PharmaTalkRadio

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.

Producer:

Valerie Bowling

Executive Director, Conference Forum

Guest Host:

Bruce Bloom, JD

President & CSO,Cures Within Reach

Panelists:

James Potter

Investment Director,Numbers for Good

Flóra Raffai

Executive Director,Findacure

Dr Rick Thompson

Scientific Officer, Findacure

Helpful Websites:

findacure.org.uk

numbersforgood.com

www.theconferenceforum.org

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, MD, PhD

Head, Immunotherapy Section, Director, Medical Oncology Service, Office of the Clinical Director, Center for Cancer Research, National Cancer Institute

Axel Hoos, MD, PhD, VP, Oncology R&D,GlaxoSmithKline

The Immuno-Oncology360° conference is scheduled for February 2-3, 2016  at the New York Academy of Medicine in NYC. For more information, please visit www.theconferenceforum.org.

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 by: Katherine Vandebelt Global Head, Clinical Innovation, Eli Lilly and Company

Guests:

Jeff James, MBA, CEO, Wilmington HealthJennifer Byrne, CEO, PMG ResearchAllen Buechler, MBA, Strategy and Operations, Eli Lilly and CompanyToyin Okanlawon, MD, MPH, Senior Health Care Researcher, Harvard Business School Health Care Team

For more information on cutting edge topics in clinical research/trials visit:

Dpharm US, visit www.theconferenceforum.org

Dpharm Europe, visit www.theconferenceforum.org

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 Director of the NYU Cancer Institute Melanoma Research Program. After finishing her studies at University of Medicine & Dentistry of New Jersey, School of Osteopathic Medicine, Dr Pavlick completed her residency in internal medicine and her fellowship in hematology/oncology at Memorial Sloan Kettering Cancer Center. In 1999, she went on to become the Director of Clinical Oncology at UMDNJ in New Jersey before coming to NYU.

The next IO360 conference will take place February 2-3, 2016 at the New York Academy of Medicine in NYC. For more information, visit www.theconferenceforum.org.

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, California. It is one of the best face-to-face opportunities for R&D leaders in emerging biotechs to:

1. Address the unique challenges associated with directing and managing all R&D functions with limited resources, while raising capital, working and meeting with investors, and strategizing for appropriate exits.

2. To create a network of CMOs & other R&D leaders from small to midsize life science companies to share ideas, solutions and support.

For information, visit www.theconferenceforum.org

Partial and full scholarships available for start-ups.

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 Partner, Flagship Ventures, Vikas Goyal, MBA Principal, SR One, and Jeffrey Moore, DPhil, MBA President, MPH Venture Management

The next CMO Summit is November 9-10 in Burlingame, California. It is one of the best face-to-face opportunities for R&D leaders in emerging biotechs to:

1. Address the unique challenges associated with directing and managing all R&D functions with limited resources, while raising capital, working and meeting with investors, and strategizing for appropriate exits. 2. To create a network of CMOs & other R&D leaders from small to midsize life science companies to share ideas, solutions and support.

For information, visit www.theconferenceforum.org

Partial and full scholarships available for start-ups.

At the Conference Forum's 2015 Chief Medical Officer's Summit in Boston, David Schenkein, MD, CEO, Agios provided a warm and personal keynote sharing his journey as a Physican CEO. In this recording of the session, gain an insight into Dr Schenkein's views on leadership in running a biotech company and more specifically:

The journeyThe people and mentorshipsPrioritizing resourcesSuccesses and failuresOvercoming hurdlesStrategic partnershipsBusiness planningAudience Q&A

This is a great session for leadership and aspiring leadership in life sciences and beyond.

The Chief Medical Officer West Summit is this November 9-10 in the San Francisco area. See www.theconferenceforum.org for speaker line up and agenda information. The CMO West conference is dedicated to addressing the unique challenges faced by CMOs and their staff in managing R&D in emerging biotechs.

PharmaTalkRadio is a non-profit program organized and supported by the Conference Forum to give easy and free access of helpful information to all industry professionals and students in the life sciences.

Clinical Air Episode #14 is pleased to present a discussion on Consumer Electronics in Clinical Research.Craig Lipset, Head of Clinical Innovation R&D at Pfizer welcomes guests from Rebar Interactive and Eli Lilly to address and explore an update on what's available, what's capable and what's working with consumer electronics in clinical research. We explore topics including, but not limited to:

How to scale new toolsThe level of validation of different instrumentsThe impact of tools like the Apple Research KitWhat future apps will offer

Hosted by Craig Lipset, Head of Clinical Innovation, R&D, Pfizer

Guests:

Rahlyn Gossen, Founder, Rebar Interactive

Michael Luker, Director, Clinical Innovation, Eli Lilly

Katherine Vandebelt, Senior Director, Clinical Development Innovation, Eli Lilly

*Please note this session has some background sound interference at the start of the program.

The last 30 years of Immuno-Oncology research have provided strong evidence that tumors do recognize the immune system and their development can be stopped or controlled long term.

Given the impressive survival data over the past five years, it is not surprising that Immuno-Oncology is arguably the most exciting area in the advancement of science and patient care today.  However, with all research, there are plenty of challenges and to get a better understanding of this innovative approach to cancer research, we are pleased to welcome to the program, James Gulley, MD, PhD of the National CancerInstitute and Roy Baynes, MD, PhDat Merck Research Labs. Joining Drs Gulley and Baynes is Kate Woda, Director of theIO360 conference taking place at Columbia University Faculty House on June 29-30 in NYC.

Host:

Valerie Bowling, Producer, Pharma Talk Radio

Guests:

James Gulley, MD, PhD, Head, Immunotherapy Section, Director, Medical Oncology Service, Office of the Clinical Director, Center for Cancer Research, National Cancer Institute

Roy Baynes, MD, PhD, Senior Vice President, Global Clinical Development, Merck Research Labs

and

Kate Woda, Director, IO 360