Clinical Pharmacology & Biopharmaceutics
Open Access

Abstract

Senior management in biotechnology organizations span the gamut of industry expertise from deep academic and research backgrounds to corporate, global biopharma skills, and everything else in between. This internal collective corporate experience and history often drives how a clinical research organization (CRO) partners are eventually selected, and often without considerations to other key imperative elements that determine the best fit, for the immediate as well as the long-term needs of a clinical development program. The presenters will utilize case-study examples from biotechnology companies in Europe, Japan, and the US to describe how biotechnology companies can increase their chances of success in choosing an appropriate external clinical development partner. Understanding where blind-spots often occur, how to navigate internal corporate mind-sets, and individual biases will be discussed through case-examples. Various approaches and solutions will be highlighted, and specifically tailored for the small- to mid-size biotechnology companies. The presenters will also discuss critical issues in the selection process such as fees, deliverables, timelines, and managing disappointments.

Biography

E-mail: hs@lumisinternational.com