On Pharma

March 30, 2007

Deflating Pharma’s Acronyms and Fake Diversity Programs

Filed under: Miscellany — pharmamanufacturing @ 12:44 p.03.

Some recent posts on Pharma Giles will be appreciated by any of you who have been subjected to overinflated corporate initiatives with acronyms to match, such as WIND (Ways of Increasing New Developments).  Or obviously forced corporate diversity programs, as skewered in “De longa you verk here di verse it gets” , which includes an interview with global HR director Siobhan Man Hater.  Click on to watch if you have never seen the classic “Diversity” episode of “The Office (U.S.).  After all, it’s Friday and you won’t have to see them again until Monday.

 -AMS

The Rise of India’s Tata: Latest New Project’s With GSK

Filed under: Miscellany — pharmamanufacturing @ 12:44 p.03.

It is becoming increasingly difficult to find a pharmaceutical IT/engineering project today that doesn’t involve Tata Consultancy Services (TCS).  This week brought news of a project with GSK. Unedited press release below.

GlaxoSmithKline (GSK) and Tata Consultancy Services announced an agreement to establish a global drug development support centre in Mumbai to help meet the demands of the growing GSK pipeline.Under a multi-year multi-million dollar contract agreed by the two companies, TCS will provide a variety of services in clinical research, including Clinical Data Management and Clinical Submissions Support. The partnership will help GSK expand capacity in response to increased efficiency demands, leverage the high-quality talent pool in India, and benefit from cost and process improvements.

The centre will house a TCS team of highly skilled professionals including pharmacologists, PhDs in life sciences, post-graduates in Pharmacy, and individuals with a life sciences background experienced in clinical-data management and programming. TCS will bring in its strong domain expertise, superior talent management skills, flexible operating models, proven transition capabilities and performance driven processes. (more…)

How Good Are Your Manufacturing Operations? Take Our Survey and Find Out

Filed under: Operational Excellence, The Pharma Industry — pharmamanufacturing @ 12:44 p.03.

Are Toyota tools and Six Sigma working for you; where do they fall short?  Is management empowering staff to make the best decision, or taking a top down approach? Are you going paperless, using new technology, or sticking with the status quo?   Take our benchmarking survey, learn what your peers are doing and compare results (to be interpreted in our next issue).

-AMS

FDA Inspections: Quality vs. Quantity; Is it Time to Remove the “F” from FDA?

Filed under: FDA and Regulatory Issues, Miscellany — pharmamanufacturing @ 12:44 p.03.

By its own admission, FDA is doing fewer food and pharma inspections, a fact that Ed Silverman wrote about yesterday on Pharmalot. It seems a dangerous trend, and Representative Waxman first pointed it out last Summer, correlating it with drug quality and safety problems.

Maybe I’ve just drunk the FDA Kool-Aid, but, in a time where resources are dwindling,  I do believe in prioritizing risk and prioritizing inspections, so that those facilities that pose the greatest risk are inspected first. This is part of an overall FDA plan that makes sense and is showing positive results.

Why should one take a “traffic ticket” approach and assume that a large number of unecessary and poorly done inspections trumps a smaller number of risk-prioritized inspections?

But I think that it’s time for the Agency to “decouple” Food from its activities, so that it can focus on drugs, especially since that field is becoming so complex, and leave food inspections to the Department of Agriculture, or perhaps, as has been proposed, a separate Agency. 

Imagine a field inspector with a science degree (could be in Geology) inspecting the Fulton Fish Market in the morning, Novartis’ upstate facility in the afternoon, and a Massachusetts biopharmaceuticals plant the next day?  And also remember that, apart from the Inspectorate Training program, overall  continuing education and training budgets for  inspectors and reviewers have been cut at FDA for the past few years. 

Can anyone be expected to be “on top of” both food and pharma/biotech anymore? I don’t think it’s a question of laxity, but suggests a need for more funding from the government, more training, resources and focus.

Novartis to Discontinue Zelnorm; Personalized Marketing Needed for NSAIDs

Filed under: Miscellany — pharmamanufacturing @ 12:44 p.03.

More from the FDA.  The ailment that this drug treats is clearly linked to high stress levels, suggesting that non-drug approaches might be explored: yoga, acupuncture?

But, on the NSAID front, it was interesting to see that Celebrex may be making a comeback.  Unfortunately, some former Vioxx takers know that it doesn’t always work, at all.  More arguments for personalized medicine.

