YourEncore Insights - Life Sciences

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

Posted by YourEncore on 4/13/17 4:24 PM

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.

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Topics: Press Release

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

Posted by Jim Combs on 4/13/17 10:00 AM

 

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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Topics: Pharmcast, Digital Health

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

Posted by Jim Combs on 3/23/17 1:28 PM

 

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.

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Topics: Pharmaceutical Industry, Pharmcast, launch communications, compliance, biologics

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

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

Posted by Patrice Napoda on 2/15/17 8:00 AM

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. 

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Topics: Regulatory, Medical Device, EU MDR

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