This podcast tells the story of how a community-based COVID-19 research study was formed from a partnership between Oracle Health Sciences, Javara Research and Wake Forest Baptist Health, with the end goal of using regional infection patterns to understand the virus and develop strategies to contain it. Kathy Vandebelt of Oracle sat down to talk about the partnership enhanced Oracle's Therapeutic Learning System, which was set up to track how physicians were treating individuals infected with th...
Jul 27, 2020•24 min•Season 1Ep. 1
PharmaTalk Radio’s Kate Woda welcomes guest, Erin Newburn, Director and Field Applications Scientist at Personalis on the topic of IO Biomarker Discovery and Personalized Cancer Therapy and how Personalis is enabling this. Guest Bio: Erin Newburn, PhD joined Personalis as a Field Applications Scientist in 2013 with over 12 years of research experience in the areas of molecular biology, genetics, and biotechnology. As the Director of the Field Applications Scientist team, Dr Newburn’s group has t...
Jun 19, 2020•28 min
As the country goes through the phases of reopening, what does that mean for the patient and site experience in clinical trials? PharmaTalkRadio’s Valerie Bowling discusses the future of clinical trials with Dr Ray Dorsey, Matt Kibby and Craig Lipset. Together they address lessons learned from the rapid adoption of technologies to allow for more decentralized trials and their impact on study participation design moving forward, what sponsors can do to set themselves up for success, and the possi...
Jun 18, 2020•32 min
In this podcast, Mark Scherzer, producer of Mobile in Clinical Trials gives an overview of what to expect at the 2020 virtual conference. The 7th annual meeting is co-chaired by Bayer's Michelle Shogren and Healthmode's Dan Karlin and reports on the latest progress in applying mobile-digital tools and patient-facing technologies for flexibility while connecting and empowering patients. It will feature collaborative, experience-based case studies to help R&D move faster to provide more choice...
Jun 18, 2020•5 min
In this podcast, first recorded at the 2019 DPharm: Disruptive Innovations conference, Takeda's Dr Andrew Plump and Dr Jessica Scott discuss how they have developed KPIs that support innovation for patient-engagement. Dr Plump leads Takeda's global R&D organization, where he provides strategic direction and oversights. He specializes in bringing and unwavering focus on patients and a deep commitment to innovation and positive change in the healthcare industry. Speakers: Andrew Plump, MD, PhD...
May 10, 2020•26 min
In this podcast, first presented at the 9th annual DPharm: Disruptive Innovations conference, Starbucks' Robert Mercer sits down with Eli Lilly's Joe Kim to discuss the end-user experience in mobile technology. This out-of-industry example covers how they approach innovation and in particular how they designed their mobile experience with the customer in mind. More specifically: Barriers and executive buy-inRolling out the mobile experienceBalancing the scale of new solutions across stores aroun...
May 09, 2020•21 min
In this podcast, first presented at the 9th annual DPharm: Disruptive Innovations conference, Healthgrades' founder Kerry Hicks sits down with Craig Lipset for a keynote discussion on transparency and the future of patient expectations. "Everyone likes progress and no one likes change." - Kerry Hicks Kerry Hicks is the founder of Healthgrades, which puts the power of transparency into millions of patients' hands on provider visit experiences. The discussion begins with his vision for Healthgrade...
May 09, 2020•22 min
One of the goals of the Human Genome Project was to improve therapeutic options for those born with serious inherited diseases. Today gene therapy is beginning to realize this promise, with the ever-increasing level of clinical investigation in the space, and the first products coming to licensing in the last few years. In this podcast, first recorded at the 2019 PODD: Partnership Opportunities in Drug Delivery conference, Dr Katherine High, Spark Therapeutics, reviews the current state of gene ...
May 08, 2020•29 min
Subcutaneous (SC) delivery has become the norm for treating diseases such as Rheumatoid arthritis and multiple sclerosis, and there remains great potential to offer home- or even self-administered SC delivery for several other biotherapeutics. Given that there are a number of products already on the market, they can be examined to understand what improvements and changes can be made to increase product development opportunities and also enhance the patient experience. In this podcast, first reco...
May 08, 2020•41 min
This podcast, first recorded at the 2019 PODD: Partnership Opportunities in Drug Delivery conference explores the value of drug delivery technologies both to patients and pharma with a focus on the future direction of the field. This will include a review of the state of the art for traditional modalities such as small molecules and biologics and then expand the conversation to the challenges for less common modalities such as peptides and nucleic acids. The panel members will discuss the potent...
May 07, 2020•42 min
Merck has a long history of being open to utilizing a wide range of delivery technologies for both enabling and life cycle management. In this leadership keynote, first recorded at the 2019 PODD: Partnership Opportunities in Drug Delivery conference, Dr Allen Templeton, VP, Pharmaceutical Sciences, discusses how Merck's strategy of utilizing DDS has evolved and the role of enabling drug delivery technologies play in the Merck R&D pipeline. What emerging DDS technologies and modalities does M...
