Pitfalls of technology licensing, urgent need for training among issues covered at panel discussion on Taiwan’s biologics business environment

By Dave Silver

March 9, 2017
To take advantage of its strong science base and a growing number of small innovative companies, Taiwan’s burgeoning biopharmaceutical industry will need to start planning now to develop personnel skilled enough in GMP manufacturing and clinical trials to meet the demands and rigors of such a highly technical field. That was one of the take home messages from the panel discussion at this year’s Biologics World Taiwan, the annual meeting for the local biopharmaceutical community, held in Taipei, Taiwan.

The discussion held on the first day of the two-day event was billed as a session identifying business strategies to suit Taiwan, and expanded into topics including the pitfalls of licensing technology from academia, how the government could better help the sector, and how to train personnel for a career in pharma manufacturing. With close to 500 biotech (with 60 considered in biopharmaceutical development) and around 350 pharmaceutical companies, but with combined revenues of only around US$6 billion, less than just the research spend for Pfizer in 2016 (US$7.8 billion), Taiwan’s companies are considered very small scale, with opportunities thus limited. The industry is in need of direction if it is to compete with Korea for example, with its larger sized firms such as biosimilars developer Celltrion, backed by its giant conglomerates or chaebols.

The panel consisted of moderator Lai Jiann-shiun, Senior Director R&D, OBI Pharma, Taiwan; Scott Liu, CEO & President, Henilus Biopharmaceuticals, USA; Alan Liss, CEO, GXP Farm, and Senior VP, Product Development, Original Biomedicals, Co., Ltd. based in Tainan; Lin Nan-horng, Senior VP, Head of R&D, CHO Pharma, Taiwan; and Chen Pei-jiun, President, CRO and drug developer TPG Biologics, Taiwan.

Liss, with background including time at the US FDA, and now working in Taiwan with Original Biomedicals, was certain that Taiwan was ready to step up.

“Taiwan has already demonstrated the ability to make biosimilars, but they need to show the ability to make innovative products. We have a lot of unmet medical needs in the world that need to be addressed by biologics, and I’m hoping that Taiwan is one of the groups that can address it,” he said.

Innovative products need an innovative pipeline, and for most companies this means in-licensing, particularly from academia. But this is never easy.

“If you license from academia, you’ll find this out quickly,” said Lin. “Their purpose is different [to industry]. What they really want is to publish papers. Sometimes with their biological data, or the way they are doing the process, it cannot apply to an industrial scale. This means we have to spend a lot of time to validate their technologies.”

Lin recommended maintaining strong communication channels with your technology partner post-transfer. In CHO Pharma’s case, being Taiwan’s Academia Sinica. “We have to meet with their people often just to get their knowhow on the product. With one product right now we’re meeting them once every two weeks.”

Or as Liss put it: “Industry and academia are just different animals, and very hard to merge.”

Chen offered first hand experience of some licensing pitfalls.

“Over the years we’ve worked with many pharma companies licensing products from academic institutes in Taiwan. In all cases, there have been a lot of problems, such as when a protein degraded within two days, or when it precipitated out in the medium. In one case research showed a drug candidate had good cytotoxicity for liver cancer cells, but we couldn’t get it to show the same in our cancer cell samples. So in all these cases, the pharma companies suffered a lot trying to push these projects forward,” said Chen.

Because of these issues TPG Biologics now has a co-development strategy with client companies where TPG is more then just a service or CRO company and takes a more hands-on role in a drug’s development, with a large part of this verifying and validating technologies prior to in-licensing, explained Chen.

On the topic of licensing, comments from the floor included one where the experience in Taiwan was not a favorable one.

“We tried also to find license deals in Taiwan, but we failed,” recalled Jiang Wei-dong, president of US-based Henlix Biotech. “Companies here have unrealistic expectations. Even if they try and fail to out-license, they still don’t want to lower their expectations. And by the way, the products we looked into here are still available. If we had taken them over at that time, they may have had some success,” he added.

As to what the government could do to better assist in the development of the industry, Liss suggested that the TFDA, Taiwan’s drug approval authority, should follow the US FDA’s lead in collaborating more with industry partners, to become more than just a document review agency.

“If you look at the history and success of biotechnology in the US, it really came about when the FDA started partnering with industry; from attending meetings, to helping write guidance documents, to even staffing up with industry expertise.”

In comparison, with the TFDA the philosophy doesn’t seem to be the same, lamented Liss. “They just seem overworked.”

“We all do good science, but the ‘d’ part and the approval part requires this kind of partnership. And that’s still the missing piece in Taiwan,” he added.

And to help local small companies with the burden of developing a drug at the Phase I to early Phase II stage, Liss had a suggestion: shared facilities funded by the federal government and supported by large and small pharma that helped people in small companies with their ideas.

“It’s the infrastructure to get to the first stage of the IND with little or no money invested. We could have commercial CROs do this in Taiwan or we could have a government facility for only Phase I, a small-scale facility. You’d know if your technology had merit or not, without having major investments,” adding that many success stories have come out of the US by companies using such federal facilities.

And more could be done to prepare for the future staffing of local biologics facilities and companies, suggested conference presenter Michael Payne, Principal Technical Consultant, Process Solutions, of Merck’s Australia office.

“To take a discovery from the lab environment into a GMP manufacturing environment may require skill sets that are not yet available in Taiwan. We need to start to develop people now, for five years from now. And we can look at what Singapore did, academically, in working on clinical trials education, to start to have people who are adept at organizing, administering and analyzing data from clinical trials,” he suggested.

Biologics World Taiwan 2017 is the fifth rendition of this event held annually in Taipei, Taiwan, and part of a regional series of healthcare and biotech-themed conferences organized by events and training company IMAPAC of Singapore.