Get ready for Ax-S Thursdays, the FREE e-Conference Series on integrating clinical research into modern healthcare delivery.

We created the Ax-S Thursdays e-Conference Series to deliver deep, actionable knowledge on clinical trial innovation, including decentralization, repurposing, and Expanded Access protocols to effectively bring clinical research into healthcare delivery.

Premium Pass

Ax-S Pharma Premium Membership includes guaranteed access to all e-Conference Series programming.

Exhibiting and Commercial Partnering

The Role of Early Access to Medicines in the COVID19 Crisis

Live panel session

Thursday, Nov 5, 2021 | 12:00pm – 1:30pm Eastern

Networking/Partnering afterward

Peter Marks, MD, PhD | Michael Joyner, MD | Paul Aliu, PhD | Jess Rabourn, CFA

COVID19 has showcased the need for swift but diligent clinical research of new medicines and diagnostics.   To address the clinical need for early access, stakeholders have many options, including large-cohort Expanded Access and the Emergency Use Authorization.  This session will discuss the role of these early access mechanisms, how they relate to the ongoing clinical development of a particular product, and their relevance to the development of COVID19 countermeasures.

Speakers:

Peter Marks, MD, PhD, Director, Center for Biologics Evaluation and Research, FDA
Michael Joyner, MD, Faculty Member, Mayo Clinic
Paul Aliu, PharmD, Global Head Medical Governance, Chief Medical Office, Novartis Pharmaceuticals
(Moderator) Jess Rabourn, CFA, Executive Producer, Ax-S Pharma

LiveCast A

Includes 24/7 access through Dec 31, 2020

Free for first 1000 registrations

Integrating Research into Modern HealthCare Delivery

Live panel session

Thursday, Nov 12, 2021 | 12:00pm – 1:30pm Eastern

Networking/Partnering afterward

Craig Lipset | Suanna Bruinooge, MPH |  Andrew Shuman, MD

Life Science innovators are discovering that including more people in the development of new medicines yields “real-world” information that may quicken the path to marketing approval.   Decentralization, Master Protocol, and Expanded Access are emerging tools to engage patients and doctors who otherwise would be left out.  This session explores the increasing overlap of clinical research and clinical care and how this overlap can serve the needs of both science and healthcare.

Speakers:
Craig Lipset, Founder, Clinical Innovation Partners
Suanna Bruinooge, MPH, Director of Research Strategy, CENTRA, ASCO
Andy Shuman, MD, Chief of Clinical Ethics Services, University of Michigan Medical School

LiveCast B

Includes 24/7 access through Dec 31, 2020

Free for first 1000 registrations

The 2020 Report Card on Pre-Market Access to COVID19 Diagnostics, Therapeutics, and Vaccines

Live panel session

Thursday, Jan 7, 2021 | 12:00pm – 1:30pm Eastern

Networking/Partnering afterward

Kevin Weatherwax | Lee Gehrke, PhD | Peter Marks, MD, PhD

The year 2020 presented the public with an unprecedented healthcare delivery challenge:  A rapidly spreading, global contagion with poor characterization and serious to fatal outcomes in segments of the infected population.  This session reviews the countermeasures that were developed in response to the COVID-19 pandemic and examines whether pre-market access programs -including EUA and Expanded Access- were adequately utilized to meet the world’s urgent healthcare and research needs.

Speakers:
Peter Marks, MD, PhD, Director, Center for Biologics Evaluation and Research, FDA
Kevin Weatherwax, Managing Director, Michigan Institute for Clinical and Health Research, University of Michigan Health System
Lee Gehrke, PhD, Professor, Institute for Medical Engineering and Science, MIT

Week 1

Includes 24/7 access from
Monday Jan 4 through
Sunday Jan 10

Free for first 1000 registrations

Frameworks for Reimbursing Exploratory Treatment
On Stage Panel Session from Expanded Access Summit 3.0 Exclusive Replay w/ Live Q&A

Exclusive replay with live Q&A

Thursday, Jan 14, 2021 | 12:00pm – 1:30pm Eastern

Networking/Partnering afterward

Jess Rabourn, CFA | Alexander Natz | Peter Pitts | Edmund Pezalla, MD, MPH

How do we establish fair reimbursement for exploratory treatment that doctors and patients find reasonable in light of the unmet medical need in unsolved diseases?  Should “reasonable and necessary” be redefined in Medicare?  This session examines new possibilities for an economically viable “learning healthcare system”.

