WE BELIEVE

To save lives and end the COVID Pandemic,

we can and must accelerate patient access,

development and approval of new COVID treatments

by augmenting traditional concepts with modern

technology and data analytics.

This will achieve rapid and responsible patient

access as well as robust evidence for the

many promising COVID-19 therapies.

 

WHO WE ARE

We are a coalition of patient-focused experts and leaders across healthcare including physicians, medical researchers, drug developers, data scientists, bioethicists, engineers and corporate executives.

We are concerned that the traditional approach of development, approval and access to new COVID-19 therapies achieves available therapies too late:

 

Too late to protect the thousands of lives at risk now, and

too late to reopen the economy with the speed that people need.

We joined forces to design a faster solution

and bring together the right stakeholders who implement this solution. 

We are solely committed to the patient. We act and speak as private concerned citizens and not on behalf of any organization we are members of.

Thomas Bock, MD, MBA

Co-Founder

Founder and past CEO, HeritX Inc.

Chair, Healthcare Advisory Board, Columbia Business School

Former Senior VP, Global Head of Medical Affairs, Alexion

Ulo Palm, MD, PhD

Co-Founder

Former Senior VP of Digital Sciences, Allergan

Corporate Secretary, TransCelerate BioPharma Inc.

Lixia Wang, PhD

Co-Founder

Vice President,

Biostatistics and Data Management,

Intercept Pharmaceuticals

Beatrice D. Ellerin

President, New York City

Health Business Leaders

Director, Healthcare Program, Columbia Business School

Jamie Macdonald

Chief Executive Officer,

Parexel

Gavin Nichols

Executive Vice President,

Informatics and Information Technology, Parexel

Peter J. Pitts

President, Center for Medicine

in the Public Interest

Visiting Professor,

University of Paris, Descartes Medical School

 

Former Associate Commissioner,

US Food and Drug Administration

 

OUR MISSION

Our mission is to save lives threatened by the

current COVID-19 pandemic by accelerating 

patient access and development of COVID-19 therapies.

To succeed, we drive the design and implementation of an

integrative, patient-centric way of developing new COVID-19

therapies that leverages digital sciences and technology.

We envision that all COVID-19 patients will have immediate

access to promising investigational therapies through

randomized clinical trials (RCTs) or prospective

real-world evidence (RWE) studies, monitored

on one integrated research platform.

RCTs and RWE studies will thus augment each other and

generate robust evidence for regulatory approval

at highest speed.

WHY

COVID-19 is a pandemic emergency.

In the US alone, far more than 100,000 people will die in the current first wave of COVID-19. A second wave is expected in the coming fall and winter.

We need an armament of effective COVID-19 treatments. The approved emergency use of Remdesivir is an important milestone, but more work is needed to minimize the death toll and create the foundation to re-open the economy. 

We must develop additional treatments in case COVID-19 becomes resistant. We need combination therapies to further improve patient outcomes. We need oral formulations to already treat early stages of COVID-19 infections at home. 

________

The current system where hundreds of independent, competing trials are

launched, is ineffective, overwhelming for researchers and regulators, 

and takes too long to fight this pandemic. 

In contrast, an integrated research platform will enable a

COVID-19 master protocol and the comparative, accelerated

testing of new treatments—all in one place.

Such an integrated research platform with a randomized, controlled

master protocol trial (RCT) will generate the most comprehensive and

comparable body of evidence for COVID-19 treatments. 

Importantly, patients who do not qualify for the mRCT will have the

opportunity to participate in a prospective real-world evidence (RWE)

study, ensuring that patients can have access to promising

investigational therapies.

________

This approach will enable the fastest generation of substantial

evidence for regulatory approvals, the best individual treatment

decisions at any time, and will leave no patient behind. 

STRATEGY

Facilitate the implementation of a multi-therapy master protocol for

prospective COVID-19 RCTs + RWE studies through digital science

and technology that can deliver robust evidence about the benefits

and risks of investigational therapies.

Build alliance with technology and clinical research companies that create

an integrated research technology platform for these studies.

Collaborate with global regulators on approval pathways for COVID treatments based on RCT and RWE studies, thus creating incentives for pharmaceutical companies to offer early access to more patients.

Facilitate adoption of integrated research platform by COVID researchers

and the pharmaceutical industry.

Educate society that a more patient-centric and effective way of developing

new treatments in a deadly pandemic is possible and necessary.

OUR APPROACH

OF LEARNING FROM EVERY SINGLE PATIENT

An

Integrated Research Platform

with a

Master Protocol for RCTs and Prospective RWE Studies

plus

Advanced Analytics

enabling

Fast Patient Access & Robust Evidence

 

 

ADVISORS

Kenneth Getz, MBA

Professor and Deputy Director, Center for the Study of

Drug Development

Tufts University School of Medicine

Founder and Board Chair

Center for Information and Study on Clinical Research Participation

Geraldine McGinty, MD

MBA, FACR

Chief Strategy Officer,

Weill Cornell Medicine

Chair, Board of Chancellors,

American College of Radiology

Non-Executive Director,

IDA Ireland

Debbie Hart

President and

Chief Executive Officer,

BioNJ

Christopher Langan, MD

Regional Chief Medical Officer.

Memorial Hermann Health System,

Houston, TX

Jon Kleinman

Partner

Insigniam

Jack C. Lewin, MD

Chairman,

National Coalition on Healthcare

Past President and CEO,

Cardiovascular Research Foundation

Former Chief Executive Officer,

American College of Cardiology

Sarah J.L. Edwards, PhD

Professor of Bioethics,

Department of Science and Technology Studies,

University College London

UK

Thomas I.H. Dubin, JD, MPH

Vice Chair, Board of Directors,

Norwalk Hospital

Leadership Council,

Yale School of Public Health

SVP and Chief Legal Officer (ret.)

Alexion Pharmaceuticals

Harpreet Ram, MBA

Chief Executive Officer,

EVR Patient Access Programs

Lothar Kanz, MD

Chairman Emeritus,

Medizinische Klinik,

Universitätsklinikum Tübingen,

Germany

Prem Narang, PhD, FCP

Former Vice President and Global Head, Regulatory Affairs,

Novartis Oncology

Former Vice President and Global Head, Regulatory Affairs,

GE Medical Diagnostics

Jack A. Stroh, MD

FACC, FACP, FSCAI

Interventional Cardiologist

Associate Professor of Medicine

Rutgers RWJ Medical School

PARTNER ORGANIZATIONS

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