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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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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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.
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.
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.
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.
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.
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.
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
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.