Open source paradigm could swipe biz from CROs: Beroe

In a study – conducted for Outsourcing-Pharma.com – research analyst Sudarsan Pakaravoor said a lull in innovation for rare and orphan indications has led vendors to seek more innovative ways to work with industry.

He said the traditional industry, made up of a series of contract research organisations (CROs) and vendors is too “fragmented” ​and therefore the discovery process is divided.

However “open source”​ drug discovery – by which a contractor buys a compound with little data, shares that data with a sponsor and then provides development services for a fee – could be a way to plug the gaps, Pakaravoor told us.

The idea is taken from the operating system Linux, whose developer lifted the patents on its platform with the belief that more eyes on the project would mean more development.

The vendor then has rights to the resulting compounds.

“The open innovation can be successfully applied to improve the efficiency of clinical trials and drug discovery,”​said Pakaravoor.

Areas of potential​

Pakaravoor said development of rare and orphan medication in particular would benefit from the model.

He said: “​Rare diseases are caused by a known genetic variant. This makes the drug discovery process more straightforward than for other common diseases with mass markets and lowers the risk of drug failure in the later stages of development.​

“Open source would be the right solution as knowledge and data assembly are some of the major challenges in the development of drug for rare diseases.”​

He added that with orphan and rare drugs gaining more importance in the industry as they can generate big money from a small subset of patients, open sourcers could take business from the traditional providers, CROs (contract research organisations).

And with some sponsors now actively seeking open source solutions - such as “the first open source drug development company” ​Transparency Life Sciences (TLS) - and a host of not-for-profit and government organisations coming out of the woodwork to meet the demand, Pakaravoor believes it will not be long until open source vendors make a “big impact”​ on the industry.

“These emerging vendors will have a significant impact on the big pharmaceutical buyers in the near future,” ​he said. “Those who would enable the open innovation in pharmaceutical R&D would make a major impact.”​

Emerging markets​

Pakaravoor added that government support will help drive the open sourcing industry for players looking to get involved – especially in emerging markets.

He said that a need for innovation in drug development in “neglected”​ indications like Malaria, Tuberculosis, Leshmaniasis has led authorities in developing markets to take notice of the new model, and added that support from those bodies will increase in coming years.

As an example, he said the Indian Government’s Open Source Drug Discovery (OSDD), a web-based subset of the Council for Scientific and Industrial Research (CSIR), has “already received a funding of $12 Million from the Indian government with a total project outlay of $46 Million.”​