KATHRYN L. ACKLEY, PhD
Oligonucleotide CMC Consultant, United States of America

Abstract

Small biotech companies are driving the development of many novel drugs. These companies often lack the resources of their big pharma counterparts.
The strategic use of pharmaceutical consultants can help to mitigate risks, ensure compliance, and accelerate the overall drug development process. In this work, recommendations for how to select consultants and establish consulting agreements are provided. Suggestions for areas where consultants may be particularly impactful during drug development are also given.

The time required to bring a new drug to market is estimated to be 10-15 years at a cost of 1-2 billion dollars (1).
Only 10% of the drugs in clinical development go on to be approved for commercial sale. Multiple factors contribute to these grim statistics. Drugs often fail in clinical trials due to lack of efficacy, toxicity, and poor drug-like properties (2). Drug developers must press for ways to successfully bring drugs to market while decreasing the time and cost of development if they are to continue to deliver value to patients and investors. Small biotech companies are key players in the development of novel drugs (3).
These companies are entrepreneurial in nature and frequently lack the financial, technical and human resources of their big pharma counterparts.
For these small companies, consultants can be the key to accelerating drug development.

Consultants are professionals with specialized skills and experience in a particular aspect of drug development (e.g. regulatory affairs) or with a particular therapeutic modality (e.g. monoclonal antibodies). Consultants may work in large organizations that sell consulting services ...