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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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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.

Dec 14, 2016

This week on The Pharmcast, we talk with Dr. June Almenoff, former President, Chief Medical Officer and Board Member of a biotech, which was recently acquired in 2014 by Forest Laboratories for $1.2 billion.

Almenoff helped the company successfully progress its Irritable Bowel Syndrome drug from Phase 2 through the FDA submission, which the FDA approved in 2013.

Everyone talks about learning from failure, but this week, we learn from success. Join us as we sit down with Dr. Almenoff to talk about her story and lessons she learned along the way.

Dec 7, 2016

This week in The Pharmcast, we asked two of our top regulatory policy Experts to give us their holiday wish-lists, and top things to watch for in 2017.

Leading the discussion is Dr. Tim Franson, who is the former VP of Global Regulatory Affairs and Global Patient Safety for Eli Lilly & Company, and also happens to be the Chief Medical Officer at YourEncore.

Joining him is Peter Pitts, former FDA Associate Commissioner. Peter was named one of the 300 Most Powerful People in American Healthcare by Modern Healthcare Magazine, and frequently contributes to national media outlets - including CSNBC, Fox News and the Wall Street Journal.

We know it'll be an interesting discussion, and we hope you enjoy.

 

Nov 30, 2016

This week in The Pharmcast, we catch up with Dr. Elliott Sigal, former Chief Scientific Officer of Bristol-Myers Squibb.

In 2012, The Wall Street Journal called Dr. Sigal "The Best R&D Chief in Pharma," largely for helping deliver BMS' "String of Pearls" strategy that helped position BMS as a major player in the immuno-oncology space.

In Episode 4 of the Pharmcast, we talk with Dr. Sigal about leadership, portfolio decisions and what made him successful on his journey.

Nov 16, 2016

According to a global study by Mergermarket and Reed Smith, 94 percent of senior life sciences executives plan to make an acquisition in 2016, so biotech firms need to do everything possible to make sure they are properly positioned to get the most value for their asset.

 

Oct 27, 2016

A continuation of our maiden voyage of the Pharmcast, we talk with a trio of former Bristol-Myers Squibb executives, who developed and delivered BMS’ “String of Pearls” strategy, that delivered first-class medicines to patients and positioned BMS as a clear leader in the immuno-oncology space.

Oct 27, 2016

For our maiden voyage of the Pharmcast, we talk with a trio of former Bristol-Myers Squibb executives, who developed and delivered BMS’ “String of Pearls” strategy that delivered first-class medicines to patients and positioned BMS as a clear leader in the immuno-oncology space.

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