The Syneos Health Podcast Series dissects some of the most complex issues biopharma leaders are facing today. Our clinical and commercial experts provide time-tested solutions, as well as perspectives on the news of the day. Hosted by Jeff Stewart, a long-time industry consultant who has advised biopharma leaders on licensing, mergers and acquisitions, pricing and market access, commercialization and go-to-market strategies, each episode explores the challenges and considerations involved with bringing biopharmaceuticals to the market.

 

 

Recent Episodes:

 

MOAs in ONC: The Latest and Greatest in the Oncology Pipeline

July 3, 2019 | Jeffrey Stewart, Jessica Lee, Ph.D.

 

Summary:

Oncology continues to be one of the hottest therapeutic areas in the biopharmaceutical industry, but one that also poses some of the greatest challenges to developers.

Jessica Lee, Ph.D., Managing Director in the Commercial Advisory Group at Syneos Health Consulting, discusses the most recent and promising innovations in oncology therapeutics, the opportunities and challenges for combination therapies, and what could be the next great breakthrough.

 

 

Episode 037: Psychology in Clinical Trials

June 19, 2019 | Jeffrey Stewart, Alexandria Wise-Rankovic

 

Summary:

When it comes to clinical trials, what do clinical psychologists bring to the table?

Quite a lot, says Alexandria Wise-Rankovic, Ph.D., a clinical psychologist and Senior Vice President, Clinical Development in the CNS Business Unit at Syneos Health. In this episode, Dr. Wise-Rankovic discusses the important role of the clinical psychologist in clinical trials beyond recruitment, even beyond trials for psychiatric therapies – and how this role could be the key to developing and implementing trials that account for the true patient experience.

 

 

Episode 036Commercialization for Emerging Companies

June 05, 2019 | Jeffrey Stewart, Nick Marasco

 

Summary:

The biopharmaceutical market has evolved quite a bit over the last five to 10 years.  As more emerging companies are opting to commercialize on their own, they can no longer look to the “tried and true,” traditional strategies for bringing a therapy to market – those rules no longer apply.  So what’s the new normal, and what does it mean for this new generation of developers?

Nick Marasco, Executive Vice President for Global Business Development and Commercial Solutions at Syneos Health, discusses some of the biggest changes in the commercialization landscape and how they might impact how companies go to market, as well as some best practices to keep in mind along the path to launch (hint: preparation should start earlier than you think!).

 

 

Episode 035How Translational Science Can Solve Pharma's Productivity Puzzle

May 15, 2019 | Jeffrey Stewart, Riaz Bandali, George Scott

 

Summary:

The infrastructure we rely on to create new medicines is in sore need of an upgrade. More and more investigational drugs are streaming into the pipeline. But most of them fail in clinical trials, draining corporate resources, disappointing investors, and shattering the hopes of patients.  Financially speaking, return on investment (ROI) for R&D in biopharma is at an all-time low of 1.9%. 

In a recent article, Riaz Bandali, President, Early Phase Clinical Services and George Scott, Senior Vice President, Early Phase Operations for Syneos Health, posit that translational science – the evidence-based process of converting research findings into tangible health improvements – offers companies an opportunity to make better decisions about the clinical path for an investigational drug.  

Listen in to hear more from Bandali and Scott about how companies can use translational science as a toolkit for determining very early on which drug candidates will have the best chance of breaking through to clinical – and ultimately – commercial success.

 

 

Episode 034Can the Gut Microbiome Revolutionize Medical Care?

May 01, 2019 | Jeffrey Stewart, Erin Minstry, Thunicia Moodley

 

Summary:

Research in the area of live biotherapeutics has exploded in the last seven years. There is still much to learn about whether a dysregulated gut microbiome (dysbiosis) causes disease, or whether disease leads to dysbiosis – but the potential for significant contribution to healthcare is there.

Erin Mistry, Senior Managing Director, and Thunicia Moodley, Senior Engagement Manager for Syneos Health Consulting, talk about the prospects for microbiome research, implications for future medical care, and the challenges inherent in bringing a new therapeutic area to the forefront.

