Trials with Maya Z

Andrew Freeman spent over two decades at GSK, where he led the company's efforts on clinical trial transparency - trial registration, results reporting, and sharing patient-level data with researchers. Yet when his own father was diagnosed with late-stage cancer, he couldn't find him a trial through clinicaltrials.gov. He gave up and found one through a personal contact instead. As Andrew puts it, that shouldn't be the way it works.

Andrew was at the WHO meeting in Geneva where the 20 or so data elements for study registration were identified, and since the end of 2022 he chairs the board of ISRCTN, the UK's clinical study registry.

In this episode, Andrew and Maya discuss:

• Why a "compliance mindset" and a "transparency mindset" are not the same thing - and why studies outside the regulatory definition of a clinical trial should still be transparent
• What the latest HRA metrics really show: 94% of UK studies registered sounds good, until you see that only around 44% published their results
• How ISRCTN is trying to make transparency easier - mandatory plain language summaries, mandatory recruitment site information, and a results posting system now in its second prototype
• Where AI could help make trial information understandable for patients, carers, and the public

Naomi Litchfield’s passion for Early Access Programs (EAPs) stems from a personal experience - her sister’s life was saved by an early access drug after being diagnosed with four rare cancers. With nearly 20 years of industry experience, Naomi is now the Director Patient Advocacy at Bionical Emas.

In this episode, Naomi and Maya discuss:
 • What Early Access Programs are and how they work
 • How EAPs provide hope and open doors for patients in need
 • The challenges and considerations involved in setting up an EAP

Early Access Resources:
https://bionicalemas.com/resources/johnson-johnson-guide-to-expanded-access/
https://bionicalemas.com/resources/what-is-a-clinical-trial/
https://bionicalemas.com/resources/what-is-an-early-access-program/
https://bionicalemas.com/resources/what-is-real-world-data/

Follow Maya Zlatanova: https://www.linkedin.com/in/mayazlatanova/
Follow Naomi Litchfield: https://www.linkedin.com/in/naomi-litchfield-499670122/

Clinical trials are evolving, but are we innovating fast enough? In this episode Maya sits down with Philip Raeth from Palleos Healthcare to explore how new trial designs can challenge the status quo. From adaptive methodologies to efficiency-driven models, we discuss how rethinking trial structure can help us tackle industry-wide hurdles—not just in patient recruitment and retention, but in trial execution, costs, and outcomes. What does the future of clinical trials look like? Tune in as we brainstorm new possibilities.

Follow Philip Raeth: https://www.linkedin.com/in/philip-raeth-51911114/
Follow Maya Zlatanova: https://www.linkedin.com/in/mayazlatanova/

Paul Simms is the CEO of Impatient Health and a trailblazing voice in the life sciences industry. Paul is on a mission to push the boundaries of pharma. He works with innovators and early adopters to inject “mutation pressure” into the status quo, ensuring bold ideas and creative solutions make their way into the market. Drawing on his experience as a speaker, event organizer, and consultant, Paul discusses how pharma can evolve to truly align with patients’ needs. Together, with Maya they explore the intersection of innovation, behavioral science, and systemic transformation in healthcare.

What You’ll Learn:
- Why Paul believes the pharma industry is still in its infancy and how it can grow.
- What “mutation pressure” means and how it can drive innovation in pharma.
- The critical role of patient engagement and behavioral science in improving healthcare outcomes.
- How Paul’s work with major pharma companies has shaped his views on the future of the industry.
- Practical lessons from other industries, including fashion and tech, that pharma can adopt.

In this episode of Trials with Maya Z, Maya and patient expert and advocate Orit Rindner discuss the intersection of patient needs and clinical trials, highlighting real-world challenges and insights from rare disease research:

• The impact of standard of care on patient willingness to join clinical trials
• Challenges in rare disease trials and patient recruitment
• The importance of aligning clinical trials with patient realities

Follow Maya Zlatanova: https://www.linkedin.com/in/mayazlatanova/
Follow Orit Rindner: https://www.linkedin.com/in/oritrindner/  

• (00:00) - Chapter 1

"Only 1-4% of global healthcare R&D funding is dedicated to female-specific conditions beyond cancer, despite women representing 51% of the population.” Meet Estelle Jobson - an EUPATI Fellow and a patient advocate living with endometriosis. In this episode, Maya and Estelle discuss the limitations of standard care for this chronic condition and call for research that addresses its diverse symptoms. 

• Why Standard care for endometriosis fails to address patient needs?
• What is wrong with the current definition of endometriosis?
• What are the current treatment gaps?

Follow Maya Zlatanova: https://www.linkedin.com/in/mayazlatanova/
Follow Estelle Jobson: https://www.linkedin.com/in/estelle-jobson-27389821/

• (00:00) - Introduction and Background

Join Maya Zlatanova and Ritesh Patel from Finn Partners as they dive into the evolving world of real-world data in clinical trials. Discover the challenges of integrating diverse patient data, the role of social determinants in trial outcomes, and how emerging technologies like AI and digital biomarkers are set to revolutionize the industry. Packed with insights on collaboration and innovation, this episode is a must-listen for anyone passionate about transforming healthcare through data-driven strategies.

Follow Maya Zlatanova: https://www.linkedin.com/in/mayazlatanova/
Follow Ritesh Patel: https://www.linkedin.com/in/riteshpatel/

Ella Balasa has experience on both sides of the research spectrum - as a patient with cystic fibrosis and as a scientist examining antibiotic-resistant bacteria. She is on a mission to amplify patient voices in drug development. In this episode Ella and Maya discuss:

• Ella’s journey and advising experience
• The difference in the patient journey in US vs. Europe
• The often overlooked challenges in patient access to care

Follow Maya Zlatanova: https://www.linkedin.com/in/mayazlatanova/
Follow Ella Balasa: https://www.linkedin.com/in/ella-balasa/

Meet Jan Poleszczuk, a mathematician turned healthcare innovator and a CTO of CliniNote. In this episode Maya and Jan talk about:
- The top 3 challenges hindering the quality of RWD
- How CliniNote is helping doctors generate quality data while simplifying their workflow
- The potential of RWD in clinical trials 

Tune in to explore the good, the bad, and the ugly of Real-World Data and how innovators like Jan Poleszczuk are working to unlock its full potential to improve patient care and drive healthcare innovation.

Follow Maya on LinkedIn: https://www.linkedin.com/in/mayazlatanova/ 
Follow Jan on LinkedIn: https://www.linkedin.com/in/jan-poleszczuk-70200117/

Learn more about CliniNote: https://clininote.com/

• (00:00) - Introduction and Background

Meet Esther Howard, Mental Health Advocate, Researcher and CEO of Bezyl. In this conversation, Esther shares her unique perspective on the importance of understanding patient journey, not just as a scientific necessity, but as a fundamental human duty for researchers. Esther explores the three critical prongs of patient journey: standard of care, the specifics of the patient's disease, and the often-overlooked aspects of their daily lives. She emphasizes the need for researchers to look beyond the protocol and embrace a more holistic view of patients' experiences, arguing that by embracing our human duty to understand and empathize with patients' experiences, we can not only advance scientific knowledge but also create a more compassionate and patient-centric approach to clinical research.

Follow Maya Zlatanova: https://www.linkedin.com/in/mayazlatanova/
Follow Esther Howard: https://www.linkedin.com/in/esther-howard-7352b3b3/
Learn more about Bezyl: https://www.linkedin.com/company/bezyl/

• (00:00) - Introduction and Background