Scott Stern Kellogg School of Management speaks about “New Drug Development: From Laboratory to Blockbuster to Generic,”

Scott Stern, Associate Professor, Kellogg School of Management, speaks on the topic of, “New Drug Development: From Laboratory to Blockbuster to Generic,” at the Judicial Symposium on The Pharmaceutical Industry: Economics, Regulation, and Legal Issues, hosted by the Northwestern Law Judicial Education Program

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Health Council of Canada says some prescription drugs approved for use in Canada may be less safe than consumers think, due to poor Pharmacovigilance/Post Market Surveillance rules

Canada’s Food and Drugs Act relies on drug companies to submit adverse reaction reports, which drug users submit if they suspect they are experiencing negative side effects. Drug users also can submit the reports directly to Health Canada, but it still leaves the government to rely on outside parties to report problems.

In 2009, Health Canada received 27,496 adverse reaction reports — a number that has increased steadily over time. Health Canada needs the power to require pharmaceutical companies to conduct more post-market monitoring and to share the results, Abbott said. The council also would like to see the federal government hold the power to impose penalties for companies that do not comply.

Health Canada is already modernizing its regulations to allow for stronger monitoring after the drug goes to market. The government also has established a Drug Safety and Effectiveness Network to study the safety of drugs in the market.

The Canadian pharmaceutical industry welcomes modernized regulation, said Mark Ferdinand, vice-president of police research and analysis for RX&D, the pharmaceutical industry association in Canada.

However, Ferdinand said consumers should recognize that there is already a formal, rigorous post-market reporting system in place.

“No one has any interest in seeing a drug used inappropriately in the real world. A lot of people have invested a lot of time, effort, certainly money … to ensure what they are producing and what they are providing to patients is safe and effective,” he said.

Ferdinand said drug safety often depends on the way medicine is prescribed. He said it has to be “the right medication, for the right person, at the right time.”


Eli Lilly CIO Michael Heim says Lilly will increase use of cloud computing in clinical data management

Eli Lilly’s CIO Michael Heim says that the drug giant’s right to know where in the cloud its data resides, and to know the provider’s disaster recovery plans are chief issues that will drive the use of cloud computing in clinical data within drug discovery and development projects.

An interview with Michael Heim is available at InformationWeek

personalized medicine might be making drug development more complicated

According to a new report from the Tufts Center for the Study of Drug Development at Tufts University 12 to 50 percent of the drugs companies are developing, depending on the company, involved a personalized medicine approach.

The Tufts report is based on a survey of 25 companies, large and small, to which 16 companies responded, as well as interviews with representatives of 13 companies.

Relatively few drugs are now accompanied by such so-called companion diagnostic tests. They are most common in oncology. The breast cancer drug Herceptin, for instance, is given only to women whose tumors have an abundance of a protein called Her2.

According to the report Other key therapeutic areas in which personalized medicine is making headway include cardiovascular, central nervous system, and immunologic therapies, whereas personalized medicine development is just getting started for metabolic and respiratory therapies, as well as virology.

 

World Ecconomic Forum India Economic Summit | Collaborative strategy for drug discovery

The Coverage of the World Ecconomic Forum India Economic Summit is available at  http://blog.livemint.com/wefindia/

I was more interested in the Collaborative Strategy for Drug Development read the interview with Suven Lifesciences a prefered partner to Eli Lilly and Co in Drug Discoverya dn Development in India. http://www.livemint.com/2009/11/10204140/India-Economic-Summit–Collab.html

 

India looses USD 1 Billion Investment in Drug R&D to China due to lax Indian patent laws-

Did I really read the news correct or was I just plain drunk on a weekend while reading it. Turns out it is true. Just a week after the Novartis CEO has blasted the Indian IP laws, Novartis has announced plans to invest 1 Billion US Dollar in China for Drug Discovery and Developement. The plan calls for hundreds of new hires and new research facilities in Changshu.

Novartis is  waging a high-stakes court fight over patent protection for the cancer blockbuster Gleevec, No wonder the Novartis CEO Daniel Vasella had enough and announced that the subcontinent’s reputation as a low-cost R&D center is losing its luster.

In 2006, Novartis made a commitment to build a $125 million R&D facility in Hyderabad. The next year, after the company lost a patent battle over its blockbuster cancer drug, Gleevec (
I thought China also didnt had a great IP law to speak of. How many times we saw news stories about fake chinesse counterbrands.
But here is the upside , the chineese dont challenge the patents in Courts. China is behind India in pharmaceutical chemistry, so they are not so keen in spending time to another way to manfacture the drug. But China is way ahead of India in Medicinal Chemistry,  pre-clinical and toxicological study infrstructre. SFDA the Chineese equivalent of FDA, is taking a lot bold steps and investment to ensure fast trial registration, proper Pharmacovigilance reporting etc. net net it is faster to run R&D in China
India is yet to have solid infrastructre or plans for clinical trial monitoring or pharmacovigialance . The WHO fund for a national pharmacovigilance monitoring policy and infrastructre has already elasped in 2008. And we are yet to see any increase in number of adverse events reported in India .
India will make similar progress, he opined, when Indian pharmaceutical companies have more IP they want to protect. Then, the companies will force the government to act and increase IP protection.
Pfizer announced it would close six out of its 20 R&D facilities around the globe as part of its post-Wyeth-acquisition consolidation but the company’s Shanghai R&D operation is not affected – an implicit endorsement of China’s R&D.
Ok we Indians will wait till then , and just pray that the Red Dragon is not going to burn the Indian the pharma industry till that time

Shorter Path to drug Discovery share research on failed compounds between companies the new MIT lead approach-

The moment I learned about this new project started by MIT, I could think of only one thing, I want to be part of it.  The Massachusetts Institute of Technology, have, started a pharmaceutical innovation program  to help drug companies adapt some successful approaches now used in aeronautics, like lean management and information-sharing among rivals.

The M.I.T. initiative, called NEW Drug Development ParadIGmS or NEWDIGs has garnered the support of

  • Aetna
  • Bayer Healthcare
  • Brookings Institution
  • Centers for Disease Control and Prevention (CDC)
  • Eli Lilly and Company
  • U.S. Food and Drug Administration (FDA)
  • Johnson & Johnson
  • Medco Health Solutions Inc.
  • Pfizer Inc.
  • Quintiles Transnational Corp.
  • Vertex Pharmaceuticals Inc.
  • WellPoint Inc.

One short-term goal is to identify, and rectify, the root causes of bottlenecks in the existing system. Longer term, the ambition is to create new prediction models, new ways to share information about the biology of diseases, and a new inclusiveness involving earlier participation of regulators, health insurers, health care providers and patients.

So How do they plan to change the way we conduct drug discovery and developement?

1.  share information about compounds they have tried and shelved, for reasons like toxicity or inefficacy.

Results of clinical trials are availale online for free, whether or not they succeed. But no pharma company talks about projects that fail at an earlier stage. A result is that companiesother  waste many millions going down experimental paths that their competitors have already tried and failed.

A visual Path of the changes suggested in the Enterprise Transformation is shows here , the document can be downloaded from the MIT website

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