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.
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.
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.
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.
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