Speakers:

Michael H. Hinckle

Partner
K&L Gates LLP (Research Triangle Park, NC)

Keith Flanagan

Transition Lead for Policy, OGD/CDER/FDA, Office of Generic Drugs
United States Food and Drug Administration (Rockville, MD)

Keynote Address

July 24, 2014 9:15 am

Gary J. Buehler R.Ph.

VP, Global Regulatory Intelligence and Policy
Teva Pharmaceuticals Industries Ltd. (North Wales, PA)

Romit Kamdar

Partner
Akara Group LLC (Morristown, NJ)

Conference Adjourns

July 25, 2014 5:00 pm

Mr. Sean Moriarty

Vice President, Legal Affairs
Lupin Pharmaceuticals, Inc. (Baltimore, MD)

Ildiko Mehes

Vice President & General Counsel, North America Generics Leader, U.S. Generics Products & Portfolio
Teva Pharmaceutical Industries Ltd.

Hon. Joseph A. Dickson

U.S.M.J.
United States Federal District Court, District of New Jersey

Hon. Ruben Castillo

U.S. Dist. Ct., N.D. Ill.

Moderator: Teresa “Terry” Stanek Rea

Partner
Crowell & Moring LLP (Washington, DC)

Huong Nguyen

Senior Director, Intellectual Property
Impax Laboratories, Inc. (Hayward, CA)

Gregory J. Glover MD

Principal
Pharmaceutical Law Group PC (Washington, DC)

Stephen R. Auten

Partner
Taft Stettinius & Hollister LLP

Co-Chairs’ Opening Remarks

July 24, 2014 8:15 am

Chandra Vattikonda M.Pharm., Ph.D.

Executive Director, Biopharmaceuticals
Par Pharmaceuticals, Inc. (Spring Valley, NY)

Candis Edwards

Senior Vice President, Regulatory/Clinical Affairs
Amneal Pharmaceuticals LLC (Hauppauge, NY)

Delphine W. Knight Brown

Partner
Axinn, Veltrop & Harkrider LLP (New York, NY)

Jay Lefkowitz

Partner
Kirkland & Ellis LLP (New York, NY)

Richard DiCicco

Chairman
Harvest Moon Pharmaceuticals USA, Inc. (Falls Chuch, VA)

John L. Dauer Jr.

Chief Patent Counsel
Sun Pharmaceutical Industries, Inc.

Christine Simmon

Senior Vice President, Policy & Strategic Alliances
Generic Pharmaceutical Association (GPhA) (Washington, DC)

Carmen M. Shepard

Senior Vice President, Global Policy and Regulatory Counsel
Mylan Inc. (Washington, DC)

Co-Chairs’ Opening Remarks

July 24, 2014 8:15 am

Speakers:

Michael H. Hinckle

Partner
K&L Gates LLP (Research Triangle Park, NC)

Keith Flanagan

Transition Lead for Policy, OGD/CDER/FDA, Office of Generic Drugs
United States Food and Drug Administration (Rockville, MD)

Keynote Address

July 24, 2014 9:15 am

Gary J. Buehler R.Ph.

VP, Global Regulatory Intelligence and Policy
Teva Pharmaceuticals Industries Ltd. (North Wales, PA)

Romit Kamdar

Partner
Akara Group LLC (Morristown, NJ)

Conference Adjourns

July 25, 2014 5:00 pm

Mr. Sean Moriarty

Vice President, Legal Affairs
Lupin Pharmaceuticals, Inc. (Baltimore, MD)

Ildiko Mehes

Vice President & General Counsel, North America Generics Leader, U.S. Generics Products & Portfolio
Teva Pharmaceutical Industries Ltd.

Hon. Joseph A. Dickson

U.S.M.J.
United States Federal District Court, District of New Jersey

Hon. Ruben Castillo

U.S. Dist. Ct., N.D. Ill.

Moderator: Teresa “Terry” Stanek Rea

Partner
Crowell & Moring LLP (Washington, DC)

Huong Nguyen

Senior Director, Intellectual Property
Impax Laboratories, Inc. (Hayward, CA)

Gregory J. Glover MD

Principal
Pharmaceutical Law Group PC (Washington, DC)

Stephen R. Auten

Partner
Taft Stettinius & Hollister LLP

Co-Chairs’ Opening Remarks

July 24, 2014 8:15 am

Chandra Vattikonda M.Pharm., Ph.D.

Executive Director, Biopharmaceuticals
Par Pharmaceuticals, Inc. (Spring Valley, NY)

Candis Edwards

Senior Vice President, Regulatory/Clinical Affairs
Amneal Pharmaceuticals LLC (Hauppauge, NY)

Delphine W. Knight Brown

Partner
Axinn, Veltrop & Harkrider LLP (New York, NY)

Jay Lefkowitz

Partner
Kirkland & Ellis LLP (New York, NY)

Richard DiCicco

Chairman
Harvest Moon Pharmaceuticals USA, Inc. (Falls Chuch, VA)

John L. Dauer Jr.

Chief Patent Counsel
Sun Pharmaceutical Industries, Inc.

Christine Simmon

Senior Vice President, Policy & Strategic Alliances
Generic Pharmaceutical Association (GPhA) (Washington, DC)

Carmen M. Shepard

Senior Vice President, Global Policy and Regulatory Counsel
Mylan Inc. (Washington, DC)

Co-Chairs’ Opening Remarks

July 24, 2014 8:15 am