutical Technology in conjunction with Advanced Pharmaceuticals)
China is Pharma's new growth frontier, but for many Western firms, it is still terra incognita in terms of its regulatory and business environment. In this unique program, Mr. Xiong Yu, Vice President of the China Institute for the Pharmaceutical Industry (CIPI), China's national organization charged with shaping the industry's future in China, outlines the important issues any US concern must take into consideration in order to do business in China. This is a rare opportunity to learn about how to navigate this new landscape.
Panelists:
- Xiong Yu, Vice President, China Institute for the Pharmaceutical Industry (CIPI)
- Feng Li, Senior Vice President, Advanced Pharmaceuticals
- Moderator: Michelle Hoffman, Editorial Director, Pharmaceutical Technology
In this very special program, Mr. Xiong Yu, Vice President of the China Institute for the Pharmaceutical Industry (CIPI) discusses how China will be shaping its pharmaceutical industry and the role that western companies can play. Among the topics Mr. Yu will address are the following:
- Development trends in China's pharmaceutical industry
- An overview of laws and regulations of drug in China
- Overview of policies governing drugs imported to China
- Current status of IP protection
- Successful cases of drugs imported into China
- Opportunities for international pharmaceutical companies in China
2:30 – 3:30
Outsourcing Panel Discussion with Jim Miller, President PharmSource, and Outsourcing columnist for Pharmaceutical Technology
In this panel discussion, we bring together both sides of the outsourcing question--industry procurement officers and service providers—to review current challenges and strategies in outsourcing.
Moderator:
- Jim Miller, President PharmSource, and Outsourcing columnist for Pharmaceutical Technology
Panelists:
- Mark Scheftel, Executive Director, Direct Materials Procurement, Merck Global Procurement
- Peter T. Bigelow, President, North American Operations, Patheon
Fernando Muzzio is a Professor II of Chemical Engineering at Rutgers University. His research interests comprise solid dose pharmaceutical product and process design. He is a frequent lecturer at FDA events, and in 2010 he has been appointed a voting member of the FDA committee on Pharmaceutical Sciences and Clinical Pharmacology. He also was the academic member of the PQRI task force on Blend Uniformity. Professor Fernando Muzzio is also a consultant to 50+ companies, the president of Mixing Consultants Inc, and the director of the National Science Foundation Engineering Research Center on Structured Organic Particulate Systems.
Dr. Alex Chueh is the Director/Team Leader of the Technology, Science and Operations group in Pfizer Global Supply division in Pfizer Inc. Dr. Cheuh has been working for Pfizer Inc. for the past 20 years, he has assumed various responsibilities including new products and processes development, commercial scale-up, technology transfer, new processing technology development, processing understanding research; root causes analysis, commercial technical support and pilot plant and analytical laboratory operations management. Alex received his M.S. and Ph.D. degree in Pharmaceutics from University of Rhode Island. He is a member of the American Association of Pharmaceutical Scientists and International Society for Pharmaceutical Engineering.
Peter T. Bigelow brings nearly 30 years of technical operating and engineering experience to Patheon. Mr. Bigelow most recently served as Senior Vice President at Wyeth Pharmaceuticals, where he had responsibility for Wyeth's global consumer healthcare product manufacturing and oversight of Wyeth's operations in Latin America. Peter joined Wyeth in 1995 and in his 14 years had several executive posts spanning the breadth of pharmaceutical manufacturing and technical operations. Prior to joining Wyeth, Peter spent 13 years with SmithKline Beecham (now GlaxoSmithKline) in a variety of engineering and operations roles. He holds a BS in Mechanical Engineering from Villanova University and an MBA from Philadelphia University.
Mark Scheftel is the Executive Director for Direct Materials Procurement in Merck's Global Procurement organization. He became the head of Direct Materials Procurement in May 2007. He leads a global team of 45 people based in all regions of the world and is accountable for managing an external company wide spend of approximately $2 billion, covering the direct materials spend areas of APIs/Intermediates, Contract Manufacturing and Packaging, Basic and Specialty Chemicals, Packaging Components, and Biologics, Sterile, and Vaccine Raw Materials and Devices. Prior to joining Merck, Mr. Scheftel held a series of leadership positions with increasing responsibility in IBM Global Procurement, spent several years in a management consulting role with Booz, Allen, & Hamilton. He has a Masters in Business Administration degree from New York University, and a Bachelors of Engineering degree in Electrical Engineering from Stony Brook University.
Feng Li is a Mar, LLC an international company engaged in technology transfer to China, licensing of drugs to China and obtaining SFDA approvals for drugs and devices in China. Dr. Li has a Ph.D in pathology and an M.D. from Shanghai Medical University and has more than eight years industrial field application support experience, more than five years biomedical research experience in protein chemistry, cell biology and molecular biology, expertise in computational analysis and interpretation of genomic and proteomic data utilizing bioinformatics tools. Dr. Li is also bilingual, speaking fluent Mandarin (Chinese) and English.
Mr. Yu, Xiong is the vice president of China Institute of Pharmaceutical Industry. Mr. Yu, Xiong was the vice president of Shanghai Institute of Pharmaceutical Industry until December 2010. Mr. Yu, Xiong has more than 20 years' experience in Drug research and Development and pharmaceutical industry management. Mr. Yu, Xiong is the president of Shanghai Techwell Biopharmaceutical and serves as board member at several pharmaceutical companies including Shangdong Lukang Pharma, Shanghai Modern Pudong Pharmaceutical Factory Cooperation. Mr. Yu, Xiong also serves as a member of the scientific board at BioVeda China Fund. Mr. Yu, Xiong received his degree of organic chemistry from Fudan University.
Dr James Evans
Associate Director Novartis-MIT Center for Continuous Manufacturing
Dr. Moheb Nasr
Director, Office of New Drug Quality Assessment, CDER, FDA
Bob Speziale
Vice President, Business Development, Invetech
