Embed Size (px)
Citation preview
Creating a global community of industry, regulatory and academic
professionals in the field of biopharmaceutical development
What is CASSS?CASSS is an agile, non-profit scientific organization whose strength is in bringing together professionals from industry, academia and regulatory agencies to solve scientific and technical problems in order to advance the development of biopharmaceuticals.
What is CASSS?
What is CASSS?
Practical Applications of Mass Spectrometry
What is CASSS?
What is CASSS?
What is CASSS?
Who is CASSS?• Global Participation:
• Asia (8.1%), Australia (0.1%), Canada (1.4%), Europe (18.8%), Latin America (3.4%), Middle East (0.2%), United States (68.1%)
• 2,922 Attendees** at 21 events (vs 2,327 in 2015)**Note this in spite of blizzard-related cancellations in January 2016.
• 5 CMC Fora; • 671 Attendees
• 6 Symposia;• 1,421 Attendees
• 12 Discussion Groups: 4 SF Bay Area; 6 DC Area and 2 Midwest
• 830 AttendeesNearly ½ of the attendees were new to CASSS
Manufacturing, Quality andRegulatory Considerations for Cell & Gene Therapies• Bring regulators, industry and academics together to
establish expectations for development and regulatory paths.
• Generate new scientific and technical solutions for developing cell and gene therapy products, e.g. sterility, process validation, reference standards
Coming: July 2018Washington, DC Area
CASSS near you …Local Discussion Groups Wash, DC & NetherlandsFormed locally to enable communities of industry, academic and regulatory professionals to meet in an informal setting to share ideas and experiences.
See website for more info
Regional ForumsFull-day sessions, with talks, panel discussion and roundtables.
• Midwest: March 2018 – Exact date TBDSt. Louis, MO
• Nor Cal: April 26, 2018 South San Francisco, CA
• New England:May 2, 2018Cambridge, MA
Join us in 2018
Practical Applications of Mass Spectrometry
EUROPE ▪ JAPAN ▪ NORTH AMERICA ▪ SOUTH AMERICA
September 9-12, 2018San Francisco, CA USA
Jan. 30 - Feb. 1, 2018 Washington, DC USA
September 9-12, 2018San Francisco, CA USA
April 16-17, 2018Silver Spring, MD USA
6-9 March 2018Barcelona, Spain
April 9-11, 2018Providence, RI USA
January 29, 2018Washington, DC USA
14-16 May 2018Noordwijk, Netherlands
July 16-17, 2018Gaithersburg, MD USA
3-4 December 2018Tokyo, Japan
Other Programs include• Student and PostDoc Study and Travel Grants:
Provides financial assistance to PhD students and academic post docs to present work and participate in conferences.
• Fellowships for Innovative Learning: A new program that will provide grants for students to pursue learning opportunities outside their current academic program.
• Resource Sharing: Speaker presentations, case studies and white papers are available at www.casss.org.
What makes CASSS different?• CASSS utilizes our dedicated, volunteer network of
experienced scientists to bring together the right people (experienced leaders in the field), the right way (a culture of engagement), at the right time (scientifically relevant content).
• Our promise to you: At every CASSS meeting, you will meet the right people and gain tangible knowledge that will help you achieve your deliverables of advancing analytical technologies and bring safe and efficacious biopharmaceutical medicines to patients worldwide.
Help make CASSS even better• Get involved: Attend meetings, ask
questions, seek out other attendees, engage in discussions.
• Stay involved: Follow up with meeting contacts, provide topic suggestions for upcoming meetings, volunteer your time and effort for future meetings.
• Get others involved: Share meeting outcomes with colleagues. Spread the knowledge.
Welcome to
JAPAN 2017
4 – 5 December 2017Tokyo Marriott Hotel
Tokyo, Japan
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
CMC Strategy Forum History
• The CMC Strategy Forum was launched in 2002 from the well established WCBP Symposium.
• To date, more than 40 Forums have been held in the US (typically 3 per year) resulting in the publication of over 25 peer-reviewed 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.
CMC Strategy Forum History• The CMC Forum Japan was launched in 2012 with
support from PMDA and JPMA and has been very successful for the past three years. The CMC Strategy Forum Japan 2017 will be the 6th in the series.
• The inaugural CMC Forum Latin America was launched in August 2014 with support from ANVISA (Brasil), local industry, as well as multiple Latin American regulatory agencies. To date, we have held three Latin America fora with the support of ANVISA and COFEPRIS (Mexico). We look forward to a continued Latin American presence in future years.
