On this episode, Dr. Anke-Peggy Holtorf joins us to help demystify the complex processes of regulatory affairs and health technology assessment (HTA) and explain the crucial role of patients in these processes. Anke acts as Secretary of the Board at Health Technology Assessment international  and is a Steering Committee member and project coordinator for the Patient and Citizen Involvement in HTA Interest Group. She is co-editor of the 2nd edition of the book on Patient Involvement in HTA, which will be published in 2025. Anke has also taught graduate courses in International Health Policy, HTA, and the role of patient involvement. Anke's global experience and depth of knowledge spanning decades shine through as she simplifies some highly technical and complex concepts for our listeners.  Chapters:0:00 - Introductions1:34 - Overview of regulatory affairs and HTA6:48 - The regulatory approval process12:09 - Patient involvement in regulatory affairs22:19 - Overcoming barriers to patient involvement27:32 - Regulatory success rates30:30 - The HTA process32:32 - Differences in healthcare models36:46 - Factors evaluated in HTA43:45 - Patient involvement in HTA54:32 - Advice for patients and stakeholders59:08 - Reflections with Caitlin and ClarindaResources and definitions:HTA - Health Technology Assessment Reimbursement: the process by which healthcare providers are compensated/paid back for the medical services they provide, either by the government or through insuranceOut-of-pocket costs: when patients pay for their own medical costsFDA - US Food and Drug AdministrationEMA - European Medicines AgencyChinese FDA QALY - Quality adjusted life yearsWHO - World Health OrganizationNICE - National Institute for Health and Care Excellence, UKCF Trust - Cystic Fibrosis Trust EUPATI - European Patients' Academy on Therapeutic Innovation EUCAPA - European Capacity Building for Patients Anke's report on Patient Involvement in HTA in Europe - full report and short versionHave feedback or suggestions for us? We'd love to hear from you!Website: notjustpatients.comLinkedIn: Not Just PatientsEmail: info@notjustpatients.com

On this episode, we speak to Mark Duman, Chief Patient Officer at MD Healthcare, about digital health and health data, how digital therapeutics get developed and approved, and how challenges around access and equity can be navigated. Mark is a clinician, management consultant, and patient advocate who works with several healthcare organisations to harness digital health, improve market access, and embed patient engagement in healthcare products and services.Join us for this insightful conversation on a hot and rapidly evolving topic.Chapters0:00 - Introductions1:47 - Mark's story3:46 - Scope of digital health and health data6:11 - Enhancing patient care12:15 - Patient engagement14:44 - Regulations and reimbursement21:59 - Challenges around access and equity28:55 - Development process and patient inclusion37:35 - Data privacy and ethics47:18 - Future of digital health52:57 - Advice for patients/stakeholders56:39 - Reflections with Caitlin and ClarindaResources/abbreviationsCerner system for electronic health recordsQALY – quality-adjusted life yearsWALY – wellbeing-adjusted life yearsSalford Lung StudyPREMS – patient-reported experience measuresPROMS – patient-reported outcomes measures ABPI - Association of the British Pharmaceutical IndustryABHI - Association of British HealthTech IndustriesEUPATI Patient Engagement RoadmapDTA - Digital Therapeutics AllianceDIME – Digital Medicine SocietyNICE – National Institute for Health and Care Excellence, UKSleepioNesta reportCE MarkDTAC – Digital Technology Assessment CriteriaDTS (data security and protection) toolkitScotland’s Patient Experience ProgrammeFlatiron Health Patient Voices PanelGDPR - General Data Protection RegulationInformation Governance ToolkitsHMO - health maintenance organizationZOE StudyLloyd’s Bank Consumer Digital IndexPatient InnovationHave feedback or suggestions for us? We'd love to hear from you!Website: notjustpatients.comLinkedIn: Not Just PatientsEmail: info@notjustpatients.com

