The Botanical Drug Development Consortium (植物新藥聯盟) yesterday announced it has signed a letter of intent to collaborate in meeting standards set by the US Food and Drug Administration (FDA) on plant-derived medicinal products.
The initiative aims to help Taiwanese, Chinese and Malaysian companies, as well as a number of plant growers, meet the FDA’s General Agricultural and Collection Practice (GACP) standard set last year, which ensures that source plants grown and harvested for use in botanical drugs meet requirements in terms of consistent potency and quality.
Formed in 2015 under the Development Center for Biotechnology (DCB, 生物技術開發中心), the consortium has been a major proponent of the nation’s botanical drugs industry.
Approval for new drugs is a lengthy and stringent process that brings the possibility of immense opportunities once attained, Botanical Drug Development president and chief operating officer Lawrence Gan (甘良生) said at a signing ceremony at the BioTaiwan Exhibition in Taipei.
The FDA requires suppliers to submit comprehensive filings on the chemistry, manufacturing and control aspects of botanical drugs when filing an application to conduct a phase III clinical trial, Gan said, adding that the requirements have made it difficult for developers to become growers.
The initiative establishes partnerships between developers and growers, while helping growers meet GACP standards using the consortium’s technology platform and other resources.
In particular, the consortium, as well as the DCB, are to focus on meeting the FDA’s requirement of at least three GACP-certified plantations to ensure adequate supply, Gan said.
“Unlike pharmaceuticals produced in a lab, the plants used in botanical drugs are grown under a wide range of conditions, with variables — such as temperature and rainfall — potentially leading to inconsistent properties,” DCB natural resource development director Chung Yun-shan (鍾玉山) said.
The challenge lies in making sure that all three plantations, which might be in different countries, all produce plants with the same attributes, Chung said.
“We offer our partners proven cultivation methods, as well as a cloud computing-backed technical platform, to collect data to meet the FDA’s standards,” Chung said.
“We also match biotech companies with investors,” he said.
Adherence to the GACP is required before any new botanical drug can get its foot in the door to the US’ immense market, Chung said.
The institutions also provide consultation on designing preclinical and clinical studies.
The consortium is helping a Taiwanese and a Thai company to improve products made from Bacopa monnieri, a herb that has been used in Thailand as a remedy against neurological diseases, Chung said.
The partnership aims to prove and improve the potency of B monnieri through preclinical trial studies, with the hope of elevating the remedy to a botanical drug, Chung said.
Chung said that while higher-priced new oncology drugs are out of reach for most Southeast Asian consumers, botanical drugs are a viable entry point for Taiwanese companies, due to their significantly lower costs.
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