Clinical Trial Podcast | Conversations with Clinical Research Experts

In this interview, I had the honor of speaking with Richard Stubbs, who is the President of the New Zealand Association of Clinical Research. 

Throughout my career, I’ve always been fascinated by clinical trials conducted in the Asia-Pacific region. Richard pulls the curtains for us today and shares with us how easy and valuable it is to conduct clinical trials in New Zealand. 

Richard is a surgeon by training and also the managing director of P3 Research that is composed of three clinical trial sites in the region.

We tackle a variety of topics including the regulatory framework, start-up process, and even the possibility of moving to beautiful New Zealand to learn and practice clinical trial management.

I hope you enjoy this energetic interview with Richard Stubbs. 

[Show Notes]

• A surgeon by training, president of P3 Research, president of New Zealand Association of Clinical Research (NZ-ACR), a national organization
• New Zealand has the first world health system
• Investigator and industry-sponsored research in New Zealand 
• Ethics committee approval process 
• Organization’s mission is the education of clinical research site personnel (research coordinators, nurses, administrators)
• Conference every other year and then more frequent regional meetings
• Access to templates for contracts and indemnity documents, standardized for all sites across New Zealand, similar to MAGI template
• Schedule 6 in the contract allows sponsors to add additional verbiage in the contract
• Political activity encouraging the government to streamline the process for research (ex: New Zealand pavilion at BIO 2019)
• Provisional approved and what it means
• Medical device approval in New Zealand and how it’s different from drug approval
• Regulations in New Zealand for Clinical Research
• Reasons why New Zealand is a great location to conduct clinical research, especially for early phase studies 
• • Intellectual property protection
  • No IND needed
  • Fair budget
  • Quick data
  • Quality data
  • Other regulatory bodies trust the data
• New Zealand is part of the Asia Pacific and Japan (APJ) region
• Site Selection in New Zealand 
• • How to find sites
  • What to consider
• Regulatory approval and site start-up processes in New Zealand
• • Site start-up (gathering essential documents as governed by GCP)
  • A centralized and electronic ethics approval process 
  • Approval of the Ministry of health to allow the importation of the unregistered drug (SCOTT committee that replaces the IND) 
• Role of the ethics committee in participant reimbursement 
• • Payment to patients generally diminishes with the increase in the phase of the study
• Importance of embedding clinical research in clinical care
• Overhead costs at public and private hospitals in New Zealand
• Only make surplus money out of clinical research is the volume
• Thinking of clinical research in terms of value to patients and their staff
• Moving to New Zealand to start a career in clinical research. There is a need for professionals such as doctors and nurses.
• Value systems in New Zeland such as men and women equality 

In this episode, I had the opportunity to speak with Antoinette Frankum, who currently serves as the Vice President/Executive Director of Clinical Research at CROMSOURCE, a global Clinical Research Organization (CRO).

Antoinette has over 20 years’ experience leading teams and managing complex clinical trials in the biopharma and medical device industry.  At CROMSOURCE, she is part of the executive team responsible for the US and international clinical operations. 

Antoinette graduated from University of California, Los Angeles (UCLA), where she received her Bachelor's degree and executive management certificate.

In this interview, Antoinette and I talk about what it takes to be a successful clinical project management professional.

You will learn about effective ways to communicate with senior leadership, how to conduct a brainstorming session, the importance of a “Lessons Learned” document and much more. We wrap up on a very topic of growth versus fixed mindset. 

My advance apologies for the poor sound quality in the first half the interview but the content is still audible (and valuable).

Hope you enjoy this interview with the all amazing Antoinette (Torres) Frankum.

Show Notes:

Antoinette (Torres) Frankum on LinkedIn

• Project Manager versus Program Manager: what is the difference? 
• Technical skill sets needed to become an effective clinical project management professional
• Creating and managing study timelines including tools such as Microsoft Gantt
• Understanding your stakeholders in clinical research
  • Investigators
  • Patients
  • Regulatory authority
• Understanding your stakeholders in clinical research
• Managing patient expectations
• Managing resources and budget
• How to assess clinical trial risks as a CRO?
  • Feasibility 
  • Identify what is going to impact timeline, budget, resources
  • Quality issues
• The right way to conduct a brainstorming session with your team
• Why you should conduct lessons learned during the close-out phase?
• Abundance thinking (growth mindset) versus scarcity thinking (fixed mindset)
• Helping your executive team by problem-solving
• Effective communication strategies with senior leadership
• Sites and CROs are on the same team
• It is okay to make mistakes
• Communication and people skills will help you grow faster
• Asking for feedback and ways to improve as a clinical research professional

