Paul A. LaBrec

Customer-focused Biostatistics & Programming Director with over 15 years of experience in the clinical research and pharmaceutical industry. Expertise in managing clinical trials (phases I, II, III, and IV) and conducting research in Academic Medical and Population Health settings. Skilled in sponsor relationship management, project operational and financial management, business development, and leadership and development of biostatisticians and programmers. Proficient in implementing biostatistics functions, including study protocols, SAP, dataset and Table, Listing, Figure (TLF) development using CDISC and ICH guidelines. Experienced in ensuring quality validation across North America, Asia Pacific, and Europe. Proven track record of leading Biostatistics and Programming teams in Functional Service Partnership (FSP) and fee-for-service models. Actively involved in process improvement initiatives and representing teams through presentations and panel participation at industry conferences and meetings. Holds a Bachelor's degree in Anthropology and a Master's degree in Epidemiology from the University of Arizona.

• Successfully grew FSP relationships and optimized efficiency
• Supported multiple successful BLA and NDA submissions
• Mentored multiple associates to become leaders

Recent Experience

• A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of XXX Treatment Compared to Sham Control in Subjects with Primary Indeterminate Lesions or Small Choroidal Melanoma
• XXX for the Treatment of Newly Diagnosed H3 K27M-mutant Diffuse Glioma Following Completion of Radiotherapy: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Multicenter Study
• A Phase 1/2 First-in-Human Study of XXX, a H1047X Mutation-specific PI3Kα Inhibitor as Monotherapy and in Combination with Other Antineoplastic Agents in Advanced Solid Tumor Patients
• A Phase 1/2 First-in-Human Study of XXX in non-small cell lung cancer harboring EGFR exon 20 insertion mutations
• A Phase 1/2 Dose Escalation/Expansion Study of XXX as Monotherapy and in Combination with Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies
• A Phase 1, Open-Label, Dose Escalation and Expansion Study of XXX in Patients with Advanced Solid Tumors
• A Phase 1/2 Study of XXX in Participants with Locally Advanced or Metastatic Solid Tumors
• A Phase 1 Study to Evaluate the Safety and Tolerability of a Combination Autologous CD19 CAR T Cell Therapy (XXX + XXX) in Subjects With Relapsed or Refractory CD19+ Hematologic Malignancies
• A Phase 1/2 Dose Escalation and Expansion Study of XXX for the Treatment of Adults with Moderately Severe or Severe Hemophilia B
• A multicenter, double-blind, randomized, placebo-controlled Phase 3 cancer prevention trial of selenium supplementation as protective of non-melanoma skin cancer

• CDISC Methodology
• ICH Guidelines
• Response Assessment in Neuro-Oncology (RANO)
• Audit Experience
• SAS

Publications:

· Wasson J.H., Soloway L., Moore L.G., LaBrec P.A., Ho L. (2017). “Development of Care Guidance Index Based on What Matters to Patients.” Qual Life Res 11.

· Soloway L.E., Moore L.G., Herzig A., LaBrec P.A.  2016.  The Utility of a Health Risk Assessment in a Midwest Medicaid population.  Abstracts. Am. J. Hum. Biol., 28: 267–302. doi: 10.1002/ajhb.22831

Presentations:

· LaBrec P.A. “Linking Healthcare Claims and Electronic Health Records (EHR) for Patient Management – Diabetes Case Study.” Presentation at Pharmaceutical Industry SAS User’s Group One Day Conference. San Diego CA. October, 2016. [same paper presented at PharmaSUG 2014]

· LaBrec P.A. “Social Networks Aren’t just for Kids’: Social network analysis can inform network service areas.” Presentation in the Research Track, 3M Value-Based Care Conference: Data, Decisions, and Driving Results. Chicago, IL. September, 2016.

· LaBrec P.A. “Health Care’s ‘One-Percenters’: Hot-Spotting to Identify Areas of Need and Opportunity.” Presentation in the Healthcare section, SAS Global Forum. Las Vegas, NV. April, 2016.

· DePesquo M.A, Gorrell P., Wansink D., Nelson G., LaBrec P.A. “Health are Transparency: Will It Work?” Panel presentation in the Healthcare section, SAS Global Forum. Dallas, TX. April, 2015.

· LaBrec P.A. “All Payer Claims Databases (APCD) in Data Transparency and Quality Improvement.” Presentation in the Healthcare section, SAS Global Forum. Dallas, TX. April, 2015.

· LaBrec P.A. “Linking Healthcare Claims and Electronic Health Records (EHR) for Patient Management – Diabetes Case Study.” Presentation in the Healthcare Analytics section,

· Pharmaceutical Industry SAS User’s Group Conference. San Diego CA. June, 2014. [awarded ‘Best Paper’ in Healthcare Analytics section]

· LaBrec P.A. “Using Data to Optimize Network Performance.” Health Insurance Exchange Summit West. Los Angeles, CA. November 6, 2013.

· LaBrec P.A. “The Manager’s Skillset: How to Move from Programmer to Manager.” PharmaSUG 2010 Conference Proceedings. May, 2010.

· LaBrec P.A and Golder, D. “Issues in Managing a Large (20+) Programming Group” Paper in Management Section of PharmaSUG 2006, Bonita Springs, FL. June, 2006.

· Walker D.R., Wetzel, J.C, Atkinson, S.R., McKinney, B.K., LaBrec, P.A. “Chronic Disease and Hospital Utilization: Focus on Diabetes and Asthma.” Poster Presentation at the 2000 Annual American Health Services Research Meetings, Los Angeles, CA. 2000.

· LaBrec P.A., Clark, L.C., Walsh, B.T., Giuliano, A., de Zapien, J.G., Meister, J.S., Lash, S., Reid, M.E. "Design for a Study of a Reported Cluster of Cancer and Lupus in Santa Cruz County, Arizona." Presentation at the Workshop on Health and Hazardous Waste Issues Related to the U.S.-Mexico Border. August 27-29, 1994, 1999.

• SDTM001: An Introduction to the Study Data Tabulation Module, CDISC, 03/01/21
• Trained in CDISC Essentials, CA Occidental Consultants, 01/01/08
• Numerous leadership training programs, Ongoing
• Project management training (incl. traditional and agile methodologies), Ongoing
• Software training in SAS, SQL, R, and Python, Ongoing