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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COMMUNICATIONS COMPLIANCE COURSES
FOR PROFESSIONAL DEVELOPMENT

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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 BIO International Convention attracts 14,000+ biotechnology and pharma leaders for one week of intensive networking to discover new opportunities and promising partnerships. Position yourself for success at this year's event, June 5-8, in Boston! This year, we unite to stand up for innovation, stand up for truth, and stand up for science. It’s time to inspire, honor, and recognize the true value of the breakthrough work biotech performs for society.

View this webinar to learn more about what’s happening at BIO 2023 and what the BIO One-on-One Partnering™ system can do for your business goals. Explore the program speakers & topics, networking opportunities, partnering system fundamentals, gain insight to best practices for partnering, and much more! For more information and to register for BIO 2023, please visit https://www.bio.org/convention 

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

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.

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

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.