Trials with Maya Z

The Value of Early Access Programs With Naomi Litchfield

Maya Zlatanova — Mon, 23 Mar 2026 18:18:51 +0200

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/

The Power of Innovative Trial Designs with Philip Raeth

Maya Zlatanova — Tue, 18 Mar 2025 13:29:00 +0200

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/

How to get from Sick Care to Health Care and Rethinking Pharma’s Role with Paul Simms

Maya Zlatanova — Fri, 31 Jan 2025 10:00:00 +0200

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.

Patient Engagement and Standard of Care in Rare Disease Trials with Orit Rindner

Maya Zlatanova — Tue, 10 Dec 2024 10:00:00 +0200

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
(00:00) - Introduction to Clinical Research and Patient Advocacy
(02:28) - The Intersection of Patient Advocacy and Clinical Trials
(04:49) - Patient Perspectives on Clinical Trials
(06:47) - Engagement of Patients in Clinical Trial Design
(10:11) - Isolated vs multidisciplinary approach
(12:27) - The Role of Patient Advocates in Clinical Research
(16:12) - Impact of Current Events on Clinical Research in Israel

Endometriosis: Why Standard Care Isn't Cutting It - Exploring the Gaps with Estelle Jobson

Maya Zlatanova — Tue, 26 Nov 2024 10:00:00 +0200

"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
(02:00) - Lack of Funding for Women's Health Research
(05:34) - Challenges in Diagnosing and Treating Endometriosis
(09:23) - Limitations of Current Clinical Trials
(15:57) - The Need for Fresh Perspectives in Endometriosis Research
(25:47) - Including a Wider Range of Patients in Clinical Trials
(30:15) - Addressing the Diverse Symptoms of Endometriosis
(36:29) - Summary and Conclusion

RWD Data and Trust in Clinical Trials: Ritesh Patel’s Take

Maya Zlatanova — Tue, 19 Nov 2024 11:30:00 +0200

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/

The patient journey in US vs EU and how involving patients early on can help with Ella Balasa

Maya Zlatanova — Thu, 14 Nov 2024 14:52:56 +0200

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/

Real-world data: The Good, the Bad and the Ugly with Jan Poleszczuk from CliniNote

Maya Zlatanova — Tue, 29 Oct 2024 11:15:00 +0200

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
(02:58) - The issues with RWD
(06:47) - The Importance of Medical Notes in Real-World Data
(11:34) - Automating Transcription of Doctors' Notes
(17:09) - Empowering Doctors to Generate High-Quality Data
(19:28) - Focusing on Doctors' Jobs to Improve Real-World Data
(21:26) - Conclusion and Future of Real-World Data

Understanding the Patient Journey is Our Duty as Researchers: Esther Howard's Insights from Two Decades in Clinical Research

Maya Zlatanova — Tue, 22 Oct 2024 10:27:52 +0300

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
(03:22) - Understanding the Patient Journey
(11:38) - The Importance of the Patient Journey
(18:42) - Patient Needs and Perception
(22:22) - The Role of Real-World Data
(28:57) - Implications for Clinical Trials

Connecting the Dots in The Patient Journey - The Importance Of Patient Trust with Heidi Floyd

Maya Zlatanova — Tue, 15 Oct 2024 11:00:00 +0300

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 teams. She discusses the common reasons patients may choose to quit clinical trials and the need for greater understanding and support of patient circumstances.

Follow Maya Zlatanova: https://www.linkedin.com/in/mayazlatanova/
Follow Heidi Floyd: https://www.linkedin.com/in/heidi-floyd-b89b179/

(00:00) - Introduction and Heidi's Breast Cancer Journey
(04:06) - Becoming a Patient Advocate
(06:36) - The Importance of Patient Engagement
(10:27) - Addressing Financial and Logistical Barriers
(15:28) - The Role of Technology in Patient Engagement
(19:28) - The Choice for Pregnant Women in Clinical Research

Building the Batman Belt: Leveraging Data and Standard of Care in Trials with Travis Caudill

Maya Zlatanova — Tue, 08 Oct 2024 11:00:00 +0300

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://www.linkedin.com/in/mayazlatanova/
Follow Travis Caudill: https://www.linkedin.com/in/feasibility/

(00:00) - Introduction and Background
(04:34) - The Access to Data and Tools for Analysis
(08:57) - The Focus on Optimizing Clinical Trials
(13:01) - The Impact of Data on Geographical Selection
(15:46) - The Importance of the Patient Journey
(20:07) - Engaging Investigators and Leveraging Data
(21:54) - Predicting Clinical Trial Success
(24:06) - Simplifying Decision-Making
(25:56) - Protocol Variability
(27:55) - The Need for Quick Decision-Making
(31:52) - Building Comprehensive Platforms
(34:42) - Balancing Experience and Protocol
(36:56) - Global Access and Data Penetration

How To Prevent Clinical Trial Nightmares With Ilknur Lechthaler

Maya Zlatanova — Tue, 01 Oct 2024 11:32:00 +0300

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, timelines, and budget constraints.

Follow Maya Zlatanova: https://www.linkedin.com/in/mayazlatanova/
Follow Ilknur Lechthaler: https://www.linkedin.com/in/ilknur-lechthaler/

Mapping the Patient Journey: Roadmap to Successful Trial Design with Todd Georgieff

Maya Zlatanova — Tue, 24 Sep 2024 11:00:00 +0300

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 systems? Todd shares insights on these questions and more.

