Featured Speakers:

Matthew Streeter

General Manager, Catalent Nottingham

Matthew Streeter serves as the General Manager at Catalent Nottingham site, bringing over two decades of rich experience in Operations and Quality within diverse industries including Pharmaceutical, Medical Device, and Printed Packaging. A seasoned professional, Matthew has notable experience in developing systems that align with various regulatory and certification requirements. His skill set is particularly strong in ensuring compliance with the standards of main regulatory and accreditation body audits, which is crucial in the highly regulated pharmaceutical industry. He has a proven track record of delivering a quality ethos within organizations, ensuring strong organizational performance. His focus on sustainable improvement is a testament to his commitment to not only meet but exceed industry standards. His leadership style and deep understanding of operational excellence have been instrumental in driving consistent and sustainable improvements across the businesses he has been involved with.

Stephen Tindal

Director, Science & Technology, Catalent

Stephen Tindal is the Director of Science and Technology at Catalent. His work is largely focused on preclinical to phase 1 development and is based on assessing preclinical data to help define any challenges to dosage form development. Stephen has more than 36 years of experience at Catalent, where he has held roles of increasing responsibility and has demonstrated expertise in root cause investigation, technology innovation and supporting business development. He holds a bachelor’s in Chemistry and Analytical Science from Loughborough University, Loughborough, U.K.

Katsuhiro Mihara

Head of Clinical Development & PK/PB, Venn Life Sciences

Katsuhiro Mihara, RPh, PhD is a registered pharmacist and with a PhD in Pharmaceutical Sciences from the University of Tokushima. He joined Venn in 2016 to lead the Clinical Development department and is currently also leading Venn’s business in the Netherlands. Before joining Venn, he held leadership and senior scientist positions in clinical development and pharmacology at Abbott, Merck Sharp and Dohme, Schering Plough and Organon, giving him over 25 years of experience in preclinical/early clinical drug development in big pharma, biotech, and provider alike. He has been involved in numerous drug development projects as project leader, clinical trial manger and/or study director in multiple therapeutic areas, including, but not limited to, oncology, immunology, dermatology, urology, gynaecology and CNS from early discovery to marketing. His experiences also include due diligence of various drug development projects with primary focus on risk assessments including evaluation of regulatory documents at major milestones (e.g., pre-IND, End of Phase I/II meetings) for investors.

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.

Matt Ling

Director, Scientific Services, Catalent Nottingham

Dr Matt Ling has over 20 years’ experience in the pharmaceutical industry, much of this gained in big pharma, with roles in analytical, formulation development, advanced drug delivery and project leadership spanning all phases of discovery and development. He has a PhD in Organic Chemistry from the University of Nottingham. Matt has a keen interest in the application of drug delivery technologies to address the challenges of modern pharmaceutical agents with experience in approaches to enhancing the bioavailability of poorly soluble drugs, developing nanomedicine technologies, and developing products for paediatric administration. He is a member of the Site Leadership Team at Catalent Nottingham.

Navigating Early Drug Development Journey: Strategies for Successful Phase1