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Utilizing Digital Health Data to Improve Management, Prevention & Wellness May 05, 2020

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Given the increase in focus on digital health and connected device development to improve "patient centricity" and the user experience, there is a large amount of clarity and evidence needed on how to truly ladder in these efforts to achieve the uiltimate outcome for patients. The answer lies in leveraging the power of contextualized, extrinsic data that while readily available given the acceleration of technologies and tools available today, are not readily apparent to connected therapeutic ecosystems as a whole - patients, clinicians, and developers of products and solutions. This podcast, first recorded at the 2019 PODD: Partnership Opportunities in Drug Delivery conference, Dr Chris Kovalchick, Eli Lilly and Company, discusses examples from both inside and outside the drug delivery industry to demonstrate how interrogating the massive amount of environmental and background information readily available can be used to activate the seismic shift needed to move us all towars the ultimate goal for all of our customers - improved wellness and awareness. To learn more about the 10th annual PODD: Partnership Opportunities in Drug Delivery conference please visit www.theconferenceforum.org

Understanding Jansen's Metaphyseal Chondrodysplasia May 05, 2020

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In the fourth episode of our series highlighting rare diseases, Conference Forum reporter Danny McCarthy sits down with Neena Nizar, EdD, Founder and Executive Director of the Jansen's Foundation, to discuss Jansen's Metaphyseal Chondrodysplasia. Jansen type metaphyseal chondrodysplasia is an extremely rare progressive disorder in which portions of the bones of the arms and legs develop abnormally with unusual cartilage formations and subsequent abnormal bone formation. The Jansen's Foundation goal is to speed up and fund the process of finding a cure and treatment for the rare disease. For more information: https://www.thejansensfoundation.org/ For more information about our podcasts and the upcoming Patients as Partners event: www.theconferenceforum.org

The Collective Struggle to Evolve Data and Analytics Culture & Capabilities May 04, 2020

Show notes

In this podcast, first presented at the 9th annual DPharm: Disruptive Innovations conference, Cellarity's Milind Kamkolkar presents on the collective struggle to evolve a drug development organization's data and analytics culture and capabilities. Including: The theory of going digital in drug developmentIdentifying hype from realityWhat is the program we are trying to solve?Take a big, complex organization and evolving it to be digitally modernWhat is the intended use of the data?Priorities, structure, culture and next steps Speaker: Milind Kamkolkar, Chief Data Officer, Cellarity The 10th annual DPharm: Disruptive Innovations event is scheduled to take place on September 22-23, 2020. Learn more here.

Re-Thinking Clinical Development - Using Historical Data to Transform Trials May 04, 2020

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In this podcast, first presented at the 9th annual DPharm: Disruptive Innovations conference, Genentech's Aaron Mann discusses the use of historical data to transform clinical trials and how to rethink clinical development. Speaker: Aaron Mann, Global Program Lead, Industry Collaborations Data Sharing Initiatives, Genentech, a member of the Roche Group The 10th annual DPharm: Disruptive Innovation event is scheduled to take place on September 22-23, 2020. Learn more here.

The Evolution of Using Real World Data to Create Trial Readiness Cohorts May 03, 2020

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In this podcast, first presented at the 9th annual DPharm: Disruptive Innovations conference, Johnson & Johnson's Dr Martine Lewi discusses the evolution of their use of Real-World Data in their clinical programs. Including: What is the state of the art in real-world data and how is patient data being used today?Innovation initiatives at J&JAccelerating the drug development cycle Speaker: Martine Lewi, PhD, MBA, Janssen Clinical Innovation, Scientific Director, Johnson & Johnson The 10th annual DPharm: Disruptive Innovations event is scheduled to take place on September 22-23, 2020. Learn more here.

The PD-FIDI: Developing a Digital Endpoint for Parkinson's Disease May 03, 2020

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In this podcast, first presented at the 9th annual DPharm: Disruptive Innovations conference, Sanofi's Laura Kling discusses developing a digital endpoint for Parkinson's Disease using wearables. Speaker: Laura Kling, Director, Digital Innovation, Sanofi The 10th annual DPharm: Disruptive Innovations event is scheduled to take place on September 22-23, 2020. Learn more here.

