Recorded on: May 25, 2021

Description: The presenters provide insight into how Pfizer delivered their safe, highly effective COVID-19 vaccine in less than a year — by treating the entire clinical development process as one protocol managed by one team — so you can, too. They’ll discuss:

• Why executive level support is essential in breaking down organizational barriers;
• How to compress cycle times using standardized metrics, machine learning, parallelization and other techniques;
• How risk management is critical to optimizations across the clinical trial continuum and is pivotal to balancing quality, cost and speed constraints; and
• How to centralize and coordinate activities across departments with technology, ultimately eliminating internal silos and building a team of one.

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Speakers: Ralph Russo, Senior Director and Global Head, Clinical Database Management Pfizer; Jonathan Rowe, Associate Principal, R&D Excellence, ZS Management Consulting; Keith Dorricott, MCC Ambassador, and Lead of the MCC Site Selection & Start-Up Process Metrics Development Work Group; and Elvin Thalund, Director, Industry Strategy, Oracle Health Sciences

Recorded on: May 20, 2021

Description: Thomas Altmann, global technical manager at Ecolab, will explain how cleaning processes can be evaluated using bench scale studies, sharing:

• How to improve or optimize cleaning processes using experiments;
• How to perform an assessment on all cleaning processes to determine the variable factors that influence cleaning effectiveness and performance;
• How laboratory bench scale studies can be used to identify an effective cleaning process; and
• How to evaluate lab trials and translate resulting data into manufacturing instructions and SOPs.

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Speaker: Thomas Altmann, Global Technical Manager, Ecolab

Recorded on: May 19, 2021

Description: Two members of King & Spalding’s FDA and Life Sciences practice give you an overview of the ASCA pilot, show you how to conform to it and use it to your advantage, explaining:

• Who may participate in the ASCA pilot;
• Pros and cons of participating;
• What participants can expect;
• Implications of the ASCA pilot moving forward; and
• What information is made available on pilot participants.

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Speakers: Quynh Hoang, Senior Regulatory Consultant in the FDA and Life Sciences practice at King & Spalding; and Elaine Tseng, artner in King & Spalding’s nationally recognized FDA and Life Sciences

Recorded on: May 6, 2021

Description: This webinar explains what’s coming, identifies the constraints and power shifts within the biotechnology industry and clarifies how you can adjust now so you can move ahead. You’ll learn:

• What clinical trials will look like after the safety restrictions are lifted;
• Which trends will not survive (but should!); and
• Who will call the shots when trials restart.

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Speaker: James Allgood, Product Marketing, Egnyte for Life Sciences

Recorded on: May 5, 2021

Description: Natalie Weber, a quality engineer at MasterControl, Inc., explains the new landscape of remote audits, clarifying:

• How to achieve the same goals during remote audits;remote audits are conducted and what they include;
• Why digitizing is the only way to perform remote audits; and
• Regulators’ attitudes toward remote audits.

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Speaker: Natalie Weber, Quality Engineer, MasterControl, Inc.

Recorded on: April 21, 2021

Description: Two lawyers in Ropes & Gray’s Life Sciences Regulatory and Compliance practice explain what can be gleaned from the forthcoming pandemic-influenced guidances impacting drug development, real-world evidence and digital health. They’ll discuss:

• Regulatory framework for biosimilars and possible changes with planned FDA guidance addressing labeling, promotion, interchangeability and exclusivity;
• Drug exclusivity framework and possible changes with planned FDA guidance addressing 180-day exclusivity, pediatric exclusivity and three-year exclusivity;
• Current state of real-world evidence in drug development, key open questions and planned FDA guidance addressing regulatory considerations with the use of real-world data to support FDA decision-making for drugs and biologics; and
• Emerging topics related to drug development and anticipated FDA guidance addressing decentralized clinical trials, substantial evidence and breakthrough therapy designation.

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Speakers: Kellie Combs, Partner, Ropes & Gray’s Life Sciences Regulatory and Compliance Practice; and Sarah Blankstein, Senior Associate, Ropes & Gray’s Life Sciences Regulatory and Compliance Practice

Recorded on: April 15, 2021

Description: This webinar will help you determine whether an eTMF system is the right choice for your team. Through expert advice and tips, you’ll gain insights into:

• The five signs of eTMF readiness;
• eTMF features and functions;
• Predictors of eTMF success;
• The time and money savings from an eTMF; and
• Building support for an eTMF initiative.

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Speaker: Ken Lownie, Head of North American Operations, Agatha

Recorded on: April 8, 2021

Description: With this webinar, you’ll be able to determine the differences between traditional medical device regulations and software as a medical device (SaMD) regulations. It covers:

• The unique and novel risks software-intensive medical devices pose to the healthcare system;
• Difficulties and benefits that can come from SaMD versus 510(k) compliance;
• How automated RegOps could reduce preparation time for FDA submissions; and
• How building regulatory practices directly into the systems development lifecycle could ease inspection and audit burdens.

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Speaker: Shahid Shah, Founder of Netspective Communications

Recorded on: April 6, 2021

Description: Eric Henry addresses the defense of cybersecurity during facility inspections and product submissions in light of the latest regulatory literature, including:

• How cybersecurity relates to design controls and the quality system more generally;
• Key tips for defending cybersecurity during an FDA inspection or notified body audit, even when the investigator or auditor is not familiar with cybersecurity concepts;
• How addressing cybersecurity risk relates to product risk management; and
• What regulatory literature currently exists globally and some of the ways they compare to each other.

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Speaker: Eric Henry, Senior Quality Systems and Compliance Advisor in the FDA and Life Sciences practice of the law firm King & Spalding

Recorded on: March 24, 2021

Description: Tom Comstock presents LNS Research’s latest findings on the intersection of Industrial Transformation (IX) and Quality 4.0 specific to life sciences organizations, including pharmaceutical, biotechnology, medical device and more. He discusses:

• How you can improve your quality monitoring and outcomes;
• Why your data and its analysis are core to both Industrial Transformation IX and Quality 4.0;
• The role of executive leadership in transformation and the quality team as a key business partner; and
• What the leading cause of failure is in meeting your quality objectives and how you can avoid it.

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Speakers: Tom Comstock, Principal Analyst, LNS Research; Stephen McCarthy, Vice President of Digital Innovation, Sparta Systems