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.
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.
This week on The , 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 , we talk with
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.
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.