Translational Research Platform Translational research, transforms - - PowerPoint PPT Presentation

 ‘Translation’ refers to the application of the results of basic biomedical research to the practice of medicine.  It is the process of converting discoveries made in the laboratory into clinical interventions that provide a direct benefit to human health.  Bridging the gap between the discoveries achieved at the ‘bench’ and interventions and therapies at the ‘bedside’ remain a challenge.  Translational Research is a two-way process to translate discoveries into clinical application and the translation of clinical findings into the understanding of molecular mechanisms.

Definition: “Investigation of methods, interventions and variables that

influence adoption by individuals and organizations of evidence-based practices to improve clinical and operational decision making in health care.” (Titler, 2008, p. 1- 115-1-116).

TRANSLATIONAL RESEARCH Translational Research Platform

Translational Research Platform Translational research, “transforms scientific discoveries arising from the laboratory, clinical, or population studies into clinical applications…” (Source: National Cancer Institute, National Institutes of Health)

Translational Research

Translational Research

Figure 1 Model for translational research, as proposed by the Evaluation Committee of the Association for Clinical Research Training.8

• T1 research seeks to foster new or improved scientific understanding or patient care.
• T2 research facilitates improved patient outcomes, optimization of medical practices,

and improved community health.

• T3 research promotes further scientific understanding of human health and disease.

TRANSLATIONAL RESEARCH PHASE

Dougherty, D. et al. JAMA 2008;299:2319-2321

Translational Research Platform

IDEA MARKET

Universities Research Institutes Start-up Firms R & D Firms Larger Companies

Translational Research Platform

Teaching Research Publishing Competing for grants Individual career ambitions

To do this, the basic motive to do research has to change in terms of ‘addressing an unmet need’ and not to start with an already available publication. Translational Research Platform

Technology Issues Business/Market Factors Intellectual Property Challenges

Technology and Product Development Product/Market Fit Value Proposition Partnership Strong IP Position

SUCCESSFUL INNOVATIONS Translational Research Platform

 Thinking about innovative process and

• utcome value

 Mentoring; counseling student-lead research  Users of student generated materials  Documentation- Process, Case Studies, Broader Impacts  Communication- Internal & External  Knowledge Sharing

 Capture of process  Connecting teams  Facilitating Project Development  Publishable Research Teaching case or Examples  Training

Translational Research Platform

S. No. COMMERCIALIZATION PARAMETER SCORE REMARKS

• I. a

Fulfilling an unmet need 25 New vaccine or disease diagnostics that is not so far available

• I. b

Reducing existing cost with equivalent performance 20 Reverse engineering; import substitute

• I. c

Improving existing performance –

• vercomes lacunae

15 Mab-based cELISA improves specificity; DIVA II Novel - IP protected 25 More so for multinationals III Fulfilling regulatory requirements 10 Milk adulteration; Fat / protein content; Bull testing; RFFIT; canine parentage IV Availability of complete portfolio 15 Not restricted to only one disease diagnosis but for other related diseases also V Ease and market of technology adoption 12.5 User-friendly; POC – strip test, FPA VI Availability of raw materials / ingredients 7.5 For bulk production – Mabs, recombinant proteins; tuberculin etc. VII Create awareness / Aggressive Marketing 5 Users need to know of availability

Translational Research Platform

Technologies change rapidly Changing priorities Demand and buying capacity

SCIENCE TECHNOLOGY BUSINESS IP REGULATION

Translational Research Platform

PRODUCTS PROCESSES

More impact Less impact User friendly Sample collection, transport, time etc. more critical Field based Laboratory POC (Proof of Concept) Time lag Disease diagnosis Characterization – sexing, A1/A2, parentage Need to be technologically less demanding Can be technologically more demanding

Technology landscaping

– Understand what is occurring in your technological area:

• technological trends
• subjects of research
• emerging research fields

– Avoid reinventing the wheels

• find existing solutions to a technical problem
• find solutions that are not yet protected

– Watch your competitors

• key players
• patent portfolios
• technical strategies

– Survey third parties patents

• patenting trends
• threats
• infringements

Translational Research Platform

• Thinking ‘backwards’ – ‘market to mind’
• Pose several questions in your research area
• Identify priorities
• Do a technology landscaping
• Do a FTO (freedom to operate) search / strategy
• Then do the ‘science’ – Be willing to accept failures
• Immediately protect the ‘science’ through IPR
• Do a mutually trusting collaboration especially with

industry – ‘win-win’ situation for both parties

• Satisfy regulatory requirements

Translational Research Platform

COMPULSORY LICENSING

• section 84 (a) that the reasonable

requirements of the public with respect to the patented invention have not been satisfied, or (b) that the patented invention is not available to the public at a reasonably affordable price,

• r (c) that the patented invention is not

worked in the territory of India.

Supreme Court says no to Bayer, upholds compulsory license on Nexavar

• anti-cancer drug – sorafenib tosylate
• crucial drug for patients living with kidney and

liver cancer

• Bayer - Rs. 2,80,000 per month per patient.
• Natco - Rs. 8, 800 per person per year
• 8842 in one yr vs 200 in 3 yrs

“Herbal exfoliating composition comprising Phaseolus mungo and Cyphomandra betaceae” Indian Patent No: 292860

Translational Research Platform

CASE STUDY – 1

Novel and stable pharmaceutical composition of vitamin A analogs . Patent filed no. : 813/CHE/2011

Translational Research Platform

CASE STUDY – 2

Patent No.: US 8,999,384 B2

CASE STUDY – 3

Arise, Awake, Stop not till the goal is reached

• Swami Vivekananda

21