Planning For and Addressing Missing Data in Mobile Clinical Trials May 02, 2020

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This podcast presents a session on planning for and addressing missing data form the 2019 Mobile in Clinical Trials conference. When a protocol dictates a set period of time for data collection, what happens when there's a gap in the data due to technical glitches or human error? What are the regulatory and operational implications? Discussion points include: How to prepare for missing dataHow do we handle missing data?How to rewrite protocols so that you avoid the trapForewarning and communicating with regulatorsRegulatory advice on how to address missing data Moderator: Jennifer Goldsack, MBA, Executive Director, Digital Medicine Society (DiMe) Panelists: Ariel Dowling, PhD, Associate Director of Digital Clinical Devices, Data Sciences Institute, Takeda Pharmaceuticals Marie McCarthy, MBA, Senior Director of Product Innovation, Information Technology, ICON plc Carrie Northcott, PhD, Project Team Lead, Early Clinical Development, Digital Medicine, Pfizer Shyamal Patel, PhD, Director of Data Science, Digital Medicine & Translational Imaging, Pfizer The 2020 Mobile in Clinical Trials event will take place on September 21. Learn more here.

Balancing Innovation with Solid Common Sense to Deliver Innovative Medicines May 02, 2020

Show notes

In this podcast, first presented at the 9th annual DPharm: Disruptive Innovations conference, Merck's Mark Travers presents a cornerstone discussion on Balancing Innovation with Solid Common Sense to Deliver Innovative Medicines. Merck is walking the walk in disrupting how to restore best practices for people, products, and productivity. With a clear vision on output, their remarkable team mapped a plan to an enterprise to change operational delivery. In this R&D Leadership session hear the story on how they are delivering what they promise: How to plan upfront once and do it properlyGetting the basics right and what do you need to disrupt to get thereSignificant changes on greatly improving monitoringThe use of iPad technology to monetize CRA visitsHow monitoring reports got reduced from 8 to 2Building a stable workforce with strong employee engagementBehavior, structure, systems and toolsScaling it Speaker: Mark Travers, PhD, MBA, VP, Head of GCTO Regions, Monitoring Excellence, Global Operations, Merck & Co. The 10th Annual DPharm: Disruptive Innovations conference is scheduled for September 22-23, 2020. Learn more here.

Virtual Trials: What are We Striving for and Measurements of Success May 01, 2020

Show notes

This podcast presents a panel discussion from the 2019 Mobile in Clinical Trials conference on what we are striving for and measurements of success in virtual trials. Discussion points include: How is it getting our of pilotville?What is the barrier to adoption?Factors that impact success: Risks and Patient Preferences Moderator: Adama Ibrahim, EMBA, Associate Director, Performance Operational Capabilities, Global Clinical Operations, Biogen Panelists: Christopher Ceppi, Chief Product Officer, Science 37 Jamileh Jamison, MD, Head of Clinical Development, HealthMode Hassan Kadhim, Director, Clinical Trial Business Capabilities, GCO, BMS Casey Orvin, President, Society for Clinical Research Sites (SCRS) John Reites, Chief Product Officer, THREAD Research The 2020 Mobile in Clinical Trials event will take place on September 21. Learn more here.

Escaping Pilotville: How to Scale Mobile / Digital Deployment in Clinical Trials May 01, 2020

Show notes

This podcast presents a session from the 2019 Mobile in Clinical Trials conference on Escaping Pilotville: How to Scale Mobile/Digital Deployment in Clinical Trials. Discussion points include: What KPIs are used to evaluate success/failure of a pilot?What are the barriers to scale, even when a pilot is a success?What are the operational models used by innovation teams to support deployment?Which models are working?Are study teams equipped to take on deployment efforts?What resources must be made available?How to position for scaleHow can industry remove the fear and transition from addition to the replacement of traditional efforts?Show good evidence of what works at scaleWhat should this include? Moderator: Michelle Shogren, Director of Innovation, Pharma R&D Clinical Operations, Bayer Panelists: Arthur Combs, MD, FCCP, FCCM, CMO, MC10 Ken Thoelke, EVP, Chief Scientific Officer, PRA Health Sciences The 2020 Mobile in Clinical Trials event will take place on September 21. Learn more here.

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