Speakers:

Jess Rabourn, CFA, CEO WideTrial Inc
Alexander Natz, Secretary General, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)
Peter Pitts, President, Center for Medicine in the Public Interest (CMPI)
Edmund Pezalla, MD, MPH, Former National Medical Director and VP, Aetna (2007 – 2016); CEO of Enlightenment BioConsult

Week 2

Includes 24/7 access from Monday Jan 25 through Sunday Jan 31

Free for first 1000 registrations

Reimbursement for Pre-Market Medical Countermeasures in COVID19

Live panel session

Thursday, Jan 21, 2021 | 12:00pm – 1:30pm Eastern

Networking/Partnering afterward

Robert Walker, MD | Ed Pezalla, MD, MPH | Jess Rabourn, CFA

Throughout 2020 supply deals news outlets announced new supply deals for highly visible vaccines and therapeutics, but what about the not-so-visible?  Who actually funds pre-market access to exploratory countermeasures?  Does Emergency Use Authorization guarantee reimbursement for the supply and clinical oversight of these medications?  This session examines the rules and practices as applied in COVID19.

Speakers

Robert Walker, MD, Director, Division of Clinical Development, Biomedical Advanced Research and Development Authority (BARDA), HHS
Edmund Pezalla, MD, MPH, Former National Medical Director and VP, Aetna (2007 – 2016); CEO of Enlightenment BioConsult
(Moderator) Jess Rabourn, CFA, WideTrial Inc

Week 3

Includes 24/7 access from Monday Jan 18 through Sunday Jan 24

Free for first 1000 registrations

The Right Relationship Between Treatment and Research
On Stage Panel Session from Expanded Access Summit 3.0 Exclusive Replay w/ Live Q&A

Live panel session

Thursday, Jan 28, 2021 | 12:00pm – 1:30pm Eastern

Networking/Partnering afterward

Stuart Bell, PhD | Paul Aliu, PhD | Amy Barone, MD | Suanna Bruinooge, MPH | Michael Kurilla, MD, PhD
Can treatment-use of investigational medicines strengthen the clinical development process? This session examines approaches to maximize learning from clinical care including drug repurposing and Expanded Access programs (EAPs).  New structures for Master Protocol and E.H.R. interoperability are presented.

Stuart Bell, PhD Vice President, Consulting, Inceptua Medicines Access
Paul Aliu, PharmD Global Head Medical Governance, Chief Medical Office, Novartis Pharmaceuticals
Amy Barone, MD Medical Officer, Oncology Center of Excellence, FDA
Suanna Bruinooge, MPH Director of Research Strategy, CENTRA, ASCO
Michael Kurilla, MD, PhD Director, Clinical and Translational Science Awards (CTSA) Program, NCATS, NIH

Week 4

Includes 24/7 access from Monday Jan 18 through Sunday Jan 24

Free for first 1000 registrations

Platform Trials, Repurposing Studies, and Clinical Discoveries

Live panel session

Thursday, Feb 4, 2021 | 12:00pm – 1:30pm Eastern

Networking/Partnering afterward

Amy Abernethy, MD | Paul Aliu, PhD | Suanna Bruinooge, MPH

At the last two annual Expanded Access Summits (2019 and 2020), FDA’s Dr. Janet Woodcock emphasized the growing role for “Platform Trials”, which can include both non-marketed and marketed products and dynamically add experimental treatment regimens for targeted groups of patients. This session explores the frontier of the “Learning Healthcare System” whereby larger segments of a disease population can participate in interventional trials.

Paul Aliu, PharmD Global Head Medical Governance, Chief Medical Office, Novartis Pharmaceuticals
Amy Abernethy, MD, PhD Principal Deputy Commissioner and Acting Chief Information Officer, FDA
Suanna Bruinooge, MPH Director of Research Strategy, CENTRA, ASCO

Week 5

Includes 24/7 access from Monday Feb 1 through Sunday Feb 7

Free for first 1000 registrations

Addressing Population Needs with Unlicensed Medicines
On Stage Panel Session from Expanded Access Summit 3.0 Exclusive Replay w/ Live Q&A

Exclusive replay with live Q&A

Thursday, Feb 11, 2021 | 12:00pm – 1:30pm Eastern

Networking/Partnering afterward

Amar Bhat, PhD | John Lagus | Hilary Marston, MD, MPH | Robert Walker, MD
In a pandemic, how does a healthcare system provide access to pre-market / non-marketed medicines that could serve as emergency treatment options. How do BARDA, NIH, and private industry best utilize Expanded Access and Emergency Use Authorizations. This January 2020 session presents emergency response frameworks in the U.S. and other territories and examines how well equipped we are to deal with a major outbreak.

