SOMERSET, N.J. – July 11, 2017 — Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, today announced it is to host a half-day symposium on API and formulation development throughout discovery and early clinical phases, at the Sheraton Boston Hotel in Boston, Massachusetts, on Sunday July 16, 2017. The symposium will take place ahead of the Controlled Release Society (CRS) Annual Meeting, which runs from July 17 – 19, 2017, at the Sheraton Boston Hotel and Hynes Convention Center.
Entitled “Start Earlier, Move Faster: Smart Drug Development and Design from Candidate to Phase One,” the workshop will see speakers from Catalent, along with industry experts, address a number of key considerations for transitioning a molecule from discovery to clinic, including API and formulation development, pharmacokinetic and preclinical toxicology studies, and regulatory requirements. By addressing these issues early and comprehensively in development, problems such as escalating timelines, costs and regulatory issues may be avoided later.
The presentations, which will feature practical and applied case studies, are:
• “Importance of API characterization and optimization to improve developability of small molecule drugs,” Dr. Manuel Sanchez-Felix, Senior Fellow, Novartis;
• “Investigating the pharmacokinetic challenges of oral small molecule drugs,” Dr. Jan Neelissen, Scientific Adviser, Catalent;
• “Technology agnostic formulation selection for preclinical toxicology studies,” Mr. Stephen Tindal, Director Science & Technology, Catalent;
• “Phase one dose form prototyping,” Mr. Brent Moody, Director, Business Development, Catalent;
• “CMC and quality considerations,” Dr. Patrick Crowley, Consultant, Callum Consultancy, former VP Pharm Development at GSK.
For more information on the workshop and to register, visit www.controlledreleasesociety.org.
During the CRS Annual Meeting, on Monday July 17 at 1:15 p.m., Dr. Cornell Stamoran, Founder of the Catalent Applied Drug Delivery Institute and Catalent’s VP Strategy, will join a panel of experts from industry and academia, including affiliates of the Catalent Institute, to discuss “Drug Delivery 2017: the Path Ahead”. The panel will assess the current state of small and large molecule drug delivery including formulation, dose forms, Chemistry Manufacturing and Controls (CMC), and devices. The panel will also discuss which of the currently applied strategies are working, where further innovation is needed, and the evolving perspectives of stakeholders.
Catalent experts will also be presenting two scientific posters during the course of the event:
•Monday July 17, 3 p.m. “A Plackett-Burman study to investigate the effect of milling on the performance of melt extruded indomethacin formulation”
•Tuesday July 18, 3 p.m. “Analysis of physicochemical characteristics to profile drug candidates likely to benefit from lipid formulation”
Catalent is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs approximately 10,000 people, including over 1,400 scientists, at more than 30 facilities across five continents, and in fiscal 2016 generated $1.85 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com