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:
2023年3月30日 | Jeffrey Stewart and Ankita Chowdhury
Last year the FDA approved the first gene therapy for hemophilia B. This year, the first gene therapy may be approved in the US for hemophilia A. What does the gene therapy revolution mean for patients, payers, and pharma?
Ankita Chowdhury, Senior Engagement Manager, Commercial Advisory at Syneos Health®, joins the podcast to discuss the landscape of recent hemophilia gene therapy approvals, the state of upcoming additional therapies to market, and key considerations for developers to address in order to optimize access, pricing and reimbursement for patients impacted by this rare disease.
2023年3月21日 | Jeffrey Stewart, Dennis Kim and Em Coriale
The Inflation Reduction Act of 2022 is a landmark United States federal law which aims to curb inflation by, among other things, lowering prescription drug prices. What can this mean for biopharmaceutical companies?
Dennis Kim, Senior Engagement Manager and Em Coriale, Director in the Value & Access team at Syneos Health, dive into the details of this piece of legislation, the true meaning of “unjustified price increases,” what negotiation might look like and how companies can prepare for the new reality.
2023 Health Trends: AI: Finally Fit for Purpose
2023年3月14日 | Leigh Householder and Andrew Barron
How will Artificial Intelligence continue to impact the healthcare industry and its potential to introduce new technologies, enabling a shift from promise to performance?
In this episode of the limited Trend Talks series, Leigh Householder Host & Author, 2023 Health Trends: Personally, Purposefully Building What’s Next, sits down with Andrew Barron, SVP of Global Site Start Up & Regulatory, to discuss.
Listen to the podcast here or watch the video to find out what they are thinking about ChatGPT, the next industrial revolution and more.
2023 Health Trends: AgeTech with Musician, Actor and Patient Advocate James Ian
2023年2月27日 | Leigh Householder and James Ian
In this episode of the limited Trend Talks series, Leigh Householder Host & Author, 2023 Health Trends: Personally, Purposefully Building What’s Next, sits down with James Ian , a Musician and Actor who lives with Spinal Muscular Atrophy Type Three—a rare neuromuscular disease that attacks the neurons that control all the voluntary muscles in the body. James is a passionate advocate for disability inclusion, particularly in the arts and entertainment industry, and here they discuss representation of disabilities through authentic, intentional and purpose-driven advocacy in media and technology.
2023年2月20日 | Caroline Masterman-Smith, Matt Neal, Stuart Goodall and Hannah Riley
This new podcast mini-series features interviews with industry leaders, focusing on hot topics within Regulatory Operations (Reg Ops).
Reg Ops is evolving in response to a rapidly changing regulatory landscape as well as the industry’s focus on achieving operational efficiency and excellence. Technological innovations such as advancements in Regulatory Information Management (RIM) capabilities are accelerating Reg Ops in their transition from traditional operational roles to more strategically focused roles, including a shift toward Delivery Excellence. Organizations must adapt to the evolution of Reg Ops, including rethinking their approach to attracting and retaining talent, to remain competitive and at the forefront of innovation.
In this episode, Reg Ops Edition host Caroline Masterman-Smith is joined by Matt Neal, Senior Director, Global Regulatory Affairs Operations at Atara Biotherapeutics; Stuart Goodall, Vice President of Regulatory Services Delivery at Syneos Health; and Hannah Riley, Engagement Manager within R&D Advisory at Syneos Health to discuss how the regulatory world has moved from truckloads of paper to electronic processes; how that, in turn, has changed the skillsets required for the Reg Ops function; and how companies need to think and act differently in order to attract and retain the talent they need.
Life Sciences Dealmaking: ディールメーカーの2023年意識調査
2023年2月15日 | Jeffrey Stewart and Neel Patel
It’s a volatile time for biopharma, and a unique juncture in our industry’s history. War in Ukraine, a bearish market and supply chain chaos are just a few of the factors that kept much of the industry away from the table. Entering 2023, the investment and dealmaking panorama remains a puzzle. Despite worries and uncertainties, there are hints that dealmaking intensity may be poised for a rebound after a year of inertia that mirrored the slump in major biotech stock indexes. What lies ahead for dealmaking in the biopharmaceutical industry in 2023?
Our 13th Dealmakers’ Intentions Survey attempts to answer this question, based on responses from more than 100 members of the biopharma community, most of them with executive-level influence on decision making. This report, released recently at Biotech Showcase—an event co-located with the famous J.P. Morgan Healthcare Conference in San Francisco—captures their expectations for deal activity, supply and demand for specific assets and different development stages, pitfalls leading to failure and other factors affecting dealmaking.