Books Mentioned:

Mindset: The New Psychology of Success by Carol S. Dweck

The Gifts of Imperfection: Let Go of Who You Think You're Supposed to Be and Embrace Who You Are by Brené Brown

Rising Strong: How the Ability to Reset Transforms the Way We Live, Love, Parent, and Lead by Brené Brown

In this episode, I had an epic conversation with an amazing human being who has been a force behind my clinical research knowledge and training.

Jessie is a Project Director at Abbott. She has led several important clinical programs including the approval of Abbott’s flagship medical device, the XIENCE V drug-eluting stent in the United States and Japan.

Jessie is a wizard in clinical research processes and can systemize any broken process. She is also a world-class expert in the selection and management of clinical research organizations (CROs).

In this episode, I had an opportunity to speak with Jessie about how to get into clinical research, outsourcing and supplier management, the evolution of the CRA role and much more.

Please join me in welcome Jessie to the Clinical Trial Podcast.

Show Notes:

• Getting into clinical research via technical roles such as data management and biometrics
• What makes a great statistician?
• Experience gained working for a big and small company
• Writing a statistical analysis plan
• Making CRO-Sponsor relationship work and how to succeed with outsourcing
• Getting unstuck - understanding how CROs and sponsors work
• Identifying clinical safety gaps and plugging in a CRO
• Protecting yourself as a sponsor when you outsource safety
• Working with CRO through iterations and why RACI may not work for you
• Outsourcing clinical events committee (CEC) and data safety committee (DMC)
• MEDRA coding: how it works, automation, generic versus specific coding
• Reducing CRO/ outsourcing budget and how to do it?
• Evolution of CRA role - drafting a protocol to writing reports
• Key Performance Indicators (KPIs) for a clinical research organization
• Turnover at a CRO and why it matters
• Financial KPI - money spent relative to the actions that were supposed to happen with that money
• Developing a process mindset - 5 major things that need to happen from beginning to end
• Evaluating employee performance relative to others
• Standing out by managing a chaotic situation, managing senior management discussions, ability to move the conversation along to get to a conclusion, working on “hot” projects that delivered results  
• Volunteer yourself to get involved
• Moving beyond conference calls and emails - pick up the phone and talk to someone
• Clinical research is about working in a field where your work really matters

Karmen Trzupek, MS, CGC, is part of the leadership team at Informed DNA where she is responsible for ocular and rare disease genetics services.

In this phenomenal interview, Karmen shares with us the world of genetic testing and the role it plays in clinical trials.

Karmen is a certified genetic counselor since 2005. She earned her masters in Genetic Counseling from Northwestern University and a bachelor’s in Microbiology from University of Illinois

Prior to joining Informed DNA, Karmen was a genetic counselor and research assistant at Oregon Health & Sciences University.

She has been a board member at the Hear See Hope Foundation and Usher Syndrome Coalition. Karmen is also a member of the National Society of Genetic Counselors, member and author of "NSGC Telegenetics Practice Guidelines" Working Group, member of the Association for Research in Vision and Ophthalmology, member and author of American Academy of Ophthalmology Clinical Working group to develop "Recommendations for the Clinical Assessment of Patients with Inherited Retinal Diseases"

Her work has been published in GeneReviews; Current Opinion in Ophthalmology; Investigative Ophthalmology and Visual Science; Ophthalmic Genetics; Archives of Ophthalmology; and Ophthalmology Clinics of North America.

Please join me in welcoming Karmen on the Clinical Trial Podcast.

