Episódios
-
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.
(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
Follow Maya Zlatanova: https://www.linkedin.com/in/mayazlatanova/
Follow Todd Georgieff: https://www.linkedin.com/in/toddgeorgieff/ -
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 -
Estão a faltar episódios?
-
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)
-
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/
https://www.nytimes.com/2024/06/14/magazine/parkinsons-smell-disease-detection.htmlhttps://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
Learn more about Joy Milne and her work: -
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
-
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/
(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
Follow Angie Schwab: https://www.linkedin.com/in/angie-schwab/ -
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
-
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 -
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/
-
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/
(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
Follow Dr. Lorna Pender: https://www.linkedin.com/in/dr-lorna-pender-14a458107/ -
Meet Martin Krauss - the CEO of FGK 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-EffectiveFollow Maya Zlatanova: https://www.linkedin.com/in/mayazlatanova/
Follow Martin Krauss: https://www.linkedin.com/in/martin-krauss-460b489/ -
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
-
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/
(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
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 -
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 -
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
-
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
-
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 -
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
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.
Mentioned in this episode: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 -
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
-
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
- Mostrar mais
