Pharmatalkradio

Originally recorded at the inaugural Patients as Partners Europe event, held in London in February 2017. Patient, industry, and regulatory perspectives are provided by Alastair Kent of Genetic Alliance UK, Dr Anton Hoos of Amgen Europe, and Isabelle Moulon of the EMD as they discuss on innovative ways of to include patient involvement in medicines development. The Patients as Partners Europe program seeks to understand and incorporate the patient's voice in designing clinical trials and developing a clinical endpoint, as well as vastly improve the patient's entire experience in a clinical trial. The 2nd annual Patients as Partners EU event will be held January 23-24, 2018 at Radisson Blu Portman Hotel, London, UK.

Originally recorded during the 3rd annual Immuno-Oncology 360° in February 2017, this panel discussion addresses clinical challenges within immuno-oncology. One of the IO360° lead advisors, Dr James Gulley of the National Cancer Institute, moderates the session between Merck’s Dr Roy Baynes, nanoString Technologies’ Dr Alessandra Cesano, MD Anderson’s Dr Patrick Hwu, and inVentiv Health’s Robert Millham. Dr Hwu and Dr Baynes are also speaking on the 2nd annual Rational Combinations 360° program in June 2017, which is an exciting meeting dedicated to combination therapy in IO. Save the date for the 4th annual IO360° conference, taking place February 7-9, 2018 in New York City.  

Originally recorded during a panel session at the 2017's Immuno-Oncology 360°, Mark Simon of Torreya Partners moderates the conversation around issues, controversies, and other important business aspects of IO. He's joined by IO360° lead advisor and SVP at GSK, Dr Axel Hoos, Dr Robert Ang of Neon Therapeutics, Dr Jeffrey Bockman from Defined Health, Dr Jeffrey Legos from Novartis Pharmaceuticals, and Dr Chandra Ramanathan at Bayer Healthcare. Save the date for the 4th annual IO360° conference, taking place February 7-9, 2018 in New York City.

During the preclinical science plenary session from 2017's Immuno-Oncology 360° conference, Dr Charles Drake's talks about "Sequencing of Combination Agents."  Dr Drake is Director, Genitourinary Oncology and Co-Director Immunotherapy Associate Director, Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center. Previously, he was an associate professor of oncology, urology and immunology at the Johns Hopkins School of Medicine. He also serves as Co-Director of the Prostate Cancer Multidisciplinary Clinic. His areas of expertise include immunotherapy and the diagnosis and treatment of cancers of the prostate, kidney, bladder and testes. Dr Drake graduated with a BS in electrical engineering and MS in biomedical engineering from Rutgers University in Piscataway, NJ. He then received a PhD in immunology from the National Jewish Center for Immunology, and in 1997 completed an MD at the University of Colorado Health Sciences Center. He conducted an internal medicine residency on the Osler

At 2016's Rational Combinations 360° meeting, Dr Patrick Hwu of MD Anderson Cancer Center delivered a keynote address on the future outlook behind combination immunotherapy. Dr Hwu addresses innovations behind combination therapy, specifically focusing on what’s next after checkpoint combinations and whether combination of adoptive T-cell therapy and anti-checkpoint inhibitor therapies are the next wave. Dr Hwu serves as a lead advisor for the 2nd annual Rational Combinations 360° meeting, which takes place June 28-29, 2017, at the The New York Academy of Medicine. Preview the program agenda, including Dr Hwu's plenary session on "DE-RISKING OF COMBINATION IMMUNOTHERAPIES."

