Welcome to. January 27, Renaissance Mayflower Hotel Washington, DC USA

Transcription

1 Welcome to January 27, 2014 Renaissance Mayflower Hotel Washington, DC USA

2 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)..

3 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 2 nd Annual CMC Strategy Forum Japan Awarded over $33,000 in Student Travel Grants; 37 students awarded 135 Volunteers serving on Scientific Organizing Committees

4 CASSS Family of Meetings 18 th 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

5 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

6 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

7 CASSS Family of Meetings CE in the Biotechnology & Pharmaceutical Industries October 12-16, 2014 Hyatt at Olive 8 Seattle, Washington CMC Strategy Forum Japan December 2014 Tokyo, Japan

8 CASSS Family of Meetings CMC Strategy Forum LATAM 2014 August 2014 Exact Date TBD Brasilia, Brazil

9 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

10 Find out more

11 Welcome to January 27, 2014 Renaissance Mayflower Hotel Washington, DC USA

12 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

13 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

14 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

15 Find out more about past CMC Strategy Forums Look under ARCHIVES for past Forum information and publications.

16 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

17 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)

18 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

19 Sustaining Diamond Program Partner Genentech, a Member of the Roche Group Sustaining Platinum Program Partner Biogen Idec

20 Sustaining Gold Program Partner AbbVie, Inc. Sustaining Silver Program Partner Pfizer, Inc.

21 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)

22 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

23 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

24 CMC Strategy Forum January 2014 Bridging Analytical Methods for Release and Stability Testing: Technical, Quality and Regulatory Considerations Forum Co-Chairs: Nadine Ritter, Global Biotech Experts Reb Russell, Bristol-Myers Squibb Company Timothy Schofield, MedImmune Scientific Organizing Committee: Yves Aubin, Health Canada Lokesh Bhattacharyya, CBER, FDA Alfred Del Grosso, CBER, FDA Laurie Graham, CDER, FDA

25 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)

26 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 TODAY - Monday, January 27 by 3:00 pm don t forget to complete and hit SUBMIT