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Market Access Best Practices: Focus on Digital Health 2020


Speaker(s): Adam McArthur, Erin Bell, Hannah Murfet, Julia Weisberg, Kelly Sieben, Lesley Maloney, Rachel S Turow, Rujul Desai, Sarah Cowlishaw
Recorded on: Aug. 5, 2020
PLI Program #: 300651

Lesley R. Maloney, Pharm.D., is Head, U.S. Regulatory Policy for Roche Diagnostics.  In that role, she is responsible for guiding Roche Diagnostics’ regulatory policy efforts in the United States.  In addition, she is also responsible for global regulatory policy efforts related to digital health.  Prior to joining Roche Diagnostics, she worked for the U.S. Food and Drug Administration in the Office of the Commissioner, where she served in various roles, including Deputy Chief of Staff, Senior Policy Advisor, and Deputy Associate Commissioner for External Affairs.  Dr. Maloney holds a doctor of pharmacy degree from the University of Oklahoma and did an Executive Residency in Association Leadership and Management at the American Society of Health-Systems Pharmacists.   


Julia Weisberg is Senior Corporate Counsel, Global Regulatory and Patient Safety.  Julia started in this role as part of the newly formed Patient Data & Privacy Law group following Bristol Myers-Squibb’s recent acquisition with Celgene Corporation.  In this capacity, Julia is the lead lawyer supporting BMS’s Global Regulatory & Safety, Global Drug Development organization.  Prior to this role, Julia was Senior Counsel, US Market Access, R&D Strategic Collaborations, and WW Commercialization.  In this capacity, she advised on and negotiated managed care contracts to ensure open access across all BMS marketed products, provided legal support to the global medical team handling multi-national academic center research collaborations, and advised the global field force capabilities and training organization.  Julia started at BMS as Counsel, US Commercial Law & Compliance, serving as a commercial and regulatory lawyer supporting multiple oncology products.   In her roles supporting multiple parts of BMS, Julia has served on leadership teams for US Market Access and WW Patient Safety, serving as a strategic partner directly delivering practical, effective, and innovative legal solutions to support business needs while mitigating and defending against legal risks to enable the delivery innovative medicines to patients.  Prior to joining BMS, Julia was an associate at Pepper Hamilton, LLP in Philadelphia, representing pharmaceutical and health care clients in products liability, white collar, and regulatory matters in a variety of areas, including potential off-label marketing of products, violations of the Anti-Kickback or Anti-Bribery Statutes. Julia holds a J.D. from Temple University, Beasley School of Law and a B.A. from the Pennsylvania State University, Schreyer’s Honors College.


Adam McArthur is Assistant General Counsel at AstraZeneca and has over 15 years in-house experience in the life sciences sector.

Adam has global responsibility for a team supporting M&A, Business Development and Technology Transactions across AstraZeneca’s business units.


The group covers the most significant transactions and projects for the organisation, from traditional IT outsourcing and licensing to innovative digital health and AI deals, developing digital therapeutics and leveraging software as a medical device. Work covers complex cross-jurisdictional transactions and contentious matters.

Adam previously worked at Novartis in Basel, Switzerland and in private practice in the UK.

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. From a Digital Health perspective, AstraZeneca’s focus is on science driven digital therapeutics, developing differentiated digital solutions that drive health improvements and better outcomes for our patients.


Erin Bell is an Assistant General Counsel at Pear Therapeutics, Inc. Prior to Pear, Erin was at Sunovion Pharmaceuticals, where she served as Sr. Counsel for the Psychiatry Franchise Commercial and Medical teams. Erin also served as Corporate Counsel at PerkinElmer, where she supported multiple medical device businesses that ranged from lab developed testing assays and instruments to cord blood banking. Erin started her legal career as a prosecutor with the Middlesex District Attorney’s Office. In her free time, Erin enjoys planning adventures and day trips with her toddler, running 5Ks and sampling craft beers.


Hannah Murfet is a Senior Compliance Manager at Microsoft Research Ltd in Cambridge, where she is responsible for managing the health data compliance program. She works collaboratively with the research teams to ensure regulatory compliance across a number of projects, predominately focused in the area of artificial intelligence in healthcare.

Hannah’s experience included a range of medical technologies, having worked in both biotech and medical device start-up companies prior to joining Microsoft.

Hannah has experience in both medical device and information governance compliance, as applied to considerations for use of health data and machine learning. She is also an Honorary Fellow of the PHG Foundation, and as part of this regularly speaks and writes about topics such as algorithms as medical devices and black-box medicine.

LinkedIn: www.linkedin.com/in/hmurfet


Kelly Sieben is Divisional Privacy Program Owner at Microsoft in the Seattle area. He has a passion for driving high-value, customer focused experiences and solutions as well as extensive experience in enterprise-wide customer focused solution delivery and program management for technical and non-technical processes related to marketing, privacy compliance, governance and escalation/incident response programs. 


Rachel Turow is Associate General Counsel, Regulatory Law & Policy at Teva Pharmaceutical Industries Ltd. In this role, Rachel provides regulatory legal support to Teva’s specialty pharmaceutical business, and supports Teva’s drug-device combination products and digital health projects. She works with Regulatory Affairs, project and brand teams, the US businesses, Business Development, Government Affairs, and lifecycle management. She counsels clients on a wide range of FDA regulatory matters through all phases of the product lifecycle, and provides strategic advice on FDA legal and policy issues affecting Teva’s products.  In addition, Rachel is the US Head of Regulatory Policy for Teva.

 

Previously, Rachel was Director, Regulatory Policy, at Novo Nordisk Inc. Prior to joining Novo Nordisk, Rachel spent five years at FDA in policy roles.  She was a Regulatory Counsel in CDER’s Office of Regulatory Policy where she responded to citizen petitions and wrote guidance documents and regulations.  She also sat on CDER’s 505(b)(2) committee, the working group to implement the DQSA, and was the office’s subject matter expert on combination products, fixed-combination drugs, Rx-to-OTC switches, and administrative procedures to withdraw approval of drugs.  When she started at FDA she served as Special Assistant to Jeff Shuren, Director of CDRH, where she supported the Center on MDFUA reauthorization, innovation initiatives, and responded to various issues on Capitol Hill.

 

Rachel began her legal career as a corporate lawyer at United Therapeutics Corporation where she handled the panoply of legal matters that arise at a startup biopharmaceutical company.  Rachel holds a JD and MPH from the University of Michigan and a BA in Biology from Stanford University.  She is a mom to three boys and is passionate about dark chocolate.

 


Rujul Desai is Of Counsel in Covington & Burling's regulatory health care practice group, based in Washington D.C.   He advises clients across a wide range of global market access issues, including strategies for new product launches, pricing and reimbursement, payer formulary access, value-based contracting, distribution network design, patient access and affordability programs, e-prescribing, digital health, and the use of health economic data and modeling for the promotion of drugs, devices, and diagnostic products.


Sarah Cowlishaw is a Partner in the life sciences group at Covington & Burling LLP, based in London.  Her practice focuses on regulatory and commercial law, with a particular focus on digital health.  She advises major national and multinational technology, pharmaceutical and biotechnology, diagnostic, medical device and consumer product manufacturers on a wide range of regulatory, compliance, transactional and legislative matters.  Sarah serves as one of the leaders of Covington’s multidisciplinary Digital Health Initiative, which brings together the firm’s considerable resources across the broad array of legal, regulatory, commercial and policy issues relating to the development and marketing of digital health technologies.