7th Annual HPAPI Summit - Boston 2018

Enabling Robust, Safe and Cost-Effective Production
of Highly Potent APIs

I have worked closely with industry experts from Genentech, Novartis, SafeBridge and Biogen to identify the most critical issues companies face in developing HPAPIs efficiently, safely and cost-effectively. The questions below address some of the key issues they raised:

How much containment is enough?
What do tox and safety limits actually mean in the real world?
What are the best criteria to select CMOs to work with?

These issues have guided the development of the agenda for this year’s 7th Annual HPAPI Summit, returning to Boston from June 19-21. 21 expert speakers will grapple with these key questions throughout the conference, and to shed some light on how they will do that, here’s a sneak preview of some key presentations from the agenda:

How much containment is enough?
Mylan’s Shaun Larsen will present a frank and honest cost review on containment approaches to handle potent compounds. This will provide you with invaluable context and background when you next fact tough decisions about which containment approaches to pursue.

What do tox and safety limits actually mean in the real world?
Novartis’ Marc Abromovitz will make the case for data-driven risk based decision-making when it comes to setting exposure controls, and explore factors beyond OELs and banding to ensure the limits reflect the reality of the compound itself.

What are the best criteria to select CMOs to work with?
A panel of experts including Merck’s Timothy Maher will discuss the business and technical questions you should be asking CMOs, as well as who should be involved in the selection process. Ensure that external manufacturing maintains internal quality and safety standards, without breaking the budget.

See the full details of what will be discussed as well as our expert speaker faculty here: http://bit.ly/2G2lrtY