December 12, 2023
Speakers: Mackensie Vernetti, Phillip Ebner , Christiaan Engstrom
Want to learn more about events happening during JPM Week 2024 and how you can better navigate (and survive) it all? Attend this webinar to get a grasp of all your options for networking and educational opportunities, hear from two panelists on how they approach this busy week,…


Big4Bio has heard your concerns loud and clear, and their pre-JPM Week/BioWeekSF online webinar, sponsored by BIO (Biotechnology Innovation Organization), is here to provide solutions and insights that will transform your JPM2024 experience.
The panelists are industry experts who understand your pain points and provided actionable solutions:
– Dawn Bell, PharmD, Founder/Director, Myracle Therapeutics
– Kimberly Ha, Founder & CEO, KKH Advisors
– Chris Garabedian, Chairman & CEO, Xontogeny
– Lindy Fishburne, Managing Partner, Breakout Ventures
and BIO Partnering at JPM Week context from
– Mackensie Vernetti, Vice President, Partnering, Biotechnology Innovation Organization (BIO)

View this conversation highlighting how BIO member companies are leveraging biotechnology innovations to enable advances in climate adaptation, mitigation, and resilience. Hear how diverse feedstocks and manufacturing processes are targeting emission reduction breakthroughs in hard-to-reach sectors. Learn how regulation and policy can better incentivize innovation and be structured to support new and emerging technologies throughout research, development, demonstration, and deployment.

It's been one year since the passage of the IRA. The Centers for Medicare & Medicaid Services has moved forward implementing the law's various provisions, including the new Medicare negotiation program and the redesign of the Medicare Part D benefit. Learn the latest developments from our panel of experts, including how the IRA is impacting biopharmaceutical companies today. Panelists delve into other important issues beyond the IRA, including new developments in Medicaid, 340B, and the emergence of Prescription Drug Affordability Boards in a number of states.

Following reauthorization by Congress of the SBIR/STTR Programs in 2022, there are new rules companies should familiarize themselves with concerning required disclosures of foreign affiliations or relationships with foreign countries. In addition to mandating disclosures prior to receiving SBIR awards, companies must also regularly update NIH following any changes to a disclosure. View this webinar organized by the Biotechnology Innovation Organization (BIO) for a comprehensive discussion on how to effectively navigate these new rules as you apply for SBIR awards.
This webinar is co-hosted by the National Institutes of Health (NIH) Seed Office.

With the majority of biological studies conducted in academic settings but nearly all innovative new drug clinical trials sponsored by industry, improving translational research success rates for commercialization is critical to bringing new treatments to patients. Surveys of academic tech transfer offices and the biopharma industry executives working on such alliances cite as obstacles two highly controllable factors: disagreement about alliance performance metrics and misalignment of deal terms priorities. This panel discusses best practices for removing such obstacles to accelerate more promising ideas into clinical development for patients.
BIO's updated 2023 report, "U.S. Biotechnology Translational Research: Partnership Models, Management Principles, and Best Practices," is available for download at the link below. The webinar also summarizes major findings from that BIO report as context for the panel discussion and audience Q&A.

The Cell and Gene Therapy (CGT) Science Series is a quarterly seminar series focused on scientific topics related to cell and gene therapy products. The CGT Science Series is intended to foster scientific exchange between the Biotechnology Innovation Organization (BIO), the American Society of Cell & Gene Therapy (ASGCT), and Center for Biologics Evaluation and Research (CBER) review staff on a variety of topics that span the CGT product lifecycle. The seminars are planned as 60-minute virtual webinars featuring a speaker from one of the three organizations. The CGT Science Series will enable a deep dive into a specific technical and/or scientific area. Topics in the series may include but are not limited to, nonclinical, CMC, clinical, or post-market phases of development related to CGT product lifecycle.
Moderator:
– Anne-Virginie Eggimann, Tessera
Opening Remarks:
– Cartier Esham, Chief Scientific Officer, Biotechnology Innovation Organization (BIO)
Speaker:
– Jing Liao, Director, Vector Development and Operations, Alexion Pharmaceuticals

This Biotechnology Innovation Organization (BIO) webinar explains that the days of the one-page marketing slicks are over, as companies and investors now expect brief “Pitch Decks” when engaging in conversations with them. This diverse panel of experts explain how to make an effective pitch to them, so that you can tailor your BIO partnering strategy to achieve a maximum ROI.

