U Mass Boston International Epidemics Honors Class

October 18, 2011

Berkeley W. Cue, PhDUMass-Boston 1965-1969 (BA in Chemistry)

BWC Pharma Consulting, LLCctcuefamily@aol.com

@greenchembuzz

U Mass Boston (U Mass Gas), the Early Years

• I was part of the first class starting in 1965• Classes were held while construction was occurring• People wandered in to classrooms to pay their gas bill• For freshman chemistry labs we watched ACS movies of lab

experiments

100 Arlington Street, Park Square, Boston

1. In terms of patents and pharmaceuticals, why do you think there is so much information floating around in the media and news that focus on the idea of monopolies, corruption, etc., giving pharmaceutical companies and practices an overall bad name?

First Generation Anti Viral Drugs

(Symmetrel) Amantidine HCl (Flumadine) Rimantidine HCl

Second Generation Anti Viral Drugs

Relenza (zanamavir) Tamiflu (oseltamavir)

Sales ≠ Profit• For every pharmaceutical sales dollar

– 20% represents cost to manufacture the drug– 20% goes to R&D to discover new drugs– 20% goes to pay governmental taxes– 20% goes to S&GA– 20% goes to shareholders who invest in the

company

So $3 billion sales = $600 million profits

Source: David Taylor, wca environment, 2nd International Conference on Sustainable Pharmacy: Incentives and perspectives – Osnabruck 2010

The innovation problem

In the 10 years since 1995 R& D expenditure has trebled whilst success rate has halved.

Sometimes Production Can Be Stopped for GMP/Quality Issues

• Genzyme Completes Remediation of GMP Issues at Major Facility– Genzyme has completed all necessary actions to respond to the FDA’s

recent warning letter that cited GMP deficiencies at the company’s Allston, Mass., production facility. “The FDA has begun the inspection process at the plant to determine if the deficiencies cited in its warning letter have been satisfactorily addressed,” the company says in a statement last month.

– Resolving the warning letter is important for the company because the Allston production site manufactures Genzyme’s best-selling biologics — Gaucher’s disease treatment Cerezyme (imi-glucerase), Myozyme (alglucosidase alfa) for Pompe disease and Fabrazyme (agalsidase beta) for Fabry disease. Fill and finish activities for the biologics Aldurazyme (laronidase) and Thyrogen (thyrotropin alfa) also are conducted at the plant.

– http://www.fdanews.com/newsletter/article?articleId=117739&issueId=12722

Flu Vaccine Shortage

• AURORA, Colo. (Feb. 2, 2009) - Influenza alone causes more than 20,000 hospitalizations and 260 deaths in children in the United States annually. During the 2004-2005 flu season, a severe vaccine shortage occurred across the United States because all flu vaccine produced by one major manufacturer was deemed unusable. – http://www.uchsc.edu/news/newsrelease/2009/feb/

vaccine.htm

H1N1 Vaccine Shortage• October 17, 2009-Officials at the federal Centers for

Disease Control and Prevention had expected about 40 million doses of the swine flu vaccine to be distributed by the end of the month, but it looks as though a maximum of 28 million to 30 million doses will actually be shipped, said Dr. Anne Schuchat, director of the CDC's National Center for Immunization and Respiratory Diseases. That's about 25% fewer than expected. – http://www.latimes.com/news/nationworld/nation/la-sci-

swine-flu17-2009oct17,0,4189877.story