Clinical Trial Podcast | Conversations with Clinical Research Experts

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

In this interview, I had the pleasure of speaking with Stephen Smith. Stephen has several years of project management experience in the healthcare industry. His experience isn’t limited to clinical project management. Stephen has served as senior program management director where was the glue between R&D, marketing, clinical and manufacturing teams for rare disease and oncology drugs. Stephen shares his experience working for top-notch organizations such as Genentech, Gilead Sciences, Audentes Therapeutics and more. Since the time we recorded this interview, Stephen has changed employers. However, our discussion of challenges with clinical trials for rare diseases, the process for career development and importance lifelong learning still holds true. In this interview, Stephen and I discuss why communicating clearly is important and how being humble and calm can make you a super-star. There is a wealth of information on people skills that all of us need to hone and develop in order to accelerate our clinical research career. Please join me in welcoming the all-amazing Stephen Smith to the Clinical Trial Podcast.

In this interview with Dr. Jeffrey Kingsley, we talk about what it takes to start and manage a clinical trial site, the world of site networks, how an investigator can decide whether or not a clinical study is worth their time, volunteering for Association of Clinical Research Professionals (ACRP), Food and Drug Administration (FDA) audits, books and a lot more. Dr. Kingsley is the President and CEO; Institute for the Advancement of Clinical Trials DBA IACT Health and an owner of 11 clinical trial sites. He is a Fellow at Association of Clinical Research Professionals. Dr. Kingsley graduated with a master's in business administration from Emory University, a doctorate in osteopathic medicine from Philadelphia College of Osteopathic Medicine, a master's in science, biochemistry and a bachelor's of science, biology, chemistry, history, cultural anthropology from the University of Scranton. Please join me in this value-packed interview with Dr. Jeffrey Kingsley.

Ryan Jones, CEO and Co-founder of Florence Healthcare, shares his journey from tech to clinical trials, emphasizing the role of innovation in addressing major challenges. He discusses how e-regulatory solutions can streamline workflows and enhance site autonomy. The conversation shifts to the importance of building a strong team in clinical research and strategies for cold calling hiring managers to stand out. Ryan also touches on balancing personal life with professional innovation, providing valuable insights for aspiring entrepreneurs in healthcare.

“Technology makes our lives easier, but it doesn’t replace people” - Melissa “Liss” Easy The dynamic, engaging Melissa “Liss” Easy is the Founder of clinical operations technology provider DrugDev, which is now part of IQVIA. Early in her career Liss was consulting to a Contract Research Organization and became frustrated by inefficiencies in matching investigators to pharma protocols. She started DrugDev to bring sponsors and investigators together by focusing on the needs of the doctors, giving them better technologies and service and more open communication.The DrugDev network Liss began now hosts over 85,000 active investigators in 120 countries in addition to profile and experience information for 450,000+ investigators from 85 pharma and biotech companies. And, DrugDev has expanded to offer a suite of clinical operations solutions used on nearly 2,000 clinical trials.Liss’s honors include being named one of the PharmaVOICE 100 most influential people in life sciences; winning the Partnerships in Clinical Trials Woman of the Year award; and, being named to the a Philadelphia Business Journal Healthcare Innovator.Liss is an extraordinary example of how radical change is creating a new phase in clinical research. I hope you’ll enjoy hearing this extraordinary woman's perspective on how technology can fundamentally change clinical trials and global healthcare for the better.About This Podcast EpisodeListen to it on iTunes.Stream by clicking here.Download as an MP3 by right-clicking here and choosing “save as.” This episode is brought to you by CBI Events CBI has put together an Global Risk Based Monitoring event for clinical research professionals such as yourself. CBIs Global Risk-Based Monitoring event is back for its third year to bring together thought leaders from around the world to benchmark, share best practices, evaluate technologies, overcome operational hurdles and make the most out of RBM. Attend this year’s event to gain best practices in protocol design, receive hands-on demonstrations of new technologies that you cannot learn in an RBM webinar, benchmark face-to-face with peers, develop new strategies in algorithm design and prepare for the future of RBM. Register today and get your $500 off your registration using the promo code CTP500. This is an exclusive offer is only available to the Clinical Trial Podcast listeners. Selected Links from the EpisodeDrugDev Society of Clinical Research Sites Why Isn't Your CRO Using E-Consent? Exl Events Investigator Database Bank connecting investigators with sponsors and CROs LastPass, an amazing password management tool SCRS Summit Books Lean In: Women, Work, and the Will to Lead by Sheryl Sandberg Show Notes: Making new pharmaceutical products available to patients who need them sooner [02:20] Making the leap from advertising and marketing  [03:38] Disney to Drugs [05:10] Working on large deals at a CRO and pulling people together from different departments [06:23] Creating like a LinkedIn for investigators and sponsor companies  [07:24] Moving away from contacting physicians via faxes to contacting them via email [08:26] Is there legal or regulatory reason as to why you can't do this in clinical research? [08:50] Reaching out to people your network, asking people what they want and questioning assumptions  [10:19] Electronic patient consent [11:02] Fostering site and industry collaborations via the Investigator Database Bank [13:52] How to make sites lives easier? [15:09] Process for developing strategic partnerships with other organizations [16:22] Everyone wants experienced investigators, but if no one gives them that first chance [18:09] Advice for start-up founders [20:28] Choosing and attending conference [21:47] What are we doing in the 21st century that we must stop doing right now and get ready to change? [22:52] User experience, doing everything just once, and batching tasks [29:42] Once the site is activated, don’t expect them to magically come up with patients [30:34] Ensuring you have a steady study pipeline as a clinical trial site [32:10] Is joining a site network worth it? [35:48] Getting started with new software technologies and importance of staff training [40:04] If you hire someone to do some work, you have to trust them [42:20] Hiring people [43:57] People underestimate how hard it is to manage people remotely [46:17] Building relationships, genuine relationships and being interested in people [47:43] You should listen to people, whether they be more senior or junior than you [49:46] Being a female, there are some additional challenges that you can have in the workplace [54:00] Subscribing to newsletters and attending conferences [55:22] Advice to her younger self [57:55] QUESTION: What was your favorite lesson from this episode? Leave me a comment below and thanks for listening.

