Note to File: A Clinical Research Podcast – Details, episodes & analysis

Kerri Weingard is a founding partner and global chief operating officer at Verified Clinical Trials (VCT). VCT is the largest global research subject database to reduce dual enrollment and prevent protocol violations. Ms. Weingard is also the CEO and founder of Study Scavenger and Clinical Hero. Both companies are dedicated to clinical trial recruitment and education. Ms. Weingard, who is a nurse practitioner, holds a master’s degree in science from Stony Brook University. She, before creating VCT and Study Scavenger, has conducted over 500 clinical trials as a research administrator and sub-investigator. She has more than two decades of experience in the field and is a member of a number of professional organizations, including the American Society for Clinical Pharmacology and Therapeutics, the Drug Information Association and the Association of Clinical Research Professionals.

Ignacio Handal is the CEO at Clinicom Healthcare. Ignacio has completed a multitude of FDA phase I, II, & III studies in pharmaceuticals, and devices over two decades. In 2022 Ignacio was honored with one of the highest honors in Clinical Research, the Christine Pierre Clinical trials lifetime achievement award of which only 8 clinical researchers globally have ever been awarded.

Early in his career Ignacio, Co-Founded the 5th leading private CNS research site in the US called Harmonex Neuroscience research in 2003 that continues excelling to this day.

Ignacio and his team have used 100% of the profits of their research trials over the last twenty years to develop the world's first online mental health assessment software that can assess anyone remotely for 81 mental health conditions in one virtual adaptive ML assessment. Clinicom has helped patients all over the world find answers on their mental health journey. Clinicom has also helped accelerate enrollment and patient identification for precise inclusion and exclusion criteria in 70 phase II and III studies in the US. The Clinicom mission is to give every patient a voice and to bring equity and access to mental health. Clinicom currently serves patients on 6 continents.

This week we discuss how to improve site selection, the challenges of vendor selection, and how Clinicom was born from a site.

Ignacio Handal on LinkedIn:  https://www.linkedin.com/in/iggyhandal/

Clinicom on the web: www.clinicom.com/overview

Learn more about our sponsor, Veeva Vault: http://sites.veeva.com

Learn more about our sponsor, Inato: https://go.inato.com/41YxjXY

Amy is a leader with experience in clinical trial program operations and regulatory compliance. As a results-driven professional, she has a proven ability to oversee program processes, project management, quality improvement, and timely execution of clinical trials. Knowledgeable in academic and large healthcare settings, as well as public health and private physician practices. Her areas of expertise focus on early phase human pharmaceutical clinical research in the specialties of pediatrics, oncology, neurology, cardiology, infectious disease, dermatology, and diabetes.

This week we discuss the increasing complexity of clinical trials operations, connecting SOPs to processes and the difference between QC and QA.

Dan Otap is a Principal Alliance & Partnerships Lead within Genentech’s Research and Early Development unit (gRED). Dan’s clinical trial operations and compliance background uniquely position him to provide attuned insight into relational site engagement. Dan serves on various internal Roche/Genentech work streams related to clinical trial execution and innovation. He holds positions with the Association of American Cancer Institute (AACI) as well as the Society of Clinical Research Sites (SCRS). Dan has presented at various clinical research conferences and has authored multiple peer reviewed publications spanning clinical trial topics ranging from Community Oncology Practices, to overall site/sponsor relationships.
 
Prior to his arrival at Genentech, Dan established his career in oncology clinical trials at various world-leading institutions. His first position was a Research Study Assistant within the Department of Neurology at Memorial Sloan Kettering Cancer Center (MSKCC). In 2011, Dan was recruited to Columbia University Medical Center to become the Clinical Research Manager within the Department of Neurology, Division of Neuro-Oncology. In 2012, he took on a dual appointment between the CUMC Department of Neurology and the Clinical Research Management Office (CRMO) within the Herbert Irving Comprehensive Cancer Center (HICCC). He was instrumental in the creation of an internal QA/Monitoring Division within the Cancer Center.. He subsequently was appointed as the Associate Director, Regulatory Affairs within HICCC, and oversaw all regulatory submission processes, compliance/monitoring/auditing activities, DSMC/PRMC managers, Multi-Site Operations, and IND Office processes, which assisted clinical investigators with correspondence with the FDA. His last site based position was at City of Hope Comprehensive Cancer Center in Pasadena, CA. where he served as the Executive Director of Community & Affiliate Practices, focusing on development of clinical trial infrastructure across 30+ satellite locations across southern California.

