January 25, 2017
By Karyn Korieth, BioSpace.com Breaking News Staff
Taiwan Liposome Company (TLC), a specialty biopharmaceutical company that uses lipid-based technologies to improve the safety and efficacy of injectable drugs, plans to expand its global development and manufacturing capabilities this year in the United States, Australia and China.
Growth plans for the Taipei-based company include increasing its international workforce, which stood at 160 last year, by about 25 positions. The additional roles will include clinical and product development across various expertise, created in part by recent advancements in lead clinical programs, and differ among the subsidiaries depending on expansion plans for each region.
“We want to build a stronger base in each region,” TLC President George Yeh told BioSpace. “Our company strategy focuses on developing drugs with a global strategy and leveraging different types of local resources to speed up timelines or reduce costs.”
TLC, which was founded in 1997, uses proprietary lipid-based technologies to develop new chemical entities (NCEs) or new formulations of existing drugs that can last longer, target specific tissues or reduce toxicity for diverse indications, including cancer, osteoarthritis and degenerative eye disease.
Yeh’s comments on hiring and growth plans follow the announcement that the company has obtained approvals to initiate a Phase II trial of a sustained-release treatment for osteoarthritis at sites in Taiwan and Australia after receiving favorable top-line results from a Phase I/II safety and efficacy trial.
TLC also has received regulatory approvals in the U.S. and Taiwan to begin a Phase I/II clinical trial for an oncology product, TLC178, designed to lower toxicity of current therapies, which has orphan drug designation from the FDA for the cutaneous T-cell lymphoma indication. Other products in clinical trials, including treatments for liver cancer and degenerative eye diseases, also advanced during the past year.
The company’s business strategy calls for focusing its international workforce on the technology and product development side of the business. The company then works with various commercialization partners, including Teva Pharmaceuticals and Sandoz AG, a division of the Novartis Group, for product distribution. TLC also has agreements with production sites, including a contract with Pfizer for scale-up processes and commercial manufacturing at a facility in Australia acquired from Hospira.
At TLC Biopharmaceuticals, the company’s San Francisco, Calif-based subsidiary, areas for expansion include early stage research, for which TLC collaborates with Stanford University and other institutions in the Bay Area, clinical development and regulatory affairs.
In Australia, plans are underway to increase the number of products being manufactured at Pfizer’s Hospira production site and to strengthen capabilities for first-in-human clinical studies.
Meanwhile, in China, where teams historically have focused on regulatory and strategic partnership functions, TLC plans to develop its clinical and manufacturing teams in order to leverage government incentives for locally made products as some of its therapies reach the New Drug Application (NDA) stage.
TLC also maintains staff at subsidiary sites in Tokyo, Japan and Leiden, the Netherlands.
As it expands globally, TLC continually adjusts the balance between internal and external expertise, keeping the positions that require knowledge of core competencies in-house while engaging consultants for specific functions and projects. TLC hires local employees or consultants in each region whenever possible. Yet in Asia, Yeh said U.S. teams or consultants are sometimes needed to fill a skills gap in translational work.
“Only recently has more talent started to come back to Asia from the States,” said Yeh. “In the last one or two decades, there is talent, but not enough experience in doing translational research. That is where there is a huge gap in Asia compared to the U.S.”
Since TLC uses highly specialized lipid-based technologies to design its drug delivery systems, finding new talent with a similar background can be difficult. The company, however, invests in individuals passionate about their type of drug development and provides training courses on the company’s technology and development strategy to all new employees.
The company also fosters a culture of teamwork and collaboration across different groups or skill sets. Team members are exposed to multidisciplinary functions, which allows them to understand the development pathway from different viewpoints, and contribute to cross-functional discussions about future risks and how to reduce them.
“A lot of new ideas come out of these face-to-face interactions. We don’t expect everybody to know everything. But at least you can understand what other people do and how that fits into the whole drug development process. That is really important,” said Yeh.
