Colin Edwards Email & Phone Number

Columbus, Ohio Metropolitan Area

• Member of the Transcatheter Heart Valve (THV) Medical Affairs Scientific Communications team• Proactively prioritize, identify, assess, and critically summarize relevant scientific and medical literature across the THV therapeutic area, including the SAPIEN 3 Ultra and SAPIEN 3 Ultra RESILIA aortic valves and SAPIEN 3 pulmonary valve with Alterra adaptive present• Collaborate with physician investigators and other healthcare professionals in the development of scientific communications content, such as conference proceedings (abstracts and presentations) and manuscripts• Conduct literature reviews to address internal and external THV medical information queries• Collaborate with physician investigators on analysis of Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry and other data and the presentation/publication of the resulting abstracts and manuscripts• Lead the maintenance and continued development of the global scientific content repository• Partner with physician education program to develop content for training slide decks• Participate in conference coverage of select major relevant medical/scientific conferences (Transcatheter Cardiovascular Therapeutics, New York Valves, PCR London Valves, American College of Cardiology, and others) and create summaries

Columbus, Ohio, United States

• Key member of the Clinical and Medical Affairs global Scientific Communications team, crafting manuscripts, abstracts, and presentations. Provide consultation to Clinical Operations, R&D, Regulatory, and Marketing for the following global products:- Anesthesia and Emergency Medicine: hemostatic dressing, intraosseous vascular access device, and freeze-dried plasma- Interventional Cardiology: large-bore vascular closure device- Interventional Urology: prostatic urethral lift system to treat symptoms of benign prostatic hyperplasia• Provide scientific, medical, and clinical review for internal and external projects, including cross-functional partnerships with Sales, Marketing, R&D, Regulatory, and Legal departments. Conduct literature reviews and write case reports and clinical study summaries.• Manage global off-label use response program, training 2,300 employees in the commercial team and in Clinical and Medical Affairs with >95% completion rate. Maintain off-label use response tracking system and re-wrote policy on global off-label use response.

Columbus, Ohio Area

Mentored internal/external investigators and coordinated national system-level research (involving from three to 94 hospitals). Provided consultations and monitored research projects for Trinity Health employees across the system who were planning research activities, including literature review, protocol development, statistical methodology development, budget planning, System Office approval, research contract execution, IRB approval, grant submission, data procurement, and manuscript preparation.Planned, publicized and coordinated research education for Trinity Health research community, including annual national Research Summit, Research Education Series webinars, and research program intranet site resources in order to increase research skills, knowledge, awareness, and networking among Trinity Health employees.Established liaisons with Trinity Health research leaders across the system who were engaged in research activities. Served as primary System Office contact for research leaders from 35 hospitals, providing updates on current research operations and research compliance best practices, as well as communicating changes in federal research regulations.* Provided comprehensive research support to investigators, from initial protocol development to final manuscript preparation, previously unavailable from a single Trinity Health System Office employee.* Organized and conducted national Trinity Health Research Summit, with more than 60 scientific abstract submissions in 2019 and post-Summit participant evaluation indicating that 58% and 26% of participants rated the Summit as “excellent” and “good”, respectively.* Organized January 2019 Research Education Series webinar shortly after starting in position with highest number of participants (n=109) since Research Education Series began in 2016.

Columbus, Ohio Area

Directed research activity at 4 Mount Carmel hospitals and NCI clinical trials at outpatient cancer center. Oversaw department operating budget and clinical research activity across healthcare system, including 175 clinical trials and registries for physician investigators, 90 research and quality improvement projects for resident physicians, fellows, Graduate Medical Education faculty, and IRB oversight of human subject protections for 137 studies. Managed department clinical research involving trials in oncology, cardiac devices, perinatology, neurosciences, orthopedics and family medicine.* Expanded cardiac and vascular device clinical research program from 2 clinical trials and 2 registries in 2012 to 12 clinical trials and 4 registries in 2018. Changed department’s cardiac and vascular study portfolio from primarily registries and post-market approval studies to primarily complex, Phase III trials. Gained recognition for health system at international cardiology conferences and in multiple international journal publications for work on cutting-edge cardiac and vascular clinical research.* Increased research and quality improvement project activity conducted by 120 physicians in Colorectal Surgery, Family Medicine, General Surgery, Internal Medicine, Obstetrics/Gynecology, Orthopedic Surgery, and Transitional Year residency and fellowship programs from 13 projects in 2012 to 73 in 2018.* Negotiated numerous clinical trial agreements and budgets with pharmaceutical and medical device industry sponsors, as well as with investigators at various healthcare systems such as Abbott, Boston Scientific, Edwards Lifesciences, BTG International, GlaxoSmithKline, LivaNova, Medtronic, Brigham & Women’s Hospital, Johns Hopkins University, The Ohio State University, the University of Denver, Nationwide Children’s Hospital, and the University of California, Los Angeles.

