Board Chair | Chief Regulatory & Scientific Strategist

• Apr 2020 - Present

Regulatory compliance, strategy and scientific affairs. Clinical trials and operations, medical monitor. FDA, EMA, CMS, TGA. Overseeing drug development of biologics through various stem cell raw materials with academic collaboration. Management of grants and submission for stem cell therapies. Develop and execute global regulatory strategies for cell therapies in various therapies/ pipelines, including IND submissions, and Phase 1, 2a, 2b, clinical trials utilizing my academic and professional network to identify various sites and PI’s. Working with OUS governments and regulatory bodies for stem cell therapies and data collections. Overseeing rare disease clinical trials/therapies to ensure completion and access to unmet needs of patients. Scientific Data Management and collection for regulatory submissions including pre-clinical, USA & Outside USA human clinical therapies for NDA/BLA submission and commercialization purposes including orphan drug designation. Compliance review / audit on GMP, GCP, GLP, GXP.

Principal

• 2015 - Present

Lead consultant providing strategic solutions to life sciences and healthcare industries. Working with the leadership and team members in every organization to ensure projects are executed and carried out as designed. Proven delivery of results with guaranteed satisfaction and ROI. Projects include: Regulatory and Strategy, Drug discovery and Innovations, health systems' clinical research operations & improvement, build out, governance and develop operational tools for new or expansions within health systems based on strategic alignments and business needs. Experience with global medicine and access to therapies in under-developed countries. Risk/Benefit Analysis providing value-based care and therapies to better communicate with the payors & HTA bodies. Life Sciences consulting in drug development & medical devices including MSL, HEOR, regulatory, pricing, & reimbursement strategies. Assisting with research facilities build-out in compliance with GCP, cGMP, GLP, GXP regulations & implementations to include obtaining regulatory certifications (ISO/ICH, clean lab, etc.). Precision medicine and gene-sequencing capabilities. Tissue bank regulatory and compliance expert. Provide leadership for development, implementation and evaluation of CQI, HEDIS, NCQA, JC goals to achieve high quality institutions. Clinical trials management, regenerative medicine and cell therapies. Medical Science liaison and global value dossier expertise across various diseases/therapeutic areas. Research and Development strategist. Biotech/biopharma start-up experience including clinical trials, project management and data science management leveraging technical platforms and applications. Close working relationship with the FDA and global health authorities on regulatory activities for compounds and biologics through all phases of development, post-approval, and for the life cycle of the products. IND, NDA and BLA and MAA submission experience.

Associate Professor of Clinical (Adjunct Professor)

• 2010 - Present

Chief Administrative Officer - Cancer Research Clinical Institute

• 2016 - 2018

Working collaboratively with all executives and stakeholders, oversee the day-to-day operations and human resource activities of the oncology program while coordinating cancer services and research projects throughout the network of hospitals and healthcare facilities. Multiple IRB Oversights, including compliance and regulatory management of all clinical and basic science research. Precision Medicine. Regulatory oversight of human tissue collection and banking. Planning and build out of lab, tissue and biospecimens. Compliance review / audit on GMP, GCP, GLP, GXP. Collaborate with all internal and external team members (clinical developments, biostatisticians, medical affairs, market access) to ensure strategically appropriate payer-and-patient relevant endpoints (evaluating all protocols for study designs, comparator selection and outcomes measures. Managing over 35 clinical trials Phase I-III for immunotherapy study (Keytruda / Merck for melanoma, urothelial/bladder cancers and NSCLC indications). Various Glioblastoma safety & efficacy studies (BI, ApexBio, Northwest Bio"(DCVax®-L)",etc. Working collaboratively with the leading industry sponsors in oncological diseases such as Kite (CarT), Amgen, BMS, Pfizer, Merck, and others. Medical monitor for a 15-year NCI-awarded grant with 32 sites internationally (sentinal node, melanoma and soft tissue sarcoma). Precision Medicine, specific to Oncological diseases. Regulatory oversight of human tissue collection and banking. Planning and build out of lab, biospecimens, etc. which are crucial to the discovery of therapies to address cancer and oncological diseases.

Chief Operating Officer

• 2016 - 2018

Enhance the daily operations and finances of the Providence LA Region Research through the integration of strategic planning and comprehensive leadership. Leading the rapid design to align the basic science & clinical research structure within the system as a comprehensive business unit. Responsible for clinical trials management, monitoring, regulatory and compliance. IRB executive and co-chair. Overseeing all clinical operations, including quality systems management, pre-clinical and clinical drug development. Multiple disease indications: Oncology (Hematology, UroGyn, Lung, CNS, Melanoma, Breast, Surgical Oncology, etc.) Developed a robust department infrastructure, to include regulatory strategy, regulatory operations, medical writing, labeling, regulatory advertising and promotion for patient recruitment, and quality systems management (QMS). Established precision medicine and gene sequencing structure to ensure access to resources throughout the Research Institutes within the Region. Compliance review / audit on GMP, GCP, GLP, GXP.

Chief Administrative & Strategy Officer - Research Operations

• 2011 - Apr 2015

Assisting the off-site clinics to be on par with the health systems' regulatory and clinical operations. Ensuring all clinical research/ trials set up in the satellite clinics are in compliance with the industry sponsored regulatory and strategic requirements. Lead project execution and ensure accountability through initiation, planning, execution, and control (cost, time, quality and risk). Managing and mitigating risks throughout all aspects of clinical operations and project management. Compliance review / audit on GMP, GCP, GLP, GXP.

Executive VP of Research, Regulatory Strategy & Operations

• 2009 - 2015

Overseeing all clinical and basic science research operations, including federal and state grant management of over $1billion. Managing clinical trials (Phases 1-4) as well as post-Market surveillance for medical devices. Overseeing all regulatory and compliance structure/requirements, as well as responsible for Quality Systems Management. Management of disease indications for various service lines/diseases (e.g., Ophthalmology, Cardiovascular, CNS, Orthopaedics, Oncology, Endocrinology, Auto-immunology, etc.) Responsible for all aspects of Regulatory Affairs related to clinical development, CMC, and commercialization. Coordinating regulatory activities across functions within the organization, including CMC, pre-clinical, clinical and discovery to ensure compliance with the FDA and other global regulatory agencies which were essential to the industry-sponsored team members as well as the investigator initiated IND/NDA trials. Research facilities build-out in compliance with GMP, GCP, GLP, GXP requirements.

Chief Research Officer

• 2000 - 2015

Provided oversight of all clinical research operations including regulatory, compliance, financial, and administrative management of USC and its hospital affiliates (CHLA, Verdugo Hills, etc.). Clinical Trial Units management. Managed 250 clinical and non-clinical staff with 4 directly reporting Administrative Managers. Train, educate and mentor clinical site staff and new hires on goals and protocols in accordance with GCP, ISO’s, ICH, FDA, HCC, GMP, GXP, and clinical study & manufacturing SOP guidelines to meet company expectations. Clinical trial oversight for multiple therapies, managing scientific issues, protocol development and monitoring in compliance with regulatory requirements. Collaborating closely with the Biopharma in trial design and endpoint development to achieve optimal deliverables. This included designing studies, authoring protocols, engaging with sponsors and the study teams, interact with health authorities to provide safety and efficacy data and educate site staff. Managed a budget of $56.8M in pharma industry support, state and federal grants and disease specific Foundation philanthropy, in addition to $180M in hospital service lines' operating budgets.