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:

 

APAC EDITION: Clinical Development in Japan

September 9, 2020 | Robbie Chana, Stephane Gouteux

 

Summary:

In the past decade, Japan’s biotech and pharmaceutical industries have expanded into global markets, and continue to evolve in light of recent regulatory changes and challenges.

Stephane Gouteux, Vice President and General Manager of Japan Clinical Solutions at Syneos Health, discusses overall healthcare trends and pharmaceutical trends in Japan, and also explores the opportunities available for major market players, including contract research organizations (CROs).

For a deeper dive into our perspective on the changing immune-oncology landscape in APAC, read this report.

 

Learning Agility

September 2, 2020 | Jeffrey Stewart, Kiely Flanigan, Karen White

 

Summary:

The COVID-19 pandemic has forced companies to adapt in unprecedented ways. More than ever, learning agility – the desire, capability, and skillset that allow people to navigate change and uncertainty – has become critical to organizational success and can lead to new opportunities. 

In this episode, Syneos Health® experts, Karen White, Vice President of Human Resources and Kiely Flanigan, Director of Global Medical Affairs from our consulting team, discuss why learning agility matters and how it can add value to business areas across the pharmaceutical industry, from global drug launches to the increasing number of rare disease therapies. 

 

 

China vs. Cancer

August 26, 2020 | Jeffrey Stewart, Patrick Nealon, Nick Kenny

 

Summary:

Within the last two years, the regulatory environment has evolved dramatically in China, allowing clinical trials to get off the ground faster and providing greater opportunity for drug development in the region.  

Syneos Health experts Patrick Nealon, Executive Vice President and Head of the Oncology Business Unit, and Nick Kenny, Chief Scientific Officer, discuss the extraordinary pace of investment and innovation in cancer drug development in China, the risks and challenges that arise from scaling clinical operations in the country’s untapped market, and the impact that such changes will have on U.S. pharma.  

For a deeper dive into our perspective on the changing immune-oncology landscape in APAC, read this report.

 

 

Rapid Early Phase Clinical Trials

August 6, 2020 | Jeffrey Stewart, David Wyatt

 

Summary:

In an industry where time is money, rapid startup in early phase clinical trials – where patients receive a drug for the first time – is critical.  But what does rapid mean, exactly, and why is it so important?

David Wyatt, MD, Vice President, Medical Affairs at Syneos Health discusses rapid early phase startup, explaining the advantages and complications that can arise, as well as the requirements for its success.

 

 

Payer Power, Part 3

July 15, 2020 | Jeffrey Stewart, Keith Kelly

 

Summary:

The entirety of the US healthcare system was reformed with the advent of Obamacare in 2009 – and we’re still feeling the aftershocks over a decade later.

So says Keith Kelly, Senior Managing Director, Value, Access and HEOR at Syneos Health Consulting, who returns to the Syneos Health Podcast to continue the discussion on the trajectory of payer influence in the healthcare marketplace.  

Listen to our previous episodes in the series, Payer Power and Payer Power, Part 2, to get the full story. And for additional market access-focused content, check out these recent publications:

 

 

Coronavirus Special Edition Episode 12: COVID-19 and Children

June 19, 2020 | Jeffrey Stewart, Pierre Omnes, Alex Cvetkovich Muntañola

 

Summary:

Over the course of the COVID-19 pandemic, information has varied around whether or not – and how severely – children are affected by the virus. 

In this episode for our Coronavirus Special Edition Series, Pierre Omnes, Executive Director, SSU and Regulatory and Alex Cvetkovich Muntañola, MD, Executive Director, Clinical Development at Syneos Health, share what we’ve learned so far about the impact of COVID-19 on children’s health, and how approaches to clinical trials for this specific population have been altered.

Stay tuned for more installments of the Coronavirus Special Edition Series, which explores, from an operational standpoint, the impact of COVID-19 on the biopharma industry, the challenges for rapid R&D in an outbreak environment, and the opportunities to leverage technology and innovation to address these critical issues. Additional materials and insights can also be found in our COVID-19 Resource Center.

 

 

CORONAVIRUS SPECIAL EDITION, Episode 11: Rare Disease Clinical Trials and COVID-19

June 2, 2020 | Jeffrey Stewart, Zizi Imatorbhebhe

 

Summary:

The COVID-19 pandemic has impacted drug development, and rare disease drug development in particular – and the industry in general grapples with challenges in this new clinical trial environment. 