The 3rd annual DPharm Europe: Disruptive Innovations to Advance Clinical Trials event is led by Co-Chairs Dr Sue Collier (GSK) and Dr Jeff Kasher (Patients Can’t Wait).  This radio blogcast gives a five minute overview of the event, which presents global case studies on: Real World Clinical Trial Strategies and ResultsNew Leadership in Driving Clinical Trial InnovationStrategies to Validate the Siteless TrialCommunity Outreach and Education in Clinical TrialsNew Financial ModelsPatient Involvement and EngagementBrexit Update and Potential Impact on R&DProtocol SimulationAdaptive Trial Model  DPharm EU takes place at the Millennium Hotel in London on February 8-9, 2017. For more information, visit www.theconferenceforum.org

We are delighted to bring the Patients as Partners US event to Europe on February 6-7 in London. We would like to thank our European attendees at the US conference for challenging and encouraging us to bring the conference to Europe. The goal of creating patient centricity as the ecosystem within pharma can not be achieved without patient involvement.  Patients as Partners Europe is accredited by Patients Included and addresses what matters most to patients to enable them to engage in clinical research. Patients as Partners EU is co-produced with patients, industry, academia, government and nonprofit organizations to establish a well-rounded program that addresses the needs of all stakeholders seeking to implement and advance patient involvement across the entire clinical development continuum. Each session seeks to put ideas into action and must demonstrate the what, where, when and how behind the topic. This radio blog post provides a seven minute overview on what to expect at the conference. For more in

 The 3rd annual Immuno-Oncology 360° event takes place February 1-3, 2017 in NYC.  Lead advisors, Dr Axel Hoos (GSK) and Dr James Gulley (NCI) co-present a program that provides a  360-degree approach addressing the most-up-to-date information regarding business aspects, clinical advancements and scientific data that will help accelerate clinical trials and FDA approval, ultimately transforming the way cancer is treated. In this brief radio blog post, get a five minute overview on what to expect at IO360 2017! For more information on the entire event and speaking faculty, visit, www.theconferenceforum.org      

Members of the DPharm team engage in an informal conversation to highlight what's happening in innovation and the latest thinking to disrupt clinical trials at the 6th annual event. Also discussed is a brief history of how this conference dedicated to applying disruptive thinking to clinical trials came to be. This conversation is well worth listening to if you plan to attend DPharm or want to get a sense of the quality and depth this program brings to clinical trial executives. DPharm takes place September 20-21, 2016 at the Fairmont Copley Plaza Hotel in Boston. Also featured on September 19 is a full day on Mobile Applications to Enhancing Clinical Trials. DPharm Link for More information or to Register: http://theconferenceforum.org/conferences/disruptive-innovations-us/overview/ Host: Valerie Bowling, Executive Director, DPharm Guests: Meredith Sands, Executive Director, Business Development, DPharm Elizabeth Bard, Business Development Director, DPharm  

Pfizer’s “Blue Sky” approach to transforming clinical research in Parkinson’s disease is an inspiring example of patient-centric innovation. Conference Forum's, Valerie Bowling welcomes co-host, Ed Miseta, Clinical Leader.com in a discussion with members of Pfizer’s "Blue Sky" team. Together they discuss the vision, goals and journey in taking a new approach to advancing drug development. More specifically, the Blue Sky team talks about their partnership with IBM, (first of its kind) decisions on how to use a device in a trial, real time data collection, an 1800s house for a 21st Century research and more.  Co-Hosts:  Valerie Bowling, Executive Director, The Conference Forum Ed Miseta, Chief Editor, Clinical Leader and Contributing Writer, Life Science Leader Guests:  Stephen Amato, PhD, Project Manager, BlueSky, Pfizer David Caouette, MBA, Senior Director, Strategy and Operations Lead, BlueSky and Quantitative Medicine, Pfizer    Daniel Karlin, MD, Senior Director, Quantitative Medicine, Clinical Lead

This discussion provides helpful approaches for Chief Medical Officers (CMOs) and other R&D leadership in biotech on how to communicate effectively in times of good, bad or unexpected news. Also discussed in this program are factors to evaluate for the discontinuation of a program. Dr Mark Weinberg, Chief Medical Officer and Managing Director of Halloran Consulting Group will be joined by Dr Lee Allen, CMO, Argos Therapeutics to discuss strategic communication strategies CMOs/R&D leadership can utilize to effectively deliver unexpected or difficult news.  More specifically: How do you communicate successfully?How does a CMO manage an unexpected realization?Tips on being an advocate and skeptic for your programsFlexibility and decision making with dataScenario planningTips on communicating to the publicEvaluating factors for discontinuing a programRationalizing your portfolio? Who decides? Guests: Lee Allen, MD, PhD, CMO, Argos Therapeutics Mark Weinberg, MD, MBA, CMO and Managing Director, Halloran

