Pharmatalkradio

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 June 29-30, 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 June 29-30, 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 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 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 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

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 Learn more at theconferenceforum.org

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 Learn more at theconferenceforum.org

In this podcast, hear a session from the 2019 Patients as Partners EU conference on How do Patients Become Partners in the Sharing of Data to Advance Science? How to encourage the sharing of suitably anonymized data to further medicines development for the benefit of patients?What are the barriers/issues? Public mistrust of pharma? Language, medical records versus coded data? Speakers: Natalie Banner, PhD, Understanding Patient Data Lead, Wellcome Trust Richard Stephens, Patient/Consumer Lead, Chair Consumer Forum, NCRI   The 4th annual Patients as Partners EU conference will take place on January 27-28, 2020 in London, UK. To learn more about the program and patient centricity in R&D, visit theconferenceforum.org.

In this podcast, hear a panel discussion presented at the 2019 Patients as Partners EU conference on Best Practices for Pharma - Patient Advocacy Partnerships.  Pharma and advocacy representatives discuss: • Advocacy point of view on is what pharma is doing in clinical trials and medicines development truly patient-centric? • How can advocacy groups work with the pharmaceutical industry to improve the clinical trial process? • How can advocacy get their foot in the door at pharma? Pharma’s advice. • How can pharma and advocacy better work together? • Explore the value of pharma reps spending time at an advocacy office to better understand what they do • How can this partnership impact patients and medicines development? Moderator: Chris Macdonald, Head of Research, Pancreatic Cancer UK Panelists: Vanessa Pott, Director, Patient Advocacy & Strategic Partnerships, Merck KGaA Natasha Ratcliffe, PhD, Research Involvement Manager, Parkinson’s UK   The 4th annual Patients as Partners EU conference

In this podcast, hear a session from the 2019 Patients as Partners EU meeting where Merck's Vanessa Pott presented a case study on Innovative Medicines Development and Merck KGaA's next phase of Patient Centricity in R&D.  The 4th annual Patients as Partners EU conference will take place on January 27-28, 2020 in London, UK. To learn more about the program and patient centricity in R&D, visit theconferenceforum.org.

In this talk, recorded at the 5th annual IO360° Summit, Dr Alex Minella, Amgen, provides a clinical update on AMG 420, an anti-BCMA BiTE® This talk addresses the: Summary of IND enabling preclinical studiesFirst-in-human trial designFirst-in-human trial data (safety, efficacy) Save the date for the 6th annual Immuno-Oncology 360° Summit on February 26-28, 2020 at the Crowne Plaza Times Square in New York City. Learn more at www.io360summit.com