What determines the success or failure of partnerships in new product development? How could small biotech startups create a faster and cost-effective way to bring new treatments to patients? In this webinar, experts will explore the journey from molecule candidate selection to first in human clinical studies, discussing the process from initial formulation conception to forming accelerated pathways to clinical trials. Attendees will have opportunities to discuss molecule developability, formulation development and the clinical trial supply manufacturing process, as well as ask specific questions relating to their own research and development.
Date: April 26, 2022 04:00 PM Zurich / 10:00 AM ET
Location: Virtual webinar
Key learning objectives:
- Understand the importance of choosing the right development partner
- Learn best fit and best practice of formulation approaches for poorly soluble drugs
- Discover why integrated solutions have the potential to save time throughout the development process, and offer accelerated project timelines
Speakers
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Stephen Tindal, Director, Science & Technology, Catalent
Stephen Tindal is Director of Science and Technology at Catalent, where he 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’ 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. |
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Mark Saunders, Consultant, P2C-Pharma Ltd
Dr Mark Saunders received his degree in Biochemistry from The University of Exeter and his PhD from the London School of Pharmacy. He is a tested professional with scientific and leadership skills in the pharmaceutical industry who has spent nearly 20 years working in and leading various contract research and development organizations. After completing his PhD, Mark joined a spin-out CRO providing outsourced support for physiochemical properties testing for NCEs. The company quickly grew and Mark oversaw the implementation of both the solid-form screening and formulation groups, including the Phase I / II clinical manufacturing for oral and inhaled drug products. After the business was acquired in 2007, Mark immediately went on to found Kuecept Ltd, an early-stage CRO specializing in designing bespoke preclinical and early-clinical formulations for drugs that exhibit complex bioavailability barriers (oral, parenteral and inhaled RoAs). Since establishing the business in 2007, the company’s technical expertise was globally recognized by over 100 leading pharma and biotech organizations and in April 2016, Kuecept Ltd was acquired by Aptuit LLC. After 2 years supporting the integration of the group into the wider Aptuit business, Mark left to set up his own consulting service, P2C Pharma Ltd. In addition to his consultancy role, Mark is also a Strategic Advisor at Fluid Pharma, a technology company providing drug delivery solutions for taste-masking and GI targeting for paediatric and geriatric patients as well as being a Director at Relevo Ltd, a technology disruptor company providing digital respiratory healthcare devices to aid patient compliance in medication adherence. |