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Nature of Drug Discovery Research
The key to developing modern drugs is to search for a substance that will serve as an active principle for a specific therapeutic intervention. This substance can be man-made (a synthetic compound) or derived from living organisms (a natural compound). A natural compound has an advantage over a synthetic one in that nature optimized it for a specific biological function during evolution. Moreover, natural products possess very often complex chemical structures covering a complementary chemical space populated by conventional synthetics. Due to the complexity of many natural compounds, they cannot easily be synthesized or copied in a chemistry laboratory, strengthening their proprietary feature. To find a biological active compound, extracts from plants, animals or microorganisms are passed through different biological assays to determine the activity against specific targets, for instance, anti-malaria, anti-tuberculosis, or anti-cholesterol. Once the crude extract shows positive results, natural product chemists will use various methods to fractionate and identify an active compound from mixtures of compounds in that extract. Most of the time, these compounds require further chemical modification in order to improve their pharmacological profiles, such as solubility, stability, efficacy, toxicity, or oral bioavailability. Subsequently, these “lead compounds” will be assessed in pre-clinical test systems (efficacy, safety and pharmacokinetic study in animals), followed by 3 clinical phases in humans to elaborate data on efficacy, safety and formulation. After submission to the federal authorities such as the US Food and Drug Administration (FDA) for reviewing, the approval for market introduction is granted. On average, it takes approx 14 years and a budget of US$1.7 billion to develop one medicine.
BIOTEC-Novartis Partnership
This partnership is based on the complementary expertise of both parties. BIOTEC’s expertise lies in the knowledge of certain microorganisms, ranging from collection, identification, preservation to culturing conditions, and in the isolation and preliminary characterization of pure natural compounds from such microorganisms, whilst Novartis has expertise in the discovery, characterization, development and worldwide commercialization of compounds derived from both synthetic and natural-product sources. The partnership aims to find potential use of microorganisms, and natural compounds derived from microorganisms, as sources for innovative medicines.
Success of Phase I Cooperation
Phase I of the BIOTEC-Novartis Partnership commenced in 2005 for an initial term of three years. During this Phase, more than 2,500 microbial isolates and 70 pure compounds were investigated. Many of the microbial strains have proven their ability to produce new compounds. The pure compounds and extracts from the microbial strains continue to be evaluated against novel drug targets from all disease areas of the Novartis research portfolio, such as infectious and cardiovascular diseases, oncology, or immunology.
In addition to research collaboration, capacity building is an element of focus in this partnership through the internships of BIOTEC scientists in the research laboratories at Novartis Switzerland and through lab courses and seminars of Novartis experts at BIOTEC. This Partnership has enabled BIOTEC to automate and improve its extraction and chemical screening systems. Expertise in taxonomy and isolation of certain types of microorganisms acquired during the Partnership also enabled BIOTEC to discover 2,000 more strains. These strains are considered to be assets of Thailand and are now maintained at the BIOTEC Culture Collection where they are available for other research programs in Thailand, outside of the BIOTEC-Novartis Partnership.
Cooperation was managed by a Joint Steering Committee (JSC), co-chaired by one representative each from BIOTEC and Novartis. Through the JSC, scientists shared research results, discussed research plans and could better arrive at informed decisions, making this cooperation an EQUAL PARTNERSHIP with close involvement and interaction of researchers from Novartis and BIOTEC. Five JSC meetings were held throughout Phase I.
Term and Scope of Phase II Cooperation
- The Cooperation spans over a 3-year period, from June 2008- May 2011.
- BIOTEC will share microorganisms and purified natural compounds to Novartis to undergo its full drug discovery and development program. BIOTEC, however, will retain ownership of these microorganisms and natural compounds and thus can still use them to pursue its core research in various fields such as neglected diseases, namely tuberculosis and malaria, industrial enzymes and substances with potential for biocontrol.
- In addition to the financial contribution towards collaborative research, this partnership also reflects the Convention on Biological Diversity’s principles on sustainable use and benefit sharing. BIOTEC, on behalf of the Royal Thai Government, will be rewarded with payment and/or royalty of sale, the amount of which is determined in the agreement, when a drug is developed from materials supplied by BIOTEC. To ensure sustainable development, Novartis will provide training for Thai scientists in terms of six research internships (3 months each) in the area of drug discovery technology at Novartis Research Unit in Basel, Switzerland. From time to time, Novartis will also dispatch experts to conduct workshops and seminars in Thailand. Novartis scientists will also provide advice to BIOTEC with respect to strategic direction and fine-tuning of BIOTEC’s natural products and drug discovery program and business.
- The cooperation will be managed by a Joint Steering Committee (JSC) consisting of scientists from both parties.
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