YourEncore Insights - Life Sciences

Jim Combs

Recent Posts

The Future is Here: Using Big Data and Artificial Intelligence in Oncology (Ep. 15 of The Pharmcast)

Posted by Jim Combs on 3/16/17 12:19 PM

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.

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Topics: Pharmcast, Artificial Intelligence, Oncology, Big Data

Working with the FDA: Developing a Regulatory Strategy That Works (Ep. 14 of The Pharmcast)

Posted by Jim Combs on 3/2/17 4:00 PM

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.

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Topics: Regulatory, FDA, Pharmcast

Riding the Policy Roller Coaster in 2017: A Policy Update with Dr. Tim Franson (Ep. 13 of The Pharmcast)

Posted by Jim Combs on 2/16/17 8:30 AM

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.

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Topics: Regulatory, FDA, Pharmcast, policy, pdufa

NDA Mistakes to Avoid: An Interview with Dr. Joseph Lamendola (Ep. 12 on The Pharmcast)

Posted by Jim Combs on 2/13/17 9:00 AM

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Topics: FDA, Pharmcast, NDA

Medtech Valuation Killers: 10 Regulatory & Commercialization Traps to Avoid (Ep. 11 on The Pharmcast)

Posted by Jim Combs on 2/8/17 8:00 AM

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Topics: Regulatory, Medical Device, Med Dev, Pharmcast

Patient Engagement: Putting Rare Disease Patients First (Ep. 10 on The Pharmcast)

Posted by Jim Combs on 1/30/17 12:00 PM

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, outline the unique challenges of engaging the rare disease population, and her advice to developers.

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Topics: Rare Disease, R&D, Pharmcast

No Surprises: Improving Medical Devices Due Diligence (Ep. 9 on The Pharmcast)

Posted by Jim Combs on 1/25/17 12:00 PM

This week on The Pharmcast, we discuss 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, with two former Johnson & Johnson medical devices executives, Donna Godward and Dr. Janet Vargo.  Understanding what to look for (or present) during due diligence will reduce risks and lead to a better evaluation for the transaction.

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Topics: Medical Device, Med Dev, Pharmcast

FDA 483 Responses: Avoiding Common Pitfalls and Deficiencies (Ep. 8 on The Pharmcast)

Posted by Jim Combs on 1/12/17 8:00 AM

This week on The Pharmcast, we explore best practices and common pitfalls in FDA 483 Responses. 

In 2015, there were an average of 175 inspections and 10 warning letters issued per month by the Center for Devices and Radiological Health alone.  Regulatory inspections and 483 findings are a part of being a life sciences company.  However, how companies respond can have a major impact on patient safety and business performance.

To share best practices, we held a special presentation with two of our top medical device experts, Victor Chance and Judy Meritz, to outline what they’ve learned over the course of their 20+ year careers in the medical devices industry.

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Topics: Medical Device, Med Dev, FDA, Supply Chain, Pharmcast

Bioethics in Biopharma: Lessons on Safety, Big Data and Bioethics from Dr. Don Therasse  (Ep. 7 on The Pharmcast)

Posted by Jim Combs on 1/5/17 12:26 PM

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.

With over 26 years of experience working with Lilly, Therasse held a diverse set of roles ranging from clinical research physician, to medical director, to medical affairs leader, and finally to patient safety leader.  Beyond drug safety, Don Therasse is a thought leader in bioethics and is credited with building Lilly's internal bioethics group.

In our conversation with Dr. Therasse, we explore experiencing a major patient safety event, building a bioethics program, the promise (and limitations) of big data in patient safety, and success formulas for transitioning into new departments within a large biopharma company. 

If you have topics you would like YourEncore to explore on future episodes of The Pharmcast, please email Pharmcast@yourencore.com with feedback or suggestions.

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Topics: Pharmaceutical Industry, Quality & Safety, Pharmcast

From Big Pharma to Biotech C-Suite: Industry and Career Insights from Dr. June Almenoff (Ep. 6 on The Pharmcast)

Posted by Jim Combs on 12/15/16 10:40 AM

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 Actavis for $1.2 billion.

With an M.D. and Ph.D., Dr. Almenoff began her career as a faculty member at Duke University before landing a position at GlaxoSmithKline (GSK) in their medical R&D division and scientific licensing.  However, after 13 years at GSK,  a new opportunity presented itself in 2010 when Dr. Almenoff was invited to head up a small biopharma company as President & CMO, which she would soon lead into a $1.2 billion acquisition.

Almenoff helped the company successfully progress its Irritable Bowel Syndrome drug from Phase 2 through the FDA submission, which the FDA approved in 2015 on its first review cycle.

Everyone talks about learning from failure, but from our discussion with Dr. Almenoff, we learn from success.  I asked Dr. Almenoff about her keys to success, drug development trends, and the lessons she's learned across her 'big pharma' and biotech career.

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Topics: Pharmaceutical Industry, Pharmcast