What is the quality, capacity and efficiency of running clinical trials in Puerto Rico? In this discussion we speak with Dr Myrto Lee, Director, PwC'sStrategy&, UK and Dr Kosmas Kretsos, Executive Director of the Puerto Rico Consortium for Clinical Investigation to learn about key initiatives and outcomes so far to make running clinical trials more attractive in Puerto Rico. For more information about conductingclinical trials in Puerto Rico, please visit www.PRCCI.org. Why consider Puerto Rico for clinical trials?Status of new sites to expand clinical trial networksStatus of a central coordinator with sites to reduce bureaucracy e.g. central IRB, central invoicingPatient access and costsPatient engagementAccess to new technologiesTraining Guest Host: Dr Myrto Lee, Director, PwC's Strategy&, UK Guest: Dr Kosmas Kretsos, Executive Director, PRCCI (Puerto Rico Consortium for Clinical Investigation), Puerto Rico Producer: Valerie Bowling, Executive Director, the Conference Forum

Frustrated that a promising therapy for a rare cancer was sitting in a freezer due to the lack of a relatively modest amount of funding, author Alexander Masters helped lead a campaign to crowd-fund a clinical trial: the result, iCancer.org.uk. The money required was indeed raised by a wealthy individual primarily, in return for being in the trial. At DPharm Europe, Pfizer's Craig Lipset interviewed on stage Alexander to share his story. We are delighted to present the journey and latest updates on PharmaTalk Radio.  The story of the formation of iCancer.org.uk and the Oncolytic Virus FundAn alternative way to make clinical trials more accessibleEthical and moral issuesA possible disruptive and sustainable model for other neglected medicines The next DPharm: Disruptive Innovations to Advance Clinical Trials event takes place September 20-21 in Boston. DPharm Europe is scheduled for February 8-9, 2017 in London. For more information about these events or our Immuno-Oncology events, visit, www.theconferenceforu

Generic drugs can be repurposed to create effective treatments in unsolved diseases. However, there is no economic incentive for industry to pay for a clinical validation and regulatory approval process for most generic drug repurposing because it will not achieve the necessary ROI. Cures Within Reach, FindaCure, Numbers For Good and the National Health Service in England are working together to the create a new economic solution to this problem by piloting the first ever Rare Disease Generic Drug Repurposing Social Impact Bond (SIB). This SIB would be a “pay for success” initiative, in which investors fund the proof of concept repurposing clinical trials and the government provides a payment to the SIB for any repurposed therapies that both improve patient outcomes and reduce healthcare costs. The government success payment would allow the SIB to repay the investors, and have additional funds for the next group of repurposing clinical trials, creating a sustainable funding source for generic drug repurposing

Pharmatalk's Valerie Bowling welcomes Anton (Tony)  Hoos, MD, PhD, Head of Medical, Amgen Europe and Marc Boutin, JD, Chief Executive Officer, National Health Council.  We address how industry and patients can work together to incorporate the patient voice in drug development and to improve patient's experience in clinical trials. We examine the current challenges and barriers to patient involvement, progress and next steps.  Host:  Valerie Bowling, Executive Producer, PharmaTalk Radio Guests: Anton (Tony) Hoos, MD, PhD, Head of Medical, Amgen Europe   Marc Boutin, JD, Chief Executive Officer, National Health Council Both Dr Hoos and Mr Boutin will be speaking at the Patients as Partners conference scheduled for March 14-15, 2016 in Philadelphia. For more information, visit www.theconferenceforum.org