Topics discussed with Karmen:

• Evolution of genetic testing from one gene at a time to multiple genes at the same time
• Genetic testing in rare diseases such as inherited retinol diseases
• Cost of genetic testing
• Panel testing where multiple genes are tested at the same time
• How genetic tests are regulated
• Clinical trials in genetic testing and the benefits of genetic testing
• Role of a genetic counselor and how they work with patients, sponsors, patient foundations, and medical providers
• Recruitment challenges for sponsors for finding patients with rare diseases
• Use of telemedicine to expand access for patients
• Difference between genome and exome (whole) sequencing
• When is whole genome/ whole exome sequencing clinically relevant/necessary
• Our biggest challenge is trying to manage the volume of data
• Benign versus pathogenic variation in our genes
• What is Variant Interpretation crisis and Variant of uncertain significance (VUS)?
• Why insurance companies are willing to pay for genetic testing to determine the cause of the disease?
• Test the function of a particular genetic variance to:
• • Identify patients
  • Understand which patients qualify for gene therapy
• Very few drugs are approved for gene therapy for genetic diseases
• Antisense Oligonucleotide (ASO) Therapy
• How gene therapy is augmenting abnormal misfolded version of an amyloid
• RNA interference Therapy
• Precision medicine
• Difference between gene editing and gene therapy
• How does one become a genetic counselor?
• Why did we decide to start with gene therapy for retinal disease?
• Challenges with gene therapy
• Informed DNA team consist of genetic counselors primarily responsible for clinical, policy and consulting work
• Standards for panel testing

In this episode, I share with you strategies and tactical advice on patient recruitment.

Patient recruitment is the foundation of any clinical study.

If your trial doesn’t enroll the minimum number of patients required per protocol, you or your company cannot get the data you need to prove your trial hypothesis, determine product safety and effectiveness.

More importantly, you cannot bring the medical product to the market on time (or possibly never!). This means loss of revenue and profits for the sponsor but more importantly, the patients that need your therapy won’t get it.

In this podcast, I’m going to share with you 4 amazing strategies that will help you with patient recruitment.

If you’re directly involved in a clinical study as a sponsor, CRO or even a site, this episode is a must-listen. If you’re creating a product or service for clinical research professionals, you need to ensure your work ultimately supports patient recruitment.

Hope you enjoy listening to this solo episode by yours truly.

This episode is brought to you by CBI Events.

The team at CBI has put together a Digital Therapeutics event in New York City on December 3-4, 2018. Topics range from strategies for new digital health projects to perspectives from the venture capital community on investment requirements for digital therapeutics.

Whether you’re a pioneer in this space or want to know just the right amount of information to get started, this event is going to value packed for you.

Some benefits from your participation in this event include:

• Learning strategies on how to ensure data integrity
• Understanding regulatory approaches to digital therapeutics and how to seamless approval in all regions
• Finding out about payer approval requirements and uncovering changing business models
• Collaborating with others on standard definitions and approaches to what constitutes a digital therapeutic
• And much, much, more.

If you want to learn and network with others in the Digital Therapeutics space, you should attend the 2018 event in New York City on December 3-4, 2018.

As a listener to this podcast, I’ve got an exclusive $500 discount to this event. When I mean exclusive, it really is exclusive.

So head over to http://www.cbinet.com/digitaltherapeutics and use the code CTP500 at check-out to get your $500 discount.

Register today to get your exclusive $500 off your event ticket using the code CTP500. This offer is only available to the Clinical Trial Podcast listeners.

Our guest on the show is Dr. Lindsay McNair, Chief Medical Officer for the WIRB-Copernicus Group, a central Institutional Review Board (IRB) overseeing more than 200,000 clinical research protocols and more than 2,700 institutions and 700 local Institutional Biosafety Committees.

In her current role, Dr. McNair develops strategic partnerships with pharma/biotech companies for comprehensive ethical and clinical services. She oversees a consulting group which provides consultation on human research protection, ethical trial design, protocol development, development of ethical clinical research policy and practices and much more.

Dr. McNair has more than 15 years of experience in clinical research and drug development strategy. She has designed and provided medical monitoring for Phase 1-4 clinical studies in a variety of therapeutic areas, including multiple oncology indications, hepatitis C, multiple inflammation indications (psoriasis, multiple sclerosis) and other areas.

Dr. McNair is also an adjunct Assistant Professor at Boston University and teaches in the School of Public Health and in the Master’s of Clinical Investigation graduate programs, on the design and conduct of clinical research studies.

She speaks frequently on the ethical conduct of clinical research studies as part of pharmaceutical drug development and improving interactions between ethics committees/ research review boards and the pharmaceutical industry.

Dr. McNair graduated from the University Of Connecticut School Of Medicine and trained in general surgery at Boston University Medical Center. She has a Master’s in Public Health (Biostatistics/Epidemiology and Health Policy), and a Master’s of Science in Bioethics (research ethics).

