Trials with Maya Z
This podcast explores the world of clinical trials, focusing on why 90% of trials fail and 85% get delayed. Host Maya Zlatanova, CEO of TrialHub, interviews passionate industry experts to uncover what makes trials more successful or challenging. Each episode dives into the planning and execution of clinical research, offering insights from experienced professionals. The goal is to understand the factors that impact trial outcomes and improve future studies.
Episodes
The Transparency Mindset: Why Clinical Trial Results Still Go Missing with Andrew Freeman
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
The Value of Early Access Programs With Naomi Litchfield
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 •
The Power of Innovative Trial Designs with Philip Raeth
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
How to get from Sick Care to Health Care and Rethinking Pharma’s Role with Paul Simms
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 consult
Patient Engagement and Standard of Care in Rare Disease Trials with Orit Rindner
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 trialsChallenges in rare disease trials and patient recruitmentThe importance of aligning cli
Endometriosis: Why Standard Care Isn't Cutting It - Exploring the Gaps with Estelle Jobson
"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 di
RWD Data and Trust in Clinical Trials: Ritesh Patel’s Take
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 innov
The patient journey in US vs EU and how involving patients early on can help with Ella Balasa
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 experienceThe difference in the patient journey in US vs. EuropeThe often overlooked challenges
Real-world data: The Good, the Bad and the Ugly with Jan Poleszczuk from CliniNote
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 in
Understanding the Patient Journey is Our Duty as Researchers: Esther Howard's Insights from Two Decades in Clinical Research
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, an
Connecting the Dots in The Patient Journey - The Importance Of Patient Trust with Heidi Floyd
Meet Heidi Floyd, a breast cancer survivor, patient advocate, and champion for transforming clinical trials through authentic patient engagement. In this powerful episode, Heidi shares her remarkable journey of navigating cancer treatment while pregnant.Heidi emphasizes the critical importance of building meaningful relationships between patients, healthcare providers, and clinical trial
Building the Batman Belt: Leveraging Data and Standard of Care in Trials with Travis Caudill
Meet Travis Caudill, Vice President of Feasibility and Clinical Informatics at ICON, a seasoned expert in the world of clinical trial optimization. Discover how Travis and his team are navigating the complexities of trial feasibility—using data to optimize site selection, understanding local patient journeys, and anticipating changes in the standard of care. Follow Maya Zlatanova: https:/
How To Prevent Clinical Trial Nightmares With Ilknur Lechthaler
Ilknur Lechthaler is an expert in clinical operations, research, and startup investments. Ilknur discusses how the industry's awareness of the significance of country-specific standard of care has evolved over the past decade. Together with Maya they dive into the practical aspects of country selection and the factors that influence decision-making, such as regulatory requirements, timeli
Mapping the Patient Journey: Roadmap to Successful Trial Design with Todd Georgieff
Meet Todd Georgieff - a veteran in drug development and clinical operations with expertise in optimizing global trials. In this episode, Todd and Maya explore the critical aspects of protocol optimization and patient burden quantification. How does understanding local standard of care impact trial success? What are the ethical implications of providing treatments in different healthcare s
How Access to Treatments Impacts Trials: From Protocol Development, to Country and Site Selection with Kasia Harris
Meet Kasia Harris - an expert in clinical trial feasibility and planning with experience in both CRO and Pharma. bringing valuable insights into the complexities of global healthcare systems. In this episode, Kasia and Maya delve into the critical role of understanding local standard of care in clinical trial success. They explore feasibility assessments, protocol, country, and site-spec
Viagra's Hard Lessons: Why Understanding the Patient Journey is Non-Negotiable with Annabel de Maria Bosch
Meet Annabel de Maria Bosch - the Chief Patient Officer at Alira Health with nearly three decades of experience in patient engagement across the pharmaceutical industry. In this insightful conversation, Annabel shares her unique perspective on the critical importance of understanding the patient journey and its impact on clinical trial success. Follow Maya Zlatanova: https://www.linkedin.
