Access to Novel Medical Products with Dr. Alison Bateman-House
Clinical Trial Podcast | Conversations with Clinical Research Experts
Release Date: 11/05/2023
How Clinical Research Hiring Decisions Are Actually Made with Giovanni Lauricella
Clinical Trial Podcast | Conversations with Clinical Research Experts
Why do qualified candidates apply to role after role in clinical research and never hear back? In this episode of the Clinical Trial Podcast, we unpack what’s really happening behind the scenes in the hiring process. Getting hired isn’t just about your technical skills. It’s about how hiring managers assess risk, how recruiters decide who to champion, and who actually gets attention versus who gets ignored. Kunal Sampat is joined by Giovanni Lauricella, Co-Founder and CEO of Lifeblood, an executive search firm specializing in MedTech. With over 15 years of experience placing board...
info_outline
Designing and Conducting Observational Studies with Thomas Newman, MD, MPH
Clinical Trial Podcast | Conversations with Clinical Research Experts
What separates strong clinical research from misleading conclusions? Often, it comes down to study design. In this episode of the Clinical Trial Podcast, Kunal Sampat sits down with Dr. Thomas Newman, Professor of Epidemiology and Biostatistics at UCSF and co-author of Designing Clinical Research, to break down how observational studies actually work. While randomized controlled trials are often considered the gold standard, observational studies are essential in many real-world settings. But they come with challenges including bias, confounding, and misinterpretation that can lead to...
info_outline
Cardiovascular Device Development: From Idea to Reality
Clinical Trial Podcast | Conversations with Clinical Research Experts
Bringing a high-risk cardiovascular device from concept to patient care requires more than innovation - it requires carefully designed clinical trials, strong operational execution, and close collaboration with regulators and physician investigators. In this episode of the Clinical Trial Podcast, Kunal Sampat speaks with Nicole Haratani about how cardiovascular device clinical trials are actually designed and run. Nicole is Vice President of Clinical Affairs at Supira Medical and has spent more than two decades working in medical device clinical research, particularly in cardiovascular...
info_outline
Best Practices for Clinical Trial Budgeting
Clinical Trial Podcast | Conversations with Clinical Research Experts
Clinical trial budgeting remains one of the biggest bottlenecks in study startups, driving delays, rework, and frustration across sponsors, CROs, and research sites. In this episode of the Clinical Trial Podcast, recorded live at Research Revolution, a clinical research conference hosted by Florence Healthcare, we take a hard look at why clinical trial budget negotiations continue to break down—and what experienced operators are doing differently. This conversation brings together sponsor, site, and consultant perspectives to unpack the real drivers of delay, including slow escalation...
info_outline
Risk Based Monitoring in Clinical Trials with Artem Andrianov
Clinical Trial Podcast | Conversations with Clinical Research Experts
Risk-based monitoring has been discussed in clinical research for more than a decade, yet many organizations still struggle to implement it in a meaningful and effective way. In this episode of the Clinical Trial Podcast, we sit down with Dr. Artem Andrianov, a leading expert in clinical data quality and risk-based quality management, to unpack what risk-based monitoring really means in today’s regulatory landscape. Artem has over 25 years of experience in the pharmaceutical industry and is the CEO and cofounder of Cyntegrity a company that specializes in data driven risk management...
info_outline
Leading a Clinical Research Organization in the European Union with Dr. Philip Raeth
Clinical Trial Podcast | Conversations with Clinical Research Experts
In this episode of the Clinical Trial Podcast, host Kunal Sampat sits down with Dr. Philip Räth, Managing Director of Palleos Healthcare, to discuss leading Clinical Research Organization (CRO) in the European Union (EU). Managing a Clinical Research Organization is far more than project oversight. CRO leaders juggle sponsor expectations, site relationships, internal talent, regulatory demands, and profitability. A strong CRO partner can jumpstart a clinical trial for industry or academic sponsors that have limited infrastructure. A mismatched CRO, on the other hand, can derail timelines, add...