Follow Maya Zlatanova: https://www.linkedin.com/in/mayazlatanova/
Follow Todd Georgieff: https://www.linkedin.com/in/toddgeorgieff/

(00:00) - Introduction and Background
(03:12) - Understanding the Local Patient Pathway and Standard of Care
(10:54) - Making Clinical Trials More Attractive to Patients
(19:29) - The Implications of Not Considering Standard of Care
(23:37) - Quantifying Patient Burden in Clinical Trials
(28:38) - Feasibility of Quantification Method for Global Trials
(37:47) - The Future of Clinical Trials: Data Interoperability
(41:41) - Predicting the Next Game Changer for Clinical Trials

How Access to Treatments Impacts Trials: From Protocol Development, to Country and Site Selection with Kasia Harris

Maya Zlatanova — Tue, 17 Sep 2024 11:10:00 +0300

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-specific considerations. Kasia highlights how standard of care impacts patient enrollment, country and site selection, and overall trial efficiency. This episode is a must listen for anyone involved in planning or conducting international clinical trials.

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

Follow Kasia Harris: https://www.linkedin.com/in/kasia-harris-md-16316b44/

(00:00) - Introduction and Background
(03:06) - Feasibility Assessment
(06:07) - Importance of Understanding the Local Standard of Care
(10:40) - Impact of Standard of Care on Patient Enrollment
(25:28) - Challenges of Assessing the Standard of Care
(27:09) - Standard of Care in Selecting Comparators and Budget Implications

Viagra's Hard Lessons: Why Understanding the Patient Journey is Non-Negotiable with Annabel de Maria Bosch

Maya Zlatanova — Tue, 10 Sep 2024 12:44:07 +0300

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.com/in/mayazlatanova/
Follow Annabel de Maria Bosch: https://www.linkedin.com/in/annabeldemaria/

Annabel shares some very curious studies in the episode:

1)Stergiopoulos et al., Measuring the Impact of Patient Engagement and Patient Centricity in Clinical Research and Development (2020);

2)Levitan et al., Assessing the Financial Value of Patient Engagement: A Quantitative Approach from CTTI’s Patient Groups and Clinical Trials Project (2018);

3)Getz, Establishing Return-on-Investment Expectations for Patient-Centric Initiatives (2015)

From Carer to Catalyst: Joy Milne's Journey to Revolutionize Parkinson's Research

Maya Zlatanova — Thu, 05 Sep 2024 13:46:00 +0300

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 of the challenges faced by women with the disease.

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

Learn more about Joy Milne and her work:

https://www.nytimes.com/2024/06/14/magazine/parkinsons-smell-disease-detection.html
https://www.npr.org/sections/health-shots/2020/03/23/820274501/her-incredible-sense-of-smell-is-helping-scientists-find-new-ways-to-diagnose-di

(00:00) - Introduction to Joy Milne and her Advocacy Work
(05:40) - Balancing Biotech Work and Caregiving
(06:34) - Challenges in Parkinson's Research and Lack of New Medications
(10:37) - Differences in Parkinson's Disease between Men and Women
(14:18) - Encouraging Early Diagnosis in Parkinson's
(16:56) - Variations in Parkinson's Care across Countries
(18:43) - The Importance of Patient Engagement in Clinical Trials
(21:04) - Challenges in Communication between Researchers and Patient Advocates
(23:34) - The Benefits of a Person-Based Approach in Healthcare
(25:49) - The Implications of Patient Public Involvement in Research
(29:20) - Positive Changes and Future Outlook in Parkinson's Research

The true cost of patient acquisition and the ever-rising site burden with Ted Trafford

Maya Zlatanova — Tue, 03 Sep 2024 11:57:00 +0300

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/mayazlatanova/
Follow Ted Trafford: https://www.linkedin.com/in/tedtrafford/

Check out Ted's post mentioned in the episode: https://www.linkedin.com/posts/tedtrafford_clinical-trial-marathon-activity-7221841156958011392-tb1e

Fail-Proofing Clinical Trials: Lessons in Smart Planning with Angie Schwab

Maya Zlatanova — Mon, 26 Aug 2024 12:51:48 +0300

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 involving all stakeholders - including patients - in study design. They explore how poor initial planning can set trials up for failure and discuss innovative solutions, including the role of automation and AI in streamlining processes and reducing errors. Angie's vision for the future of clinical trials, emphasizing digitalization, standardization, and intelligent study design from the ground up, offers a compelling look at the evolving landscape of clinical research.

Follow Maya Zlatanova: https://www.linkedin.com/in/mayazlatanova/
Follow Angie Schwab: https://www.linkedin.com/in/angie-schwab/

(00:00) - Introduction and Background
(02:42) - The Importance of Thorough Planning
(07:26) - Understanding the Local Standard of Care
(12:38) - Passion for Startup and Problem Solving
(17:44) - The Role of Automation and AI
(22:41) - The Future of Clinical Trial Startup
(25:53) - Moving Towards Digitalization and Standardization

Small Patients, Big Challenges: Obstacles in Paediatric Rare Disease Research with Begonya Nafria

Maya Zlatanova — Thu, 22 Aug 2024 11:56:34 +0300

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 rare diseases have no approved treatment, emphasizing the urgent need for increased research investment and improved access to cross-border clinical trials for children and young patients in Europe . This conversation underscores the importance of meaningful patient engagement in designing better trials and ultimately improving care outcomes for children and young people.

