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 ord...
Dec 17, 2019•43 min
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 ...
Dec 16, 2019•1 hr 11 min
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 Therap...
Dec 04, 2019•3 min
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...
Dec 04, 2019•10 min
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 biotechCo...
Dec 03, 2019•35 min
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 reco...
Dec 03, 2019•40 min
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...
Dec 02, 2019•32 min
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
Dec 02, 2019•37 min
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 conce...
Dec 02, 2019•37 min
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
Dec 01, 2019•29 min
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, C...
Nov 06, 2019•22 min
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...
Nov 05, 2019•26 min
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.
Nov 04, 2019•22 min
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
Nov 01, 2019•23 min
At the 2019 Patients as Partners EU meeting, Servier's Lode Dewulf presented a discussion on connecting employee-centric culture to patient-centric culture. This presentation covered the following points: • What impact can engaged employees have on positioning the company as the preferred partner for patients and other collaborators? • How can this be done? And for what purpose? • How do you engage your employees and empower them to implement patient involvement strategies? • Inspiring employees...
Nov 01, 2019•20 min
In this podcast, listen to a session from the 2019 Patients as Partners EU conference on Sanofi Eliciting Patient Experience Data During Clinical Trials to Better Understand Patient-Perceived Benefits and Disadvantages of their Drugs. Dr Aude Roborel de Climens, PRO/COA Lead at Sanofi discusses how they capture patient experiences during clinical research and the benefit of collecting direct patient feedback. More specifically, she presents how they evaluate and analyse qualitatively and quantit...
Oct 31, 2019•20 min
In this podcast, hear a session presented at the 2019 Patients as Partners EU conference on the Process to Understand the Language of Patients and the Value of Health Literacy. Who is responsible for delivering the why and how of getting involved in medicines development? Pharma, regulators or advocacy groups?What practical goals can the industry set to effect change?How are we communicating the trial information to patients and care partners to help them understand and make informed decisions?H...
Oct 30, 2019•21 min
In this podcast, hear a case study from the 2019 Patients as Partners EU conference on UCB and Parkinson's UK Working Together to Improve a Phase 2 Trial through Patient Involvement. In 2018, UCB and Parkinson’s UK co-developed a workshop to enable the UCB research team to work together with people affected by Parkinson’s to discuss and develop a potential phase 2 clinical trial. The aim of the workshop was to better understand people’s thoughts on clinical trials and get feedback on key feature...
Oct 29, 2019•33 min
The pipeline of adoptive T-cell therapies and other cell based immuno-oncology programs continues to expand with a number of modifications and improvements to the first generation programs. These platforms include improved spcificty and delivery - including non-viral platforms, targeting of multiple antigens, editing constructs, and a variety of strategies to address toxicity and the tumor microenvironment. This panel of experts, moderated by Dr Gbola Amusa, Chardan and recorded at the 5th annua...
Oct 17, 2019•48 min
This panel moderated by Dr Andrew Baum, Citi and recorded at the 5th annual IO360° Summit discusses the preparation of an IPO, straight licensing with the transition to a public company and decision making on prioritization within portfolios. Panelists include: David Epstein, Flagship PioneeringDan Passeri, Cue Biopharma 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
Oct 16, 2019•36 min
In this talk recorded at the 5th annual IO360° Summit, Dr Charles Link Jr, Newlink Genetics, addresses how IDO changes the T-cell balance in the tumor microenvironment. This talk addresses how: IDO creates local immunosuppression by increasing T regulatory cellsIDO often works in concert with PDL-1 mediated immunosuppressionIDO mediated T-cell immunosuppression leads to poor prognosis in melanoma Save the date for the 6th annual Immuno-Oncology 360° Summit on February 26-28, 2020 at the Crowne P...
Oct 16, 2019•16 min
In this podcast from the 2019 Immuno-Oncology 360° conference, Cello Health BioConsulting's EVP, Oncology Practice Head, Dr Jeff Bockman discusses deal-making and investments in the I-O space to see what can be learned about the expanding and shifting landscape of BioPharma and investor interest by examining who is placing what kinds of bets on which targets and modalities, at what stage and with what terms. Additional topics include: Where are the next big paradigm shifts going to be?Where is t...
