John Mann, Clinical Executive and DCT Operational Strategist

Mr. Mann has 25 years in clinical research all within operations and project management. He has worked in several CROs and in his last CRO position at Vault Health, John focused on the implementation and operationalizing decentralized clinical trials.

Scott Bergeron, Partner | Red Nucleus

Trained as a Clinical Social Worker, Scott has developed a 20 year career in health education and clinical research to help bring access to new treatments to patients. Ranging from rare disease and gene therapies to broader treatments in CNS, Oncology, and Neurology. Scott led a global strategic consulting group to support drug development strategy for regulatory, clinical development and technology and is now helping to bring innovative patient directed technology to capture clinical trial data in decentralized models for Red Nucleus Clinical.

Kristin Faber, Vice President of Clinical Trial Recruitment | Spectrum Science

Kristin is currently the VP of Clinical Trial Recruitment at Spectrum Science, a global health marketing and communications agency. With more than 14 years of experience in the patient recruitment space across a variety of therapeutic areas including cardiovascular, gastrointestinal, diabetes, infectious disease, renal failure, autoimmune disorders, neurology, gynecology, oncology, pediatrics and orthopedics, she currently lives in North Carolina with her husband, three kids, two dogs, two cats, and a bearded dragon.

Scott Bergeron, Partner | Red Nucleus

Trained as a Clinical Social Worker, Scott has developed a 20 year career in health education and clinical research to help bring access to new treatments to patients. Ranging from rare disease and gene therapies to broader treatments in CNS, Oncology, and Neurology. Scott led a global strategic consulting group to support drug development strategy for regulatory, clinical development and technology and is now helping to bring innovative patient directed technology to capture clinical trial data in decentralized models for Red Nucleus Clinical.

Pierre-Frédéric Omnes, Executive Director | TransPerfect

Pierre-Frédéric Omnes is a subject matter expert on global Clinical Trials Regulatory Operations, Study Start up, and EU Clinical Trial Regulation (corporate readiness, implementation, EU Portal, transparency). Pierre has over 20 years of experience in global Clinical Research Organizations and Pharma Companies as Regulatory Affairs consultant. Pierre supported in the last 15 years the coordination, support and oversight of numerous multinational clinical trial applications globally for small molecules, biologics and advanced therapies across several therapeutic areas as well as EU Clinical Trial Regulation (EU CTR) readiness activities. Pierre is chairing the ACRO’s (Association of CROs) EU Scientific and Regulatory Committee and is involved in several representative activities related to the EU Clinical Trial Regulation. Since 2019 Pierre is one of the industry representatives and Sponsors’ Lead Sponsor Product Owners in the EMA New Delivery Model Initiative for the development of the EU Portal (Clinical Trial Information System, CTIS). This EUCTR engagement continues post EU CTR Go Live for continued improvement of CTIS functionalities.

Tim Keutzer, Chief Development Officer | Spero Therapeutics

Tim Keutzer is the Chief Development Officer at Spero Therapeutics. Tim has almost 30 years experience in the pharmaceutical industry, spanning multiple functional and therapeutic areas. Prior to joining Spero, he was Vice President of Program and Portfolio Management at Cubist Pharmaceuticals. While there, he was the program leader for ceftolozane/tazobactam, which progressed rapidly from Phase 1 to Phase 3, and was approved in the US in December of 2014. Prior to that role, he also lead several of Cubist’s in-licensed development programs, and also lead the commercial supply chain for Cubicin. His experience before Cubist spans the drug development continuum across multiple drug classes, and includes preclinical PK/PD and clinical operations at Genetics Institute, as well as global strategic marketing and program management at Wyeth. Tim began his career in contract toxicology labs. Tim studied English and microbiology at the University of Kentucky in Lexington, KY.

Kristin Faber, Vice President of Clinical Trial Recruitment | Spectrum Science

Kristin is currently the VP of Clinical Trial Recruitment at Spectrum Science, a global health marketing and communications agency. With more than 14 years of experience in the patient recruitment space across a variety of therapeutic areas including cardiovascular, gastrointestinal, diabetes, infectious disease, renal failure, autoimmune disorders, neurology, gynecology, oncology, pediatrics and orthopedics, she currently lives in North Carolina with her husband, three kids, two dogs, two cats, and a bearded dragon.

Pierre-Frédéric Omnes, Executive Director | TransPerfect

Pierre-Frédéric Omnes is a subject matter expert on global Clinical Trials Regulatory Operations, Study Start up, and EU Clinical Trial Regulation (corporate readiness, implementation, EU Portal, transparency). Pierre has over 20 years of experience in global Clinical Research Organizations and Pharma Companies as Regulatory Affairs consultant. Pierre supported in the last 15 years the coordination, support and oversight of numerous multinational clinical trial applications globally for small molecules, biologics and advanced therapies across several therapeutic areas as well as EU Clinical Trial Regulation (EU CTR) readiness activities. Pierre is chairing the ACRO’s (Association of CROs) EU Scientific and Regulatory Committee and is involved in several representative activities related to the EU Clinical Trial Regulation. Since 2019 Pierre is one of the industry representatives and Sponsors’ Lead Sponsor Product Owners in the EMA New Delivery Model Initiative for the development of the EU Portal (Clinical Trial Information System, CTIS). This EUCTR engagement continues post EU CTR Go Live for continued improvement of CTIS functionalities.

John Mann, Clinical Executive and DCT Operational Strategist

Mr. Mann has 25 years in clinical research all within operations and project management. He has worked in several CROs and in his last CRO position at Vault Health, John focused on the implementation and operationalizing decentralized clinical trials.

Scott Bergeron, Partner | Red Nucleus

Trained as a Clinical Social Worker, Scott has developed a 20 year career in health education and clinical research to help bring access to new treatments to patients. Ranging from rare disease and gene therapies to broader treatments in CNS, Oncology, and Neurology. Scott led a global strategic consulting group to support drug development strategy for regulatory, clinical development and technology and is now helping to bring innovative patient directed technology to capture clinical trial data in decentralized models for Red Nucleus Clinical.

Adam Samson, Head of Clinical Delivery Operations, RWE Clinical Trials | Walgreens

Adam has conducted clinical trials across multiple therapeutic areas as a coordinator, monitor, project manager, and executive within academia, sites, CROs, pharma, tech, and retail pharmacy. He currently serves as Head of Clinical Delivery Operations at Walgreens, where his primary role is to operationalize existing locations to conduct clinical trials. Adam also serves as adjunct faculty at The George Washington University in the Master’s in Clinical Research Administration program, as well as serving as a core member in the Decentralized Trials & Research Alliance (DTRA) working group to map the participant journey in decentralized clinical trials.