Pharmatalkradio

In this PharmaTalk podcast, MaryAnne Rizk, PhD, of IQVIA, leads a multi-perspective panel discussion on monitoring in the digital age as data becomes the new currency.  Together they discuss how AI and ML are empowering sponsors and sites to predict risk before it happens, how modernization is expanding remote monitoring capabilities and the waterfall impact of that on analytical roles, and how this technology can be leveraged to benefit patient engagement and data standards.  Dr Rizk went into deeper detail on this subject at the 2020 DPHARM: Disruptive Innovations conference. Moderator: MaryAnne Rizk, Ph.D. - SVP Digital R&D, IQVIA Guests: Michael Mittleman – Patient Advocate Ray Reilly – VP, Clinical Operations, TG TherapeuticsRajneesh Patil – Head, Process, Technology & Analytics, IQVIA For more information about PharmaTalk podcasts, visit theconferenceforum.org. A special thanks to the team at IQVIA for their support in presenting this podcast. 

In this PharmaTalk episode, Thomas Klein, founder and CEO of Be the Partner, discusses how to implement new retention and engagement methods to stop patients from "vanishing" in the clinical trial process. Mr Klein sat down with PharmaTalk's Danny McCarthy to discuss potential solutions, including transparency of data, increasing communication before, during and after trials, and truly making patients "partners" in the research.  Mr Klein presented at the 2020 Patients as Partners virtual conference.  Guest: Thomas Klein is the CEO and founder of Be the Partner, a technology company that is focused on how patients can use their health data to improve outcomes for themselves and others around the world. For more information go to or contact www.bethepartner.com. 

Kate Woda, IO Combinations 360° Conference Director, gives a 7 minute overview on what you can expect at the 5th annual IO Combinations 360° conference taking place October 1-2 virtually. 2020 Key Topics: Discovery / Preclinical ScienceBispecificsTranslational Science & BiomarkersNext Generation Cell TherapyClinical DevelopmentsOperationalizing CombinationsBusiness AspectsEmerging Technologies Keynotes Include: Ronald Germain, MD, PhD, National Institutes of HealthSteve Hamilton, Melanoma Cancer SurvivorEdward Tenthoff, Piper Sandler & Co. 2020 Strategic Leadership: Dan Chen, MD, PhD, IGM BiosciencesAxel Hoos, MD, PhD, GSKAlexandra Snyder, MD, Merck Research LabsOmid Hamid, MD, The Angeles Clinic and Research InstituteRaluca Verona, PhD, Janssen R&DJames Gulley, MD, PhD, National Cancer Institute, NIHTheresa LaVallee, PhD, Parker Institute for Cancer ImmunotherapyRoy Baynes, MD, PhD, Merck Research LabsMichael Kalos, PhD, ArsenalBio Learn more about the upcoming IO Combinations 360° virtual confe

In this PharmaTalk podcast, Kelly McKee of Medidata leads a multi-perspective panel discussion on the challenges and opportunities of adopting a decentralized model for clinical trials and ensuring clinical trial continuity with live video visits.  Together they discuss lessons learned from the rapid adoption of technologies to allow for more decentralized trials, how incorporating multiple perspectives highlights areas of growth when utilizing a decentralized approach, and the possibility of hybrid trials becoming the new normal for the near future.  Host: Kelly McKee is the Senior Director of Patient Recruitment and Registries at Medidata Guests:  Anne Marie Mercurio is a patient and research advocate and caregiver. Rosamund Round is Vice President of PAREXEL’s Patient Innovation Center. Jeff Kingsley, DO, is the founder and CEO of IACT Health.  For more information about PharmaTalk podcasts, visit theconferenceforum.org. A special thanks to the team at Medidata for their support in presenting this podcas

Chair of the Partnership Opportunities in Drug Delivery (PODD) event, Dr Barbara Lueckel, Global Head of Research Technologies Partnering at Roche, presents an annual year-in-review of the drug delivery landscape from 2018. Dr Lueckel’s opening remarks are a highlight of PODD every year, and we’re excited to have her return as program chair for the 2020 event, taking place virtually October 8-9, 2020. About Dr Lueckel: Barbara is the Global Head of Research Technologies Partnering and a member of the Roche Pharma Partnering leadership team since May 2019. In her role she is working closely with the two research and early development organizations at Genentech and Roche (gRED and pRED) to identify transformative science developed by biotechs around the globe and help set up partnerships with such biotechs to enable novel discovery programs with the goal to increase the number of medicines impacting patients’ lives. Prior to Roche, Barbara worked at Novartis for ten years both on formulation development of p

This podcast dives into the history of creating a gene therapeutic for Duchenne Muscular Dystrophy. Dr Richard Jude Samulski has been studying gene therapy and the use of the AAV vector for decades. Recently, preliminary results from Pfizer were published on a small gene therapy trial for Duchenne Muscular Dystrophy with promising results, and Pfizer is scheduling a larger trial for later this year. That gene therapy originated from Dr Samulski work and from AskBio, and uses an adeno-associated virus to carry a healthy copy of the dystrophin gene; the virus was injected into boys with DMD, broke into their muscle cells, and replaced their non-working gene. Dr Samulski sat down with PharmaTalk's Danny McCarthy to discuss the process of creating an AAV vector to carry the gene therapeutic, the mechanisms of the therapy in DMD and what the future of the gene therapy landscape might look like.  Guest: R. Jude Samulski, PhD, is President, Chief Scientific Officer and Co-Founder of Asklepios BioPharmaceutical a