From Carer to Catalyst: Joy Milne's Journey to Revolutionize Parkinson's Research
Meet Joy Milne, a remarkable woman whose unique sense of smell is revolutionizing the world of Parkinson's research. In this episode, Joy shares her personal story of love, loss, and unwavering determination to make a difference in the lives of those affected by Parkinson's, from her groundbreaking work with researchers at the University of Manchester to her advocacy for greater awareness
The true cost of patient acquisition and the ever-rising site burden with Ted Trafford
Meet Ted Trafford - a seasoned clinical research expert with nearly three decades of experience and a passion for driving innovation in the industry. As the Director of Business Development at Probity Medical Research, Ted brings unique insights into the challenges faced by sites, sponsors, and patients in the clinical trial landscape.Follow Maya Zlatanova: https://www.linkedin.com/in/may
Fail-Proofing Clinical Trials: Lessons in Smart Planning with Angie Schwab
Meet Angie Schwab - founder of EZ Research Solutions and a passionate expert in clinical research with a focus on improving trial startup processes. In this episode, Angie and Maya dive deep into the challenges and solutions in clinical trial design and execution. Angie shares her insights on the critical importance of thorough planning, understanding local standards of care, and involvin
Small Patients, Big Challenges: Obstacles in Paediatric Rare Disease Research with Begonya Nafria
Meet Begonya Nafria - Head of the Patient Engagement in Research Department at Hospital Sant Juan de Déu Children’s Hospital, championing the cause of paediatric clinical research. In this eye-opening episode, Begonya and Maya delve into the unique challenges of conducting clinical trials for children, especially those with rare diseases. Begonya highlights the startling fact that 95% of
Rethinking The Role of Standard of Care in Clinical Trials With Dan Sfera
Dan Sfera really needs no introduction - founder of the Clinical Trials Guru he has been publishing content in the clinical research space since 2010. In this episode, Dan and Maya talk about the challenges of patient recruitment and retention, explore the importance of considering clinical trials as a care option, and the implications of not prioritizing the patient perspective in trial
How the Patient Voice Can Help Shape The Perfect Trial Design with Robert Joyce
Meet Robert Joyce - a patient advocate living with multiple chronic illnesses who has turned his experiences into a powerful voice for change in healthcare. In this episode, Robert and Maya explore the complex journey of living with secondary progressive multiple sclerosis, asthma, sarcoidosis, and chronic pain. They discuss the critical importance of including patient voices in clinical
The Importance of Patient Engagement on the Outcomes of Clinical Trials with Dr. Lorna Pender
Meet Dr. Lorna Pender - a passionate patient advocate and engagement expert dedicated to amplifying patient voices in healthcare. In this episode, Lorna and Maya explore the vital role of patient engagement in shaping the clinical trial landscape. Lorna highlights how early patient engagement can drive the success of clinical trials and stresses the importance of industry creating accessi
How Germany’s Standard of Care Influences Clinical Trial Participation with Martin Krauss
Meet Martin Krauss - the CEO of FGK Clinical Research, an expert in clinical research with a mission to advance medical treatments and improve patient outcomes. One year after their last episode together, Martin and Maya meet again to talk about the current challenges and developments in the clinical research landscape. Why is there a decline in biotechnology investments globally and how
What It’s Like to Build a Patient-Friendly Pharmacological Unit with Oren Cohen
In this episode, Maya meets Dr. Oren Cohen, who brings more than 30 years of healthcare, research, and clinical development experience to his role, including several senior medical and operational leadership positions at a biotechnology company and another global CRO.Oren is President at Fortrea Inc which has patient-friendly clinical research units in US and the UK. A hot topic is the u
Standard of Care or Clinical Trials: How Do Patients Choose Between Their Options? Conversation with Carole Scrafton