Aug 29, 2019•22 min
Pharma Talk Radio producer, Valerie Bowling recently spoke with a young Alzheimer's patient, Jeff Borghoff. Jeff was officially diagnosed with Alzheimers in 2016 and is an active and patiionate patient advocate. Jeff generously shares his experience from diagnosis, to the experience of a clinical trial to his work in advocacy. Jeff will be speaking at the Patients as Partners conference on June 29-30, 2020 in Philadelphia. For more information, visit theconferenceforum.org We look forward to bri...
Aug 23, 2019•19 min
In this podcast from the 2018 Mobile in Clinical Trials conference, Mohammad Ali, Global Head Digital Trials- Global Clinical Operations, Boehringer-Ingelhiem and Joe Dustin, Principal, Mobile Health, Medidata Solutions discussed the internal infrastructure that is required for the successful scaling of mobile/digital tools in clinical trials. The discussion focuses on how to come to terms with the demand of data, understanding the skill set required to purposefully use the data and implementing...
Aug 23, 2019•22 min
In this podcast from the 2018 Mobile in Clinical Trials conference, patient advocate, Cindy Geoghegan sat down with Dr Daniel Karlin, CEO, Healthmode and Deanna Lennon, Director of Business Development, Medable Inc for a discussion on aligning the promise of technology with the patient voice. The panel explores patient perspective on being monitored continuously and pharma perceptions of what patients want versus what patients really want. Speakers: Cindy Geoghegan, Patient Advocate Daniel Karli...
Aug 22, 2019•35 min
In this podcast from the 2018 PODD: Partnership Opportunities in Drug Delivery conference, Dr Christopher Kovalchick, Chief Engineer, Drug Delivery & Devices R&D Innovation at Eli Lilly and Company presented on incorporating of digital monitoring biomarkers into drug delivery. More specifically a framework is presented which stratifies key components and advances the concept of contextualized biomarkers. The framework codifies how direct, indirect, composite and contextualized composite ...
Aug 22, 2019•18 min
In this podcast, Valerie Bowling, Director of PODD, walks you through what to expect at PODD 2019 in under 4 minutes. The 9th annual PODD conference features the following: Building a Company around a Transformative Drug Delivery Invention with MIT's Dr Robert Langer, Dr Sangeeta Bhati, Dr Giovanni Traverso and Harvard Medical School's Dr Jeffrey Karp.Modality Fluid Development: Tales of Evolving Pipelines and Drug Delivery Solutions with Merck's, VP, Pharmaceutical Sciences, Dr Allen TempletonG...
Aug 20, 2019•4 min
It is estimated that between 7-10 million people, globally have Parkinson's disease. Our guest on Pharma Talk Radio, Lesley Gosden is living with Parkinsons and she is an outstanding patient advocate, who experienced the GDNF clinical trial. In this podcast discussion, our guest will give us an insight into living with Parkinson's, about the GDNF clinical trial, lessons for all stakeholders and in particular how the success rate of clinical trials could be improved from the patient’s point of vi...
Aug 19, 2019•25 min
In this podcast from the 2018 Mobile in Clinical Trials conference, Dr Paul Glimcher, Julius Silver Professor of Neural Science and Physiology at NYU alongside Dr Daniel Karlin, CEO at Healthmode presented on the future of mobile data in clinical trials. Drs Glimcher and Karlin discussed this rapidly evolving space with an emphasis on the barriers and opportunities in the mobile health arena. More specifically: • What are the Barriers to gathering an incorporating Mobile data into clinical trial...
Aug 15, 2019•16 min
In this podcast from the 2018 Mobile in Clinical Trials conference, Eli Lilly's Joseph Kim, Sr Advisor, Clinical Operations and Digital Registry, Digital Health Office | Translational Technology & Innovation, reported on incorporating a variety of mobile devices – including a smart phone, smart insulin pens, connected devices, mifi, and laptops, into a clinical trial. Considerations and lessons learned for: • Connecting all the devices • Implementation differences between traditional vs site...
Aug 15, 2019•27 min