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 Chinese, Japanese or English—simultaneous translation
Japan Scientific Program Organizing Committee• Kazuhiko Chikazawa, Pharmaceuticals and Medical Devices Agency
(PMDA) • Ayako Enokida, Pharmaceuticals and Medical Devices Agency (PMDA)• Futaba Honda, Pharmaceuticals and Medical Devices Agency (PMDA)• Yasuhiro Kishioka, Pharmaceuticals and Medical Devices Agency (PMDA)• Junichi Koga, Daiichi Sankyo Co., Ltd.• Noriyuki Matsumoto, Japan Pharmaceutical Manufacturers Association
(JPMA) (Secretariat)• Nao Nakamura, Sumitomo Dainippon Pharma Co., Ltd. • Kei Nishimura, UCB Japan Co., Ltd.• Hisako Ohnishi, Japan Pharmaceutical Manufacturers Association (JPMA)
(Secretariat)• Yutaka Osawa, Asahi Kasei Pharma • Kyoko Sakurai, Pharmaceuticals and Medical Devices Agency (PMDA) • Kazuhisa Uchida, Kyowa Hakko Kirin Co., Ltd.• Masatoshi Yamada, Nippon Kayaku Co., Ltd.• Takeshi Yoshino, Chugai Pharmaceutical Co., Ltd.
CMC Strategy Forum Global Steering Committee
• Siddharth Advant, Celgene Corporation USA• Daniela Cerqueira, ANVISA-Brasilian National Health Surveillance Agency,
Brasil• Yasuhiro Kishioka, PMDA-Pharmaceuticals and Medical Devices Agency,
Japan• Junichi Koga, Daiichi Sankyo Co., Ltd., Japan • Steven Kozlowski, CDER, FDA, USA• Ingrid Markovic, CBER, FDA, USA• Rohin Mhatre, Biogen, USA• Anthony Mire-Sluis, AstraZeneca, USA• Wassim Nashabeh, F. Hoffmann-La Roche Ltd., Switzerland (Chair)• Ilona Reischl, AGES-Austrian Medicines and Medical Devices Agency, Austria• Anthony Ridgway, Health Canada, Canada• Nadine Ritter, Global Biotech Experts, LLC, USA• Mark Schenerman, CMC Biotech-MAS Consulting, USA• Thomas Schreitmüller, F. Hoffmann-La Roche Ltd., Switzerland • Karin Sewerin, BioTech Development AB, Sweden
Forum Program Partners•Chugai Pharmaceutical Co., Ltd.
•Daiichi Sankyo Co., Ltd.•Dainippon Sumitomo Pharma Co., Ltd.
•Eisai Co., Ltd.•Kissei Pharmaceutical Co., Ltd.
•Kyowa Hakko Kirin Co., Ltd. •Takeda Pharmaceutical Company Limited
Strategic Program Partners• AbbVie, Inc.
• Biogen• F. Hoffmann – La Roche Ltd.• MedImmune, A member of
the AstraZeneca Group
Leading Media Partners•BioProcess International
•International Pharmaceutical Quality
Media Partners•The Analytical Scientist•BioProcessing Journal
•Genetic Engineering & Biotechnology News•LC/GC Asia Pacific
•The Pathologist•separationsNOW.com•Technology Networks
Monday Schedule Change• 12:00 – 13:15 Buffet Lunch• 13:15 – 14:30 Regulatory Panel Discussion• 14:30 – 15:00 PM BreakICH Q12 Update • 15:00 – 15:15 Introduction • 15:15 – 15:45 Frank Montgomery talk • 15:45 – 16:15 Yasuhiro Kishioka talk • 16:15 – 17:15 ICH Q12 Panel Discussion • 17:15 – 18:45 Networking Reception
CMC Strategy Forum Japan 2017• Recent Trends in the Regulation of
Biopharmaceutical Products• ICH Q12 Update• Challenges in Global Development of Drug
Device Combination Products• Use of Prior Knowledge to Support CMC
Development in Conventional and Expedited Settings
CMC Strategy Forum Japan 2017
• Attendees pre-registered - 118• Number of regulators pre-registered – 15• Number of companies represented – 50• Number of countries represented – 15
(Austria, Canada, China, Denmark, Finland, Germany, Iran, Japan, Singapore, South Korea, Sweden, Switzerland, Thailand, United Kingdom, USA, Vietnam)
Survey and Feedback
Your Feedback is Important
We need your help to build our Forums for the future.
CMC Strategy Forum Evaluations will be sent via email on Tuesday, 5 December.
Please be sure to complete the survey and hit SUBMIT
Please feel free to answer in Chinese or Japanese; we can translate
Reminders / Announcements
Please be courteous and turn off your cell phones during the lectures.
Reminders / Announcements
PLEASE DO NOT take photos or video of lectures unless approved by the presenter.
Special Thanks to…CASSS Staff:
• Karen A. Bertani, CMP, Global Community and Knowledge Sharing Director (CMC Forum Manager)
• Stephanie L. Flores, CAE, Executive Director• Amy Cano, Project Coordinator• Julie Fowle, Meeting Coordinator• Anna Lingel, CMP, Meeting Coordinator• Carisa Lubeck, Business Information Analyst• Renee Olson, Senior Program Manager• Catherine Stewart, Finance ManagerAudio-Visual Support:
• Michael JohnstoneMJ Audio-Visual Productions
