Val Harding

Combine knowledge of leadership, business, science and innovative practices to advance drug development from research to market for a diverse range of pharmaceutical products. Advise, coach and mentor to unleash creative confidence, build individual and organizational capacity, capability and agility to deliver innovative solutions for value creation. Drive innovative ideas and thinking; finding the sweet spot of desirability, feasibility and viability for implementation, action and impact.

Site Head: Post acquisition by the Roche Group, led the transition of assets and operations to enable accelerated simultaneous NDA, JNDA and MAA submissions for entrectinib (Rozlytrek) under respective BTD, Sakigake and PRIME paradigms. Executive Leadership Team: contributed to the development and successful delivery of the portfolio and organization objectives. CMC Function Lead: provided strategic direction and operational oversight to deliver innovative and quality pharmaceutical sciences to advance the pipeline to commercialization for the benefit of cancer patients. Built agile internal capabilities and lean external drug substance and drug product vendor network to progress five in-licensed oncology assets. Provided guidance to multi-disciplinary project teams on the build and execution of integrative innovative development strategies to effectively and efficiently advance programs.

Operated across multiple disciplines to enable the design and rapid progression of differentiated drug molecules and drug products. Developed, enhanced and implemented cross-functional strategies and practices to deliver value-driven differentiated therapies. Integrated awareness of standard of care, patient and economic drivers to inform patient-focused product innovation and design.

Created a global drug product design organization, cultivating a learning organization to enhance productivity. Delivered six major new product global regulatory filings and two product launches. Established a novel alliance with academia to drive innovation and expand capability to design drug products with minimal material consumption, experimentation and cycle time. Developed and implemented flexible, cost-effective operating model for global sourcing of drug product science and technology capabilities.

Post Wyeth acquisition, rapidly assimilated key talent from both organizations to create a high performing global group with unified vision. Established function to create opportunities for affordable branded and generics products in established and emerging markets, resulting in the development and launch of three branded generics, helping to exceed target budget for revenues for the Business Unit. Led the deployment and advancement of computational tools for drug product and process design; reduced cost and cut cycle time.

Led successful turnaround of department incorporated in Warner-Lambert acquisition. Resolved complex manufacturing and technology transfer issues that were delaying project launch resulting in significant revenue return. Redesigned model for to accelerate internal progression of new drug candidates from selection to first-in-human / patient studies. Established new ophthalmology formulation design and development capabilities following Pharmacia acquisition; led cross-functional collaborations to optimize cycle time; aided decision making for portfolio growth investments and new global disease area product line.

Created industry-leading Material Sciences and assessment functions to predict, design and characterize materials for manufacturability and drug product performance with minimal resource and material consumption. Prepared and defended complex CMC control strategy for oral and intravenous drug products and novel drug delivery technology; enabled two new products to go to market - not possible without technology.

Project Leader, 1987 – 1993 Team Leader, Pharmaceutical Research / Development, 1993 – 1996