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“The Long Tail…”

News Posted on Tue, April 26, 2016 23:17:48

The new pharma manufacturing reality includes a challenge that nobody talks about – yet. But hopefully it will come soon, because it will be a huge challenge:

There are many, many small diseases in the world. Some of them are recognised as rare diseases and few of them does have a treatment – typically an “orphan drug”. Orphan drugs are manufactured in very small volumes. Very, very small, in fact. But since the orphan drug products generally are quite expensive, nobody really cared in the past how effective the drug manufacturing was.

In fact there has been several instances of orphan drugs manufacturing warning letters because the manufacturing of these small volumes are more like an art than like a craft. But of course the GMP requirements are the same for all commercial products, no matter what the production volume is. So some of the most important orphan drug companies have had significant warning letters or even concent decrees on their manufacturing, sometimes leading to scaring drug shortage situations for the very small patient populations.

But this is only a beginning. The number of orphan drugs is growing rapidly – actually exponentially. And some of the latest mergers and acquisitions are driven by the prospects of orphan drugs. Money are flowing into orphan drugs rapidly – so products will flow out. Some orphan drugs products are about to loose patent protection – and all products are under price pressure in all countries. So we need a cost-effective way to product orphan drugs, throughout the supply chain.

And this is only the beginning, in my opinion. You may have noticed that within almost every disease indication recent studies shows that there are several sub-types of the disease. And drugs does not work equally well for all disease subtypes. Some of them does not work at all for some of the subtypes, in fact. So we must expect that more and more diseases are split into subtypes as the scientific research progresses. It is good news for patients – and bad news for manufacturers. Because much more flexibility will be needed – and we don’t have it. Yet.

I am a big admirer of Wired Magazine. It rarely covers the pharmaceutical industry, but when it does, it is very inspiring. Anyway, many years ago the former editor in chief, Chris Andersson coined a term called “The Long Tail“. It has to do with media, not with pharmaceuticals. But I think it is a very visionary term that expresses our future manufacturing challenge: a long tail of smaller and smaller products that each address a very important, albeit small, disease indication. So visionary pharmaceutical manufacturers will have to start to think different and face the fact that their pipeline of new products looks like “The Long Tail”…!

Risk in pharma manufacturing

News Posted on Mon, March 07, 2016 23:29:15

It is not new that the pharmaceutical industry is conservative and not good at changes. This has been the case for decades – and it used to be for a very good reason: To protect quality, compliance and patients – and by that also the business. So most pharmaceutical companies are really slow to adapt changes. Also those changes that have proved to best practice. Pharmaceutical companies does not use best practice. They do what they used to do. Which is sometimes far from best practice.

At a recent event on parenteral manufacturing hosted by the German/Austrian/Swiss (DACH) affiliate of ISPE there were many best practices shared, both from originator drug manufacturing, contract manufacturing and service providers. These were examples used in real practice. Some of them have been used for almost 10 years and have proven their robustness as well as their superiority. Some are about the next generation isolators, others about the management of highly potent substances and about achieving agility and flexibility in pharmaceutical manufacturing. The event was very well attended and there were many discussions with good questions and answers. As it has been the case in most of the professional pharmaceutical events over the last decade.

Everyone understands that the pharmaceutical industry is changing and also that the regulators are starting to endorse and even encourage pharmaceutical innovation within manufacturing. The US FDA even went so far in its recent re-organisation to form the Office of Pharmaceutical Quality and the Emerging Technology Team (ETT) that will look into innovation opportunities for pharmaceutical manufacturing (among others) including technologies such as continuous manufacturing.

But at the end of the day the pharmaceutical industry questions and answers leads to very few new decisions. Even at an event such as the well-planned ISPE DACH Parenteral event I will bet that the outcome is limited. Some companies shared new solutions that improves quality, flexibility and efficiency at the same time. Solutions that works and that has been inspected and approved by regulators. But the risk of changing what you do today is still too high. So the pharmaceutical industry will probably stay conservative much longer than it has to. Maybe until one of the new technologies proves to be so disruptive that change will be necessary. Maybe until FDA endorses an Emerging Technology that starts a wakeup call to move on…?