Subject to change
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The speakers will briefly describe their experiences with negotiating PRV terms in license agreements, and how PRvs factor into their research programs.
The speakers will then delve into the nuts and bolts of some successful strategies each has used to negotiate reasonable and mutually acceptable revenue sharing terms for Priority Review Vouchers (PRVs) in agreements, particularly exclusive license agreements. We will also discuss ways of determining what each party contributed to the clinical development of the drug of interest that may be eligible for a PRV in the future and carefully thinking about “unique” market considerations such as extremely small patient populations, or disproportionally affects poor and marginalized populations.
The panelists will discuss the following guidelines during the panel discussion:
Strategies for maximizing life science commercialization in view of such heightened standards
IP protection strategies
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Join us for a panel discussion examining approaches to technology partnering with global health organizations to widen market channels and increase access to medical products in underserved markets. The panel will discuss how funding and licensing collaborations between non-profit, multilateral, and industry partners can achieve meaningful and measurable improvements in equitable, global access, without diminishing commercial opportunities. You will hear practical guidance on access-oriented agreement terms, as well as real-world examples of implementing global access partnerships, and metrics for measuring their success beyond revenue generation.
Venture capitalists and universities got together for over 1-1/2 years and hashed out a template License Agreement that, if adopted by more universities and investors, could greatly speed up negotiations. The template agreement allows for negotiations around issues of particular importance to the parties but uses standard definitions and traditional compromises to make the process more efficient and effective. This is just the beginning of a deal-making trend that you need to know about!
The panel will bring together speakers from a philanthropic venture fund/foundation, technology transfer office of an academic institution, a research and drug development company, and a private equity investment fund. The panel will explore the economic, scientific, social and even personal interests the parties have in funding and carrying out translational research. From funding of early stage research at an academic institution to drug development and commercialization at a biotechnology company, the panel will address the roles of funding from a disease-focused philanthropic venture fund and private equity investment. How transactions between the funders and research organizations can support drug development and also benefit the various stakeholders. The panel will consider successful strategies for structuring transactions between the parties that will lead to therapeutic development and optimal economic benefits for all.
The life sciences industry has been among the most active sectors for licensing activities and transactions in recent years. Cutting-edge technological developments are transforming food, drugs, and cosmetics. Life sciences companies are subject to a wide range of regulatory requirements. This panel will discuss how regulatory landscape may impact deal making. In particular, the session will look at some unique regulatory issues in the U.S. and Canada, including the new Modernization of Cosmetics Regulation Act of 2022 (MoCRA) that was signed into law on December 29th, 2022.
Pharma Partnering Reputation Survey and Life Sciences Sector Meeting
Ryan Coe, Partner of the Triangle Insights Group, will present findings from the most recent Pharma Partnering Reputation Survey, highlighting most favored partners across the pharma landscape. Sector Leadership will also provide updates on sector activities, and lead into sector networking.
Join us at a game show styled presentation on written description and enablement issues for U.S. patents and what innovators and defendants can do in this everchanging patent environment. Exciting prizes to be won – Game on!!
The Inflation Reduction Act of 2022 (the IRA or the Act) is poised to reshape Medicare pricing, the reimbursement of drugs, commercial practices, and the drug development landscape in the biopharmaceutical industry. Life sciences deal makers need to understand the Act’s intricacies and implications in order to successfully navigate this changing environment. This workshop will provide a brief overview of the IRA’s drug price negotiation program and follow that overview with a discussion that analyzes the impacts of the Act on licensing transactions from the perspective of global pharmaceutical companies (typically licensees), biotech companies and academic institutions (typically licensors), and venture capitalists. The aim of the workshop will be to provide attorneys and other deal makers with knowledge of both IRA drug pricing issues and the contractual levers available to help them find solutions and close licensing deals.
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Merger and acquisition activity in the biopharmaceutical industry declined dramatically on both a volume and value basis in 2022. However, biopharmaceutical licensing and collaboration deals have fared better with overall values increasing slightly over the prior year. Given current economic and regulatory uncertainty, biopharma companies appear to be placing greater emphasis on licensing partnerships as opposed to acquisitions.
Notably, the portion of life science partnership deals relating to preclinical assets has been increasing steadily over the past several years. These preclinical assets are often platform technologies including everything from cell and gene therapies to digital assets and devices. The complexity of these promising new technologies can lead to larger and more complex intellectual property portfolios consisting of not just multiple patents but also trade secrets and know-how.
This panel will discuss approaches for partnering around increasingly complex assets at various stages of development.
Marc Maladro, Vice President at CZI, Mike Perham, Director of Innovations at HHMI’s Janelia Research campus, and Arden Yang from the Allen Institute in Seattle will discuss the increasingly important role that non-governmental funding plays in bioscience and computational research, how these institutions balance openness to collaboration and dissemination of basic science technologies, and other priorities to their institutes. Privately-funded institutes like these have more flexibility in their technology management and licensing programs, but also missions that may be unique to a founder’s vision. They also increasingly fund top researchers producing fundamental discoveries and technologies that spread through the non-profit and industrial scientific enterprise.