Ax-S Thursdays is a series of 4 biweekly webinars broadcast in February and March 2021. Join us in a fully interactive, virtual conference environment.

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

General Admission: Free registration for the whole series.

Exhibits & Commercial Partnerships

Platform Trials, Repurposing Studies, and Clinical Discoveries

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

Networking/Partnering afterward

Merit Cudkowicz, MD | Suanna Bruinooge, MPH | Kevin Weatherwax | Michael Kurilla, MD, PhD

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.

Merit Cudkowicz, MD, Director, Sean M. Healey & AMG Center for ALS at Mass General Hospital
Suanna Bruinooge, MPH, Director of Research Strategy, CENTRA, ASCO
Kevin Weatherwax, Managing Director, Michigan Institute for Clinical and Health Research, University of Michigan Medical System
Michael Kurilla, MD, PhD,  Director of Clinical Innovation, NCATS, NIH

Innovation Showcase with Mika Newton, Chief Executive Officer, xCures

March 25, 2021

Includes 24/7 conference site access through Sunday, March 28

Live broadcast included in Gen Admission, Replay available in Premium Section for a fee.

Decentralized, Virtual, and Hybrid Clinical Trials

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

Networking/Partnering afterward

Craig Lipset | Jen Horonjeff, PhD | Michelle Longmire, MD | Hassan Kadhim

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
Jen Horonjeff, PhD, CEO, Savvy Cooperative
Michele Longmire, MD, Founder and CEO, Medable
Hassan Kadhim, Director, Clinical Trial Business Capabilities, Bristol Myers Squibb

March 11, 2021

Includes 24/7 conference site access through Sunday, March 28

Live broadcast included in Gen Admission, Replay available in Premium Section for a fee.

Smarter Data Capture in Hybrid Clinical Programs

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

Networking/Partnering afterward

Amy Abernethy, MD, PhD | Michael Kurilla, MD, PhD |  Eric Perakslis, PhD | 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:
Amy Abernethy, MD, PhD, Principal Deputy Commissioner and Acting Chief Information Officer, FDA
Michael Kurilla, MD, PhD,
Director, Clinical and Translational Science Awards (CTSA) Program, NCTS, NIH
Eric Perakslis, PhD, Chief Science, and Digital Officer at the Duke Clinical Research Institute
Tobias Polak, MSc, Director, Real World Data, MyTomorrows

Feb 25, 2021

Includes 24/7 conference site access through Sunday, March 28

Live broadcast included in Gen Admission, Replay available in Premium Section for a fee.

The 2020 Report Card on Pre-Market Access to COVID-19 Diagnostics, Therapeutics, and Vaccines

Thursday, Feb 11, 2021 | 2:00pm – 3:30pm Eastern

Networking/Partnering afterward

Paul Aliu, PharmD | Lee Gehrke, PhD | Michael Joyner, MD | Naomi Lopez | 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 for segments of the infected population.  This session reviews the countermeasures 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:

Paul Aliu, PharmD, Global Head Medical Governance, Chief Medical Office, Novartis

Lee Gehrke, PhD, Professor, Institute for Medical Engineering and Science, MIT

Michael Joyner, MD, Medical Faculty, Mayo Clinic

Naomi Lopez,
Director of Healthcare Policy, Goldwater Institute

Peter Marks, MD, PhD, Director, Center for Biologics Evaluation and Research, FDA

Feb 11, 2021

Includes 24/7 conference site access through Sunday, March 28

Replay included with General Admission

CME Accreditation

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

Partners

Headline Sponsors

Logo: WideTrial
mytomorrows-logo

Community Partners

Logo: Parent Project Muscular Dystrophy
Logo: American Society of Clinical Oncology
Logo: Rare Revolution Magazine