Creating a global community of industry, regulatory and academic professionals to solve scientific and technical problems in order to advance the

Transcription

1 Creating a global community of industry, regulatory and academic professionals to solve scientific and technical problems in order to advance the development of biopharmaceuticals.

2 What is CASSS? CASSS is an agile, non-profit scientific organization whose strength is in bringing together professionals from industry, academia and regulatory agencies to solve scientific and technical problems in order to advance the development of biopharmaceuticals.

3 Through our portfolio of meetings and other programs, CASSS enables knowledge-sharing, global access and regulatory capacity building by leveraging strategic partnerships, scientific expertise and a diversity of views in all of our activities.

4 1. Knowledge Sharing Aspirations CASSS is: The global hub for best practices and technical information in the field of biopharma development and regulation The trusted partner connecting industry professionals, subject matter experts, health authorities, academia and instrument developers Fostering the next generation of talent, helping them identify career path opportunities in the field.

5 Knowledge Sharing Current State: Portfolio of Meetings EUROPE JAPAN NORTH AMERICA SOUTH AMERICA Practical Applications of Mass Spectrometry More than 3,400 members participate annually in CASSS interest-based symposia and fora. Meeting dates and locations at:

6 2. Global Access Aspirations CASSS is: Encouraging innovation by fostering free exchange of knowledge - 7 Continent Strategy Aligning and focusing global industry on local issues A bridge between innovation and delivery Facilitating the networking among thought leaders and thereby encouraging breakthrough science A conduit for bringing innovative products to market

7 Global Access: Current State 3% 1% United States 6% Europe Asia 19% 70% Latin America Canada

8 3. Regulatory Capacity Building Aspirations CASSS is: Fostering globally aligned regulatory processes - Facilitate agency to agency dialogue and interaction - Breaking down barriers A catalyst for progress in the field A forum for highly ethical, scientifically sound and innovative paths for development of biologically derived medicines

9 Regulatory Capacity Building: Current State Regions represented: Africa, Asia, Australia, Canada, Europe, Latin America, Middle East, United States Regulatory agencies: 32 Regulatory agency representatives: over 300

10 Other Programs Include Student and Post-doctoral Candidate Study and Travel Grants: Provides financial assistance to PhD students and academic post docs to present work and participate in conferences. Fellowships for Innovative Learning: A new program that will provide grants for students and post docs to pursue learning opportunities outside their current academic program. Resource Sharing: Speaker presentations, case studies and white papers are available at

11 Help make CASSS even better Get involved: Attend meetings, ask questions, seek out other attendees, engage in discussions. Stay involved: Follow up with meeting contacts, provide topic suggestions for upcoming meetings, volunteer your time and effort for future meetings. Get others involved: Share meeting outcomes with colleagues. Spread the knowledge.

12 Welcome to CE Pharm: 20 th Symposium 20 th Symposium on the Practical Applications for the Analysis of Proteins, Nucleotides and Small Molecules September 9-12, 2018 Hilton San Francisco Union Square Hotel, San Francisco, CA

13 CE Pharm 2018 CE Experts: A Panel Perspective on Past, Present and Future Noberto Guzman, Princeton Biochemicals Inc., USA Amy Herr, University of California, Berkeley, USA Susan Lunte, University of Kansas, USA Wassim Nashabeh, Genentech, a Member of the Roche Group, USA SungAe Suhr Park, Samsung Bioepis, South Korea J. Michael Ramsey, University of North Carolina, USA

14 CE Pharm Recipients of CE Pharm Award Norberto Guzman, Johnson & Johnson Kevin Altria, GlaxoSmithKline Anthony Chen and Wassim Nashabeh, Genentech, Inc Stacey Ma, Genentech, Inc SungAe Suhr Park, Amgen Inc Oscar Salas-Solano, Seattle Genetics, Inc Franka Kálmán, University of Applied Sciences Western Switzerland András Guttman, Northeastern University Michel Girard, Health Canada Cari Sänger - van de Griend, Kantisto B.V Sarah Kennett, CDER, FDA Margaret Ruesch, Pfizer, Inc Winner will be announced Wednesday at 10:

15 CE Pharm 2018 Keynote Speakers Amy Herr, University of California, Berkeley, USA Protein + Isoform Profiling in Single Cells: Electrophoretic Cytometry Barry Karger, Professor Emeritus Northeastern University, USA CE in Drug Development: Where Have We Been and Where Are We Going?

16 CE Pharm 2018 Student Travel Grant Winners Young Scientist Session Wednesday 13:45 14:15 (10 minutes each) Taehong Kwon* Massachusetts Institute of Technology, USA Julia Kahle Technical University Braunschweig, Germany Natalie Arvin University of Michigan, USA A Nanofluidic Device for Continuous Online Monitoring of Antibody Quality in Continuous Biomanufacturing Size-based and Charge-based Separations for Biopharmaceutical Analysis Comparative Performance Studies with Various Electrophoretic and Chromatographic Techniques Microfluidic Western Blotting with Improved Throughput and Sensitivity *Poster Presentations Ashraf Ali Inha University, South Korea Sarah Lum University of Notre Dame, USA Separation of Protein and Peptides using Styrene/ Nphenylacrylamide Porous Layer Immobilized Open Tubular Capillary Column (P-101-M) Battling the Backlog: Novel CZE System for Forensic Separations (P-117-M)

17 CE Pharm 2018 Strategic Program Partners

18 CE Pharm 2018 Program Partners

19 CE Pharm 2018 Exhibitors 908 Devices Inc. Advanced Electrophoresis Solution Ltd. BiOptic Inc. CMP Scientific, Corp. PerkinElmer Inc. ProteinSimple, a Bio-Techne brand ProZyme, A part of Agilent SCIEX Thermo Fisher Scientific

20 CE Pharm 2018 Staff Noelle Atkins, Administrative Coordinator Karen Bertani, Director, Global Engagement and Knowledge Sharing Catherine Federle Stewart, Finance Manager Stephanie Flores, Executive Director Julie Fowle, Program Planning and Even Specialist Anna Lingel, Exhibitor Relations and Technology Specialist Renee Olson, Senior Program Manager Mike Johnstone Owner MJ Film/Video Productions CASSS Sharing Science Solutions 5900 Hollis Street, Suite R3 Emeryville, CA TEL FAX

21 CE Pharm 2018 Organizing Committee Tim Blanc Eli Lilly & Company Tara Enda Bristol-Myers Squibb Company Mei Han Amgen Inc. Göran Hübner Boehringer Ingelheim Pharma GmbH & Co. KG Nomalie Jaya Seattle Genetics, Inc. Steffen Kiessig F. Hoffmann-La Roche Ltd. Nate Lacher Pfizer, Inc. Mark Lies SCIEX Henry Luo Regeneron Pharmaceuticals, Inc. David Michels Genentech, a Member of the Roche Group (Co-Chair) Kathir Muthusamy Regeneron Pharmaceuticals, Inc. SungAe Suhr Park Samsung Bioepis Richard Rustandi Merck & Co., Inc. Maria Schwarz Solvias AG Zoran Sosic Biogen Ewoud van Tricht Janssen Infectious Diseases and Vaccines Joel Welch CDER, FDA (Co-Chair)

22 CE Pharm 2018 Mobile App Accessible on your mobile device, tablet, or laptop View the meeting schedule and speaker abstracts Connect with fellow attendees Need assistance? Stop by registration in the Golden Gate Foyer.

23 CE Pharm 2018 Please silence your cell phones during the lectures. Please do not take photos or video of lectures or posters unless approved by the author.