For a deeper dive, check out our new white paper here: https://www.syneoshealth.com/perspectives/can-gut-microbiome-revolutionize-medical-care

 

 

APAC Edition: Medical Affairs in China

April 26, 2019 | Robbie Chana, Sam Ying

 

Summary:

APAC Edition: The role of Medical Affairs has changed dramatically in China over the last 10-15 years, moving from what was once considered a secondary support function to one now at the forefront of a more patient-centric paradigm.

Sam Ying, Vice President and General Manager for Syneos Health Commercial in China, discusses the evolution of the Medical Affairs function in China, the rise of the Medical Science Liaison (MSL) and other customer-facing roles, and the importance of digital transformation in the region.

 

 

Episode 033From DTC to DT"Me" - The Future of Communications in Pharmaceuticals

April 17, 2019 | Jeffrey Stewart, Amy Hutnik

 

Summary:

The art of communications in the pharmaceutical industry is becoming more complex.

According to Amy Hutnik, Chief Growth and Transformation Officer for Syneos Health Communications, we’ve evolved from the point of DTC (Direct to Consumer) to the extremely individualized opportunity of DT“Me” (Direct to Me).  The landscape has changed dramatically in terms of not only the sheer number of channels available to us for communicating with our audience, but also in the data available to provide the insights we need to make decisions about how, when and how much we spend on our promotional activities.

Listen in for a discussion on the way the space has changed in terms of decision-making and spend/budget planning, the necessity for breaking down the silos in large companies, why (despite popular belief) personal promotion is not dead – and a look at what lies ahead in the future of communications in pharmaceuticals.

 

 

Episode 032Navigating the New EU Medical Device Regulations

April 03, 2019 | Jeffrey Stewart, Adam Steadman

 

Summary:

New regulations, which were adopted on May 26, 2017, will affect all device and diagnostics manufacturers looking to sell products in the EU, with stricter requirements being introduced in order for these products to be approved.  We are just over a year out from implementation of some of these European Union Medical Device Regulations (EUMDR), set for May 2020. With the deadline looming, how prepared should manufacturers be at this point – and how prepared are they?

Adam Steadman, Vice President, Clinical Development, Medical Devices & Diagnostics at Syneos Health, discusses the importance of these regulatory changes, highlights some of the key steps manufacturers need to take and examines the challenges inherent in gathering the data required for re-certification and ultimately, renewed market approval, in the EU.

If you want to see more on this topic, check out our white paper and webinar.

 

 

APAC EditionAcceleration in Asia

March 29, 2019 | Robbie Chana, Sebastian Bather

 

Summary:

In this first episode of the Syneos Health Podcast: APAC Edition, host Robbie Chana speaks with Sebastian Bather, President of APAC in Japan for Syneos Health, about key trends in Asia Pacific with potentially high impact on the biopharmaceutical industry in the region, including significant growth and change in regulation in China, great interest in digital, and the increasing talent war, among others, and what companies need from their partners in order to adapt to and leverage this rapid evolution of the market.

For more on the changing APAC landscape, tune in to Episode 030 – Land of Opportunity: R&D in Asia Pacific, and stay tuned for more coming up on the APAC Edition.

 

 

Episode 031: Real World Evidence in Europe

March 20, 2019 | Jeffrey Stewart, Alastair MacDonald

 

Summary:

According to the Syneos Health 2019 Health Trend Ten, perhaps the biggest shift for 2019 and beyond is global focus on understanding what product differentiation looks like in real-world environments.  In Europe in particular, countries are implementing more stringent measures that will impact how value is assigned in the future – and real world evidence (RWE) will play a key role.

Alastair MacDonald, Senior Vice President, Real World and Late Phase at Syneos Health, discusses the complex landscape in Europe, why “real world” and “late phase” are no longer synonymous, the four key stakeholders driving the need for RWE, and more.

