PDURS: 7 Experts to Follow As the Draft FDA Guidelines Progress

Want to keep current on the FDA’s Draft Guidelines for Prescription Drug Use Related Software (PDURS)? Follow the LinkedIn profiles of these professionals at the forefront of integrating digital health solutions with pharmaceutical products affected by PDURS.

PDURS: The Agency Perspective

Martin Culjat, PhD, Eversana – Martin Culjat is the Senior Vice President and Global Head of Digital Medicine and Regulatory Innovation at EVERSANA. He leads initiatives on the commercialization and regulatory strategy for digital medicine products. With a background in biomedical engineering, Dr. Culjat has a wealth of experience in navigating complex regulatory environments and bringing innovative digital health solutions to market. Follow Martin on LinkedIn.

PDURS: The Managed Care Perspective

Susan Cantrell, AMCP –  Susan is CEO of the Academy of Managed Care Pharmacy (AMCP), which applies clinical and scientific evidence to support the appropriate use of medications to enhance patient and population health outcomes while optimizing use of limited health care resources.  The AMCP has asked the FDA for clarifying language around the use of clinical trial requirments in PDURS.  Follow Susan on LinkedIn

PDURS: The Pharma Perspective

Edward Cox, Pfizer – Ed Cox is the Head and General Manager of Digital Health and Medicines at Pfizer. His role involves integrating digital health technologies with pharmaceutical products to enhance patient outcomes and streamline drug development processes. He has a strong background in both the pharmaceutical industry and digital health, making him a key player in the intersection of these fields. Follow Edward on LinkedIn

PDURS: The Patient Perspective

Omri Shor, Medisafe – Omri is Founder and CEO of Medisafe, the global leader in patient medication and journey management with more than 12 million registered users, in 26 languages with a behavioral AI database approaching 50B data points. Realizing that no solutions work if patients don’t use them, Shor built Medisafe from idea to market leader with millions of patients, multi-million dollar revenue, dozens of employees and massive value to shareholders, specializing in technology solutions that not only attract but retain and engage patients using digital.  Follow Omri on LinkedIn

PDURS: The Legal Perspective

Tina Papagiannopoulos, Foley Hoag – Lucy is counsel at Foley Hoag in Washington, DC, assisting clients with a variety of regulatory, policy, and compliance matters related to the (FDA), with a primary focus on therapeutics. An expert in counseling clients on effective engagement with the FDA through formal agency meetings, public comment and petitioning processes. She also provides subject-matter expertise on various litigation and transaction matters involving life sciences companies. Follow Tina on LinkedIn.

PDURS: The Trade Group Perspective

Andy Molnar, DTA – Andy is Chief Executive Officer, Digital Therapeutics Alliance (DTA),  a trade organization focused on the needs of the clinically validated digital therapeutics industry. Before joining DTA, Andy worked in leadership roles with industry companies Cognoa and Pear Therapeutics, focusing on how to commercialize software as a medical device (SaMD) products, generating meaningful evidence for payors, commercial planning, and working with various government agencies and trade organizations to update policy for reimbursement. Follow Andy on LinkedIn

PDURS: The Researcher Perspective

Lucy Vereshchagina, PhRMA – Lucy is Senior Vice President, Science & Regulatory Advocacy a the Pharmaceutical Research and Manufacturers of America (PhRMA), which has recommended the FDA consider clearer definitions and distinctions between promotional and non-promotional labeling to avoid unnecessary compliance complexities in teh final PDURS guidelines. Follow Lucy on LinkedIn.