“I enjoy conversations. It takes you somewhere different” - Gabriel D'Amico-Mazza Gabriel is one of the most positive and enthusiastic individuals I know in clinical research. This was one of the main reasons I wanted him to be on this show. He is an expert in business development at a clinical trial site, GCP Research, in Quebec, Canada. Since joining GCP Research in 2010, Gabriel has led recruitment and advertising for Phase 2 and Phase 3 clinical studies. He has been involved in over 40 clinical studies and has been an integral part of the growth of GCP Research. Gabriel graduated from Concordia University with a BSc and a Specialization in Biology. He has also finished a follow-up Graduate Diploma program in Health Care Management from McGill University.Please join me in this fun and insightful conversation with Gabriel D’Amico-MazzaAbout This Podcast Episode 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 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 Show Notes: 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] What was your favorite part of this interview? Let me know in the comments section below.

“We’re at the threshold of an astounding period in medical discovery” - Manuel Prado Manuel Prado is an amazing individual who has founded three companies in the clinical space. He spent much of his youth in Peru and worked in investment banking before transitioning into medical transcription and real-world data.  Manuel and I had an amazing conversation about how we’re missing a lot of eligible patients in clinical trials by only focusing on EMR and claims data and his solution to address issues with clinical data sources. We also talked about life philosophy, clinical resources that can take your career to a different level and the pace of change in the life sciences industry. Hope you enjoy my interview with the all amazing Manuel Prado. About Manuel Prado Spending much of his youth in Lima, Peru, Manuel Prado attended Southern Methodist University before beginning his career in investment banking. When presented with an opportunity to take a year’s sabbatical to travel the globe, he took it, meeting his now-wife in Thailand before returning to his California home. Inspired by his cultural journey, Prado soon founded the first of his three companies, VIVA Transcription Corporation, which developed patent-pending technology that brought the company national brand presence in the field of medical transcription, serving over 7,000 physicians across all 50 states and employing more than 400 people globally.In 2010, Manuel Prado began to transition away from the daily management of VIVA and founded RealHealthData, which provides real-world healthcare insights derived from medical transcription documents. With virtually real-time data coming from over 100,000 physicians across the country from every possible specialty, RealHealthData boasts a client list which includes many of the largest pharmaceutical companies in the world. Prado is also the founder of Adhearx, a company that collects data from automated phone calls to patients, which reveal the true causes of medication non-adherence. About This Podcast Episode 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 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] QUESTION: What was your favorite lesson from this episode? Leave me a comment below and thanks for listening.

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]  

“It is important that you start with the big picture” - Dr. Manfred Stapff This is episode Dr. Manfred Stapff, Chief Medical Officer at TriNetX shares with us the use and application of real-world data in clinical trial. Manfred Stapff is a physician and board-certified clinical pharmacologist with an extensive career in clinical and pharmaceutical medicine. He was formerly an Executive Director at Actavis, Forest Laboratories, and Merck and also served as a Medical Officer in the German Air Force. Manfred earned his MD and Ph.D. from the Ludwig Maximilian University of Munich. In this interview, Manfred shares his personal story as a general physician for pilots to an industry professional in clinical trials. Manfred also has exceptional advice for physicians looking to get into clinical research. To wrap up, we talk about his role as a liaison between medical science and clinical operations.   I hope you enjoy this interview with Dr. Manfred Stapff. 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 Manfred LinkedIn 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] QUESTION: What was most useful for you in this episode? Leave me a comment below and thanks for listening.