Please join me in welcoming Dr. Lindsay McNaire on the Clinical Trial Podcast.

This episode is brought to you by CBI Events.

The team at CBI has put together a Digital Therapeutics event in New York City on December 3-4, 2018. Topics range from strategies for new digital health projects to perspectives from the venture capital community on investment requirements for digital therapeutics.

Whether you’re a pioneer in this space or want to know just the right amount of information to get started, this event is going to value packed for you.

Some benefits from your participation in this event include:

• Learning strategies on how to ensure data integrity
• Understanding regulatory approaches to digital therapeutics and how to seamless approval in all regions
• Finding out about payer approval requirements and uncovering changing business models
• Collaborating with others on standard definitions and approaches to what constitutes a digital therapeutic
• And much, much, more.

If you want to learn and network with others in the Digital Therapeutics space, you should attend the 2018 event in New York City on December 3-4, 2018.

As a listener to this podcast, I’ve got an exclusive $500 discount to this event. When I mean exclusive, it really is exclusive.

So head over to http://www.cbinet.com/digitaltherapeutics and use the code CTP500 at check-out to get your $500 discount.

Register today to get your exclusive $500 off your event ticket using the code CTP500. This offer is only available to the Clinical Trial Podcast listeners.

Christina Mack, Ph.D., MSPH is Sr. Director of Epidemiology and Clinical Evidence in the IQVIA Real-World Insights division.

She is a recognized expert in effectiveness studies for medical devices and pharmaceutical products, sports injury research, and pharmacoepidemiology methods including the use of external comparators, propensity scores, instrumental variables, and missing data.  

Her work focuses on the use of electronic health record systems and claims data for research, with a focus in study design methodology, maternal health, orthopedics, oncology, and infectious disease.  

Dr. Mack oversees development of large evidence hubs and novel studies that augment primary data collection with existing data and leads the IQVIA Injury Surveillance and Analytics team which serves as the epidemiologic research arm of the NFL and NBA.

She is an epidemiologist and computer engineer by training, with Ph.D. and master’s degrees from the University of North Carolina at Chapel Hill and an engineering degree from the University of Notre Dame.  

Currently, Dr. Mack holds an academic appointment as Adjunct Assistant Professor of Epidemiology at the University of North Carolina at Chapel Hill and serves on the Advisory Board of the Carolina Health Informatics Program.

Dr. Mack has published manuscripts in leading journals and authored several chapters in the Agency for Healthcare Research and Quality (AHRQ) landmark publication "Registries for Evaluating Patient Outcomes: A User's Guide" on the topics of designing registries for studies of medical devices, selection of data elements for observational research, missing data, and research networks.  

She is a speaker at regulatory, governmental, and academic forums on epidemiologic methods and novel study designs as well as careers in research.

Last but not the least, she has over fifteen years of scientific and technical experience working for Johnson & Johnson, GlaxoSmithKline, IBM, and the World Health Organization in addition to her work at IQVIA. Her regulatory experience includes advising the FDA, most recently as faculty at the 2017 MDEpiNet Annual Meeting and at the FDA Cardiac Research Safety Consortium discussing novel research methods and use of electronic medical records for outcomes trials.  

Please join me in welcoming Dr. Mack on the Clinical Trial Podcast.

Resources and organizations mentioned in this episode:

IQVIA

Food and Drug Administration (FDA)

Pubmed

ClinicalTrials.Gov

Norwegian Mother and Child Cohort Study (MoBa)

Global Fund

Clinton Foundation

World Health Organization and HIV

IBM

Johnson and Johnson

Organization of Eastern Caribbean Islands

Outcomes Sciences

MIT

Harvard School of Public Health

University of Lusaka

Quintiles

Healthcare Business Women's Association

Agency for Healthcare Research and Quality (AHRQ) landmark publication “Registries for Evaluating Patient Outcomes: A User’s Guide” on the topics of designing registries for studies of medical devices, selection of data elements for observational research, missing data, and research networks

American College of Cardiology

National Cancer Institute

FDA's Sentinel Initiative

NBA

NFL

MDEpinet

University of North Carolina Chapel Hill

New York Times

People mentioned in this episode:

Manuel Prado

Dr. Nancy Dreyer

Dr. Mark Travis

Rob Cahill

Technology makes our lives easier, but it doesn't replace people.

