March / April 2017

Partnerships: A Potential Game Changer

Michael A. Arnold, RPh

The Pharmaceutical Engineering November-December 2016 editorial, “Collaboration Key in the Quest for Quality,” written by editor in chief Anna Maria di Giorgio, said it well: Collaboration is a strength, and “ISPE members are its ambassadors.” Therein lies our opportunity—to move the needle, or to be (as some might say) disruptively innovative in our industry.

Disruptive innovation” is often associated with the use of technology in decisions and events that transform our businesses. But I believe the term also applies to the opportunity to develop partnerships that could have a similar game-changing effect on industry and our efforts to meet patient expectations. Here’s an example from my experience in the investigational medicinal product (IMP) arena that makes my point.

Let’s start with the use of interactive response technology, or IRT. In the IMP world, this technology has the capability to manage several areas of clinical trial conduct: good manufacturing practice and good clinical practice. Examples include distribution, random assignment and dispensing to patients, expiry date management, drug accountability, recalls, and others. Here’s the interesting point: The banking industry has used this form of technology for at least the past 15 years in ATM machines and credit card transactions. It has also been used (or at least attempted) to manage expiry date transactions for investigational medicinal products for equally as long. It has not been accepted in the global regulatory arena, however, and even today cannot be used to manage clinical trial processes outside the United States.

Why is this the case? Well, it’s not for lack of trying. I participated in a presentation to several non-US regulatory agencies in an effort to gain approval for global use of this technology. In my experience, even though the regulators quickly understood the technology and its many benefits (quality and compliance) they were interested but not supportive. They were not supportive for one significant reason: the lack of industry standards on the use and development of IRT technology.

If we think about it, this makes sense. How can we expect regulators to endorse a “process” that could conceivably have hundreds of variations with no global standards or definitions? It would be an inspector’s nightmare and difficult for them to effect remediation.

If we as an industry don’t strive for standardization and alignment, we will experience similar challenges as we look to implement additional technologies such as electronic labels, dispensing verification, and others on the horizon.

So how can we implement new and innovative ways to conduct our business when we have no standards and our efforts are not globally aligned? One likely way is through the development of partnerships with like-minded societies and organizations, which could drive the appropriate level of standardization and use of these innovative technologies!

Regulatory agencies like the Pharmaceutical Inspection Co-operation Scheme (PIC/S) provide examples of what can be done. The welcome message on the PIC/S website reads:

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is a non-binding, informal co-operative arrangement between Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use. It is open to any Authority having a comparable GMP inspection system. PIC/S presently comprises 49 participating authorities coming from all over the world (Europe, Africa, America, Asia and Australasia).

PIC/S aims at harmonising inspection procedures worldwide by developing common standards in the field of GMP and by providing training opportunities to inspectors. PIC/S’ mission is to lead the international development, implementation and maintenance of harmonised GMP standards and quality systems of inspectorates in the field of medicinal products. [emphasis in original]

One only needs to visit the PIC/S website to see some of the significant accomplishments they have made as a result of this partnership. There is clearly an opportunity for professional organizations like ISPE to partner with each other and, in a way, drive disruptive innovation and facilitate more efficient implementation of innovative technologies. Working collectively in the interest of our industry would be a gamechanger. Industry, as well as our patients, would benefit tremendously.

What are we waiting for?