Neel Patel, Executive Managing Director, Commercial Advisory Group at Syneos Health and lead author of the report, joins the podcast to discuss the industry’s first time back in person at J.P. Morgan in three years, as well as key findings from the survey.
2023 Health Trends: Personally, Purposefully Building What's Next
2022年11月29日 | Leigh Householder
Summary:
What’s Changed, What’s Changing and What Matters Most Right Now
In this inaugural episode of the limited podcast series on 2023 Health Trends, we’re setting the stage with Host & Author, 2023 Health Trends: Personally, Purposefully Building What’s Next, Leigh Householder.
Leigh provides a high-level look at what will be different this year. First, she discusses urgent optimism and the personal, purposeful commitments we have; to take our industry and our world to next. She goes through 12 Health Trends spanning technology, healthcare advancement and human engagement. These trends help us imagine what could be; our next – the future. Listen and learn what’s changed, what’s changing and what matters most right now.
Learn more about 2023 Health Trends here.
Real World Evidence and Rare Diseases, Part 3: レジストリの価値
2022年11月3日 | Jeffrey Stewart, Mike D'Ambrosio, Ray Huml and Susan Goodlow
Summary:
When it comes to the generation and use of real-world data (RWD), there are variable and evolving stakeholder needs. Put it in the context of a rare disease, where patient samples are decreasing as diseases splinter with increasing specificity in diagnosis, and the prospect of meeting these stakeholder needs becomes more daunting. Layer on special circumstances—like a required 15 years of post-approval follow-up data for cell and gene therapies (CGT)—and the cards seem to be stacked against you. One way companies can alleviate the burden of RWD generation is through patient registries.
Mike D’Ambrosio, VP, Head of Real World Evidence Solutions, Susan Goodlow, VP, RWE and Late Phase Operations and Ray Huml, Head of the Rare Disease Consortium at Syneos Health, discuss the importance of registries for clinical research—particularly for rare disease and CGT, the evolution of rare disease registries and opportunities for the future, and how we can unlock the value of RWD generated from rare disease registries, for all stakeholders.
The views expressed in this podcast belong solely to the speakers and do not represent those of their organization.
2022年10月5日 | Jeffrey Stewart, Stephanie Gonzalez and Alison Holland
Summary:
Common misconceptions surrounding decentralized research often deter sponsors from attaining its key benefits—and this is especially true for small or emerging biotechs with limited shots on goal. But by separating fact from fiction and understanding how to identify fit for purpose solutions, these companies can lay the roadmap for successful implementation of a decentralized clinical trial (DCT) strategy.
Stephanie Gonzalez, Senior Vice President and Head of Global Biotech Solutions at Syneos Health and Alison Holland, Executive General Manager for Decentralized Clinical Trials at Medable debunk some common myths and provide an overview of the benefits decentralization can bring to biotechs.
The views expressed in this podcast belong solely to the speakers and do not represent those of their organization.
September 22, 2022 | Jeffrey Stewart, Lee Taurman and Carl Sailer
Summary:
Early stage biotech companies have traditionally had limited options to get their first asset to market: in most cases, they pursue deals with larger partners, losing control of their intellectual property and limiting their future financial returns, or become a fully integrated company through heavy investment and a great deal of risk.
Opportunities for outsourcing some—or all—of a company’s commercial operations can be an option, but many companies have misconceptions about the highly viable “third option” of commercializing with a proven outsourced partner.
Lee Taurman, Executive Vice President and Head, Full-Service Commercial and Carl Sailer, Vice President and Global Go-to-Market Lead, both from Syneos Health, discuss the wide range of outsourcing options companies can consider that reduce risk, manage costs and optimize performance while maintaining control of their asset—while debunking some of the myths associated with this alternative path to market.
For more on commercial options for biotech companies on the verge of market entry, check out these insights:
ON-DEMAND WEBINAR: Preparing and Aligning Your Biotech Organization for Commercial Success
PRESENTATION: Investing for Commercial Success as an Emerging Company
バイオ医薬品の上市を成功させるためのパートナーとなるエージェンシー選びの5つのポイント
先行きが不透明な時代に透明性がバイオテクノロジー企業の差別化要因になり得るのか
July 14, 2022 | Jeffrey Stewart, Pete Robinson and James Barwick-Silk
Summary:
Cell and gene therapies have come a long way in the past 20 years. And more recent advances and successes with CRISPR and CAR-T technologies have left the field of opportunity wide open for treatments that can potentially move the needle, particularly for patients with oncologic or rare diseases. But with great advancements come significant challenges.