info_outline
Sponsor, Site, and Technology Vendor Collaboration with Mike Wenger
Clinical Trial Podcast | Conversations with Clinical Research Experts
To get more insights about clinical research technology from a vendor’s perspective, I invited Mike Wenger on the Clinical Trial Podcast. Mike Wenger is a software developer with over 15 years of experience creating innovative solutions in clinical research. At the Michael J. Fox Foundation for Parkinson’s Research, he worked to connect Parkinson’s patients with clinical studies. He later developed Citeline Connect, bridging patient recruitment companies with pharmaceutical organizations, and founded VersaTrial to streamline clinical trial site workflows. Mike is...
info_outline
Inspection Readiness with Donna Dorozinsky
Clinical Trial Podcast | Conversations with Clinical Research Experts
To discuss what inspection readiness entails, I invited Donna Dorozinsky, Founder & CEO of Just in Time GCP to the show. Donna is a business consultant who has over 30 years of experience in study operations that includes clinical operations, safety, data management, biostatistics, clinical supply management, and TMF management. Her vast experiences dealing with small to large pharmaceutical companies, academic centers, regulatory agencies, clinical research organizations, and investigator sites provides her with the knowledge to assist research...
info_outline
Clinical Trials in Saudi Arabia with Dr. Majed Al Jeraisy
Clinical Trial Podcast | Conversations with Clinical Research Experts
Saudi Arabia’s modern healthcare system, diverse patient population, and research-savvy healthcare professionals make it a great place to conduct clinical trials. To learn more about the clinical trial requirements in Saudi Arabia, I invited Professor Majed Al Jeraisy on the show. Dr. Al Jeraisy is an Associate Professor of Pharmacy Practice, College of Pharmacy, King Saud Ben Abdulaziz University for Health Sciences and Pediatric Clinical Pharmacy Consultant in King Abdullah Specialized Children Hospital. He was appointed as the chairman of the research office at King Abdullah...
info_outline
Cardiology Clinical Trials with Dr. Gregg Stone
Clinical Trial Podcast | Conversations with Clinical Research Experts
To learn more about this important field of cardiovascular clinical research, I invited Dr. Gregg Stone on the podcast. Dr. Stone is an Interventional Cardiologist and Director of Academic Affairs for the Mount Sinai Heart Health System and Professor of Medicine (Cardiology) and Professor of Population Health Sciences and Policy at the Icahn School of Medicine at Mount Sinai in New York, NY. He has served as the national or international principal investigator for more than 150 national and international multicenter randomized trials and studies (many of which have led to new device...
info_outlineProviding patients access to novel medical products can be challenging to navigate for sponsors and trial participants alike.
To learn more about expanded access, compassionate use, Right to Try laws, I invited Dr. Alison Bateman-House, PhD, MPH, MA, an Assistant Professor in the Division of Medical Ethics at NYU Grossman School of Medicine.
Dr. Bateman-House is co-chair of the Working Group on Compassionate Use and Preapproval Access (CUPA), an academic group that studies ethical issues concerning access to investigational medical products and which consists of patient advocates, clinicians, members of industry, current and former FDA staffers, lawyers, and academics, among others.
She advises biopharmaceutical companies, patient advocacy organizations, governmental, and non-governmental entities about clinical trial design and non-trial access programs, and she serves as ethicist for numerous data safety monitoring boards overseeing clinical trials.
She has published and spoken extensively on non-trial access to investigational medical products, equity in clinical trials, individualized therapeutics, the history and ethics of using humans as research subjects, and public health ethics.
Sponsor(s):
This podcast is brought to you by Florence Healthcare. Florence eliminates chaotic workflows in clinical research operations with remote access and digital workflow platforms. More than 12,000 study sites, sponsors, and CROs in 45 countries trust them to accelerate their operations. To learn more, visit https://florencehc.com
This podcast is brought to you by Slope. Slope drives operational excellence for highly complex, sample-intensive, early-phase clinical trials. The platform transforms chaotic clinical trial supply chains into protocol-specific operational workflows for sponsors, CROs, clinical research sites and labs. Learn more at https://www.slopeclinical.com/