North­eastern Uni­ver­sity and the U.S. Food and Drug Admin­is­tra­tion (FDA) have signed a part­ner­ship agree­ment to advance methods of analysis for devel­oping safe, complexprotein-​​based drugs known as bio­log­ical drugs.

The agree­ment estab­lishes a research col­lab­o­ra­tion, along with edu­ca­tional, training and out­reach pro­grams for mem­bers of the FDA, industry and acad­emia in the areas of biotech­nology and ana­lyt­ical chemistry.

Northeastern’s Center for Advanced Reg­u­la­tory Analysis, housed within the Bar­nett Insti­tute of Chem­ical and Bio­log­ical Analysis, will lead the research projects, which include the devel­op­ment of methods that assess the struc­tural attrib­utes, safety and effi­cacy of bio­log­ical drugs.

The center will also develop crit­ical new tech­nology to ana­lyze these drugs and sup­port the devel­op­ment ofbi­o­log­ical products.

North­eastern has the unique exper­tise and state-​​of-​​the-​​art equip­ment to test and ana­lyze the most com­plex sam­ples and find toxic impu­ri­ties that could oth­er­wise remain hidden even through clin­ical trials,” explains Barry Karger, director of the Bar­nett Institute.

Our part­ner­ship with the FDA will ulti­mately help enhance and accel­erate clin­ical trials, intro­duce safe and effec­tive new drugs, lower pre­scrip­tion costs, and save lives,” Karger con­tinues. “We hope to strengthen this rela­tion­ship with the FDA and find new oppor­tu­ni­ties for collaboration.”

As part of the agree­ment, North­eastern and the FDA will develop joint research pro­grams and training activ­i­ties for part­ners in industry and acad­emia. They will also seek to enhance the vis­i­bility of their work through training activ­i­ties, meet­ings and symposia.

The col­lab­o­ra­tion with the FDA builds on Northeastern’s goals of devel­oping pro­grams and training that advance the field of reg­u­la­tory sci­ence. The Uni­ver­sity plans to unveil a pro­fes­sional sci­ence master’s degree in reg­u­la­tory sci­ence later this year.

To learn more about the­Bar­nett Insti­tute of Chem­ical and Bio­log­ical Analysis at North­eastern Uni­ver­sity, visit: http://​www​.north​eastern​.edu/​b​a​r​n​e​tt/