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

Follow Begonya Nafria: https://www.linkedin.com/in/bnafria/

Let’s help Begonya's project on language discrimination in cross-border trials:

If you’re a parent of a child with a rare disease, please collaborate by responding to this survey (available in 22 European languages): https://bit.ly/Survey_Parents_CT

If you’re interested in getting involved as an AMBASSADOR for Begonya’s research project on language discrimination in access to paediatric cross-border clinical trials in Europe, please complete this form: https://bit.ly/CT_Ambassadors

Rethinking The Role of Standard of Care in Clinical Trials With Dan Sfera

Maya Zlatanova — Tue, 20 Aug 2024 12:34:51 +0300

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 design.

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

Follow Dan Sfera: https://www.linkedin.com/in/dansfera

(00:00) - Introduction and Background
(02:17) - Understanding the Patient Journey
(06:01) - Motivations and Expectations of Patients
(10:11) - Building trust with the patient
(11:44) - Clinical Trials as a care option
(19:57) - Implications of Ignoring the Patient Journey

How the Patient Voice Can Help Shape The Perfect Trial Design with Robert Joyce

Maya Zlatanova — Thu, 15 Aug 2024 13:31:57 +0300

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 trial design, the impact of local standard of care on treatment decisions, and the need for improved communication and transparency in healthcare. Robert's insights shed light on the real-world implications of reimbursement rules, access to treatment, and the diversity of patient experiences in clinical trials.

(00:00) - Introduction and Background
(03:43) - The Importance of Including the Patient Voice
(07:31) - Challenges in Accessing Treatment and Standard of Care
(10:47) - Cultural and Systemic Differences in Patient Engagement
(17:26) - Choosing between clinical trial and Standard of care
(22:17) - Choosing Between Established Treatment and Clinical Trials
(25:20) - The Impact of Standard of Care on Clinical Trial Participation
(28:15) - The Need for Transparent Communication and Patient Involvement

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

Follow Robert Joyce:

Facebook: https://www.facebook.com/A30MinuteLife

Twitter: https://twitter.com/A30MinuteLife

Blog: https://www.A30MinuteLife.com

Instagram: https://www.instagram.com/A30MinuteLife/

YouTube: https://www.youtube.com/channel/UC4QT-lK_dIzrHLdqGqatZ_g

LinkedIn: https://www.linkedin.com/in/a30minutelife/

The Importance of Patient Engagement on the Outcomes of Clinical Trials with Dr. Lorna Pender

Maya Zlatanova — Tue, 13 Aug 2024 13:09:31 +0300

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 accessible, tailored programs that optimize the patient journey.

Follow Maya Zlatanova: https://www.linkedin.com/in/mayazlatanova/
Follow Dr. Lorna Pender: https://www.linkedin.com/in/dr-lorna-pender-14a458107/

(00:00) - Introduction to Lorna Pender and Patient Engagement
(02:28) - Incorporating Patient Voices and the Local Standard of Care
(06:27) - Reaching Diverse Patient Populations
(09:46) - The Importance of Understanding the Patient Journey
(12:13) - Patient Engagement: Driving Successful Clinical Programs
(15:18) - Challenges in Patient Access to Treatment

How Germany’s Standard of Care Influences Clinical Trial Participation with Martin Krauss

Maya Zlatanova — Thu, 08 Aug 2024 11:58:11 +0300

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 is that affecting the dynamics of the market? What are the challenges in implementing the Clinical Trial Information System (CTIS) in Europe? How is the new Medical Research Act in Germany going to increase efficiency and benefit patients?

(00:00) - Introduction of Martin Krauss
(01:43) - Challenges and Decline in Investments in Clinical Research
(03:24) - The Challenges and Improvements of the CTIS in Europe
(17:05) - The Impact of the Medical Research Act in Germany
(28:35) - Promoting Clinical Research and Raising Awareness
(33:16) - Making Clinical Trials More Efficient and Cost-Effective

Follow Maya Zlatanova: https://www.linkedin.com/in/mayazlatanova/
Follow Martin Krauss: https://www.linkedin.com/in/martin-krauss-460b489/

Learn more about FGK Clinical Research: https://fgk-cro.com/

What It’s Like to Build a Patient-Friendly Pharmacological Unit with Oren Cohen

Maya Zlatanova — Tue, 06 Aug 2024 15:00:00 +0300

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 unit in Leeds. It’s state of the art as Oren himself describes it. Created with patients in mind, this center is a true example in the industry. Would it resolve the patient recruitment challenge? Has Fortrea paved the way for the future of clinical trials?

