The development of targeted therapies and precision medicines has revolutionized cancer treatment, resulting in more effective and potentially less toxic therapeutic options for patients. Furthermore, regulatory agencies including the FDA have implemented accelerated approval pathways, fostering innovation and promoting faster commercialization of novel oncology drugs. In this dynamic landscape, the role of CDMOs becomes even more critical.
In this webinar, the speakers will explain what the gold standard is for an outsourcing partner for high potent oral solid dose therapies, the necessary equipment and facilities and how to maintain flexibility in a multi-product facility. They will also discuss a real-world case study, highlighting the importance of selecting the right CDMO for high potent outsourcing.
Join this webinar and discover outsourcing options for highly potent oral solid dose therapies, and learn how CDMOs can transfer, handle and deliver their product to clinic and to market.
Speakers
David O’Connell, Director of Scientific Affairs, PCI Pharma Services
David O’Connell is the Director of Scientific Affairs at PCI Pharma Services, an integrated full service provider expertly delivering a seamless transition from development to commercialization. After graduating from Glasgow Caledonian University with a BSc. in applied bioscience, David spent seven years as a Supervisory Scientist working for Aptuit in Edinburgh before moving to Penn Pharma as Head of Formulation Development in 2009. Here he played a vital part in the design of the potent Contained Manufacturing Facility (CMF), which won the ISPE Facility of the Year award for Facility Integration (2014). In 2013 David took on the role of Director, Pharmaceutical Development at the PCI site in Tredegar and in 2017 became PCI’s Director of Scientific Affairs.
Message Presenter
Lauren Angove-Parry, Director of Development, PCI Pharma Services
Lauren Angove-Parry currently serves as Director of Development at PCI Pharma Services’ high potent development and manufacturing facility in Wales, UK. Having graduated from the University of the West of England, Bristol, with a BSc. in forensic science in 2006, Lauren began her career as an analyst at Penn Pharma. Lauren quickly advanced into increasingly senior roles before serving as Director of Quality Control in 2019, eventually moving into her current role overseeing NPI, analytical development and process optimization.
Message PresenterWho Should Attend?
This webinar will appeal to senior level professionals in the pharma, biopharma and biotech industries, particularly those involved in outsourcing decision, whose job roles relate to:
- Drug Discovery
- Clinical Operations
- Commercial Operations
- Chemistry, Manufacturing and Controls (CMC)
- Product/Portfolio Management
- Supply Chain Management
- Medicinal Chemistry
- Analytical Chemistry
- Drug Product Manufacturing
- Outsourcing
- Clinical Trial Manufacture
What You Will Learn
Attendees will discover:
- What it means to be the gold standard CDMO outsourcing partner today
- The complexities involved with handling highly potent molecules
- The equipment and facilities required to develop, manufacture and scale-up highly potent drug products
- How a multi-product CDMO maintains flexibility for its clients
Xtalks Partner
PCI
PCI is a leading global CDMO, providing integrated end-to-end drug development, manufacturing and packaging solutions to increase product speed to market and opportunities for commercial success. PCI brings the proven experience that comes with more than 90 successful product launches each year and over five decades in the delivery of supply chain healthcare services. With 30 sites across Australia, Canada, North America, the UK and Europe and over 4,300 dedicated employees, our mission is to bring life-changing therapies to patients. Leading technology and continued investment enable us to deliver development to commercialization solutions throughout the product lifecycle, collaborating with our clients to improve the lives of patients globally.
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