Lead global product development strategies, meetings, and relationships with 10+ biotech company(s) – pre-clinical through commercial. Initiated multiple pilot programs with RWE, epidemiologist, and data scientist to leverage AIML.
•Start-up- new asset in PhIII-revising TPP to align clinical strategy to commercial market viability.
•Start-up-in licensing negotiations – Reported to CEO. De-risked asset, involved changes to standard of care. Lead TPP validation, primary/secondary research, publication/evidence plan, RWE cluster analysis w/EMR/claims data, patient advocacy group (client representative) -PRO development/focus groups with team in Japan/Canada. Board approval to go into second rare indication for further product development for PhIb to registration product development strategy.
•Start-up-building Global Product Team. Lead multiple workstreams with indication prioritization, regulatory (pre-IND gap analysis), CMC/preclinical workstreams, SAD/MAD (multiple indications), foc

Developed alliances and product development strategies (PhIb-PhIV) with 15+ oncology and rare disease biotech companies, Texas Biomedical Research Institute, Halloran, and additional vendors. Generated $70+M in RFPs for Clinical Development, REMS, RWE, and Pharmacovigilance. Negotiated Master Service Agreements and tiered discounting structures.

Responsible for business relationship and product development strategies for 25+ companies - Vaccine, Oncology, Rare Diseases, Infectious Disease, Immunology, Dermatology, and GI programs with biotech companies. Identified opportunities for early (POC and natural history studies) through late stage (PhIb PhIII), including post marketing commitments (PhIV). Coordinated the integration ofbiomarker & companion diagnostic strategies into client programs, global regulatory strategy, and market access. Initiated & contracted LabCorp data use pilot with client (2017). Generated over $175+M in revenue.

Start up venture, private equity backed as of 2014. Rheumatoid arthritis longitudinal disease registry with over 45,000 participating patients, more than 270,000 office visits with 555 contributing physicians.
•Established projected revenue pipeline, from $20M to $250M+ in defined product development/timelines with large biotechnology/pharmaceutical 15+ companies.
•Managed key relationships for internationally - Eastern EU and Asian markets.
•Collaborated with clients to define biosimilar global product development strategies.
•Defined/expanded product development strategy aligning scientific and operational expectations.

Recruited to start-up with a charter for product development and to expand use of clients' disease registries. Corrona, LLC, retained our company as their commercial team after closing on private equity in April 2014.
•Developed strategy to expand the use of disease registries (Corrona.org), across lifecycle and market channels, within the pharmaceutical/biotech industry. International expansion focus.
•Managed and developed industry relationships and implement strategies to expand disease/data registries. Re-engaged previous clients and addressed outstanding historic issues.

transfer license agreement for transplant device - UTHSCSA. Co-founded start up, raised $650K.
•SemioClinical Consultant– Led the development of product delivery methodology and ROI valuation for a $50M Lilly/Quintiles software co-development.
•AzayaTherapeutics – Performed due diligence on a liposome technology, resulting in tech transfer license with University ofTexas Health Science Center San Antonio (UTHSCSA), and subsequently awarded $1M by the Texas Emerging Technology Fund.
•InvictusEngineers – Advised founders on early medical device product dev. and market
•PhyllisBrowning/Christies Great Estates Affiliate – 2009: $5.9M sales, 2008: $3.2M sales

Hired by Head of Genzyme Oncology Business Unit to be the Team Leader at Ilex Oncology prior to acquisition. Key collaborator for Ilex and Genzyme for alemtuzumab product lifecycle ($36M+ budget).
•Led product development team for delivery ofoncology (Chronic Lymphocytic Leukemia) and non-oncology (Multiple Sclerosis) integrated product development and business plans.
•Managed global partnership/alliance: Co-chair of the collaborative Global Product Team with both clinical development and commercial partners, CMC, non-clinical, regulatory, quality, legal.
•Initiated commercialization for p53 oncology prognostic test.
•In-licensed second-generation compound and IP for early stage development.
•Managed Key Opinion Leader relationships for product development and Investigator Sponsored Studies.

Managed and implemented clinical trials in Hong Kong, Brazil, EU, and US in rare disease (acromegaly), coordinated with product development and commercial team. Negotiated contracts/budgets and managed CROs, laboratories, and Principal Investigator sites. Managed Key Opinion Leader relationships. Led development of clinical trial protocols across global project teams. Chief Scientific Officer recruited me to lead the global eClinical strategy during company consolidation efforts (2001).
•Devised a strategy for electronic data capture throughout Global
● & D, building consensus across global cross-functional disciplines in Senior Management.
•Developed business plan for eClinical implementation.
•Executed Corporate Master Service Agreement and Corporate Enterprise Agreement for EDC.
•Steering Committee member of the Development IT Architecture –initiated R&D restructure

Start up company with an electronic data capture product that incorporated data/document/trial/image management. Company unsuccessful closing series
● funding.
•Created Focus Group: pharmaceutical/biotechnology/CRO and previous FDA employees.
•Defined new product functionality to increase usability at all levels of the clinical trial and registry process. Developed change request prioritization methodology.

Hospital restructuring firm, acquired by Cardinal Health. Improved productivity, cost savings, quality, service, and operating efficiencies: resulted in annual savings of 20%, over $1. 1M.
•CCS Associates, LLC (Regional Clinical Research Associate) - Boutique CRO for the chemo preventative branch ofthe National Cancer Institute (NCI). Managed both Pharmaceutical and Investigator grant trials and implemented trial protocols on behalf of the NCI with COX-2 inhibitor. Developed/managed task matrix for multi-company collaboration with NCI, CRO, & Pharmaceutical company during their acquisition. Recruited by Enmed.