Meet Carole Scrafton, a passionate patient advocate and founder of Flutters and Stutters, a patient organization dedicated to improving the lives of those affected by chronic illnesses and rare diseases. In this episode, Carole and Maya explore how Standard of Care shapes the patient journey and experience throughout healthcare, going beyond just access to treatment. Follow Maya Zlatanova
How to Ensure Data Integrity and Security in Clinical Research with Daniel Schwarz
In this episode, Maya meets Daniel Schwarz, a co-founder and CIO at the Institute of Biostatistics and Analyses Ltd., a spin-off from Masaryk University, Brno, Czech Republic. With a robust background in biomedical engineering, neuroimaging, and clinical data management, Daniel's work focuses on leveraging advanced data management systems to support significant healthcare projects.Maya a
Decentralized Trials After the Hype with Moe Alsumidaie
In this episode, Maya meets Moe Alsumidaie, who is the Chief Editor of The Clinical Trial Vanguard. Moe holds two decades of experience in the clinical trials industry. The Clinical Trial Vanguard is an online platform that provides comprehensive information, analysis, and news related to clinical trials. It caters to a wide audience, including researchers, healthcare professionals, inve
How to Adopt a Beginner’s Mindset in Trials with Leen Kawas
In this episode, Maya meets Dr. Leen Kawas. Dr. Kawas is creating a biotech-focused fund to support life science innovations, utilizing her background as an inventor, scientist, and entrepreneur. She first led and co-founded Athira, a company for late-stage clinical programs. She took it public in 2020, raising over $400 million. Notably, she was the first woman in 20 years in Washingto
The Future of AI-Powered Trials with Stefan Schröder
How can we harness the power of AI to create more patient-centric clinical trials? Can technology and empathy coexist in healthcare? In this episode, Maya meets Stefan to explore the integration of artificial intelligence in clinical trials. Stefan and his team at Enroll With assist clients in using AI to improve various aspects of clinical trials, from site selection to creating content
The Big Shift in Cancer Treatment with Gretchen Knoll
In this episode, Maya meets Gretchen Knoll. She has over 20 years of experience in pharmaceutical clinical development, now she focuses on enhancing care for severely ill patients and reducing healthcare costs through strategic collaborations. Maya and Gretchen Knoll discuss the challenges and potential transformations in clinical research. They delve into the need for a shift from organ-
Why Diversity in Trials Is Doomed Until We Fix Reimbursement with Sam Whitaker
In this episode of 'Trials with Maya Z', host Maya Z interviews Sam Whitaker from Mural Health, discussing the pressing issue of patient reimbursement in clinical trials. Sam Whitaker is a Founder and CEO of Mural Health, a tech company on a mission to make it easy to participate in clinical research. Mural Health was founded in 2022 as Sam’s effort to evolve the product he invented, the
A Clinical Trials Odyssey with Ross Jackson
In this episode, Maya meets the author of two well-received books. Ross Jackson consults with and advises organizations within the clinical trials industry. He helps them improve patient recruitment and retention.Maya and Ross discuss the following topics:(0:51) What led Ross to write the books on patient recruitment(6:39) Patient recruitment in 1999 vs now(10:06) Doing country localizati
How to Market Clinical Trials to the Right Participants with Colin Sholes
In this episode, Maya meets Colin Sholes. Colin is the founder of Cure Clinical Inc., a US-based software company building a comprehensive database for clinical research performance analysis.Maya and discuss the following topics:(4:29) Why is a direct-to-consumer business similar to patient recruitment(8:06) How to balance the pitch to patients with the site demands(11:23) How to achieve
Tackling Immigrant Bias in Clinical Trials with David Rosenbaum
In this episode, Maya meets David Rosenbaum to talk about immigrants in clinical trials. David helps scatter the immigrant bias with clinical trials in Turkey and other Balkan countries. However, it’s an ongoing administrative effort. David is the Founder of Rosenbaum Group. It is a CRO operating since 2019 in the south-eastern Balkans and Turkey. The organization focuses on clinical tria
