PRELIMINARY AGENDA ** Attendees must already be registered to attend cphi Japan conference**

Transcription

1 PRELIMINARY AGENDA ** Attendees must already be registered to attend cphi Japan conference** The Future of Biologics Development and Manufacturing 20 April :00 16:00 Big Sight Exhibition Center, Tokyo, Japan Conference room: 会議棟 6F 607 Conference Tower 6F Welcome and Introductions of CMC Biologics Session Chair: Graham Byng, PhD, Senior Director Business Development, CMC Biologics, Seattle Overview of CMC Biologics Gustavo Mahler, PhD, Global President & CEO, CMC Biologics, Seattle Accelerating the Biotech Value Chain by Implementation of High Through-Put Technologies Torben P. Frandsen, PhD, Vice President, Process Development., CMC Biologics, Denmark CHEF1 An Efficient Platform for Development and Manufacturing of Biologics Lena Nielsen, PhD, Director of Upstream Development, CMC Biologics, Denmark Tea Break AGC s Approach to Microbial GMP Manufacturing of Commercial Biologics: Effective Process Development and Proven Expertise Soichiro Ikeda, Associate Director, Bioscience Division, AGC Chemicals Company, Tokyo Exploring the Potential of Continuous Multi-Column Chromatography (MCC) John Moscariello, PhD, Vice President, Process Development., CMC Biologics, Seattle MAb 2012 Case Study: Presented with Tioma Therapeutics (SPEAKER: to be confirmed) Tioma Therapeutics & John Moscariello, PhD, Vice President, Process Development, CMC Biologics, Seattle Introduction to the PROVEO Alliance: An Integrated Solution for ADC Development and Manufacturing Robert Broeze, PhD., Chief Business Officer, CMC Biologics, Seattle Close of program Gustavo Mahler, PhD, President & CEO, CMC Biologics Seattle Program Closed

2 Session Chair: Graham Byng, PhD. Senior Director, Business Development Dr. Graham Byng joined CMC Biologics in May 2014 as Senior Director of Business Development with responsibilities for the Asia market. Graham has over 40 years of Pharmaceutical Industry experience, with over 25 years experience in contract services to Pharmaceutical and Biotech companies. This includes the areas of business development, technology transfer, and process development. Prior to joining CMC Biologics, he was President of Byng Biotech Services, as an international agent for Asian companies and prior to this he was Vice President and General Manager for the Biotechnology division of MDS Pharma Services with responsibilities for Global Business Development as well as operations in Taiwan and Seattle. Graham has a PhD and BSc from Liverpool University, England. Gustavo Mahler, PhD. President & CEO Dr. Gustavo Mahler joined CMC Biologics in 2008 as president. In 2010, he was named global Chief Operations Officer and in January, 2016 he became Chief Executive Officer. Prior to joining CMC Biologics, Gustavo worked for 15 years at Bayer in United States, Europe and Latin America serving in various manufacturing and general management positions. He received his PhD in Biochemistry from the University of Buenos Aires, and he also has a Master of Business Administration degree from the University UNED of Madrid and an Executive Certification in Management from MIT Sloan.

3 Presenters (in order of presentation): Torben P. Frandsen, PhD. Vice President, Process Development CMC Biologics, Copenhagen, Denmark Dr. Torben P. Frandsen joined CMC Biologics in 2013 and has more than 16 years experience in the biopharmaceutical and biotech industry. He has held various positions within development, quality assurance, manufacturing, and quality assurance of new biologics. Prior to joining CMC Biologics, Torben was Vice President, Process Development at Symphogen, where he played a key role in the successful non-clinical and clinical development of several product candidates. Torben has more than 30 peer-reviewed publications and is a frequent speaker at renowned international conferences. He earned a PhD in protein chemistry from the University of Southern Denmark. Lena Nielsen, PhD. Director, Upstream Process Development CMC Biologics, Copenhagen, Denmark Lena Nielsen joined CMC Biologics in January 2015 bringing over 15 years experience in molecular biology, cell line development and process development. Dr. Nielsen has a proven track record in line management and working in cross-functional and international teams. Prior to joining CMC biologics, Lena was at BioInvent International, Active Biotech AB and Alligator Bioscience, as Manager/Director of teams mainly focusing on antibody development. She also held a post-doctoral position at Dept of Biochemistry, University of Wisconsin. Lena has a PhD in Molecular Genetics and an MSc in Biotechnology from Lund University. Soichiro Ikeda, Associate Director, Bioscience Division, AGC Chemicals Company, Tokyo To be updated with profile.

4 John Moscariello, PhD. Vice President, Process Development Dr. John Moscariello joined CMC Biologics in 2014 and serves as the Vice President for Process Development. Prior to joining CMC Biologics, he held director-level positions at Amgen focused on process development and characterization, clinical and commercial technology transfer, and process validation. John has a PhD in Chemical and Biological Engineering from the University of Wisconsin-Madison and a Bachelors of Chemical Engineering from the University of Delaware. To be confirmed Guest speaker Tioma Therapeutics To be updated with profile. Robert Broeze, PhD. Chief Business Officer, Global Business Development Dr. Robert (Bob) Broeze joined CMC Biologics in 2015 and serves as the Chief Business Officer, responsible for global business development and marketing. He has over 30 years of experience in the biopharmaceutical and contract manufacturing industries including positions as Senior VP, Business Development at Gallus Biopharmaceuticals, LLC (now Patheon Biologics) and Chief Commercial Officer and Chief Executive Officer at Laureate BioPharma. His technical expertise spans research, development, protein characterization, validation, testing and cgmp manufacture of biopharmaceutical products, from pilot to Phase III clinical and commercial scale with a strong emphasis on monoclonal antibody products for therapeutic and diagnostic use. He also held senior positions in R&D and operations at Purdue BioPharma L.P., Bard BioPharma L.P and at Cytogen Corporation. Bob is a graduate of Rensselaer Polytechnic Institute where he earned his B.S. and Ph.D. degrees.

5 About CMC Biologics CMC Biologics is leading the industry among CMOs in customer satisfaction, technical excellence, and quality Right and On Time. With three facilities in the USA and Europe, the Company provides fully integrated biopharmaceutical development and manufacturing solutions to clients globally. The Company has proven expertise in delivering custom solutions for the scale-up and cgmp manufacture of protein-based therapeutics for pre-clinical, clinical trials and commercial production. The Company s wide range of integrated services includes cell line development, bioprocess development, formulation and comprehensive analytical testing. Clients can also benefit from CMC Biologics proprietary CHEF1 Expression System for mammalian production. CMC Biologics is one of only a few CMO s that have extensive expertise with microbial manufacturing using both bacterial and yeast fed-batch processes. The Company has successfully expressed antibody fragments, growth factors, antigens, enzymes and other proteins using multiple modes of expression including secretion (yeast), periplasmic secretion, soluble intracellular expression, and inclusion bodies. CMC Biologics optimizes media, feeds and processes for high cell density E. coli and P. pastoris production. As the largest dedicated, independent biologics contract manufacturer in the world, CMC Biologics has a demonstrated track record of success and expertise. 15 years of leadership in contract process development and manufacturing Experienced and dedicated personnel, averaging 16 years of industry experience Providing biomanufacturing solutions to customers on five continents More than 80 projects completed with more than 60 customers, from pre-clinical studies through commercial production 18 microbial manufacturing processes 5 perfusion manufacturing processes 11 biosimilars More detailed information can be found at