welcome to · 2018. 4. 2. · ce pharm 2017 keynote speakers wassim nashabeh, f. hoffmann-la roche...

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Welcome to September 17-20, 2017 Boston Park Plaza Hotel, Boston, MA 19th Symposium on the Practical Applications for the Analysis of Proteins, Nucleotides and Small Molecules

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Page 1: Welcome to · 2018. 4. 2. · CE Pharm 2017 Keynote Speakers Wassim Nashabeh, F. Hoffmann-La Roche Ltd., Switzerland Global Biologics Regulatory Trends: Opportunities and Challenges

Welcome to

September 17-20, 2017Boston Park Plaza Hotel, Boston, MA

19th Symposium on the Practical Applications for the

Analysis of Proteins, Nucleotides and Small Molecules

Page 2: Welcome to · 2018. 4. 2. · CE Pharm 2017 Keynote Speakers Wassim Nashabeh, F. Hoffmann-La Roche Ltd., Switzerland Global Biologics Regulatory Trends: Opportunities and Challenges

Well separated peaks by nature…

Page 3: Welcome to · 2018. 4. 2. · CE Pharm 2017 Keynote Speakers Wassim Nashabeh, F. Hoffmann-La Roche Ltd., Switzerland Global Biologics Regulatory Trends: Opportunities and Challenges

CE Pharm 2017

Keynote Speakers

Wassim Nashabeh, F. Hoffmann-La Roche Ltd., Switzerland

Global Biologics Regulatory Trends: Opportunities and

Challenges

Cari Sanger – van de Griend, Kantisto B.V., Netherlands

AQbD and CE- Speeding Up or Slowing Down?

Gerhard Scriba, Friedrich Schiller University of Jena, Germany

CE Enantioseparations and Application to the Determination of

the Stereoisomeric Purity of Drugs

Page 4: Welcome to · 2018. 4. 2. · CE Pharm 2017 Keynote Speakers Wassim Nashabeh, F. Hoffmann-La Roche Ltd., Switzerland Global Biologics Regulatory Trends: Opportunities and Challenges

CE Pharm 2017

Strategic Program Partners

Page 5: Welcome to · 2018. 4. 2. · CE Pharm 2017 Keynote Speakers Wassim Nashabeh, F. Hoffmann-La Roche Ltd., Switzerland Global Biologics Regulatory Trends: Opportunities and Challenges

CE Pharm 2017

Program Partners

Page 6: Welcome to · 2018. 4. 2. · CE Pharm 2017 Keynote Speakers Wassim Nashabeh, F. Hoffmann-La Roche Ltd., Switzerland Global Biologics Regulatory Trends: Opportunities and Challenges

CE Pharm 2017

Exhibitors

908 Devices Inc.

Agilent Technologies

CMP Scientific, Corp.

PerkinElmer

ProteinSimple, a Bio-Techne brand

ProZyme

SCIEX

Thermo Fisher Scientific

Page 7: Welcome to · 2018. 4. 2. · CE Pharm 2017 Keynote Speakers Wassim Nashabeh, F. Hoffmann-La Roche Ltd., Switzerland Global Biologics Regulatory Trends: Opportunities and Challenges

CE Pharm 2017 Staff

Renee Olson

CASSS – Senior Program Manager

Stephanie Flores

CASSS – Executive Director

Julie Fowle

CASSS – Meeting Coordinator

Mike Johnstone

Owner – MJ Film/Video Productions

CASSS – Sharing Science Solutions

5900 Hollis Street, Suite R3

Emeryville, CA 94608

510-428-0740 TEL

510-428-0741 FAX

www.casss.org

Page 8: Welcome to · 2018. 4. 2. · CE Pharm 2017 Keynote Speakers Wassim Nashabeh, F. Hoffmann-La Roche Ltd., Switzerland Global Biologics Regulatory Trends: Opportunities and Challenges

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.