Maya and Oren unravel the secret sauce to success and much more in the latest episode. Watch it to learn about:

(0:55) What’s Dr. Oren Cohen’s Professional Experience

(2:37) Why Is Fortrea’s Unit in Leeds So Special

(8:20) How Critical Is the Unit’s Structure to Trials Efficiency

(14:10) Can We Replicate Fortrea’s Success in Leeds Elsewhere

(16:57) Lessons Learned from Building a Patient-Friendly Pharmacological Unit

(22:14) The #1 Thing to Make Trials More Patient-Friendly

Maya Zlatanova, CEO of TrialHub

Dr Oren Cohen, President, Clinical Pharmacology Services and Chief Medical Officer at Fortrea Inc.

(00:55) - What’s Dr. Oren Cohen’s Professional Experience
(02:37) - Why Is Fortrea’s Unit in Leeds So Special
(08:20) - How Critical Is the Unit’s Structure to Trials Efficiency
(14:10) - Can We Replicate Fortrea’s Success in Leeds Elsewhere
(16:57) - Lessons Learned from Building a Patient-Friendly Pharmacological Unit
(22:14) - The #1 Thing to Make Trials More Patient-Friendly

Standard of Care or Clinical Trials: How Do Patients Choose Between Their Options? Conversation with Carole Scrafton

Maya Zlatanova — Wed, 31 Jul 2024 19:03:48 +0300

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: https://www.linkedin.com/in/mayazlatanova/
Follow Carole Scrafton: https://www.linkedin.com/in/fibroflutters-655756108/
Flutters & Stutters: https://www.facebook.com/FibroFlutters https://www.linkedin.com/company/flutters-and-strutters/posts/?feedView=all

(00:00) - Introduction and Importance of Standard of Care
(02:22) - Standard of Care from a patient's perspective
(05:50) - Carole's patient journey
(11:00) - Factors Influencing the Decision to Join a Clinical Trial
(21:49) - Standard of Care Across Countries
(25:47) - The Role of Patient Engagement in Clinical Trial Protocol Development

How to Ensure Data Integrity and Security in Clinical Research with Daniel Schwarz

Maya Zlatanova — Wed, 19 Jun 2024 15:00:00 +0300

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 and discuss the following topics:

(1:04) Get to know Daniel Schwarz

(4:34) What’s the secret sauce to a modern EDC

(6:58) Why companies shouldn’t underestimate data management

(8:58) What are the regulatory expectations in data management

(11:04) The main challenge in starting an EDC from scratch

(17:33) The role of AI in EDC and data management

(19:40) What can make trials more patient-friendly

Follow our LinkedIn page for more insights from the world of clinical trials.

Maya Zlatanova, CEO of TrialHub

Daniel Schwarz, Co-Founder and CIO at the Institute of Biostatistics and Analyses Ltd.

(01:04) - Get to know Daniel Schwarz
(04:34) - What’s the secret sauce to a modern EDC
(06:58) - Why companies shouldn’t underestimate data management
(08:58) - What are the regulatory expectations in data management
(11:04) - The main challenge in starting an EDC from scratch
(17:33) - The role of AI in EDC and data management
(19:40) - What can make trials more patient-friendly

Decentralized Trials After the Hype with Moe Alsumidaie

Maya Zlatanova — Wed, 05 Jun 2024 15:00:00 +0300

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, investors, and industry enthusiasts, aiming to keep them informed about the latest developments in clinical trials.

Maya and Moe delve into the world of clinical trials, discussing decentralized clinical trials, the role of AI, regulatory trends, and patient-centric design. Moe shares insights on how to enhance the success and efficiency of clinical trials, emphasizing innovations like digital twins, digital biomarkers, and the need for trust and collaboration in the field.

(02:42) Meet Moe Alsumidaie

(04:29) Is the Momentum for DCT's Dying

(09:02) Current Trends and Future Outlook of Decentralized Clinical Trials

(14:00) The Role of AI in Clinical Trials

(22:13) How Digital BiomarkersTransform Clinical Trials

(25:35) Examples of Patient-Centric Approaches in Clinical Trials

Follow our LinkedIn page for more insights from the world of clinical trials.

Maya Zlatanova, CEO of TrialHub

Moe Alsumidaie, Chief Editor of The Clinical Trial Vanguard

Must-reads from The Clinical Trial Vanguard

Your Guide to Validate Clinical Trial DHTs

The Future of DCTs

Stanford’s New Leap in Personalized Medicine and Trials

Digital Twins: The Future of Clinical Trials

(02:42) - Meet Moe Alsumidaie
(04:29) - Is the Momentum for DCT's Dying
(09:02) - Current Trends and Future Outlook of Decentralized Clinical Trials
(13:00) - The Role of AI in Clinical Trials
(22:13) - How Digital BiomarkersTransform Clinical Trials
(25:35) - Examples of Patient-Centric Approaches in Clinical Trials

How to Adopt a Beginner’s Mindset in Trials with Leen Kawas

Maya Zlatanova — Wed, 22 May 2024 15:00:00 +0300

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 Washington State, and one of only 22 female founders in the US, to take a company public.

Maya and Leen discuss the critical role of patient-centric clinical trial design and the importance of engaging with patients early in the clinical development process to ensure the success of clinical trials. Leen also talks about the challenges and solutions in making clinical trials more effective, including addressing patient diversity, optimizing the patient experience, and the importance of integrating clinical operation insights into clinical research for better outcomes.

