Biotechnology Development

Developing a successful biotechnology company is no easy task. Faced with the long development times for pharmaceutical products, risk is high. The underlying risk is that of outright failure of the technology, whether in pre-clinical proof of concept stage or more expensively at the clinical development stages. However one of the easiest areas to fail is to succumb to the temptation of chasing too many development options and in the process losing focus.

Inventors face the additional challenge of coming to terms with the regulatory requirements to receive approval from government agencies. It is often perceived that this can be addressed later, given the length of R&D development time. However a successful development program is underpinned both by the inherent success of the technology and the strategy to develop it. In pharmaceutical R&D, development strategy is integral with regulatory strategy. A successful product R&D strategy cannot ignore the regulatory requirements at each stage of the process and more importantly that they have to be planned for well in advance. Successful R&D executives are looking at the final submission requirements that are years away while designing the interim steps, each with their own sets of requirements.

Making course corrections in order to stay on track is part of any successful R&D program. Sometimes entirely new opportunities arise that are worth making a detour, but these must be carefully assessed as less significant but equally compelling opportunities often present themselves during the R&D process. The exuberance of discoveries must be tempered with the wisdom of experience to ensure that in the end, a company is built, rather than a series of expensive venture capital funded science projects.

We offer founders early stage companies general oversight on approaching the R&D process and on the various commitments required to develop a biopharmaceutical product.

For more information, contact us at biotechnology.

If you are looking for a position at PRCI, use this link instead: HREnquiries@prcintl.com