Recorded on: Feb. 17, 2022

Description: If you’re involved in developing gene and cell therapy products, the FDA and other regulators have made it clear: comparability studies are essential to product approval. This webinar explains:

• FDA requirements for comparability studies for gene and cell therapy products;
• Best practices for risk analysis and mitigation using comparability studies;
• How to design an effective comparability protocol for a gene or cell therapy product; and
• How to construct a statistical approach to comparability.

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Speakers: Scott R. Burger, Principal, Advanced Cell & Gene Therapy; William E. Janssen, Principal, WEJ Cell and Gene Therapy Consulting Services

Recorded on: Feb. 16, 2022

Description: Using the legal and scientific methods he developed over 30 years, Baker & Hostetler partner Lance Shea shares his straightforward framework and methods so you can:

• Assess the reliability of data, information or evidence and the weight they provide for regulatory or litigation decisions;
• Evaluate the persuasive strength of such data, information or evidence;
• Direct the development of evidence to support requests for or responses to regulatory actions; and
• Guide the advocacy of product performance evidence to address regulatory, litigation and policy issues.

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Speaker: Lance Shea, Partner, Baker Hostetler

Recorded on: Feb. 15, 2022

Description: Experts Steve LoSardo and Mariya Boychuk explore what you can expect to see in the coming year and provide examples of life science organizations that are managing this growth well. They cover:

• The impacts of COVID-19 on digital health;
• What the term “digital health” means;
• Technology for clinicians, including AI-driven diagnostic tools; and
• Key factors to consider in building a digital health solution.

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Speakers: Steve LoSardo, Vice President of Life Science Solutions and Consulting, and Mariya Boychuk, Senior Business Analyst, SoftServe

Recorded on: Jan. 20, 2022

Description: This webinar helps answer your biggest questions about new and forthcoming changes to FDA policies and personnel. The panel will discuss:

• The major FDA issues, challenges and accomplishments of 2021;
• The priorities for the new FDA commissioner in 2022;
• The priorities for the FDA medical centers in 2022 as they transition to a new normal; and
• Provisions to be included in user fee legislation and how they will affect daily business.

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Speakers: Wayne Pines, President, Healthcare, APCO Worldwide; Kevin Madagan, Partner, Life Science Health Industry Group, Reed Smith; Nancy Myers, CEO and Founder of Catalyst Healthcare Consulting; Dave Fox, Partner, Hogan Lovells; Jeff Gibbs, Director, Hyman Phelps & McNamara

Recorded on: Jan. 20, 2022

Description: Mike Jovanis shares digitization opportunities and proven best practices that will help you drive proactive quality management across quality and manufacturing. You will learn:

• How digital transformation enables companies to pursue quality excellence;
• Opportunities to unify and streamline systems and processes; and
• Best practices from leading companies to enable proactive quality management.

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Speaker: Mike Jovanis, Vice President of the Vault Quality product suite for Veeva

Recorded on: Jan. 13, 2022

Description: Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, explains how to build a quality culture within your organization. She shows you how to:

• Define the leadership objectives that must be at the root of quality initiatives;
• Achieve buy-in so that employees accept and adhere to product integrity and ethical standards;
• Manage product lifecycles, with an open discussion of quality hazards in each stage of business; and
• Promote — and gain wide acceptance for — collaboration, and how to pick your team.

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Speaker: Susan Schniepp, Distinguished Fellow, Regulatory Compliance Associates

Recorded on: Jan. 12, 2022

Description: Legal and regulatory experts Kristin Davenport, Rujul Desai and Christina Kuhn detail the avenues that you can take to achieve a successful premarket review from the FDA, including:

• FDA premarket review pathways;
• Breakthrough device designation and STeP; and
• Medical coverage of innovative technology (MCIT) pathway.

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Speakers: Kristin Davenport, of Counsel, Covington & Burling LLP; Rujul Desai, of Counsel, Covington & Burling LLP; and Christina Kuhn, Associate, Covington & Burling LLP

Recorded on: Jan. 11, 2022

Description: Susan M. Proulx, PharmD, Managing Director, Drug Safety at Leaderboard Branding is an international leader in preventing medication errors due to brand name confusion. During this webinar she shares:

• How the prescreening process relates to attributes that may contribute to medication errors in naming drugs;
• Suggested methods of evaluating the risk of medication errors related to naming;
• The FDA process for notifying applicants that have similar names in the FDA queue; and
• The phonetic and orthographic computer analysis (POCA) criteria and its use in evaluating name similarity.

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Speaker: Susan M. Proulx, PharmD, Managing Director, Drug Safety at Leaderboard Branding

Recorded on: Dec. 15, 2021

Description: Explore the legal and regulatory risks that reviewers may spot when assessing marketing materials. You’ll learn about:

• FDA regulations and guidance related to digital and virtual promotion and marketing tactics;
• The future of promotions and marketing; and
• Red flags and risk areas that legal and regulatory reviewers may spot when assessing virtual promotion materials.

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Speakers: Susan Lee, Partner, Goodwin’s Life Sciences Group and FDA Practice; and Elizabeth Mulkey, Senior Associate, Goodwin’s Technology and Life Sciences Group and FDA practice

Recorded on: Dec. 14, 2021

Description: With this expert advice, you’ll eliminate confusion around defining extractables and leachables and learn to determine which regulatory requirements apply. This webinar covers:

• The specifics of what constitutes an extractable or leachable;
• Evaluating USP guidelines and industry standards;
• How to design an extractable and leachable program that meets your development goals and addresses regulatory requirements; and
• Frequent analytical challenges associated with extractables and leachables.

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Speaker: Kevin Wells, Group Leader, Eurofins BioPharma Product Testing-Columbia