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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. Each episode explores the challenges and considerations involved with bringing biopharmaceuticals to the market.
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In this episode, recorded from the floor of the CNS Summit, host Andy Moniz, Vice President of Therapeutic Strategy and Innovation at Syneos Health, sits down with Cristina Duran, CEO of Evinova, to discuss her transformative journey in life sciences and the future of patient-centric innovation in healthcare.Cristina shares insights from her experience leading R&D transformation at AstraZeneca, where she pioneered patient-centric approaches to clinical trials. She discusses how Evinova is...
In this special series of the Syneos Health Podcast, we celebrate 15 years of innovation in collaboration with CNS Summit, a community of innovators and life science industry leaders devoted to discovering better, more efficient ways to advance the industry through innovation, collaboration, and technology. Over the course of the series, we will feature conversations with key experts and members of the community on how the life sciences industry is continuing to reinvent itself in the pursuit...
Launched in 2021 by the FDA's Oncology Center of Excellence, Project Optimus seeks to reshape traditional oncology trial designs and dosing paradigms, shifting from maximum tolerated doses to precision dosing strategies. While the FDA's hope was that the added time and cost of collecting comprehensive dose and exposure response data would benefit both patients and sponsors, there is also concern and debate in the biotech community that, if the Optimus formula is closely followed, the addition...
There is a significant unmet need for medicines to treat neuropsychiatric and neurological conditions in underserved patient populations. Recently, there has been renewed interest in psychedelic, hallucinogenic and dissociative compounds to meet those needs. In clinical trials, a wide array of these compounds are showing efficacy across a variety of indications. Syneos Health experts Andy Moniz, Dr. Leslie Moldauer, Zelma Gandy Don Sing and Lindsay Crampton—along with Dr. Aaron Koenig, C...
As the biopharma industry strives to ensure that clinical trials reflect the rich diversity of the patient populations they aim to serve, the challenges to make this possible have fallen on the trial sites. In a recent webinar, Syneos Health experts Jane Bentley and Juliette Roberts from our Oncology Therapeutic Strategy & Innovation team, and Kelli Defenbaugh from Patient Recruitment and Retention Management, offered robust strategies and actionable insights tailored to overcome obs...
Use of circulating tumor DNA (ctDNA) – small fragments of DNA that are released into the bloodstream by cancer cells – as a diagnostic tool represents a significant shift toward more precise, personalized cancer care, enhancing both trial efficiency and patient experience. Unlike traditional tissue biopsies, which sample a single tumor site, ctDNA offers a real-time, comprehensive view of the genetic mutations present in the tumor throughout the body. By offering faster, more detailed insight...
Medical science liaisons—or MSLs—within pharmaceutical companies deal in a special currency: scientific exchange and real-world insights gathering. Only they can share certain types of information with a growing number of medical stakeholders. And only they can bring back medical insights to guide strategic development and brand decisions. Yet, can anyone be certain that this highly valuable currency is being spent wisely?Recently, some of our Medical Affairs experts led an engaging webinar o...
AI is seemingly everywhere now in our lives, including healthcare and drug discovery and development. AI certainly has the potential to enable major advances than development of more effective and safe medical products. And in fact, GenAI has already been successfully used in drug discovery. But are we fully leveraging the current AI yet in practical ways? Are our trial designs informed appropriately by AI and data? From the mundane document generation and handling to the complex patient...
The World Economic Forum projects that by 2050, climate change could cause 14 million additional deaths and $12 trillion in global healthcare costs. And this will exacerbate global health inequities with our most vulnerable populations, including women, youth, elderly, lower-income groups, and hard-to-reach communities bearing the brunt of this change. We think we know the culprits…but do we really?The fact is, the healthcare sector is responsible for almost 5% of global greenhouse gas emissi...
Alzheimer's disease is a challenging and devastating diagnosis that affects memory and cognitive skills, with no known way to predict, track, treat, or cure it effectively. In 2024, around 90 million people over the age of 65 will be living with Alzheimer's. Clinical trials for new treatments have faced high failure rates, partly because it's difficult to identify the right patients at the right stage of the disease. The potential solution to this dilemma might lie in AI, which could help ana...
