From The Editor | July 20, 2017

You Decide: Technologies Impacting Drug Development And Manufacturing

Source: Outsourced Pharma
Louis Garguilo

By Louis Garguilo, Chief Editor, Outsourced Pharma
Follow Me On Twitter @Louis_Garguilo

You Decide: Technologies Impacting Drug Development And Manufacturing

Quickly: What three new technologies are most impactful to your drug development and manufacturing activities? No profound thoughts, just an extemporized response: What immediately comes to mind? I’m guessing you can make your list with little effort.  

Now, just as quickly, think of your supply chain partners. How do those technologies relate specifically to your outsourcing processes, and decisions?

That’s it. Thanks for joining today’s flash mind exercise. You’ve also joined executives on the Outsourced Pharma Editorial Advisory Board who did the same. Chances are their thoughts are similar to yours, but how about we compare them. Similarities and differences will both be instructive ... and lead to some deeper introspections.

Two Quick Examples

Let’s start with an example from one board member that includes some very specific technologies, insightful specifically because of its narrowed focus:

1) Single Use Systems as they expand in scope and capacity

2) Alternatives to VHP [vaporized hydrogen peroxide] for isolator sterilization

   (Noxilizer, iHP, etc.)

3) Closed Vial Filling

These technologies reduce the capital required and the size of the footprint of a facility.

They all provide a greater level of sterility assuredness. They reduce the complexity of the operation, and allow the capacity to expand.

How close to this type of thought pattern were you? Here’s an example that casts a somewhat wider net:

1) Continuous Manufacturing

2) Biologics/Peptides Manufacturing and associated Analytical Testing

3) Delivery and Device Technologies

Each of these areas reflects our continued focus on innovation and the evolving nature of our clinical development pipeline. We expect to collaborate accordingly with strategic partners as we continue to develop and expand these technologies.

As in these two examples, single use technology and continuous manufacturing are often mentioned as the most impactful to our industry, and certainly may have made your personal list.

Let’s next focus, and add some analysis, on good ol’ IT – information technology, referenced in one regard or another by most of the board responders.

Personalization As A Technology (PaaT)

If the IT world can have SaaS (software as a service), why not PaaT (personalization as a technology) for us? Another board member seems to be heading in that direction. Here are her top three technologies:

1) Personalization of medicine (e.g., gene therapies)

2) Extreme characterization (genetic and otherwise) of patients, diseases, treatments, etc.

3) Digital technology advances

And her explanation: “I see personalization [of medicine], and characterization [of disease and patients], impacting us already” in our drug development and manufacturing outsourcing industry. “Lot and campaign sizes are much smaller (in the extreme, one lot per patient). Genetic characterization advances are beginning to support the targeting of treatments to patients with very specific genetic profiles (Keytruda is an example). This will require CMOs to be much more flexible.”

She adds: “It also requires an incredibly higher sophistication of bookkeeping (a.k.a. data integrity), which, fortunately, could be supported by item three [digital technology advances] if we can pull it all together.”

In other words, PaaT.

Cloud Cover

Think about it: Why wouldn’t the cloud become an increasingly important driver of advancing drug development and manufacturing, particularly for outsourcing services and supply chain management?

We intuitively subscribe to its operating model: third-party technology platforms providing services and products you’d rather not build out yourself, or that don’t fit into your core capabilities or focus. And we speak the language of the cloud already: criticality of access to historic and new data from widespread originations, the search for deep integration for advanced analytics and real-time data visualization, and the transference of all of this to external partners and regulators.

The cloud aptly describes a particular challenge in our industry today: serialization.

“The only practical way to establish the needed connectivity, and immediate visibility to support serialization, is to leverage the cloud,” is how one board member described it. “Currently practically everyone has a compliance focus with the DSCSA [2013 Drug Quality and Security Act]. In the long run, and thinking this through, this could greatly impact how patients and consumers actually get their drugs,” as well as connect drug owners more closely to supply chain and other service partners.

Unfortunately, “theft and counterfeiting are serious issues” when considering how people get their drugs delivered today. To combat these challenges, another sky-based technology, if you will, that is joining the cloud (or perhaps more accurately, the cloud is now joining it), is advanced GPS tracking technology.

“Companies are using increasingly sophisticated GPS tracking to prevent theft,” says our board member. If you put together connectivity and data in the cloud, with satellites protecting the integrity of drug products, and new thinking for the actual delivery of drugs to market, “You can think of this like a regulated Amazon.com for pharmaceuticals.”

Still, many suggest that comparatively, we’ve been slow to move forward. Perhaps for some good reasons, including regulatory challenges, but predominately because the same technology enhancing real time data and data-tool sharing can create even more security (and IP) breaches, potentially on a much larger scale.  

So the cloud can indeed be looked at from both sides. It’s undeniably becoming a fundamental driver of our own industry’s IT revolution, but brings with it some potentially stormy weather.

Technology: A Family Affair

Finally, let’s mention a few more IT subjects brought up by our board. One member stated that from his vantage point, most important to our industry’s moving forward are “IT systems specifically utilized to enable end-to-end lifecycle management.”

The reason this was a top three candidate? “With the growth in external suppliers, and also the complexity of regulatory approval processes, this end-to-end visibility has taken on a critical dimension. Is a change approved for a particular country? Can a product be released to that market?  Today these seemingly straightforward questions often require many manual processes and checks.”

This experienced pharma executive added that lead-time reduction for material production is key to his operations. “This is not about a single technology, but it speaks to the family of technologies and initiatives that can be put together to reduce lead time. These technologies, systems, and concepts include such things as on-line testing, real-time release, and rapid changeover.”

So there you have it. I hope this simple exercise will assist Outsourced Pharma readers in your much deeper pursuits of parlaying technology into improved methods for drug development and manufacturing, and even more spectacular outcomes for patients. If you would like to submit your top three list of technologies, I’d be happy to receive them at Louis.Garguilo@LifeScienceConnect. I’ll continue to do my best to bring more executive interviews and analysis on these and other emerging technologies, and as always, welcome all of you as a part of the process.