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New approaches and tools to maximize success on the journey from research product to the clinic

Tuesday, May 8, 2018 | Royal Sonesta Hotel, Cambridge, MA

Biologic drug substances are increasingly complex, creating numerous difficulties for biopharmaceutical companies from higher candidate failure rates to expression and manufacturing challenges. It is crucial for biotech companies to reduce risks associated with development projects by selecting the best candidates, the most appropriate expression system and by developing a robust manufacturing process that provides the greatest likelihood of reaching the commercialization stage.

Please join us for a one-day, technical symposium to gain insight from scientists with breadth and depth of knowledge in the different approaches and techniques to successfully progress therapeutic proteins from discovery to the clinic. Learn about updates on new and established tools including expression technologies, and programs designed to get your candidate to the clinic rapidly. Enjoy our networking lunch and take advantage of our afternoon Lonza Clinic, where you’ll have the opportunity to speak one-on-one at our “Ask-the-Expert Sessions” for advice and tips on a development challenge you are facing.

Agenda:

08:30 – 09:00 Delegate Registration, Breakfast
09:00 – 09:05 Welcome
09:05 – 9:45 Yvette Stallwood, Ph.D. | Head of Applied Protein Services, Lonza Pharma & Biotech

Early developability assessment tools and successful de-risking strategies to support progression of biologics from discovery to clinical development
9:45 – 10:45 Andy Racher, Ph.D. |Principal Scientist, Future Technologies, Lonza Pharma & Biotech

Expression tools for the rapid development of high-yielding and stable mammalian cell lines and microbial strains for late discovery to the clinic and beyond. An introduction of new technologies for the expression of complex proteins and next generation ADCs will be described
10:45 – 11:00 Break
11:00 – 11:30 Satish Singh, Ph.D. | Head Drug Product Process Development, Lonza Pharma & Biotech

Aspects of a successful drug product development program that enable rapid progression to preclinical and clinical trials including phase appropriate product formulation, analytical and process development activities
11:30 – noon Marty Jefson |CEO, Pinteon Pharmaceutical

Customer Presentation
noon to 1:00 Networking Lunch
1:00 – 1:30 Jeet Vaghijiani | Head of Commercial Development, Lonza Pharma & Biotech

Building a successful project plan that highlights critical elements for an IND submission – how they fit together and options for compression
1:30 – 2:00 Tom Perrone | Head of Regulatory Affairs, Portsmouth

Regulatory considerations for a successful IND submission including risk mitigation strategies to overcome the challenges involved in early phase projects
2:00 – 4:00 Lonza Clinic

Our experts will be on hand for one-on-one sessions to answer your questions about development challenges you are facing
4:00 Delegates depart

Registration is closed.


Venue details: Royal Sonesta Hotel, 40 Edwin H Land Blvd, Cambridge, MA 02142 | Tel: (617) 806-4200