Grunenthal's Technology Model For The 21st Century
By Louis Garguilo, Chief Editor, Outsourced Pharma
We’re entering our era of technology.
It’s transferring preeminence from science to tech innovation, and, according to a Pharma executive, “moving the pharmaceutical industry from a model of drug discovery to a focus on drug development and manufacturing.” (She prefers anonymity; she works in a discovery organization.)
The advance will be broad-based. New players will enter, from digital and network IT to process instrument and manufacturing equipment purveyors. Some traditional biopharma will retool for cross-functional innovation. Tech implementation of all hues will coalesce in the outsourcing model, the extended supply chain, and all forms of contract development and manufacturing organizations (CMOs).
Grünenthal of Aachen, Germany, is a leader in this new tech paradigm. This historic and still family-owned R&D organization is a global biopharma, a utilizer of CMOs, and very much a company leveraging technology to combine it all.
Its newest combination is in the U.S. Alexander Kraus, VP Product Development, Technical and Government Affairs, Grünenthal USA, Inc., explains the undertaking in this exclusive interview with OutsourcedPharma.com.
Undeterred Deterrent Technology
Kraus took up his position in the U.S. in 2011 to oversee the spread and further development of Grünenthal’s abuse-deterrent technologies for opioids and other narcotics-based medicines. The company has now announced a major partnership with Patheon for this purpose, in this case specifically to advance its INTAC® technology.
Grünenthal is pursuing a model for efficiency in technology development to broaden markets, reduce costs associated with regulatory requirements, and attain the high degree of innovation required to provide “breakthrough value” to patients, and the healthcare system on a larger scale.
“Our role is to establish a network of strategic partners and service providers, and an environment for actualization of our technologies,” explains Kraus. “We’ve focused on innovation in our core competency, not on overhead or services more elegantly and efficiently dealt with by service partners.”
Already, Grünenthal’s INTAC technology for abuse deterrence is included in a number of FDA-approved products in the extended release (ER) opioid market, such as Purdue Pharma’s OxyContin, and ENDO’s OPANA ER. Kraus believes this is the tip of the proverbial iceberg.
“It’s important we do everything we can so safer products can come to market on a broader scale,” says Kraus of the corporate mission. “That’s the only way to unlock the full societal benefit of abuse-deterrence technology. The Patheon relationship (details below) offers vast potential to efficiently advance INTAC as a platform for all abused prescription opioids, and to develop a variety of marketable products for bothbranded and generic manufacturers.”
There are challenges. “Unfortunately, we’ve seen the pendulum in the opiate prescriber world swinging in the opposite direction,” explains Kraus.
“Physicians are increasingly concerned in prescribing opiates to patients. They’ve heard about risks of abuse and addiction. This may result in a situation where eligible patients that would benefit from these pain medications suffer if they cannot have access. We need to help educate prescribers and caregivers in their understanding of the do’s and don’ts in opioid-based pain management. It’s first incumbent on us as the technology providers and manufacturers to do the best we can to create safer products.”
That effort to swing the pendulum more favorably brings us back to our emerging era of technology. What will it look like?
Tech Triangulation
The future for widespread tech innovation and distribution in the drug industry currently depends on models of triangulation. The drug industry may never move to an “open architecture,” or an industry of app developers around a tech platform (e.g., an iPhone) to bring consumers innovation, but Grünenthal moves us closer to those models.
To whit, an R&D company (Grünenthal) locates a process development and manufacturing platform for a technology (INTAC) at a service provider (Patheon) to allow for further development and the manufacture of new products by other companies (biotechs and Pharma).
Grünenthal has already tried out this model in degree. They currently work with PMRS (Horsham, Pennsylvania), a CMO that took over responsibility for manufacturing OPANA ER.
In the new Patheon partnership, Grünenthal provides expertise and access to the proprietary abuse-deterrent technology, while Patheon takes on responsibility for establishing the necessary environment for implementation and the development of customer relationships.
According to Kraus, Grünenthal believes that “the CMO helps provide value from its expertise and experience in bringing technologies to a larger scale for the development of new (and propriety) third-party products. For commercial relationships, this provides customers the chance to directly interact with a potential manufacturer as well.
“Overall,” he continues, “it’s the strategic creation of an environment to house our proprietary technology with machinery specifically designed for the manufacturing process.”
Variations of this model assure prospective technology adopters they are not captive to any one “preferred” manufacturing location. For example, if a company partners with Grünenthal for the development of a prototype of an abuse-deterrent product, “they are not bound in any way to commercially manufacturer with the CMO. We can work out agreements of many kinds.”
Technically, Everyone Wins
Grünenthal also benefits directly from this model, when looked at as a traditional provider-sponsor relationship. “For us it’s a win because we have access to these capabilities and capacities for our development projects currently running, and for new formulation projects that we can apply to our own portfolio.”
Patheon’s win is of course its being established as the expert and a preferred partner to companies looking to utilize, further develop and/or manufacture products with the INTAC technology.
“On a broad strategic plane,” says Kraus, “Together we are investing in developing new products, establishing the site, creating the knowhow, the efficiencies, scales and skills that we anticipate will be needed to address the next level of technologies and abuse-deterrent products. This is immediate to the opioid and prescription stimulants markets, but could serve many other markets as well. We’re dedicated to ensuring this is a technology accessible to the widest patient populations possible.” Kraus emphasis ultimately the most important winners are those patients.
But the final win is for the entire biotechnology and pharmaceutical industry. Here is a prime example of a business model for tech innovation, widespread tech distribution, and for a 21st Century in biopharma grown desperately dependent on new technologies for further advancements.