By W. Douglas Walkling, Ph.D., FAAPS, Walkling Drug Delivery System Advisory

The evaluation of drug delivery systems must by necessity have the acceptance of upper management. Otherwise, understandably, nothing goes forward. However, I have been party to cases where preconceptions have set opinions to the extent that I wonder why a consultant was called if, perhaps, for no reason than to find someone who is happy to be agreeable for a fee.

In one case, the client company was a non-pharmaceutical firm whose engineers had designed and developed a novel manufacturing process suitable for immediate release, solid oral dosage units. The novel process, yet untried at pilot scale, had produced prototype units with exceptional dose precision and accuracy. In addition, it had the potential for becoming a high throughput, continuous manufacturing and packaging process. Marketing intelligence had directed the client toward finding a partner in the pharmaceutical business with an NCE to couple with its novel process. That strategy had not proved to be successful, as no company could be found willing to risk delays in launching an NCE because of unforeseen problems with an untested, novel system. The development strategy was then shifted toward developing a controlled delivery system. Some prototype systems were prepared but there was nothing remarkable about the performance of the systems versus systems offered by several more conventional technologies already on the market. Further complicating the development of a controlled delivery system was the need to make the process more labor- and capital-intensive as some conventional technologies had to be incorporated. A decision was made to continue with the development of some of the controlled delivery prototypes instead of exploiting the features of the technology as an advanced manufacturing process for immediate release systems. In spite of the ultimately fatal flaws in the controlled delivery concept, no interest could be generated for this novel technology for its use in immediate release systems manufacture. Novelty and controlled drug delivery together was held dear by upper management.

In the second case, the client company was a pharmaceutical company. The client saw a novel drug product by combining a prodrug of a generic drug with a novel, patent protected delivery system. The client had the option of a patent-expired prodrug available from a toll synthesizer or a novel, patent protected prodrug from an entrepreneur. The patent protected prodrug would have been more expensive to synthesize, had an undetermined safety profile, and would require royalty payments, but did not offer clinical advantages. In addition, the novel prodrug’s patent did not offer patent protection beyond the term of the patent protecting the delivery system. The decision was in favor of the novel prodrug because “it was novel” — a preconception highly valued by the client’s marketing division. Ultimately, though satisfactory terms could not be reached with the novel prodrug’s entrepreneur, it was still impossible to generate interest in proceeding with the “non-novel” prodrug.

I view these cases as examples of opportunities lost or, perhaps more correctly, abandoned due to a fixed mindset that blocks the exploration of product concepts that were not part of the original strategy.

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W. Douglas Walkling evaluates drug delivery and pharmaceutical technologies for venture capitalists, for patent attorneys, and for drug delivery system and pharmaceutical developers. E-mail: [email protected] / cell: 240-599-6361 / Web: www.walklingdrugdelivery.com.