Welcome to

January 26, 2015 The Mayflower Hotel

Washington, DC USA

Mission Statement

• Provide a venue for 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, 35 Forums have been held in the US (typically 3 per year) resulting in the publication of 27 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 first 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 will be 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 Idec, USA

• Anthony Mire-Sluis, Amgen Inc., USA

• Wassim Nashabeh, F. Hoffmann-La Roche Ltd., Switzerland (Chair)

• Ilona Reischl, BASG / AGES, Austria

• Anthony Ridgway, Health Canada, Canada

• Nadine Ritter, Global Biotech Experts, LLC, USA

• Mark Schenerman, MedImmune, 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 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

North America Program

Committee • Siddharth Advant, Kemwell Biopharma

• Yves Aubin, Health Canada

• John Bishop, CBER, FDA

• Barry Cherney, Amgen Inc.

• JR Dobbins, Eli Lilly and Company

• Julia Edwards, Biogen Idec

• John Hennessey, Novadigm Therapeutics, Inc.

• Joseph Kutza, MedImmune, A member of the AstraZeneca Group

• Kimberly May, Merck & Co., Inc.

• Anthony Mire-Sluis, Amgen Inc.

North America Program

Committee continued

• Stefanie Pluschkell, Pfizer, Inc.

• Nadine Ritter, Global Biotech Experts, LLC

• Reb Russell, Bristol-Myers Squibb Company

• Dieter Schmalzing, Genentech, a Member of the Roche Group

• Timothy Schofield, MedImmune, A member of the AstraZeneca Group

• Zahra Shahrokh, STC Biologics, Inc. and ZDev Consulting

• Jeffrey Staecker, Genzyme, a Sanofi company

• Andrew Weiskopf, Biogen Idec

Sustaining Program Partners Diamond Program Partner • Genentech, a Member of the Roche

Group

Platinum Program Partners • AbbVie, Inc.

• Biogen Idec

• MedImmune, A member of the

AstraZeneca Group

Silver Program Partner • Pfizer, Inc.

Forum Program Partners

Amgen Inc.

Genzyme, a Sanofi company

Gilead Sciences

Janssen Pharmaceutical R&D, LLC

Merck & Co., Inc.

National Institute of Standards and

Technology (NIST)

Novo Nordisk A/S

Leading Media Partners

•BioProcess International

•International Pharmaceutical Quality

Media Partners •American Laboratory

•American Pharmaceutical Review

•The Analytical Scientist

•BioProcessing Journal

•BioTech International

•Genetic Engineering & Biotechnology News

•LCGC North America

•The Medicine Maker / The Pathologist

•Pharmaceutical Outsourcing

•RSC Advances

•separationsNOW.com

•Technology Networks Limited

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 2015 Combination Products for Biopharmaceuticals:

Emerging Trends in Development, GMPs and Regulatory

Expectations

Forum Co-Chairs:

• Sarah Kennett, CDER, FDA, USA

• Andrew Weiskopf, Biogen Idec, USA

Scientific Organizing Committee:

• Siddharth Advant, Kemwell Biopharma, USA

• Jee Chung, CDER, FDA, USA

• Gary Hartman, Amgen Inc., USA

• Mark Lee, CBER, FDA, USA

• Lana Shiu, CDRH, FDA, USA

• John Towns, Eli Lilly and Company

CMC Strategy Forum January 2015

• Attendees pre-registered – 196 (Combo Products)

• Attendees pre-registered – 161 (Host Cell Proteins)

• Number of regulators pre-registered – 50 (total)

• Number of companies represented – 88 (total)

• Number of countries represented – 15 (Australia,

Austria, Brasil, Canada, China, Denmark, France,

Germany, Ireland, Japan, Netherlands, Sweden,

Switzerland, United Kingdom, USA)

CMC Strategy Forum Summer 2012

• “Such delivery devices fall under the device regulations and have vastly different design, development, and validation requirements than the protein drug product itself…

• …the regulatory environment has changed whereby biological drug product, in even simple delivery systems, are now considered combination products…”

A lot can happen in 2 ½ years…

• FDA’s pen, jet, related injectors guidance finalized

• FDA glass syringe guidance to supplement ISO-11040-4

• cGMP Requirements for Combination Products become effective

• More experience gained with Design Controls, Human Factors guidance, etc.

A lot can happen in 2 ½ DAYS!