Billion Dollar Bets: Lessons on Innovation from a BMS Chief Scientific Officer, Dr. Elliott Sigal

December 1, 2016, 5:00 am

≫ Next: Holiday Wish-Lists and Watch-Outs From Regulatory Leaders

≪ Previous: The Pharmcast: 9 Biotech Valuation Killers

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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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Holiday Wish-Lists and Watch-Outs From Regulatory Leaders

December 8, 2016, 6:56 am

≫ Next: From Big Pharma to Biotech C-Suite: Industry and Career Insights from Dr. June Almenoff

≪ Previous: Billion Dollar Bets: Lessons on Innovation from a BMS Chief Scientific Officer, Dr. Elliott Sigal

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From Big Pharma to Biotech C-Suite: Industry and Career Insights from Dr. June Almenoff

December 15, 2016, 7:40 am

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

≪ Previous: Holiday Wish-Lists and Watch-Outs From Regulatory Leaders

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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.

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

January 5, 2017, 9:26 am

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

≪ Previous: From Big Pharma to Biotech C-Suite: Industry and Career Insights from Dr. June Almenoff

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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.

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

January 12, 2017, 5:00 am

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

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

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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.

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

January 25, 2017, 9:00 am

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

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

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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.

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

January 30, 2017, 9:00 am

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

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

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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.

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

February 8, 2017, 5:00 am

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

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

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

February 13, 2017, 6:00 am

≫ Next: Executive Briefing: EU Medical Device Regulation | 5 Ways EU MDR Will Impact Your Business [White Paper]

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

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Executive Briefing: EU Medical Device Regulation | 5 Ways EU MDR Will Impact Your Business [White Paper]

February 15, 2017, 5:00 am

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

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

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The European Union has agreed on a new Medical Device Regulation meant to improve patient safety and data  transparency. The regulation is extensive and impactful – it touches many functions within the company and  companies that fail to comply will not be allowed to sell products into the EU. With the legislation expected to  publish in 2017, companies will have three years to bring medical devices into compliance and, under a separate new regulation for IVD’s, five years for these products.

With the EU finally reaching the agreement, the compliance clock is ticking. Although many functions are impacted, regulatory leaders will most likely be responsible for driving corporate compliance.  If you’re just starting the process, download Executive Briefing: EU Medical Device Regulation to learn five ways EU MDR will impact your business. 

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

February 16, 2017, 5:30 am

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

≪ Previous: Executive Briefing: EU Medical Device Regulation | 5 Ways EU MDR Will Impact Your Business [White Paper]

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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.

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

March 2, 2017, 1:00 pm

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

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

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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.

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

March 16, 2017, 9:19 am

≫ Next: 7 Best Practices in Biologics Launch Communications (Ep. 16 of The Pharmcast)

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

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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.

7 Best Practices in Biologics Launch Communications (Ep. 16 of The Pharmcast)

March 23, 2017, 10:28 am

≫ Next: Welcome to the Real World: A Reality Check for Digital Health with Dr. Ron Razmi (Ep. 17 of The Pharmcast)

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

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On this episode of The Pharmcast, Heidi Youngkin shares seven best practices for successful biologic launch communication.

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 seven-point formula for successful biologic launch communication.

Welcome to the Real World: A Reality Check for Digital Health with Dr. Ron Razmi (Ep. 17 of The Pharmcast)

April 13, 2017, 7:00 am

≫ Next: YourEncore Announces Addition of Michelle DeJonge and Dr. James Wood as Strategic Advisors for Medical Devices & Diagnostics Practice

≪ Previous: 7 Best Practices in Biologics Launch Communications (Ep. 16 of The Pharmcast)

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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. 

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YourEncore Announces Addition of Michelle DeJonge and Dr. James Wood as Strategic Advisors for Medical Devices & Diagnostics Practice

April 13, 2017, 1:24 pm

≫ Next: The Frontiers of Rare Disease Development: Advances in Regulatory Science with Dr. Tim Franson (Ep. 18 of The Pharmcast)

≪ Previous: Welcome to the Real World: A Reality Check for Digital Health with Dr. Ron Razmi (Ep. 17 of The Pharmcast)

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INDIANAPOLIS, IN--YourEncore (www.yourencore.com), a company that helps firms in the life sciences, consumer products and food sciences industries solve complex innovation, compliance and productivity challenges, announced that both Michelle DeJonge and James (Jimmy) Wood, M.D., have joined the company as Strategic Advisors for YourEncore’s Medical Devices & Diagnostics practice.

