Accelerated development of first-in-human (FIH) programmes. Lonza’s SimpliFiH® Solutions
ABOUT THIS WEBINAR
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 commercialisation – though they typically lack the “bricks and mortar” necessary to bring a compound to the market alone. Finally, more than 70 percent of the pipeline molecules require enabling technologies to deliver them.
In this webinar, Lonza presented its approach to its FiH (first-in-human use) drug substance and technology-enabled drug product development programme, designed specifically to provide customers with a standardised and rapid, phase-appropriate early clinical supply programme (SimpliFiH® Solutions). It features Lonza’s process following the regulatory framework required to enable phase appropriate drug substance and drug product development; the focus on acceleration of the programme 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 programme is laid out as integrated Drug Substance, Particle Engineering and Drug Product services, enabling drug substance and drug product delivery in about 40 weeks 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 optimised formulations.
The presentation includes case studies to further discuss the services available through Lonza’s SimpliFiH® Solutions program and provides a line of sight for post FIH milestones.
Learning outcomes of this webinar:
- Single source approach to first-in-human drug substance and drug product development programme, with a standardised and rapid, phase-appropriate early clinical supply programme (SimpliFiH® Solutions)
- Integrated programme that enables drug substance and drug product delivery in about 40 weeks from the start of the project to the readiness
- Drug product formulation design is guided using biorelevant screening tools to rapidly and predictively develop optimised formulations.
David Lyon, Ph.D. Sr. Fellow Research, Lonza Pharma & Biotech
David Lyon received his BSc in Chemistry from Western Washington University and PhD 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.
He currently serves as a Senior Fellow, Research advising internal and external collaborations in bioavailability enhancement technologies, modified release and bioprocessing. David has been involved in numerous technology innovation efforts during his career including the development of amorphous dispersions, modified release formulations, engineered particles for inhalation, nanotechnology and formulation and processing of biotherapeutics.
Conrad Roten, Ph.D. Group Leader R&D API Chemical Services, Lonza Pharma & Biotech
Conrad Roten earned his PhD 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 organisation in Switzerland and the US. Dr Roten has over 25 years’ experience in the specialty ingredients and pharmaceutical manufacturing industry.
Conrad Roten is Associate Director, Group leader for API Development Services Highly Potent Products for Pharma Operations at Lonza. His team is responsible for the process development of highly potent chemical processes for clinical phase supply as well as manufacturing of early and late phase supply of lab scale manufacturing products. Dr Roten has worked on a broad range of products in process development, production and project management, leading tech transfers within Lonza plants and from and to customer sites, from lab scale up to 10m3 scale. In recent years his work focus has been on highly potent products.