• Connect with Gabriel D'Amico-Mazza on LinkedIn
• GCP Research
• Facebook Blueprint
• Health Canada
• Vantage Biotrials
• Clinical Research Association of Canada
• Association of Clinical Research Professionals
• Society of Clinical Research Associates

• Business development for clinical trials [01:06]
• Recruiting participants, why people want to be in clinical trials [02:36]
• The composition of a small site in clinical research [11:05]
• Process for building relationships with a network of doctors and specialists [13:20]
• Three things that motivate physicians  [16:50]
• How doctors get paid in a hospital setting [20:04]
• Average bill rate for a general practitioner in Canada [21:16]
• Gabriel's journey from college to clinical research [24:02]
• Working with Quebec sites if you are a sponsor or CRO personnel from another country [28:00]
• Social media marketing to recruit trial patients [32:00]
• Key Performance Indicators (KPIs) at GCP Research [45:20]
• How to get feedback to improve clinical trial conduct [52:05]
• Attending clinical research conference [56:28]
• Email vs. calling people and why picking up the phone makes a difference [59:55]

About Manuel Prado

About This Podcast Episode

Selected Links from the Episode

• Connect with Manuel Prado on LinkedIn
• The Center for Information and Study on Clinical Research Participation  (CISCRP)
• The New England Journal of Medicine
• Kevin Kelly & The Inevitable
• Brene Brown
• 750 Words
• 5 Minute Journal
• Fierce Pharma
• Fierce CRO
• Fierce Biotech
• Fierce Medtech
• Center Watch
• Modern Medicine
• PM360
• Pharmaceutical Executive
• Real Health Data
• Adhearx

Show Notes:

• Manuel’s journey into clinical research [01:48]
• Medical transcription and the problem RealHealthData is trying to solve [05:34]
• Analyzing claims and EMR data and how it’s impacting recruitment in clinical trials [08:57]
• What physicians are looking at when making referrals to specialists  [10:54]How clinical data companies can engage with sponsors [19:00]
• FDA and real-world data [27:52]
• Impact of real-world data on clinical roles [30:09]
• The pace of change in life science industry [35:52]
• Why you should consider journaling [43:17]
• Sabbatical and surfing [48:17]
• Passion and life philosophy  [53:17]
• Where is reliable data coming from and what clinical researchers should focus on [55:29]
• Morning routine, staying focused and not getting distracted  [59:17]
• Making mistakes and not failure [1:00:52]
• Two issues with data sources: Timeliness of data and data on female and minority participants [1:07:00]

In this interview, Norm and I dig deep into the business of clinical research. You’ll hear us talking about what it takes to run a clinical trial site, the importance of clinical research training and certifications, negotiation strategies, remote monitoring, challenges of being a research coordinator, our love for Ben Franklin and much, much more.

Hope you enjoy my interview with the all amazing Norman Goldfarb.

About Norman Goldfarb

Norman Goldfarb is a seasoned executive and leading authority on clinical research best practices. He has authored or presented hundreds of articles and talks on clinical research. He is Managing Director of First Clinical Research, Editor of the Journal of Clinical Research Best Practices, and Chairman of MAGI.

Show Notes:

• Norm’s transition from high tech to clinical research via his work on a patient recruitment software [01:53]
• Why clinical research site business is a hard business [04:28]
• The career path of site principal investigators [06:20]
• Advice for recent graduates in the field of medicine  [10:30]
• Challenges of being a study coordinator and how to overcome them [12:15]
• Pros and cons of remote monitoring [15:45]
• Importance of standardization in research [20:03]
• Model Clinical Trial Agreement Template [23:35]
• Resources of study coordinators negotiating clinical trial agreements [24:55]
• Ben Franklin [28:01]
• On writing controversial articles in clinical research  [29:45]
• Certification in clinical research and does it matter [31:01]
• On negotiation  [36:04]
• Two-year requirement for taking certification exams and what matters most in clinical research [40:25]
• High road marketing [49:31]
• Philosopher's Stone [53:29]
• Why should someone be in clinical research in the first place? [56:57]

Selected Links from the Episode:

• Connect with Manfred

• Lancet
• Drug Information Association (DIA)
• Association of Clinical Research Professionals (ACRP)
• Food and Drug Administration (FDA)
• Journal of Clinical Hypertension
• American Heart Association (AHA)
• New England Journal of Medicine (NJEM)
• TriNetX
• Merck
• Good Clinical Practice
• ICH