Pete Robinson, Vice President, Medical and Scientific Strategy and Head of the Cell & Gene Therapy Consortium and James Barwick-Silk, Director, Scientific Strategy, Cell & Gene Therapy at Syneos Health discuss the latest exciting developments, as well as hurdles the biopharmaceutical industry must overcome – from R&D, to manufacturing, to access and reimbursement – in order to successfully bring these therapies to market.
For more from our experts in rare disease, be sure to check out:
Innovation Perspectives in Rare Disease Drug Development
サイネオス・ヘルスのポッドキャスト：Mental Health in Rare Disease
サイネオス・ヘルスのポッドキャスト：Epilepsy, the Central Nervous System and Rare Disease
Prioritizing Mental Health Services for Those Living With Rare Disease
Rare Disease Drug Development: Clinical, Scientific, Patient, and Caregiver Perspectives
If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.
Like what you’re hearing? Be sure to rate and review us!
We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at [email protected].
2022年5月17日 | Suma Ramadas and Josh Ziel
Summary:
Reporting from the floor of the Medical Affairs Professionals Society (MAPS) Global Annual Meeting, this podcast series features interviews with industry leaders, focusing in on the impact and value of Medical Affairs today, where the function is heading and how we are going to get there.
Episode 1: Be Bold - Preparing Medical Affairs for 2030 and Beyond
As a function uniquely positioned to address evolving market dynamics, how can Medical Affairs prepare for 2030 and beyond? In this first episode, hear from Josh Ziel, Executive Vice President, Scientific Services at Syneos Health as he unpacks how we can get beyond incremental improvements to really be bold and think forward as we bring Medical Affairs into the future.
Episode 2: Measuring the Immeasurable: Value and Impact of Medical Affairs
It’s no question that Medical Affairs has historically struggled to show value and impact within its organization. In this second episode of the series, Arshi Gupta, Managing Director, Medical Affairs at Syneos Health and Deb Crawford, Director, MSL Team at Teva Pharmaceuticals discuss the intricacies involved in measuring what seems, well, immeasurable.
Be sure to listen to the other episodes in this series here.
The views expressed in this podcast belong solely to the speakers and do not represent those of their organization.
Episode 3: MAPS Edition: Stakeholder Engagement in a Data-Driven Environment
Reporting from the floor of the Medical Affairs Professionals Society (MAPS) Global Annual Meeting, this podcast series features interviews with industry leaders, focusing in on the impact and value of Medical Affairs today, where the function is heading and how we are going to get there.
There’s been an overall shift in the healthcare ecosystem toward more proactive and cross-functional engagement, altering the fundamental nature of conversations from the perspective of Medical Affairs. In this episode, Anita Holz, Executive Director and Therapeutic Area Head, Cardiometabolism, Clinical Development and Medical Affairs at Boehringer Ingelheim, discusses the evolving interface with healthcare professionals and the power of omnichannel engagement in an increasingly data-driven environment.
Be sure to listen to the other episodes in this series here.
The views expressed in this podcast belong solely to the speakers and do not represent those of their organization.
Episode 4: MAPS Edition: Recruiting For the New Profile of Medical Affairs (Jackie Tisch)
Reporting from the floor of the Medical Affairs Professionals Society (MAPS) Global Annual Meeting, this podcast series features interviews with industry leaders, focusing in on the impact and value of Medical Affairs today, where the function is heading and how we are going to get there.
As Medical Affairs has evolved, so have the acumen required for Medical Affairs professionals and leaders to succeed. In this episode we sit down with Jackie Tisch, Managing Director, Taylor Strategy Partners, to discuss the new profile of Medical Affairs, how recruiting for these roles has changed and challenges in finding the right fit.
Be sure to listen to the other episodes in this series here.
The views expressed in this podcast belong solely to the speakers and do not represent those of their organization.
Episode 5: MAPS Edition: Bringing Medical Affairs Into the C-Suite
This podcast series features interviews with industry leaders, focusing in on the impact and value of Medical Affairs today, where the function is heading and how we are going to get there.
Today we are speaking with Dr. Kirk Shepard, co-founder of the Medical Affairs Professional Society (MAPS) and Chief Medical Officer and Head of Global Medical Affairs at Eisai. Dr. Shepard has effectively brought Medical Affairs into the C-Suite, and in this episode we discuss the importance of education, communication, collaboration – and what needs to change as the function continues to advance as a value-based strategic leader.
Be sure to listen to the other episodes in this series here.
The views expressed in this podcast belong solely to the speakers and do not represent those of their organization.
Episode 6: MAPS Edition: Value Demonstration- A View From the Top
This podcast series features interviews with industry leaders, focusing in on the impact and value of Medical Affairs today, where the function is heading and how we are going to get there.
