Late this summer, I was privileged to spend a weekend with Dr. Lex Adjei, Chief Scientific Officer of XIOS Pharmaceuticals. While our wives made a trip to Chincoteague beach, Lex and I stayed behind to discuss innovation. With 44 US patents to his name and a sterling resume of achievement (see sidebar), this is a topic well suited to him, and his thoughts are well suited to this, the first installment of Innovation Insights.
In my mind, five valuable insights on innovation emerged as we spoke, two of which are illustrated by packaging examples: 1) Innovation requires that discovery be bridged to practical application; 2) Innovation requires at least two types of people – discoverers and change agents; 3) Pharmaceutical innovation frequently occurs at the intersection of two or more companies; 4) Innovation frequently occurs at the intersection of technologies; and 5) Innovation often stretches our conventional use of language.
As Lex described the pharmaceutical innovation process, it consists of two broadly defined steps: basic laboratory research and the practical application of that research to benefit humankind. In the first step, researchers apply fundamentals from the life sciences to produce academic knowledge that may result in the discovery of a new chemical entity (NCE) or a new adaptation of an existing molecular entity. In the second step, change agents lead the way toward the practical application of that knowledge to develop a new product that meets unmet therapeutic needs. Innovation occurs when academic discovery is successfully bridged to practical application.
Lex points out that the development path and assessment of clinical safety and efficacy is shorter and less time intensive when completed under the amended new drug application (ANDA) process of the FDA . Reformulation of “best in class” drug delivery platforms for existing conventional pharmaceuticals, bio-therapeutic agents and 21st century NCEs can result in drug companies gaining proprietary and exclusive rights when using this process. The bottom line is that drug manufacturers, patient groups, insurance carriers, prescribers and lawmakers all benefit as a result of the reduced cost and time it takes to bridge the gap between the research and its practical application.
Lex has great respect for the diligent efforts of the devotees of life science who go into the lab each day to seek new and practical discoveries that can be leveraged to result in safe and effective therapeutic products in the marketplace. These folks are never satisfied with what they know and want to press on to learn new things such as how the body functions, how it interacts with its environment, and how compounds administered systemically affect biological and biochemical functions in vivo. These grueling and expensive efforts may bring recognition to the researchers, such as publication of their findings in peer-reviewed journals, but these academic discoveries, while necessary, are not sufficient for innovation to occur.
Sometimes the result of these research efforts will be the discovery of a new chemical entity or technology that has the potential to provide health benefits to patients that existing products are unable to provide. Such a new chemical entity or technology has the potential to bring further recognition to the discovering company, perhaps in the form of a large infusion of cash from the sale of this new compound to a second, usually larger drug company that will advance the innovation process. Pharmaceutical innovation often occurs across, or at the intersection of, two different companies.
Lex believes that 99.99% of new ideas in science and technology don’t mean anything because of their lack of translation to practice. Ideas need to go from concept to launch where they add value by improving the ways and means of doing things.
Companies that own or acquire an NCE or new drug delivery technology must take on the role of change agent for this to occur. Without a change agent, there will be no innovation.
This two-company scenario isn’t so surprising when one considers Lex’s opinion that it takes the teaming of two types of people to bring about innovation. The creative types who make new discoveries are never effective change agents; and change agents are not necessarily discoverers. This implies that innovation must be a team activity in which the change agent serves as the quarterback.
The change agent needs to paint the vision, lift spirits, rally the resources and fend off the skeptics and detractors who would rather spend nothing and maintain the status quo. Rather than looking at a new idea and seeing all of the reasons it can’t fly, innovation requires people who recognize the obstacles but are confident that they can be overcome.
As Lex continued to describe his views on innovation, he used examples from his 25+ years of experience in the industry. His primary area of interest has been drug delivery to the airways through inhalation. This method of delivery may be used for local treatment of diseases such as asthma, COPD and cystic fibrosis; or for systemic treatment of diseases elsewhere in the body. His company, Xios, is presently focused on the reformulation of CFC-containing products using the environmentally friendly propellant, hydrofluroalkane (HFA). XIOS also plans to offer breath-activated applicators (the part that the patient breaths through) containing an integral electro-mechanical dosage tracking and control system. This system will insure delivery of the correct dose, alert the patient to the need for a refill, and allow the doctor to monitor patient usage throughout the life of the product. The system has other potential applications, such as preventing the illegal diversion of controlled substances that could be dispensed in the form of a liquefied gas. This patented idea, like many innovations, occurs at the intersection of two technologies by essentially embedding a process control and a manufacturing execution system (MES) system within the product package.
I use the word package because as our discussion proceeded, we noted that the two of us were using the same words to mean different things. Lex talked about the canister and its valve as the primary package, the actuator and mouth adapter as the secondary package and the little paper consumer box that the unit went into, along with the label and package insert, as the tertiary package. I thought of the assembly consisting of canister, valve, actuator and adapter as a single medical device that was put into a primary package, the box. That box would then go into a secondary carton and so on. Clearly, there are implications for innovation, perhaps even a paradigm shift, as the vocabulary of medical devices and packaging overlap, merge or become confused.
Vocabulary impacts our perceptions, our perceptions impact our discoveries and our discoveries enable innovation. If one of us perceives something as a medical device and the other perceives it as a package, the actions that follow that perception will be altered. Those who are able to use vocabulary in unique ways are likely to be more innovative. Innovators think about the intersection of technologies in ways that lead to the creation of new words like mechatronics or autogration. When you hear new forms of words like this, look for innovation.
Lex believes that there isn’t anything new in the world that God hasn’t already created. It is up to teams of people to discover what God has made and to find ways to make those discoveries useful to mankind. Discovery precedes innovation. The basic elements that constitute a new idea must be there before anything new and innovative can be implemented. Innovation is taking the discovery and making something productive from it, despite all of the obstacles that others may throw in the way. Innovation requires visionary agents of change.
Lex and his new company, XIOS Pharmaceuticals, hope to revolutionize patient care by being change agents that bridge the chasm between academic knowledge and innovative treatments for disease. These treatments will utilize the latest in innovative packaging technology. XIOS plans to be innovative by working with other companies at the intersections of their interests. And they are being innovative in applying technology in ways that stretch our use of existing packaging vocabulary. I salute their efforts and wish them well.
Akwete (Lex) Adjei
BS in Pharmacy, University of Science and Technology, Kumasi, Ghana BS, MS & PhD in Pharmaceutical Science, University of Texas, Austin
30 years in pharmaceutical industry Vice-President of Research & Development for KOS Pharmaceuticals Volwiler Fellow at Abbott Laboratories Holder of 44 US patents and others worldwide Author of 28 peer reviewed publications Submission of 3 New Drug Applications, 10 Amended NDA’s, 2 Biologic License Applications
Reviewer and editor:
Fellow, American Association of Pharmaceutical Scientists
Phi Kappa Phi, Sigma Xi, Rho Chi
Invitation: We are looking for companies or individuals that have unique insight into innovation to feature in upcoming Innovation Insights articles. Send your suggestions to Keith Campbell at Campbell@Packworld.com