Concept to dosing: Challenges in new orphan drugs

Orphan drugs make up some of the most consequential new medicines approved in the past five years. That trend is only going to accelerate, with a slate of new innovative biopharmas entering the clinic with therapies that promise to make a difference for patients who have no good options today. There's an urgency to develop these drugs and get to market as fast as possible while maintaining a first-class development program that can withstand the rigors of regulatory scrutiny.

In this Endpoints Webinar, we've invited a group of experienced cancer drug developers to discuss key strategies in managing an orphan drug program.

Matthew Mollan, Ph.D., Regional Head of Operations at Catalent, will review the developability challenges of orphan oncology drugs and provide recommendations for innovator companies to consider in order to avoid common pitfalls during scale-up.

Registrants will also get unique access to a Catalent executive summary titled: Exclusive Orphan Drugs Industry Survey Results

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Ethan Perlstein

Ethan Perlstein

Founder and CEO, Perlara

Over the course of the last 20 years, first as a graduate student at Harvard University in the Department of Molecular and Cell Biology with PhD advisor Professor Stuart Schreiber and then as an independent postdoctoral fellow at the Lewis-Sigler Institute at Princeton University, Dr. Ethan Perlstein developed an approach to studying old drugs and discovering new drugs in model organisms called evolutionary pharmacology. In 2014, he founded Perlara PBC, the first biotech public benefit corporation (bioPBC) partnering with entrepreneurial families to cure rare genetic diseases. Ethan is also CEO of Maggie's Pearl, a clinical-stage biotech joint venture between Perlara and a PMM2-CDG family based in Michigan.

Matthew Mollan

Matthew Mollan

Regional Head of Operations, Early Phase Development

Matt joined Catalent in 2012 as General Manager, Kansas Ci​ty following the acquisition of the site from Aptuit, and during his tenure, successfully grew the business from less than $30M in revenue to over $100M last year while overseeing the launch of 16 new oncology and rare disease products over that timeframe. Prior to joining Catalent, Matt was with Aptuit from 2007 following a number of years with Pfizer and Warner-Lambert in roles of increasing responsibility.

Matt holds a Bachelor’s in Pharmacy and a Doctorate in Pharmaceutical Sciences from Rutgers University.

Arsalan Arif

arsalan arif

Founder & Publisher, Endpoints News

Arsalan Arif is a news media entrepreneur who set out in 2015 to build his vision of an independent biotech news company at Endpoints News.