On this episode, we speak to Avishek Pal about how patients can better access and contribute to medical publications.In parallel to his day job as Global Medical Director of Cell & Gene Therapy at Novartis, Avishek is affiliated with the Institute for Biomedical Ethics at University of Basel, investigating how medical research information in plain language may improve health literacy and autonomy in patients with chronic diseases.Join us as we discuss how patients seek medical information, the role of generative AI, and initiatives fostering better patient access and involvement in medical literature.Chapters:0:00 - Introductions1:48 - Patients' information-seeking patterns4:38 - Role of health literacy6:21 - Importance of accessing medical literature8:44 - Information overload & reliability15:24 - Plain-language summaries26:43 - Publication bias in medical research30:54 - AI for medical information39:25 - Patients as authors49:53 - Future of medical publications53:15 - Advice for different stakeholders56:44 - Reflections with Caitlin & ClarindaResources and abbreviations:Cochrane LibraryPubmedGoogle ScholarCF - cystic fibrosis Avishek’s landscape analysis paper on plain-language resourcesFuture Science Group, now a part of Taylor & FrancisBecaris PublishingEnvision GroupA&E - accident and emergencyCF Trust - Cystic Fibrosis Trust NHS - National Health Service, UKCDC - US Centres for Disease Control and PreventionNIH - National Institutes of Health, USFDA - US Food & Drug AdministrationEMA - European Medicines Agency Chat-GPTAvishek's paper on ethical considerations for plain-language materialsEUPATI - European Patients’ Academy on Therapeutic InnovationPIF TICKDiscernICMJE (International Committee of Medical Journal Editors) authorship criteriaClarinda’s Patient Perspective paperCoalition SHave feedback or suggestions for us? We'd love to hear from you!Website: notjustpatients.comLinkedIn: Not Just PatientsEmail: info@notjustpatients.com

In this episode, we speak to Dr. Victor Montori about the importance of shared decision-making in healthcare. Dr. Montori is the Robert H. and Susan M. Rewoldt Professor of Medicine at Mayo Clinic. An endocrinologist, health services researcher, and care activist, he is the author of more than 750 peer-reviewed publications and is among the most cited researchers in clinical medicine and in social science. He is a recognized expert in evidence-based medicine, shared decision making, and minimally disruptive medicine. He is also the author of the book Why We Revolt, and is leading a movement, a Patient Revolution, for Careful and Kind Care for all.In our conversation, we discuss the need for patient-centred care that involves and respects individuals as holistic beings, the challenges that inhibit shared decision-making in practice, and the broader societal need to foster self-care and community support. Chapters0:00 - Introductions1:40 - What is shared decision-making?5:30 - Careful and kind care 9:24 - Forms of shared decision-making14:58 - Victor's motivation18:50 - How much time should doctors spend?23:20 - Is shared decision-making for all patients?27:15 - Who is responsible for shared decision-making?31:28 - Where can clinicians learn shared decision-making?35:46 - A Patient Revolution44:25 - Barriers to overcome50:08 - Tackling an insurmountable challenge55:43 - Reflections with Caitlin & ClarindaHave feedback or suggestions for us? We'd love to hear from you!Website: notjustpatients.comLinkedIn: Not Just PatientsEmail: info@notjustpatients.com

On this episode, we talk to Robert Joyce about the critical role of patient involvement in clinical research and the various ways in which patients can bring rich perspectives to the research and development process.Robert has lived with chronic illness all his life, but following a traffic accident in 2014, he was left with debilitating symptoms. No longer able to work, Robert started his blog, a 30 minute life, to share his experiences, and also has a podcast of the same name. In 2019, Robert also became involved in clinical research, eventually earning the title of Embedded Patient Researcher and becoming a co-applicant on the trial of a therapy for Multiple Sclerosis. Unfortunately he was not permitted to continue in this role, but is now an advocate for more patients to be involved in research.Chapters:0:00 - Introductions1:25 - Role of an embedded patient researcher8:10 - Benefits of patient involvement in research15:56 - Different ways patients can be involved in research23:08 - Role of country/disease-specific patient organisations25:08 - Challenges and initiatives for rare diseases27:37 - Initiatives to bring patients closer to research29:10 - Robert's story and personal challenges33:55 - Challenges to patient involvement35:44 - What needs to be done to overcome barriers44:22 - Engaging funders in patient involvement51:30 - Advice for patients looking to get involved53:01 - Advice for stakeholders looking to involve patients55:38 - Reflections with Caitlin and ClarindaHave feedback or suggestions for us? We'd love to hear from you!Website: notjustpatients.comLinkedIn: Not Just PatientsEmail: info@notjustpatients.com

