2024 Speakers

Commissioner of Food and Drugs
FDA

Robert M. Califf, M.D


Rare Community Member

Tanita Allen

Professor, Division of Genetics & Metabolism, University of Wisconsin School of Medicine and Public Health; Director of Newborn Screening Program at Wisconsin State Laboratory of Hygiene

Mei Baker, MD, FACMG

CEO
American Society of Gene and Cell Therapy

David Barrett, JD

Rare Community Member and Associate Professor
Department of Nutrition and Food Studies, College for Community Health, Montclair State University

Mousumi Bose, PhD

Vice President
Federal Affairs, ALS Association

Rich Brennan, MA

Deputy Director, Division of Rare Diseases Research Innovation
NCATS, NIH

P.J. Brooks, PhD


Office of Congresswoman Anna G. Eshoo (CA-16) 

Jordan Brossi

Director, Access Policy
Muscular Dystrophy Association

Joel Cartner, Esq.

Center Director for the Center for Drug Evaluation and Research (CDER)
Food and Drug Administration

Patrizia Cavazzoni, M.D.

Head of Global Rare Disease and Member of the Board
Chiesi Pharmaceuticals

Giacomo Chiesi

General Manager, US Rare Diseases
Sanofi

R. Duane Clark

VP of Corporate Relations
National Organization for Rare Disorders (NORD)

Patrick Collins

Vice President for Federal Affairs
Leukemia & Lymphoma Society

Brian Connell

Vice President of Therapeutics Development
California Institute of Regenerative Medicine

Abla Creasey, PhD

VP, Data Science
Jazz Pharmaceuticals

Mat Davis

Director, Advocacy & Engagement Strategy
Center for Rare Diseases, ICON 

Kendall Davis, MPH

Director of Research, Co-founder
Malan Syndrome Foundation

Christal Delagrammatikas, PhD

Vice President, Policy
National Heath Council

Jennifer Dexter

Senior Partner, Global Public Policy, Regulatory & Governmental Strategy
Flagship Pioneering

Tom DiLenge

Senior Vice President of Policy and Advocacy
Cystic Fibrosis Foundation

Mary Dwight

Co-Founder & President
Every Cure

David Fajgenbaum, MD, MBA, Msc

Director of the Office of Clinical Evaluation (Cell and Gene Therapies)
Super Office of Therapeutics Products(OTP), CBER, FDA

Lola Fashoyin-Aje, MD, MPH

Principal and Founder, Rubrum Advising
Former CMS Chief Medical Officer and Director of the Center for Clinical Standards and Quality

Lee Fleisher, MD, LLM

Entrepreneur in Residence
Google Ventures

Nicole Gaudelli

CEO
NORD

Pamela Gavin

Chief Executive Officer
Agios Pharmaceuticals

Brian Goff

President and CEO
Blueprint Medicines

Kate Haviland

CEO
Healr Solutions, Steering Committee Member, MA RDAC

Guadalupe Hayes-Mota, MBA, MS, MPA

Research Director
Real-World Evidence (RWE), Duke-Margolis Institute for Health Policy

Rachele Hendricks-Sturrup, DHSc, MSc, MA

Senior Policy Analyst
NORD

Allison Herrity, MPH

Division of Medical Genetics
University of Washington School of Medicine

Fuki M. Hisama, MD, FACMG

Executive Vice President, Global Product Strategy & Commercialization
Biogen

Rachid Izzar

Founder
The Calliope Joy Foundation and Cure MLD

Maria Kefalas, PhD, MA

Executive Director
TBRS Community

Jill Kiernan

President, US Business Unit and US Country Head
Takeda

Julie Kim


Ropes & Gray LLP

Gregory Levine, JD

Associate Director for Innovation and Partnership
OCP, OTS, CDER, FDA

Qi Liu, PhD, MStat, FCP

Co-Founder and Executive Chairman
RallyBio

Martin Mackay, PhD


University of Rochester 

Samuel Mackenzie, MD, PhD

Director, Center for Biologics Evaluation and Research (CBER)
US Food & Drug Administration (FDA)

Peter Marks, MD, PhD

Chief Medical Officer
FDA

Hilary Marston, MD, MPH


Rare Community Member

Mayra Martinez

Global Rare Disease Commercial Lead
Pfizer

Gemma Mayman


Rare Community Member

Maria Miller

President of R&D
Taysha Gene Therapies

Sukumar Nagendran, MD

Chief Medical & Scientific Officer
National Organization for Rare Disorders (NORD)

Edward Neilan, MD, PhD

CEO
TargetCancer Foundation

Jim Palma

Associate Director, Medicaid Market Access
GeneDx

Holly Paparounis

Senior Research Scientist
RTI International

Holly Peay, PhD, MS

Director of CDER Office of New Drugs
Division of Rare Disease and Medical Genetics, FDA

Catherine Pilgrim-Grayson, MD, MPH

Executive Partner
Sofinnova Investments

Maha Radhakrishnan, MD

Vice President, Policy & Regulatory Affairs
National Organization for Rare Disorders (NORD)

Heidi Ross, MPH

Science Program Director
CSNK2A1 Foundation

Gabrielle Rushing, PhD

Director
National Center for Advancing Translational Sciences (NCATS), NIH

Joni Rutter, PhD


National Bleeding Disorders Foundation

Maria Santaella, RN-BC, MSN, PhD(c)

Senior Vice President, Science and Technology
Medical Device Innovation Consortium

Joseph Sapiente

President
Scheer & Company

David Scheer

Senior Director, FasterCures
Milken Institute Health

Kristin Schneeman

Deputy Administrator and Director of the Center for Medicare
Centers for Medicare & Medicaid Services (CMS)

Meena Seshamani, MD, PhD

CBER Office of Therapeutic Products
Office of Clinical Evaluation

Rosa Sherafat-Kazemzadeh, MD

Chief of Staff and Strategy
Foundation for Sarcoidosis Research

Tricha Shivas

Senior Medical Advisor, Real-World Evidence Analytics, Office of Medical Policy
CDER, FDA

Kimberly Smith, MD, MS

Associate Professor of McKusick-Nathans Department of Genetic Medicine, Associate Professor of Pediatrics
Johns Hopkins University

Nara Sobriera, MD, PhD

CEO
Center for Innovation & Value Research

Jason Spangler MD, MPH, FACPM

Interim Director, Center for Devices and Radiological Health (CDRH)
US Food & Drug Administration (FDA)

Michelle Tarver, MD, PhD

General Counsel
Senate HELP Committee

Barrett Tenbarge

Managing Principal
Leavitt Partners

Josh Trent

Executive Director
Rare Disease Diversity Coalition

Jenifer Waldrop, MS

Executive Vice President, Head of Clinical Development and Clinical Operations
Savara

Yasmine Wasfi, MD, PhD

Partner
Goodwin Procter LLP

Matt Wetzel

Vice President and Head of Commercial Strategy and AI
OM1

Joseph Zabinski, PhD, MEM

Partner
OrbiMed

Tal Zaks, MD, PhD

Keep up-to-date on the latest NORD Breakthrough Summit news

Name(Required)