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.

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.

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.   

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.

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.

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.

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.

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.

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.