How to Improve Integrity in Clinical Research with Leeza Osipenko
In this episode, Maya meets Dr. Leeza Osipenko. She is the founder and the CEO of a non-profit organization Consilium Scientific. It is dedicated to improving the integrity of clinical research.Maya and Leeza discuss the following topics:(2:18) The role of NICE in developing clinical standards(6:23) Why did Leeza start Consilium Scientific(9:35) How to avoid suboptimal clinical trials(19:
The New Generation of Leadership with Andreas Beust
In this episode, Maya meets Andreas, who is a part of the new generation of CRO leaders. He has new ideas and concepts of how to bring better clinical research services to the market and make trials more accessible.Maya and Andreas discuss the following topics:(2:55) Why aren’t more students pursuing careers in clinical trials?(6:35) What does the Association of International CROs do?(10:
How to Make Clinical Trials More Transparent with Till Bruckner
In this episode, Maya meets Till, the founder of TranspariMED. Till is a political scientist by background, now focused on raising awareness about clinical trial transparency. Maya and Till discuss the following topics:(1:19) How to achieve transparency in clinical trials(3:37) Should all trials be fully transparent(5:26) The current state of clinical trial transparency(8:32) Who should e
Leveraging Social Media for Patient Recruitment with Steve Wimmer
In this episode, Maya meets Steve. Steve is the VP of partnerships for 1nHealth. He brings a wide-ranging scope of experience to his role, having worked previously in digital marketing, e-commerce, and education. He is primarily responsible for assessing digital recruitment feasibility and developing external partnerships.Maya and Steve discuss the following topics:(2:00) The common thing
Pioneering Site-Centric Transformation with Raymond Nomizu
In this episode, Maya and Raymond discuss the following topics:(2:09) What’s happening right now with clinical sites(5:23) Should sites choose their own tech stack(8:24) How to build better ePRO workflows(13:06) The 1 way to offer global solutions for sites(16:09) What is the future of sites(23:09) How can clinical trials get more collaborative Tune in today and start expanding your knowl
Clinical Trials From a Patient’s Perspective with Carole Scrafton
In this episode, Maya sits with Carole Scrafton, Director and Co-Founder of a Patient Advocacy Organisation. They deep dive into the following topics:(4:00) How has access to clinical trials altered?(8:36) Do companies approach patients for clinical trials?(11:47) How to assess proposals from small companies?(16:13) Who should be more proactive: doctors or patients?(19:55) Carole’s first
How to Speed Up Clinical Trials with Kimberly Tableman
In this episode, Maya and Kimberly, Founder and CEO of ESPERO, discuss the following topics:(2:20) What does a Head of Digital Clinical Trials do?(4:36) How can we speed up clinical trials?(7:54) Top inefficient trial processes requiring a shift(12:00) The main challenge in clinical trials(15:38) Bridging the gap between companies and patients(20:00) How to improve protocol design(23:51)
Getting Transparent on Clinical Translations with Duncan Shaw
In this episode, Maya and Duncan, president of DTS Language Services, shed light on translations involved in clinical trials. They discuss the following topics:(2:09) The mission and purpose behind informed consent(4:35) How to apply D&I to the informed consent (6:45) What problems arise in translating consent forms(10:37) AI and translations in clinical trials(12:47) Best practices i
How Empathy Impacts the Pediatric Patient Experience with Aaron Horowitz
In this episode, Maya and Aaron Horowitz, CEO & Founder of Empath Labs, dive deeper into the role of empathy in clinical trials. They discuss the following topics:(2:43) Why did Aaron create Emapth Labs?(4:46) How does the teddy bear from Empath Labs work?(8:21) How does Aaron get inspired to create these products?(11:09) How can you engage pediatric patients and understand their expe
How To Use AI To Accelerate Clinical Trials with Jennifer Bittinger
