PowerPoint Presentation · 2019-05-06 · •Karen A. Bertani, CMP, Director of Meetings (CMC Forum...
Transcript of PowerPoint Presentation · 2019-05-06 · •Karen A. Bertani, CMP, Director of Meetings (CMC Forum...
Welcome to
JAPAN 2015
9 – 10 November 2015Tokyo Marriott Hotel
Tokyo, Japan
What is CASSS?
Practical Applications of
Mass Spectrometry
EUROPE ▪ JAPAN ▪ NORTH AMERICA ▪ SOUTH AMERICA
CASSS is the leading non-profit professional scientific membership
society that provides networking and peer-to-peer learning
opportunities for professionals involved in the development and
regulation of biopharmaceutical products worldwide.
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.
What makes CASSS better?• You!
• Get Involved: Ask questions, Seek out other attendees,
Attend the receptions, Engage in discussions. Make the
most of your time here!
• Stay Involved: Participate in the CASSS on-line
discussion group, Follow up with meeting contacts,
Provide suggestions for upcoming meeting topics,
Volunteer your time and effort for future meetings.
• Get Others Involved: Share meeting outcomes with
colleagues; Spread the work to others about the value you
derived from the meeting.
"Every man owes part of his time and money to the business or industry to which he is
engaged." --- Theodore Roosevelt
Find out more at www.casss.org or speak with
a committee member or staff at registration.
Welcome to
JAPAN 2015
9 – 10 November 2015Tokyo 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, over 35 Forums have been held in the US (typically 3 per year) resulting in the publication of over 25 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 the PMDA and JPMA and has been very successful for the past three years.
• The inaugural CMC Forum Latin America was launched in August 2014 with support from ANVISA (Brasil), local industry, as well as multiple LATAM regulatory agencies and was very successful. The 2nd CMC Forum Latin America was held in August 2015.
CMC Strategy Forum Global
Steering Committee• Siddharth Advant, Kemwell Biopharma, USA
• John Dougherty, Eli Lilly and Company, USA
• Junichi Koga, Daiichi Sankyo Co., Ltd., Japan
• Steven Kozlowski, CDER, FDA, USA
• Rohin Mhatre, Biogen, USA
• Anthony Mire-Sluis, Amgen Inc., USA
• Marcelo Moreira, ANVISA-Brasilian National Health Surveillance Agency, Brasil
• 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
• Daisaku Sato, PMDA-Pharmaceuticals and Medical Devices Agency, Japan
• Mark Schenerman, MedImmune, A member of the AstraZeneca Group, USA
• Thomas Schreitmüller, F. Hoffmann-La Roche Ltd., Switzerland
• Karin Sewerin, BioTech Development AB, Sweden
Find out more about past
CMC Strategy Forums
Look under ARCHIVES
for past Forum
information and
publications.
www.casss.org
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
Japan Scientific Program
Organizing Committee• 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.
• In Eui Lee, Chugai Pharmaceutical Co., Ltd.
• Noriyuki Matsumoto, Japan Pharmaceutical Manufacturers Association (JPMA) (Secretariat)
• Yuuki Miyatake, Teijin Pharma Ltd.
• Kei Nishimura, UCB Japan Co., Ltd.
• Hisako Ohnishi, Japan Pharmaceutical Manufacturers Association (JPMA) (Secretariat)
• Daisaku Sato, Pharmaceuticals and Medical Devices Agency (PMDA)
• Yasushi Shikata, Eisai Co., Ltd.
• Kazuhisa Uchida, Kyowa Hakko Kirin Co., Ltd.
• Masatoshi Yamada, Nippon Kayaku Co., Ltd.
• Reiko Yanagihara, Pharmaceuticals and Medical Devices Agency (PMDA)
Forum Program Partners
•Astellas Pharma Inc.
•Baxalta Japan Limited
•Chugai Pharmaceutical Co., Ltd.
•Daiichi Sankyo Co., Ltd.
•Eisai Co., Ltd.
•Kissei Pharmaceutical Co., Ltd.
•Kyowa Hakko Kirin Co., Ltd.
•Nippon Kayaku Co., Ltd.
•Takeda Pharmaceutical Company Limited
Sustaining Diamond
Program Partner
• F. Hoffmann-La Roche Ltd.
Sustaining Platinum
Program Partner
• AbbVie, Inc.
• Biogen
• 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
•The Medicine Maker
•The Pathologist
•separationsNOW.com
•Technology Networks
CMC Strategy Forum Japan 2015
• Recent Trends in the Regulation of
Biopharmaceutical Products
•Development of Biosimilars:
Technical Aspects
• ICH Q12 Overview: Established
Conditions / Approved Matters
• ICH Q12 Overview: Post-approval
Change Management Protocol
(PACMP)
CMC Strategy Forum Japan 2015
• Attendees pre-registered - 109
• Number of regulators pre-registered – 20
• Number of companies represented – 42
• Number of countries represented – 10
(Canada, China, Finland, Indonesia, Japan,
Singapore, South Korea, Switzerland,
Thailand, USA)
Special Thanks to…CASSS Staff:
• Karen A. Bertani, CMP, Director of Meetings (CMC
Forum Manager)
• Stephanie L. Flores, CAE, Executive Director
• Anna Lingel, Project Coordinator
• Linda Mansouria, CMP, CMM, Manager of Meetings &
Events
• Renee Olson, Senior Program Manager
• Catherine Stewart, Director of Finance
Audio-Visual Support:
• Michael Johnstone
MJ Audio-Visual Productions
Reminders and Announcements
• Please remember to be courteous by turning all cell phones off and refraining from conversations in the meeting rooms
• 12:45 – 14:00 Buffet Lunch in Ballroom North
(different location)
• 18:30 – 20:30 Networking Reception in
Ballroom North
• Evaluation form – online link will be sent to
your email on Wednesday, 11 November –
don’t forget to complete and hit SUBMIT