Life Sciences Luncheon and Forum - Regulatory Landscape: Changes at the FDA and Impacts on Devices and Drugs
Join NCLifeSci members for a networking luncheon and panel discussion on the Regulatory Landscape: Changes at the FDA and Impacts on Devices and Drugs.
- Anna Abram, senior advisor, Akin
- Juliana Blum, chief executive officer, BioAesthetics
- Cartier Esham, chief executive officer, Esham Strategies and executive director, Alliance for a Stronger FDA
- Megan Robertson, attorney, Epstein Becker Green (moderator)
- Charity Schuller, executive director, regulatory affairs, and head, regulatory intelligence and delivery, PPD, part of Thermo Fisher Scientific
Thank you to our event sponsors.
Agenda
| May 15 | |
| 11:30 AM - 11:40 AM | Check-in/Registration |
| 11:40 AM - 12:10 PM | Networking Lunch |
| 12:10 PM - 12:20 PM |
Welcome and Sponsor Remarks
Laura Gunter, president, NCLifeSci |
| 12:20 PM - 1:25 PM |
Regulatory Landscape: Changes at the FDA and Impacts on Devices and Drugs
Anna Abram, senior advisor, Akin Juliana Blum, CEO, BioAesthetics Cartier Esham, CEO, Esham Strategies and executive director, Alliance for a Stronger FDA Megan Robertson, attorney, Epstein Becker Green (moderator) Charity Schuller, executive director, regulatory affairs, and head, regulatory intelligence and delivery, PPD, part of Thermo Fisher Scientific |
| 1:25 PM - 1:30 PM |
Closing Remarks
Laura Gunter, president, NCLifeSci |
| 1:30 PM - 2:00 PM | Extended Networking |
Anna Abram, senior advisor, Akin
Abram is a respected health policy thought leader who advises a range of clients in health care with a particular focus in life sciences. Her policy experience includes more than a decade on Capitol Hill, including serving as Sen. Richard Burr’s health policy director at the Senate HELP Committee, as well as serving as the FDA’s deputy commissioner for policy, legislation and international affairs and as an associate director at the White House. Abram is a graduate of the University of Pennsylvania.
Juliana Blum, chief executive officer, BioAesthetics
Blum spent over 20 yrs as the co-founder of Humacyte, leading the development, management and execution of a commercial scale bioengineering platform, eventually transitioning the start up to a public company in 2021. Currently, she is the CEO of BioAesthetics, an early stage company developing novel tissue grafts that are transformed with various drug eluting polymers to treat and repair multiple types of wounds, surgical injuries and soft tissue reconstructions. Blum is also an executive in residence at the North Carolina Biotechnology Center where she provides entrepreneurial mentoring and coaching for the early stage companies in the Center’s loan portfolio. She sits on the board of directors of inSoma Bio. Blum received her B.S. from Carthage College and Ph.D. in molecular biology and cardiovascular gene therapy from Loyola University.
Cartier Esham, chief executive officer, Esham Strategies and executive director, Alliance for a Stronger FDA
Esham works to empower thought leadership, disrupt the status quo and advance innovative health policy solutions. Prior to launching her own firm, she served as the chief scientific officer at the Biotechnology Innovation Organization where she managed and directed BIO’s policy development, advocacy, research and educational initiatives. Esham has over 20 years of health policy experience. Prior to BIO, she was a vice president and director of research at Dutko Worldwide where she worked on a variety of environmental, education, science, technology and health care related issues on the federal, state, and local levels. Esham has a Ph.D. in microbiology from the University of Georgia, a master’s degree in marine biology from the University of North Carolina at Wilmington and a bachelor’s degree from the University of Kentucky.
Megan Robertson, attorney, Epstein Becker Green
Robertson's background allows her to understand the unique compliance challenges faced by, and the development opportunities available to, companies in the life sciences industry. These include drug and device (and combination product) manufacturers, digital health and software product developers, clinical laboratories, research sponsors, clinical research sites, and contract research organizations. Medical devices are a key focus area for Robertson, including evaluation of the regulatory status of software and other digital products, particularly those involving artificial intelligence-enabled functions. She also coordinates due diligence efforts on behalf of private equity firms to perform risk-based regulatory and compliance assessments of investments in these types of businesses. She is also co-lead of Epstein Becker Green’s Clinical Laboratories Focused Initiative and regularly advises lab clients and stakeholders on state and federal compliance considerations. Robertson has an undergraduate degree in genetics from Clemson University.
Charity Schuller, executive director, regulatory affairs, and head, regulatory intelligence and delivery, PPD, a part of Thermo Fisher Scientific
Schuller has over 20 years of experience at PPD Clinical Research Business of Thermo Fisher Scientific. She oversees regulatory intelligence, policy, advocacy, publishing and country regulatory solutions. Schuller provides strategic consultation to clients on global development strategies and interpretation of regulatory guidelines. Previously, she held roles in regulatory affairs in academia and industry. She has a bachelor's degree in chemistry from West Virginia Wesleyan College, a PharmD from West Virginia University and M.S. in clinical research from Campbell University.
NCLifeSci members must register online. You will need to create a login to your new member portal in order to sign up for the forum.
If you are not a member and are interested in learning more, please contact NCLifeSci Membership Director Natacha Janvier.
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