YourEncore recognizes the importance of providing cross-functional expertise for their clients, and focuses on nurturing a network of Experts rich in technical and strategic expertise.

DeJonge has an extensive background in Supply Chain and Operations leadership, which will be extremely valuable to medical devices companies. With a career spanning more than 30 years in supply chain and manufacturing for medical devices, pharmaceutical, and CPG  companies, she is the former VP of the Office of Strategy & Execution for Johnson & Johnson Supply Chain, where she was responsible for managing supply chain and operations across all segments of the organization, with a primary focus in the Medical Devices & Diagnostics division.

"I am excited to bring 30+ years of supply chain experience in solving complex challenges the medical device industry is facing. Now, more than ever, is the need for customer focused solutions in assuring continuity of quality products and services throughout the globe,” says DeJonge on her decision to join YourEncore.

The Frontiers of Rare Disease Development: Advances in Regulatory Science with Dr. Tim Franson (Ep. 18 of The Pharmcast)

May 10, 2017, 5:00 am

≫ Next: State of the Industry: U.S. Regulatory Policy Improvements (Ep. 19 of The Pharmcast)

≪ Previous: YourEncore Announces Addition of Michelle DeJonge and Dr. James Wood as Strategic Advisors for Medical Devices & Diagnostics Practice

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This week on The Pharmcast, we catch 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 Tim to share his lessons learned and understand what’s happening on the frontiers of rare disease drug development.

State of the Industry: U.S. Regulatory Policy Improvements (Ep. 19 of The Pharmcast)

May 12, 2017, 5:00 am

≫ Next: Ten Tips for Enterprise Technology Adoption in Pharma

≪ Previous: The Frontiers of Rare Disease Development: Advances in Regulatory Science with Dr. Tim Franson (Ep. 18 of The Pharmcast)

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In this episode of The Pharmcast, we share a recording from our May 5th webinar, State of the Industry: U.S. Regulatory Policy Overview. Parthenon-EY and YourEncore recently conducted a nationwide survey of life sciences experts to query them on recent market trends, uncover their points of view on potential regulations, refine their current business models and gain insights into what discovery efforts might yield better results. With all the rhetoric surrounding the drug industry from political, news and personal channels, we wanted to know what “those who know” think of various ways to improve the system.

We asked 10 simple questions, soliciting input from more than 50 past and present industry executives and Experts from pharmaceutical, consulting and pharmacy backgrounds. What we heard was informative, provocative and in some cases unsurprising — but important to consider. 

Ten Tips for Enterprise Technology Adoption in Pharma

June 1, 2017, 5:00 am

≫ Next: How Blockchain is Revolutionizing the World and Changing Healthcare as We Know It (Ep. 20 of The Pharmcast)

≪ Previous: State of the Industry: U.S. Regulatory Policy Improvements (Ep. 19 of The Pharmcast)

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The RFP processes are robust, the ROI models are compelling, the software is best of breed, and the expectations are high. So, why do so many software deployment programs in Pharma fail to deliver their intended benefits?

This often is because after all of the effort, money, and time that is spent, the technology itself is poorly used. This may be due to any combination of misconfiguration, poor training, misaligned processes, human stubbornness, or other factors, but it doesn’t have to be that way. To this end, adoption must be a central component of planning for your next software deployment project.

How Blockchain is Revolutionizing the World and Changing Healthcare as We Know It (Ep. 20 of The Pharmcast)

June 14, 2017, 1:48 pm

≫ Next: Social Media & Postmarketing Surveillance - Signal vs. Noise

≪ Previous: Ten Tips for Enterprise Technology Adoption in Pharma

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In this episode of The Pharmcast, we join YourEncore Expert, Darryl Glover, to discuss one of the hottest technologies on the market today: blockchain.

We've heard some people say that if the internet was invented today, it would be built using blockchain. So, what exactly is blockchain, and how exactly can it revolutionize the world and change the healthcare industry as we know it? 

Darryl Glover is just the person to ask. Darryl is a YourEncore Expert, and the Chief Clinical Officer and co-founder of iSolve, focused on applying blockchain-based solutions to pharma-industry problems.