In this continuation from our previous episode, Colin Oliver, PhD, MBA, Managing Director, Medical Affairs Consulting at Syneos Health, steps in as guest host to dig in more deeply with Eisai’s Dr. Kirk Shepard on a critical question: How do we make the case to our cross-functional partners that Medical Affairs deserves a seat at the leadership table? And how can we demonstrate the value that Medical Affairs can bring to that table?
Be sure to listen to the other episodes in this series here.
The views expressed in this podcast belong solely to the speakers and do not represent those of their organization.
If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.
Like what you’re hearing? Be sure to rate and review us!
We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at [email protected].
Training the Next Generation of Pharma
May 13, 2022 | Jeffrey Stewart, Jennifer Sozio and Audra Holleman
Summary:
The clinical research enterprise faces a clear and present personnel shortage, creating inefficiencies for clinical trial sponsors and contract research organizations, many of whom find themselves in a constant recruitment cycle for qualified clinical research associates (CRAs) in a hyper-competitive job market.
While industry has traditionally recruited for these roles from healthcare and scientific programs or settings, we are now seeing a shift from requiring that specific, role-based experience to a more foundational competency-based model. This means potentially looking outside of those traditional sources. But how to we find, recruit and train this next generation?
Jennifer Sozio, Senior Vice President, Clinical Operations and Audra Holleman, Vice President, Clinical Development at Syneos Health discuss the new profile of CRA candidates, challenges and opportunities for recruitment in the current market, and how to train and prepare a growing pool of new CRA resources focused on quality, project delivery and commitment to advancement.
Learn more about the Syneos Health Clinical Training Institute here.
If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.
Like what you’re hearing? Be sure to rate and review us!
We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at [email protected].
2022年4月27日 | Jeffrey Stewart and Jon Haas
Summary:
The medicine may be “transformational,” but doctors won’t write the script if payers don’t reimburse.
And there’s a veritable alphabet soup of players – everything from KAMs to NAMs, MSLs to MSOLs, PBMs to IDNs, and more – involved in negotiating the path to reimbursement and, ultimately, access for innovative therapies before they hit the market.
Jon Haas, Senior Director, Market Access at Syneos Health, discusses the complex process, how companies can best position their product for access and what really matters to payers in the long run.
For more on value and access in biopharma, check out:
How Competition Affects Market Access for Rare Disease Therapeutics, Part 1
How Competition Affects Market Access for Rare Disease Therapeutics, Part 2
Future-Forward Planning: What Drug and Device Manufacturers Need to Know About Preventive Drug Lists
2021 Update: Non-Personal Promotion: What Do Payers Want?
The Other Path to Access: Strategies for Direct Employer Engagement
サイネオス・ヘルスのポッドキャスト：Trade and Distribution in Pharma: It's Complicated
What to Expect on Drug Pricing in the Democratic Trifecta
If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.
Like what you’re hearing? Be sure to rate and review us!
We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at [email protected].
Epilepsy, the Central Nervous System and Rare Disease
2022年4月13日 | Jeffrey Stewart, Dr. Nermina Nakas and Dr. Jane Williams
Summary:
Nobody thinks about epilepsy as a rare disease. But epilepsy syndromes actually make up a large portion of CNS rare diseases. And while progress has been made in developing therapies that treat the symptoms of epilepsy, the true underlying causes can be difficult to pinpoint and treat.
But progress is being made, and Nermina Nakas, MD, MPH and Jane Williams, MD, MPH, Executive Medical Directors in CNS at Syneos Health – and contributors to the book Rare Disease Drug Development: Clinical, Scientific, Patient and Caregiver Perspectives – join Jeff Stewart to discuss recent developments in rare disease epilepsy clinical trials, what they have learned and what drug developers need to know about treating young patients with neurological rare diseases.
For more on the topics covered in this episode, be sure to check out:
Innovation Perspectives in Rare Disease Drug Development
サイネオス・ヘルスのポッドキャスト：Mental Health in Rare Disease
Rare Disease Drug Development: Clinical, Scientific, Patient, and Caregiver Perspectives
If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.
Like what you’re hearing? Be sure to rate and review us!
We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at [email protected].
2022年3月23日 | Jeffrey Stewart and Dr. Veeru Goli
Summary:
Did you know that over half of doctors leverage the placebo effect in treating patients? Placebo can be a powerful tool in medical practice—and in clinical research.
Veeru Goli, MD, Vice President, Medical and Scientific Management, Syneos Health, unpacks the case for use of placebo in clinical treatment, and if applied properly, how the placebo effect can help in clinical trials.
If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.
