Translational Medicine by ToufiqS

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									TRANSLATIONAL MEDICINE

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Contents
 What is Translational Medicine?  Biomarker  Application of Biomarker  Key Steps In Translational Medicine

 Vibrant research
 Advantages  Challenges

 Clinical Trials
 Conclusion
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What is Translational Medicine?
“Translational Medicine is a branch of medical

research that attempts to more directly connect basic research to patient care.”
The emphasis is on linkage between the lab & patients bedside, without a real disconnect which is often called “Bench to Bedside” .

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Conventional Medicine approach

Translational Medicine Approach
Target

Discovery &
Validation

Patient Information

Lead Discovery

Bench to Bedside & Back
Clinical Development Pre-Clinical Development
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Lead Optimization

BIOMARKERS
“Biological substances or features that can be used to indicate normal biological Processes, disease processes or responces to therapy.” Biomarkers can be physiological indicators, such as heart rate or BP or they can be molecules in the tissues blood or other body fluids. Biomarker research is inherently dependent upon an individual’s willingness to donate biological material such as DNA, blood or tissue fragments to research community for various purposes. Why should patient donate?
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Application of biomarkers
Discover molecules & regulatory events which are central to health & disease
Evaluate their potential as diagnostic/ prognostic/ predictive biomarkers.

Design & develop clinically useful assays

Translational Medicines “in action”supporting the interface between laboratory & patients.
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Co-evaluation of biomarkers with IND

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Developing role for biomarkers
Complement/enhance traditional safety measrues.
Provide novel approaches to assessing safety during Drug Development Process. Provide drug life cycle safety / personalised safety.

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Key Steps In Translational Medicine :1)Patients with a particular genetic variation respond positively to certain medicines. 2)Recruitment of patients at all stages of disease. 3)Enrollment of additional patients to screen for biomarkers for accuracy of approach. 4)Development of molecular diagnostic test that is economically and technically feasible for use in clinical setting.

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Contd…
5)Implementation of pre-clinical studies of the drug.

6)Implementation of clinical trials.
7)Collection & study of biospecimen from patients treated with new drug to assess biological activity.

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VIBRANT RESEARCH
Cancer/ leukaemia Cardiovascular / stroke Endocrinology Neurodegenerative disease Immunity infection Inflammation Transplantation

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ADVANTAGES :Patient oriented medicines Rare chances of side effects or adverse reaction Helpful in retaining withdrawal drugs Utilized by large pharma companies to manage R&D cost more effectively & improve productivity Biomarkers are helpful to inhibit toxicology & safety concerns during later developmental stages.

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Challenges :Translation of Clinical studies into medical practice Lack of sufficient fundings Regulatory burdens

Shortage of qualified investigators
Shortage of willing participants

Incompatible databases
Lack of public support
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Clinical Trials For Translational Medicines 1. Clinical trial that is going on :Phase-2 study of anti metastatic, anti angiogenic therapy in postmenopausal patients with Hormone receptor negative breast cancer. [A translational breast cancer research consortium (TBCRC) trial.]

This study is currently recruiting participants sponsored by INDIANA University. Purpose: The purpose of this study is to evaluate the impact of
MPA alone and in combination with low dose oral chemotherapy in patients.
CONDITION INTERVENTION PHASE

Hormone receptor negative Breast cancer

Drug : Medroxyprogesterone Progesterone Acetate (MPA)

Phase -2
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2. Clinical Trial that is completed :Cytochlor & Tetrahydrouridine as radio sensitizers & cisplatin combined with radiation therapy in treating patients with advanced squamous cell cancer. This study has been completed.Sponsors & Collaborators are Sylvester Cancer Centre & National Cancer Institute(NCI)

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Purpose :Rational radiation therapy uses high energy x-rays to damage tumor cells. Radiosensitizing drugs such as Cytochlor & Tetrahydrouridine may make tumor cells more sensitive to radiaton therapy. Drugs used in chemotherapy such as Cisplatin work in different ways to stop the growth of tumor cells. Either by killing the cells or by stopping them from dividing, combining radiosensitizers with chemoherapy and radiation therapy may kill more tumor cells.
CONDITION
Head and Neck cancer

INTERVENTION
Drug : Cisplatin Cytochlor

PHASE
Phase-1

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CONCLUSION
Translational Medicine Research is a circular process which has no single starting point or ending point.

It is mainly done for the right treatment for the right patients.
Translational Medicine also provides an opportunity for patients to be involved in discovery science.

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Contd…
Often known as “Bench To Bedside” by which biomedical community takes a focused point of view to move research discoveries from the laboratories into clinical practice to diagnose & treat patients. Translational Medicine involves many more people than traditionally were involved in clinical trial both for discovery steps & clinical testing .

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BIBLIOGRAPHY

1)www.clinicaltrials.gov
2) www.fda.gov/cder/genomics

3) www.pharmabiz.com
4) www.expresspharma.com 5)www.biobankcentral.org

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