May 07, 2020•26 min
In this podcast, first recorded at the 2019 PODD: Partnership Opportunities in Drug Delivery conference, John Merhige, Credence MedSystems, Inc and Mathias Romacker, formly with Pfizer discuss the journey of an emerging medical device company from a blank piece of paper toward commercialization. Topics include: The early days: starting the company and inventing with implementation in mindThe importance of listening to the customer and incorporating feedback early - and why that can be difficultS...
May 06, 2020•21 min
Effective drug delivery collaborations combine a wide range of experiences and viewpoints with common goals to achieve successful clinical and regulatory outcomes. But the path to developing this eventual relationship is not without challenges, as partnerships that are not clearly defined upfront or effectively managed downstream can quickly derail the best of intentions. In this podcast, first recorded at the 2019 PODD: Partnership Opportunities in Drug Delivery conference, BMS and Halozyme pan...
May 06, 2020•32 min
How are industry leaders looking to bridge the gap from pilot systems to scaled solutions in the market? In this podcast, first recorded at the 2019 PODD: Partnership Opportunities in Drug Delivery conference, a panel of Connected Health leaders in the industry provide their views on how they are developing value propositions that resonate with internal and external stakeholders. Defining business and operational models that benefit patients and support evolving healthcare payment structures, wh...
May 05, 2020•29 min
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 eco...
May 05, 2020•19 min
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 g...
May 05, 2020•24 min•Season 1Ep. 4
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, st...
May 04, 2020•27 min
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.
May 04, 2020•16 min
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 ...
May 03, 2020•16 min
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.
May 03, 2020•10 min
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 communicat...
May 02, 2020•31 min
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 ...
May 02, 2020•24 min
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, S...
May 01, 2020•39 min
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...
May 01, 2020•26 min
This podcast presents a session from Merck on Mobilizing Mobile Efforts and Engineering for Scale at the 2019 Mobile in Clinical Trials conference. Mobile tool/device implementation has been widely accepted, tested, and piloted in clinical research. With the bar set, Merck looks to challenge it and create an ecosystem that continues to set the bar higher with a scalable model. In this session, Kai Bode walks the audience through their approach to coordinating and prioritizing digital efforts, bu...
Apr 30, 2020•16 min
This podcast presents a panel discussion on What a Successful Digital Trial Looks Like from the 2019 Mobile in Clinical Trials conference. Including: What is a digital trial?Is a common definition needed in order to scale for success?What does success look like? Fully remote, data sharing, device/tool implementation?How do we measure success? And when?What about accessibility?patient/investigator experience?tool/device effectiveness?data quality and usability?did digital help answer the necessar...
Apr 30, 2020•33 min
In the third episode of our series highlighting rare diseases, Conference Forum reporter Danny McCarthy sits down with Fernando Albertorio, PhD, to discuss Hermansky-Pudlak Syndrome. Dr Albertorio is co-founder of Sunu, Inc, which creates wearable, IoT and mobile technology that empowers independence for people who a blind and visually impaired. Dr Albertorio is also an advocate for increasing awareness and treatments for managing Hermansky-Pudlak Syndrome (HPS). HPS is an extremely rare autosom...
Apr 29, 2020•21 min•Season 1Ep. 3
The COVID-19 pandemic has meant that, more and more, clinical trials are being disrupted or interrupted completely. Without the continuous momentum and contact, trials will lose patients as gaps in studies lengthen. To combat that, Be the Partner designed “Bridge,” a new solution on their Patient Portal specifically for continuing secure, ongoing connectivity with trial patients during any temporary pauses in trials as a result of COVID-19. The end goal of “Bridge” is to maintain patient engagem...
Apr 29, 2020•18 min•Season 1Ep. 1
PharmaTalk Radio's Valerie Bowling welcomes guest, Kent Thoelke, EVP and CSO at PRA Health Sciences on his experience in rapidly setting up both therapeutic and vaccine focused programs for COVID-19. More specifically, they discuss lessons learned, what the new normal will look like for clinical trials and serving the needs of thousands of people who are currently in clinical trials. Guest Bio: Kent Thoelke is Executive Vice President and Chief Scientific Officer at PRA Health Sciences. Mr. Thoe...
Apr 28, 2020•43 min
In the second episode of a three-part series dedicated to highlighting rare disease, Conference Forum reporter Danny McCarthy sits down with C Frank Bennett, PhD, of Ionis Pharmaceuticals, to discuss Spinal Muscular Atrophy. Dr Bennett is Executive Vice President and Chief Scientific Officer at Ionis Pharmaceuticals, and one of the founding members of the company. He is responsible for continuing to advance antisense technology and expanding Ionis drug discovery platform. Dr. Bennet is a co-reci...
Apr 14, 2020•22 min•Season 1Ep. 2
