Creating a global community of industry, regulatory and academic

professionals in the field of biopharmaceutical development

What is CASSS?

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

Knowledge Sharing

Practical Applications of Mass Spectrometry

EUROPE ▪ JAPAN ▪NORTH AMERICA ▪SOUTH AMERICA

3,400 Attendees at 21 events in 2017(vs. 2,900 in 2016)

• 6 CMC Fora; (vs. 5 in a typical year)• 1,064 Attendees

• 6 Symposia;• 1,521 Attendees

• 11 Discussion Groups & Regional Forums:• 2 NCRF; 2 MWRF 5 DCDG; 3 NLABDG• 817 Attendees

Nearly ½ of the attendees were new to CASSS

Global Access

70%19%

6%

3% 1% United States

Europe

Asia

LatinAmerica

Canada

Regulatory Capacity Building374* participants from 24 countries

• Australia• Austria• Belgium• Brazil• Canada• China• Czech Republic• Denmark• Finland• France• Germany• Ghana

• Hungary• Ireland• Israel• Japan• Mexico• Netherlands• South Korea• Spain• Sweden• Taiwan• United Kingdom• United States

* Also includes academic participants

Cell & Gene Therapy Products (CGTP): Manufacturing, Quality and Regulatory Considerations

• Bring regulators, industry and academics together to establish expectations for development and regulatory paths.

• Generate new scientific and technical solutions for developing cell and gene therapy products, e.g. sterility, process validation, reference standards

July 10-12, 2018Bethesda North Marriott Hotel, Rockville, MD

CASSS is innovating

CASSS is near you…Local Discussion Groups Wash, DC & NetherlandsFormed locally to enable communities of industry, academic and regulatory professionals to meet in an informal setting to share ideas and experiences.

See website for more info

Regional ForumsFull-day sessions, with talks, panel discussion and roundtables.

• Nor Cal: April 26, 2018 South San Francisco, CA

• New England:May 2, 2018Cambridge, MA

• Midwest: October 23, 2018 Chicago, IL

CASSS is more: Academic Outreach• 59 Student Travel Grants totaling $43,903

Figures from FYE 6/30/2017

Guinevere S.M. KammeijerLeiden University Medical Center, Leiden, Netherlands

"I feel honoured and grateful that I received the travel grant and I am excited to use my gained experience and knowledge for future research as well for my role as a committee member in the newly established NLabdiscussion group supported by the CASSS organization."

Daihyun Kim The Biodesign Institute - Arizona State University

"It was a great opportunity to interact with scientists, engineers, and corporate researchers from various fields at the forum for the discussion of

new cutting-edge research on the apex of separation, fundamental science, method, and technology developments to new applications

related to human health, medicine and the environment."

Academic OutreachFellowships totaling $31,600 (new in 2017)

Not pictured is scholarship recipient Donovan Guttieres, Center for Biomedical Innovation, MIT who is completing a masters in Economic Models for the Manufacturing and Supply of Biologics: Evaluating Innovations Towards Global Access

Frantisek Svec Fellowships for Innovative Studies

Daniela Espinosa-Hoyos of Cambridge, MA, USA, applied for the Svec Fellowship to train under the supervision of Dr. Valentina Fossati of the New York Stem Cell Foundation to learn the techniques of human stem cell culture and, in particular, advanced protocols for induction of pluripotency from human skin cells, and derivation of human oligodendrocytes.

Bert Wouters, of Amsterdam, the Netherlands, will be using his Svec Fellowship to fund a one-month research stay at the University of Tasmania to acquire new skills to support the rapidly increasing use of 3D printing in analytical chemistry.

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.

Find resources (speaker presentations,

case studies and white papers), how to participate,

and more atwww.casss.org

Join us in 2018 and 2019

Practical Applications of Mass Spectrometry

EUROPE ▪ JAPAN ▪ NORTH AMERICA ▪ SOUTH AMERICA

September 9-12, 2018San Francisco, CA USA

January 29-31, 2019 Washington, DC USA

September 9-12, 2018San Francisco, CA USA

April 16-17, 2018Silver Spring, MD USA

12-15 March 2019Dublin, Ireland

April 8-10, 2019San Mateo, CA USA

14-16 May 2018Noordwijk, Netherlands

July 16-17, 2018Gaithersburg, MD USA

3-4 December 2018Tokyo, Japan

January 28, 2019Washington, DC USA

Welcome to

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

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

Scientific Program Committee• Thomas Arroll, Seattle Genetics, Inc., USA• Evangelos Bakopanos, Health Canada, Canada• Katrin Buss, BfArM, Germany• David Cirelli, Pfizer, Inc., USA• Jill Crouse-Zeineddini, Amgen Inc., USA• Chana Fuchs, CDER, FDA, USA• Denise Gavin, CBER, FDA, USA• Stephen Hartman, AbbVie, Inc., USA• Xu-Rong Jiang, AstraZeneca, USA• Helena Madden, Biogen, USA

Scientific Program Committee (continued)• Bruce Meiklejohn, Meiklejohn Consulting, USA• Thomas Millward, Novartis Pharma AG,

Switzerland• Bhavin Parekh, Eli Lilly and Company, USA• Mike Sadick, Catalent Pharma Solutions, USA• Sally Seaver, USA• Max Tejada, MedImmune, A member of the

AstraZeneca Goroup, USA• Marcel Zocher, Bristol-Myers Squibb Company,

USA

Strategic Program PartnersStrategic Diamond Program Partner

Strategic Platinum Program Partners

Strategic Gold Program Partners

Strategic Silver Program Partner

Bronze Program Partner

Exhibitor Program Partners

Media Partners

Special Thanks to…CASSS Staff: • Karen A. Bertani, CMP, Director, Global Engagement and

Knowledge Sharing (Bioassays Symposium Manager)• Amy Cano, Member Communications and Marketing Specialist• Stephanie L. Flores, CAE, Executive Director• Julia Fowle, Program Planning and Event Specialist• Anna Lingel, CMP, Exhibitor Relations and Technology Specialist• Carisa Lubeck, Business Information Analyst• Renee Olson, Senior Program Manager• Catherine Stewart, Director of Finance

Audio-Visual Support: • Michael Johnstone

MJ Audio-Visual Productions

Bioassays 2018Attendee Statistics

• Attendees pre-registered – 139• Number of regulators pre-registered – 34• Number of companies represented – 51• Number of countries represented – 11 (Argentina,

Belgium, Brazil, Canada, France, Germany, South Korea, Sweden, Switzerland, United Kingdom, USA)

• Number of first time attendees – 62 • Number of speakers – 16

4 Great Sessions1. Fundamentals of Bioassay

2. Blazing a New Path: Are New Generation Biotherapeutics Giving You a Complex (Bioassay)?

3. Structure Function Assessment for Monoclonal Antibodies and Beyond

4. Regulators: What’s on Your Mind?

Reminders / Announcements10:35 – 11:20 First Time Attendee Networking Event12:20 – 13:25 Lunch and Learn: Exhibitor Partner

Scientific Showcase17:30 – 18:15 Exhibitor Partner Scientific Showcase18:15 – 19:30 Exhibitor and Poster Reception

Survey and Feedback Your Feedback is Important!We need your help to build our meeting for the future. Bioassays 2018 Evaluations will be sent via email Tuesday. Please be sure to complete the survey and hit SUBMIT.

Reminders / Announcements

Please turn off your cell phones during the lectures.

Reminders / Announcements

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

Reminders / Announcements

To connect to wi-fi: attwifiChoose: I have a Promotion CodeType: Doubletree2018

And you should be connected!