Presents

Speakers & Moderators

The Combination Products Summit speakers are handpicked by the Combination Products Summit Strategic Committee to deliver purpose-driven content that dives below the surface, challenge status quo, engage attendees in collaborative dialogue, and provide practical information that can be implemented. Our speakers are thought leaders who are sure to facilitate insightful discussion.

Khaudeja

Bano

Ex-Amgen

Vice President Combination Product Quality

Kim

Belsky

AFDO/RAPS Healthcare Products Collaborative

Strategic Facilitator for MedCon and Combination Products Summit

Kristen

Benokraitis

Biogen

Global Head of RegCMC Device and Combination Products

James

Bertram

FDA

Director, Office of Combination Products

Francis

Blacha

Eli Lilly and Company

Senior Vice President of Quality

Ashley

Boam

FDA

Director, Office of Policy, Center for Drug Evaluation and Research (CDER)

Tim

Chesworth

AstraZeneca

Senior Director Regulatory Affairs – Devices & Digital Therapeutic

Anchal

Choudhuri

Biologics Consulting

Senior Consultant

Katie

Chowdhury

AbbVie

Director, Global Regulatory Affairs, Medical Device Team, Digital Health, Emerging Tech and Combination Products

Isabelle

Clamou

European Commission

Policy Officer

Fran

DeGrazio

Strategic Parenteral Solutions

Principal Consultant

Danita

Dixon

FDA

Associate Director for Information Management

Carolyn

Dorgan

Suttons Creek

Director, Technical Services

Courtney

Evans

Suttons Creek, Inc.

Principal Regulatory Consultant

Andrew

Fine

FDA

Senior Advisor in Division of Clinical Review in OGD

Andrea

Gray

FDA

Biomedical Engineering Advisor, Center for Biologics Evaluation and Research (CBER)

Anjali

Gupta

Novo Nordisk

Director Regulatory Affairs – Cell Therapy Device Development

Nishchay

Gupta

Genentech

Senior Regulatory Program Director

Laxman

Halleppanavar

Credence Med

Head of Project Management

Ryan

Hoshi

AbbVie

Director, Regulatory Policy and Intelligence

Shannon

Hoste

Patient for Pathway Health

Chief Scientific Officer

Erez

Kaminski

Ketryz

CEO & Founder

Tina

Kiang

FDA

Director, Division of Regulation and Guidance (DRG), Office of Policy for Pharmaceutical Quality (OPPQ), Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER)

Elizabeth

Kunkoski

FDA

Health Science Policy Analyst, Center for Drug Evaluation and Research (CDER)

Kristina

Lauritsen

FDA

Combination Product Policy Advisor, Center for Drug Evaluation and Research (CDER)

Jill

Lee

Novo Nordisk

Senior Director, Regulatory Policy

Juliane

Lessard

FDA

Director, Division of Drug Delivery, General Hospital Devices, and Human Factors, Center for Devices and Radiological Health (CDRH)

Willy

Liou

Amgen

Director of Regulatory Affairs

Jason

Lipman

Sanofi

Senior Director, Global Regulatory Affairs, Device and Combination Products

Patricia

Love

FDA

Deputy Director, Office of Combination Products

Alex

Lyness

TTP Plc

Business Development Director – Drug Delivery

Annette

Marthaler

FDA

Senior Regulatory Counsel, Office of Combination Products

Amanda

Matthews

Pfizer

Executive Director, Head of GRS Medical Devices

Ryan

McGowan

AstraZeneca

Director, Digital Devices and Combination Products

John

McMichael

AstraZeneca

Director, Medical Devices & Combination Products

Hemal

Mehta

Johnson & Johnson

Associate Director, Global CMC-Regulatory Affairs, Medical Devices and Combination Products

Shruti

Mistry

FDA

Assistant Director, Injection Devices Team, Center for Devices and Radiological Health (CDRH)

Sarah

Mollo

FDA

Combination Products Analyst, Center for Devices and Radiological Health (CDRH)

Susan

Neadle

Combination Products Consulting

Principal Consultant & President

Brian

Neely

FDA

Chemist, Center for Drug Evaluation and Research (CDER)

Chelsea

O’Connell

Amgen

Director, Global Regulatory and R&D Policy

Bonnie

Odom

Epstein Becker & Green, P.C.

Partner in the Healthcare and Life Sciences Practice

Peter

Petrochenko

Regeneron Pharmaceuticals

Associate Director in Regulatory Strategy

Renato

Ravanello

Genentech

Senior Director, Device Development

Andrea

Redd

Eli Lilly

Associate Vice President, Global Regulatory Affairs, Drug Delivery & Combination Products

Suzette

Roan

Sanofi

Associate VP, Head of GRA Devices

John

Schalago

Novartis

Executive Director, Sr GPRD

Carsten

Schaufuss

CSL Behring

Director, Combination Products

Tine

Schroder-Albeck

ALK A/S

Senior Quality Assurance Professional

Stephanie

Shapley

FDA

Associated Director for Policy, Office of Combination Products

Jiaying

Shen

Merck

Distinguished Scientist, Medical Device and Combination Product Development, Regulatory and Quality

Chin-Wei

Soo

Genentech/Roche

Global Regulatory Head – Devices and Combination Products

Eric

Staib

Syneos Health

Vice President, Corporate Quality

Alan

Stevens

AbbVie

Global Head of Complex Devices and Drug Delivery Systems, RA CMC Devices

Brandi

Stockton

Triality Group

Managing Partner

Abhishek

Telang

Merck

Director, Device Quality and Regulatory

Nikhil

Thakur

FDA (Invited)

Senior Program Manager, Quality and Compliance

Olga

Tkachenko

European Commisison

Policy Officer

Nathalie

Vandenkoornhuyse

Coherus

Executive Vice President, Regulatory Affairs

James

Wabby

AbbVie

Global Head – Emerging Technologies, Combination Products, and Devices

Chirag

Walawalkar

Merck

Director, Device Design & Process Development

James

Wise

CSL Behring

Combination Products Drug Delivery Devices

Jerzy

Wojcik

Edgeone Medical

Vice President, Regulatory and Quality Services

Rich

Wolf

RxLogix Corporation

Vice President of Client Relations

Lisa

Wright

Nordisk

Director of Regulatory Policy

Jenny

Wu

AstraZeneca

Associate Director, Human Factors,

Andrew

Yeatts

FDA

Combination Product Policy Analyst, Center for Devices and Radiological Health (CDRH)

Rumi

Young

Novo Nordisk

Director, Regulatory Policy

More speakers will be added soon!

This conference IS co-sponsored by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services. The contents are those of the presenters and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. government.