Like what you’re hearing? Be sure to rate and review us!
We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at [email protected].
Mental Health and Rare Disease
2022年2月9日 | Jefferey Stewart, Keri McDonough and Dr. Michelle Bailey
Summary
Life with a rare disease can have infinite milestones, setbacks, traumas and triumphs—all likely to be interlaced with a variety of factors that can influence mental health and quality of life.
In fact, psychological symptoms are estimated to affect 75% of rare disease patients. Whether the cause is from the physical disease or dynamics surrounding it, it is time to remove the stigma around talking about mental health, understand the unique challenges of this community, and drive support and solutions to address them.
In advance of Rare Disease Day 2022, Keri McDonough, VP, Head of the Patient Voice Consortium and Michelle Bailey, MD, Senior Medical Director at Syneos Health, sit down with host Jeff Stewart to discuss the impact of mental health on the rare disease community.
To find the resources discussed on the podcast:
New York Times: I’m Haunted by Sisters With Sickle Cell: Two Thrived. Two Suffered
Rare Disease Day 2022: Collaborating to Make Mental Health in Rare Disease Stigma-Free
For more on the topics covered in this episode, be sure to check:
Innovation Perspectives in Rare Disease Drug Development
The Syneos Health Pocast: 希少疾病の現状への対処
Rare Disease Drug Development: Clinical, Scientific, Patient, and Caregiver Perspectives
If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.
Business Continuity Through Strategic Outsourcing
2022年1月5日 | Jeffrey Stewart, Michael Jimmink and Jim Reidy
Summary:
The COVID-19 pandemic had had a considerable impact on biotech and pharma services outsourcing, as companies struggled to overcome supply chain issues in production, manufacturing and talent. This held true not only from an R&D perspective, but throughout the product lifecycle as biopharma continued to bring therapies to an evolving market.
Michael Jimmink, Vice President, FSP 360 and Jim Reidy, Vice President, Business Development, Deployment Solutions from Syneos Health discuss ways to navigate business continuity through strategic outsourcing, including why, how and when to consider outsourcing solutions, as well as ways to utilize fit-for-purpose resourcing while maintaining strategic oversight.
For more on the topics covered in this episode, be sure to check out:
2022 Health Trends: Insights for Industry Change Agents
Are You Assembling the Right Team for Commercial Success?
FSP 360: A Flexible, Customizable Solution for Your Outsourcing Needs
Outsourcing R&D in Today’s Market
If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.
2021年8月11日 | Leigh Householder and Dr. George Li
Summary:
In this episode of the Syneos Health Podcast: 2021 Health Trends Edition, we welcome Dr. George Li, Vice President, and General Manager in clinical solutions for mainland China, Hong Kong and Taiwan. Together with podcast host and Managing Director, Omnichannel Strategy, Leigh Householder, he discusses the rapid and dramatic growth occurring in the Chinese pharmaceutical and biotech market.
If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.
2021年7月28日 | Leigh Householder and Ryan Maglione
Summary:
In this episode of the Syneos Health Podcast: 2021 Health Trends Edition, we discuss how to empower and amplify critical field teams as access and engagement evolve and change with the ‘new normal’ of a post-pandemic world.
Listen and learn as Ryan Maglione, SVP, Global Commercial Talent at Syneos Health shares his latest thinking with trends expert, podcast host and Managing Director, Omnichannel Strategy, Leigh Householder.
Learn More About Commercial Recruiting Solutions from Syneos Health.
If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.
2021年7月15日 | Jeffrey Stewart
Summary:
In this episode of the Syneos Health Podcast: 2021 Health Trends Edition, we share the latest thinking on the potential for our industry to make healthcare interactions and communications more personal and useful.
Many life sciences organizations are quickly moving into that world of right person, right message, right moment messaging and scaling internal expertise and external partnership to move from one-to-one messaging to synchronized personal/nonpersonal communications to truly optimized engagement.
Listen and learn from Syneos Health experts, Leigh Householder, Managing Director, Omnichannel Strategy, Howard Brock, Senior Managing Director, Customer Engagement/Consulting, Alex Brock, Managing Director, Omnichannel (EU) and Dr. Annah Sclafani, Data Scientist.
Curious where your organization sits on the omnichannel maturity curve? Click here.
If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.
Talking to Our Families About COVID-19 Vaccines
2021年8月25日 | Jeffrey Stewart
Summary:
This week, the US Food and Drug administration approved the first COVID-19 vaccine. But will this help accelerate the vaccination effort? The US Surgeon General gave a public warning recently: "Health misinformation is an urgent threat to public health. It can cause confusion, sow mistrust, and undermine public health efforts, including our ongoing work to end the COVID-19 pandemic.” Also this week, the Kaiser Family Foundation released a report saying the number one reason for those who changed their minds and got vaccinated, the single thing that worked best, was talking with family.
