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How to Align the Promise of Technology with the Patient Voice Aug 22, 2019

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In this podcast from the 2018 Mobile in Clinical Trials conference, patient advocate, Cindy Geoghegan sat down with Dr Daniel Karlin, CEO, Healthmode and Deanna Lennon, Director of Business Development, Medable Inc for a discussion on aligning the promise of technology with the patient voice. The panel explores patient perspective on being monitored continuously and pharma perceptions of what patients want versus what patients really want. Speakers: Cindy Geoghegan, Patient Advocate Daniel Karlin, MD, CEO, Healthmode Deanna Lennon, Director of Business Development, Medable Inc

The Role of Digital Biomarkers and the Impact on Drug Delivery Aug 22, 2019

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In this podcast from the 2018 PODD: Partnership Opportunities in Drug Delivery conference, Dr Christopher Kovalchick, Chief Engineer, Drug Delivery & Devices R&D Innovation at Eli Lilly and Company presented on incorporating of digital monitoring biomarkers into drug delivery. More specifically a framework is presented which stratifies key components and advances the concept of contextualized biomarkers. The framework codifies how direct, indirect, composite and contextualized composite data can drive innovation for the application of digital biomarkers in healthcare. In addition, application in disease and wellness is highlighted and incorporation in clinical feedback loops and closed-loop systems is illustrated. Dr Kovalchick is returning to PODD 2019 to present on Achieving the Ultimate Outcome for Patients- Utilizing Digital Health Data to Improve Disease Management, Prevention and Overall Wellness. The 9th annual PODD conference with take place October 7-8, 2019 in Boston, MA. Learn more at theconferenceforum.org

PODD: Partnership Opportunities in Drug Delivery 2019 Overview in 4 Minutes Aug 20, 2019

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In this podcast, Valerie Bowling, Director of PODD, walks you through what to expect at PODD 2019 in under 4 minutes. The 9th annual PODD conference features the following: Building a Company around a Transformative Drug Delivery Invention with MIT's Dr Robert Langer, Dr Sangeeta Bhati, Dr Giovanni Traverso and Harvard Medical School's Dr Jeffrey Karp.Modality Fluid Development: Tales of Evolving Pipelines and Drug Delivery Solutions with Merck's, VP, Pharmaceutical Sciences, Dr Allen TempletonGene Therapy Keynote with Spark Therapeutics, President and Head of R&D, Dr Katherine HighZeitgeist Presentation on Immune Targeting Nanomedicine by AstraZeneca’s, VP, External Innovation and Novel Product Technologies, Dr Anand SubramonyConference Chair opening remarks provided by AstraZeneca's, Dr Shawn Davis Additional Featured Speakers: Roche’s, Senior Portfolio Strategy Director, Dr Beate Bittner will moderate the Formulation & Device Lifecycle Management for Biotherapeutics – Clinical and Industry Perspectives on Subcutaneous Delivery panel.Drug Delivery Pipeline and Technologies, A Year in Review, with Pharmacircle’s, VP, Kurt SedoDelivering Flexible Dosage Forms with Pfizer's Dr Advait Badkar The 9th annual PODD conference will take place on October 7-8, 2019 in Boston, MA. Learn more at theconferenceforum.org

A Patient Perspective on Living with Parkinson's Disease and the GDNF Trial Aug 19, 2019

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It is estimated that between 7-10 million people, globally have Parkinson's disease. Our guest on Pharma Talk Radio, Lesley Gosden is living with Parkinsons and she is an outstanding patient advocate, who experienced the GDNF clinical trial. In this podcast discussion, our guest will give us an insight into living with Parkinson's, about the GDNF clinical trial, lessons for all stakeholders and in particular how the success rate of clinical trials could be improved from the patient’s point of view. Ms Gosden will be the Keynote patient advocate speaker at the Patients as Partners EU conference taking place in London on January 27th and 28th and for more information, visit theconferenceforum.org. Guest: Lesley Gosden, Patient Advocate Host: Valerie Bowling, Producer, Pharma Talk Radio For more information about the GDNF Trial: Reflections on the GDNF Trial

The Future of Mobile Data in Clinical Trials: Challenges and Opportunities Aug 15, 2019