Breast cancer is the most common type of cancer among women worldwide, and it can be treated with different modalities, such as surgery, chemotherapy, radiation, hormone therapy and targeted therapy. However, even after the primary treatment, some cancer cells may remain in the body and cause recurrence or metastasis. This is where adjuvant therapies come in: they are additional treatments that aim to reduce the risk of cancer coming back or spreading to other parts of the body.In this episod...
This is an exciting time in the development of new medicines to treat both rare and age-related eye diseases. But what is it like in the trenches to develop and deliver clinical trials that evaluate both the safety and efficacy of these potential new medicines for diseases of the eye?In this episode, Nick Kenny, Syneos Health CSO and interim podcast host, is joined by Eileen Schramm, Senior Clinical Trial Manager, and Nicole Curry, Senior Project Manager, both in the Syneos Health Ophthalmolo...
In March 2024, the FDA approved a groundbreaking gene therapy for children with a specific form of leukodystrophy, offering hope to those with no current care options. However, the approval came with a hefty price tag, making headlines as the most expensive medicine in the world at $3,500,000 per patient. With the cost of innovation so high, what can we do to de-risk development, ensure affordability and achieve equitable access to these potentially life-changing therapies for the long term?N...
After 7 years as the Syneos Health Podcast's founding and flagship host, Jeff Stewart is stepping down. Here, he reflects on his experience and bids farewell.It doesn't end here - stay tuned for new episodes with new host(s), coming soon!(Jeopardy! clip courtesy of Ken Jennings.)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 be...
Patient assistance programs can make a huge difference for patients who need expensive medicines but can't afford them. In this episode, Jeff Stewart talks with Dave MacLeod, Managing Director, Value & Access at Syneos Health about the benefits and challenges of patient assistance programs, which provide free or low-cost medicines to eligible patients. They discuss how these programs can improve access, adherence, and outcomes, as well as the operational and regulatory issues involve...
The Inflation Reduction Act (IRA), signed into law by President Joe Biden in August 2022, brings significant changes to the U.S. pharmaceutical market as it rolls out over the next 10 years.Today we dive deep into the IRA with Tiffany McCaslin, Managing Director, Value, Access and Health Outcomes at Syneos Health. Drawing from her extensive background in healthcare policy and industry strategy, Tiffany offers invaluable insights into the practical implications of this landmark legislation for...
For the first time, the technology behind Wall Street and Formula One racing is being used in pharmaceuticals—and it’s offering unparalleled potential for innovation in clinical trial execution and healthcare delivery.In this episode, host Jeff Stewart is joined by Darren Coleman, the general manager of RxDataScience, a Syneos Health company, who discusses KX technology, the world’s fastest time series database and analytics engine, and how it is now being applied to improve clinical trial ef...
When it comes to launching a pharmaceutical product in today’s market—especially as an emerging company—strategic investment can make all the difference.Drawing from a recent study on investing for commercial success, Michael Sarshad, Managing Director in the Commercial Advisory Group at Syneos Health, discusses the key factors for successfully launching a drug in today's market; the importance of strategic investment, timing and team experience in exceeding launch forecasts; and the diverse ...
Age-related vision loss is a rising concern for our growing aging population. According to the most recent data published by the CDC, nearly 20 million Americans aged 40+ have been diagnosed with some form of age-related macular degeneration (AMD). By the age of 75, roughly 1 in 3 people living in the United States will have some form of AMD, and about 1 in 4 of those will have a vision-threatening, late-stage form of AMD. These statistics underscore the need for heightened public awareness a...
The FDA has finalized a rule that addresses how drug ads must be presented in TV and radio commercials. The rule, proposed in 2010 and now effective from May of this year, aims to provide clarity and guidelines for pharmaceutical companies in presenting side effects and contraindications in a balanced manner. But it’s still a 27-page document.Here, we’ll boil it down for you.Matthew Snodgrass, head of US Digital and Social Strategy at Syneos Health, sheds light on the 13-year journey from pro...
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