For more content related to real world evidence, check out our interview with David Thompson in Episode 001: The Real World Evidence Revolution, our Syneos Short in Episode 020: 21st Century Cures and our recent white paper on determining Which Real-World Research Design is Best.

 

 

Episode 030: Land of Opportunity: R&D in Asia Pacific

March 6, 2019 | Jeffrey Stewart, Robbie Chana

 

Summary:

Big changes are happening in Asia, opening up a world of possibilities for biopharmaceutical companies to accelerate clinical development of innovative medicines.

Robbie Chana, Vice President, Business Development, Asia Pacific talks about the unique opportunity for biopharma in the region, such as regulatory and financial incentives for innovation – but also the unique challenges that come with being a large, diverse and still developing market.

We will soon be kicking off a series of episodes focused on the Asia Pacific region, hosted by Robbie and featuring interviews with experts from that region.  Stay tuned!

 

 

Episode 029: Commercial Models of the (Very Near) Future

February 20, 2019 | Jeffrey Stewart, Howard Brock

 

Summary:

A commercial model built to deliver blockbuster drugs to the market is no longer effective – particularly for delivering therapies for complex disease states to smaller, more targeted patient populations and specialty providers.  But what will the new, “commercial model of the future” look like?

There’s no one clear answer, but Howard Brock, Senior Managing Director and head of customer and digital engagement in the Commercial Advisory Group at Syneos Health Consulting, believes the key will lie in how we use data to better engage with the customer.  Pharma wants to take a page from the playbooks of Amazon, Google and Facebook – but we need to figure out how to adapt those models to work within the complex regulatory and privacy limitations of the biopharma marketplace.  Here he discusses the challenges biopharma CEOs are facing, the role of technology in the process, and how approaches like dynamic assembly will get us closer to a successful, targeted customer engagement model. 

 

 

Episode 028: World Cancer Day

February 1, 2019 | Jeffrey Stewart, Bob Millham, Dave Querry

 

Summary:

The treatment of cancer has undergone a sea change in the span of a generation.  In this two-part episode for World Cancer Day, we discuss the increasingly complex oncology landscape, from both a clinical and clinician perspective.  

First, Bob Millham, Executive Vice President of Clinical Development and head of our Oncology Center of Excellence, addresses the potential of clinical research in driving toward a world where cancer is treated more like a chronic condition than a death sentence – and the ongoing, critical importance of engaging patients in the process.

We then hear from Dave Querry, President of The Navicor Group, on the evolving role of the oncologist and how manufacturers need to think about engaging differently with this increasingly specialized practitioner.

 

 

Episode 027: Caregivers

December 11, 2018 | Jeffrey Stewart, Carolyn Stephenson, Ilya Vedrashko

 

Summary:

It’s just one word.  But it carries the weight of over 43 million people, about a quarter which spends 41 hours or more per week providing care for loved ones with medical conditions.  

Caregivers are not just influencers for healthcare decision-making; many are the decision makers, according to Carolyn Stephenson, SVP, Director of Insights, and Ilya Vedrashko, Managing Director, Communications Research at Syneos Health.  Together, they’ll tease out key findings from their recent survey of over 1,000 caregivers to truly understand these individuals and what lies beneath the surface in their experiences and perception.

 

 

Episode 026The Health Trend Ten - Clinical Perspective

November 27, 2018 | Jeffrey Stewart, Leigh Householder, Nick Kenny

 

Summary:

As we head toward the close of the year, we are already looking to see what 2019 has in store. Drawing on the knowledge and experience of more than 200 leaders and experts who work on the front lines of healthcare, we identified 10 critical shifts that will change how we test and commercialize novel new therapies and innovations in the years ahead.  

In our last episode, we heard about some of the commercial insights from the Health Trend Ten. Today, Leigh Householder,  EVP / Managing Director, Insights and Innovation, and Nick Kenny, Chief Scientific Officer at Syneos Health, discuss key clinical trends that will impact the industry going into 2019 – including the “trials everywhere” model, the power of digital innovation, China’s disruptive impact and the penultimate importance of data.   

