YourEncore Insights - Life Sciences

Jim Combs

Recent Posts

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 [email protected] 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

Holiday Wish-Lists and Watch-Outs From Regulatory Leaders (Ep. 5 on The Pharmcast)

Posted by Jim Combs on 12/8/16 9:56 AM

 

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Topics: Pharmaceutical Industry, Regulatory, FDA, Pharmcast

Billion Dollar Bets: Lessons on Innovation from a BMS Chief Scientific Officer, Dr. Elliott Sigal (Ep. 4 on The Pharmcast)

Posted by Jim Combs on 12/1/16 8:00 AM

 

Each week in The Pharmcast, we talk with top industry experts from our network or beyond about hot industry topics, leadership, and the path to success. This week in The Pharmcast, we catch up with Dr. Elliott Sigal, the former Chief Scientific Officer of Bristol-Myers Squibb.

In 2012, Dr. Sigal was called by Scrip Pharma Intelligence "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.

As referenced in both Episode 1 and Episode 2 of The Pharmcast,  Dr. Sigal, through internal development and making sizable asset acquisitions, developed a pipeline of first-in-class medicines that helped transform the company, the industry, and most importantly, the lives of hundreds of thousands if not millions – of patients. 

When asked what his "secret sauce" to success was, he said it was not just one thing, but the culmination of many things.  Below are the three of the things Dr. Sigal attributed to his success.

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Topics: Pharmaceutical Industry, Pharmcast

9 Biotech Valuation Killers (Ep. 3 of The Pharmcast)

Posted by Jim Combs on 11/17/16 8:00 AM

 

This week in the Pharmcast, we discuss "9 Biotech Valuation Killers" with Dr. Brian Daniels, the former SVP of Global Development for Bristol-Myers Squibb and now Venture Partner with 5AM Ventures, and Dr. Don Therasse, former VP of Global Patient Safety and Medical Affairs for Eli Lilly & Company.  

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Topics: Pharmcast

Leading the Bristol-Myers Squibb Transformation (Part 2) (Ep. 2 of The Pharmcast)

Posted by Jim Combs on 11/10/16 8:00 AM

 

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.

In part 2 of the roundtable, we start off with John Celentano, who was responsible for delivering a large organizational transformation to fund reinvestment in their innovation pipeline.

With the "string of pearls" strategy in place, it was time to figure out how BMS was going to pay for their acquisitions, and continue to fund the development of new products.

Knowing they needed to fundamentally change how they ran the business, the BMS board set out with something they referred to as "the productivity transformative initiaitive."

After restructuring the way the company ran, by shrinking the company and increasing productivity, the board members of BMS set their sites on investing in innovative products and technologies - primarily biologics. At the time, only about 6-7% of major drus were biologics. But, the BMS executives estimated that in the future, the biologic market would near 25%.

In what was, at the time, a make-or-break decision, the BMS executives made a leap-of-faith, $2.3 billion acquisition of a small company called "Medarex," a company that focused on immuno-oncology medicines.

Despite originally being heavily criticized by leaders in the oncology field for the alliance, BMS was well on their way to becoming a leader in the immuno-oncology space. 

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Topics: Pharmcast

Leading the Bristol-Myers Squibb Transformation (Part 1) (Ep. 1 of The Pharmcast)

Posted by Jim Combs on 11/9/16 2:25 PM

 

We are pleased to announce that YourEncore has officially joined the podcasting ranks with the launch of the YourEncore Pharmcast, your weekly dose of wisdom from top life science minds.   Each week we will speak with top industry experts in our network or beyond about hot industry topics, leadership, and the path to success. 

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.

What follows is a tremendous case study on leadership, portfolio decisions, organizational transformation, and most importantly, developing life-changing medicine for patients.

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Topics: Pharmcast