Pharmatalkradio

First recorded at the 2nd annual Drug Delivery West conference, Dr Carlos Schuler, Incarda Therapeutics discusses transforming cardiovascular treatment with pulmonary delivery. This podcast discusses: Pioneering a novel approach for treating cardiovascular conditions by the oral inhalation routeWill be the ONLY non-invasive, self administered product for acute management of Paroxysmal Atrial Fibrilation, providing rapid cardioversionIn Phase 2: Dose dependent conversion observedWorking on enhancements to greatly improve speed of delivery To learn more about the 3rd annual Drug Delivery West conference happening May 11-12, 2020 in San Francisco, CA please visit www.drugdeliverywest.org

In this podcast, first recorded at the 2nd annual Drug Delivery West conference, Dr Isabelle Aubert, University of Toronto, provides an introduction to MRI-guided focused ultrasound (MRIgFUS) and reviews applications in preclinical models of neurodegenerative disorders where therapeutic molecules, gene therapy vectors, and progenitor cells are injected intravenously and delivered from the blood to targeted areas of the brain with MRIgFUS. Dr Aubert will describe the seminal work of the Sunnybrook team on MRIgFUS-BBB modulation, without exogenous therapeutic, leading to glial plasticity, amyloid pathology reduction, hippocampal neurogenesis and improved cognitive functions in a preclinical model of Alzheimer's disease.  To learn more about the 3rd annual Drug Delivery West conference happening May 11-12, 2020 in San Francisco, CA please visit www.drugdeliverywest.org

Bringing clinical research as a care option to patients is arguably the greatest change we can collaborate on to give patients the best choices of care and to help make clinical trial options easier for providers to access. This panel, moderated by Dr Irfan Khan, TrialScout and recorded at the 6th annual Patients as Partners US conference, will explore how to collaborate to create better strategies to inform patients on clinical research and trial participation.  Key talking points include: Demystifying physician/research burdens. What are physicians really up against?How to better inform physicians of clinical research and trialsHow can more physicians get involved in research and communicate the offering of clinical trials?Patient perspectives on clinical research as a care option Panelists include: Dr Alistair Lindsay, GSKLinnea Olson, Patient AdvocateDr Sanjay Sethi, University of BuffaloDr Kelly Wade, Children's Hospital of Philadelphia & CHOP Newborn Care at Pennsylvania Hospital/ University of Pen

In this fireside chat, moderated by Ken Getz, Tufts CSDD/CISCRP and recorded at the 6th annual Patients as Partners US conference discusses the following: How do you create a culture that enables new strategic, operating and organizational models to flourish?How do you drive a patient-centric organization while continuing to execute on business imperatives? How do you balance that?How do you drive a patient-centric agenda through the value chain?How do you engage your employees and empower them to implement patient involvement strategies? And, how do you enlarge the outlook of employees who are stuck in status quo? Guests include: Julie Gerberding, MD, MPH, MerckJayne Gershkowitz, Amicus Therapeutics To learn more about the 7th annual Patients as Partners US conference happening March 16-17, 2020 in Philadelphia, PA please visit www.patientsaspartners.org

This case study presented by Thérèse Johnsen, Novartis and first recorded at the 6th annual Patients as Partners US conference, discusses how the patient perspective was included from the earliest planning of a clinical trial and how it impacted the design, trial sites and the patient experience throughout the study. To learn more about the 7th annual Patients as Partners US conference happening March 16-17, 2020 in Philadelphia, PA please visit www.patientsaspartners.org

This 5 minute podcast summary helps prepare listeners on what they can expect at the4th Annual Patients as Partners Europe event, taking place January 27th and 28th in London. The venue is the Millennium Gloucester Hotel. In a nutshell, Patient as Partners is the first conference in Europe dedicated to understanding how working with patients can drive greater clinical trial efficiencies throughout the entire medicines development process. It is ultimately about how to reduce risk in the development of hugely, costly clinical trials through working with patients. It is a wonderful opportunity for pharma and biotech and patient disease advocacy groups to come together and learn from each other.  The 2020 Summit is chaired by Claire Nolan, of Charities Research Involvement Group, GSK’s Andrew Garvey and Parexel’s Rosamund Round.  Our patient keynote guest is Lesley Gosden. Lesley is a Parkinson’s patient and advocate who participated in the GDNF clinical trial, which was featured on the BBC. For more informat