During this webinar, panelists discuss strategies for biotechnology companies to manage economic downturns and weakened investor interest in the biotech industry. Our expert panel of industry leaders share their insights and experiences on how to maintain momentum and emerge stronger during periods of economic uncertainty.
This webinar is designed to provide practical advice and actionable strategies that can be implemented immediately. The panel covers the following topics:
• Effective communication and investor relations strategies during economic downturns
• Actions biotechs can take to cut costs without sacrificing innovation and growth
• How to pitch to investors during weakened investor interest periods

U.S. Department of Justice (DOJ) statistics suggest that enforcement will be a top government priority in 2023, including for pharma/life sciences. Warning or untitled letters from the U.S. Food and Drug Administration (FDA) will serve as ammunition for DOJ cases. Statements about product safety will be heavily scrutinized.
Do you know what to watch out for? Has your company trained its employees and marketing agencies on how to appropriately implement the requirements for promotion? What activities require extra vigilance? The prior downturn in enforcement can be linked to the development of a response to COVID-19, which diverted government resources across the board. Now trends suggest the FDA, DOJ, and Office of Inspector General (OIG) will return to active healthcare enforcement in 2023 for violations of the Food Drug and Cosmetic Act (FDCA), False Claims Act and the Anti-Kickback Statute in part attributable to the goal of obtaining additional financial recoveries.
This webinar hosted by the Biotechnology Innovation Organization (BIO) has these learning objectives:
—Understand the current trends for government enforcement
—Dissect the compliance implications of increased enforcement on the industry
—Identify specific cases that are clear examples for company concern
—Isolate the key principles for avoiding violations
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FOR PROFESSIONAL DEVELOPMENT
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through May 15, 2023
in honor of this webinar!
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The COVID-19 pandemic has transformed the way we work, and the biotech industry is no exception. As the world recovers, companies are navigating a new landscape of changes in HR, office and lab space, and real estate. To help you understand and prepare for these changes, the Biotechnology Innovation Organization (BIO) convened this webinar, The New Normal: Post-COVID Workforce and Office Trends.
In this webinar, we cover:
--The changing biotech real estate market, rise of innovation districts, and what it means for your company
--How HR policies have evolved in response to the pandemic, including remote work and employee support programs
--Evolving workforce talent demands Changes in office and lab space design to ensure employee safety and productivity

Accepting the Status Quo: Subject Matter Eligibility Nearly a Decade after Mayo
This Biotechnology Innovation Organization (BIO) webinar discusses the reality that almost a decade after the Supreme Court’s decision in Mayo v. Prometheus, the current subject matter eligibility standard has become the status quo with little prospect for change. Speakers will discuss how innovators can best protect their technology under these circumstances, how subject matter jurisprudence has impacted the patent process, and whether incremental changes could improve the situation.

The Biotechnology Innovation Organization (BIO) and BioFlorida present "The Transformative Potential of Genomic Medicine 2.0." Genomic technologies create powerful tools that have the potential to diagnose, treat, and permanently subdue many human diseases. Technologies such as gene therapy, gene editing, and CRISPR are just some of the newest terms as researchers and clinicians work on new approaches to develop lifesaving, disease-altering treatments. This session provides in-depth discussion regarding how treatment is changing in rare diseases and the sickle cell community, and how public and private payers are approaching coverage of these crucial treatments. The session opens with statements from two legislators, then the panel features two patients and an expert in alternative payment models to provide information and answer questions from policymakers.
Representative Sam Garrison
Florida House of Representatives
House Health and Human Services Committee Republican Majority Whip
Senator Bobby Powell
Florida State Senate
Legislative Black Caucus Chair

Nearly 30 life science SPAC deals have closed or announced definitive agreements within the past year, helping private companies access new capital and public markets quickly. However, even recent traditions in SPAC deal terms continue to evolve because of statements from regulators regarding the accounting for warrants, shifts in investor expectations, and the availability of PIPE deal supporters, among other factors. View this Biotechnology Innovation Organization (BIO) webinar's discussion of best practices for negotiating SPAC deal terms in today’s market to maximize raising capital to serve biomedical innovation. Learn from the following deal-making experts as they answer audience questions during the session.
This session is part of the "Anatomy of a SPAC Deal" Webinar Series, sponsored by Chardan.

More than 60 public Special Purpose Acquisition Companies (SPACs) are currently seeking life science companies for merger deals. Join this Biotechnology Innovation Organization (BIO) webinar to learn which financial, scientific, and managerial characteristics are most appealing to SPAC sponsors and the critical factors biotech management teams should prioritize in reviewing SPACs as potential fundraising sources. Learn from the following deal-making experts as they answer the moderator's and the audience's questions during the session.
This session is part of BIO's "Anatomy of a SPAC Deal" Webinar Series, sponsored by Chardan.

Calculating the Benefits of Biotechnology Climate change is a clear and present danger to society. Industries and governments are taking action to confront this crisis, committing to sustainability goals that reduce environmental impact and improve the health and well-being of communities. To be confident in sustainability claims, it is critical to accurately calculate the environmental benefits of biotechnologies and how that value transfers through complex supply chains. Our BIO Impact webinar will explore efforts to promote consistent sustainability accounting, as well as highlight BIO members’ transformative innovations and the partnerships & collaborations that are leveraging the demands of climate mitigation and propelling a resilient biobased economy of the future.

Join the Biotechnology Innovation Organization (BIO) for an expert discussion on Section 112, focusing on the enablement of functional language. We'll review how this is playing out in district court litigation and in the PTAB and also discuss potential prosecution strategies. The discussion will focus on recent enablement-related cases, including Amgen v. Sanofi and the cases that led to that landmark decision.