In this episode for our Coronavirus Special Edition Series, Zizi Imatorbhebhe, Global Lead of Rare Disease Clinical Development at Syneos Health, discusses the numerous challenges involved in rare disease drug development and how the pandemic has heightened the need to adapt innovations and strategic considerations to accelerate development.  

To read more about rare disease clinical trials in the age of COVID-19, download our white paper.

 

 

NEWYORKBIO BIOPHARMA INNOVATORS SERIES: Yelp Ratings for Clinical Trials

May 27, 2020 | Jeffrey Stewart, Irfan Khan

 

Summary:

In this episode of our Biopharma Innovators Series in partnership with NewYorkBIO, we feature an influencer who is passionate about community engagement, and patient education and empowerment.

Irfan Khan, MD, CEO of Circuit Clinical, discusses the challenges for patients and physicians in navigating the current clinical trial system and how consumer-related technology platforms could potentially bring clinical trials more easily to the masses.

 

 

NEWYORKBIO BIOPHARMA INNOVATORS SERIES: Taming the Healthcare Data Explosion

May 15, 2020 | Jeffrey Stewart, Marc Berger

 

Summary:

In this episode in our Biopharma Innovators Series in partnership with NewYorkBIO, we feature a leader in the field of real world data and outcomes research.

Marc Berger, MD, Head of the Real World Evidence Product Advisory Board for SHYFT Analytics and former Vice President of Real World Data and Analytics at Pfizer, discusses the double-edged sword inherent in the veritable mountain of data available to us, from issues of privacy and accessibility of data to how companies can query this data in order to efficiently and effectively glean the insights they need.

 

 

NEWYORKBIO BIOPHARMA INNOVATORS SERIES: Real World Data for Clinical Innovation

May 8, 2020 | Jeffrey Stewart, Craig Lipset

 

Summary:

Continuing our Biopharma Innovators Series in partnership with NewYorkBIO, we welcome a recognized leader at the forefront of innovation in clinical research and medicine development.  

Craig Lipset, former Head of Clinical Innovation at Pfizer, discusses where real world data (RWD) fits within the context of the clinical trial continuum, and innovative ways RWD can be used to drive better planned and executed studies as well as to drive greater efficiency.

 

 

CORONAVIRUS SPECIAL EDITION, Episode 10: Ventilating the COVID-19 Patient

May 6, 2020 | Jeffrey Stewart, Bill Croft

 

Summary:

As the COVID-19 pandemic continues, clinicians are learning more about the impact of the disease on the body, particularly in the lungs, and it’s shaping the way hospitals need to think about treating these patients – specifically with regard to what type of breath support to use.

In this episode in our Coronavirus Special Edition Series, Dr. Bill Croft, Ed.D, Ph.D., RRT, RCP, Executive Director of the North Carolina Respiratory Care Board, discusses the unique physiology of the COVID-19 lung, the pros and cons of BiPAP versus mechanical ventilators, and a more refined, incremental treatment path for breath support in COVID-19 patients.

 

 

CORONAVIRUS SPECIAL EDITION, Episode 9: Telemedicine in the Age of COVID-19

April 23, 2020 | Jeffrey Stewart, Jodi Scarbrough

 

Summary:

In the midst of a pandemic situation that requires social distancing measures to minimize personal contact, how are non-emergency physicians continuing to engage with their patients? Further, what are their expectations around pharmaceutical field representatives and how they need to receive important information on potential products for treating their patients? A recent survey of 263 US clinicians provides a glimpse into their perspective.

In this episode in our Coronavirus Special Edition Series, Jodi Scarbrough, Director of Custom Research at Syneos Health, discusses the impact of the COVID-19 pandemic on the adoption of telemedicine and teledetailing, and how these platforms might play out in a post-pandemic environment.

 

 

CORONAVIRUS SPECIAL EDITION, Episode 8: Payers and COVID-19

April 16, 2020 | Jeffrey Stewart, Adrian Garcia, Katherine Seay

 

Summary:

In this Coronavirus Special Edition Series, we’ve talked a lot about the clinical implications of the COVID-19 pandemic. But what is the impact on the commercial side? Specifically, how are payers – key players in getting patients access to therapies – continuing to conduct business, and how are current conditions   affecting priorities, if at all? Syneos Health advertising firm GSW conducted a survey to find out.

