Welcome to. April 4-5, DoubleTree by Hilton Hotel Silver Spring, MD USA

Transcription

1 Welcome to April 4-5, 2016 DoubleTree by Hilton Hotel Silver Spring, MD USA

2 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.

3 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.

4 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 or speak with a committee member or staff at registration.

5 Welcome to April 4-5, 2016 DoubleTree by Hilton Hotel Silver Spring, MD USA

6 Purpose Provides a forum for presentation and discussion of bioassay methodologies, the application of bioassays during biopharmaceutical process development and manufacture and learn expectations from regulatory authorities on assessment of biological potency Foster collaborative technical and regulatory interactions Share information with the regulatory agencies to assist them in merging good scientific and regulatory practices

7 How did we get here? Symposium was born from the CMC Strategy Forum series CASSS Board of Directors approved funding in June 2008 Scientific Program Committee formed in late 2008 First Bioassays meeting was held in November 2009

8 Scientific Program Committee Thomas Arroll, Seattle Genetics, Inc., USA Evangelos Bakopanos, Health Canada, Canada Katrin Buss, BfArM, Germany Jill Crouse-Zeineddini, Amgen Inc., USA Camille Dycke, Genentech, a Member of the Roche Group, USA Chana Fuchs, CDER, FDA, USA Denise Gavin, CBER, FDA, USA Stephen Hartman, AbbVie, Inc., USA

9 Scientific Program Committee (continued) Xu-Rong Jiang, MedImmune, A member of the AstraZeneca Group, USA Helena Madden, Biogen, USA Bruce Meiklejohn, Eli Lilly and Company, USA Thomas Millward, Novartis Pharma AG, Switzerland Mike Sadick, Catalent Pharma Solutions, USA Sally Seaver, Seaver Associates LLC, USA Max Tejada, Gilead Sciences, USA

10 Sustaining Program Partners Platinum Program Partners AbbVie, Inc. Biogen Idec MedImmune, A member of the AstraZeneca Group Gold Program Partners Novo Nordisk A/S Pfizer, Inc.

11 Program Partners Amgen Inc. Eli Lilly and Company

12 Exhibitor Program Partners Arlenda DiscoverX Corporation Eurofins Lancaster Laboratories Labcyte, Inc. PPD, Inc. Promega Corporation Stegmann Systems GmbH

13 Media Partners American Laboratory / Labcompare American Pharmaceutical Review Analyst / Analytical Methods The Analytical Scientist BioProcess International BioProcessing Journal Chemical Communication Chemical Science / Chemical Society Reviews Genetic Engineering & Biotechnology News IPQ Publications The Medicine Maker / The Pathologist Pharmaceutical Outsourcing SeparationsNOW.com Technology Networks

14 Special Thanks to CASSS Staff: Karen A. Bertani, CMP, Director of Meetings (Bioassays Symposium Manager) Stephanie L. Flores, CAE, Executive Director Anna Lingel, Project Coordinator Carisa Lubeck, Business Information Analyst 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

15 Bioassays 2016 Attendee Statistics Attendees pre-registered 137 Number of regulators pre-registered 14 Number of companies represented 55 Number of countries represented 6 (Canada, Denmark, Germany, Japan, Switzerland, USA)

16 Reminders / Announcements 17:15 19:00 Exhibitor Partner Scientific Showcase 19:00 21:00 Exhibitor and Poster Reception Survey and Feedback Your Feedback is Important We need your help to build our meeting for the future. Bioassays 2016 Evaluations will be sent via Tuesday. Please be sure to complete the survey and hit SUBMIT

17 Reminders / Announcements Please turn off your cell phones during the lectures.

18 Reminders / Announcements Please do not take photos or video of lectures or posters unless approved by the author.