A recognized expert within the medical device industry, Chris is highly skilled in biostatistics, scientific communications and regulatory meetings. Chris is experienced with an array of different technologies and therapeutic/diagnostic areas, including cardiovascular disease, gastroenterology, neuromodulation, neurology, oncology, ophthalmology, orthopedics, pain medicine, respiratory/sleep medicine and urology. 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.

Chris holds a Master’s Degree in Biostatistics and a Bachelor’s Degree in Mathematics.

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

PUBLICATIONS

• Powell R et al, “Comparison of Transcatheter Arterialization of Deep Veins to Standard of Care in Patients with No-Option Chronic Limb Threatening Ischemia”, Annals of Vascular Surgery, 99, 50-57.
• Parikh S, et al, “Use of Paclitaxel-Coated Devices for Femoropopliteal Interventional Procedures: The Final Results of an Updated Patient-Level Meta-Analysis of Randomized Controlled Trials, The Lancet, 2023, 402 (10415), 1848-1856
• Azizi M, et al, “Endovascular ultrasound renal denervation to treat hypertension: the RADIANCE II randomized clinical trial”, JAMA, 2023, 329 (8), 651-661.
• Kirtane A, et al, “Patient-Level Pooled Analysis of Ultrasound Renal Denervation in the Sham-Controlled RADIANCE II, RADIANCE-HTN SOLO and RADIANCE-HTN TRIO Trials”, JAMA Cardiology, 2023, 8 (5), 464-473.
• Azizi M, et al, “Effects of Renal Denervation vs Sham in Resistant Hypertension After Medication Escalation: Prespecified Analysis at 6 Months of the RADIANCE-HTN TRIO Randomized Clinical Trial”, JAMA Cardiology, 2023, 7 (12), 1244-1252.
• Guichard et al, “Rationale and Design of the Proactive-HF Trial for Managing Patients With NYHA Class III Heart Failure by Using the Combined Cordella Pulmonary Artery Sensor and the Cordella Heart Failure System”, Journal of Cardiac Failure, 2023, Vol 29, Issue 2, P171-180.
• Rocha-Singh K et al, “Mortality and paclitaxel-coated devices: an individual patient data meta-analysis”, Circulation, 2020, 141 (23), 1859-1869.
• Holmes D, et al “Implanted Monitor Alerting to Reduce Treatment Delay in Patients with Acute Coronary Syndrome Events”, Journal of the American College of Cardiology, 2019, Vol 74, No. 16.
• Azizi M, et al, “Endovascular ultrasound renal denervation to treat hypertension (RADIANCE-HTN SOLO): a multicenter, international, single-blind, randomiszed, sham-controlled trial”, The Lancet, 2018; 9 391(1037):2335-2345.
• Rocha-Singh K, Beckman J, Ansel G, Lyden S, Schneider P, Mehta M, Dake M, et al. “Patient-Level Meta-analysis of 999 Claudicants Undergoing Primary Femoropopliteal Nitinol Stent Implantation”, Catheterization and Cardiovascular Interventions, 2017;89(7):1250-1256.
• Silberstein S, Calhoun A, Grosberg B, Lipton R, Cady R, Goadsby P, Simmons K, Mullin C, Liebler E, Saper J, “Chronic Migraine Headache Prevention With Non-invasive Vagus Nerve Stimulation: The EVENT Study”, Neurology, 2016; 87(5):529-38.
• Brunner K, Bunch J, Mullin C, May H, Bair T, Elliot D, Anderson J, Mahapatra S. “Clinical Predictors of Risk for Atrial Fibrillation: Implications for Diagnosis and Monitoring”, Mayo Clinic Proceedings; 2014, 89(11):1498-1505.
• Westfall M, Krantz S, Mullin C, Kaufman C, “Mechanical Versus Manual Chest Compressions in Out-of-Hospital Cardiac Arrest: A Meta-Analysis”, Critical Care Medicine, 2013; 41 (7): 1782-1789.
• Dorian P, Burk C, Mullin C, Bubien R, Godejohn D, Reynolds M, Lakkireddy D, Wimmer A, Bhandari A, Spertus J, “Interpreting changes in quality of life in atrial fibrillation: How much change is meaningful?”, American Heart Journal, 2013; 166(2):381-387.
• Holmes D, Reddy V, Turi Z, Doshi S, Sievert H, Buchbinder M, Mullin C, Sick P. “Percutaneous Closure of the Left Atrial Appendage Versus Warfarin Therapy for Prevention of Stroke in Patients with Atrial Fibrillation: A Randomised Non-Inferiority Trial”, The Lancet, 2009 August; 374(9689):534-542.
• Bunch T, Day J, Olshansky B, Stolen K, Mullin C. “Newly detected atrial fibrillation in patients with an implantable cardioverter-defibrillator is a strong risk marker of increased mortality”, Heart Rhythm, 2009 January; 6(1):2-8.
• Gilliam F, Singh J, Mullin C, McGuire M, Chase K. “Prognostic Value of Heart Rate Variability Footprint and Standard Deviation of average 5-minute intrinsic R-R intervals for Mortality in Cardiac Resynchronization Therapy Patients”, Journal of Electrocardiology, 2007 40:4, 336-342.
• Visnegarwala F, Raghavan S, Mullin C, Bartsch G, Wang J, Kotler D, Gibert C, Shlay J, Grunfeld C, Carr A, El-Sadr W. “Sex differences in the associations of HIV disease characteristics and body composition in antiretroviral-naive persons”, American Journal of Clinical Nutrition, 2005 82: 850-856.
• MacArthur R, Perez G, Walmsley S, Baxter J, Mullin C, Neaton J. “Comparison of Prognostic Importance of Latest CD4+ Cell Count and HIV RNA Levels in Patients with Advanced HIV Infection on Highly Active Antiretroviral Therapy”, HIV Clinical Trials, Volume 6, Number 3 / May-June 2005.
• El-Sadr W, Mullin C, Carr A, Gibert C, Rappoport C, Visnegarwala F, Grunfeld C, Raghavan S. “Effects of HIV disease on lipid, glucose and insulin levels: results from a large antiretroviral naive cohort”, HIV Medicine, Vol 6, 2005.
• Perez G, MacArthur R , Walmsley S, Baxter J, Mullin C, Neaton J. “A Randomized Clinical Trial Comparing Nelfinavir and Ritonavir in Patients with Advanced HIV Disease (CPCRA 042/CTN 102)”, HIV Clinical Trials, Vol 5, Number 1, January-February 2004.