Category Archives: Manufacturing

How to identify risky suppliers?

Getting to know to a potential supplier for the first time? Trying to improve communication with existing suppliers and technical partners?

Quality or technical assessments, questionnaires or audits are  regularly used to gather information on a suppliers.

Do you rely on a paper based systems? getting your supplier to fill out a questionnaires and return it in pdf form by email or by post?

There are many software offerings now that allow you to transfer existing questionnaires to an electronic form and and then allow your suppliers/partners to fill in these forms in real time.

An example of a solution called RCP Score that I have been working on recently is given below:

You as a purchaser see in real time how the response to the questionnaire by your supplier is progressing. A score is generated measuring the type of responses you are getting and completeness of the overall response.

But can you convert the data gathered from such questionnaires into measuring risk in your supply chain? Can you utilise the data received back from your suppliers to actually measure  risk amongst your suppliers?

 RCP Score allows  suppliers to complete their questionnaire on-line, with responses immediately calculating a risk index. Action items can be  created depending on responses to questions and again these action items and their completion (or not!) feed into the risk calculation for that supplier.

 If you use a on-line method of communicating and receiving quality and technical response to questionnaires, I would welcome very much hearing from you. Do these systems calculate risk scores for your suppliers, based on the answers and actions you see back?

 If you would like to find out more about RCP Score software, running quality assessments with your suppliers on-line and calculating a risk index for your supply network, then please contact me on either +353 87 294 0436   or paul@actexpharm.com

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New very different therapeutic applications for existing drugs

Over the last couple of days I have read about an old drug Citalopram (Celaxa, Lundbeck)  initially developed for the treatment of depression, has now  been the subject of early research into the treatment of Alzheimers.  Researchers from University of Pennsylvania in Philadelphia and Washington University Medical School in St. Louis, set out to explore the untapped powers of antidepressants, SSRIs to reduce production of beta-amyloid, a plaque that having grown on brain cells causes Alzheimers.(Ref: LA Times May 14th, 2014)citalopram

This very early research work into Citalopram has shown it effective in at least stopping the spread of the plaque (in mice) but not (as yet) rolling it back. What about other good examples of products/molecules developed in the past, that have found new subsequent uses? I’ve put together a table below identifying 10 compounds some of which have successfully been indicated and been awarded licenses for new applications. I have tried to pick out products that have found applications in other areas, very different from the original therapeutic application that they were developed to target. I did find quite a few molecules that have extended their application within the same sector that they orginally targeted, a common example of this is in the cancer sector.

Most of the molecules listed below in the table  through their brand names, are now household names for their initial application. Though the newer or subsequent application typically doesn’t replicate the sales  success of their original use, some like aspirin are now mainstreamaspirin in the alternative application such as in the case of aspirin, in  the treatment of hypertension.


If you know of other good example of older molecules/products that have been used in very different applications than those they were orginally developed for, I would welcome hearing from you and I will update this blog with the information.


Table showing a list of 10  molecules with their existing/original application along with newer applications.

Exisiting molecule Originator Company Original Application New or Secondary Application
Citalopram* Lundbeck Depression Alzheimers*
Sildenafil Pfizer Hypertension Erectile Dysfunction
Aspirin Bayer Pain Management Hypertension
Botox Allergan Stabismus/Blepharospasm Cosmetic use/Migraines
Perphenazine* Schering Plough Antipsychotic Leukemia*
Thalidomide Grunenthal Sedative/nausea Leprosy/myeloma
Sirolimus Pfizer Organ/transplant rejection Controlling a rare lung disease in children
Tamoxifen* AZ Cancer Bipolar depression*
Raloxifene Lilly Osteoporosis Breast Cancer
AZT/Zidovudine** GSK Cancer** HIV/Aids

Notes

* study of these molecules for these new applications is still at an early stage and have not been approved for marketing for these indications.

** Failed in clinical trials in the use as a treatment for certain cancers

 

References

LA Times:Preventing Alzheimer’s disease — with an antidepressant http://www.latimes.com/science/sciencenow/la-sci-sn-alzheimers-antidepressant-20140513-story.html

TedBlog: 9 old drugs that learned new tricks: The head of the National Institutes of Health shares medicines that turned out to have multiple uses. http://blog.ted.com/2013/03/22/9-old-drugs-that-learned-new-tricks-the-head-of-the-national-institutes-of-health-shares-medicines-that-turned-out-to-have-multiple-uses/

Antipsychotic Drug Fights Leukemia in Model: Perphenazine http://www.dddmag.com/news/2014/01/antipsychotic-drug-fights-leukemia-model

 

 

Into the future, from milk powder to pharma super power…

Remembering recently visits during the 1980’s to the then Glaxo company in Greenford-London, the Glaxo factory was built (in an art-deco design) in the 1930’s,  and represented very much the birth of the modern pharmaceutical industry in the United Kingdom. I was told during my visit that the Glaxo factory  was originally a milk powder producer, and that during the Second World War, the factory at Greenford was pressed into manufacturing penicillin products to help the war effort. Glaxo obviously took this opportunity presented by the war, and went on to become a pharmaceutical super power within the industry. In the meantime GlaxoSmithKline have now moved out of the Greenford site and the site now awaiting sale and redevelopment. The latest news is old Glaxo factory is going to become an apartment complex, that’s progress!!

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Glaxo building in Greenford, London.

This got me thinking about how both companies and industries evolve. There is a definite life cycle both in a company and the surrounding pharma-sector. We are only too aware of this in Ireland at the moment where some of our manufacturing companies are currently experiencing the patent cliff on a number of their products with the accompanying drop in sales. The modern industry here was initially built around the advent of the blockbuster drug but has quickly had to adapt what it does due to the demise of some of these successful products due to patent expiry and also manufacturing competition from other countries. From being very much gone from having a pharma industry based around the manufacture of bulk ingredients, the sector has looked for opportunities to both move down stream and evolve. So we have the addition of formulation manufacture to some of the bulk ingredients plants. Many of the formulations and products  included hard to handle materials and complex manufacturing. But again, many countries now offer this type of production, so again we had to look further  into the manufacture of biologics and new biotechnology products. Ireland has successfully attracted companies such as Amgen, Genzyme, Weyth Biotech (now Pfizer), Janssen Biotech, Biomarin, Alexion and Regeneron.  The move from small to large molecule synthesis and formulation is well under way!! As both companies and the sector grows, Ireland is also developing an accompanying  pharma service sector. This is represented by such companies as Alkermes, PPD,  TopChem, Almac and Icon.  They deliver chemical and biological development skills right across the life time of a drug product from discovery chemistry through to manufacture and distribution. These service companies need skills and knowledge in how to communicate globally effectively with sponsors/clients and deliver projects and development on time. It is not just anymore a case of being a toll manufacturer of bulk ingredients operating from a recipe developed elsewhere. Now service companies find themselves at the heart of a worldwide development process both in clinical development but also at the manufacturing stage.

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Alkermes biulding in Athlone, Co. Roscommon, Ireland.

The future? This must involve discovering and bringing to market new drugs and medicines here in Ireland. Central to this effort, the government has been developing and supporting centres of research excellence at the Universities and also putting money into organisations such as the excellent National Institute for Bioprocessing Research and Training (NIBRT). This is exactly the type of government intervention that is needed and will help support the evolution of a research based industry in future years.

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NIBRT building in South Dublin

For further information of companies mentioned in this blog please go to www.pharmaservicesdirectory.com