SCB Elects New Executive Committee Officers to Advance Growth and Community Engagement Goals in 2019–2020
Washington, DC (March 19, 2019) — On February 25, SCB conducted our second Executive Committee officer election, selecting Dr. Richard McFarland as President, Michael Orrico as Treasurer, and April Lynch as Secretary. A fourth position—Vice President—remains open and may be filled in the coming weeks. SCB elects new Executive Committee officers on a biennial basis to re-energize the organization with fresh perspectives and ensure that our leadership team’s expertise is aligned with our near-term goals.
SCB had a lot of exciting accomplishments during the 2017–2018 term:
Hired our first full-time staff members
Established and strengthened relationships with standards development organizations (SDOs), accreditation bodies, and Manufacturing USA Institutes
Engaged the regenerative medicine community through participation in meetings, webinars, and industry publications
Coordinated more than 10 standards advancement projects on the path to development.
In 2019–2020, we’re looking forward to continuing that momentum with guidance from the new Executive Committee by expanding the reach and diversity of our stakeholders, initiating new standards advancement projects prioritized by the community, and hiring an executive director to further focus our strategic activities.
We sat down with the three new officers for a brief Q&A about their vision for the next two years.
Richard McFarland, President
Richard McFarland, Ph.D., MD who served as secretary during the previous term, is a committed advocate of regenerative medicine standards and has been involved in the area since his time at FDA/Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies. He is currently employed as Chief Regulatory Officer of ARMI/BioFabUSA and brings two decades of experience in standards development at various SDOs and 15 years of policy development experience at FDA.
How does your past experience translate to your role as SCB president?
As SCB’s secretary, I have been deeply involved in its day-to-day operations as well as promoting the growth of the organization. I have participated in or led groups to identify needs and played an active role in the execution of plans to secure those needs.
What do you see as the upcoming priorities and trends for the regenerative medicine field?
I expect to see a shift in focus to de-risking the development of specific products by reducing the time, cost, and regulatory uncertainty of development as more standards gaps are identified in areas like manufacturing and supply chain (including transportation and clinical application). I see this as a sign of maturation in the regenerative medicine field.
How can SCB best support regenerative medicine standards development over the next two years?
We can make the greatest impact through promotion of use of existing standards in regenerative medicine product development, identification of standards gaps, and facilitating development of regenerative medicine-related standards for SDOs.
Michael Orrico, Treasurer
Michael Orrico is a current SCB board member who has been involved in tissue engineering and regenerative medicine for more than 25 years through his work with the Cryobiology Lab at MIT, as well as Aastrom Biosciences and AxoGen. He is currently an executive consultant to biotech companies.
How does your past experience translate to your role as SCB treasurer?
I've had a number of leadership roles that required me to collaborate with academic and corporate researchers in funding the development of tissue products, devices, and biologics. I believe I can provide an industry perspective to help SCB effectively address the priorities of regenerative medicine companies and other companies working in the field. I also focused on healthcare and entrepreneurial finance in my executive MBA program at Columbia.
What do you see as the upcoming priorities and trends for the regenerative medicine field?
Industry and researchers will begin to look toward better performance standards that allow them to focus more on real innovation rather than reinventing the wheel when it comes to validating common aspects like storage and transportation. In addition, there is an industry-wide need to develop standards for tissues and cells that go beyond simple viability measures. As these standards are established, stakeholders can agree to look beyond the survival of cells to assess how they will proliferate and have the desired therapeutic effect in a product.
How can SCB best support regenerative medicine standards development over the next two years?
I think SCB has the opportunity to bring industry's perspective to the process of advancing characterization and specification standards for biologics and help build a consensus in this area around which methods are best. I believe that recognized, inter-company standards are key to the continued growth of cell- and tissue-based therapies.
April Lynch, Secretary
April Lynch is an engaged proponent of regenerative medicine standards for supply chain, digital infrastructure, transportation, and labeling who brings more than a decade of experience in personalized medicine. She has actively participated in SCB projects through her role as Senior Vice President of Product Marketing at Vineti. She is passionate about communication and sees it as key to the success of regenerative medicine.
How does your past experience translate to your role as SCB secretary?
My product strategy work at Vineti requires ongoing understanding of regenerative medicine advances, including scientific innovations, updated policy requirements, and enabling technologies for both. A core component of my work at Vineti focuses on supporting standard-setting efforts, as well as promoting an ethos of community and collaboration among the cell and gene therapy industry through educational events and conference presentations.
What do you see as the upcoming priorities and trends for the regenerative medicine field?
Regulatory agencies have clearly communicated that they will support rapid regenerative medicine development, as long as that innovation is buttressed by a reliable framework of policies and standards. Now, the regenerative medicine community, in both academic and industry settings, has the opportunity to greet this encouragement with an organized, responsive drive for standards. This is truly an inspirational time to be involved in the creation of personalized therapeutics.
How can SCB best support regenerative medicine standards development over the next two years?
Part of SCB’s unique value is its ability to provide a natural, unforced forum for cross-disciplinary discussions of broad, significant issues that are not easily addressed. This forum, in turn, creates the necessary space for standards work. As we move forward, we can focus on finding opportunities to facilitate key discussions and promote a community-minded ethos of responsible growth within the regenerative medicine field.