Page 9: Welcome to · 2018. 4. 2. · CE Pharm 2017 Keynote Speakers Wassim Nashabeh, F. Hoffmann-La Roche Ltd., Switzerland Global Biologics Regulatory Trends: Opportunities and Challenges

CE Pharm 2017

Student Travel Grant Winners

Late Breaking Session – 13:15-13:40

Isomeric Separation of Positively Labeled N-glycans by CE-ESI-MS

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

P-136

Enhancing Microchip Electrophoresis with Embedded Fused Silica

Capillary for Cellular Analysis

Benjamin T. Mehl, St. Louis University, USA

P-117

Capillary Electrophoresis of Antiperspirant Ingredients: Characterization

and Quantification of Aluminum Chlorohydrates Oligomer

Nesrine Ouadah, IBMM University of Montpellier, France

Page 10: Welcome to · 2018. 4. 2. · CE Pharm 2017 Keynote Speakers Wassim Nashabeh, F. Hoffmann-La Roche Ltd., Switzerland Global Biologics Regulatory Trends: Opportunities and Challenges

CASSS meetings 2017-2018

Practical Applications of

Mass Spectrometry

EUROPE ▪ JAPAN ▪ NORTH AMERICA ▪ SOUTH AMERICA

September 9-12, 2018

San Francisco, CA USA

Jan. 30 - Feb. 1, 2018

Washington, DC USA

September 9-12, 2018

San Francisco, CA USA

April 16-17, 2018

Silver Spring, MD USA

6-9 March 2018

Barcelona, Spain

April 9-11, 2018

Providence, RI USA

9-10 October 2017

Mexico City, Mexico

4-5 December 2017

Tokyo, Japan

January 29, 2018

Washington, DC USA

14-16 May 2018

Noordwijk, Netherlands

July 16-17, 2018

Gaithersburg, MD USA

Page 11: Welcome to · 2018. 4. 2. · CE Pharm 2017 Keynote Speakers Wassim Nashabeh, F. Hoffmann-La Roche Ltd., Switzerland Global Biologics Regulatory Trends: Opportunities and Challenges

CASSS near you …

• New England: NEW!

September 28, 2017

Boston, MA

• Midwest: October 5, 2017

Indianapolis, IN

• Nor Cal: October 12, 2017

South San Francisco, CA

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

Page 12: Welcome to · 2018. 4. 2. · CE Pharm 2017 Keynote Speakers Wassim Nashabeh, F. Hoffmann-La Roche Ltd., Switzerland Global Biologics Regulatory Trends: Opportunities and Challenges

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.

Page 13: Welcome to · 2018. 4. 2. · CE Pharm 2017 Keynote Speakers Wassim Nashabeh, F. Hoffmann-La Roche Ltd., Switzerland Global Biologics Regulatory Trends: Opportunities and Challenges

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.

Page 14: Welcome to · 2018. 4. 2. · CE Pharm 2017 Keynote Speakers Wassim Nashabeh, F. Hoffmann-La Roche Ltd., Switzerland Global Biologics Regulatory Trends: Opportunities and Challenges

CE Pharm 2017

Organizing Committee Tim Blanc Eli Lilly & Company

François de l’Escaille Analis s.a./n.v.

Mei Han Amgen Inc.

Göran Hübner Boehringer Ingelheim Pharma GmbH & Co. KG

Steffen Kiessig F. Hoffmann-La Roche Ltd. (Co-Chair)

Nate Lacher Pfizer, Inc.

Mark Lies SCIEX

Henry Luo Regeneron Pharmaceuticals, Inc.

David Michels Genentech, a Member of the Roche Group (Co-Chair)

SungAe Suhr Park Samsung Bioepis

Richard Rustandi Merck & Co., Inc.

Oscar Salas-Solano Seattle Genetics, Inc.

Maria Schwarz Solvias AG

Zoran Sosic Biogen

Ewoud van Tricht Janssen Infectious Diseases and Vaccines

Hermann Wätzig Technical University Braunschweig

Joel Welch CDER, FDA

Page 15: Welcome to · 2018. 4. 2. · CE Pharm 2017 Keynote Speakers Wassim Nashabeh, F. Hoffmann-La Roche Ltd., Switzerland Global Biologics Regulatory Trends: Opportunities and Challenges

CE Pharm 2017

Please silence your cell phones during the lectures.

Please do not take photos or video

of lectures or posters unless approved by the author.