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