A recognized expert within the medical device industry, Chris is highly skilled in biostatistics, scientific communications and regulatory meetings. Experienced with an array of different technologies and therapeutic/diagnostic areas, he has participated in over 200 FDA meetings, including more than 25 FDA Advisory Committee (Panel) meetings. Chris has also helped dozens of global manufacturers understand and translate complex ideas and data into simple and convincing concepts, leading to successful regulatory, scientific and business outcomes. He has been instrumental in bringing many novel products to market.

CORE COMPETENCIES

• Clinical trial design and analysis, including adaptive designs and Bayesian methods
• Well-versed in FDA regulations, formal guidance and common/evolving practices and traditions
• Provided instruction in biostatistics and clinical trials for multiple universities and FDA staff
• Co-author of a chapter on statistical methods for translational research
• Member of multiple steering committees/scientific advisory boards
• Serves as a journal editorial board member
• Co-author of numerous peer-reviewed manuscripts
• Provides due diligence for investors and strategic partners
• Experience with IDE, PMA, 510(k) and de novo submissions
• Formally trained in GCP, GLP, 21 CFR Part 11, 58, 312, 812; ISO 14155-2020, ISO 9001 and MEDDEV 2.7.1

RECENT PROJECTS

• Led large meta-analysis of individual patient-level data from multiple manufacturers; findings were incorporated into FDA communications to healthcare providers
• Advised on use of methods for producing valid scientific evidence with non-randomized studies, greatly reducing the time and cost of clinical data requirements
• Helped obtain regulatory approval through use of statistical methodologies to salvage unsuccessful trials
• Strategized with start-up companies leading to funding opportunities and successful acquisitions
• Assisted sponsors responding to CMS concerns, leading to favorable coverage decisions