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In this podcast from the 2018 Mobile in Clinical Trials conference, Dr Paul Glimcher, Julius Silver Professor of Neural Science and Physiology at NYU alongside Dr Daniel Karlin, CEO at Healthmode presented on the future of mobile data in clinical trials. Drs Glimcher and Karlin discussed this rapidly evolving space with an emphasis on the barriers and opportunities in the mobile health arena. More specifically: • What are the Barriers to gathering an incorporating Mobile data into clinical trials? • What are the most important new datatypes that are evolving in the Mobile Health space? • How can we use Real World Measurements to identify new classes of clinically relevant endpoints to go beyond Billing Codes? • Can we expect to see large-scale Mobile databases for synthetic use on the model of EMRs and ICD codes? • How should we think of these new classes of data, are they just novel bioindicators or something else? Dr Karlin is returning to Mobile 2019 as co-chair. Speakers: Paul Glimcher, PhD, Julius Silver Professor of Neural Science and Physiology, NYU Daniel Karlin, MD, CEO, Healthmode

Eli Lilly: How to Launch Multiple Mobile Devices in a Hybrid Setting Aug 15, 2019

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In this podcast from the 2018 Mobile in Clinical Trials conference, Eli Lilly's Joseph Kim, Sr Advisor, Clinical Operations and Digital Registry, Digital Health Office | Translational Technology & Innovation, reported on incorporating a variety of mobile devices – including a smart phone, smart insulin pens, connected devices, mifi, and laptops, into a clinical trial. Considerations and lessons learned for: • Connecting all the devices • Implementation differences between traditional vs siteless • Coordinating the equipment; challenges and successes • Lessons learned • What’s next? Speaker: Joseph Kim, Sr Advisor, Clinical Operations and Digital Registry, Digital Health Office | Translational Technology & Innovation, Eli Lilly & Co

Pfizer’s Atopic Dermatitis Clinical Trial with Digital Wearable Technology Aug 08, 2019

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In this podcast from Mobile in Clinical Trials 2018, Pfizer's Project Team Lead, Early Clinical Development, Digital Medicine, Dr Carrie Northcott speaks about considerations and lessons learned from the validation, verification and use of digital wearable technology in a Atopic Dermatitis Clinical Trial and some of Pfizer's forward-leaning work in decision making around novel digital endpoints. Dr Northcott is coming back to Mobile 2019 to share results and next steps on this trial. Speakers: Carrie Northcott, PhD, Project Team Lead, Early Clinical Development, Digital Medicine, Pfizer, Inc

Merck’s Digital Health and Al Strategy: Progress Report Aug 07, 2019

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In this session presented at the Mobile in Clinical Trials 2018 conference, Merck's Kai Bode and Jyoti Shah share an exciting update on the company's progress in implementing a digital health and AI strategy. Session takeaways include: What Merck is doing in digital health and AIExternal collaborations on AISmart trial initiative to enable patient-centric studies Kai Bode is returning to Mobile 2019 to share an update on Merck's digital strategy 2.0 and how they are engineering for scale. Speakers: Jyoti Shah, Associate Director, Data Development MRL IT, Merck & Co, Inc Kai Bode, Director, Digital and Analytics Technology, Merck & Co, Inc

How Digital Biomarker Innovation is Modernizing Clinical Endpoints Jul 31, 2019

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In this session from DPharm 2018, Roche provides an update on the company's progress in how they are collecting data with sensor technology and turning it into a clinically meaningful endpoint with multiple indications, including Parkinson's disease and Multiple Sclerosis. Session takeaways include: Understand what Digital Biomarker innovation means for the future of clinical development and potentially personalized healthcare.Be inspired to use mobile sensors technology in the context of clinical trials and beyond.Develop a detailed understanding of the underlying complexity to run such efforts and be able to plan for it.Understand how regulators are looking at these novel approaches. Speaker: Christian Gossens, PhD, MBA, Global Head Early Development Workflows, pRED, Informatics, Roche Pharmaceutical Research and Early Development (pRED) The 9th annual DPharm conference with take place on September 17-18, 2019 in Boston, MA. Learn more at theconferenceforum.org.

Regenerative Medicine as a Disrupter in Clinical Trials Jul 30, 2019

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This is a keynote session from DPharm 2018. Dr Atala, a renowned key opinion leader on the topic of regenerative medicine, brings the DPharm audience a fascinating presentation on how it's possible to reduce the number of patients needed in clinical trials with the advancement of regenerative medicine, and how regenerative medicine can improve accuracy and speed up the clinical trial process. Speaker: Anthony Atala, MD, Director, Wake Forest Institute for Regenerative Medicine The 9th annual DPharm conference will take place on September 17-18, 2019 in Boston, MA. Learn more at theconferenceforum.org.

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