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The Pharmcast

YourEncore's Pharmcast is your weekly dose of wisdom from today's top life science minds. YourEncore is a leading provider of proven expertise in the life sciences industry. Focused on highly experienced R&D or technical talent, YourEncore gives clients the people or insights needed to outpace, outthink and outperform. Each week in the Pharmcast, we talk with top industry experts in our network or beyond about hot industry topics, leadership, and the path to success.
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The Pharmcast
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Now displaying: 2017
Jun 14, 2017

In this episode of The Pharmcast, we join YourEncore Expert, Darryl Glover, to discuss one of the hottest technologies on the market today: blockchain.

We've heard some people say that if the internet was invented today, it would be built using blockchain. So, what exactly is blockchain, and how exactly can it revolutionize the world and change the healthcare industry as we know it? 

Darryl Glover is just the person to ask. Darryl is a YourEncore Expert, and the Chief Clinical Officer and co-founder of iSolve, focused on applying blockchain-based solutions to pharma-industry problems.

May 11, 2017

In this episode of The Pharmcast, we share a recording from our May 5th webinar, State of the Industry: U.S. Regulatory Policy Overview. Parthenon-EY and YourEncore recently conducted a nationwide survey of life sciences experts to query them on recent market trends, uncover their points of view on potential regulations, refine their current business models and gain insights into what discovery efforts might yield better results. With all the rhetoric surrounding the drug industry from political, news and personal channels, we wanted to know what “those who know” think of various ways to improve the system.

We asked 10 simple questions, soliciting input from more than 50 past and present industry executives and Experts from pharmaceutical, consulting and pharmacy backgrounds. What we heard was informative, provocative and in some cases unsurprising — but important to consider. 

If you're interested in hearing the full webinar, including a Q&A to conclude the session, visit www.info.yourencore.com/insights.

Apr 30, 2017

This week in the Pharmcast, we caught up with Dr. Tim Franson to discuss the leading edge of rare disease drug development. 

Dr. Franson has been actively helping Parent Project Muscular Dystrophy, a Duchenne Muscular Dystrophy Patient Advocacy group, which is doing pioneering work collaborating with FDA to inform benefit-risk and establish FDA guidance.

Duchenne has been a great test case, so we sat down with Dr. Franson to share his lessons learned and understand what’s happening on the frontiers of rare disease drug development.

Apr 13, 2017

This week on The Pharmcast, we tackle one of the hottest topics in the life sciences and healthcare industry: digital health. The promise of digital health is enticing, and a logical evolution of the digital economy. However, some of the early euphoria is waning as the demands of implementation, application and ROI are becoming more important, and in some cases - more elusive. 

So what is the current state of digital health for life sciences? What're some of the obstacles life sciences companies have to overcome to drive adoption? And what're some of the most promising applications of digital health for the life science companies? These are all questions we discuss with this week's guest, Dr. Ron Razmi. 

Mar 22, 2017

On this episode of The Pharmcast, Heidi Youngkin shares her formula to successful launch communications for biologics.

Heidi Youngkin is a 13-year veteran from Johnson & Johnson, where she served as the Executive Global Director of Global Pharmaceutical Communications and the Global Marketing Group.

After leaving Johnson & Johnson, she became the SVP of Marketing for Inventiv Health's Patient Marketing Group, so she brings a wealth of knowledge about marketing and communication strategy.

When it costs over $2.5B dollars to develop a drug, according to the most recent Tufts study, the pressure to have a successful launch is great.

Throw in that the industry is facing tighter scrutiny on pricing and value, that the science of biologics is getting more nuanced, and that there is more competition for the patients' or prescribers' time, and the world of launch communications is getting much more complex.

To help make sense of it all, join us this week as Heidi shares her formula for successful biologic launch communication.

Mar 15, 2017

On this week's episode of The Pharmcast, we talk with YourEncore Expert, Philippe Barzin, on the future of big data and artificial intelligence in oncology. Based off Philippe's article, Artificial Intelligence Fighting Cancer and Transforming Public Health, we talk with Philippe on five ways artificial intelligence will transform oncology treatment, and how biopharma companies can start adopting these tools to improve performance.

Philippe spent over 15 years at Johnson & Johnson, where among other things, he helped implement machine-learning and big data solutions for product safety and resource planning applications.  I am also proud to share that he is one of YourEncore's newest Experts.  

