Upload
others
View
1
Download
0
Embed Size (px)
Citation preview
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 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
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