September 5, 2024
Speakers: Bernard V. Fallon, Louisa Conklin, Ravi Kiron, PhD, MBA, Carolyn Ng, PhD, Ruchita Sinha, MBA
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…
![Investors](/sites/default/files/styles/bio_media_side_card_auto/public/2019-10/48944836107_a500b61ab2_w.jpg?itok=KWR9VdxU)
November 14, 2024
Speakers: Mackensie Vernetti
BIO One-on-One Partnering™ is back at the San Francisco Marriott Marquis for JPM Week 2025 and with 70% more meeting space! Attend 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…
![partnering](/sites/default/files/styles/bio_media_side_card_auto/public/2023-06/partnering_story.png?itok=cJcSdjHa)
![BIO 2024 BIF Conference logo](/sites/default/files/2024-08/bio_bif2024_logo_small.png)
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.
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Join this webinar to learn about the many exciting opportunities available at the 2024 BIO Asia-Taiwan International Conference & Exhibition. This live web event will cover:
- Overview of the event schedule
- Preview of conference sessions and programming
- Live demo of the BIO One-on-One Partnering system, including new features such as Optional Meeting – Participants, to enhance your business partnering experience
- Q&A with the speakers
Date: June 21, 9:00 a.m. Taipei Standard Time / June 20, 9:00 p.m. EDT
![Touchlight](/sites/default/files/2023-02/thumbnails%207.png)
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
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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.
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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.
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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.
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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.
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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.
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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
![Placeholder Image](/act-root/bio/assets/images/webinar-popup-default.jpg)
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.
![Balloon in storm clouds photo](/sites/default/files/2023-04/stormy-clouds-and-balloon.png)
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
![Loudspeaker and caution tape image](/sites/default/files/2023-04/illustration_of_cautious_communication_recrop.png)
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.
SEE COURSES LIST
![Lauriel Earley webinar screenshot](/sites/default/files/2023-05/lauriel_earley_webinar_screenshot.png)
Cell + Gene Therapy Science Series
An ASGCT collaboration with BIO and FDA
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), American Society of Gene & Cell Therapy (ASGCT), and FDA's 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.
Short and Long Read Sequencing for AAV Characterization
The inaugural CGT Science Series seminar focused on NGS characterization of AAV and was presented by Dr. Lauriel Earley.
Dr. Earley is a Senior Scientist with Shape Therapeutics who has been studying the basic biology of adeno-associated virus for over decade. During her graduate studies at Oregon Health & Science University, she examined the role of assembly-activating protein under the mentorship of Dr. Hiroyuki Nakai. After receiving her PhD, she joined Dr. Jude Samulski's laboratory at the University of North Carolina, Chapel Hill and took on a project to characterize the intrinsic promoter ability of the inverted terminal repeat sequences from various AAV serotypes. Dr. Earley joined Shape Therapeutics in 2019 and is currently leading their vector platform development team. In addition, Dr. Earley has been an active member of ASGCT since 2012 and is currently serving on the Patient Outreach Committee.
![Hourglass image](/sites/default/files/2023-04/long-covid-hourglass_1.png)
This is the first meeting in a series of conferences cohosted by the Biotechnology Innovation Organization (BIO) and Solve M.E. that are designed to foster a private-public engagement and create an R&D roadmap for diagnostics and treatments for Long COVID and Post-infection Diseases.
Objective: Convene stakeholders to advance R&D to diagnose and treat Long COVID and post-infection diseases to:
--Increase awareness among drug developers to the unmet need and business opportunity in these indications
--Establish a knowledge base of emerging research in Long COVID and existing body of data in other post-infection diseases (such as dysautonomia, myalgic encephalomyelitis/ chronic fatigue syndrome, mast cell activation, and others).
--Highlight potential biological targets for therapeutic and preventative approaches
--Engage experts and regulators to inform design of clinical studies
--Establish a pre-competitive collaborative network
Recorded on February 21, 2023. Part 1 of 3.
![Hourglass image](/sites/default/files/2023-04/long-covid-hourglass_1.png)
This is the first meeting in a series of conferences cohosted by the Biotechnology Innovation Organization (BIO) and Solve M.E. that are designed to foster a private-public engagement and create an R&D roadmap for diagnostics and treatments for Long COVID and Post-infection Diseases.
Objective: Convene stakeholders to advance R&D to diagnose and treat Long COVID and post-infection diseases to:
--Increase awareness among drug developers to the unmet need and business opportunity in these indications
--Establish a knowledge base of emerging research in Long COVID and existing body of data in other post-infection diseases (such as dysautonomia, myalgic encephalomyelitis/ chronic fatigue syndrome, mast cell activation, and others).
--Highlight potential biological targets for therapeutic and preventative approaches
--Engage experts and regulators to inform design of clinical studies
--Establish a pre-competitive collaborative network
Recorded on February 21, 2023. Part 2 of 3.
