PharmaTalkRadio

This podcast, first recorded at the 6th annual Patients as Partners US conference and moderated by Jan Nissen, Merck discusses the complexities of diversity and waht actions we can take to raise clinical trial awareness and enrollment that is reflective of the demographics of the populations.

This panel discusses:

What are some examples of how industry has approached diversity such as developing partnerships, education and awareness to identify and address the barriers of diversity?Is industry and advocacy engaging on the community level? If so, how?How has advocacy helped with outreach, awareness and recruitment of diverse populations for clinical trials?How do we engage with patients who are without technology access or those globally whereby the latest technological advances are not the norm?

Panelists include:

Caroline Donovan, Lupus TherapeuticsLisa Fitzpatrick, The Community Wellness CollectiveKelly Franchetti, ICON plcDr Tara Hiley, GenentechPatricia Roselle, Sanofi

To learn more about the 7th annual Patients as Partners US conference taking place June 29-30, 2020 in Philadelphia, PA please visit theconferenceforum.org

If you truly want to bring patients in as stakeholders, we have to start at the beginning by understanding patients, their lifestyles and how the trial protocols are developed to reflect that. This session moderated by Dr Marilyn Metcalf, GSK and recorded at the 6th annual Patients as Partners US conference discusses understanding these dynamics and how they will help industry design appropriate initiatives that help meet its goals while aligning with patient's needs.

This session addresses:

What can we learn and what resources can we use to develop a baseline understanding of patient lifestyles?What can sponsors do throughout trial protocols that can help support patients, help alleviate their worries/concerns?What is the decision making process a patient goes through when considering treatment options?What do patients consider when determining to participate/not participate in a clinical trial?How can pharma help support/provide tools that will help patients while deciding which treatment pathway they choose?How can advocacy groups support this and how do they help inform patients?

Panelists include:

Robert Long, Uplifting AthletesLilly Stairs, Patient and AdvocateMary Stober Murray, BMSHannah Watson Eccard, InspireRobert Weker, Three Time Cancer Survivor

To learn more about the 7th annual Patients as Partners US conference happening June 29-30, 2020 in Philadelphia, PA please visit theconferenceforum.org

This multi-center FDA podcast moderated by Anindita Saha, (CDRH) FDA and first recorded at the 6th annual Patients as Partners US conference, focuses on patient engagement and regulatory decision making.

This podcast discusses:

What is each center doing in terms of patient engagement?What initiatives are underway and what is the impact they will have?What are the synergistic efforts across the FDA centers?How are the patient involvement initiatives within the FDA moving the needle forward in order to create greater efficiencies and better outcomes for patients?

Panelists include:

Megan Moncur, (CBER) FDADr Michelle Tarver, (CDRH) FDAPujita Vaidya, (CDER) FDA

To learn more about the 7th annual Patients as Partners US conference happening June 29-30, 2020 in Philadelphia, PA please visit theconferenceforum.org

In this series, first recorded at the 6th annual Patients as Partners US conference, is led by Craig Lipset, formerly with Pfizer discusses the ideas of patients 'donating' data, patient data ownership, data rights, and why this is a disruptive force in advancing clinical trials, we address the need to ensure we have the appropriate systems, security, and the ability to withstand a Facebook/Cambridge Analytica Scenario. Craig is joined by Mark Scrimshire, NewWave/CMS and Bray Patrick-Lake, Duke Clinical Research Institute.

To learn more about the 7th annual Patients as Partners US conference happening June 29-30, 2020 in Philadelphia, PA please visit theconferenceforum.org.

In this podcast, Kate Woda, Conference Director provides an overview of Cell & Gene Therapy Day in less than 4 minutes. Cell & Gene Therapy Day takes place on February 27, 2020 in New York City and convenes stakeholders spanning the science and business communities to report on the latest cell and gene therapy progress to fight a wider range of cancers beyond hematologic malignancies.

Key Topic Areas: 

Landscape and Evolution to Marketplace: ProgressNew Scientific Frontiers in Cell Therapies for Solid TumorsCell Therapy Pivotal Developments for Solid TumorsCurrent and Future Innovations Toward GMP Manufacturing of CAR and TCR Engineered T CellsFDA Led Session on the Evolution of Regulatory Policy for Cell & Gene Therapy

Cell & Gene Therapy Day is available as an independent one day program with a luncheon and networking reception, to learn more please visit theconferenceforum.org

Alternatively, attendees can register for the three day IO360° program, which includes Cell & Gene Therapy Day. For more information on IO360°, please visit www.io360summit.com

In this 10 minute podcast, Kate Woda, Conference Director for IO360°, walks you through what to expect at 2020 IO360° Summit happening February 26-28, 2020 in New York City. IO360°convenes stakeholders spanning the science and business communities to report on the latest data impacting immuno-oncology to fight a wider range of cancers.

The 6th annual IO360° Summit features the following plenaries:

Discovery/Preclinical ScienceImaging AspectsClinical OperationsBispecificsBusiness DevelopmentsCell & Gene TherapyTranslational ScienceEmerging BiomarkersIO Novel TechnologiesAI & Machine LearningClinical Developments

Keynotes:

Dr Carl June, University of PennsylvaniaDr Arie Belldegrun, AllogeneDr Andrew Baum, CitiDr Crystal Mackall, Stanford University School of Medicine

Learn more at www.io360summit.com

Dr Jeffrey Chodakewitz, former EVP, Clinical Medicine and External Innovation, CMO at Vertex Pharmaceuticals, joins the Chief Medical Officer Summit for the first time to discuss his incredible journey as a CMO. Recorded at the 7th annual Chief Medical Officer Summit, Dr Chodakewitz sits down with Dr Julie Krop, AMAG Pharmaceuticals to discuss the following:

The journeyPrioritizing resourcesSuccesses and failuresOvercoming hurdlesCareer decisionsTransitioning from large pharma to small biotechConsiderations for building your team in large and small companies

Learn more at theconferenceforum.org

This session, recorded at the 7th annual Chief Medical Officer Summit and moderated by Dr Martin Childers, Asklepios BioPharmaceutical, discusses designing clinical trials for gene therapy.

Topics covered include:

How to utilize adaptive trial design within the specific context of a gene therapy - are there any unique aspects of development conducive to this approach?How to ensure flexibility when pushing for an accelerated pathway?Communicating pros and cons of development options and your recommendation to your CEODe-risk identifying the primary efficacy endpoint without a proof of concept phaseHow to interpret the current FDA guidanceFactors to consider around in-vivo and ex-vivo regulatory guidanceHow to use the guidance to direct the path of your programGlobal regulatory considerations and how to overcome them 

Panelists include:

Edward Conner, MD, Sangamo TherapeuticsKathleen Reape, MD, Spark Therapeutics

Learn more at theconferenceforum.org

In this talk, first recorded at the 7th annual Chief Medical Officer Summit, Dr Tal Zaks, Chief Medical Officer, Moderna Therapeutics shares his experience and lessons learned through one of the biggest transitions a Chief Medical Officer can make in biotech:

Expanding the role of the CMO to meet the requirements of a public companyInsights into the experienceManaging growthWhat role does the CMO have in articulating the data of clinical trials What role does the CMO have in business development opportunitiesWhat are the personal implications of being a CMO in a publicly traded companyLessons learned

Learn more at theconferenceforum.org

In this session recorded at the 7th annual Chief Medical Officer Summit, Dr Steve Kanes, Chief Medical Officer, Sage Therapeutics, discusses how a company considered as an "up and comer" in the Cambridge biotech sector navigated the development and approval of the first treatment specifically designed for postpartum depression.

Learn more at theconferenceforum.org