Chris Broderick, Ctbs, Rac Email & Phone Number

Research Triangle Park, Nc, Us

➢ Support operations and strategic planning around market access, clinical trials, intellectual property development, commercial scaling, and federal reporting obligations➢ Lead clinical and regulatory operations including eCTD technical writing of commercial IND package that resulted in FDA clearance and IRB approved Phase II clinical study for subcutaneous biologic➢ Support various research projects including patent-pending potency assay program, downstream bioprocessing, and grant collaboration projects➢ Manage financial budgets, investor relations, and support manufacturing cost accounting within Enterprise Resource Planning software

Research Triangle Park, Nc, Us

➢ Founded company to follow a vision for developing evidence-based therapeutic technologies➢ Secured small debt financing to jump start company’s commercial distribution operations to achieve cash flow to support research & development➢ Support market access strategy for use of allogenic tissues in wound care, ophthalmic, and intra-articular joint applications➢ Leading intellectual property strategy and building a portfolio of patents to protect discovery phase findings➢ Support and lead quality assurance and regulatory affairs initiatives➢ Lead and support implementation of GxP complaint software to support current and future commercial operations➢ Lead FDA correspondence and scientific writing team for Request for Designation, pre-IND Meeting Requests, pre-IND Briefing Package

Research Triangle Park, Nc, Us

Improving the lives of patients though regenerative tools while driving stakeholder results.

➢ Lead regulatory/quality initiatives for class II medical device company to manage FDA 483 and recall on over 3,000 implants - resulted in FDA recall termination➢ Attended US Regulatory Affairs courses through NC Regulatory Affairs Forum at Duke Clinical Research Instititue and Office of Regulatory Affairs and Quality - resulted in US RAC certification on 1st exam attempt

➢ Founded company in 2013, recruited startup team, developed IP-protected technology, supported build-out of manufacturing facility, and commercialized human amniotic tissue and musculoskeletal tissue transplant product lines➢ Led Note/Series A securities offering and secured $1.5M in startup funding with $3M in distribution commitments➢ Liaise with regulatory auditors from US FDA and AATB➢ Designed Quality Management System to integrate with advanced IT platform➢ Led implementation of off-the-shelf Oracle-based Enterprise Resource Planning (ERP) software; responsible for conducting all staff training, and supporting the integration of all regulatory activities into ERP➢ Developed all promotional materials, and coordinated the development and integration of quality verification studies such as semi-quantative ELISA analysis, histology analysis, and post-processing protein degradation studies into promotional and educational literature➢ Supported the development of Good Automated Manufacturing Practices (GAMP®5) software validation; designed software test protocol scripts for all software modules utilize under the Quality System➢ Developed advanced electronic workflows for CAPA, ECO, MRB, and Deviations with 21 CFR Part 11 compliance for electronic signature➢ Successfully isolated and preserved human amniotic fluid stem cells; coordinated stem cell expansion and phenotype analysis with a multifaceted cross functional research and development team utilizing patented 3D stem cell expansion technology➢ Negotiated and completed Research Grant Agreement of human amniotic fluid collection study

Orlando, Fl, Us

➢ Developed $1.8M in organic sales within first 18 months for a variety of human tissue allograft technologies by effectively recruiting, negotiating, contracting, and managing sales for over 25 U.S. distribution agencies that resulted in record sales➢ Designed and implemented a successful $2M business development plan for orthobiologic OEM ➢ Instructed classroom sales training and lead surgeon education events on sterilization protocols and HCT/Ps regulatory requirements ➢ Communicated and recruited international distribution partners in South American, Canada, Korea, Turkey, and India➢ Liaise with Regulatory Affairs consultants in all countries to provide respective Quality System elements, and prepare dossier packages for health ministry review➢ Built 21 CFR 1271 compliant marketing material to promote human demineralized bone putty, structural spinal allografts, and human soft tissue allograft technologies➢ Developed IT analytical tools to identify inventory turnover ration, and developed and implemented improvement strategies based data analysis reports generated

➢ Developed operational infrastructure for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) storage and distribution establishment➢ Registered and corresponded with US FDA for establishment of a storage and distribution facility for human tissue➢ Developed Standard Operating Procedures (SOPs) to meet regulatory compliance for storage and distribution of human tissue – 21 CFR 1271➢ Responsible for hospital billing and collection processes, communicating regulatory registrations and licenses to hospital materials management personnel, and ensuring compliance was met with product supply➢ Responsible for hospital billing and collection processes, communicating regulatory registrations and licenses to hospital materials management personnel, and ensuring compliance was met with product supply➢ Coordinated and hosted meetings with insurance coding personnel at hospitals, surgery centers, and physician offices to address skin graft substitute HCPCS coding and related CPT codes➢ Promoted unique allograft terminal sterilization technologies using CO2 combustion methods

➢ Small start investment and consulting firm structured to support novel hospital bed medical device technology and manage a small partnership investment fund➢ Provided a supporting role to CEO of pre-revenue startup during a successful Series A offering of $2.5M for the design and development of patent protected acute care hospital bed➢ Became familiar with the Regulation D 506 securities offering process, provisional and non-provisional patent strategies, corporate governance, and other Director and shareholder matters relevant to early-stage funding strategies ➢ Identified and facilitated meetings with a number of healthcare organizations, angel investors, and other key contributors to support product development and commercialization efforts ➢ Transitioned to independent consulting role and equity position to provide consultation on achieving regulatory requirements associated with Class II medical Device exempt from pre-market approval/notification, AC-powered adjustable hospital bed, under 21 CFR 820

Goose Creek, South Carolina, Us

➢ Recruited orthopedic and spinal implant sales reps, marketing personnel, and sales managers nationwide for a variety medical device and biologic manufacturing companies➢ Hired sales representatives and sales management staff for Integra, Orthovita, Lanx, Stryker Instruments, Bacterin, and other medical device and biologic manufacturers➢ Supported marketing efforts for Atlas Distribution (same owner), by promoting unique technologies used in the sterilization and processing of various human tissue allograft technologies

➢ Trained in the marketing and promotion of a variety of healthcare products and services as an outsourced business development and recruiting representative➢ Promoted lumbar bracing, bone growth stimulators, topical pain management, DVT Prophylaxis, PEEK, and spine hardware nationwide to independent distributors and distributor-agencies➢ Developed a national network of independent sales representatives in medical device, tissue allograft, biologic, and healthcare service distribution

Lakewood, Co, Us

➢ Completed and was Certified as Emergency Medical Technician (EMT) Training; Challenged and became Certified in Outdoor Emergency Care®, a nationally recognized program designed to help manage outdoor-based emergency care.➢ Achieved Senior Ski Patroller in 3 years, surpassing 20-year veterans of the Patrol by demonstrating advanced skills in advanced alpine skiing and rescue techniques, and the ability to transport injured skiers through use of rescue toboggans➢ Team Leader responsible for working with fellow Ski Patrol team to assure daily setup of mountain to manage large volume of skiers over numerous winter ski seasons➢ Responded to a variety of medical emergencies on ski slopes and lead teams to ensure patient standard of care was met and enhanced customers experience at the mountain

Master’S Of Science - Biomanufacturing, Principles In Cgmp Biomanufacturing

Bachelor’S Of Science Business Administration - Economics & Information Systems, Business