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 the virus and making the information available for others to learn from, for a real-world surveillance study. The collaboration resulted in the addition of a new component for the platform, the Patient Monitoring System, which aided in collecting daily information across a large population of participants and offering them the potential to participate in regular testing. That technology is being used for multiple studies on local, regional, national and now global levels.  In the conversation, Ms Vandebelt also discus

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 the responsibility of providing both pre- and post-sale scientific and technical support for the Personalis ImmunoID NeXT Cancer Portfolio. Dr Newburn completed her postdoctoral training at the National Institute of Mental Health (NIMH) investigating candidate susceptibility genes for major psychiatric illnesses. Dr Newburn received her PhD from the Ohio State University in Integrated Biomedical Science as a Presidential Fellow. Information about Personalis, visit www.Personalis.com  Information about upcoming con

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 possibility of hybrid trials becoming the new normal for the near future.  Guests:  Ray Dorsey, MD, is the David M. Levy Professor of Neurology and Director of the Center for Health & Technology at the University of Rochester. Matt Kibby is President, Principal of BBK Worldwide Craig Lipset is the founder of Clinical Innovation Partners and the former Head of Clinical Innovation and Venture Partner at Pfizer You can find all three of our guests speaking at either the upcoming Mobile in Clinical Trials conference or

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 choices for patients and investigators while obtaining better outcomes in drug development.

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, President, Research & Development, Takeda Pharmaceuticals Jessica Scott, MD, JD, Head of R&D Patient Engagement, Takeda Pharmaceuticals 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, 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 around the globe with the need to maintain existing operations and deliveryHow Starbucks engages with the customers to learn and develop innovative new solutions Speakers: Robert Mercer, Design Director, Global Digital products, Starbucks Joseph Kim, MBA, Sr. Advisor, Clinical Operations and Digital Registry, Digital Health Office, Translational Technology & Innovation, Eli Lilly & Co. 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, 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 Healthgrades, what it was like to build it, early fears, and unintended consequences. Also covering: the intersection of patient experiences, technology, and clinical research as well as Kerry's insights on why you must consider transparency with everything you build moving forward. Speakers: Kerry Hicks, MBA, Founder, Healthgrades Craig Lipset, MBA, former Head of Clinical Innvation, Pfizer The 10th annual DPharm: Disruptive Innovation is scheduled to take place on September 22-23, 2020. Learn more here.

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 therapy, including the development of therapies for diseases that were previously untreatable, and, for diseases where therapeutics already existed, the development of therapies that greatly lessen the burden of treatment for the patient and the family. Hurdles in clinical development of gene therapy will be discussed. Examples will be drawn from already approved products and from investigational agents in late stage development. To learn more about the 10th annual PODD: Partnership Opportunities in Drug Delivery con

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 recorded at the 2019 PODD: Partnership Opportunities in Drug Delivery conference, you will hear from clinicians (pharmacist and physician) and industry to gain insight into needs and preferences of future SC biotherapeutic formulations and devices. For example, panelists will address the issue of reducing costs and dose complexity, improving adherence, and also provide input on changes they would like to see in future SC biotherapeutic products. Moderated by: Dr Beate Bittner, Roche Panelists include: Dr Mary Nauffal, B

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 potential scientific barriers for these future delivery technologies and the industry's willingness to invest to address these barriers. Moderated by: Dr Shawn Davis, AstraZeneca Panelists include: Dr Advait Badkar, PfizerAndré LaFreniere, BattelleMaria Teresa Peracchia, SanofiDr Julia Rashba-Step, PhosphorexTheresa Scheuble, Johnson & Johnson To learn more about the 10th annual PODD: Partnership Opportunities in Drug Delivery conference please visit www.theconferenceforum.org

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 Merck view as the most promising, and why. To learn more about the upcoming 10th annual PODD: Partnership Opportunities in Drug Delivery conference please visit, www.theconferenceforum.org

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 difficultStaying in the long game - the mindset, endurance and approach to ensure you are ready when opportunity appearsCollaborating within the supply chain - why it's challenging and the right approach To learn more about the 10th annual PODD: Partnership Opportunities in Drug Delivery conference please visit www.theconferenceforum.org

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 panelists will shed light on key considerations, challenges and lessons learned during the pre-deal courting process as well as their ongoing successful alliance. Moderated by: Jennifer Guzman, Halozyme Therapeutics Panelists include: Michael Cucolo, BMSBrian Davideit, BMSRenee Tannenbaum, Halozyme TherapeuticsTom Witt, Halozyme Therapeutics To learn more about the 10th annual PODD: Partnership Opportunities in Drug Delivery conference please visit www.theconferenceforum.org

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, while delivering strong returns to the business is central to this discussion. Moderated by: Kevin Deane, Phillips-Medisize Company Panelists include: Dhairya Mehta, TakedaPaul Upham, Roche/GenentechPaul Schultz, BrightInsightAmir Zur, Teva Pharmaceuticals To learn more about the 10th annual PODD: Partnership Opportunities in Drug Delivery conference please visit www.theconferenceforum.org