Listen to part one of our Health Trend Ten series – the commercial perspective – here

 

 

Episode 025: The Health Trend Ten - Commercial Perspective

November 27, 2018 | Jeffrey Stewart, Leigh Householder, Bryan Distefano

 

Summary:

As we head toward the close of the year, we are already looking to see what 2019 has in store. Drawing on the knowledge and experience of more than 200 leaders and experts who work on the front lines of healthcare, we identified 10 critical shifts that will change how we test and commercialize novel new therapies and innovations in the years ahead.

In this first of two episodes on the Health Trend Ten, Leigh Householder,  EVP / Managing Director, Insights and Innovation, and Bryan Distefano, EVP, Sales, Selling Solutions at Syneos Health, discuss key commercial trends that will impact the industry going into 2019 – including the precarious state of the healthcare practitioner, a rewiring of launch (and how we invest), the sales force of the future, and the potential (inevitable?) shift of the “M” in CMO.  

Listen to part two of our Health Trend Ten series – the clinical perspective – here

 

 

Episode 024Content that Clicks

October 31, 2018 | Jeffrey Stewart, Matthew Snodgrass, Michael Pearlman

 

Summary:

In our increasingly digital world, it was only a matter of time before search and social marketing would start to take on an important role in clinical trial patient recruitment. But with shaken trust in data security combined with sensitivities around medical data privacy, will potential patients click?

Matthew Snodgrass and Michael Pearlman from the Syneos Health Digital & Social Strategy team discuss the results of a survey of potential clinical trial participants on their perceptions and opinions of online channels as a means for receiving clinical trial information - and the many opportunities this channel offers for patients and sponsors alike.

 

 

Episode 023: The Clinical Trial Marathon, at a Sprint

October 3, 2018 | Jeffrey Stewart, Kellie Malloy, Eleanore Doyle

 

Summary:

Clinical trials are arguably the largest investment a biopharma company makes in bringing a product to market - in dollars, and time. Driving the stakes higher: the patient is waiting. How can we improve the process, realize shorter and more efficient trials, and ultimately get the therapy to that patient faster?

Syneos Health Clinical Solutions experts Kellie Malloy, Executive Vice President and General Manager and Eleanore Doyle, Senior Vice President, Strategic Resourcing, share their thoughts on the current state of and future opportunities for clinical trials – including the impact and potential of technology, improvements in recruitment and enrollment… and keeping the human element in mind throughout.

 

 

Episode 022: Spending for Launch Success

September 19, 2018 | Jeffrey Stewart, Sachin Purwar

 

Summary:

When it comes to investing in the launch of your biopharma product, how much is too much?  Is there such a thing as too little? Director Sachin Purwar and his colleagues from the Commercial Strategy & Planning practice of Syneos Health Consulting set out to answer these questions - and found the "sweet spot" for launch spending that could mean the difference between success and failure.

The team's review of 19 emerging biopharma company launches was recently published in IN VIVO. In this episode, Sachin discusses with host Jeff Stewart special considerations, pitfalls to avoid, and the implications of spend on the potential for a new product to fly - or flop - in its first year out of the gate.

 

 

Episode 021: The Sales Force Training (R)evolution

September 5, 2018 | Jeffrey Stewart, Celeste Mosby

 

Summary:

Biopharmaceutical sales forces have changed dramatically over the past decade.  And not just the sales forces - the industry, customers, technology and more have all undergone tremendous evolution. As a result, the way we train sales forces and other customer-facing roles has and will have to adapt accordingly.

Celeste Mosby, Vice President of Learning Design in the Syneos Health Learning Solutions group, has seen a lot of this change and describes what can be considered a revolution in the development of training approaches that are efficient and effective, intuitive and immersive. In this episode, Mosby discusses some of the newer learning methods being implemented, what selling skills are key in the new paradigm, the growing importance of clinical knowledge and more.

