AUGUST 31, 2007

• Preformulation of Parenteral Dosage Forms: 9:00-9:45 a.m.: Dr. Xie (USA)
• Formulation Challenges in Development of Protein Drugs: 9.45 - 10.30 a.m.: Dr. Gokarn (USA)

• Moist Heat Sterilization in Autoclaves: 10:45 - 11:30 p.m.: Prof. Pinto (BRAZIL)
• Sterile Liquid Filtration: 11:30 - 12:15. p.m.: Mr. Dong (CHINA)
• Validation of Steam Sterilization: 12:15 - 1:00 p.m.: Dr. Ruggierello (ITALY)

• Sterile Air Filtration: 2:15 - 3:00 p.m.: Mr. Dong (CHINA)
• Radiation Sterilization of Active Drug Substance: 3:00 - 3:45 p.m.: Prof. Pinto (BRAZIL)

• Overview of Development of Monoclonal Antibodies: 4:15 - 5:00 p.m: Dr. Zeng (USA)
• Scale up of Biological Products: 5:00 - 5:45 p.m: Dr. Cherian (ITALY)

SEPTEMBER 1, 2007

• Formulation Challenges in Needele-free Vaccine Delivery: 9:00 - 9:45 a.m.: Dr. Ciftci (USA)
• Strategies for Developing High Conc. Monoclonal Antibodies: 9:45 -10:30 a.m.: Dr. Liu (USA)

• Protein-Surfactant Interactions: 10:45.-11 :30 a.m.: Dr. Cherian (ITALY)
• Interfacing Biotech with Nanotechnology: 11:30-12:15 p.m.: Dr. Ciftci (USA)
• Protection Against Counterfeiting: 12:15 - 1:00 p.m.: Dr. Liu (CHINA)

• Future of Biotherapeutics: from Molecules to Market: 2:00 - 2:45 p.m.: Dr. Nema (USA)
• Validation of Water for Injection Systems: 2:45 - 3:30 p.m.: Eng. Curto (ITALY)
• Revised WHO Guidelines for Stability: 3:30 - 4:15 p.m.: Prof. Saleh (EGYPT)

• GMP Sterile Filling Systems: 4:30 - 5:15 p.m.: Mr.Thomas (GERMANY)
• Validation of HVAC Systems: 5:15 - 6:00 p.m.: Eng. Curto (ITALY)

Dr. Eng. Paolo Curtò is Managing Director of DOC, a STILMAS Group Company specializing in Validation & cGMP Consulting for the Italian and International Pharmaceutical Industry. He has 20 years of international industrial experiences, working in US- FDA approved Pharmaceutical Manufacturing Companies, as Engineering & Validation Director, in Pharmaceutical Engineering Companies and in Pharmaceutical Equipment Suppliers Companies.

Dr. Kadriye Çiftci is Director of Drug Delivery at ICON Clinical Research. She has over 13 years of experience in academia and pharmaceutical R&D. Dr. Ciftci completed her training at University of Illinois at Chicago, Chicago, IL and University of Michigan Medical School in Ann Arbor, Michigan. She has held a Tenure Track Assistant Professor position at Temple University and a Research Fellow position at Schering Plough Research Institute. Her special interests include the development of drug delivery systems particularly biotech products and vaccines, gene therapy, and cancer research.

Mr. Yan Dong is Senior Sales Manager of Pall Lifesciences BioPharm Division in China. He has been working in pharmaceutical and lifesciences fi eld for more than twelve years, including two years in new drug development, and 10 years sales and marketing in multinational companies. He holds a BSc degree of Beijing University in Chemical Engineering, and an MBA from Tsinghua University.

Dr. Yatin Gokarn is Principal Scientist at Amgen, at Seattle, and leads a protein formulations group in the Pharmaceutics Department there. Yatin has an undergraduate degree in chemical engineering from University Institute of Chemical technology, Mumbai, India and MS and Ph.D. degrees in biochemistry from the University of New Hampshire. He has over 9 years experience in pharmaceutical industry, with tenures at Pharmacia / Pfi zer and Amgen.

Dr. Jun Liu is a Senior Scientist at the Late Stage Pharmaceutical and Device Development Group at Genentech, Inc. He received his Ph.D. degree in Biochemistry from the University of New Hampshire. He has numerous scientifi c publications and presented nationally and internationally on the topics of protein formulation, stability and analytical characterization. He is currently leading a formulation group at Genentech that is responsible for development of protein formulation, drug delivery systems and biophysical characterization.

