December 5, 2024
Speakers: Mackensie Vernetti, Ali Ardakani, Hemmie Chang, David Del Bourgo, Donna L. LaVoie
Want to learn more about events happening during JPM Week 2025 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 panelists on how they approach this busy week and…
BIO One-on-One Partnering™ is back at the San Francisco Marriott Marquis for JPM Week 2025 and with 70% more meeting space! View this webinar to hear about how BIO’s partnering system can help you source new partnerships and manage your meetings for JPM Week. Learn about BIO’s onsite meeting space in San Francisco, tips and tricks for using the system, and how to schedule your meetings with different location options. Also, get a look at how you can stay in-the-know about networking and other opportunities during JPM Week. For more information about BIO Partnering at JPM Week, please visit: https://www.bio.org/events/bio-partnering-jpm/registration
This webinar covers:
- Preview of BIO’s onsite meeting space in San Francisco
- Partnering best practices & how to schedule your meetings
- Live demo of the partnering system & advanced features
- Intro to BIO and Novateur Ventures’ JPM Week Events Guide mobile app
- Q&A with the host
So far, 2024 biotech markets and funding are trending better than last year, but volatility is on the upswing. Join this webinar to hear experienced perspectives on what investment signals to be watching to position yourself for a strong springboard into closing out the year before JPM Week restarts the cycle. This webinar will also preview the panel topics and speakers for the upcoming BIO Investor Forum as well as demonstrate how best to utilize the event’s BIO One-on-One Partnering System to connect with investors and more.
More than $4B of deals between biopharma companies and AI specialists were announced last year. Similar to the massive quality leap from GPT-2 to GPT-4 and the record-breaking consumer adoption rates of AI tools, that same exponential progress and uptake is coming to biotech AI. 2024 may bring the first one-trillion-parameter protein language model. Companies are already using AI to program, as opposed to discover, antibodies. This level of opportunity and change brings with it urgency—— companies need to rethink from the ground up how their R&D should work to compete in a new era defined by the intersection of biology, data, and AI.
In this webinar, learn how companies are updating their approach to R&D, with a focus on:
- AI-Ready Data: Improving generation of high-quality biomedical data to support AI model building and model tuning
- AI-Enabled Scientists: Integrating the right models directly into scientists’ workflows for everyday use
- Scalability: Making performance, speed, privacy, and cost tradeoffs for deployment of AI, and connecting the wet and dry labs
The FDA has established the Split Real-Time Application Review (STAR) pilot program. The purpose of this program is to shorten the time from the date of a complete submission to the action date, in allowing earlier patient access to therapies that address an unmet medical need.
In this webinar, FDA staff will give an overview of the program, including the eligibility criteria for the pilot, and will answer your questions about participating in the program.
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, Senior Advisor, 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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BIO, CSBA, and AdvaMed hosted a special briefing to discuss the success of SBIR/STTR programs, their economic impact, and the important next steps to Federal reauthorization.
The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs are highly competitive award-based programs that encourage domestic small businesses to engage in Federal Research/Research and Development with the potential for commercialization.
Federal funding for the SBIR/STTR Program will expire on September 30, 2022, and we need your support to ensure timely reauthorization! Hear from successful SBIR/STTR grantees and technical experts on these vital programs. After this webinar, you will be able to effectively advocate for Federal SBIR/STTR program reauthorization.
- Opening Remarks: Overview and Department of Defense Priorities
- Investing at the Speed of Need: Novel Technologies and Platforms to Accelerate Drug Development
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.
- 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.