See a breakdown of all the ideas Maya and Leen share:

(01:09) How Leen Kawas got from a Pharmacist to a Biotech Entrepreneur

(02:39) Why a patient-centric approach is crucial for clinical trials

(05:36) Lessons from patient interactions

(19:23) Why site selection and staff retention are essential

(26:33) How to Empower Study Coordinators

(28:17) The way to build strong relationships with sites

(30:21) How to navigate the challenges with CROs

(37:19) How investors evaluate Biotech companies

(40:03) What is the future of clinical trials

Maya Zlatanova, CEO of Trialhub

Leen Kawas, Co-Founder of Propel Bio Partners

See all episodes starring Leen

(01:09) - How Leen Kawas got from a Pharmacist to a Biotech Entrepreneur
(02:39) - Why a patient-centric approach is crucial for clinical trials
(05:36) - Lessons from patient interactions
(19:23) - Why site selection and staff retention are essential
(26:33) - How to Empower Study Coordinators
(28:17) - The way to build strong relationships with sites
(30:21) - How to navigate the challenges with CROs
(37:19) - How investors evaluate Biotech companies
(40:03) - What is the future of clinical trials

The Future of AI-Powered Trials with Stefan Schröder

Maya Zlatanova — Wed, 08 May 2024 15:00:00 +0300

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 and virtual patient simulations that can eliminate the need for placebo patients. Although it may seem contradictory, they believe that technology can make healthcare more human-centered, ultimately helping people recover faster.

Maya and Stefan reveal a vision for the future where AI not only optimizes trials but also strengthens the connection between science and humanity.

(03:58) The broken state of clinical trials

(06:47) AI’s role in bringing a big change in trials

(13:20) Exploring AI solutions

(27:34) What’s the AI integration in Pharma

(32:15) Why empathy is what we need in clinical trials now

Follow our LinkedIn page for more insights from the world of clinical trials.

Maya Zlatanova, CEO of TrialHub

Stefan Schröder, Founder of Enroll With

(00:00) - Intro
(03:58) - The broken state of clinical trials
(06:47) - AI’s role in bringing a big change in trials
(13:20) - Exploring AI solutions
(27:34) - What’s the AI integration in Pharma
(32:15) - Why empathy is what we need in clinical trials now
(00:00) - Chapter 7

The Big Shift in Cancer Treatment with Gretchen Knoll

Maya Zlatanova — Wed, 17 Apr 2024 10:00:00 +0300

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-based cancer treatment to tumor classification, the importance of patient empowerment and education, and the potential of AI and predictive analytics in advancing drug discovery and personalized medicine.

(00:54) Getting to know Gret Knoll

(02:49) Why do we need to shift from organ to receptor-based classification

(07:29) The challenges with using molecular testing at scale

(15:09) What are the challenges and opportunities in clinical trials

(21:20) What is the new role of psychedelics in clinical research

(30:17) The power of predictive analytics and AI in medicine

(32:40) How to empower patients for better trial outcomes

Mentioned in this episode:

Fabrice André: Gretchen references an article by Fabrice André in Nature magazine, discussing his frustrations with current cancer treatment methodologies. "Forget lung, breast or prostate cancer: why tumour naming needs to change”
FindMeCure: Maya mentions FindMeCure, a platform that supports patients in finding clinical trials.
Gustave Roussy Institute: Gretchen notes the Gustave Roussy Institute in France for its work in predictive analytics and new oncology practices.
AlphaFold: Mentioned by Gretchen as a research initiative like Google DeepMind, focusing on protein structures and potentially new treatments, including psychedelics for depression.
PARP Inhibitors: Discussed in the context of drug approvals for various cancers and their use in clinical trials, specifically highlighted by Gretchen.

Maya Zlatanova, CEO of TrialHub

Gretchen Knoll, Président and CEO of Wyvern Quill Consulting

Follow the show on LinkedIn to connect with guests and learn first about new episodes.

(00:54) - Getting to know Gret Knoll
(00:49) - Why do we need to shift from organ to receptor-based classification
(00:29) - The challenges with using molecular testing at scale
(00:09) - What are the challenges and opportunities in clinical trials
(00:20) - What is the new role of psychedelics in clinical research
(00:17) - The power of predictive analytics and AI in medicine
(00:40) - How to empower patients for better trial outcomes

Why Diversity in Trials Is Doomed Until We Fix Reimbursement with Sam Whitaker

Maya Zlatanova — Tue, 02 Apr 2024 10:00:00 +0300

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 ClinCard, when he founded Greenphire in 2008.

Maya and Sam explore how one-third of Americans are excluded from participating in clinical trials due to financial constraints and eligibility for welfare programs. The dialogue highlights the need for the clinical research industry to address financial barriers. Here are the topics Maya and Sam deep dive into:

(01:03) Introducing Sam Whitaker: The Man Behind a Great Mission

(03:01) The Reimbursement Dilemma: How It Affects Patient Diversity in Clinical Trials

(20:30) Exploring Solutions: Legislative Efforts and Centralized Reimbursement Models

(31:15) Empowering Change: How You Can Support and The Ideal World for Clinical Trials

Sign the letter to Congress and support Sam’s mission.

Tune in today for a thrilling journey into the world of clinical trials – expand your knowledge!

