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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.

Michael J. Koren, MD, is a practicing cardiologist and Chief Executive Officer at Jacksonville Center for Clinical Research, which conducts clinical trials at 7 locations in Florida. He received his medical degree cum laude at Harvard Medical School and completed his residency in internal medicine and fellowship in cardiology at New York Hospital/Memorial Sloan-Kettering Cancer Center/Cornell Medical Center. He is a fellow of the American College of Cardiology, fellow and two-time president of the Academy of Physicians in Clinical Research, and the regional chapter of the American Heart Association. Dr. Koren has served as an Investigator in over 2,000 trials and as the international lead investigator for many multi-centered trials including ALLIANCE, ROLE, TREAT to TARGET, OSLER, and MENDEL studies. He has written and co-authored over 100 peer-reviewed articles and been published in the most prestigious medical journals. Dr. Koren has also designed a research training course for physicians now in its 20th year. On a personal note, Dr. Koren developed a life-long interest in technology and Public Health during his time at The Massachusetts Institute of Technology and The Harvard School of Public Health. He also loves music. He has written two musical plays.

Gunnar Esiason is a cystic fibrosis and rare disease patient leader, who is passionate about early-stage drug development, patient empowerment and health policy. Professionally, he developed a patient engagement platform for a medical nutrition company, built a venture philanthropy practice at the Boomer Esiason Foundation and was the head coach of his high school alma mater’s varsity hockey team. He has consulted on clinical trial development, a real-world evidence population health study, and a cystic fibrosis-specific mental health and wellness screening tool. Gunnar has been the face of fundraising efforts for the Boomer Esiason Foundation, which has yielded more than $160 million for the fight against cystic fibrosis since he was diagnosed with the condition in 1993. Gunnar holds an M.B.A. from the Tuck School of Business at Dartmouth, an M.P.H. from the Dartmouth Institute for Health Policy & Clinical Practice, and a B.A. from Boston College. He sits on the board of directors at the Boomer Esiason Foundation and No Patient Left Behind. His health policy opinions have been featured in the Wall Street Journal, USA Today, The Hill, and STAT News. He currently leads patient-facing strategy at Florence Healthcare. This week we discuss Gunnar’s experience as a clinical trial participant, decentralized clinical trials, participant reimbursement and so much more.

As CEO of YPrime, Shawn Blackburn provides strategic leadership and direction. Since co-founding YPrime in 2006, Shawn has led the company growth from a two-person consulting firm to a global organization that focuses on evolving technologies to help accelerate development timelines, simplify process complexity, and improve data quality across the clinical development continuum. With a background in systems architecture and information management, Shawn has built a reputation for helping companies discover insights about future opportunities by bringing together siloed information in meaningful context to support strategic decision making. Prior to YPrime, Shawn had a long career as a technology consultant for Cephalon and Parexel. While at Cephalon, he was instrumental in the company’s development of applications to improve clinical trial workflow and provide deeper visibility into clinical trial performance. This week we discuss clinical trial technology, the lack of flexibility of many tech vendors, and decentralized clinical trials.

With over 25 years in the Clinical Research field, Michelle has experienced the clinical trial journey from multiple perspectives: patient, caregiver, site, CRO, and Pharma. She has now launched her own company, Innovate In What You Do! LLC, to bring all these together to help others improve their way of working with the user voice included. As the industry works through the disruptive nature of flexible, device enabled, community focused trials, her years of experience bring value to the multiple players in this ecosystem. Michelle’s greatest passion, beyond adrenaline sports, is customer focused innovation and responding to the voice of patients/participants, sites, and study teams. This week we discuss the complexity of breaking down silos, the downside of sponsors customizing everything, and importance of making your voice heard.

Mike Wenger is a software developer who has been building solutions for clinical research for 15 years. Mike worked at the Michael J. Fox Foundation for Parkinson's research connecting Parkinson's patients to clinical studies, built Citeline Connect to connect patient recruitment companies and pharma companies, and is now the founder and CEO of VersaTrial, a platform that reimagines the clinical trial site workflow. This week we discuss the chaos the clinical trial sites often deal with, how this chaos can impact research participants and how sites can stay better organized with a simple browser extension.

