Welcome to

January 27, 2014 Renaissance Mayflower Hotel

Washington, DC USA

What is CASSS?

MISSION: What We Do

CASSS is the global premier, non-profit scientific society facilitating

the interaction among industry, academic and regulatory professionals

VALUE PROPOSITION: The Reason People Choose CASSS

Our promise to our constituents is that by attending a CASSS meeting,

you will meet the right people and gain tangible knowledge that will

help you bring biopharmaceutical medicines to patients who need

them more quickly, safely and for less cost. CASSS utilizes our

network of volunteers to bring together the right people, the right way

(a culture of engagement), at the right time (timely, scientifically

relevant content).

.

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

2013 Highlights include:

• 11 Symposia, including 2nd Annual CMC Strategy Forum Japan

• Awarded over $33,000 in Student Travel Grants; 37 students

awarded

• 135 Volunteers serving on Scientific Organizing Committees

CASSS Family of Meetings

18th Symposium on the Interface of

Regulatory and Analytical Sciences

for Biotechnology Health Products

January 28 – 30, 2014

Mayflower Renaissance Hotel

Washington, DC

3rd International Symposium

on Higher Order Structure of

Protein Therapeutics

February 18 – 20, 2014

Crystal City Marriott at Reagan

National Airport, Arlington, Virginia

CASSS Family of Meetings

Scientific Approaches &

Regulatory Strategies

March 24 – 25, 2014

Sheraton Silver Spring Hotel

Silver Spring, Maryland

CMC Strategy Forum Europe

5 – 7 May 2014

Hilton Sorrento Palace

Sorrento, Italy

CASSS Family of Meetings

CMC Strategy Forum

July 21 – 22, 2014

Gaithersburg Marriott

Washingtonian Center

Gaithersburg, Maryland

Symposium on the Practical

Applications of Mass Spectrometry

September 9 – 12, 2014

Silverado Hotel

Napa, California

CASSS Family of Meetings

CE in the Biotechnology &

Pharmaceutical Industries

October 12 - 16, 2014

Hyatt at Olive 8

Seattle, Washington

CMC Strategy Forum Japan 2014

8 – 9 December 2014

Tokyo, Japan

CASSS Family of Meetings

CMC Strategy Forum LATAM 2014

August 2014 – Exact Date TBD

Brasilia, Brazil

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

Find out more… • www.casss.org

Welcome to

January 27, 2014 Renaissance Mayflower Hotel

Washington, DC USA

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 Forum History • The CMC Strategy Forum was launched in 2002

from the well established WCBP Symposium

• To date, 29 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

• The CMC Forum Japan was launched in 2012 with support from the PMDA and JPMA and has been very successful for the first two years

CMC Forum Format

• The Forum has two components:

- Presentations and case studies (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

Find out more about past

CMC Strategy Forums

Look under ARCHIVES

for past Forum

information and

publications.

www.casss.org

CMC Strategy Forum Global

Steering Committee • Siddharth Advant, ImClone Systems, USA

• John Dougherty, Eli Lilly and Company, USA

• Christopher Joneckis, CBER, FDA, USA

• Junichi Koga, Daiichi Sankyo Co., Ltd., Japan

• 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, Global Biotech Experts, USA

• Mark Schenerman, MedImmune, USA

• Thomas Schreitmüller, F. Hoffmann-La Roche Ltd., Switzerland

• Karin Sewerin, BioTech Development AB, Sweden

North America Program

Committee • Sid Advant, ImClone Systems (GSC Liaison)

• Yves Aubin, Health Canada

• John Bishop, CBER, FDA

• Barry Cherney, Amgen Inc.

• JR Dobbins, Eli Lilly and Company

• Julia Edwards, Genentech, a Member of the Roche Group

• John Hennessey, Novadigm Therapeutics, Inc.

• Joseph Kutza, MedImmune

• Kimberly May, Merck & Co., Inc.

• Anthony Mire-Sluis, Amgen Inc. (GSC Liaison)

North America Program

Committee continued

• Stefanie Pluschkell, Pfizer, Inc.

• Nadine Ritter, Global Biotech Experts (GSC Liaison)

• Reb Russell, Bristol-Myers Squibb Company

• Timothy Schofield, MedImmune

• Zahra Shahrokh, ZDev Consulting

• Jeffrey Staecker, Genzyme, A Sanofi Company

• Andrew Weiskopf, Biogen Idec

Sustaining Diamond

Program Partner

• Genentech, a Member of the

Roche Group

Sustaining Platinum

Program Partner

• Biogen Idec

Sustaining Gold Program

Partner

• AbbVie, Inc.

Sustaining Silver Program

Partner

• Pfizer, Inc.

Forum Program Partners

Amgen Inc.

Eli Lilly and Company

Genzyme, A Sanofi Company

Janssen Pharmaceutical R&D, LLC

MedImmune

National Institute of Standards and

Technology (NIST)

Leading Media Partners •BioProcess International

•International Pharmaceutical Quality

Media Partners •The Analytical Scientist

•BioProcessing Journal

•BioTech International

•Genetic Engineering & Biotechnology News

•LCGC North America

•Technology Networks Limited

•RSC Advances

•Wiley/Journal of Separation Science

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

CMC Strategy Forum January 2014

Accelerated Product Development – Leveraging

Combined Industry and Regulator Knowledge to Bring

Products to Patients More Quickly

Forum Co-Chairs:

• Joseph Kutza, MedImmune

• Kimberly May, Merck & Co., Inc.

• Anthony Mire-Sluis, Amgen Inc.

Scientific Organizing Committee:

• Michelle Frazier, Amgen Inc.

• Emanuela Lacana, CDER, FDA

• Emily Shacter, ThinkFDA

CMC Strategy Forum

January 2014

• Attendees pre-registered – 157 (Accelerated Product

Development)

• Attendees pre-registered – 138 (Bridging Analytical

Methods)

• Number of regulators pre-registered – 42 (total)

• Number of companies represented – 79 (total)

• Number of countries represented – 18 (Australia,

Austria, Brazil, Canada, Chili, China, Denmark,

France, Germany, Hungary, Ireland, Italy, Japan,

Netherlands, Sweden, Switzerland, United Kingdom,

USA)

Reminders and Announcements

• Please remember to be courteous by turning all cell phones off and refraining from conversations in the meeting rooms

• 18:15 – 19:30 Networking Reception

• Evaluation form – we’ve gone GREEN - online

link will be sent to your email TODAY -

Monday, January 27 by 3:00 pm – don’t forget

to complete and hit SUBMIT