In this episode in our Coronavirus Special Edition Series, Adrian Garcia, Senior Vice President, Head of Payer & Integrated Health and Katherine Seay, Executive Vice President, Managing Director, Managed Markets at GSW, discuss the impact of the pandemic on payers, important considerations for manufacturers in engaging with these organizations in this environment, and the potential impact on formulary decision-making going into 2021.

 

 

CORONAVIRUS SPECIAL EDITION, Episode 7Continuity in Clinical Trials

April 2, 2020 | Jeffrey Stewart, Paul Colvin, Nicole Stansbury

 

Summary

The COVID-19 pandemic is impacting clinical trials in many ways, not the least of which being the ability for sponsors to continue traditional oversight activities such as on-site clinical trial monitoring. The Association of Clinical Research Organizations (ACRO) has issued recommendations for clinical trial monitoring that will help maintain continuity in clinical trials wherever possible.

In this episode in our Coronavirus Special Edition Series, Paul Colvin, President, Clinical Solutions and Nicole Stansbury, Vice President, Global Clinical Monitoring at Syneos Health, discuss the role of risk-based monitoring and opportunities for remote options that can potentially ensure continuity, trial viability and data preservation through this pandemic and beyond.

Read more about remote risk-based monitoring in action in this Clinical Leader article, and be sure to watch our webinar on implementing remote clinical trial monitoring.

 

 

CORONAVIRUS SPECIAL EDITION, Episode 6: The Leader's Experience

March 29, 2020 | Jeffrey Stewart, Alistair Macdonald

 

Summary:

Ensuring the health and safety of the workforce – while maintaining business as usual – is a delicate balance in the face of the COVID-19 pandemic.  

In this episode of our Coronavirus Special Edition Series, Syneos Health CEO Alistair Macdonald discusses the unique decisions to be made as a pharmaceutical organization practicing corporate responsibility in the name of public health.

 

 

CORONAVIRUS SPECIAL EDITION, Episode 5: Surviving the Ventilator Shortage

March 24, 2020 | Jeffrey Stewart, Keith Robinson

 

Summary:

A critical shortage of mechanical ventilators is anticipated in many countries, including the United States, because of the ongoing COVID-19 pandemic. A potential emergency solution would be the use of bi-level positive airway pressure (BiPAP). BiPAP may be used in the hospital setting with appropriate precautions for intubated COVID-19 patients experiencing Acute Respiratory Distress Syndrome (ARDS). Use of BiPAP on an emergency basis may delay or obviate the need for invasive ventilation in appropriate COVID-19 patients.

In this episode for physicians on the front lines treating patients with COVID-19, Keith Robinson, MD, a critical care pulmonologist at Syneos Health, discusses how, when, and in which patients, the use of BiPAP can potentially be used in place of mechanical ventilators. 

For more information on this solution, download the full white paper. And to learn more about the Syneos Health Ventilator Initiative, visit www.COVID-BiPAPinfo.com.

 

 

CORONAVIRUS SPECIAL EDITION, Episode 4: Clinical Trials Through Pandemics

March 24, 2020 | Jeffrey Stewart, Lou Boccumini

 

Summary

In the midst of the COVID-19 pandemic, late stage clinical trials are at risk of disruption as shelter-in-place and more restrictive lockdown requirements roll out across the globe. How can these trials continue if patients can’t get to the clinic?

In this episode in our Coronavirus Special Edition Series, Lou Boccumini, head of the infectious disease team at Syneos Health, discusses ways that developers can maintain continuity of their clinical trials during a pandemic – and how to create resiliency in their clinical trials for the future.

 

 

CORONAVIRUS SPECIAL EDITION, Episode 3: Virtual Clinical Trials

March 20, 2020 | Jeffrey Stewart, David Thompson

 

Summary

In the midst of a pandemic, industry is looking for ways to ensure continuity of clinical trials while keeping patients safe. Virtual approaches to clinical research leverage digital technologies to bring the study to the patient, and may be – in time – a viable option for limiting personal contact and possible spread of disease during outbreak situations.

