An Open Forum on Sci­en­tific and Reg­u­la­tory Issues — March 2–4, 2008 — Boston Mar­riott Copley Place Hotel

The Bar­nett Insti­tute of Chem­ical and Bio­log­ical Analysis at North­eastern Uni­ver­sity is proud to announce its role as host of BIOGENERICS 2008: An Open Forum on the Sci­en­tific and Reg­u­la­tory Issues, held from March 2–4, 2008. By the year 2010, $20 bil­lion worth of pro­tein phar­ma­ceu­ti­cals will be off patent and in a market open to generic man­u­fac­turers. The Insti­tute will act as a cat­a­lyst to assemble influ­en­tial industry leaders on the global level for a com­pre­hen­sive and open dis­cus­sion about the ques­tions and issues sur­rounding this devel­op­ment. The unique con­fer­ence will show­case the latest sci­en­tific advances, spe­cific case his­to­ries and dis­tin­guished panels.

The Bar­nett Insti­tute at North­eastern is a leader in bio­an­a­lyt­ical research. This con­fer­ence under­scores this lead­er­ship role in ana­lyt­ical and sci­en­tific aspects of pro­tein analysis by bringing all con­stituen­cies together to address unmet sci­en­tific needs of regulators.

The deci­sions addressing the bio­generic industry will have far reaching impacts in the futures of the phar­ma­ceu­tical, health­care and biotech­nology indus­tries world­wide,” said Barry L. Karger, Director of the Bar­nett Insti­tute and James L. Waters Chair at North­eastern. “BIOGENERICS 2008 will bring the highest levels of industry and reg­u­la­tory lead­er­ship into an open and detailed dis­cus­sion, focusing on the sci­en­tific method­ology needed by the FDA to deter­mine that bio­generics are appro­pri­ately safe and effective.”

The deci­sions on bio­generics will be of cru­cial impor­tance to other areas as well, including research, acad­emia, insur­ance, advo­cacy, ven­ture cap­ital and the media. For the first time ever, this three-​​day con­fer­ence will bring together a dis­tin­guished group of aca­d­e­mics, indus­trial leaders, reg­u­la­tors, lawyers and leg­is­la­tors from all of these areas to dis­cuss impor­tant con­cerns facing the bio­generics (biosim­i­lars) industry.

A wel­come address via video is sched­uled to be given by Sen­ator Edward Kennedy, Chairman of the U.S. Senate Com­mittee on Health, Edu­ca­tion, Labor and Pen­sions on Sunday, March 2nd.

The fol­lowing two days of events will include ple­nary lec­tures fol­lowed by pre­sen­ta­tions and panel discussions:

Monday, March 3rd

o Ple­nary Lec­ture by Dr. Ran­dall Lutter, Deputy Com­mis­sioner for Policy, U.S. Food and Drug Admin­is­tra­tion (FDA)

o Bio­an­a­lyt­ical – Pre­sen­ta­tions and panel dis­cus­sion by Barry L. Karger, Director of the Bar­nett Insti­tute and James L. Waters Chair, North­eastern Uni­ver­sity (Panel Chair); Charles DiLib­erti, Vice Pres­i­dent of Sci­en­tific Affairs, Barr Lab­o­ra­to­ries, Inc.; Reed Harris, Director of Ana­lyt­ical Devel­op­ment, Genen­tech, Inc.; Ram Sasisekharan, Pro­fessor of Bio­log­ical Engi­neering, MIT; Emily Shacter, Chief, Lab. Of Biochem., Div. of Ther­a­peutic Pro­teins, CDER, FDA; and Huub Schellekens, Pro­fessor, Director of the Cen­tral Lab Animal Insti­tute, Utrecht University.

o Immuno­genicity – Pre­sen­ta­tions and panel dis­cus­sion by James D. Green, Sr. Vice Pres­i­dent of Pre­clin­ical and Clin­ical Devel­op­ment Sci­ences, Biogen Idec, Inc. (Panel Chair); Takeo Hayakawa, Senior Advisor, Phar­ma­ceu­tical and Med­ical Devices Agency, Japan; Amy Rosen­berg, Director, Divi­sion of Theraspeutic Pro­teins, FDA; Meena Sub­ra­manyam, Sr. Director, Clin­ical Sci­ence & Tech­nology, Biogen Idec, Inc.; and Steve Swanson, Director of Clin­ical Immunology, Amgen, Inc.

Tuesday, March 4th

o Ple­nary Lec­ture by Dr. Jean-​​Hugues Trouvin, Chair of Bio­logics Working Party, Euro­pean Med­i­cines Agency (EMEA).

o Bio­man­u­fac­turing – Pre­sen­ta­tions and panel dis­cus­sion by Toni Lubiniecki, Vice Pres­i­dent of Tech­nology Transfer & Project Plan­ning, Cen­tocor, Inc. (Panel Chair); Stuart Builder, Con­sul­tant, Strategic Biode­vel­op­ment; William S. Han­cock, Pro­fessor of Chem­istry and Brad­street Chair, Bar­nett Insti­tute, North­eastern Uni­ver­sity; and Ganesh Venkataraman, Sr. Vice Pres­i­dent, Momenta Pharmaceuticals.

o Reg­u­la­tory – Pre­sen­ta­tions and panel dis­cus­sion by Stephen G. Dilly, CEO, APT Phar­ma­ceu­ti­cals, Inc. (Panel Chair); Robert Gar­nick, Sr. Vice Pres­i­dent of Reg­u­la­tory, Quality and Com­plience, Genen­tech, Inc.; Mathias Hukkel­hoven, Sr. Vice Pres­i­dent, Global Head of Drug Reg­u­la­tory Affairs, Novartis; Peter Hutt, Sr. Counsel, Cov­ington & Burling, LLP; and Alison Lawton, Sr. Vice Pres­i­dent, Reg­u­la­tory Affairs and Quality Sys­tems, Gen­zyme Corp.

Reg­u­la­tory agen­cies have been responding to the gen­eral public’s need for inex­pen­sive prod­ucts. This con­fer­ence will focus on prod­ucts that are far more com­pli­cated than small mol­e­cule generic drugs, and will explore what type of equip­ment is needed to test sim­i­larity, in addi­tion to the types of sci­ence needed for effec­tive reg­u­la­tion of products.

For more infor­ma­tion about the BIOGENERICS 2008 con­fer­ence, please visit www​.bar​nett​.neu​.edu/​b​i​o​g​e​n​e​r​ics or con­tact Samantha Fodrowski at 617–373-5427 or at s.​fodrowski@​neu.​edu.

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.

About The Bar­nett Institute

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.