2023 Agenda

Our 2023 event has concluded.
We are currently working on our 2024 event, but in the meantime, feel free to look over our 2023 agenda to see who spoke and what topics were discussed.
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- At a Glance
- Day 1
- Day 2
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Day 1 - Tuesday, March 21, 2023
7:45 |
Breakfast and Registration |
8:45 |
Opening Remarks from the Co-Chairs |
9:00 |
Welcome to the BioPharma Revolution: 60 Minutes on the Intersection of Science, Business, Policy, and the Law |
10:00 |
Keynote |
10:30 |
Understanding Pre-Commercialization Concerns Relative to the Products of the New BioPharma Revolution |
11:30 |
Morning Networking Break |
11:45 |
INTELLECTUAL PROPERTY PRACTICE POINTSManaging and Monetizing Patent Portfolios: Identifying Business Opportunities and Revenue Generation Through IP |
12:45 |
Networking Luncheon |
2:00 |
mRNA and CRISPR Patent Wars: What Every Life Sciences Business Executive and Counsel Need to Know |
3:00 |
The Freedom to Operate: Assessing Competitors, Mapping Opportunities, and Mastering the IP Due Diligence Process for New Modalities |
4:00 |
The Pathway from Idea to Regulatory Approval: Considerations for Clinical Trial Applications and Regulatory Clearances |
5:00 |
Conference Adjourns to Day Two |
Day 2 - Wednesday, March 22, 2023
7:45 |
Breakfast and Registration |
8:30 |
Opening Remarks from the Co-Chairs |
8:45 |
Business Considerations and New Approaches to Financing and Capital Formation for Transformative Products |
9:45 |
Searching for Sustainability: The Top ESG Challenges and Opportunities for the BioPharma Revolution |
11:00 |
Morning Networking Break |
11:15 |
CASE STUDYReal World Examples on Leveraging the Power of AI, ML, Automation and Data for the Development of Better Medicines |
12:15 |
Keynote |
12:45 |
Networking Luncheon |
2:00 |
CASE STUDYFrom Idea to Commercialized Product: Collaborations and Partnering in BioPharma |
3:00 |
ETHICSEthical Considerations for Precision Medicines: Emerging Ethical, Legal and Social Concerns Related to Trends in Precision Medicine |
4:00 |
Conference Concludes |
Day 1 - Tuesday, March 21, 2023
7:45 |
Breakfast and Registration |
8:45 |
Opening Remarks from the Co-Chairs![]() Christine Bellon ![]() Sharick Naqi |
9:00 |
Welcome to the BioPharma Revolution: 60 Minutes on the Intersection of Science, Business, Policy, and the Law![]() Julie Wu ![]() Catherine A. Brandon ![]() Rebecca K. Wood In this opening session, panelists will provide an overview of the driving force behind the BioPharma revolution and explain the opportunities it offers by detailing the design and delivery of new medicines and therapies, including gene therapy, cell therapy, CAR-T, and bispecific and RNA treatments.
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10:00 |
Keynote![]() Julia Tierney Industry is navigating several debilitating roadblocks, including a human talent shortage that falling behind the rate of technological advancement. |
10:30 |
Understanding Pre-Commercialization Concerns Relative to the Products of the New BioPharma Revolution![]() Cambria Alpha-Cobb ![]() Aaron Pereira ![]() Rana Sawaya Moderator:![]() Ryan Hagglund Despite the efficacious promise of these new modalities and their potential for commercial success, the next generation of therapies continue to face challenges that can limit their widespread consideration and commercialization. This session will consider pre-commercialization concerns for design and delivery of new medicines and therapies, including gene therapy, cell therapy, CAR-T, and bispecific and RNA treatments. Points of discussion will include:
Regulatory Considerations:
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11:30 |
Morning Networking Break |
11:45 |
INTELLECTUAL PROPERTY PRACTICE POINTSManaging and Monetizing Patent Portfolios: Identifying Business Opportunities and Revenue Generation Through IP![]() Eldora L. Ellison ![]() John Haugen Moderator:![]() Jonathan S. Caplan
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12:45 |
Networking Luncheon |
2:00 |
mRNA and CRISPR Patent Wars: What Every Life Sciences Business Executive and Counsel Need to Know![]() Anne Gussow ![]() Kelly Morgan ![]() Dan Liu ![]() David Diamond Moderator:![]() Irena Royzman Patent fights rarely demand the attention of the industry the way one battle has, and one battle may. After numerous skirmishes in the district courts, the latest round of the CRISPR battle took place before the USPTO’s PTAB which ruled each party completed on the gene editing tech doesn’t overlap and can be separately patented. Additionally, the two leading COVID-19 vaccines on the market, introduced by Moderna Inc. and BioNTech SE are currently the subject of major patent litigations relating to how those therapies are delivered. The implications of these cases are not only for the lawyers in the room – as this panel will provide an overview of these battles and detail the critical business implications which they present. Topics of discussion will include:
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3:00 |
The Freedom to Operate: Assessing Competitors, Mapping Opportunities, and Mastering the IP Due Diligence Process for New Modalities![]() Todd Spalding ![]() Chuck Sholtz ![]() Brian W. Nolan Moderator:![]() William B. Raich More companies are investing heavily in the IP rights attempting to cover the revolutionary technologies driving the biopharma revolution, while simultaneously embarking upon equally aggressive licensing programs. Thus, anyone intending to use these new technologies and therapies must be wary of investing without thorough and robust IP due diligence. As these clashes over IP begin to play out, clever participants are paying close attention and taking stock of the outcomes, as they will inform best practices for the freedom-to-operate analysis the ability to commercialize inventions. Points of discussion will include:
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4:00 |
The Pathway from Idea to Regulatory Approval: Considerations for Clinical Trial Applications and Regulatory Clearances![]() Jason Bablak ![]() Deborah Cho ![]() Charles G. Raver ![]() Deborah Hursh FDA has issued draft guidances addressing the development of the new modalities driving the biopharma revolution. These guidances offer recommendations on the information that should be included in an Investigational New Drug (IND) application. During this regulatory session, points of discussion will include:
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5:00 |
Conference Adjourns to Day Two |
Day 2 - Wednesday, March 22, 2023
7:45 |
Breakfast and Registration |
8:30 |
Opening Remarks from the Co-Chairs![]() Christine Bellon ![]() Sharick Naqi |
8:45 |
Business Considerations and New Approaches to Financing and Capital Formation for Transformative Products![]() Michael B. Harlin ![]() Thomas S. Brennan ![]() Patrick Perry Over the past five years, the biopharma industry has seen billions of dollars invested in therapeutic-based biopharma companies. VC investors appeared to be focusing on next-gen therapies, precision medicine, machine learning, and new delivery methods. However, even more recently, investors are leaving the space and longtime venture firms are funding less. As investors and companies alike attempt to navigate a new world of falling valuations, this session will offer winning strategies for new approaches to financing and capital formation. Points of discussion will include:
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9:45 |
Searching for Sustainability: The Top ESG Challenges and Opportunities for the BioPharma Revolution![]() Squire Servance ![]() Laurie A. Burlingame Sustainable financing has grown in popularity in recent years, as more institutional investors and funds incorporate Environmental, Social and Governance (ESG) investing tactics. Thus, those wishing to participate in the biopharma revolution must prepare to answer for their companies’ ESG impact to capture investment capital and prepare for potential new regulatory requirements.
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11:00 |
Morning Networking Break |
11:15 |
CASE STUDYReal World Examples on Leveraging the Power of AI, ML, Automation and Data for the Development of Better Medicines![]() Karlheinz Skowronek ![]() Ken Nesmith Moderator:![]() David Kim Artificial intelligence (AI), machine learning (ML), automation, and data analytics have the potential to improve many areas of medicine, with drug development and discovery as a principal focus. The use of these technologies can make drug development faster, cheaper, and more efficient.
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12:15 |
Keynote![]() Kendalle Burlin O’Connell, Esq. |
12:45 |
Networking Luncheon |
2:00 |
CASE STUDYFrom Idea to Commercialized Product: Collaborations and Partnering in BioPharma![]() Lauren Pignataro Rakitin ![]() Jared Auclair While smaller biotechnology companies are typically undertaking early stage research and perhaps even early clinical development in-house, the industry continues to see partnerships between big pharma and biotech in later stage development and commercialization. These collaborations are key to long-term success in the industry, as big pharma is able to provide capital and later-stage expertise and market access, while biotechnology companies are the crux of innovation. This session explores common legal and business issues at- stake in negotiating these collaborations or partnerships, such as:
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3:00 |
ETHICSEthical Considerations for Precision Medicines: Emerging Ethical, Legal and Social Concerns Related to Trends in Precision Medicine![]() Kevin E. Noonan ![]() Mercedes K. Meyer Precision medicine offers many potential advancements in patient care. However, these advanced therapies raise several ethical, legal and social concerns.
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4:00 |
Conference Concludes |