The New World of Medtech Collaborations – Watershed Developments in IP Valuation, Regulatory and Data Protection that are Reshaping the Deal-Making Landscape in the US, UK and Europe

Anisa Mohanty advises medical device, biotech and pharmaceutical companies on US Food and Drug Administration (FDA) premarket strategy and post-market compliance issues, from advertising and promotion to disclosure and periodic reporting. Her experience encompasses such matters as premarket pathways, Good Laboratory Practice and Good Clinical Practice and Good Manufacturing Practice (cGMP) and Quality System requirements.

She offers guidance to her clients on the regulatory requirements and industry standards for the development, creation and review of advertising and promotional materials for drugs and medical devices. Anisa also supports investors and companies on scoping and developing appropriate due diligence strategies for transactions and investments involving FDA-regulated drugs, medical devices and other products.

Her tenure as a Regulatory Counsel at the FDA now provides valuable perspective for clients in the life sciences industry. During her time with the organization, Anisa advised agency policymakers, regulatory and enforcement personnel on the development and implementation of a new regulatory regime for tobacco products as well as the development of interpretative guidance and regulatory policies. She was also responsible for counseling compliance and enforcement personnel on matters related to product labeling, advertising and marketing; conducting routine and directed inspections of manufacturing establishments and investigations of distribution and marketing activities; and coordinating enforcement actions.

Sharon Lamb focuses her practice on transactional and regulatory advice in the health and life sciences sector.

Sharon advises on global transactional mandates, including mergers and acquisitions and joint ventures in health services, pharma and life sciences, digital health and health data technologies.

Sharon also provides strategic, regulatory and commercial support to UK and international clients on UK health and life sciences with a focus on health services, pharmaceuticals, medical devices, digital health and health data. Sharon is widely recognized for her expertise on NHS and public law regulatory and contracting matters, including payment and reimbursement and market access. She works closely with international technology and life sciences companies on regulatory issues relating to pharmaceuticals, medical devices, digital health and health data protection. She has particular experience advising strategic and private equity investors in transactions and investments in health and life sciences.

Sharon is also well-versed in health care services governance and regulatory matters, NHS public private partnerships, procurements, joint ventures and shared working arrangements, mergers, acquisitions, health data and competition issues.

Charles (Chuck) Larsen provides clients sophisticated multijurisdictional counsel in intellectual property portfolio strategy, transactions and disputes, with a particular emphasis in bioengineering and the medical technology space. He is licensed to practice before the US Patent and Trademark Office (USPTO), the European Patent Office (EPO), US District Court, and the courts of England and Wales.

He conducts IP due diligence in the US and Europe with an emphasis on transatlantic patent validity, infringement and freedom to operate studies. He actively supports clients in US and European patent disputes including Patent Trial and Appeal Board (PTAB) proceedings, reexams, EPO oppositions and litigation.

Chuck also has extensive experience in transactional IP matters, including transaction structuring and portfolio due diligence for investments and acquisitions, and negotiating collaboration license agreements, joint ventures and other strategic commercial contracts involving key IP assets.

Chuck has advised on a wide range of technology in engineering and life sciences, including bioengineering and medical technology, pharmaceuticals, microfluidics, drug delivery, machine learning, signal processing, combustion and energy. In the medical technology sector, his experience has involved a wide range of technologies, including intravascular devices, respiratory systems, orthopedic implants, cellular therapy, tissue engineering, neuromonitoring, spine technology, electrical stimulation, healthcare informatics, DNA sequencing, software driven devices, biological manufacturing and diagnostics.