creating a global community of industry, regulatory and ... · •challenges or special...

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.

Find out more about CASSS

and how to participate at

www.casss.org

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.