The Bar­nett Insti­tute of Chem­ical and Bio­log­ical Analysis at North­eastern Uni­ver­sity has received a gen­erous lead­er­ship gift from Louis Bar­nett B’44, H’77, and his family. The $3 mil­lion dona­tion includes a $1 mil­lion chal­lenge grant from the family whose 1983 endow­ment gift is respon­sible for the name of the inter­na­tion­ally rec­og­nized research Insti­tute. The gift will help launch the new Center for Advanced Reg­u­la­tory Analysis (CARA), including the GMP/​GLP (Good Man­u­fac­turing Practices/​Good Lab­o­ra­tory Prac­tices) Reg­u­la­tory Laboratory.

Devised in col­lab­o­ra­tion with leaders of the biotech­nology industry, CARA will play a crit­ical role in ensuring drug safety and quality for all con­sumers by being a center that focuses on the reg­u­la­tory analysis of biotech­nology prod­ucts, including biosim­i­lars, and will serve as a resource to those phar­ma­ceu­tical com­pa­nies devel­oping new drugs. The GMP/​GLP Reg­u­la­tory Lab­o­ra­tory will val­i­date methods devel­oped in the research arm, as well as con­duct reg­u­la­tory analysis.

We are grateful to the Bar­nett family for their on-​​going sup­port of the pio­neering endeavors of the insti­tute. They are helping us launch a new ini­tia­tive that has enor­mous impli­ca­tions for human health and well-​​being,” said Joseph E. Aoun, Pres­i­dent of North­eastern University.

Louis and Madlyn Bar­nett, who live in Fort Worth, Texas, have been enthu­si­astic sup­porters of the Bar­nett Insti­tute, along with their three chil­dren, Laurie, Rhoda and Eliot. Laurie and Eliot, who sit on the Institute’s strategic advi­sory board, empha­sized their father’s devo­tion to sci­en­tific research and the family’s com­mit­ment to the Bar­nett Insti­tute under the lead­er­ship of its director, Pro­fessor Barry Karger, by saying, “This dona­tion is a way for us to show our con­tinued sup­port of the insti­tute and, more impor­tant, show our father that we sup­port his dreams as the insti­tute moves for­ward for many years to come.”

Louis Bar­nett, a long­time friend and col­league of Dr. Karger, refers to the Bar­nett Insti­tute as his “pride and joy” for rep­re­senting the future of research and leading-​​edge tech­nology. “Any­thing that Dr. Karger sug­gests to me is a good thing to fund. He is one of the leading people in his field in the world,” said the phil­an­thropist, whose career started with helping develop some of the first plastic poly­mers at Gen­eral Elec­tric and later went on to founding one of the largest inde­pen­dent houseware-​​products busi­nesses in the U.S.

We are trying to advance the sci­ence of reg­u­la­tory analysis and we wouldn’t be where we are without the Bar­netts’ gen­erous finan­cial sup­port,” said Pro­fessor Barry Karger, Director of the Bar­nett Insti­tute of Chem­ical and Bio­log­ical Analysis at North­eastern. “One of the most impor­tant things we can do is come up with cre­ative ways of inter­acting with industry, gov­ern­ment, and health-​​care institutions.”

With the recent fatal­i­ties asso­ci­ated with heparin making national head­lines, there is a looming crisis in com­pre­hen­sively deter­mining the com­po­si­tion of bio­log­ical agents used as drugs. The need for inde­pen­dent over­sight that com­bines reg­u­la­tory as well as cutting-​​edge research exper­tise is cru­cial in a time when $20 bil­lion worth of pro­tein phar­ma­ceu­ti­cals will be off-​​patent in two years, opening the door to com­plex biosim­i­lars that must be care­fully ana­lyzed and regulated.

The efforts of the new center are expected to have a global impact on the biotech­nology industry. CARA will develop first-​​rate drug-​​analysis methods by working to pro­duce new instru­ments for use in reg­u­la­tory envi­ron­ments and by training sci­en­tists in the latest techniques.