In the meantime, though, why not use some of the tools of personalized medicines (e.g. genomic profiling) and run detailed safety studies to determine which groups of patients are not at risk for problems, and be able to market Vioxx, Bextra, Celebrex, on that selective basis?  Each patient, as well as physician, could be given a complete list of the possible risks, likelihood of problems and have to sign a release form? 

Perhaps this is already being done? 

Can the Industry Get Past Trovan? GSK Registers Globorix, New Good-Will Meningitis Vaccine in Africa. Who Will Be Next?

Filed under: Miscellany — pharmamanufacturing @ 12:44 p.03.

Last night, I watched an old episode of Numbers that touched on drug development’s risk vs. benefit issues. Guess which part pharma played?  The villain, of course. Just as it did in The Constant Gardener, the book and later the film, works of fiction that were still inspired by the tragic results of meningitis vaccine development in Africa, and clinical trials of Pfizer’s Trovan. (For more on this, on this read Paul Thomas’ previous post about the Washington Post’s coverage last year, and Pfizer’s response)

While that tragedy must never be forgotten or diminished, it was still encouraging to read today of GSK’s registering its new meningitis vaccine, Globorix, in Africa, a drug which took over $400 million to develop, but from which the company does not expect to profit. 

Most of the “neglected” diseases that kill most people in the world each year are not profitable ones.  Merck developed its ivermectin years ago for humanitarian reasons, and more companies should (and some are) finding ways to do this.  Bills Clinton and Gates are helping these efforts, to their credit.

News of Globorix was also a reminder that, despite the many scandals and problems plaguing the drug industry, it still does manage to save lives.

Over the past few years, pharma companies have donated over $1 billion worth of medicines to sub-Saharan Africa. Such donations are excellent good will gestures and P.R., but what’s needed now are new models that allow drug companies to preserve their IP, and yet allow developing nations to become self-sufficient in producing these medicines on their own.  “Give a man a fish vs. teach a man to fish.” 

This drama is playing out in Thailand, India, Africa and around the world. Perhaps GSK’s model with this drug could be the template for more such efforts in the future?

But here is what the BBC News had to say about Globorix.

http://news.bbc.co.uk/1/hi/health/6508985.stm

New low-cost vaccine for Africa By Angus Crawford

BBC News
For the first time, Europe’s largest drugs company, GSK, is starting the registration process for a vaccine from which it never expects to make money.  Globorix will only be used in Africa to prevent meningitis at prices that may never cover its research costs.  Experts say it is a sign big companies are changing their business practices, but some critics say it is not enough. (more…)

Biotech Faces Acute Skills Shortage: Time for Another Sputnik?

Filed under: Miscellany, Operational Excellence — pharmamanufacturing @ 12:44 p.03.

Bloomberg just ran an article on the shortage of skilled biotech professionals, which has companies like Amgen and Genentech scrambling to find new talent.  Isn’t it time for a Sputnik-like approach to science education in the U.S?  Perhaps some of the billions being spent on certain tragic and fruitless activities abroad right now could be funneled into a radical revision of the educational system? To paraphrase Mr. Rumsfeld, as our contributor Emil Ciurczak recently did, if the nation doesn’t invest, it will be stuck with the workforce it has rather than the workforce it wants or needs.  Here is the article.

March 29, 2007

Relenza Update: Biota Files Amended Statement of Claim Against GSK

Filed under: Miscellany — pharmamanufacturing @ 12:44 p.03.

Today marked the day that lawyers for Australia’s Biota filed amended statement of claim against GSK for what they allege is the company’s failure to promote the drug.  We touched on this very briefly a few days ago, but noticed that Pharmalot had run a nice update of this yesterday, including a statement from Biota.  For more information than you probably want to see, including the full statement of claim summary, click here.

Here’s a “sound bite” from Biota’s legal representatives:

 ”Initial GSK management was enamored with Relenza because of its safety and efficacy against influenza. New management came in and developed an exit strategy for the drug and abandoned Relenza while assuring its developer, Biota, that GSK was using its best endeavors to market. The evidence shows a cover up of this decision.

WHO and other public health organizations recognized Relenza’s superiority for avian flu preparedness, yet GSK decided not to fill requests from foreign governments that wanted to stockpile the drug. Relenza global sales are only 3 % of those for Tamiflu – a drug that published reports shows people with bird flu develop a resistance to…”  It’s an interesting case study; both Relenza and Tamiflu appear to pose risks to some patient groups and there were some delivery and safety issues with Relenza (but Tamiflu isn’t free from issues of its own either).  We’ll cover it in more detail in our next issue.

