In this first of a four-part podcast series on the science, regulatory framework, commercial transactions, and privacy and data security considerations of each unique aspect of the current health crisis, Michael Ward, MoFo partner and global head of the firm’s Life Sciences Group and Patent Group, discusses the issues, among other topics, with:
- James Mullen, partner, founder, and head of MoFo’s Antibody Patent Group, and head of the San Diego Patent Group: What exactly is COVID-19 and why does it spread so quickly? Where did the name for the coronavirus originate? How does COVID-19 compare to the flu? What kinds of tests are available, and what can they tell us? What causes test-result delays?
- Bethany Hills, partner and head of MoFo’s FDA Regulatory + Life Sciences Compliance practice: What types of COVID-19 tests are there on the market? How do Emergency Use Authorizations (EUAs) work to lower the barrier for products to make it to market? How many EUAs has MoFo secured for its clients, and how long did they take?
- Matt Karlyn, partner in MoFo’s Commercial Life Sciences Transactions + Licensing Group and in the firm’s Technology Transactions practice: The many pharma, biotech, and tech companies collaborating to test, treat, and track COVID-19 are joining forces faster than usual. When cloud based technologies are involved, MoFo often starts with assessing the criticality of the service and the sensitivity of the data that will be used, stored, or processed. What contingencies do supply agreements need to address? If the collaborations don’t achieve their strategic objectives, what happens to the data?
- Kristen Mathews, partner in MoFo’s Global Privacy + Data Security practice: Can employers require employees to take COVID-19 tests? How must they protect the test results and how do U.S. Equal Employment Opportunity Commission guidelines and state laws apply?
James J. Mullen III
James combines his scientific experience with his legal training in his practice to craft commercially relevant solutions for his clients’ intellectual property challenges. He is the founder and head of MoFo’s Antibody Patent Group and leads the Patent Group in the San Diego office.
As a patent prosecutor, James is well versed in obtaining focused patent protection that provides a commercial advantage in the marketplace. More ›
Bethany J. Hills
Bethany advises her life sciences business clients on both pre- and post-market issues, including everything from FDA submissions and communications strategies to post-approval compliance and reimbursement issues. Her clients include medical device, drug, combination product, diagnostic, biologic, and regenerative medicine, cosmetic, dietary supplement, and food industry companies, and the investor groups focusing on these industries.
Bethany leverages her deep FDA regulatory experience and exceptional knowledge More ›
Matthew A. Karlyn has 23 years of experience in working with companies in the healthcare, pharmaceutical, medical device, and technology industries on a wide range of commercial life sciences, licensing, and technology transactions. His clients range from Fortune 100 companies to start-ups, and he regularly advises companies on matters involving IP commercialization, complex collaboration transactions, licensing initiatives, subscription-based economics, and business transactions related to More ›
Kristen J. Mathews
Kristen is a partner in our Global Privacy + Data Security Group. For more than 20 years, Kristen’s practice has focused on advising clients on the full spectrum of the most complex privacy and cybersecurity issues, including regulatory and compliance matters. An early leader in the privacy sphere, Kristen has developed comprehensive knowledge and long-term perspective, cultivated a client base across a broad range More ›
Michael R. Ward
Michael R. Ward is global head of the firm’s Life Sciences Practice Group, head of the firm’s Patent Practice Group, co-chair of the firm’s Intellectual Property Practice Group and co-chair of our global AgTech + Food Industry practice.
Dr. Ward is widely recognized as one of the world’s leading agriculture IP lawyers. As the founder and head of the firm’s Plant Intellectual Property Group, Dr. More ›