Q. Several innovative nanomedicine projects are currently being researched and developed. What is needed to push these projects
further and accelerate development?
The commercialisation of nanobased products and technologies is still mainly being conducted through start-ups and technology
business ventures. These small business units typically take an early-stage technology from a university and, over a period
of several years, attempt to acquire an intellectual property position that can attract major investor and development capital.
Concurrently, the venture has to develop a feasible path through clinical trials and regulatory clearance. Because of the
complex business relationships required, the cost to establish an intellectual-property base, the cost to conduct the fundamental
research to get to clinical trials, and the uncertainty of regulatory requirements for nanoscale therapeutics (e.g., is it
a device or a therapeutic?), many nanobiotechnology ventures end up in the "Valley of the Shadow", perhaps due to circumstances
simply beyond their control.
Realistically, the usual criteria still apply in terms of a securing a new drug application for nanotechnology-based therapeutics.
In part, these criteria include the following:
- Can the nanomaterial be produced with batch-to-batch purity and consistency under GMP conditions?
- What particular matters surround the stability and handling of the agent?
- Do the required animal toxicology studies provide an expectation that toxicities in human will be manageable?
In addition, it's important to consider the current situation with regards to patents. In the US, for instance, there is a
significant backlog of nanobased patent applications that continues to grow. These added uncertainties, coupled with an inability
to deal with them, can lead to extended development times and higher costs before the venture can even acquire the resources
to establish a clinical path. In a weak economy, early stage capital becomes virtually impossible to find.
Q. Some have claimed that many Big Pharma companies are losing interest in nanoenabled drugs. Do you agree with this statement?
In many cases, such people are referring to nanoscale-therapeutic formulations, which offer some incremental performance changes
through enhanced drug solubility and/or affinity-based targeting. Almost from inception, however, there has been a considerable
risk that the benefits of such nano drug formulations may have been too hyped and oversold. True breakthrough drug technologies
arising from this approach have yet to materialise. It also worth bearing in mind that virtually all medicines and diagnostic
agents previously available to clinicians, prior to the wave of interest in nanotechnology, were already nanoscaled. Nevertheless,
the rational design of a new generation of therapeutics is firmly based on increased sophistication that allows for localised
delivery via systemic administration, with minimal impact on normal tissue, as well as a growing understanding of tumour biology.
Pharmaceutical interest will certainly increase with the development of treatment methodologies that provide for increased
dosage forms, with higher concentrations of drug delivered to the target site.
Charles E. Seeney is Managing Director, ViCorp Tech LLC, and CEO, NanoBioMagnetics. (Edmond, OK USA).