On this episode, we speak with Bronwyn Lewis, Global Head of Patient Engagement at Boehringer Ingelheim. Drawing on her 20+ years of experience across diverse roles in the pharmaceutical industry, Bronwyn offers deep insights into how the industry is perceiving and  responding to the call for deeper patient engagement, the challenges and opportunities for better multi-stakeholder collaboration, and her vision for the future.Note: In the episode, Bronwyn mentions  Boehringer Ingelheim’s Research & Development (R&D) investment data for the year 2022. In 2023, Boehringer Ingelheim’s R&D investments increased by 14.2% to EUR 5.8 billion. R&D investments were substantial, at 22.5% of net sales (source: Boehringer Ingelheim strong growth pipeline acceleration 2023 | Boehringer Ingelheim (boehringer-ingelheim.com)).Chapters00:00 - Introductions01:03 - Defining patient engagement from the industry perspective04:06 - Bronwyn's journey into patient engagement06:51 - The Patient Engagement function at Boehringer Ingelheim10:39 - Composition of Patient Engagement teams in pharma    13:22 - Aligning the motivations of pharma and patient groups16:42 - Barriers to pharma–patient collaboration20:23 - Justifying return on investment (ROI) 26:17 - Patient engagement touchpoints and activities29:16 - Matching best-fit patients to targeted activities 32:21 - Systemic integration of patient insights into all pharma operations 36:25 - Examples of patient insights influencing decisions38:28 - Boehringer Ingelheim's Global Patient Partnership Summit44:26 - Collaboration among industry stakeholders47:56 - Visualizing the future56:14 - Advice for patients and industry stakeholders 58:13 - Reflections with Caitlin and ClarindaResources and abbreviations mentionedBoehringer IngelheimCanadian Pulmonary Fibrosis FoundationIPF - Idiopathic pulmonary fibrosisPFMD - Patient-Focused Medicines DevelopmentEUPATI Connect ROI - Return on investmentHTA - Health Technology Assessment FDA - U.S. Food and Drug Administration EMA - European Medicines AgencyPFMD - Pharmaceuticals and Medical Devices AgencyGPPS - Global Patient Partnership SummitPatient Information ForumThe PIF TICKAtomic Habits by James ClearEUPATI Fundamentals trainingHave feedback or suggestions for us? We'd love to hear from you!Website: notjustpatients.comLinkedIn: Not Just PatientsEmail: info@notjustpatients.com

On this episode, we talk to Tamás Bereczky, PhD, about how patient engagement came to be, how it has evolved over time, and what the future will look like.Living with HIV since 2003, Tamás is a stalwart in patient advocacy, serving on various boards and committees, such as the European AIDS Treatment Group and European Community Advisory Board on HIV. He also conducts and publishes academic research on patient involvement, including in R&D and HTA, and develops and delivers training on patient engagement for EUPATI.Chapters:0:00 - Introductions1:53 - Origins of patient engagement7:13 - Evolution of patient engagement11:27 - Tamás' personal story18:15 - Faces and forms of advocacy22:28 - Landscape-shaping developments and initiatives26:31 - Challenges faced by Tamás and other advocates34:08 - Initiatives looking to overcome challenges38:03 - Need for cooperation across disease areas41:26 - Tamás’ current work49:10 - Expectations and hopes55:08 - Advice for patient advocates and healthcare stakeholders57:16 - Reflections with Caitlin and ClarindaResources and abbreviations mentioned:EUPATI - European Patients’ Academy on Therapeutic InnovationEATG - The European AIDS Treatment GroupEuropean Community Advisory Board ECDC - European Centre for Disease Prevention and ControlEMA - European Medicines AgencyFDA - U.S. Food and Drug Administration EPF - European Patients ForumIAPO - International Alliance of Patients' OrganizationsDeutsche AidshilfeEMIS - The European MSM Internet SurveyCORE - Community Response to End InequalitiesNICE - National Institute for Health and Care Excellence (UK)'Epistemic injustice' as explained by Prof. Havi CarelHave feedback or suggestions for us? We'd love to hear from you!Website: notjustpatients.comLinkedIn: Not Just PatientsEmail: info@notjustpatients.com

In this pilot episode, we introduce ourselves, our ideas and aspirations for the podcast, and what you can expect to get from listening.We are excited to bring this podcast to you and hope you enjoy it! Resources mentioned in the episode:- EUPATI Patient Expert Training ProgrammeHave feedback or suggestions for us? We'd love to hear from you!Website: notjustpatients.comLinkedIn: Not Just PatientsEmail: info@notjustpatients.com