Show Notes:

• About TriNetX [02:15]
• The changing landscape in protocol design [04:16]
• How TriNetX is helping scientist and health care organizations [06:57]
• What types of people are companies like TriNetX hiring [10:54]
• Transitioning from general physician for pilots to Merck [13:32]
• Advice for medical school students and graduates interested in clinical research [18:12]
• Working at CROs - what to expect [23:27]
• Why patient enrollment is challenging [25:29]
• Why should sites consider being part of networks such as TriNetX [28:11]
• How clinical (medical) and industry can be advantageous to you [31:08]
• Importance of doing the “dirty work” in clinical research [32:46]
• Importance of doing the “dirty work” in clinical research [32:46]
• Being open to other people’s opinions [36:30]
• Dealing with tension between science and clinical operations [28:43]
• Keeping yourself informed about new clinical treatments and scientific findings [46:41]

Selected Links from the Episode

• Connect with Robin

• TVT Conference
• TCT MD
• FDA Resources
  • Drugs
  • Medical Devices
  • Biologics
• Gray Sheet
• Cardiac Interventions Today
• Graphics Design: 99Designs

Show Notes:

• Transitioning from R&D engineering to clinical research [02:39]
• Leading clinical safety and working independently [10:50]
• What it takes to switch roles [13:41]
• Finding mentors within clinical organization [16:08]
• Creativity in clinical research [19:01]
• Importance of marketing and messaging in clinical research [23:19]
• Tips and insights for CROs responsible for creating newsletters [29:18]
• How to get credibility among your peers, industry, understanding why something is important in the grand scheme of things [35:25]
• Attending conferences [37:27]

“Don’t be afraid to try new things” - James Hasegawa This is a special episode in Health Economics and Outcomes Research (HEOR) with James Hasegawa. James is a director at Abbott and is responsible for HEOR projects. In this episode, James shares insights on how healthcare reimbursement works as it related to clinical trials. We also dig into the world of Health Technology Assessment (HTA) groups and what it takes to model reimbursement for a medical product. If you’re interested in breaking from the silos of clinical research and learn about important adjacent functions such as HEOR, this episode is for you. Do you have a topic idea for my next podcast episode? If so, leave me your suggestion is the comments section below. Listen to it on iTunes.Stream by clicking here.Download as an MP3 by right-clicking here and choosing “save as.”

Selected Links from the Episode

• Connect with James

LinkedIn

• Medicare
• International Society for Pharmacoeconomics and Outcomes Research (IPSOR)
• BIO conference
• Stanford Biodesign Program
• Centre for Health Economics at University of York
• The National Institute for Health and Care Excellence (NICE)
• What is a MAC?
• Hospital Readmissions Reduction Program

Books Mentioned:

• Leading at Mach 2 by Steve Sullivan
• Good to Great by Jim Collins
• The Tipping Point: How Little Things Can Make a Big Difference by Malcolm Gladwell
• Biodesign: The Process of Innovating Medical Technologies by Paul G. Yock and Stefanos Zenios
• Methods for the Economic Evaluation of Health Care Programmes (Oxford Medical Publications) by Michael F. Drummond,‎ Mark J. Sculpher,‎ Karl Claxton,‎ Greg L. Stoddart,‎ George W. Torrance

Show Notes:

• What is Health Economics [01:52]
• James’s personal story: career path to HEOR [06:09]
• Daily routine of HEOR professionals [13:26]
• NICE and other HTA [14:30]
• HTA in the United States [15:15]
• HTA vs. MAC [16:30]
• The future of HEOR [18:59]
• Hospital Readmissions Reduction Program (HRRP) [19:58]
• Economic value and what should a medical product start-up do? [24:17]
• How to find HEOR consultants [25:00]
• Qualities of HEOR people [28:06]
• Health economic model: how to make one? [28:57]
• Working with Medicare Administrative Contractor (MAC) [31:38]
• The future of HEOR (continued) [33:20]
• On Big Data [34:57]
• Leveraging HEOR data in countries such as US and Japan [36:52]
• How does HTA function in the US [38:26]
• Resources and guidance documents on HTAs [40:23]
• HTA review process in Japan [43:30]
• Trick to learning other therapeutic areas [47:55]

What was most useful for you in this episode? Leave me a comment below and thanks for listening.