FDA regulatory expert Jim O’Reilly discusses how the FDA plans to implement the variety of provisions in the 21^st Century Cures Act and how those plans will affect manufacturers. He covers:

• How the FDA Science Board's new standards can lead to much faster product development approvals; 
• How the FDA will allocate the $500 million authorized by Congress; and
• The role of the agency’s new Office of Translational Sciences, which governs the bench-to-clinical process.

Speaker: Jim O’Reilly, Professor, University of Cincinnati College of Medicine

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European regulatory expert James Pink provides a deep dive into the new EU medical device regulations, including its 22 articles on clinical evaluation and investigation. He discusses:

• New requirements for documentation confirmation and updating;
• New separate software rules;
• Stricter requirements for implantable devices; and
• Possible sanctions for devicemakers who are not ready to comply with the new rules.

Speaker: James Pink, Vice President, NSF Health Sciences Medical Devices, Europe

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Informed consent expert Susan Brink discusses strategies for implementing an electronic informed consent system. Topics include:

• Broad v. dynamic consent;
• Integration with other systems; and
• The process of setting up an eConsent system.

Speaker: Susan G. Brink, Executive Vice President, e-consent Products and Services, Enforme Interactive, Inc.

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Patient recruitment experts David Borasky and Amanda Plucinak present strategies for expediting study recruitment. They discuss:

• How to develop data to understand why studies are behind schedule and over-budget;
• How to use proven strategies and tactics to improve your patient recruitment numbers;
• How to foster awareness of the importance of implementing  appropriate effort into creating a recruitment plan for a study; and
• How to comply with new GDPR requirements.  

Speakers: David Borasky, Vice President, IRB Compliance, WIRB-Copernicus Group; Amanda Plucinak, Quality Assurance Manager, ThreeWire

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Supply chain analyst Hedley Rees advises on the most effective techniques for forecasting and managing clinical trial materials needs. Topics covered include:

• Mapping the end-to-end physical flow of the supply chain;
• Key information flows in the supply chain; and
• Prerequisites for successful delivery of drug to site.

Speaker: Hedley Rees, Managing Consultant, Pharma Flow

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Clinical research compliance experts Jennifer Mallory and Carrie Hanger provide an overview of changes in the Common Rule set to take effect in January 2019. They discuss:

• Broad consent for secondary research;
• Limited and continuing IRB review;
• Exemptions;
• Federalwide assurances; and 
• Cooperative research.

Speakers: Jennifer Mallory and Carrie Hanger, partners, Nelson Mullins Riley & Scarborough

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Clinical trial contracting experts Suzanne Caruso and Brooke Millman discuss negotiating and finalizing site contracts to ensure that you begin your next study holding all the cards: quick startup, decreased costs, no unnecessary terms and conditions that cause hassles and delays. They cover:

• Start-up dates, deadlines, and schedules;
• Necessary and avoidable costs and expenses;
• Air-tight provisions that avoid hassles and complications;
• Enrolling patients to expedite trials and time to market; and
• Payment terms and conditions that meet your budget.

Speakers: Suzanne Caruso, Vice President, Clinical Solutions, and Brooke Millman, Vice President, Consulting Solutions, WIRB Copernicus Group

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Clinical trial specialists Kari Lotsberg and Fabian Sandoval discuss the value of having staff dedicated solely to patient recruitment. They cover:

• The five stages of recruitment;
• Recruitment problems that can stem from lack of time; and 
• Benefits of a community recruitment strategy.

Speakers: Kari Lotsberg, Manager of Site Services, ThreeWire; Fabian Sandoval, CEO & Research Director at Emerson Clinical Research Institute.

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A panel of clinical trial experts discusses the implications and opportunities presented by the developing field of gene therapy. They talk about:

• How genetic testing is being used in clinical trials;
• How precision medicine is making trial protocols more complicated; and
• Expertise and infrastructure needed to collect genetic information.

Speakers: Lindsay McNair, Chief Medical Officer, WIRB-Copernicus Group; Jill Johnston, President, Site Support & Management for Clinical Services, WCG; Karmen Trzupek, Director of Clinical Trial Services and Director of Ocular and Rare Disease Programs, InformedDNA

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IT experts Brian Mundy and Steven Beales discuss the importance of using clinical trial portals. Topics include:

• How clinical trial portals enable you to differentiate yourself from your competition with potential Big Pharma and VC partners;
• How to demonstrate you’ve got the technology solutions in place to efficiently meet milestones, deadlines, and startup times for your clinical trials; and  
• How to attract the top sites to participate in your clinical studies.

Speakers: Brian Mundy, Director of Product Strategy, and Steven Beales, Senior Vice President of IT, WCG ePharmaSolutions

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