Archives: Speakers

Multilingual professional with 15+ years experience with informatics & digital technology in the pharmaceutical / biotechnology industry. With university degrees in Bioinformatics and in Clinical R&D, Hassan has a great mix of pharmaceutical industry Drug Discovery and Clinical Operations knowledge and Informatics. He has contributed in driving forward the vision of patient centricity and digital health at BI by promoting the Remote Clinical Trial model, and implementing several innovative digital health technologies in Clinical Trials to drive Patient Centricity. A great communicator with superb interpersonal skills, Hassan regularly interacts with key stakeholders to provide innovative solutions to critical problems. He is highly motivated in constantly seeking to improve processes and efficiency while driving innovation, and acts as a key contributor to multiple projects. Over the years, he has developed experience working in a global organization that requires collaboration with multidisciplinary international partners and is an invited guest speaker in several global Pharmaceutical and Clinical R&D conferences. Hassan is an active contributor to Transcelerate and the Clinical Trials Transformation Initiative (CTTI).

Rhonda Mecl recently became the Deputy Program Director after serving as the Program’s Operations Staff Director for the previous five years.   She has a wealth of knowledge and experience having served more than 24 years in ORA managing staff and operations focused on medical devices, radiological health, and MQSA.  She facilitates policy and procedure development within OMDRHO and collaborates with medical product partners in the Office of Medical Product and Tobacco Operations, and with peers throughout CDRH during daily operations and on special projects.  Rhonda has more than 30 years of experience in FDA, starting as an ORA Investigator in Portland, OR before becoming a manager located in FDA’s Minneapolis office. 

Marc has 20+ years of Biopharmaceutical experience overseeing global clinical supply chain activities for oncology and rare disease clinical programs. Cold chain logistics experience in managing clinical supply inventory in the US, APAC, EU, US and AU regions.

Jenifer Shahan McIntosh counsels clients on privacy, data security, and data governance. She has significant experience with legal, operational, and reputational risk guidance, particularly as it relates to compliance initiatives, EU & UK clinical trial privacy requirements, product design, mergers, acquisitions, and tech transactions. She counsels clients on domestic and international privacy laws and regulations, including cross-border data transfers.

Jenifer has an extensive and diverse background in commercial litigation, including complex contract and licensing disputes, patent litigation, business torts and regulatory investigations defense—all of which she brings to her privacy and data security work. Her cybersecurity experience includes working with clients to stand-up security programs, helping clients establish robust privacy-by-design in product development, advising and guiding clients in the conduct of cyber and data governance due diligence during M&A transactions, and advising on vendor and licensing agreements regarding the transfer and security of data. She has advised leading pharmaceutical trials companies, private equity firms, SaaS service providers, health-tech, ad-tech, and e-commerce clients on privacy and data security issues in technology-driven transactions.

Jenifer is a Certified Information Privacy Professional for for the United States (CIPP/U) and licensed in New York, Colorado and Texas. Prior to her relocation to Dallas, she served as in-house counsel for a clinical trials company and web-based educational technology company. Jenifer has been quoted in the Law360 on legislation regarding privacy and big-tech tracking, and is a prolific writer on international and domestic privacy and data security law developments.

Will Newton is a Senior Reporter for Clinical Trials Arena and GlobalData Healthcare, focusing on clinical trial design, healthcare business and regulation, and new technologies. Now based in New York City, he previously covered diabetes drug development at Close Concerns’ industry-facing publication in San Francisco. William holds a BA in Economics from Williams College.