Common Pitfalls

By Sam Hall and Alastair J.J. Wood
Illustrations by Tomasz Walenta

Concept and gestation:

Scientific founders can sometimes forget that they are running a business and not a lab. It is important to use the seed capital to drive the enterprise, and not just the science, forward.
Conversely, it is possible to rush a compound from discovery into the next phase - preclinical and expensive IND- (investigative new drug) enabling studies - without adequate understanding of the basic biology underlying the putative action of the compound, thus increasing the risk of an early failure.

Infancy:

Inadequate management of dilution.
Inattention to the need for skilled business leadership in addition to gifted scientific skills.
A rush into a premature licensing transaction with a legacy pharmaceutical company, resulting in loss of control of the compound and an inadequate financial return.

Maturity:

Designing and running clinical trials based on available cash, rather than on the clinical and statistical considerations that provide the best chance for success.
Failure to recognize that the objective of early-stage drug development is to estimate the effect size, not to demonstrate that the drug is significantly better than a competitor (the aim of Phase III studies).
Failure to adequately predict effect size and variability between patients' placebo response rate could doom an effective drug.
Choosing the best/correct dose is probably the hardest decision made in drug development, and errors at this stage will haunt the program forever. A proof of mechanism dose that is too low will result in failure to demonstrate an adequate effect while a dose that is too high will result in toxicity, from which the program may never recover. The subsequent discovery that a much lower dose is as effective as the marketed dose, could have serious consequences for revenue projections.

Have a comment? E-mail us at mail@the-scientist.com

Sam Hall is an Associate and Alastair Wood is Managing Director at Symphony Capital New York, NY.