Recorded on: Sept. 21, 2022

Description: Three members of King & Spalding’s FDA and Life Sciences practice — two of whom are FDA veterans — use hypotheticals and role play to highlight best practices for sponsors to spot and mitigate high-risk issues related to the integrity of clinical data and its uses before and after product approval, as well as in crisis management, explaining:

• How disruptions brought on by the COVID-19 pandemic opened the door for unintended and deliberate breaches of the development of clinical data;
• Recent trends in FDA warning letters that signal a shift from the agency’s focus during the pandemic to the emerging “new normal” of scrutiny and inspections related to the development of clinical data and its integrity; and
• New modes of FDA enforcement, including those related to sponsor disclosure of clinical results on ClinicalTrials.gov.

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Speakers: Beverly Lorell, MD, Senior Medical and Policy Advisor, King & Spalding; Peter Leininger, Partner, King & Spalding; Mark Brown, Partner, King & Spalding

Recorded on: Sept. 20, 2022

Description: Medidata’s Olgica Klindworth, senior director of R&D, and Anne Rosenberg, director of RBQM solution services, explain how to make the data in your DCTs and modern trials work for you, enabling you to:

• Take control of the increasing volume and velocity of data within today’s clinical trials and use it to your advantage;
• Understand the common myths around data quality oversight in decentralized and hybrid clinical trials so you can increase clinical trial success; and
• Recognize and implement tools for executing effective and efficient clinical monitoring strategies as part of modern clinical trials.

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Speakers: Olgica Klindworth, Senior Director, R&D, Medidata; Anne Rosenberg, Director of RBQM Solution Services, Medidata

Recorded on: Sept. 20, 2022

Description: Today’s design and quality experts take a different approach to designing high quality medical devices. Industry experts discuss:

• Overcoming the costly impact of ineffective requirements management;
• Meeting compliance challenges with closed-loop digital traceability throughout the development and design process;
• Encouraging a proactive and risk-based approach to prevent the occurrence of problems in advance of its manifestation; and
• Using the collected data from a QMS to make proactive and informed decisions.

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Speakers: Sandra K. Rodriguez, Senior Industry Analyst, Axendia; Jeffrey Caltrider, Principal Engineer with R&D New Product Introduction, Enterprise Life Sciences Company; Vinod Nela, Leader Supply Chain & Network Operations, Deloitte Enterprise Performance; Nikki Willett, CSO/VP of Industry Solutions & Digital Transformation, ComplianceQuest

Recorded on: Sept. 15, 2022

Description: With a new commissioner and his staff on board at the FDA, with PDUFA VII about to be implemented, with a new normal developing as the pandemic wanes, there will be significant changes at the FDA that will affect every stakeholder. The speakers share:

• What new provisions in the user fee legislation will affect your daily business;
• Importance of the recent drug importation guidance and the impact of new  guidances;
• How key personnel changes at FDA will impact you; and
• Impact of drug-related “crises” on CDER’s approach to R&D and approvals.

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Speakers: Wayne L. Pines, Member of International Advisory Council and President of Healthcare, APCO Worldwide; Deborah Livornese, Director, Hyman, Phelps & McNamara, P.C.; Lowell M. Zeta, Partner in the Life Sciences and Global Regulatory, Hogan Lovells US LLP; Eva Temkin, Partner, King & Spalding FDA and Life Sciences; Kevin M. Madagan, Partner, Reed Smith

Recorded on: Sept. 14, 2022

Description: This webinar dives into the impact data strategy alignment can represent and how digital maturity awareness can help life science companies get a jump start on omnichannel engagement. You’ll learn:

• Why leveraging structured data through omnichannel is a best practice — and how to transform your unstructured data;
• Why breaking down silos and disparate systems can accelerate omnichannel success by increasing internal alignment and awareness to harmonize the digital experience platform (DXP);
• How using AI, ML, and NLP can enhance the RWD insights you need for your brand; and
• How segmentation targeting through synchronized channels with personalized engagement can increase market access, brand loyalty, and drive ROI.

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Speakers: Steve LoSardo, Vice President, Life Science Solutions and Consulting, SoftServe; Georgi Bilyukov, Director, Digital Experience Platforms, Centers of Excellence, SoftServe

Recorded on: Sept. 13, 2022

Description: Trial master file expert Laura Wiggins takes the stress out of your TMF inspection preparedness, explaining how to organize and mobilize your team for a smooth inspection. You’ll learn:

• How to overcome the main challenges of inspection preparedness, including lack of experience with regulatory inspections, lack of understanding regarding records requirements and poor documentation;
• What to do when you’re missing TMF documentation, don’t have a study team or when you’ve had a lack of study oversight; and
• How to use strategic thinking models.

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Speaker: Laura Wiggins, TMF Services Project Manager, Just in Time GCP

Recorded on: Sept. 8, 2022

Description: Get control of your data by learning the basics of developing best practices and SOPs that turn inspection nightmares into routine management tasks. You’ll cover:

• The legal basis of FDA records access authority, including what FDA can’t access;
• Types of documents commonly requested during inspections;
• Problems and pitfalls to avoid; and
• The Top 10 questions to ask about your archival process.

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Speaker: David L. Chesney, Principal, General Manager, DL Chesney Consulting, LLC

Recorded on: Aug. 25, 2022

Description: Without proper due diligence, life sciences companies may wind up with a returned product that does not meet the necessary standards for quality. This webinar covers:

• Regulatory requirements for raw material suppliers;
• Definitions of differ types of materials;
• Different risk attributes; and
• How to consider risk attributes to manage suppliers using a risk-based approach.

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Speaker: Bob Mehta, Principal Consultant, GMP ISO Expert Services

Recorded on: Aug. 10, 2022

Description: This webinar enables you to understand and comply with the FDA’s gene and cell therapy requirements and avoid common errors, so you can maintain your products’ critical quality attributes and bring them to market. You’ll learn:

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

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

Recorded on: Aug. 9, 2022

Description: Legal and regulatory expert Michael Gaba details 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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Speaker: Michael Gaba, Vice Chair of FDA Practice, Polsinelli