Working closely with Robert Gar­nick, PhD ’77, retired Senior Vice Pres­i­dent for Reg­u­la­tory, Quality and Com­pli­ance Affairs at Genen­tech, and sev­eral other key alumni from the biotech­nology industry, CARA researchers will assess whether new chem­ical analysis tech­nolo­gies using dif­ferent instru­ments, dif­ferent labs and dif­ferent oper­a­tors can be suc­cess­fully val­i­dated as sound methods.

In addi­tion to con­sid­ering opening a training academy to reach as many workers as pos­sible, the Center will also

- eval­uate the capa­bil­i­ties of existing analysis tech­nolo­gies by con­ducting cross-​​platform evaluation

- pro­vide inde­pen­dent analyses of drugs pro­duced in the U.S. and overseas

- hold joint work­shops with the FDA to dis­cuss new technologies

- develop training and accred­i­ta­tion stan­dards for reg­u­la­tory workers

Cel­e­brating its 35th anniver­sary, the Bar­nett Insti­tute is Northeastern’s oldest and most suc­cessful research center, rec­og­nized world­wide as one of the leading aca­d­emic cen­ters for the analysis and char­ac­ter­i­za­tion of pro­teins. Boasting an endow­ment of $9 mil­lion, with external funding nearing $7 mil­lion annu­ally, and almost a thou­sand pub­lished papers and sev­enty patents, the Institute’s exper­tise in sep­a­ra­tion sci­ence, mass spec­trom­etry, and NMR and trace analysis for the study of pro­teins and related sub­stances pro­vides a strong foun­da­tion for eval­u­a­tion and char­ac­ter­i­za­tion of pro­tein drugs and biosim­i­lars. As an aca­d­emic center, the Bar­nett Insti­tute is free from com­mer­cial bias, pro­viding a unique ability to col­lab­o­rate with reg­u­la­tory author­i­ties in the devel­op­ment of val­i­dated technologies.

For more infor­ma­tion, please con­tact Renata Nyul at 617–373-7424 or at r.​nyul@​neu.​edu.

About The Bar­nett Insti­tute at North­eastern University

The Bar­nett Insti­tute at North­eastern Uni­ver­sity is rec­og­nized inter­na­tion­ally as one of the pre­mier cen­ters for cutting-​​edge research and advanced training in ana­lyt­ical chem­istry for bio­med­ical appli­ca­tions. Estab­lished in 1973, the Institute’s close ties to the med­ical com­mu­nity and industry in Boston and beyond, along with its active pro­gram of licensing tech­nology, pro­vides for many “real life” appli­ca­tions of research advances which have led to innu­mer­able pub­lished papers and 70 patents.Bioanalytical research is at the inter­face of biology, med­i­cine, infor­matics and chem­istry. Stu­dents and staff in the Insti­tute are trained to think ana­lyt­i­cally and to under­stand the com­plexity of bio­log­ical sam­ples. The Institute’s entre­pre­neurial approach and com­mit­ment to excel­lence has trained over 300 stu­dents to become leaders in industry and acad­emia worldwide.

About North­eastern

Founded in 1898, North­eastern Uni­ver­sity is a pri­vate research uni­ver­sity located in the heart of Boston. North­eastern is a leader in inter­dis­ci­pli­nary research, urban engage­ment, and the inte­gra­tion of class­room learning with real-​​world expe­ri­ence. The university’s dis­tinc­tive coop­er­a­tive edu­ca­tion pro­gram, where stu­dents alter­nate semes­ters of full-​​time study with semes­ters of paid work in fields rel­e­vant to their pro­fes­sional inter­ests and major, is one of the largest and most inno­v­a­tive in the world. The Uni­ver­sity offers a com­pre­hen­sive range of under­grad­uate and grad­uate pro­grams leading to degrees through the doc­torate in six under­grad­uate col­leges, eight grad­uate schools, and two part-​​time divi­sions. For more infor­ma­tion, please visit www​.north​eastern​.edu.