Allen C.

Global Regulatory Affairs Biosurgery / Wound Closure & Healing • Led regulatory strategy and execution for new Biosurgery medical device (Class III in US). Spearheaded cross-functional team discussions to proactively identify and reduce regulatory risks, plan evidence generation, and engage Health Authorities (HAs) for early alignment. • Successfully obtained HA alignment on critical topics, leading to improved product development certainty and streamlined evidence generation pathway. • Managed global regulatory strategy and implementation for biologic-led combination product’s indication expansion into 10+ geographies. Led J&J submission writing for Category 1 application to Australia Therapeutic Goods Administration (TGA), leading to approval with non-traditional data sources. • Oversaw negotiation with Health Authorities (HAs) in 2 global jurisdictions, securing approvals of major variation of biologic-led combination product. • Provided strategic regulatory guidance and consultation (over 30 consultations) to business units across J&J MedTech, improving regulatory outcomes and elevating staff regulatory agility. • Supported Lifecycle Management to enable continued and expanded patient access of Biosurgery products (US Class III). Proposed creative solutions and coordinated execution to resolve challenging regulatory situations, leading to expedited US and EU approvals. • Mentored and guided RA staff with US/EU change assessments, regulatory strategy, and implementation. • Directed J&J MedTech PMA Community of Practice (CoP) to elevate J&J expertise in FDA PMA submissions (and associated lead-up activities). Recognized for expanding reach from 4 to 8 J&J businesses (2x expansion) and increasing engagement in the community. • Drove process improvements and enhanced staff regulatory knowledge through presentations, 1:1s, and tool development. • Global RA Innovation Award Finalist, Recipient of 20 Inspire Awards (recognition for impact on projects / colleagues).

Office of Strategic Partnerships and Technology Innovation (OST) Patient Science and Engagement (PSE) -- now known as the Division of Patient-Centered Development (DPCD) GS-14 (of 15) • Led growth of CDRH’s Patient Science and Engagement (PSE) Program (now known as the Division of Patient-Centered Development). • Managed research portfolio, budget, operations, and special projects (e.g., FDA guidance development, reviewer / manufacturer education) • Launched over $10 Million in research projects to advance the science of patient input (e.g., patient-reported outcomes (PROs), patient preference) in areas ranging from peripheral artery disease to adolescent scoliosis. • Guided development of new FDA programs (e.g., TPLC Advisory Program, Patient Science Focal Point Program), enhancements to FDA reviewer tools/templates, and implementation planning for MDUFA V (Medical Device User Fee Amendments of 2022). • Co-directed 30-member team developing review policy and processes, engaging international stakeholders, and reviewing over 1000 Emergency Use Authorization (EUA) applications, leading to timely availability of imported respirators. • Led outreach with over 20 manufacturers and suppliers (C-suite) to assess and address supply chain constraints. Successfully averted manufacturing disruption for high-impact COVID care products. • Spearheaded hands-on digital health bootcamps, impacting innovators from over 200 companies.

Office of Strategic Partnerships and Technology Innovation (OST) Patient Science and Engagement Program (PSE) -- now known as the Division of Patient-Centered Development (DPCD) GS-15 (of 15) • Supervised team of clinical outcome assessments (COAs), patient preference information (PPI), and patient engagement experts advancing policy / science and providing consultations to FDA review teams and industry. • Provided supervisory concurrence review on Consults to OPEQ review teams and advised staff on challenging submission reviews. • Developed staff, improved team cohesion, and prepared program for growth with 100% retention. • Kept CDRH Center Director apprised of internal and external developments via biweekly briefing. • Led successful rollout of 2 FDA guidance documents and webinars, fostered 5 new research and patient engagement collaborations, and supported implementation of 3 patient engagement efforts.

Office of Product Evaluation and Quality (OPEQ) Office of Health Technology 3 (OHT3) Division of Health Technology 3A (Renal, Gastrointestinal, Obesity and Transplant Devices) • Led teams of clinical / scientific experts in the review of over 150 FDA medical device submissions, including: Investigational Device Exemptions (IDEs), 510(k) Premarket Notifications, Premarket Approval (PMA) applications, 30-Day Notices of Manufacturing Changes, Q-Submissions, Accessory Classification Requests, Post-Approval Study (PAS) Supplements / Reports, Recalls, Allegations. • Recognized through two promotions (GS grade levels) for managing increasingly complex submissions. • Monitored trends in Medical Device Report (MDRs) to identify potential postmarket device safety problems, initiated safety signals, and collaborated on response teams to resolve emergent safety concerns. • Led granting of CDRH’s first New Accessory Classification Request (21 CFR 876.1510). • Ad hoc, served as Acting Branch Chief to handle branch issues, assign submissions, and review and provide concurrence on regulatory recommendations for medical device submissions.

Office of the Center Director (OCD) Temporary work assignment to shape the Digital Health Pre-Certification Program

Office of the Center Director (OCD) FDA/CDRH Strategic Initiatives • Served as reviewer for first tools to be qualified through Medical Device Development Tools (MDDT) Program. • Initiated Cross-CDRH Patient-Reported Outcomes (PRO) Working Group. • Co-led PRO workstream for CDRH "Partner with Patients" Strategic Priority. • Presented to internal stakeholder groups and engaged them in development of CDRH initiatives. • CDRH exceeded all associated Strategic Priority goals / metrics.

Optical Molecular Imaging and Nanobiotechnology Laboratory Advised by Dr. Rebekah Drezek, Professor of Bioengineering Research areas: Nano-bio interactions, hyperspectral imaging, and microbial diagnostics

Conceptualized, secured funding, and successfully launched bike rental business for environmental sustainability. Today, Rice Bikes (a merge of the bike rental and bike repair businesses) is a thriving business that sells, rents, and repairs bikes with a team of now 30+ staff. The rental arm’s original business plan remains robust and sustainable.

Trained undergraduate engineering students in communicating scientific research or design projects through oral and poster presentations.

Designed and performed experiments toward development of localized surface plasmon resonance (LSPR)-based method for quantifying amyloid-beta fibrillation. Learned from industry leaders on manufacturing and clinical testing at National Amgen Scholars Symposium.

Participated in week-long conference and site visits in Singapore and Vietnam to study the factors involved in company, country, and technology development. Explored topics of globalization, cross-cultural communication, and economic development, with focus on technology, in semester-long multi-university “Topics in Global Leadership and Technology” course. Culminated in paper and poster entitled, “Vietnam as a Center for Manufacturing and Operations: Challenges and Opportunities.”

Investigated the effect of oligonucleotide length on transfer efficiency for replication of DNA microarrays.

Developed and optimized protocols for attaching immunogenic peptide to near-IR resonant nanoshells for targeted photothermal ablation of lymphocytes. Examined effects of phase retardation on nanoshell plasmonic behavior beyond the quasi-static limit through Mie scattering calculations, mesoscopic nanoshell fabrication, and spectral analysis.

Managing Projects; Project Leadership, Management, & Communications; Negotiation Skills; Risk Management; Contract Management Principles and Practices; Scheduling and Cost Control; High-Impact Communications