Amar Bhat, PhD Interim Executive Director, Reagan-Udall Foundation, FDA
John Lagus Managing Director of Business Development, Tanner Pharma Group
Hilary Marston, MD, MPH Medical Officer, National Institute of Allergy and Infectious Diseases (NIAID), NIH
Robert Walker, MD Director, Division of Clinical Development, Biomedical Advanced Research and Development Authority (BARDA), HHS

Week 6

Includes 24/7 access from Monday Feb 8 through Sunday Feb 14

Free for first 1000 registrations

Decentralized, Virtual, and Hybrid Clinical Trials

Live panel session

Thursday, Feb 18, 2021 | 12:00pm – 1:30pm Eastern

Networking/Partnering afterward

Craig Lipset | Suanna Bruinooge, MPH | William Hoos, MBA, MS
A broader, smarter clinical development process requires inclusivity – not just a wider range of patient phenotype and demographic, but also a greater range of location – non-traditional trial sites, communities who are not part on the roster of traditional research centers, families who cannot easily travel for in-person visits. This panel explores how crucial decentralization is to the fusion of research and healthcare.

Craig Lipset Founder, Clinical Innovation Partners
Suanna Bruinooge, MPH Director of Research Strategy, CENTRA, ASCO
William Hoos, MBA MS Chief Commercial Officer, xCures

Week 7

Includes 24/7 access from Monday Feb 15 through Sunday Feb 21

Free for first 1000 registrations

Healthcare Providers and Life Science Companies Partnering for Broader Access to New Medicines
On Stage Panel Session from Expanded Access Summit 3.0 Exclusive Replay w/ Live Q&A

Exclusive replay with live Q&A

Thursday, Feb 25, 2021 | 12:00pm – 1:30pm Eastern

Networking/Partnering afterward

Chris Beardmore | Georges van Baelen, MScPh | Erika Segear, PhD, RAC | Kevin Weatherwax
How have life science companies and healthcare systems worked together to make medically-appropriate early access a feasible option for more patients? How can we reduce the overhead of data-collection and monitoring that a clinical team must bear when providing exploratory treatment? Can the data be captured and structured more effectively? This panel examines the hurdles and opportunities of pharma / healthcare collaboration around medicines access.

Speakers:
Chris Beardmore CEO, Anova LLC
Georges van Baelen, MScPh Founder and President of Arctiryon, Inc.
Erika Segear, PhD RAC Associate Director of Regulatory Affairs, Duke University School of Medicine
Kevin Weatherwax Managing Director, Michigan Institute for Clinical and Health Research, University of Michigan Health System

Week 8

Includes 24/7 access from Monday TBD through Sunday TBD

Free for first 1000 registrations

The Value of Early Medicines Access for Healthcare Delivery Systems

Live panel session

Thursday, Mar 4, 2021 | 12:00pm – 1:30pm Eastern

Networking/Partnering afterward

Peter Marks, MD | Erika Segear, PhD, RAC | Jess Rabourn, CFA

What factors does a healthcare delivery organization weigh when contemplating expanding access to new medicines? Treatment-Use programs are not commercial research, so will the costs of medical services to patients be absorbed by the health plan? The provider? The patient? This panel examines the economics and feasibility to the health systems that are pursuing large-scale Expanded Access and other exploratory treatment paradigms.

Speakers:
Peter Marks, MD, PhD Director, Center for Biologics Evaluation and Research, FDA
Erika Segear, PhD RAC Associate Director of Regulatory Affairs, Duke University School of Medicine
Jess Rabourn, CFA Executive Producer, Expanded Access Summit | CEO, WideTrial, Inc.

Week 9

Includes 24/7 access from Monday Mar 1 through Sunday Mar 7

Free for first 1000 registrations

Smarter Data Capture in Hybrid Clinical Programs

Live panel session

Thursday, Mar 11, 2021 | 12:00pm – 1:30pm Eastern

Networking/Partnering afterward

Michael Kurilla, MD, PhD | Amy Abernethy, MD | Tobias Polak, MSc

This topic returns with a look to the future of data generation in healthcare. Will we have uniform standards? Will we achieve seamless integration between non-research personal health data and research data? What will this require? Finally, can the clinical use and outcomes of new treatments take a greater role in bringing products to market, supporting -not replacing- randomized clinical trials? The speakers will present their views on our progress toward a true “learning healthcare system”.


Speakers:
Michael Kurilla, MD, PhD Director, Clinical and Translational Science Awards (CTSA) Program, NCATS, NIH
Amy Abernethy, MD, PhD Principal Deputy Commissioner and Acting Chief Information Officer, FDA
Tobias Polak, MSc Department of Health Technology Assessment, Erasmus MC

Week 10

Includes 24/7 access from Monday Mar 15 through Sunday Mar 21

Free for first 1000 registrations

CME Accreditation

We now offer Continuing Medical Education units on selected modules and webcasts.

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