Mar 2, 2017

On this week's episode of The Pharmcast, we explore the key elements of an effective regulatory strategy and how to drive value to patient and shareholders by working with the FDA. We also cover common ways agency decisions can destroy value if not done properly.

Dr. Tim Franson and Dr. Joe Lamendola recently gave a presentation to a group of private equity and venture capital funds to outline the importance of regulatory strategy for small biopharma companies.

Feb 16, 2017

We are at a time of great change and transition in the FDA. The sitting FDA chief stepped down, just when the 21st Century Cures Act passed into law; PDUFA 6 is up for renewal this year; and the new administration has signaled hiring freezes for government agencies, including the FDA.

While many of the policy and leadership changes in 2017 may not appear to make a day-to-day impact on drug developers at first, these changes can in fact have a profound impact. 

To help us understand how 21st Century Cures, PDUFA 6, and leadership changes can affect your development plans, we sit down with Dr. Tim Franson, who is not only YourEncore's Chief Medical Officer, but also Chairman of the Board  for The Critical Path Institute, the Immediate Past-President for the USP, and a key contributor to the last few PDUFAs.

 

 

Feb 10, 2017

This week on the Pharmcast, we talk with Dr. Joseph Lamendola on four New Drug Application (NDA) mistakes to avoid.

Dr. Lamendola is the former VP of U.S. Regulatory Affairs for Bristol-Myers Squibb and Schering-Plough, and now serves as the SVP and leader of YourEncore's Biopharma practice.

Joe has over 20 drug approvals to his name, so we ask Joe to share his life lessons on how to work with the FDA to receive NDA approval and ultimately get life-changing therapies to patients.

Feb 6, 2017

In this week's episode of The Pharmcast, we talk with Dr. Janet Vargo and Minnie Baylor-Henry, J.D. to share 10 mistakes medical device start-ups frequently make during development that ultimately reduce their valuation to potential acquirers.

After evaluating dozens of innovative new medical device products as an executive at Johnson & Johnson, Dr. Vargo has seen firsthand the common mistakes that small companies make. In this session, she will outline regulatory and commercialization pitfalls to avoid that will improve your speed to market, valuation, and interest from large medical devices companies.

Jan 27, 2017

This week on The Pharmcast, we turn our attention to the topic of rare disease, and more specifically: how to engage and educate rare disease patients to advance development. It's estimated that nearly 30 million Americans, or nearly 1 in 10 people,  are living with a rare disease - and almost 95% of rare diseases don't have any FDA-approved treatment. 

One of the unique challenges and perhaps keys to rare disease development is patient engagement. Patient populations are small by definition. Roughly 50% of patients are children, and benefit-risk equations are completely different from those of more traditional diseases. To learn more about engaging rare disease patients, we sit down with Dr. Lorna Speid, to discuss her stories of rare disease drug development, outlines the unique challenges of engaging the rare disease population, and her advice to developers.

Jan 19, 2017

In this week's episode of The Pharmcast, we join two former Johnson & Johnson medical devices executives - Donna Godward and Dr. Janet Vargo - to discuss M&A due diligence and best practices.

In this session, Donna Godward and Dr. Janet Vargo will discuss the areas often overlooked in due diligence efforts that can lead to expensive or even show-stopper surprises once the acquisition is complete and later development and commercial efforts are underway. Understanding what to look for (or present) during due diligence will reduce risks and lead to a better evaluation for the transaction.

Jan 11, 2017

This week on The Pharmcast, we talk with Judith Meritz, J.D. (Former Associate General Counsel at Covidien/Medtronic), and Victor Chance (Former Vice President of External Operations and Chief Supply Chain Chief Procurement Officer for J&J Medical Devices and Diagnostics), as they outline the most frequent deficiencies cited in a FDA 483 as well as highlight common pitfalls in the supply chain function when addressing compliance remediation issues.   

Jan 4, 2017

This week on The Pharmcast, we talk with Dr. Don Therasse, former VP of Global Patient Safety for Eli Lilly & Company, and current Strategic Advisor for YourEncore. 

Beyond drug safety, Don Therasse is a thought leader in bioethics and is credited with building Lilly's internal bioethics group.

Join us this week as we talk about dealing with a major safety crisis, the promise of big data in pharmacovigilance - and its limitations, and the role of bioethics in today's biopharma companies.

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