Pharmatalkradio

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

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    

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. 

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.

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.

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.

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,

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, Me

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.

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.

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, building a  prototype to test devices, mobilizing their mobile devices, mobile patient screenings, finding a workaround to perceived barriers and/or premature acceptance of timelines/processes and lessons learned. Speaker: Kai Bode, Director, Digital and Analytics Technologies, Merck The 2020 Mobile in Clinical Trials Conference will take place on September 21. Learn more here.

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 necessary clinical question?did it ensure representative patients in the study? Moderator: Craig Lipset, Former Head of Clinical Innovation, Pfizer Panelists: Jennifer Goldsack, MBA, Executive Director, Digital Medicine Society (DiMe) Jacob LaPorte, PhD, Co-founder & VP, Global Head of Novartis Biome, Novartis   The 2020 Mobile in Clinical Trials event will take place on September 21. Learn more here.

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 autosomal recessive disorder, characterized by albinism, visual impairment, and a platelet dysfunction that results in prolonged bleeding. There are currently 10 known types of HPS.  In the episode, Dr Albertorio mentions several websites for more information: HPSNetwork.org, GlobalGenes.org and Sunu.com.

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 engagement throughout the trial’s indefinite pause and aid in a successful relaunch at the appropriate time. For more information go to or contact www.bethepartner.com. 

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. Thoelke provides corporate oversight and strategy for Scientific & Medical Affairs, Pharmacovigilance & Patient Safety, Therapeutic Centers of Excellence, Real World Data, Patient Access & Experience, Digital Health & Virtual Trials, and their integration into operational delivery.  Information about PRA Health Sciences, visit PRAH.com Information about upcoming conferences and podcasts on medicine development, visit theconferenceforum.org  

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-recipient of the 2019 Breakthrough Prize in Life Sciences for his contributions to the discovery and development of SPINRAZA® (nusinersen).  Spinal muscular atrophy is a genetic, degenerative neuromuscular disorder characterized by weakness and wasting in muscles used for movement. It is caused by a loss of specialized nerve cells, called motor neurons that control muscle movement.  Dr Bennett includes two sources of information about Ionis and SMA: Ionispharma.com and Spinraza.com.

In this three-part series dedicated to the physician's perspective on living with a rare disease, Conference Forum reporter Danny McCarthy sits down with Tracy Frech, MD, to discuss Systemic Sclerosis. Tracy Frech, MD, is a rheumatologist at the University of Utah. At the university, she is the Director of the Systemic Sclerosis (SSc, scleroderma) Clinic at the University of Utah Hospital and the Director of Clinical Trials for the Division of Rheumatology. In her work, Dr Frech treats patients with, and runs clinical trials on, systemic sclerosis, a complex autoimmune disease characterized by pervasive inflammation and fibrosis, and can lead to progressive vascular and organ damage.  Dr Frech talks about the disease, current treatment and taking a more holistic approach to treating SSc. In the interview, Dr Frech references the education resource TotalSSc.com., a new disease education campaign website for healthcare providers focused on the “totality in systemic sclerosis”.

In this podcast moderated by Dr Michael Kalos, Janssen Oncology, you will hear a panel discussion from the 2019 IO Combinations 360° conference. Topic points include: What are the new opportunities in cell therapy for combinations?What the challenges are going to be with the microenvironment?What is being done to engineer cell therapy?How do you develop CARs and TCRs that deliver payloads?How do you manufacture all of this beyond mouse models to figure out how to effectively do this in patients?How do you actually go about designing trials and testing hypothesis?How do you create the regulatory framework to do these types of studies?How do you engage with regulatory agencies to get these things moving? Panelists include: Sharon Benzeno, PhD, MBA, Adaptive BiotechnologiesChaohong Fan, MD, PhD, FDABruce Levine, PhD, University of PennsylvaniaMark Stewart, PhD, Friends of Cancer ResearchBahram Valamehr, PhD, Fate Therapeutics To learn more about the upcoming IO Combinations 360° conference please visit,

Anti-PD-1 therapy has transformed cancer care but most patients do not respond. It is increasingly clear that there will be no single biomarker of response to a PD-1, and that a multi-omic approach will be required. In this podcast, first recorded at the 4th annual IO Combinations 360° conference, Dr Danny Wells, Parker Institute for Cancer Immunotherapy will address: Orthogonality and correlation of response biomarkers across histologiesIntegration of multi-omic data sets for mechanistic insights into tumor immunobiologyThe translational approaches to PD1 resistance program at the Parker Institute To learn more about the upcoming IO Combinations 360° conference please visit, www.iocombinations360.com

In this podcast, first recorded at the 4th annual IO Combinations 360° conference, Dr Darren Hodgson, AstraZeneca presented updates on PARP inhibition. Topics include: Strategies to target homologous recombination repair deficiencyMonotherapy indications and current development landscapeScientific hypotheses being explored in olaparib combinations To learn more about the upcoming IO Combinations 360° conference please visit, www.iocombinations360.com