Dr. Wen Liu was educated at Shanghai Medical University from where she received a Bachelor’s Degree in Medicine. Her educational training also includes WHO Continuing Education at Chinese Virology Institute in molecular biology, training for Quality Affairs by International Quality Directors, and several courses in GMP, Validations, Inspection and related topics. Currently she is the Site Manager for Quality Operations for Sanofi Pasteur in China.

Dr. Sandeep Nema is Senior Director, Pfi zer Global Biologics in St. Louis where he is responsible for three functions – Preformulation, Formulation Development and Product Enhancement; and Microbiology. In this role he manages biologics a Pharmaceutical R&D portfolio of over 35 projects from discovery support, formulation development, scale-up, validation through BLA fi lings. Dr. Nema received his PhD in 1992 and since then has been involved in the development of small molecules and protein drugs via parenteral delivery, first at Mallinckrodt Medical and then at Pfi zer (Searle, Pharmacia). He has been lead formulator for four launched products.

Prof. Dr. Terezinha de Jesus Andreoli Pinto is the Dean of the Faculdade de Cîências Farmacêuticas - Universidade de São Paulo (Brazil). Prof. Pinto coordinates CONFAR, a laboratory dedicated to the quality control of drugs, medicines, cosmetics and medical devices. She is president of the Council of Instituto de Pesquisas Farmacêuticas and has more than 25 years of industrial and academic experience. She is author of several books and book chapters and has authored 65 papers.

Dr. Giuseppe Ruggirello graduated in Chemistry in 1994 and in 1998 he achieved the Ph.D. in analytical chemistry from University of Palermo, Italy. He worked in a medical devices company as laboratory manager and he was technical director of an ethylene oxide sterilization plant. He was senior consultant in an international group, focused on computerized systems in the pharmaceutical environment. For four years he was responsible of the R&D department of Fedegari Autoclavi and now he is Principal Consultant of CTP, a European Consultancy Company. He is member of CEN Technical Committee 102 and of the Italian Standardization Body for the Heat Sterilization.

Dr. Abdel Aziz Saleh got his PhD degree in Pharmaceutical Sciences from School of Pharmacy, University of Alexandria, in 1968. He was appointed as Professor of Pharmaceutics in 1981, and as Vice Dean of the school in 1986. In 1989 Dr Saleh joined WHO/EMR as the Regional Adviser for Pharmaceuticals. In 1995 he was appointed Director of the Division for Health Policy and Management. He has wide experience is supporting countries in developing health policies including drug policies, and health system development, with special emphasis on recent challenges in the 21st century.

Mr. Hans Thomas has been with Bausch + Ströbel since 1972 and now holds the position of Sales and Marketing Director. He is responsible for the overseas market and in particular for Asia. After graduating in Mechanical Engineering he joined the still young company which has since developed into one of the major equipment manufacturers for pharmaceutical machinery. Over 34 years of experience in this market has provided Mr Thomas a deep insight into the fi eld of aseptic manufacturing.

Dr. Minli Xie obtained M.S. degrees with honors, in Physical Organic Chemistry and in Pharmaceutical Chemistry. After graduating with her Ph.D. degree, she joined Dupont Merck Company as Research Scientist then promoted to Senior Research Scientist. In 2000, she was recruited by Bristol-Myers Squibb Company as Sr. Research Investigator. Her work has focused on discovery support, preformulation and formulation development to support early clinical studies. In 2003, Dr. Xie joined Genentech, Inc. to start a Small Molecule Pharmaceutics
Group.

Dr. David Zeng is a consultant for biopharmaceutical development. His expertise is in protein drug product development, API process, analytical methods, aggregate characterization, manufacture and regulatory fi lings. Dr. Zeng has 10 years of experiences in biopharmaceutical industry. His last industrial position was Associate Director in Pharmaceutical R&D of Pfizer Biologicals where he was responsible for the formulation development for all Pfi zer biologicals. Dr. Zeng received his PhD in Pharmaceutical Sciences from the University of Connecticut, and BS from the Northwestern University. He has published numerous of articles and patents in protein development and aggregate characterization.