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A Few Words on Pharma Innovation…

The field of advanced process chemistry is, by its very nature, a tale of innovationAt just about the same time we were going to write on the state of peptides (key takeaways: yes – still growing, lots of promise, more drugs in the pipeline), I read a piece from Karen Langhauser – pharmamanufacturing.com’s Chief Content Director – on defining ‘innovation.’ (This was in reference to their cover article for the month, on their 2019 Innovation Awards.)

In her editorial, Langhauser makes the case that persistent, incremental improvements are the ‘bread and butter’ of pharmaceutical advancement:

“As B2B editors, much of our time at industry events is spent learning about new equipment and services designed to meet the specific needs of pharma. We hear all the stories behind this innovation and thus truly understand and appreciate the investment pharmaceutical equipment vendors put into developing and improving their products. We believe all types of innovation, whether earth-shattering or incremental, should be recognized.” (emphasis mine)

Innovation in Action
The article got me thinking about innovation, and how we see it play out in our everyday lives. For example, here at Neuland we’re surrounded by innovative people – people who spend their days discovering solutions to the challenges of drug commercialization.

Pharmaceutical scientists and process chemists are often confronted by the ‘two-steps-forward-one-step-back’ process of scientific discovery. Modifying or adding a specific chemical to a reaction, for example, may create X benefit, but result in Y or Z consequences.

Innovation in Drug APIs
Because of this, the field of advanced process chemistry is, by its very nature, a tale of innovation (or, more aptly, a series of tales).  And while it is easy enough to cast aside the generic portion of the market to shine the innovation spotlight on novel APIs, the generic portion of the market is also teeming with innovation.

Sure, it isn’t as sexy as “The Latest Great New Scientific Discovery!!!!!,” but the generic drug space – by virtue of its hyper-competitiveness – demands innovation. This often takes the form of manufacturing advances. And usually, they are incremental improvements designed to move the needle enough to establish or improve profitability… unquestionably critical achievements in a hyper-competitive market.

Indeed, it is often those ‘persistent, incremental improvements’ which pave the way for vast leaps forward in our ability to cure or manage various health conditions. Numerous small improvements add up – whether it’s an efficient peptide purification method which allows us to reimagine the economies of scale for peptide drugs, or a novel analytical method (or technology…or even knowledge) which allows the industry to identify a previously-unknown contaminant or impurity.

This latter scenario was the case with Valsartan and our (still) emerging understanding of detection and mitigation of its potential contaminants (NDMA and NDEA). While it is common outside of the pharma industry to view such recall incidents as failures, sometimes they are not. They serve to remind us how limited our scientific knowledge and capabilities can be.

And then, of course, industry makes an incremental advance to step us beyond the challenge.  Accurate HIV detection – and the later introduction of combinatorial drug therapy – are likewise examples of incremental, progressive steps towards a solution. (Note: While HIV is not, by any means, ‘solved,’ it has evolved into a manageable, treatable chronic condition in certain geographies.)

The “Next Pinnacle of Scientific Knowledge”
The limitations of our knowledge often lead us to declaring a particular emerging field the answer to understanding human health. In the late 1990’s, as the Human Genome Project and Celera Genomics raced towards human genome sequencing, genomics was declared the pinnacle. In the ensuing years, more “pinnacles” followed – proteomics, glycomics, metabolomics, lipidomics, transcriptomics and more – each holding the promise of unlocking the keys to human health.

Each one has turned out to be incredibly important to our overall understanding of human health, but none are the final answer in and of itself. Such is the nature of incrementalism – what you thought mattered actually did matter…but as part of a greater whole.

The pharmamanufacturing.com article captured this sentiment perfectly, stating that the 2019 Pharma Innovation Awards winners “offer slices of innovation.”

It’s a great way of describing it, and it extends beyond the pharmaceutical equipment & services brief of the article. Slices of innovation also includes the vast number of human health, medical & drug discoveries happening all the time, the organizations focused on the healthcare delivery side of the industry, and everything in-between…including contract pharma organizations

like Neuland who offer constantly-evolving (yes – incrementally) process development & scale-up expertise.

What do you think are the most important pharma innovations still-to-come?

What’s on your wish list?

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