In this Syneos Short, host Jeff Stewart debunks the most common myths circulating about COVID-19 vaccines and provides tips for guiding friends and family as they wade through a sea of information.
If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.
2021年7月7日 | John Reid, Jeanine O'Kane
Summary:
A great story creates a connection, elicits feelings of compassion and empathy and can ultimately influence behavior. The rise of digital platforms have enabled richer, deeper storytelling, driving a greater desire for sharing and connection. How can biopharma companies better leverage their own stories to build trust and engagement with their audiences?
John Reid, Executive Creative Director and Jeanine O’Kane, President, Public Relations at Syneos Health Communications discuss the evolution of storytelling, the impact of COVID-19 on how we communicate – and the critical importance of transparency and authenticity in the biopharma industry.
If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.
2021 Health Trends: Remote Care in 2021 and Beyond
2021年7月1日 | Leigh Householder, AJ Triano, Jodi Scarbrough
Summary:
When the pandemic took hold, practices and research sites limited physical access to protect people while health systems and industry partners moved to rapidly scale digital and voice channels to maximize patient connectivity. Regulators and payers joined the cause to reduce friction and fuel reimbursement.
As that immediacy and urgency fade, there are changed expectations among healthcare providers and patients alike that pivot off a connection, not an office or site.
In this episode of the 2021 Health Trends Podcast Miniseries, Leigh Householder, Syneos Health resident trends expert and Managing Director, Omnichannel Strategy, discusses how the rise, fall and reset of remote monitoring and commercial telemedicine will largely shape the future of care and drive how life sciences leaders engage and support patients and prescribers. Guests include Syneos Health experts AJ Triano, SVP, Customer Experience Strategy and Jodi Scarbrough, VP, Strategy and Innovation.
Learn more about our 2021 Health Trends here.
2021年6月30日 | Bryan Roman, Stephan Saba
Summary:
At the beginning of the COVID-19 pandemic and in direct response to government advisories limiting nonessential travel, healthcare practitioners (HCPs) were quick to adopt digital platforms for engaging with pharma sales reps. And interestingly, it appears that these virtual engagements are actually increasing the amount of time HCPs spend with these reps. Now, as we move past this transformative time, the future that is emerging is neither fully face-to-face nor solely digital-dedicated.
Bryan Roman, Executive Vice President of Creative Technology and Stephan Saba, Senior Vice President of Customer Experience at Syneos Health talk about innovations in technology that can better enable interactions between sales reps and their customers in a post-pandemic world.
For more on the impact COVID-19 has had on physicians’ engagement with telemedicine platforms and field force teams, check out our recent report.
Pharmacovigilance in the COVID-19 Era and Beyond
2021年5月19日 | Jeffrey Stewart, Carol Aliyar
Summary:
Right now, millions of patients are being dosed with vaccines for COVID-19, which have had accelerated development timelines in order to provide emergency use. This is a first in our industry, and it presents safety monitoring challenges for pharmaceutical companies managing an unprecedented volume of data to ensure that the benefits to patients outweigh the risks. How can they keep up – now, and in the future?
Carol Aliyar, Executive Vice President, Global Head of Safety and Pharmacovigilance at Syneos Health, discusses the impact the COVID-19 vaccine rollout on current safety monitoring processes, how biopharma needs to adjust going forward, and why the human element remains a critically important part of the solution.
2021年5月5日 | Jeffrey Stewart, Tim Arendt
Summary:
It is a common misconception in the biopharmaceutical industry that lifecycle management is really meant for the end of a product’s life, generally at the point where exclusivity is lost and generic competition erodes sales and, ultimately, the value of the brand.
According to Tim Arendt, Managing Director in the Commercial Advisory Group of Syneos Health Consulting, if done right, a lifecycle management plan developed early will actually pay off in spades in the end. Here, he discusses the importance of lifecycle management in biopharma and how companies can – and should – leverage this tool to ensure their products will reach their full potential, throughout their lifecycle.
Source Document Review in the Modern World
2021年4月1日 | Jeffrey Stewart, Audra Holleman, Nicole Stansbury
Summary:
Source Document Review and Source Data Verification have been the gold standard for ensuring data quality and patient safety for more than 30 years. This review and verification process covers a wide range of material related to study subjects including anything from consent forms and medical histories to lab results and personal diary entries and beyond, consuming a significant amount of time and budget. In recent years, we’ve seen a drive to find ways to make clinical trial monitoring more effective and cost efficient, especially with the growing use of technologies such as Electronic Data Capture (EDC) systems.