 

 

Episode 020:  A Syneos Health Short - 21st Century Cures

July 9, 2018 | Jeffrey Stewart

 

Summary:

The 21st Century Cures Act was passed at the end of 2016 in an effort to accelerate the discovery, development and delivery of new therapies. But what's in it? And what does it mean for biopharma companies?

In this first "Syneos Health Short" episode, Jeff Stewart reviews the top ten things you need to know about 21st Century Cures - and how one word changed everything.

 

 

Episode 019: A Decade of Dealmakers' Intentions

June 6, 2018 | Jeffrey Stewart, Neel Patel, Sachin Purwar

 

Summary:

The last decade has seen both depressing lows and astounding highs in biopharmaceutical dealmaking activity. Different therapeutic areas have fallen in and out of favor along with the pace of innovation and there has been a sustained focus on the next "hot spot" with high commercial value and the potential to provide solid returns for stakeholders. But certain trends have been persistent. What has changed? What has remained the same?

Neel Patel, Managing Director and Sachin Purwar, Director at Syneos Health Consulting discuss the last ten years of dealmaking and take a look forward based on the results of our 10th annual Dealmakers' Intentions Study - a report that takes the pulse of pharmaceutical executives around their expectations for licensing and acquisitions in the upcoming year.

 

 

Episode 018: Partnering with a CRO

May 23, 2018 | Jeffrey Stewart, Judy Swilley

 

Summary:

A relationship with a Contract Research Organization (CRO) is just like any other - to succeed, it requires communication, alignment on goals, respect, and ultimately, trust between two partners. In this episode, Judy Swilley, Executive Vice President and Head of Strategic Alliance Management at Syneos Health, talks about the value a CRO brings to the table, the importance of an engaged executive team on the sponsor side, and best practices for working together.

 

 

Episode 016: Payer Power, Part 2 

April 25, 2018 | Jeffrey Stewart, Keith Kelly

 

Summary:

Eighteen months is an eternity in the payer world.

Previously on The Syneos Health Podcast (Episode 003: Payer Power), we discussed the payer's rise in influence in the pharmaceutical industry. Today, we're seeing the impact of strategies payers were starting to bring to the marketplace 18-months-to-two-years ago, particularly on the pharmacy benefit side.

Keith Kelly, Managing Director, Global Access Solutions for Syneos Health Consulting, discusses key themes from the Express Scripts Drug Trend Report 2016, impact of payer controls on pharmacy benefit versus medical benefit products, how this plays out based on therapeutic area and ultimately, the challenges inherent in "bending the cost curve" for the average patient.

 

 

Episode 015: ICER - Friend or Foe?

March 14, 2018 | Jeffrey Stewart, Leslie Isenegger

 

Summary:

ICER - the Institute for Clinical and Economic Review - was established as an independent organization to examine the value of pharmaceuticals across disease categories. "But value is in the eye of the beholder," says Leslie Isenegger, principal strategist for Syneos Health Communications Reputation and Risk Management Practice, and ICER's analysis is only one piece of a very complicated puzzle. How should it fit within the broader conversation?

To try and answer this question, Isenegger provides a primer of sorts on ICER, exploring how the organization works to determine cost effectiveness and comparative effectiveness of therapies, the nature of its relationships with payers and pharma companies, the unique challenge of assessing value of orphan drugs, the growing role of the patient in value discussions and more.

 

 

Episode 014: MA-"Squared": Medical Affairs Meets Market Access

March 07, 2018 | Jeffrey Stewart, Suma Ramadas, Susan Suponcic

 

Summary:

In Episode 012: Medical Affairs from Zero, Suma Ramadas talked about the inception and growing value of the Medical Affairs function. Today, in part two of our Medical Affairs Transformation series, Suma is joined by Susan Suponcic, Managing Director and head of the Pricing & Market Access practice of Syneos Health Consulting to discuss the importance of collaboration between the Medical Affairs and Market Access functions in developing a consistent and clear medical narrative.