Westerville, Oh

Managed and coordinated all clinical research activity, with involvement from initial concept through FDA approval of DirectVision® visually-guided urinary catheter placement system. Coordinated research collaborations with local and national physician investigators and healthcare organizations; conducted literature searches; designed and wrote clinical trial protocols to demonstrate product feasibility and effectiveness; assisted with grant writing; coordinated studies; managed data collection and analysis; and documented results in form of journal manuscripts, conference presentations, posters, and investor reports.* Helped develop algorithm to resolve complex catheterization, resulting in cost savings of $552 per occurrence.* Expanded company’s marketplace via clinical research results demonstrating device feasibility, safety, and effectiveness, as well as to inform and update investors. Research results published in journals and presented at national conferences, allowing for peer review of results and gained national / international audience for innovative medical device.* Assisted with research grant applications, which placed research at forefront of company’s activities and generated needed revenue. Worked with VP, Research and Development to develop collaborations with outside organizations.

Provided strategic leadership to Cancer and Leukemia Group B (CALGB) Cytogenetics Data Management Center, an NCI cooperative group. Oversaw leukemia patient protocol eligibility determination and chemotherapy regimen stratification for 5 national/international Phase II/III clinical trials, based on chromosomal abnormalities, genetic mutations, and cell marker immunophenotyping. Conducted independent research projects in leukemia cytogenetics and molecular oncology, including clinical data collection, statistical analysis, interpreting research results, publishing manuscripts, and delivering presentations.Maintained CALGB approval for 35 cytogenetics laboratories and oversaw 7 national leukemia correlative science committee meetings per year. Prepared laboratory performance, progress, and technical reports; and presentations for physician investigators. Assisted with grant proposal submission. Supervised data managers, data coordinators, administrative assistants, and students.* Tracked patient testing results from The Ohio State University Molecular Pathology Laboratory over 10-year period and observed noticeable number of Acute Myeloid Leukemia (AML) patients with inversion of chromosome 16 (whereby CBFB-MYH11 fusion gene is created) had less common CBFB-MYH11 fusion transcript variants. Analyzed patients with rare fusion transcript variants and found them to lack mutations in KIT proto-oncogene, as well as having distinct clinical and cytogenetic features. Presented research findings at national conferences; published paper in most cited peer-reviewed publication in field of hematology, the journal Blood.* Managed reporting of FLT3 gene mutation molecular analysis results on 1,100 newly-diagnosed AML patients across US. Reported results to treating medical oncologist and data management team within 48 hours, thus allowing patients with FLT3 mutation to be randomly assigned to receive standard chemotherapy in addition to either midostaurin or placebo.

Collected and entered clinical data. Set up data management center at new location, which involved transferring research charts and large database, as well as hiring data management and administrative staff, while supporting physician investigator. Co-authored 2 abstracts and granted co-authorship on manuscript (1999).

Columbus, Oh

Served as Lead Clinical Research Associate for national Prostate Cancer Prevention Trial for main member institution (OSU) and 7 affiliate institutions. Managed local clinical trial activities, including clinical trial patient screening and follow-up, quality assurance activities, and blood and pathology specimen processing.

Ph.D., Public Health / Epidemiology

Doctoral dissertation research: “Exposure to Loud Noise and Risk of Acoustic Neuroma.” Studied risk factors for acoustic neuroma, a benign.

M.S., Preventive Medicine

Master’s thesis: “A Case-Control Study of Risk Indicators for Methicillin-Resistant Staphylococcus aureus (MRSA) in a Medical Intensive.

B.S., Microbiology (Minor In German)