Audra Holleman, Vice President, Clinical Monitoring and Nicole Stansbury, Vice President, Global Monitoring at Syneos Health, discuss the evolution of what once was a manual and time consuming process of sifting through potentially thousands of pieces of material to a far more efficient and strategic approach driven by advancements of the digital age.
Listen to Nicole Stansbury discuss the importance of risk-based monitoring previously on the podcast in our CORONAVIRUS SPECIAL EDITION, Episode 7: Continuity in Clinical Trials.
Learning Agility in Medical Affairs
2021年3月18日 | Jeffrey Stewart, Hasini Jayatilaka
Summary:
Being prepared for what you know is going to happen is hard enough, but how can you get ready for the unexpected? The answer: learning agility.
Learning agility is a set of skills, competencies and mindsets that support an organization’s ability to respond in unforeseen situations. In fact, higher levels of learning agility could help to “future proof” organizations against challenges of turbulent times, and as such will likely become a differentiator for life science companies. Best of all, learning agility is a skillset that can be developed.
In this interview with Hasini Jayatilaka, PhD, Consultant and Data and Analytics Specialist, Scientific and Medical Affairs at Syneos Health, we discuss why learning agility is particularly beneficial in Medical Affairs, six tangible ways of cultivating learning agility and a diagnostic tool that can score, analyze, benchmark and provide recommendations for improvement on an individual, functional and organizational level.
Listen to our first podcast on Learning Agility here.
Read our white paper on Learning Agility on our Insights Hub here.
To learn more about Medical Affairs at Syneos Health, click here.
Trade and Distribution in Pharma: It's Complicated
2021年2月24日 | Jeffrey Stewart, Tony Lanzone
Summary:
Getting a drug product into the hands of patients is not a simple task. What was once a straightforward “back office” operation has, with the advent of oncology, rare disease and other kinds of specialty therapeutics, risen to a level of complexity that requires greater strategy, planning and logistics acumen than ever before.
Tony Lanzone, Managing Director, Value, Access and HEOR at Syneos Health provides a deep dive into the art and science of getting therapies from the manufacturer to the patient, and how the right trade and distribution strategy can provide a true competitive advantage.
Peter Kolchinsky and Investing in Biopharma
2021年2月10日 | Jeffrey Stewart, Peter Kolchinsky
Summary:
Investing with confidence, and with a conscience – yes, it is possible to do both.
In our second interview with scientist-turned-investor Peter Kolchinsky, co-founder and Managing Partner at RA Capital Management, LP and author of The Great American Drug Deal: A New Prescription for Innovative and Affordable Medicines, we discuss his transition into biotech portfolio management, the art of unearthing potential investment opportunities through competitive mapping, and what it means to make a difference through his affiliation with nonprofit No Patient Left Behind.
Check out some of his firm’s fascinating, detailed landscape maps for COVID-19 diagnostics, therapeutics and vaccines here.
Peter Kolchinsky and The Great American Drug Deal
2021年2月3日 | Jeffrey Stewart, Peter Kolchinsky
Summary:
Biopharmaceutical innovation requires a hefty investment: A recent study published in The Journal of the American Medical Association (JAMA) reported an average cost of $1.3 billion to bring a new drug to market, from drug discovery through clinical trials to approval. And it is often the biopharma company that comes under fire when cost burden to patients is in question.
But affordability of these innovations is not the biopharma industry’s cross to bear alone, according to Peter Kolchinsky, co-founder and Managing Partner at RA Capital Management, LP and author of The Great American Drug Deal: A New Prescription for Innovative and Affordable Medicines. In this first of two interviews, Kolchinsky sits down with host Jeff Stewart to discuss the current healthcare landscape and how government, society, the insurance industry and biopharma must work together in order to fulfill what he calls the “biotech social contract” – where patients will be able to afford their treatments and society will continue to reap the benefits of medical innovation.
Real World Evidence and Rare Diseases
2021年1月13日 | Jeffrey Stewart, Dr. Raymond Huml, Dr. Javier Jimenez
Summary:
How rare is a rare disease? On their own they can be quite scarce, but did you know that one in ten people in the U.S. is afflicted with a rare disease? That’s over 30 million people. And that’s a big problem. But how do you study treatments when it’s so difficult to find patients for each rare disease? That’s when it is time to leave the lab and take a look at the real world.
