DRUG DEVELOPMENT

How to Accelerate Drug Development Through the Use of Pharmaceutical Consultants

by cyb2025

Dr. Kathryn Ackley earned her doctorate in analytical chemistry from the University of Cincinnati. She spent 16 years working in CDMOs serving the pharmaceutical industry. She has held positions in QC, production management, project management, and business development. Dr. Ackley was the Vice President of Development for Nitto Denko Avecia, one of the leading oligonucleotide CDMOs. Since 2018, Dr. Ackley has served as an independent CMC consultant. She is a member of the scientific advisory boards of the US TIDES conference and Chimica Oggi- Chemistry Today.

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 as a package, or consultants may work as sole proprietors.
Small drug companies can benefit from consultants in two distinct ways.
The first benefit is that consultants provide access to expertise that might not be available any other way. Bringing expertise in-house through permanent employment is not always possible because candidates with the necessary skill set may not exist. In some instances, consultants are the only way to access the necessary technical expertise. This is especially true when working with newer therapeutic modalities such as mRNA, oligonucleotides, and gene therapies. The second benefit consultants provide is the ability for drug companies to manage expenses.
Companies that rely solely on investor funding must carefully manage cash during development. Consultants, unlike permanent full-time employees, are utilized on an as needed basis. Accessing expertise only when it is needed allows companies to manage expenses and conserve financial resources.

 

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