Sylvain Berthelot is the Senior Voice of Customer & Stratefy Director at Calyx, one of the leaders in eClinical and Regulatory technology. In his role, Sylvain aims to transform customer feedback into insights and decisions that will positively impact trial teams, sites and patients. Sylvain has assumed various roles during his 12+ years at Calyx, and he consistently kept his focus on reducing burden for sites and patients. He is the host of the podcast Calyx Café, where industry experts talk about clinical research trends, futurology, and best practices to reliably solve the complex in clinical trials This week we discuss the often underappreciated role of IRT in clinical trials, the concept of “site approved” technology, and the zen of surfing.

Archana Sah is a clinical development thought leader with extensive (30 years) experience and passion for developing medicines for patients having led and contributed to 15 FDA/EMEA drug approvals in Oncology, Immuno-Oncology, Precision Therapeutics, Rare Diseases, Metabolic Diseases and Women's Health. She has held various global positions within biotech and pharma including Genentech/Roche, Bayer Oncology, Johnson & Johnson, ICON, two Oncology biotech start ups and a Digital tech company Medable where she led Oncology TA Solutions. She is now the Founder and CEO of AS Pharma Advisors and provides strategic advisory services to several organizations in clinical development and operations and innovations in digital health technology. She is a recognized leader/change agent passionate about bringing innovation and efficiencies within the entire clinical trial ecosystem as an advisor and speaker. She has been the co-founding chair (2019-2021) and now a member of Society for Clinical Research Sites Oncology Board and chaired the Annual Oncology Summits. She serves on the Leadership Council for Decentralized Trials and Research Alliance and has been a member of the Digital Innovation in Oncology Roundtable with DiMe. She also serves as an Advisor to American Cancer Society Cancer Action Network. She has contributed to the clinical trial sites Standardization and Harmonization with the Forum on Drug Discovery and Development, National Academy of Sciences. This week we discuss the unique challenges of implanting DCT in oncology, the ever-present need for better interoperability, and what the next 5 years of DCT might look like.

Dr. Leigh J. Mack, was clinically trained in trauma and plastic surgery and is boarded as clinical research physician. He has designed many trials in the areas of pulmonary devices, aesthetic medicine (injectables), infectious disease nano-particles, medical lasers and other devices.  He was recently a physician advisor to a 20-hospital healthcare system in utilization review and appeals.  He has designed an automated software system for participant recruitment that employs RPA to search 100,000s of EMR records in a few days time to meet potential participants for clinical trials. In 2021, he left the position of Chief Medical officer for Crucial Data Solutions and started to develop his own clinical trial software that employs RPA, micro-services and block chain type technology. He also severed in the SC State Guard as the G-7 Civil Affairs officer. This week we discuss what protocol development can learn from military planning, using AI to identify clinical trial participants and the role of pharmacogenetics in clinical trials.

David Grew is a practicing radiation oncologist and the founder of PRIMR.  PRIMR creates IRB-ready digital patient education content for clinical trials by pairing board certified physicians with graphic designers and patient advocates.   He practices medicine at a Yale-affiliate cancer center in Hartford, CT.  In this episode we discuss how patient education happens at research sites, how to keep patients engaged through ongoing education, and how video content can improve patient care.

Ardy Arianpour is CEO & Co-Founder of Seqster the leading healthcare technology company that puts the patient at the center of all their health data. He is a visionary health tech executive with 20+ years driving innovation in biotech and digital health. Prior to starting Seqster, Ardy launched several clinical and consumer-based genetic tests as CCO of Pathway Genomics, and served as SVP of Ambry Genetics, which sold to Konica in 2017 for $1 Billion. As a key player in the 2013 landmark SCOTUS decision scrapping gene patents, Ardy played an instrumental role in expanding genetic testing access with the launch of BRCA testing benefiting patients and family members across the country. Ardy received his BS in Biological Sciences from UC Irvine and an MBA from Marshall Goldsmith School of Management. He was a Medical, Marketing, and Media’s (MM&M) Top 40 Healthcare Transformer and San Diego Business Journal 40 under 40. In this episode we discuss health data silos, the history of Seqster, digital front door use cases, and which Metallica album is best.

Andrea Valente spent the past 20+ years building global clinical trial tech organizations and technologies. Recently, Andrea was named CEO of ClinOne, a company that offers a virtual clinical trial platform for patients.  Jennifer Peters had an idea to streamline payments between clinical trial sponsors and investigators, so she co-founded a company called Greenphire in 2008 which was acquired for $1.1 billion in 2021. She is also Board Chair of ClinOne. In this episode we discuss the relationship between patients and sites, the role of protocol design on participant engagement/retention, the technology adoption cycle, empowering patients by empowering sites, platforms vs interoperability, and the value of more women in leadership roles in clinical research.