In the third episode in our Coronavirus Special Edition Series, David Thompson, Senior Vice President, Real World Evidence at Syneos Health discusses potential applications for virtual research in the real world, and the pros and cons of going virtual, offering a glimpse into the future of clinical research.

 

 

CORONAVIRUS SPECIAL EDITION, Episode 2: The Clinical Experience

March 17, 2020 | Jeffrey Stewart, Gino Girardi, Jaime E. Hernandez

 

Summary:

As COVID-19 continues to spread worldwide, increasingly strict measures are being put into place in an attempt to slow it down while the scientific community pushes to identify effective antiviral options. 

In the second episode of our Coronavirus Special Edition series, Syneos Health infectious disease experts Gino Girardi, MD and Jaime E. Hernandez, MD dig into the epidemiology of COVID-19, the experience gained from past pandemics (such as H1N1 or “swine flu”), impact on health systems, and the race to find a treatment.

 

 

CORONAVIRUS SPECIAL EDITION, Episode 1: The Personal Experience

March 11, 2020 | Jeffrey Stewart, Siying Zou

 

Summary:

The COVID-19 (coronavirus) outbreak continues to grow worldwide – recently declared by the World Health Organization as a global pandemic – with widespread personal, medical, and business implications. 

In this first episode of our Coronavirus Special Edition Series, we hear the personal experience of Dr. Siying Zou, a cell biologist on the Syneos Health Consulting team in the United States. Dr. Zou is from Wuhan, China – the epicenter of the COVID-19 outbreak – and her mother and other family members have been diagnosed with the disease. This is her family’s story from the front lines, from lockdown, to hospitalization, to hope.

 

 

Episode 053Medical Affairs Series, Part Six: Commercial Plus Medical Affairs

February 19, 2020 | Jeffrey Stewart, Suma Ramadas & Andy Hurley

 

Summary:

It may seem counter-intuitive to use the words “Commercial” and “Medical Affairs” in the same sentence. But with the evolution of Medical Affairs from a tactical support function to a strategy driving organization, it’s become clear that by partnering, the collective and complementary strengths of Medical Affairs and Commercial organizations will drive greater success than ever before. 

In part six of our Medical Affairs Series, Suma Ramadas from our Medical Affairs team at Syneos Health Consulting, and Andy Hurley, who leads the Commercial Integration team at Syneos Health, discuss the intersection and alignment of Commercial and Medical Affairs functions and how they can work together to bring the full value story of a product to the customer.

 

 

Episode 0522020 Health Trends: Box Store Healthcare

February 05, 2020 | Jeffrey Stewart, A.J. Triano and Aaron Davis

 

Summary:

Radical changes in the interface of health are rapidly changing where people find care. Where is that, exactly? Quick answer: everywhere. The point of care has been steadily shifting away from where the clinic exists to wherever the patient goes. Advances in digital care connections and the growth of new customer segments have opened up entirely new ways to make healthcare more scalable and accommodating to both baby boomer demands and millennial disruption.

A.J.  Triano, Senior Vice President, Engagement Strategy at GSW Advertising and Aaron Davis, Managing Director, Value, Access and HEOR at Syneos Health Consulting, discuss the factors impacting this shift, what the new ecosystem is looking like, and what it all means for developers, health care providers, and patients in the longer term. 

 

 

Episode 051Medical Affairs Series, Part Five: Medical Affairs in the Early Stage

January 10, 2020 | Jeffrey Stewart and Steve Gomez

 

Summary

As we’ve hammered home over the last several episodes of this series, Medical Affairs can bring great value to any moment in an asset’s life cycle.  But there is one area where developers may be missing out on an opportunity to gain real traction in their efforts.

Today we dive deeper into a Medical Affairs sweet spot with Steve Gomez, Senior Engagement Manager on the Scientific and Medical Affairs team at Syneos Health Consulting, discussing the ways that today’s Medical Affairs organization can be a shepherd, strategic partner, and even the leader for an organization in the earliest stages of development.

 

 

Episode 050Real World Evidence and Rare Diseases

December 20, 2019 | Jeffrey Stewart, Michelle Leeds and Alastair MacDonald

 

Summary:

A striking life sciences trend has come into focus the past 12 months. Global regulators—often viewed as taking a conservative approach to transformative technology—have moved into the vanguard in discussions and guidance around real world data (RWD) and real world evidence (RWE).

