Wednesday, 24 June 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
The landscape in small molecule pharmaceutical development is changing. There is an increasing number of more complex, highly potent (HPAPI) compounds being brought forward in the clinic and to market, largely driven by biopharma’s oncology and immunology portfolios. Furthermore, smaller companies are driving much of the innovation—not just to the clinic but also to commercialization—though they typically lack the “bricks and mortar” necessary to bring a compound to the market alone. Finally, more than 70% of the pipeline molecules which requires enabling technologies to deliver them.
In this webinar we will present our approach to FIH (First-In-Human use) drug substance and technology-enabled drug product development program, designed specifically to provide customers with a standardized and rapid, phase-appropriate early clinical supply program (SimpliFiH® Solutions). It will feature our process following the regulatory framework required to enable phase appropriate drug substance and drug product development; the focus on acceleration of the program offered by the potential of a single source provider with a broad and robust technology and asset network; and project execution while maintaining a collaborative relationship and strategic alignment with the customer. The presented program is laid out as integrated Drug Substance, Particle Engineering and Drug Product services, enabling drug substance and drug product delivery in 40 weeks or less from the start of the project to the readiness, drug substance manufacturing to GMP drug product manufacturing. Drug product formulation design is guided using biorelevant screening tools to rapidly and predictively develop optimized formulations.
The presentation will include case studies to further discuss the services available through our SimpliFiH® Solutions program and will provide a line of sight for post FIH milestones.
David Lyon received his B.S. in Chemistry from Western Washington University and Ph.D. in Inorganic Chemistry from the University of Oregon. Following a Post-Doctoral stint at the California Institute of Technology, David joined Bend Research as a Research Chemist. During his tenure at Bend Research he held positions of increasing responsibility culminating in the role of Senior Vice President, Research prior to the company’s acquisition by Capsugel and, subsequently, Lonza. He has over 25 years experience in the pharmaceutical formulation area.
Conrad Roten earned his Ph.D. in Organic Chemistry at the ETH in Zurich (CH) and subsequently worked in several technical and management functions in the Lonza R&D and Operations organization in Switzerland and the US. Dr. Roten has over 25 years experience in the specialty ingredients and pharmaceutical manufacturing industry.
Can’t attend the webinar? Download our Technical Brief by clicking below:
- HPAPI Technical Brief
- SimpliFiH® Solutions Technical Brief