Compared with the previous decade, changes in the BioPharma industry are clearly speeding up. Firms are altering all aspects of how they approach the discovery, testing and commercialization of new drugs. And recent efforts are more transformational than the incremental improvements of the early 1990’s.This creates pressures on many areas of R&D, made worse without a unifying approach or rationale. As a scientist, I puzzled over our many reactive initiatives, and their overwhelming lack of results. As this blog unfolds, we will recap so many programs, innovations and “rethinking’s”, that one might think there is no common thread or purpose. Today, firms are trying even more new tools and initiatives affecting investment, structure and process. So war stories alone will not serve my purpose which is to frame a new way of approaching R&D transformation for greater economic success, to help guide these new efforts.
The range of effort from discovery to launch of a drug involves more types of expertise, costs and time than any other product. Improving that overall process involves scores of process stages, many of which are co-dependent (or co-resistant) for results. I have come to find it convenient to think of our aspirations as being similar to that of a building architect, who also addresses diverse and complex systems, but for a grand purpose. Proper design of the result there also requires understanding / expertise in many areas; materials science, engineering, plumbing, utility and perception of space, and so on.
In BioPharma R&D, we have the interplay of Discovery vs. Development, Clinical vs. Non-Clin processes. Some of these will be addressed later in this blog as we craft a view into what is required for proper R&D Business Architecture. Some of the issues that we will examine:
<— How clinical and non-clinical process co-depend and inform
How critical capabilities for success (below) include gathering, translating and integrating more new kinds of information (not just volume) than has ever existed before this decade
Across this broad palette of skills, materials and process, an architect is expected to get results that are measurably better than a house designed and built by committee. And yet that is exactly what has led initiatives to reform and improve R&D value chains.
‘So what do we need from an “improved” R&D architecture? In the 1990’s we recognized that getting a new drug to market faster was amazingly valuable. The “rule of thumb” for some was that it was worth $1M for every day of acceleration into the marketplace. And as a result, many redesigned their efforts to create that acceleration. As some found, you can build a house in half the time, but no one may want to buy, or live in it. This blog hopes to explore how we might map out a new discipline similar to the building architect, combining an awareness of the many disciplines involved, but with the purpose of creating better returns on the resources, monies, time, expertise and passions we so heavily invest in. Better returns not only reward the individuals and firms, but also create better and faster therapies for society that otherwise might never be created.