Isn’t my research enough? – Success amongst the learnings

Commercialising medical research has its challenges, refer to my previous two articles which share some of the challenges, and offer some helpful resources.

And “challenges” isn’t code for ‘a little tricky’ – it is estimated that only 9.6% of medicines in Phase I clinical trials actual progress to US FDA approval[1]. And a 2009 review article estimated that only about one in a thousand synthesised compounds actually progresses to clinical development[2].  Whilst statistics may vary amongst publications, the challenges of drug development are quite well known. A little daunting?  Perhaps.

But certainly there are successes, and two research programs entering the development phase are Cancer Therapeutics (CTX’s) chromatin modifying enzyme programs, which received a significant financial injection from biopharmaceutical giant Pfizer as part of a collaboration and license agreement worth up to $670M.

Cancer Therapeutics CRC (CTx) CEO, Brett Carter, shared this information with me in achieving the successful deal with Pfizer…

“For early stage, novel science it is not uncommon for deals to take over 12 months from the initial interaction to the signing of the agreement, and this was certainly the case in our deal with Pfizer. The deal process itself – diligence, agreeing deal structure and terms, gaining approvals and negotiating contracts – often takes 6 months or more and this only commences once there has been a thorough courting on the science and a commitment from the partner to enter into negotiations.”

Brett is keen to emphasise the importance of networks and relationships in building your brand with a potential partner organisation, remembering that a potential partner is likely also considering many drug development options. He suggested that, conferences, for example, are a great way to meet people with a shared interest.

So the Cancer Therapeutics CRC (CTx) story is one about good science that is amenable to drug discovery / drug development, good relationships, and, according to Brett, a good measure of “perseverance and tenacity”.

To medical researchers, Brett has this advice…

“Firstly, consider the application of your research. What is the best factor in the biology to target and what type of intervention would be most suitable for modulating that target? Finally, good fundamental biology is essential, however it is very rare that it alone is adequate to get partners on the hook. If researchers can demonstrate pharmacological modulation of a target which recapitulates genetic experiments, then the chances of getting partners to engage are far higher.”

In essence, commercialisation aspirations are best entwined with a futurist outlook of today’s medical research, enabling downstream considerations to be considered early on.

Here are a few more tips….

Three questions to consider to help you commercialise your research

–      Are you thinking “beyond the Nature paper”? (Brett’s quote)

–     What are the key relationships to start building, or to nurture, now?

What is the potential unmet clinical application of your research?

[1] Clinical Development Success Rates 2006-2015, BIO Industry Analysis, June 2016

[2] Tamini and Ellis, 2009. Drug Development: From Concept to marketing! Clinical Practice, 113:p123-131

 

In addition to Regulatory and Related Consultung Services, Mary offers industry-readiness programs for people looking to enter the pharma, biopharma, biotech, med tech and wellness organisations. Contact Mary for a complimentary industry-readiness check or discussion on how this program may be applied to your organisation.