Maya Zlatanova, CEO of Trialhub

Sam Whitaker, CEO of Mural Health

See More:

TrialHub

Mural Health

A Clinical Trials Odyssey with Ross Jackson

Maya Zlatanova — Wed, 20 Mar 2024 10:00:00 +0200

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 localization right

(15:26) How to craft a solid patient recruitment strategy

(14:58) Why DCT is the new norm now

(24:11) Why aren’t satellite sites popular enough

(28:02) Do we do clinical assessments right

Tune in today for an odyssey into the world of clinical trials – expand your knowledge!

Maya Zlatanova, CEO of Trialhub

Ross Jackson, The Man Who Wrote the Book(s) on Patient Recruitment

See More:

TrialHub

Patient Recruitment for Clinical Trials Using Facebook Ads

The Patient Recruitment Conundrum

How to Market Clinical Trials to the Right Participants with Colin Sholes

Maya Zlatanova — Thu, 07 Mar 2024 10:00:00 +0200

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 consistency in patient recruitment ads

(14:40) Are sponsors and CROs reacting to clinical sites direct feedback

(16:58) How does Cure Clinical make trials more scalable

(20:50) Do sites need better statistics or better tools

(24:00) The #1 solution to make trials more patient-friendly

Tune in today for a thrilling journey into the world of clinical trials – expand your knowledge!

Maya Zlatanova, CEO of Trialhub

Colin Sholes, Founder of Cure Clinical

See More:

TrialHub

Cure Clinical

Tackling Immigrant Bias in Clinical Trials with David Rosenbaum

Maya Zlatanova — Wed, 21 Feb 2024 10:00:00 +0200

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 trials in CNS, infectious diseases, and gastroenterology. It also supports BIOTECH research and medical devices with a patient-centric approach.

Maya and David discuss the following topics:

(2:30) Immigrant story from a clinical trial in Turkey

(7:12) What makes immigrants vulnerable patients

(9:50) The situation with immigrants and trials in the Balkans

(12:48) Ways to improve communication with authorities

(16:06) Tech portals vs direct communication with regulatory bodies

(19:40) What can ethics committees improve further

(23:02) The #1 thing to make trial patient-friendly

Tune in today for a thrilling journey into clinical trials – expand your knowledge!

Maya Zlatanova, CEO of Trialhub

David Rosenbaum, Clinical Trial Manager @ Rosenbaum Group Ltd.

See More:

TrialHub

Rosenbaum Group Ltd.

How to Improve Integrity in Clinical Research with Leeza Osipenko

Maya Zlatanova — Thu, 08 Feb 2024 10:00:00 +0200

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

(19:02) What are the mechanisms that improve clinical research integrity

(25:30) The ultimate goal of Consilium Scientific

(32:47) What is the biggest challenge in clinical trials at the moment

Tune in today for a thrilling journey into the world of clinical research – expand your knowledge!

Maya Zlatanova, CEO of Trialhub

Leeza Osipenko, CEO of Consilium Scientific

See More:

TrialHub

Consilium Scientific

The New Generation of Leadership with Andreas Beust

Maya Zlatanova — Wed, 24 Jan 2024 10:00:00 +0200

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?

(10:49) How to balance global trial coverage with local support?

(8:32) Should big companies manage local teams as mini-companies?

(18:38) How to face clinical trial challenges as an international company?

(24:43) What’s the future of clinical research organizations?

Tune in today to catch the latest insights and emerging trends in the world of clinical trials.

Maya Zlatanova, CEO of TrialHub

Andreas Beust, CEO of GCP-Service International and

President of AICROS

See More:

TrialHub

GCP-Service International

AICROS

How to Make Clinical Trials More Transparent with Till Bruckner

Maya Zlatanova — Wed, 03 Jan 2024 10:00:00 +0200

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 enforce reporting clinical trial results

(14:58) Who benefits from opacity in clinical trial results

(20:35) How to foster better transparency in trials

(29:54) What makes or breaks clinical trials

Tune in today for a thrilling journey into the world of clinical trials – expand your knowledge!

Maya Zlatanova, CEO of Trialhub

Till Bruckner, Founder of TranspariMED

See More:

TrialHub

TranspariMED

Leveraging Social Media for Patient Recruitment with Steve Wimmer

Maya Zlatanova — Tue, 28 Nov 2023 10:00:00 +0200

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 things between patient recruitment and e-commerce

(4:48) The 3 e-commerce tactics that can be applied to patient recruitment

(11:57) Are iterations of patient recruitment ads expensive

(13:53) The #1 platform for patient recruitment

(19:59) Real-life stories from patient recruitment campaigns

(27:48) What makes or breaks clinical trials

Tune in today and start expanding your knowledge!

Maya Zlatanova, CEO of Trialhub

Steve Wimmer, VP of Partnerships for 1nHealth

See More:

TrialHub

1nHealth

Pioneering Site-Centric Transformation with Raymond Nomizu

Maya Zlatanova — Wed, 18 Oct 2023 10:00:00 +0300

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 knowledge!

Maya Zlatanova, CEO of Trialhub

Raymond Nomizu, Co-Founder of CRIO

See More:

TrialHub

CRIO

Clinical Trials From a Patient’s Perspective with Carole Scrafton

Maya Zlatanova — Wed, 04 Oct 2023 10:00:00 +0300

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 experience with a clinical trial

(24:35) How to accelerate change in clinical trials?