It is not so much the case with payers. According to new research by Syneos Health on payer perceptions of RWE in rare diseases, many payers are not entirely receptive to RWE-based representations or health economic forecasts in sponsors’ dossiers or related conversations. 

What accounts for payers’ hesitation? Michelle Leeds, Vice President, Risk and Reputation Management and Alastair MacDonald, Senior Vice President, Real World Late Phase, join the podcast to examine the issues from several perspectives based on conversations with payers, drug developers, regulatory experts and patient organizations. 

 

 

Episode 049The Digital Therapeutics Alliance: A European Perspective

December 11, 2019 | Jeffrey Stewart and Jessica Shull

 

Summary: 

Earlier this year on Episode 040, we discussed the relatively new digital therapeutics landscape and the opportunities and challenges for both biopharma and tech companies.

Today, we’ll take a deeper dive from the industry side – and specifically with a European perspective –  with Jessica Shull, European Lead for the Digital Therapeutics Alliance, an international non-profit trade association of industry leaders and stakeholders engaged in the evidence-driven advancement of digital therapeutics. 

 

 

Episode 048Medical Affairs Series, Part Four: Medical Affairs in the Field

November 20, 2019 | Jeffrey Stewart, Keith Morris & Ric Phipps

 

Summary:

The Medical Science Liaison (MSL) has gone through a bit of an identity overhaul. A role that used to lean almost exclusively on scientific acumen must now more than ever also rely on business chops and people skills.  A shift akin to moving from Geek Squad…to Apple Genius Bar.

Keith Morris, Executive Managing Director, Medical Affairs at Syneos Health Consulting, and Ric Phipps, Senior Vice President, Global Field Medical Affairs for Syneos Health Deployment Solutions discuss the increased complexity of the role of as the needs of today’s customer groups are evolving and how, as a result, the required competencies and skillsets of these field teams have changed

 

 

Episode 047: Medical Affairs Series, Part Three: Moving to the Left

November 6, 2019 | Jeffrey Stewart, Suma Ramadas, Colin Oliver

 

Summary:

Traditionally, Medical Affairs has served as a support function in later phases of product development, but they now need to play a more strategic and value-based role within the organization – and that means earlier and deeper engagement.

In part three of our Medical Affairs Series, Suma Ramadas, Senior Managing Director and Colin Oliver, Director in Medical Affairs at Syneos Health Consulting, discuss how and why Medical Affairs organizations need to be involved earlier in the development life cycle.

 

 

Episode 046: Advocacy Archetypes

October 24, 2019 | Jeffrey Stewart, Keri McDonough

 

Summary:

Patients have been at the forefront of many of healthcare’s most historic moments—not just as subjects, but also as catalysts for change. Some of today’s advocates look to the early ACT UP years for inspiration; others turn to blueprints established by pioneers like Abbey Meyers or Kathy Guisti. 

In this episode, Keri McDonough, Lead, Advocacy and Patient Relations at Syneos Health, explores how certain patient advocate archetypes – the Caregiver, the Creator, the Citizen, the Magician, and the Rebel – have emerged over time and dig into how social determinants of health, politics of representation and even climate change will influence the advocates of the future.

 

 

Episode 045Measuring the Unmeasurable: Medical Affairs Metrics

October 9, 2019 | Jeffrey Stewart, Josh Samon, Colin Oliver

 

Summary:

No industry standard currently exists to measure value and impact of medical affairs, and the traditional metrics that companies often use to determine return on investment (ROI) simply don’t apply.

In this second episode in our Medical Affairs series, Josh Samon, Managing Director and Colin Oliver, Director in Medical Affairs at Syneos Health Consulting, discuss the unique challenges around defining value, and define a path forward toward creating an industry standard that truly reflects the contributions of the Medical Affairs function.

 

 

Episode 044Why We Resist

September 25, 2019 | Jeffrey Stewart, Leigh Householder, Kathleen Starr

 

Summary:

Why do people make good (and bad) decisions about their health? How can we help motivate them to change and give them the resilience to try and try again? Our industry and our world are obsessed with those questions right now.