![Hourglass image](/sites/default/files/2023-04/long-covid-hourglass_1.png)
This is the first meeting in a series of conferences cohosted by the Biotechnology Innovation Organization (BIO) and Solve M.E. that are designed to foster a private-public engagement and create an R&D roadmap for diagnostics and treatments for Long COVID and Post-infection Diseases.
Objective: Convene stakeholders to advance R&D to diagnose and treat Long COVID and post-infection diseases to:
--Increase awareness among drug developers to the unmet need and business opportunity in these indications
--Establish a knowledge base of emerging research in Long COVID and existing body of data in other post-infection diseases (such as dysautonomia, myalgic encephalomyelitis/ chronic fatigue syndrome, mast cell activation, and others).
--Highlight potential biological targets for therapeutic and preventative approaches
--Engage experts and regulators to inform design of clinical studies
--Establish a pre-competitive collaborative network
Recorded on February 21, 2023. Part 3 of 3.
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Looking for an efficient and effective way to source new partnerships and manage your meetings for JPM Week 2023? View this webinar to learn more about how BIO One-on-One Partnering™ can help. Learn about BIO’s onsite meeting space in San Francisco, how to schedule your meetings with different location options, and a get a first look at the system’s newest feature – optional meeting participants. Also get a sneak peek at how you can stay in-the-know about networking and other opportunities during JPM week.
For more information and to register for BIO Partnering at JPM 2023, please visit: https://www.bio.org/events/bio-partnering-jpm/registration.
- Preview of BIO’s onsite meeting space in San Francisco
- Partnering best practices & how to schedule your meetings
- Live demo of the system’s latest feature – optional meeting participants
- Sneak peak of BIO and Novateur Ventures’ JPM Week Events Guide mobile app
- Q&A with the host
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As an emerging life sciences company, you are overseeing talented personnel and working on multiple projects all while managing overhead costs and staying up-to-date on the industry. The Biotechnology Innovation Organization (BIO) is here to make all of that a little easier and through your membership you receive access to benefits that will save you time and money, and stay current on all things happening in our industry.
This webinar details how your company can take full advantage of your BIO membership investment via the BIO Business Solutions cost savings program.
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In 2021, the United States government launched multiple international initiatives focused on issues at the intersection of climate, agriculture, and sustainable food systems. These initiatives are housed under the U.S. Department of Agriculture (USDA) and involve a cross section of government and non-governmental partners.
As part of the 2021 UN Food Systems Summit, the United States launched a Coalition for Sustainable Productivity Growth for Food Security and Resource Conservation (the SPG Coalition) with a goal to accelerate the transition to more sustainable food systems through productivity growth that optimizes agricultural sustainability across social, economic, and environmental dimensions.
Agriculture Innovation Mission for Climate (AIM for Climate/AIM4C) is an initiative launched at COP 26 and led by the United Arab Emirates and the United States. AIM for Climate is focused on addressing climate change and global hunger by increasing investment in, and other support for, climate-smart agriculture and food systems innovation over five years (2021–2025) and enabling greater public-private and cross-sectoral partnerships.
This webinar hosted by the Biotechnology Innovation Organization (BIO) provides an update on the status of the initiatives including a look ahead to COP 27 and beyond. In addition, USDA staff helping to lead this work discuss ways for private sector partners to engage in, support, and amplify the work of the SPG Coalition and AIM for Climate.
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On August 16, 2022, President Biden signed the Inflation Reduction Act of 2022, which includes a number of significant prescription drug-related provisions, including a new drug price negotiation program in Medicare, inflation rebates in Medicare Part B and Part D, and a redesign of the Medicare Part D benefit, with a new patient out-of-pocket cap of $2,000.
Leaders from the Biotechnology Innovation Organization (BIO) as well as experts from the Hogan Lovells Life Sciences & Health Care team provide detailed overviews with Q&A on these newly enacted provisions.
The webinar covers the new drug price negotiation program, inflation rebates in Medicare, the Medicare Part D benefit redesign, and new out-of-pocket cap, as well as other important provisions that will reduce patient cost sharing.
- Introduction and Context [0:00:00–0:03:53]:
John Murphy, Chief Policy Officer, BIO - Inflation Reduction Act Background [0:03:54–0:07:26]:
Crystal Kuntz, VP Health Policy and Research, BIO - Drug Price Negotiation Program [0:07:27–0:44:07]:
Ken Choe, Partner, Hogan Lovells - Medicare Part B and Part D Inflation Rebates [0:44:08–1:18:29]:
Alice Valder Curran, Partner, Hogan Lovells - Medicare Part D Redesign [1:18:30–1:53:05]:
Melissa Bianchi, Partner, Hogan Lovells - Conclusion and Next Steps [1:53:06–1:58:02]:
John Murphy, Chief Policy Officer, BIO Downloadable webinar slides at https://bit.ly/BIO-IRA-slides
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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.