In this episode, Maya and Jennifer discuss the benefits of AI in clinical research and how it can assist medical writers in their day-to-day tasks. They also dive deeper into the cons of AI and the importance of the human-in-the-loop approach.They thoroughly discuss the following topics:(4:01) What does Narrativa do?(6:21) How do people feel about AI entering clinical research?(9:23) Are
Innovation in Clinical Research with Michelle Shogren
In this episode Maya and Michelle Shogren, CEO of Innovate in What You Do? LLC, are discussing the importance of innovation in clinical research. Michelle has been on both sides of clinical trials - as a patient and as part of the operations teams. She has almost 20 years of experience in different roles - caregiver, research coordinator, site and marketing director, CRA, and multiple ro
The Pros and Cons of CTIS with Martin Krauss
In this episode, Maya is discussing the pros and cons of the Clinical Trials Information System (CTIS) with the Managing Director of FGK Clinical Research GmbH, Martin Krauss. By background, he is a trained statistician with more than 25 years of experience in the clinical research industry. They dive deep into the following topics:(1:01) Who is Martin Krauss?(3:34) Has the CTIS improved
The Role of Mental Health Support in Clinical Trials with Esther Howard
In episode 7 Maya is talking to the founder and CEO of Bezyl Inc, Esther Howard. She has more than 20 years of experience in the health economics of developing countries and oncology clinical research operations. Her personal and professional experience inspired her to create her own company where she can focus on the mental health journey of every clinical trial patient. Maya and Esther
What Makes or Breaks a Clinical Trial Event with Alex O’Leary
In this episode, Maya’s guest is Alexander O’Leary, Director of the PBC Group which hosts the Clinical Outsourcing Group (COG) event series with events in the UK, Europe, and the USA. He has close to 14 years of experience in organizing and running clinical research events. Maya and Alex discuss clinical research events both from the perspective of organizers and attendees. They deep dive
Navigating Clinical Trials as a Small Biotech with Toni Perez
In this episode, Maya and Toni Perez discuss the challenges that small biotech companies face on a daily basis. Toni Perez has more than 36 years of experience in the clinical research industry. He has worked with both big and small pharmaceutical companies. Since 2007 he has been working as a consultant to smaller biotech companies with a headcount of 2 to 10.Maya and Toni dive deep into
How To Plan Better Clinical Trials with Dan Sfera
Looking to enhance your knowledge of planning clinical trials? Tune in to this insightful podcast episode with Maya and Dan as they discuss practical ways to plan better clinical trials.Discover the crucial roles that feasibility teams and CRAs play in clinical trials and how their involvement can significantly improve the success of the study. Additionally, learn about the importance of
Challenges and Considerations in Pediatric Clinical Trials with Jacqui Whiteway
In this episode, Maya and Jacqui provide invaluable insights into the unique considerations that go into designing and executing pediatric clinical trials. From navigating ethical concerns to ensuring that children are properly represented in study populations, they cover all the key factors that can make or break a trial. But it's not just about the technical details – Maya and Jacqui al
Clinical Trials During War Times in Ukraine with Yurii Lebid
Maya Zlatanova speaks with the CEO of Pharmaxi LLC, Yurii Lebid. Pharmaxi is a clinical research organization based in Ukraine and operating in the Eastern European market. It was one of the first clinical organizations to restore clinical trials after the war began. Maya and Yurii examine the clinical trial process during the war in Ukraine and the challenges in patient recruitment. They
Recruitment Rates in Clinical Trials with Dana Niedzielska
Maya Zlatanova speaks with the CEO of August Research, Dana Niedzielska. August Research is a clinical research organization based in Europe that provides regulatory, monitoring and project management services for clinical trials. Maya and Dana examine the challenges in patient recruitment and the reliability of recruitment rates. They dive deeper into the planning of clinical trials and
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