Brittany Sloan is the Director of Black Research Matters, a safe space exclusively for Black people to learn more about research with the purposes of being becoming better-informed decision-makers thus strengthening the community by using knowledge as a tool to navigate the medical and healthcare systems. This episode is part 2 of a 3 part series on the Tuskegee Syphilis Experiments presented by Brittany.

Dr. Daniel Fox is a translational scientist with over fifteen years of experience in research, business development, and administration. He worked in academia, small startups, global giants, and finally in site administration where he found a particular passion to help physicians to get what they need for optimal research. Dr. Fox is the founder of the Clinical Research Payment Network and an advocate for the site's legal and financial rights In this episode we discuss the biggest budget and contract issues facing clinical research sites, industry fragmentation and how to change the site/sponsor dynamic when it comes to contracting.

  Joe Dustin is Vice President of Product Strategy and General Manager for eCOA and Decentralized trials at Medable.  He is responsible for the go-to-market strategy around Medable’s solutions and is working to define what decentralized trials will become with the professionals who are living it every day. For 20 years, Joe has been in the Clinical Trials Industry at the intersection of Technology, Innovation and Science. He has held a number of roles in IT, Project Management, Solution Consulting, Product Development and Sales at tech companies like Medidata and CRF Health, and most recently was the Head of Clinical Innovation and Change Management at Bristol Myers Squibb. In this episode we discuss decentralized clinical trials (duh), the financial implications for sites, the disconnect between sponsor, vendor and site, the value proposition of site technology, and so much more.

Derk Arts has 15+ years of experience in medicine, research, and technology. He founded his company - Castor to solve the biggest issues in clinical research: a lack of inclusivity, patient focus, and impact of data. Castor enables sponsors worldwide to run patient-centric trials on a unified platform that helps them maximize the impact of research data on patient lives. Derk believes the key to achieving lasting change in the industry is through scalability and standardization. In this episode we discuss the current state of clinical trial technology, standardization of clinical trial data, the unleveraged power of research sites and the future of the CRO industry.

A technologist with over 23 years of industry experience, Raj Indupuri is responsible for establishing the eClinical Solutions vision and future-looking technology strategy. He is deeply passionate about fostering innovation to revolutionize the Life Sciences industry with ground-breaking technologies that will modernize clinical trials and bring treatments to patients faster. As an industry veteran who has been part of the evolution of Life Sciences and clinical data management for over two decades, Raj has an astute business vision to realize the digital future and enable progress and potential with data and analytics at the core of the company’s innovative products and solutions. Raj is responsible for the overall direction and management of the company and is a Mechanical Engineer with an MBA from Boston University who firmly believes data is the new fuel that will drive human progress. In this episode we discuss clintech interoperability, sites leveraging their own technology, data fabric, and the future of clinical trial technology.

Beth Baldys, as inVibe’s Head of Listening, is responsible for helping clients better understand their key stakeholders through deeper and more thorough listening. In addition to bringing patient voice to the forefront, she also works closely with the team to translate research findings into strategic and actionable insights for clients. Beth is a sociolinguist whose graduate research focused primarily on medical discourse analysis, which she continued to pursue throughout her entire career in market research. She brings 10+ years of experience, including past work analyzing doctor-patient communication. Her research has contributed to publications in Pain Medicine and The Journal of Cancer Education, as well as a recent acceptance to the CHEST 2021 Annual Meeting. In this episode we discuss the secret language of clinical trials, how to better communicate with research patients, reducing burden for patients and InVibe’s recent acquitision by THREAD Research.

Brittany Sloan is the Director of Black Research Matters, a safe space exclusively for Black people to learn more about research with the purposes of being becoming better-informed decision-makers thus strengthening the community by using knowledge as a tool to navigate the medical and healthcare systems. This episode is part 1 of a 3 part series on the Tuskegee Syphilis Experiments presented by Brittany.

Joel White is an independent consultant who founded Marketcap Consulting in June 2021 to help organizations, particularly those in the clinical research industry, improve their pricing, profitability, cash flow, and financial operations. Previously, Joel worked for about 15 years across large and small CROs leading various functions in proposals, pricing, finance, and contracting. In this episode we discuss so many site level budget and contract issues including pricing, cash flow and contract negotiations. This episode is packed with value for research sites.