Tune in today and start expanding your knowledge!

Maya Zlatanova, CEO of Trialhub

Carole Scrafton, Director & Co-Founder of Flutters and Strutters

See More:

TrialHub

Flutters and Strutters

How to Speed Up Clinical Trials with Kimberly Tableman

Maya Zlatanova — Fri, 22 Sep 2023 10:00:00 +0300

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) Why the industry is still not ready for AI and ML

Tune in today and start expanding your knowledge!

Maya Zlatanova, CEO of Trialhub

Kimberly Tableman, CEO of ESPERO

See More:

TrialHub

ESPERO

Getting Transparent on Clinical Translations with Duncan Shaw

Maya Zlatanova — Wed, 06 Sep 2023 10:00:00 +0300

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 in clinical research and translations

(15:54) Duncan’s experience from working with sponsors

(21:21) What makes or breaks a clinical trial

Tune in today and start expanding your knowledge!

Maya Zlatanova, CEO of Trialhub

Duncan Shaw, President at DTS Language Services

See More:

TrialHub

DTS Language Services

How Empathy Impacts the Pediatric Patient Experience with Aaron Horowitz

Maya Zlatanova — Wed, 02 Aug 2023 11:00:00 +0300

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 experience?

(14:46) How do companies feel toward the product?

(16:43) At what stage do CROs need the Empath Labs products?

(20:11) What is coming up next at Empath Labs?

Tune in today and start expanding your knowledge!

Maya Zlatanova, CEO of Trialhub

Aaron Horowitz, Founder & CEO at Empath Labs

See More:

TrialHub

Empath Labs

How To Use AI To Accelerate Clinical Trials with Jennifer Bittinger

Maya Zlatanova — Wed, 05 Jul 2023 12:19:05 +0300

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 people embracing the technology or is there technology fatigue?

(13:25) What are the main challenges for AI?

(19:32) Are people’s old habits a barrier to AI entering the life science industry?

(21:58) Are companies ready to start working with AI?

(25:56) Is AI affordable for small to medium-sized companies?

Tune in today and start expanding your knowledge!

Maya Zlatanova, CEO of Trialhub

Jennifer Bittinger, President at Narrativa

See More:

TrialHub

Narrativa

NEJM AI

Innovation in Clinical Research with Michelle Shogren

Maya Zlatanova — Tue, 20 Jun 2023 11:08:51 +0300

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 roles in Pharma. Michelle is now running her own company with the same goal of helping people navigate and improve clinical trials.

They dive deep into the following topics:

(2:51) Top 3 Difficulties in Clinical Trials

(5:23) How do you find innovative and sustainable solutions?

(7:11) How do you integrate new solutions?

(10:01) Incubation period when implementing a new change

(14:09) How do you innovate while running a trial?

(16:14) Common mistakes when integrating new solutions

(18:10) How do you approach innovation in a small company?

(22:19) How do you pitch your solutions in the best way?

Tune in today and start expanding your knowledge!

Maya Zlatanova, CEO of Trialhub

Michelle Shogren, CEO of Innovate in What You Do! LLC

See More:

TrialHub

Innovate in What You Do? LLC

The Pros and Cons of CTIS with Martin Krauss

Maya Zlatanova — Tue, 06 Jun 2023 11:02:07 +0300

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 transparency and centralization in clinical trials?

(5:40) What are the strengths of the CTIS?

(7:19) What are the weaknesses of the CTIS?

(11:12) How does the CTIS help you as a CRO?

(14:17) What is the impact of the CTIS on the sponsors?

(15:38) Do you receive technical support from the CTIS?

(19:19) The UK is outside the CTIS. Is that a plus or a minus for them?

(21:18) Development of clinical trials in Europe vs USA

(24:30) Martin’s recommendations for working with the CTIS

Tune in today and start expanding your knowledge!

Maya Zlatanova, CEO of Trialhub

Martin Krauss, Managing Director of FGK Clinical Research GmbH

See More:

TrialHub

FGK Clinical Research GmbH

The Role of Mental Health Support in Clinical Trials with Esther Howard

Maya Zlatanova — Tue, 23 May 2023 10:53:22 +0300

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 deep dive into the following topics:

(2:23) What is Bezyl Inc.?

(4:16) What is the story of Bezyl Inc.?

(10:36) Given your background, what would you change in clinical trials?

(13:21) What practical advice would you give to address the patient’s and the site’s needs?

(17:13) How can we make sure we consider the patient’s input in the best way possible?

(19:46) What is the site’s role in patient engagement?

(22:00) What is Esther’s project related to diversity in clinical trials?

(27:48) The importance of focusing on the patient’s life and experience

Tune in today and start expanding your knowledge!

Maya Zlatanova, CEO of Trialhub

Esther Howard, SEO of Bezyl Inc.

See More:

TrialHub

Bezyl Inc.

What Makes or Breaks a Clinical Trial Event with Alex O’Leary

Maya Zlatanova — Tue, 09 May 2023 14:09:11 +0300

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 into the biggest challenges and mistakes when planning and executing industry events

Here are the key topics that they discuss:

(2:17) How do you find out what the most important topics for events are?

(3:57) Do events only cover topics on a superficial level?

