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
ON-DEMAND
COMMUNICATIONS COMPLIANCE COURSES
FOR PROFESSIONAL DEVELOPMENT
Special Discount
Buy 2 course registrations, Get 1 FREE
through May 15, 2023
in honor of this webinar!
The Center for Communication Compliance (CCC) helps biopharmaceutical companies achieve efficient, compliant innovation in a digital world through its proprietary on-demand business solutions in education, technology, and change management.
The CCC eLearning System has set an unmatched standard for confirming regulatory competency through engaging mastery tests and expert education content across more than a dozen course options.
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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

- Repurposing and Redirecting: An Alternate Approach to Accelerating Medical Countermeasures
The US Government invests in biomedical research in many ways, including direct funding of some critical R&D areas for diagnostics, vaccines, and therapeutics that could strengthen biodefense preparedness. This BIO-hosted webinar details for the biotechnology corporate and academic community the many new and previously available sources of capital, as well as the processes for applying for funding, from the US Department of Defense.
The Department of Defense (DoD) is continuously engaging in efforts to protect the warfighter from a broad array of threats. Preparing for and responding to these threats requires key partnerships with the industry to develop vaccines, therapeutics, and diagnostics that are designed specifically to meet the unique needs of the warfighter in various situations. Many of the investments made through these partnerships also support broader applications of key biotechnologies for other unmet healthcare needs. This important webinar represents an opportunity for BIO members and the whole biotechnology community to get an update about the priorities and programs within the DoD and the ways companies can work with the Agency on their priorities.

How to Work with the Department of Defense
The US Government invests in biomedical research in many ways, including direct funding of some critical R&D areas for diagnostics, vaccines, and therapeutics that could strengthen biodefense preparedness. This BIO-hosted webinar details for the biotechnology corporate and academic community the many new and previously available sources of capital, as well as the processes for applying for funding, from the US Department of Defense.
The Department of Defense (DoD) is continuously engaging in efforts to protect the warfighter from a broad array of threats. Preparing for and responding to these threats requires key partnerships with the industry to develop vaccines, therapeutics, and diagnostics that are designed specifically to meet the unique needs of the warfighter in various situations. Many of the investments made through these partnerships also support broader applications of key biotechnologies for other unmet healthcare needs. This important webinar represents an opportunity for BIO members and the whole biotechnology community to get an update about the priorities and programs within the DoD and the ways companies can work with the Agency on their priorities.

The Biotechnology Innovation Organization (BIO) presents this webinar to hear from top Big Pharma professionals in search & evaluation licensing and venture investing about what it takes to get them interested in a new technology. We look at their recent deals and ask why they got done, explore the challenges and learn what makes a technology exciting. Then we dive into a discussion on what tech/modalities and platforms are seen as exciting. Finally, we get advice for those biotechs that are ready for licensing or investment.

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.

The Biotechnology Innovation Organization (BIO) hosts this candid chat with three major investors from our biotechnology community. Gain valuable insights and be ready to ace pitching world-changing solutions in the face of a down-trending market at the 2022 BIO International Convention, June 13-16, in San Diego, California.
For more details visit http://bio.org/convention
Introduction from Mike Liccardo, VP Corporate Development and CFO, ShareVault

Biotech Intellectual Property Law in Focus: Webinar Series
Navigating Parallel BPCIA and PTAB Proceedings – Recent Developments and Strategic Considerations
This panel hosted by the Biotechnology Innovation Organization (BIO) discusses relevant case law and trends in BPCIA litigation and related PTAB proceedings, followed by a “roundtable” on the factors that may influence litigation strategy, early case resolution, and market entry.

A private biotech that announces a definitive agreement with a SPAC jumps into the public investor spotlight and faces that attention with fewer guardrails than the IPO process, plus a need to transform board, investor, and regulatory relations. Given that most SPAC merger deals also involve follow-on PIPE investment rounds or other transactions, the full fundraising benefits of the deal strategy require a smooth de-SPAC process that a private biotech would never have encountered before. View this webinar to learn best practices for navigating from SPAC deal announcement through de-SPAC process to regular life managing a publicly traded company.

Innovation flourishes when science and consumer values are aligned and complement one another. Regulatory approaches towards innovative products cannot exist in isolation. They should be supported by credible transparency measures. A proactive approach to transparency stands to build trust and foster an inclusive environment to address our most pressing societal, nutritional, and environmental concerns. This webinar will explore the meaningful – and sometimes unexpected- actions and partnerships that are growing trust in the innovation ecosystem and delivering access to innovations that benefit people and the planet.

New algorithms and optical system improvements are expanding the frontier of cell imaging quality. Artificial intelligence techniques enable better visualization of cellular mechanisms in a wide number of applications and across multiple scientific disciplines, including advancing neurological research. View this Biotechnology Innovation Organization (BIO) webinar as it highlights how AI and imaging are being used to improve our understanding of complex and notoriously intractable disorders such as Alzheimer’s, Dementia, and related diseases. Learn from the following imaging and therapeutic development experts as they answer audience questions during the session.










