Help Drive the Development of Regenerative Medicine Standards at the March 18–19 Realizing the Benefit of 21st Century Cures through Standards Development Workshop

Washington, DC (March 6, 2019) — The two-day Realizing the Benefit of 21st Century Cures through Standards Development Workshop is fast approaching!

The workshop—co-hosted by FDA, NIST, SCB, and Nexight Group—will be held March 18–19 at the National Cybersecurity Center of Excellence in Rockville, MD, with presenters and panelists from SDOs, government agencies, and industry representing key players in the regenerative medicine community.

Through a series of presentations, interactive discussions, and small-group breakout sessions, participants will:

• Learn how participation in the standards advancement process can improve the quality and safety of regenerative medicine

• Find out how to play an active role in standards development and have a voice in shaping the standards that will impact the community

• Get an inside look at some of the regenerative medicine standards advancement efforts in progress today

• Help identify high-priority standards needs for your sector

Here’s a preview of some of the key topics that will be covered:

Introduction: Building the Foundation for Regenerative Medicine Innovation & The Standards Evolution of Regenerative Medicine

Speakers: Judy Arcidiacono (FDA) and Sheng Lin-Gibson (NIST)

• Judy Arcidiacono will introduce the 21st Century Cures Act and how it drives innovation, standards, and FDA’s work.

• Sheng Lin-Gibson will cover the history of standards and provide background on the evolution of the regenerative medicine field, as well as how standards development allows stakeholders to improve the safety and quality of regenerative medicine.

Together, these presentations provide a foundational overview of the standards development process that will be built on throughout the workshop.

Common Questions about Standards, Demystified

Panelists: Malcolm Moos (FDA), Wen Bo Wang (Fate Therapeutics), Anne Caldas (ANSI), Barbara Boyan (VCU College of Engineering) (moderator)

This panel will cover a variety of frequently asked questions—including questions collected from participants—about how the standards development process works and how to participate in it successfully. The session will include a live Q&A with the audience to address any questions sparked during the discussion.

The Importance of Reference Materials

Presenter: John Elliott (NIST)

Panelists: Keith Carson (ISBiotech), Dr. Kevin Carrick (USP), Jean Qiu (Nexcelom Bioscience LLC), Sowmya Viswanathan (University Health Network), Sumona Sarkar (NIST) (moderator)

Through a presentation, case studies, and an expert panel, this session will show how reference materials help ensure robustness of measurement, interoperability, and quality. Panelists will share their insights on best practices on the use, value, and development of reference materials.

Case studies will include:

• Adenovirus (Keith Carson)

• CD34+ (Dr. Kevin Carrick)

Starting with Success in Mind

Panelists: Dr. George Muschler (Cleveland Clinic), Alyce Linthurst Jones (LifeNet Health), Helen Parkes (LCG), Claudia Zylberberg (Akron Biotech), Chris Wiwi (Celgene) (moderator)

This presentation will use specific case studies to demonstrate how thinking about standards adoption and implementation during the development process can yield more effective and widely adopted standards. Following the case studies, a panel discussion will allow experts to share different perspectives, best practices, and lessons on the topic.

Case studies will include:

• Counting colony forming units (Dr. George Muschler)

• Osteoinductivity document (Alyce Linthurst Jones)

• qPCR/dPCR standards (Helen Parkes)

Moving from Idea to Innovation

Panelists: Brian Hawkins (Pluristyx), Michael Halter (NIST), Clare Allocca (NIST), Jessica Carmen (Pullan Consulting) (moderator)

Case studies will illustrate how specific standards needs were identified and how they evolved into standards advancement projects. Speakers will share lessons learned from the process and advice for others interested in identifying standards needs within their area of expertise. A panel discussion will offer perspectives on how to proceed with a new idea for a standard or evaluate what standards may apply to a new tool or process.

Case studies will include:

• Cryopreservation (Brian Hawkins)

• ASTM microscopy (Michael Halter)

Breakout Session: Prioritizing Areas for Standards

Participants will break into groups by sector and evaluate the impact and urgency of various standards needs identified by the regenerative medicine community. Each group will assess the best ways to approach these needs as well as identify potential challenges and roadblocks. Feedback from this session will actively inform future standards advancement activities. This is a great opportunity to have a direct impact on the future of regenerative medicine standards.

How to Get Involved

To encourage engaging and effective round table discussions, registration was limited to 100 people and is now closed. If you would like to be added to the waitlist, please contact Allison Getz (agetz@regenmedscb.org).

And follow SCB on Twitter to be among the first to know when selected presentations from the workshop are posted to the SCB web site.

To learn about other events like this one, contact SCB or sign up for our e-newsletter (below).