Kathleen Starr, PhD, Managing Director, Behavioral Insights and Leigh Householder, Executive Vice President and Managing Director, Insights and Innovation at Syneos Health, tackle these tough questions in their new book, Why We Resist.  In this episode, they talk about key principles of influence on behavior (things we all have in common), the behavioral science of segmentation (what makes us different), and how healthcare communicators can apply this knowledge to move their customers from a position of resistance to one of activation.

For a deeper dive into new ways to design communications, interventions and programs to help people make better, more confident decisions about their health, check out Why We Resist, available at Amazon and other retailers. All proceeds will benefit the STARR Coalition, a nonprofit organization dedicated to creating meaningful change in the field of mental health.

 

 

Episode 043Medical Affairs Series, Part One - A Foundation for Medical Affairs

September 11, 2019 | Jeffrey Stewart, Suma Ramadas

 

Summary:

Medical Affairs, once considered a support function, now has a seat at the table as one of the major pillars of biopharmaceutical organizations.  So now what?  Our new Medical Affairs series, which will unfold over the next several months, will explore what’s next and provide insights and best practices for “Next Gen” Medical Affairs. 

In this first episode of the series, Suma Ramadas, Senior Managing Director in the Scientific and Medical Affairs Advisory Group for Syneos Health Consulting, sets the foundation for discussion around the Medical Affairs function, how it can continue to communicate its worth, work effectively with Clinical and Commercial functions, and develop efficient processes – beginning earlier in development – that propel commercial planning and drive greater asset value.

 

 

Episode 042A Regulatory Roadmap for Real World Evidence

August 28, 2019 | Jeffrey Stewart, Stuart McCully, Tara Isherwood

 

Summary:

The need for real world evidence is growing beyond its original footprint of post-market intelligence, with uses now including regulatory approval, proof of value, maximized access and more.  However, without a true understanding of the regulatory requirements around real world evidence, there is a risk of a “Goldilocks effect”— gathering either not enough information, the wrong information, or far more information than they need. 

Stuart McCully, PhD, Vice President and Tara Isherwood, Senior Director, Real World Clinical Consulting, discuss the key information developers need in order to plan studies that will get them the intel that they need, the right way.

For more on real world evidence from across Syneos Health, check out our interviews with Alastair MacDonald in Episode 031, and Dave Thompson in Episode 01.

 

 

Episode 041: Talented Teams

August 14, 2019 | Jeffrey Stewart, Tara Fitzgerald

 

Summary:

Creating and supporting productive, motivated and happy teams is an ongoing challenge in today’s global workplace – and particularly in the fast-paced biopharmaceutical marketplace.  Incentives can differ based on region, culture, or individual.  Approaches can hinge on countless variables beyond compensation – although in some cases, cash is king.  So what’s the key to success?

Based on 25 years of experience developing clinical teams, Tara Fitzgerald, President, Clinical Development Services at Syneos Health, shares her philosophy on attracting, building and retaining top talent – and what it truly takes to lead.

 

 

Episode 040: Digital Therapeutics

July 31, 2019 | Jeffrey Stewart , Allison Murphy, Skye Hodson, PhD

 

Summary:

There are dozens of software-driven products under regulatory review for diagnosing, treating, or preventing medical conditions, defining an entirely new sector for the life sciences industry.

Today we are joined by Allison Murphy, Vice President, Business Development, Selling Solutions at Syneos Health and Skye Hodson, PhD, Engagement Manager, Commercial Advisory Group at Syneos Health Consulting, to discuss the digital therapeutics landscape, the opportunities for both biopharma and tech companies, regulatory and payer hurdles, and more.

For a deeper dive, download our report, How Digital Therapeutics Developers Can Satisfy Diverse Stakeholder Needs.

 

 

Episode 039: Talking about PIE

July 17, 2019 | Jeffrey Stewart, John Seay

 

Summary

Not that kind of pie.  In this case, PIE – or Preapproval Information Exchange – refers to the communication of clinical and health care economic information on therapies in development between U.S. population health decision makers and drug manufacturers prior to regulatory approval.  

John Seay, Vice President and Content Expert, Managed Markets Communications at Syneos Health,   discusses the benefits of PIE, best practices for entering into these discussions, and the importance of building advocacy with payer organizations as a means of maximizing access.

For more information, check out the Food and Drug Administration guidance for PIE published in June 2018.

 

 

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.

 

 

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 01: 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 09: 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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