 

 

Episode 013: Artificial Intelligence for Authentic Engagement

February 13, 2018 | Jeffrey Stewart, Duncan Arbour

 

Summary:

Since Stanley Kubrick's 2001: A Space Odyssey introduced the prospect of Artificial Intelligence (AI) with the spaceship computer system HAL, the world has had a rollercoaster relationship with the idea - from hope to hype, and everywhere in between. Have we "unleashed the demon" with AI, or does the potential of deep learning and machine learning for improving health outcomes far outweigh the fear factor? Duncan Arbour, Senior Vice President, Innovation with Syneos Health Communications, takes us on a fascinating journey through the progression of AI, its application in healthcare and touching on its potential impact on biopharma companies, healthcare providers, investors and the industry as a whole.

But what about the perspective of the patient - up till now, the missing component in healthcare's AI conversation? To answer this question, Arbour shares the findings from a new Syneos Health report, Artificial Intelligence for Authentic Engagement: Patient Perspectives on Healthcare's Evolving AI Conversation, based on a survey of 800 patients regarding their expectations and concerns around the potential role of AI in diagnosis, treatment and support in their day-to-day lives.

 

 

Episode 012: Medical Affairs from Zero

February 06, 2018 | Jeffrey Stewart, Suma Ramadas

 

Summary:

Imagine two products that are very similar. One became one of the most successful launches the organization ever had; the other one was a flop. The main difference between the two? Medical Affairs.

There was a time - not all that long ago - when the Medical Affairs function did not exist. Today, the Medical Affairs organization is critical to a successful product launch, providing foresight into understanding who all of the stakeholders are and all of their evidentiary needs: getting the right evidence at the right time, communicated in the right way, to the right audience.

Suma Ramadas, Managing Director in the Medical Practice Area at Syneos Health Consulting, discusses with host Jeff Stewart the inception of what we know today as Medical Affairs, its evolution to current state - and what needs to happen now in order for Medical Affairs to transform into the powerhouse function of tomorrow.

 

 

Episode 011: Naming, Part 2 - The Drug

January 08, 2018 | Jeffrey Stewart, Brittany Scott

 

Summary:

As we learned in our previous episode, naming a company is not something you can do by just “winging it.” The same holds true when it comes to naming a drug – especially in a podcast episode under 30 minutes.

In Part 2 of our naming series, Addison Whitney Creative Director Brittany Scott explains the ins and outs of drug naming, addresses a possible conspiracy theory and runs host Jeff Stewart through the process in a quick (and frustrating) game of “Name That Drug.”

 

 

Episode 010: Naming, Part 1 - The Pharma Company

January 08, 2018 | Jeffrey Stewart, Kristen Spensieri, Joe Daley

 

Summary:

What’s in a name? Quite a lot, actually, despite what Shakespeare says. When it comes to a merger, this can be even more important. With research showing that up to 80% of mergers fail – and one major reason being clashing corporate cultures during post-merger integration – choosing a name and brand that the entire organization can get behind is critical to success.

In this episode, listen to Kristen Spensieri of Syneos Health and Joe Daley of Syneos Health branding firm Addison Whitney discuss how the company is walking the talk – rebranding its own organization after the 2017 merger of INC Research and inVentiv Health, and how these principles can be applied to any company going through a rebrand.

 

 

Episode 009: Rare Diseases

February 26, 2018 | Jeffrey Stewart, Judith Ng-Cashin

 

Summary:

While regulatory changes have made the path to approval easier for rare disease therapies, it is by no means easy - and Judith Ng-Cashin, MD, Chief Scientific Officer of Syneos Health, warns developers getting into the market to do so with eyes wide open.

Host Jeff Stewart caught up with Dr. Ng-Cashin at a recent conference to discuss her perspective on the opportunities and challenges inherent in bringing a rare disease therapy to market, how the definition of value varies across stakeholders and why true patient engagement is critical to success.

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