2016 APEC Biotherapeutics Center of Excellence (CoE) Pilot Trainings

September 13-16 Northeastern University United States

SECTION II: CV AND PHOTOGRAPH FORM

CV AND PHOTOGRAPH FORM

2016 APEC Biotherapeutics CoE Pilot Training

September 13-16 Northeastern University, Boston United States

Title First Name Last Name

Mr. Nathan Doty

Department / Organization
Biologics Strategic Development, AbbVie Inc.

Job Title / Position

Associate Director, Biotherapeutics Regulatory Affairs

* Please write your CV briefly (approximately 150 words)

Education

Stanford Law School 1999 to 2002--J.D., 2002

Stanford Law ReviewManaging Editor; Stanford Journal of International LawSenior Articles Editor

Haverford College 1995 to 1999--B.A. Philosophy, 1999;

Phi Beta Kappa, Magna Cum Laude

Experience

AbbVie Inc., Biologics Strategic Development2015 to Present

Associate Director, Biotherapeutics Regulatory Affairs

Food and Drug AdministrationOffice of the Chief Scientist--2012 to 2015 (acting, 2012 to 2013)
Director, Office of Scientific Integrity

Food and Drug AdministrationOffice of the Chief Counsel--2009 to 2012

Associate Chief Counsel
 2016 APEC Biotherapeutics Center of Excellence (CoE) Pilot Trainings
September 13-16 Northeastern University United States

SECTION III: ABSTRACT FORM

ABSTRACT FORM

2016 APEC Biotherapeutics CoE Pilot Training

September 13-16 Northeastern University, Boston United States

Title First Name Last Name

Mr. Nathan Doty

Topic

Extrapolation of IndicationsIndustry Perspective (IFPMA)

* Please write your abstract briefly (approximately 250 words)

The Industry Perspective presentation from IFPMA (presentation) covers three topics.

1) A brief background on biosimilar development and an overview of general principles associated with
indication extrapolation for proposed biosimilar products.

2) A description of indication extrapolation issues specific to the review and approval of monoclonal

antibody biosimilars. This section discusses principles identified by regulators as well as brief discussion
of two example monoclonal antibodiesinfliximab and adalimumab.

3) A case study discussing the appropriately sensitive setting for evaluating a trastuzumab biosimilar to
justify indication extrapolation.