PharmaTalk Radio's Valerie Bowling welcomes Immuno-Oncology 360° Co-Chair James Gulley, MD, PhD,National Cancer Institute as he leads a discussion with fellow Co-Chair, Axel Hoos, MD, PhD, GlaxoSmithKline. Together they discuss what's currently happening in Immuno-Oncology and its impact on how cancer is being treated. They cover the latest challenges and next steps. More specifically they also address: Ipilumumab/Nivo/Pembro challengesWhat can we learn from the development of sipuleucel-T that may be applicable for other therapeutic vaccines?Challenges with the following modalities: Checkpoints, Oncolytic Virus', Adoptive T-Cells, Cancer VaccinesBlinitumumabThe more interesting agents in late stage development now in immunotherapy and its promiseImmune related adverse eventsAdoptive cellular therapies, what is the most promising?Will IO become backbone therapies for cancer?What's the next set of assets that are going to come out?Promises in combination therapies?What can we expect next? Guests: James Gulley

At Dpharm US 2015, Katherine Vandebelt, Global Head, Clinical Innovation, Eli Lilly hosted a talk show on MakingClinical Trials a Care Option for Patients to fantastic reviews. Valerie Bowling, producer welcomes Katherine as she hosts a similar session on Pharma Talk Radio. About the Show: This talk demonstrates how an organized multispecialty healthcare system, clinical research site network and pharma company uses clinical research as a tool and connector to help improve patient engagement in their overall healthcare management and compliance. More specifically: Healthcare System: improving health and service to patients and advocators of clinical research participationClinical Research Site Network: bringing the right patients to the right trials with increased quality of data and engagement of patientsPharma: expanding our reach to patients and getting trials done fasterShifting the paradigm: Applying a Value Based Health Care Delivery Framework to improve outcomes and reduce healthcare costs   Hosted b

In this episode of Pharma Talk Radio, we feature medical oncologist, Dr Anna Pavlick, Director of the Melanoma Program at the NYU Cancer Institute on Safety Elements of Cancer Immunotherapies. Dr Pavlick originally gave this presentation in June 2015 at the IO360 conference.  Her talk focuses on immune related adverse affects of immuno therapy. More specifically, she covers: •    Identifying warning signs and low threshold for workup and treatment •    Understanding “pseudoprogression” before response, delayed toxicities •    Reporting and assessing adverse effects during clinical trial phases •    How to predict safety concerns when moving from animal models to human trials We are pleased to bring this session to the public to help researchers, doctors, patients and care givers with some information on immune related adverse affects of immuno therapy. Please note that Dr Pavlick does occassionally refer to slides which are not included in the recording of this session. Anna Pavlick, DO, MD is the Direc

At the May 2015 Chief Medical Officer’s Summit in Boston, we featured a session on: How the Availability of Capital Impacts the Role of the CMO In this session, the panelists cover: Optimal use of the proceeds Determining a development path, new molecules vs. new studies on the same molecules Appropriate stewardship of the capital Balancing short-term and long-term objectives; particularly when they may conflict Concerns and/or benefits of early financing without having reached clinical goals Examining the new threshold in moving development forward How is the progress in the industry translating into new drug discovery? Maintaining the same rigor for investment Moderated by: Louis Brenner, MD Chief Operating Officer, Allena Pharmaceuticals Panelists: Raj Malik, MD CMO, G1 Therapeutics Jim Roach, MD CMO and SVP, Development, Momenta Pharmaceuticals Oliver Rosen, MD CMO, Deciphera Pharmaceuticals Ian Walters, MD VP and CMO, Intensity Therapeutics The next CMO Summit is November 9-10 in Burlingame

At the May 2015 Chief Medical Officer's Summit in Boston, we featured a session on: How Investors Assess R&D Biotech Management Take a look at the details below: In this session, we begin with a presentation on a perspective on the method of evaluating a disease space, which includes a comprehensive understanding of 1) the science, 2) the competitive landscape and 3) the management teams for each company. How does this get mapped out? Following will be more discussion on: Understanding the context of value proposition Strategic fit Processes used to evaluate management and an understanding of competitive strategy How best to convey your plans How best to communicate with investors (before investment) and boards (afterwards) – via the CEO or directly? Importance of clinical development plan expectations Moderated by: Peter Kolchinsky, PhD Managing Director, RA Capital Management, LLC Panelists: Jonathan Behr, PhD EIR and Market Sector Leader, Innovation, Partners Healthcare, David Berry, MD, PhD P