By David Ho, BioWorld Staff Writer

HONG KONG — December 27, 2017 — Caywon Pharmaceutical Group Ltd. is using Crowd Machine technology to become one of the first companies in China to specialize in decentralizing the pharmaceuticals development process.

The company is taking advantage of recent changes in pharmaceutical regulations in China that allow drug developers to hold a drug license without owning a manufacturing facility. China’s State Council green-lit a trial plan in May 2016, for a new drug Marketing Authorization Holder (MAH) System in 10 of the country’s richest provinces: Beijing, Tianjin, Hebei, Shanghai, Jiangsu, Zhejiang, Fujian, Shandong, Guangdong, and Sichuan. Beijing and Tianjin are cities but are governed like individual provinces. (See BioWorld Today, June 9, 2016.)

“The most important feature of the drug MAH mechanism is to separate the marketing authorization and the manufacturing license. Now contract manufacturing organizations [CMOs] can be used to produce drugs in China,” Matthew Lee, vice president of innovations at Caywon, told BioWorld. “MAHs without manufacturing capabilities for production must contract with a CMO. MAHs with manufacturing capabilities can use their own facility to produce drugs or may contract production with qualified CMOs.”

“Pharmaceutical research institutions and individual researchers in these provinces can submit application for clinical trials or marketing authorization registration,” he added.

That is good news for Caywon, which has a subsidiary in Nanjing, Jiangsu Province.

Unlike conventional companies that do both drug development and manufacturing, Caywon focuses on product definition, project management and outsourced manufacturing in a “distributed partnering” system to assemble its portfolio of drug products.

To create a system that fits its unconventional work model, Caywon is using Crowd Machine technology to create a decentralized global pharmaceutical products development and commercialization platform, becoming the earliest adopters of the technology for that purpose in the pharmaceutical industry.

Crowd Machine is best described as an advanced distributed computer. There is an app development engine embedded within it that requires no coding, which allows anyone to create decentralized apps (dApp) and smart contracts without limitation. The tech allows anyone to develop distributed blockchain apps up to 45 times faster.

Through that step toward Pharma 4.0, the company hopes to create a supply chain workflow that can be reconfigured mid-process based on individual project requirements, while maintaining a high level of data integrity, manufacturing quality and product safety using blockchain technologies.

“Crowd Machine’s technology will help with this process, enabling Caywon to bring remote teams together and standardize processes, systems and information-sharing in a secure way. The whole idea of this platform is to digitize a complex supply chain and share data across a virtualized value chain, so that means involving all parties in the product development and commercialization process,” said Lee, who sees great benefits to doing so.

“First, it will reduce the amount of time our scientists waste on aligning digital workflows, thereby reducing cost. This will also help them to be more productive as they are able to standardize systems and processes as well as sharing data securely,” he told BioWorld.

Lee said the firm has been working on implementing an information system for its management practice for some time. But getting scientists and managers to communicate what they wanted with IT was a challenge.

“Most domain experts in pharma simply did not have information technology as part of their training, so translating their workflow into digital implementation had been challenging at best. But the no-code development environment will remove the language barrier between pharma domain experts and IT experts,” he said.

Lee said that is why the pharma industry has been lagging behind other industries in terms of digital transformation. And a report by McKinsey & Co. backs up that theory, finding that the pharmaceutical industry was second to last out of eight major industries in terms of digital maturity, placing ahead of only the public sector in the study.

Beyond management of workflow and a tech upgrade, the ability of Crowd Machine tech to simplify dApp creation was also a big selling point for Caywon.

“When we looked at Crowd Machine’s App Studio, we knew it was going to be a game-changer for us. Not only can we build the digital workflow we always wanted, we also have the flexibility to evolve our system at minimum cost. It will truly enable our pharma domain experts to lead our digital transformation,” he said.

“Today’s drug developers are increasingly becoming small boutique shops focusing on specialty drugs. Many development projects can benefit from in silico simulations, but smaller pharma may not have the resources for in-house supercomputers or the computational expertise to implement ad hoc simulation codes,” Lee explained.

“With Crowd Machine, we see that it is now possible to quickly develop simulations to run on the global network of computers similar to what SETI@Home and the Folding@Home projects of earlier era achieved. But unlike the earlier projects, Crowd Machine’s ability to use blockchain will be able to ensure data integrity, security, and privacy.”

Lee said he believes it will also provide an internal economic incentive to source computational resources so that computations can be done with predictable and reliable performance. Those attributes make it possible for dApp adoption in computational drug design.

Future-proof technology

Pharma supply chain security, compliance and future proofing were also cited as key benefits of adoption.

“In 2013, President [Barack] Obama signed into law the Drug Quality and Security Act. Despite the legal mandate, we are still in the early exploratory stage and the entire industry is still not sure how to implement the technology stack to fully comply with the regulation. Crowd Machine’s blockchain agnostic approach offers a future-proof technology stack for pharma today to begin experimenting and iterating blockchain solutions,” Lee said.

“This digital transformation will also enable better patient engagement as more information is available during the product development process and ultimately improve health outcomes.”

For now, the platform will be used by Caywon’s domain experts who lack coding skills in the product definition stage. A contract research organization (CRO) would come in at a later stage when the product definition has been done.

However, the firm expects CROs and other partners to become more involved as Caywon develops the decentralized platform with Crowd Machine.

“We’re about to make a significant contribution to medical advancement. We expect our partnership with Crowd Machine will become a flexible partnership model that will inspire even greater developments in this, and other fields,” said Weining Yang, the CEO of Caywon.

Seeing potential in that, Caywon has also established a U.S. subsidiary, Lyon Stone, to create solutions for pharma and health care companies interested in adopting the Crowd Machine approach.

Craig Sproule, founder and CEO of Crowd Machine, said he believes the Caywon partnership will enable his firm to apply the concept of decentralized development to a multitude of industries on a worldwide scale.

This Article originally appeared in BioWorld — December 22, 2017 Volume 28, №247 and was republished in the BioWorld online journal on December 27, 2017