Biomedical Research to Translational Medicine * MS , Saigal A. Tuteja D. PhD and Chaturvedi D. PhD Bio Business Inc., 400 Continental Blvd, 6th Floor, El Segundo, CA 90245 [email protected] www.biobusinessinc.com INTRODUCTION (ii) CURRENT STATE OF AFFAIRS (iv) GLOBAL PROGRESS IN TRANSLATIONAL MEDICINE Drug Discovery, the first step towards creation of blockbuster and orphan drugs, occurs at a variety of academic institutions and pharmaceutical, biotechnology and / or life science industries, that predominantly work independently. With increasing new drug disapprovals, regulatory constraints and the inevitable “patent cliff”, escalating drug prices and funding impediments (also referred as “Valley of Death”), an amiable and a collaborative nexus between academia and industry offers a promising solution. This can be achieved by adopting a Translational Medicine (TM) approach. TM ensures that bounty of biomedical research is “translated” into benefits in oncology, inflammation, metabolomics and unmet needs in other challenging fields. It thus, helps in, not only improving the quality of human healthcare effectively but also streamlines resources requisite for supporting meaningful research endeavors. TM is slowly gaining momentum in leading nations of the world such as USA, UK, Netherlands, Austria, Singapore, China, Australia, Japan, Japan, India, Malaysia and South Korea. TRANSLATIONAL GAP (iii) THE TRANSLATIONAL APPROACH METHODS TRANSLATIONAL MEDICINE At BioBusiness Inc., we facilitated vital affiliations, innovative thinking and offered tools for speedy and effective translation of biomedical research into clinical applications thereby bridging the translational gap while providing an appropriate platform for professionals to learn, network and make crucial strategic decisions. RESULTS This section underscores the relevance of TM, identifies major logjams hindering its implementation, discusses propitious strategies to mitigate such hurdles, acknowledges global efforts advocating TM and how TM has facilitated overall progress in R&D. BIOMARKER DEVELOPMENT RADICAL RE-STRUCTURING Stratify Disease + Population Cordial Nexus Predictibility Autocracy + Tech Transfer Personalized v/s “One-modelfits-all” Fragmentation of R&D + Manufac. / Mktg. EDUCATION / TRAINING (i) THE BELIEF “It is much more important to know what kind of patient has a disease, than to know what kind of disease a patient has” Biotech Incubators and hubs Curriculum revision Obdurate diseases - multiple causes Economic growth Reduction of Translational Gap Innovative solutions Incentivize progress Cost effectiveness (v) SCOPE OF IMPROVEMENT C H A L L E N G E S Lack of TRANSLATIONAL EDUCATIONAL METRICS Lack of ROBUST MANAGEMENT WITH A TM VISION Lack of GOVERNMENT SUPPORT Lack of FUNDING SOURCES CONCLUSION TM helps in improving the quality of human healthcare by providing innovative solutions for hard-to-cure diseases and streamlines resources necessary to support meaningful research endeavors, hence encouraging economic growth. Heeding emerging biomarkers from regulatory and human prognosis perspective, cordial nexus amidst academia and industry and tenacious approaches to promote TM globally can render optimism regarding winning the translational race. REFERENCE Caleb Perry (1755-1822) ZIAGEN GEFITINIB TRASTUZUMAB IVACAFTOR i. Woolf, S.H. (2008) The meaning of translational research and why it matters JAMA 299(2) : 211-213. ii. Zhang, F., P. Cooke, and F. Wu, State-sponsored Research and Development: A Case Study of China’s Biotechnology. Regional Studies, 2011. 45(5): p. 575-595.