Welcome to December Hotel Okura Tokyo, Japan

Transcription

1 Welcome to 9 10 December 2013 Hotel Okura Tokyo, Japan

2 What is CASSS? Non-profit professional membership society that provides networking and peer-to-peer learning opportunities for professionals involved in the development and regulation of biopharmaceutical products worldwide. Annually CASSS symposia attract over 1,800 participants from more than 20 countries; who, on average, have nearly 10 years of experience in their jobs. Our symposia range in size from approximately 125 to 600 attendees, providing a collegial atmosphere that gives people ample opportunity to interact and network with everyone. Our goal is for CASSS to be known as the place where you gain the knowledge and the contacts to help you bring biopharmaceutical medicines to those who need them more quickly, safely and for less cost Highlights include: 11 Symposia, including 2 nd Annual CMC Strategy Forum Japan Awarded over $33,000 in Student Travel Grants; 37 students awarded 135 Volunteers serving on Scientific Organizing Committees

3 CASSS Family of Meetings CMC Strategy Forum January 27, 2014 Mayflower Renaissance Hotel Washington, DC 18 th Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health Products January 28 30, 2014 Mayflower Renaissance Hotel Washington, DC

4 CASSS Family of Meetings 3rd International Symposium on Higher Order Structure of Protein Therapeutics February 18 20, 2014 Crystal City Marriott at Reagan National Airport, Arlington, Virginia Scientific Approaches & Regulatory Strategies March 24 25, 2014 Sheraton Silver Spring Hotel Silver Spring, Maryland

5 CASSS Family of Meetings CMC Strategy Forum Europe 5 7 May 2014 Hilton Sorrento Palace Sorrento, Italy CMC Strategy Forum July 21 22, 2014 Gaithersburg Marriott Washingtonian Center Gaithersburg, Maryland

6 CASSS Family of Meetings Symposium on the Practical Applications of Mass Spectrometry September 9 12, 2014 Silverado Hotel Napa, California CE in the Biotechnology & Pharmaceutical Industries October 12-16, 2014 Hyatt at Olive 8 Seattle, Washington

7 CASSS Family of Meetings CMC Strategy Forum Japan 2014 December 8-9, 2014 Tokyo, Japan

8 CASSS Family of Meetings CMC Strategy Forum LATAM 2014 August 2014 Exact Date TBD Brasilia, Brazil

9 In addition Support students and postdocs to attend CASSS sponsored meetings Maintain archive of all CMC Strategy Forum summary papers On-line Career Center post resume/cv, create job alerts and search hundreds of jobs

10 Find out more

11 Welcome to 9 10 December 2013 Hotel Okura Tokyo, Japan

12 Mission Statement Provide a venue biotechnology/biological product discussion that focuses on relevant CMC issues throughout the lifecycle of the product Foster collaborative technical and regulatory interactions Share information with the regulatory agencies to assist them in merging good scientific and regulatory practices

13 CMC Forum History The CMC Strategy Forum was launched in 2002 from the well established WCBP Symposium To date, 30 Forums have been held in the US (typically 3 per year) resulting in the publication of over 24 white papers on a wide variety of CMC topics The CMC Forum Europe was launched in 2007 with support from the Biotech Working Party/EMA and quickly became a successful annual event

14 Find out more about past CMC Strategy Forums Look under ARCHIVES for past Forum information and publications.

15 CMC Forum Format The Forum has two components: - presentations (frame the discussion) - Workshops where open dialogue and exchange of ideas among participants is highly encouraged Typically each workshop will address about 3 specific questions related to a given topic The workshop success is dependent on active engagement of the participants Questions can be asked in either Japanese or English simultaneous translation

16 Japan Scientific Program Organizing Committee Kimio Esumi, Japan Pharmaceutical Manufacturers Association (JPMA) (Secretariat) Futaba Honda, Pharmaceuticals and Medical Devices Agency (PMDA) Yasuhiro Kishioka, Pharmaceuticals and Medical Devices Agency (PMDA) Junichi Koga, Daiichi Sankyo Co., Ltd. Tetsuya Kusakabe, Pharmaceutical and Medical Devices Agency (PMDA) In Eui Lee, Chugai Pharmaceutical Co., Ltd. Hisako Ohnishi, Japan Pharmaceutical Manufacturers Association (JPMA) (Secretariat) Jun Sakamoto, Pharmaceutical and Medical Devices Agency (PMDA) Yoichiro Shiba, Daiichi Sankyo Co., Ltd. Yasushi Shikata, Eisai Co., Ltd. Kazuhisa Uchida, Kyowa Hakko Kirin Co., Ltd. Toyohiko Yamamoto, Asahi Kasei Pharma Corp. Reiko Yanagihara, Pharmaceutical and Medical Devices Agency (PMDA)

17 CMC Strategy Forum Global Steering Committee Siddharth Advant, ImClone Systems Corporation, USA John Dougherty, Eli Lilly and Company, USA Christopher Joneckis, CBER, FDA, USA Rohin Mhatre, Biogen Idec, USA Anthony Mire-Sluis, Amgen Inc., USA Wassim Nashabeh, Genentech, a Member of the Roche Group, USA Ilona Reischl, BASG / AGES, Austria Anthony Ridgway, Health Canada, Canada Nadine Ritter, Biologics Consulting Group, Inc., USA Mark Schenerman, MedImmune, USA Thomas Schreitmüller, F. Hoffmann-La Roche Ltd., Switzerland Karin Sewerin, BioTech Development AB, Sweden

18 Forum Program Partners Baxter Limited Chugai Pharmaceutical Co., Ltd. Daiichi Sankyo Co., Ltd. Eisai Co., Ltd. Kissei Pharmaceutical Co., Ltd. Kyowa Hakko Kirin Co., Ltd. Mitsubishi Tanabe Pharma Corporation Nippon Boehringer Ingelheim Co., Ltd. Nippon Kayaku Co., Ltd. Shionogi & Co., Ltd. Takeda Pharmaceutical Company Limited Zeria Pharmaceutical Co., Ltd.

19 Sustaining Diamond Program Partner Genentech, a Member of the Roche Group Sustaining Platinum Program Partner Biogen Idec

20 Leading Media Partners BioProcess International International Pharmaceutical Quality Media Partners Analyst The Analytical Scientist BioProcessing Journal Bio Tech International Genetic Engineering & Biotechnology News Technology Networks Limited Wiley/Journal of Separation Science

21 CMC Strategy Forum Japan 2013 Attendees pre-registered Number of regulators pre-registered 20 Number of companies represented 45 Number of countries represented 14 (Austria, Canada, China, Denmark, Finland, Germany, India, Japan, Singapore, South Korea, Switzerland, Taiwan, United Kingdom, USA)

22 Special Thanks to Michael Johnstone, MJ Audio Visual Productions CASSS Staff: Karen Bertani, Director of Meetings Stephanie Flores, Executive Director Anna Lingel, Project Coordinator Linda Mansouria, Manager of Meetings and Events Renee Olson, Senior Program Manager Catherine Stewart, Finance Director

23 Reminders and Announcements Please remember to be courteous by turning all cell phones off and refraining from conversations in the meeting rooms 17:30 19:00 Networking Reception Evaluation form we ve gone GREEN - online link will be sent to your on Wednesday, 11 December don t forget to complete and hit SUBMIT