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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…?

Innovations in pharmaceutical flexible manufacturing?

Welcome Posted on Thu, January 21, 2016 20:33:07

Many pharmaceutical facilities are facing a new need for flexibility. Unlike the old “blockbuster plants” the pharmaceutical facilities of the future are no longer dedicated but multiproduct and they must be agile and flexible. Several of the newest pharmaceutical breakthrough products are quite small products from a volume perspective but they manufacture quite expensive products.

The number of new drugs approvals has been increasing the last few years with a record high 2015 and since many of the new products are for quite small markets, the demands for flexibility is high. Many pharma companies have increased their use of contract manufacturers in order to achieve the needed flexibility. By definition the CMOs generally have good multiproduct capabilities but they also face the future need of more flexibility and agility to meet their customers’ market demands.

But there is a lack of highly flexible pharma manufacturing equipment. Most of the traditional solutions are not quick to change and clean between products because there has been more focus on operational efficiency than on changeover efficiency. Like in the automotive industry 25 years ago.

You may remember that cars used to be made in dedicated facilities many years but today car plants are highly flexible with lots of robots and modular design models to enable agile and cost-effective manufacturing.

We do not use robots in the pharma industry. With few exceptions in packaging plants or in distribution warehouses. The is a need for a new pharma manufacturing paradigm that is flexible. Companies needs innovative suppliers and also some eye opening reference projects that set new standards.

The regulators such as FDA have expressed the vision of an agile, flexible and effective pharmaceutical manufacturing sector. It is up to the plant managers, engineering companies and equipment suppliers to make that vision possible…

1-January 2016

Welcome Posted on Tue, December 29, 2015 20:42:42

New blog – new pharmatrend perspectives

This is a beginning of a new blog that captures the focused area of pharmaceutical manufacturing, technology and compliance.

Why a new blog when the world is crowded with blogs? Because there is a need for independent views on what the trends are. You make take many decisions in your daily work life without having time to look across the dots that makes a line. The pharmaceutical industry has been undergoing significant changes over the last decade but we are only beginning.

My blog is dedicated to what comes. Not based on speculations but on what we know. Based on facts. As I have done in numerous keynote presentations over the last years, I connect the dots to show where the challenges will be.

Just one example: Agility. If there is one thing that the pharmaceutical industry has not yet been good at, it is agility. Why? Because the GMP’s told us not to be. For decades the pharmaceutical industry has been conservative, risk-adverse and very slow to adapt changes. But there is a new pharma reality that only few companies have understood. Despite the fact that the head of US FDA’s CDER (Center of Drug Evaluation and Research), dr. Janet Woodcock has been expressing a vision for the pharmaceutical industry for more than 10 years now, very few companies are taking it serious.

The vision of dr. Janet Woodcock is expressed as: “A maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high quality drugs without extensive regulatory oversight.”

The question for us in our companies is: how do we make it a reality? Because the fact is that the vision was not intended to be a dream. It was – and it is – intended to become a reality