March 28, 2007

Singapore Flexes its Muscle: Genentech Invests in New Facilities, Lilly Expands “Translational Medicine” Facility

Filed under: Miscellany, The Pharma Industry — pharmamanufacturing @ 12:44 p.03.

More harbingers of BIO, news from Singapore, which has been pouring investment into its biotech, biopharma  and pharmaceutical manufacturing base, recruiting top scientists and providing world-class workforce training.

The results are clearly starting to show.  Genentech is setting up one new biopharma manufacturing facility there, while Eli Lilly is expanding an existing facility to become a model for  translational medicine, and the development of new drugs using a collaborative, interdisciplinary approach and sophisticated IT . 

More on both new projects below (verbatim from press releases)

Genentech to Set Up Singapore’s First Microbial-Based Biopharmaceutical Manufacturing Facility

The Singapore Economic Development Board (EDB) announced that Genentech, Inc., one of the world’s leading biotechnology companies, has decided to establish a commercial scale microbial-based biologics manufacturing facility in Singapore – a first for Singapore’s fast growing biopharmaceuticals sector.  This is the first manufacturing investment by a U.S. biotechnology company in Singapore.
 
The estimated capital expenditure of the plant is approximately US$140 million.  It will have approximately 100 employees at steady state and provide 1,000 litres of capacity for the production of E. coli derived products.  This facility, which will be located in Tuas Biomedical Park, is intended for the manufacture of bulk LUCENTIS® (ranibizumab injection), a treatment for wet age-related macular degeneration.  Construction is expected to begin in the second quarter of 2007 with licensure anticipated in early 2010.
 
The planned Genentech plant is Singapore’s fourth biologics manufacturing facility.  Other biologics plants presently under construction in Singapore include GlaxoSmithKline Biologicals’ vaccines facility, as well as Switzerland-based biologics contract manufacturer Lonza’s two facilities, including its joint venture with Bio*One Capital.  In addition to its latest investment, Genentech had previously entered into a supply agreement with Lonza for the manufacture of certain Genentech products at the Lonza facility currently under construction in Singapore.  The agreement includes an exclusive option for Genentech to purchase the facility during the period from 2007 to 2012. 
 
“Singapore has established itself as one of the world’s most competitive and trusted manufacturing sites for pharmaceutical bulk actives and final dosage forms,” said Mr Philip Yeo, Chairman, Agency for Science, Technology and Research (A*STAR).  “We are now actively building up a critical mass for biologics manufacturing.  We believe that the decision by Genentech, the first biotechnology company in the world, to set up a plant here is endorsement of Singapore as a choice location for biologics manufacturing.” 
  (more…)

FDA Warns Against Buying Accutane (Isoretinoin) Online

Filed under: Miscellany, The Pharma Industry — pharmamanufacturing @ 12:44 p.03.

One contributor to our magazine recently asked why our coverage of anti-counterfeiting has focused only on the criminals and the wronged. Why not, he argued, attack the topic from the angle of online drug sales and consumer gullibility.

Why anyone would buy any prescription drug online (except from registered and licensed pharmacies) is beyond me.  Much less a dangerous teratogenic drug like Accutane, but an amazing number of people do, every day, hence today’s MedWatch update from FDA. Here’s hoping that some would-be online buyers take note of this.

Below, the text: FDA notified consumers and healthcare professionals of a special webpage launched to warn about the dangers of buying isotretinoin online.

Isotretinoin is a drug approved for the treatment of severe acne thatdoes not respond to other forms of treatment. If the drug is improperly used, it can cause severe side effects, including birth defects. Serious mental health problems have also been reported with isotretinoin use.

The new webpage, http://www.fda.gov/buyonline/accutane, will appear in online search results for Accutane (isotretinoin) or one of the generic versions, Amnesteem, Claravis, and Sotret. The webpage warns that the drug should only be taken under the close supervision of a physician or a pharmacist, and provides links to helpful information. The new webpage is in addition to special safeguards put in place by FDA and manufacturers of isotretinoin to reduce the risks of the drug, including a risk management program called iPLEDGE. The aim of iPLEDGE is to ensure that women using isotretinoin do not become pregnant, and that women who are pregnant do not use isotretinoin.

Read the complete MedWatch 2007 Safety summary, including a link to the FDA Accutane Product Information Page regarding this issue at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Accutane

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