creating a global community of industry, regulatory and ... · •challenges or special...
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Creating a global community of
industry, regulatory and academic
professionals in the field of
biopharmaceutical development
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.
What is CASSS?
What is CASSS?
Practical Applications
of Mass Spectrometry
What is CASSS?
What is CASSS?
What is CASSS?
What is CASSS?• Global Participation:
• Asia (8.1%), Australia (0.1%), Canada (1.4%), Europe (18.8%), Latin America (3.4%), Middle East (0.2%),
United States (68.1%)
• 2,922 Attendees** at 21 events (vs 2,327 in 2015)
**Note this in spite of blizzard-related cancellations in January 2016.
• 5 CMC Fora;
• 671 Attendees
• 6 Symposia;
• 1,421 Attendees
• 12 Discussion Groups: 4 SF Bay Area; 6 DC Area
and 2 Midwest
• 830 Attendees
Nearly ½ of the attendees were new to CASSS
CASSS meetings 2017-2018
Practical Applications of
Mass Spectrometry
EUROPE ▪ JAPAN ▪ NORTH AMERICA ▪ SOUTH AMERICA
September 19-22, 2017
Boston, MA USA
Jan. 30 - Feb. 1, 2018
Washington, DC USA
September 17-20, 2017
Boston, MA USA
May 8-9, 2017
Silver Spring, MD USA
6-9 March 2018
Barcelona, Spain
April 8-10, 2018
Gaithersburg, MD USA
22-24 May 2017
Killarney, Ireland
July 17-18, 2017
Gaithersburg, MD USA
9-10 October 2017
Mexico City, Mexico
4-5 December 2017
Tokyo, Japan
January 29, 2018
Washington, DC USA
CASSS near you …
• Nor Cal: June 1, 2017
South San Francisco, CA
• Midwest: June 8, 2017
Grays Lake, IL
• New England: NEW!
September 28, 2017
Boston, MA
Regional Forums
Full-day sessions, with talks, panel
discussion and roundtables.
Recent topics include:
• Building a "Quality" Dossier from
Phase 1 and Beyond
• Successful Strategies for Tech
Transfer
• Assessment of Criticality of Quality
Attributes for Biotherapeutics
• Challenges or Special
Considerations When Developing
ADCs and Bispecifics
CASSS near you …• Greater DC Area
1st Thursday of every
other month
Location alternates
between MedImmune in
Gaithersburg and IBBR in
Rockville.
• Netherlands
4 per year
Locations vary.
Local Discussion Groups
Formed locally to enable
communities of industry,
academic and regulatory
professionals to meet in an
informal setting to share
ideas and experiences.
• Timing: late afternoon
• Format: Short talk,
followed by discussion.
More info on web.
What makes CASSS different?
CASSS utilizes its 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).
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.
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.
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.
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 www.casss.org or speak with
a committee member or staff at registration.
Welcome to
MAY 8-9, 2017DoubleTree by Hilton Hotel
Silver Spring, MD USA
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
• 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
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
• Bhavin Parekh, Eli Lilly and Company, USA
• Mike Sadick, Catalent Pharma Solutions, USA
• Sally Seaver, Seaver Associates LLC, USA
• Max Tejada, Gilead Sciences, USA
Strategic Program Partners
Diamond Program Partner
Platinum Program Partners
Strategic Program Partners
Gold Program Partners
Program Partners
Exhibitor Program Partners
Media Partners
Special Thanks to…CASSS Staff:
• Karen A. Bertani, CMP, Director of Meetings (Bioassays
Symposium Manager)
• Amy Cano, Administrative Assistant
• Stephanie L. Flores, CAE, Executive Director
• Julia Fowle, Meeting Coordinator
• Anna Lingel, Meeting Coordinator
• 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 2017
Attendee Statistics
• Attendees pre-registered – 155
• Number of regulators pre-registered – 37
• Number of academicians - 4
• Number of companies represented – 57
• Number of countries represented – 14 (Belgium,
Brazil, Canada, France, Germany, Israel, Japan,
Netherlands, Russia, Singapore, South Korea,
Switzerland, United Kingdom, USA)
4 Great Sessions
1. The Crossroads of Bioassays & Statistics – Where
Bioanalytical Scientists and Statisticians Collaborate to
Develop Great Bioassays
2. New Bioassay Approaches and Technologies: A
Brave New World
3. The Bioassay Challenge: Applications in Product
Development
4. Regulators: What’s on Your mind?
Reminders / Announcements12:00 – 13:30 Lunch and Learn: Exhibitor Partner
Scientific Showcase
17:15 – 18:05 Exhibitor Partner Scientific Showcase
18:15 – 19:45 Exhibitor and Poster Reception
Survey and Feedback
Your Feedback is Important
We need your help to build our meeting for the future.
Bioassays 2017 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.