In this episode, we are joined by Syneos Health experts Dr. Raymond Huml, Vice President, Medical and Scientific Strategy, Head of the Rare Disease Consortium and Dr. Javier Jimenez, Executive Vice President, Real World Evidence and Late Phase. They draw on their history working with rare diseases and the challenge of developing treatments for these conditions. For diseases that are so scarce you cannot just use clinical trials, you need to incorporate real world data. The challenge becomes combining these sources of information to create the treatments that patients desperately need. Drs. Hummel and Jimenez discuss their experience navigating this difficult field and how to get the information that everyone, from regulators to biopharma companies, needs to treat rare diseases.
2020年10月21日 | Jeffrey Stewart, Sabine Dettwiler
Summary:
It may sound obvious that pharmaceutical companies operate according to the unique set of regulations, healthcare environments, market conditions, and cultures of the regions in which they operate, but what do such differences reveal about the industry as a whole?
In this episode, Sabine Dettwiler, Managing Director, Commercial Advisory Group at Syneos Health Consulting, shares some learnings from her experience in the U.S., Asia, and Europe – comparing and contrasting the pharmaceutical landscape across all three, including the challenges of clinical trial diversity, cultural barriers, and the differing values and priorities of healthcare providers.
APAC EDITION: Clinical Development in Japan
2020年9月9日 | 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.
2020年9月2日 | 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.
2020年8月26日 | 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
2020年8月6日 | 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.
2020年7月15日 | 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:
- The Great Benefits Migration of 2020
- Demonstrating Value in the Real World
- Non-Personal Promotion: What Do Payers Want?
Coronavirus Special Edition Episode 12: COVID-19 and Children
2020年6月19日 | 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
2020年6月2日 | 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
2020年5月27日 | 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
2020年5月15日 | 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
2020年5月8日 | 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
2020年5月6日 | 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
2020年4月23日 | 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
2020年4月16日 | 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 7: Continuity in Clinical Trials
2020年4月2日 | 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
2020年3月29日 | 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
2020年3月24日 | 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
2020年3月24日 | 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
2020年3月20日 | 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
2020年3月17日 | 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
2020年3月11日 | 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 053: Medical Affairs Series, Part Six: Commercial Plus Medical Affairs
2020年2月19日 | 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 052: 2020 Health Trends: Box Store Healthcare
2020年2月5日 | 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 051: Medical Affairs Series, Part Five: Medical Affairs in the Early Stage
2020年1月10日 | 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 050: Real World Evidence and Rare Diseases
2019年12月20日 | 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 049: The Digital Therapeutics Alliance: A European Perspective
2019年12月11日 | 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 048: Medical Affairs Series, Part Four: Medical Affairs in the Field
2019年11月20日 | 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
2019年11月6日 | 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
2019年10月24日 | 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 045: Measuring the Unmeasurable: Medical Affairs Metrics
2019年10月9日 | 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 044: Why We Resist
2019年9月25日 | 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 043: Medical Affairs Series, Part One - A Foundation for Medical Affairs
2019年9月11日 | 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 042: A Regulatory Roadmap for Real World Evidence
2019年8月28日 | 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
2019年8月14日 | 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: デジタル治療
2019年7月31日 | 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
2019年7月17日 | 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
2019年7月3日 | 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
2019年6月19日 | 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 036: Commercialization for Emerging Companies
2019年6月5日 | 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 035: How Translational Science Can Solve Pharma's Productivity Puzzle
2019年5月15日 | 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 034: Can the Gut Microbiome Revolutionize Medical Care?
2019年5月1日 | 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
2019年4月26日 | 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 033: From DTC to DT"Me" - The Future of Communications in Pharmaceuticals
2019年4月17日 | 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 032: Navigating the New EU Medical Device Regulations
2019年4月3日 | Jeffrey Stewart, Adam Steadman
Summary:
New regulations, which were adopted on 2017年5月26日, 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 Edition: Acceleration in Asia
2019年3月29日 | 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
2019年3月20日 | 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
2019年3月6日 | 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
2019年2月20日 | 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
2019年2月1日 | 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
2018年12月11日 | 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 026: The Health Trend Ten - Clinical Perspective
2018年11月27日 | 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
2018年11月27日 | 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 024: Content that Clicks
2018年10月31日 | 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
2018年10月3日 | 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
2018年9月19日 | 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
2018年9月5日 | 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
2018年7月9日 | 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
2018年6月6日 | 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
2018年5月23日 | 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
2018年4月25日 | 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?
2018年3月14日 | 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
2018年3月7日 | 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: 真のエンゲージメントのための人工知能
2018年2月13日 | 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
2018年2月6日 | 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
2018年1月8日 | 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
2018年1月8日 | 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: 希少疾病
2018年2月26日 | 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.
Subscribe to Our Podcast Series