(5:51) What makes or breaks a clinical trial (event)?

(8:54) Is it possible to create a synergy among the three stakeholders at events?

(13:09) How do you bridge the communication gap between patients and the industry?

(14:15) Why do people choose the attend a certain clinical research event?

(17:27) How do I select the right clinical trial event for my needs?

(19:34) Can events accelerate change in the clinical research industry?

Tune in today and start expanding your knowledge!

Maya Zlatanova, CEO of Trialhub

Alexander O’Leary, Director of PBC Group

See More:

TrialHub

PBC Group

Navigating Clinical Trials as a Small Biotech with Toni Perez

Maya Zlatanova — Wed, 19 Apr 2023 13:33:53 +0300

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 topics of leadership, trust, and teamwork when it comes to doing clinical research. Having the right expertise in your team is crucial for the successful completion of clinical trials.

Here are the key topics that they discuss:

(3:36) What are the top challenges that small biotech companies face?

(5:03) What resources do you need when planning clinical trials as a small biotech?

(7:49) How do you plan a clinical trial without much experience in the industry?

(10:28) What type of professionals do you need in your team?

(12:18) Pros and cons of hiring part-time vs full-time professionals

(15:24) When should you work with a big CRO vs a small CRO?

(20:40) What is Toni’s advice to CEOs without a clinical research background?

Tune in today and start expanding your knowledge!

Maya Zlatanova, CEO of Trialhub

Toni Perez, Founder of Toni Perez Pharma Consulting

See More:

TrialHub

How To Plan Better Clinical Trials with Dan Sfera

Maya Zlatanova — Wed, 05 Apr 2023 09:23:33 +0300

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 diversity in clinical trials and how we can make trials more accessible for a variety of populations. This can lead to better participant engagement and ultimately result in more accurate and reliable data.

Don't miss out on this opportunity to learn practical ways to improve your clinical trial planning.

Tune in now and take the first step toward planning more successful clinical trials!

Here are the key topics that they discuss:

(2:28) How are feasibility teams involved in the planning process

(6:26) Do we need to work more closely with the coordinators?

(8:03) Should sites turn to the CRAs to discuss any issues with the trial?

(11:25) Are any extra endpoints discussed in the preliminary questionnaires?

(13:38) Do these endpoints apply to diversity in clinical trials?

(17:53) How can we shorten the distance between the sites and the decision-makers?

(20:54) What would you change when planning clinical trials?

Tune in to learn more!

Maya Zlatanova, CEO of Trialhub

Dan Sfera, Co-Founder and Site Director at Yuma Clinical Trials

See More:

TrialHub

Yuma Clinical Trials

Challenges and Considerations in Pediatric Clinical Trials with Jacqui Whiteway

Maya Zlatanova — Wed, 22 Mar 2023 14:03:04 +0200

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 also bring a human touch to the conversation. They discuss the impact that clinical trials can have on children and their families and share personal anecdotes that highlight the importance of putting the needs of patients first.

Tune in today and start expanding your knowledge!

Here are the key topics that they discuss:

(3:34) Challenges in planning pediatric clinical trials

(8:30) Are decentralized trials improving pediatric research?

(13:30) What should we change in pediatric trials to make them more successful?

(18:49) Lack of resources and awareness in planning pediatric clinical trials

(22:11) Differences between trials for adults, adolescents, and children

(28:11) Problems in communication in the healthcare industry

(29:06) Helping with anxiety and trauma in clinical trial patients

Tune in to learn more!

Maya Zlatanova, CEO of Trialhub

Jacqui Whiteway, Senior Director & Pediatric Strategy Liaison at ICON plc

Clinical Trials During War Times in Ukraine with Yurii Lebid

Maya Zlatanova — Wed, 08 Mar 2023 14:01:45 +0200

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 dive deeper into success factors in clinical trials, patient and data safety, etc.

Here are the key topics that they discussed:

(2:34) How were clinical trials run prior to the war in Ukraine

(4:09) Factors that make Ukraine an appealing clinical trial destination

(8:45) How the clinical trial landscape changed after the war

(11:16) What factors are relevant to Ukraine’s success today?

(14:45) What are Ukraine’s current challenges in running successful clinical trials?

(17:48) What extra measures are taken to ensure patient and data safety?

(19:34) What was the approval procedure for the first clinical trial after the war started?

Tune in to learn more!

Maya Zlatanova, CEO of Trialhub

Yurii Lebid, CEO of Pharmaxi LLC

Recruitment Rates in Clinical Trials with Dana Niedzielska

Maya Zlatanova — Tue, 21 Feb 2023 11:17:10 +0200

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 the importance of site selection. They also talk about the disparities between the expectations of the clinical investigators and the reality of conducting clinical trials.

Here are the key topics that they discuss:

(2:33) How much can we trust recruitment rates when we plan clinical trials?

(6:53) Disparities between planning and the execution of clinical trials

(8:12) When should you seriously consider recruitment rates?

(11:31) Risk Management application in clinical trials

(13:40) Challenges in site level recruitment

(18:11) The challenge of misleading recruitment rates

Tune in to learn more!

Maya Zlatanova, CEO of Trialhub

Dana Niedzielska, CEO of August Research

See More:

August Resarch

TrialHub