Ethan Seville is a clinical research professional who has worked in a wide range of indications across various roles such as patient recruitment, coordinating, quality assurance, management, and regulatory. Ethan is now the Manger of Customer Engagement and Strategic Solutions for Slope.io, which helps researchers by ensuring their network of clinical trial patients get the exact medical supplies their care requires on time, on schedule and on budget.

In this episode, Ethan interviews me 😳.

Kate is the founder and Chief Executive Officer of Innovative Trials, a global patient recruitment organization. Kate has over 20 years of experience in the pharmaceutical and patient recruitment industry while working in clinical operations and patient recruitment positions. Kate is a vocal advocate for equality, diversity and inclusion in clinical research as well as for meaningful community engagement that puts patients and sites at the heart of the clinical research.

This week we discuss awareness vs education, the challenges of physician referrals and the importance of real community outreach.

Scott Stout has been recognized as one of the top healthcare innovators of 2021.  While working as a professional investor in high-finance, Scott identified a large gap in the clinical trial marketplace and seized the opportunity to build a team of healthcare, high tech, and venture capitalists to turn his concept of expanding clinical trials, “Beyond Clinical Trial Sites,” into a reality.  Prior to founding MedVector, Scott worked with notable companies such as Morgan Stanley and Wells Fargo Private Bank.  His entrepreneurial spirit has driven him to help numerous start-ups develop their market-fit, revenue models, capital raises, and go-to-market strategies.

This week we discuss the problem with physician referrals, how more doctors can get involved with clinical research without becoming investigators and how sites can have a more active role in an ever evolving decentralized environment.

 Jennifer Bonfrisco has spent over 30 years working in R & D for Pharma, CROs, and Academia.   She began her career in preclinical pharm/tox, transitioned to clinical research, and has never looked back. Over the years, some things have changed, but slow patient enrollment and barriers to participation have stayed static.

Trial accessibility was the spark that led Jennifer to create Corlexia Clinical Services. Jennifer spent years finding ways to make trials more patient and doctor-friendly, leading her to create a company dedicated to building customized trial solutions resulting in reaching more medical practices, patients, and families.

Corlexia allows each client to develop a comprehensive cross-functional, patient- and doctor-centric strategy. Identifying the specific needs of patients and doctors creates an early blueprint that results in a more robust, focused clinical development and regulatory roadmap. 

Corlexia partners with organizations to enhance their strategy for clinical development, regulatory affairs, and clinical trial marketing.

In this episode we discuss the importance of community engagement, the need for a human connection all throughout the patient recruitment process, and rethinking physician referrals.

Mitchell Hilbe has been involved in clinical research since high school as he was introduced to the industry at a very young age.  He carved his own path as a paramedic and EMS instructor for several years before jumping back into clinical research around 8 years ago as a CRA.  Mitch is currently working as a Sr. CRA as well as recently co-founding Kenzona Clinical Research earlier this year.  Kenzona is a designed as a scalable SMO using Veeva SiteVault. Mitch also founded the Clinical Research Justice League to advocate for better equality and ethics in the clinical trial community.

This week we discuss the challenges of staffing at the site level, how site focused tech solutions can help site owners better manage their business, the pros and cons of starting a site as a CRA, and CRC/CRA relationship dynamics.

Steve Rosenberg's career in life science and healthcare spans more than 40 years. He has led the development and deployment of cloud-based solutions with a focus on driving more integrated approaches to patient-centric trial management. 

Steve was most recently Senior Vice President and General Manager of Oracle Health Sciences. Prior to that he was the visionary behind the integrated clinical technology suite introduced by Phase Forward which was acquired by Oracle in 2010. Steve joined uMotif’s board earlier this year. 

In his spare time, Steve enjoys summers on Cape Cod with his family. Steve also sits on the board of two residential homes for abused children, and started a non-profit company, The One By One Project with his wife to help people in need in the Boston area. 

This week we discuss the state of ePRO/eCOA, the ever changing patient burden and decentralized clinical trials.