Linda Kollmar, Executive Director, Scientific Medical Patient Perspective - Oncology, Merck, shares with the audience at the 6th annual Patients as Partners US conference, Merck's strategy for bringing on a patient, as an equal stakeholder of their clinical development team, to provide patient input in protocol development and trial design. Ms Kollmar walks the audience through how this was done, the role of the patient employee and the impact it has to date on the clinical development initiatives. To learn more about the 7th annual Patients as Partners US conference taking place March 16-17, 2020 in Philadelphia, PA please visit theconferenceforum.org

This podcast moderated by Mary Murray, BMS and recorded at the 6th annual Patients as Partners US conference discusses Improving Clinical Research and Trials Though Effective Pharma/Advocacy Partnerships. Topics include: What are the key elements that make for an effective partnership between Industry and Advocacy Groups?What is not getting done or being left on the table to increase partnership value?In relation to clinical trials what can we and what must we learn from existing experiences in patient engagement that will help provide patients with the enhanced active role they deserve?From an industry perspective there are generally three key decision-making points: research priority setting, design of clinical trials, and early dialogue that can benefit from vaiours levels of patient engagement - are there other valuable areas we are missing hereFrom a patient advocacy group perspective in which areas should industry be improving its clinical research, trial development and planning? Panelists include: El

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

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 choo

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 March 16-17, 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 March 16-17, 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 Da

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 Save the date for the 8th annual Chief Medical Officer Summit happening April 6-7, 2020 at the Boston Marriott Cambridge, in Cambridge, MA. 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 Save the date for the 8th annual Chief Medical Officer Summit on April 6-7, 2020 at the Boston Mar

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 Save the date for the 8th annual Chief Medical Officer Summit on April 6-7, 2020 at the Boston Marriott Cambridge, in Cambridge, MA. 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. Save the date for the 8th annual Chief Medical Officer Summit on April 6-7, 2020 at the Boston Marriott Cambridge, in Cambridge, MA. Learn more at theconferenceforum.org

In an increasingly competitive market, there is a growing need for efficiency in attracting and retaining top talent. This session, recorded at the 7th annual Chief Medical Officer Summit, and moderated by Dr Julie Krop, AMAG Pharmaceuticals, addresses the following: How to source talent; pros and cons of recruiters versus word-of-mouthHow to make the work environment optimal to keep employees satisfiedHow to compete with the competition banging on the doorHow to ease or address relocation concerns of potential hiresWhen is a good time to have consultants or contractors filling the gapsHow to access the untapped talent in academia, do they know we exist?Benefit/risk of having non-MDs fill the gaps and guided by a physicianDoes the industry need to evolve to attract and retain talentHow do you decide whom to recruit firstHow to identify the right hire Panelists include: Kara Coluccio Bern, Perspective GroupJames Lewis, Barrington JamesChris Poshka, Govig Save the date for the 8th annual Chief Medical Officer

First recorded at the 7th annual Chief Medical Officer Summit, this session provides insight in what it takes and how to navigate and what to expect in the CEO role. Moderated by Dr Zain Kassam, Finch Therapeutics, this panel discusses: How can a CMO position themselves as a corporate leader?How to build a network of advisors and who should it include? Panelists include: Aoife Brennan, MB, BCh, BAO, MRCPI, SynlogicGreg Fiore, MD, Sollis Therapeutics Save the date for the 8th annual Chief Medical Officer Summit happening April 6-7, 2020 at the Boston Marriott Cambridge, in Cambridge, MA. Learn more at theconferenceforum.org