Integrated clinical development and supply: Breaking down the early-development journey of a small molecule

In the era of seamless drug development, reducing time to the clinic and getting rapid regulatory approval has become the goal of nearly every early drug development sponsor. Handling drug development, manufacturing, and clinical supply efficiently can help sponsors save costs and provide maximum benefit for patients. In order to improve the efficiency of the drug development continuum, integrated solutions have become an effective option for sponsor companies to streamline the transition from early development to the clinic, in addition to providing timely clinical supplies to help keep study timelines and budgets on track.

Along with a discussion, examples of real-life tactical and operational decisions involved in the integrated approach to drug development will be presented.

Learn more about:
  • The definition of integrated solutions in the pharmaceutical industry
  • The benefits and challenges of the integrated approaches
  • Insights on whether integrated solutions can be the key to achieving today's more aggressive development milestones
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Stephen Tindal

Stephen Tindal

Director, Science and Technology, Catalent

Stephen Tindal plays an important role within the company’s research and development team by providing advice to clients in Europe and Asia-Pacific on the early phase drug development and delivery technologies to progress their small molecule programs. His work is largely focused on preclinical to phase 1 development and is based on the assessment of preclinical data to help define any challenges to dosage form development. Tindal has more than 30 years of experience at Catalent where he has held roles of increasing responsibility and has demonstrated expertise in root cause investigation, technology innovation and in supporting business development. He holds a bachelor’s in chemistry and analytical science from Loughborough University, Loughborough, U.K.

Mark A. Krook

Mark A. Krook

NGT BioPharma Consultants

Mark Krook, Ph.D, is a pharmaceutical executive with more than 35 years of experience covering all aspects of small molecule Chemistry, Manufacturing, and Controls (CMC) as a part of research and development, spanning early drug studies through commercial manufacturing.

Krook began his pharmaceutical career at The Upjohn Company (finally becoming Pfizer) as a process chemist working on API process development for clinical and commercial needs, eventually moving into the leadership of global, multi-site, chemical process R&D organizations with responsibilities for both laboratory and pilot-plant facilities. From there he transitioned to portfolio management, providing broad technical, strategic and governance oversight for cross-functional CMC activities within a highly diversified portfolio of development projects.

Upon joining Johnson & Johnson (Janssen), he had responsibility for the API development group in the U.S. and took over leadership of the global CMC Portfolio Management function with accountability for CMC activities across the entire small molecule development spectrum (pre-clinical to life cycle management). His most recent role was in Janssen Supply Chain, leading End-to-End Strategy, where he helped orchestrate the lifecycle management of commercial products, via improved strategies, oversight, and governance, with attention on delivering the best product possible.

Since retiring, he has joined the leadership team of NGT BioPharma Consultants and is also an independent consultant.

Krook holds a doctorate in organic chemistry from the University of Notre Dame, South Bend, Indiana.

Arsalan Arif

Arsalan Arif

Founder & publisher, endpoints news

Arsalan Arif is a news media entrepreneur who set out in 2015 to build his vision of an independent biotech news company at Endpoints News.