Brant Murdock

Supporting innovative and leading edge business, product and integrated nonclinical- clinical development efforts in oncology, immunology, imaging & oral healthcare. Previously established and engaged 02/2006 to 10/2007 & 10/2009 to 01/2013, expert consulting business provides mature leadership-support for product and business development opportunities (drug, biologic, medical device, cosmetic, combination product), via unique breadth-depth of skills and experience, and via demonstrated ability to integrate with and lead teams of variable size and multi-disciplinary expertise - as needed by clients. Therapeutic areas of business focus on oncology, hematology, immunology, infectious disease, inflammation, medical imaging & oral health. • Integrated strategy and PDP's buttressed by nuanced regulatory analyses, • FDA engagements from Pre-IND, Pre-Submission, RFD, 513(g), 510(k) through EOP II. • Domestic & global cosmetic programs, E2E development, compliance, registrations and commercialization • Traditional & Exploratory IND/CTA programs, advancing successful candidates towards NDA/BLA/MAA • Leadership with nonclinical programs (integrated design, GLP, regulatory monitoring, reporting) • Regulatory support for clinical development programs (Phase 0-3), design to report. • Regulatory position papers/strategic reviews & business product acquisitions • Quality Systems development, audit programs (GCP/GLP/GMP), pharmacovigilance, risk management programs • Regulatory leadership with compliant drug-biologic production & quality testing programs • Process and analytical method development/validations, method & process transfer projects • Business development, strategic positioning, & commercialization support including partner negotiations.

Resigned from Philips in April 2016. Developed Regulatory Function & led worldwide Regulatory Affairs Team for Royal Philips Oral Healthcare while also Head of Regulatory and Clinical Operations across global Health & Wellness Business Group. Product platforms included prescription and OTC & Rx drugs, medical devices, cosmetics and combination products. • E2E new product innovation & development (product, formulation, process, control) • Business & global product strategic planning • Regulatory oversight of production activities, quality testing programs, process & method development, process & method transfers • Regulatory oversight of nonclinical safety testing programs • Regulatory leadership with clinical programs and clinical operations improvement programs • Regulatory oversight of compliance programs (Quality System, GMP, GLP, GCP) & audits • Lead North America regulatory engagements/submissions & manage partnerships with country organizations on global registrations (100+ countries) • Supported systems evolutions with complaints handling, safety reporting & pharmacovigilance-signals analyses - with Risk Management • Led major business integration projects, across inter-disciplinary teams and systems • Brought innovative solutions to challenges with global drugs-cosmetic supply chain • Lean & value-stream implementation, risk management & new business integration.

Regulatory and Clinical Lead for novel Malaria Vaccine Program, Malaria Clinical Trials Challenge Center and Malaria clinical trials in Africa – all first’s for non-profit Infectious Disease Research Institute - in partnership with Gates foundation, NIH & US DOD WRAIR. • Integrated product development plans for genetically-attenuated malaria parasite (GAP) Vaccine • Evaluation & establishment of full GMP production capability, followed by GMP vaccine production & testing • Strategic and highly effective Pre-IND and IND submissions & engagements • Innovative model development, nonclinical program design and execution • Lead on Phase 1-2 clinical planning and oversight, including safety & risk management programs: GAP Vaccine, Malaria Clinical Trials Challenge Center and field trials in West Africa (pregnancy malaria). • Quality System – leading interdisciplinary team on design & implementation, supporting regulatory activities, vaccine production, nonclinical testing and clinical projects. • Commercialization partner negotiations and next-generation vaccine development plans, WHO

Senior GLP expert quality assurance lead for top-tier drug/biologic and complex programs, both individually and directly oversight, audit and improvement teams. Individual and group lead on complex and leading edge programs, premier clients. • Led independent and team quality assurance & audit functions, bringing nuanced drug/biologic and global regulatory perspectives to RA/QA oversight of nonclinical study designs (toxicology, analytical), aligned to domestic and global regulatory requirements. • Strengthened of business-client interface and designated as Quality Project Leader with top-tier clients and critical or technically complex programs. • Organized continuous improvement systems-personnel projects for efficiencies, enhanced control and risk mitigation