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A Framework to Assess

Opportunities
Size of Prize
Per Indication, Per Geographical Market
Incidence & Prevalence
% Diagnosed
% Treated
Affordability
Health Infrastructure
Reimbursement
Market Size Estimation
Landscape Analysis
No. of existing Solutions
Penetration of These
Determining the Unmet
Need
Likely New Entrants
KOLs
Above Analysis
Pipeline Analysis
Commercial Estimate
Pricing Decision
Market Share
Forecast
Risks Involved
Possible Treatment
Regimen
Inputs from
Technical Team
Resources/References to be Used
For Epidemiology, Globacan and Pharmaetrack are to be used
For Pipeline analysis, Clinicaltrials.gov to be used
WHO reports may supplement some information
Anymore suggestions?
Customer Based Business Strategy Framework
Mission Where Am I
Objective
Where I want to be
Environmental
Analysis
Industry
Analysis
Company
Analysis
Customer
Analysis
Where to
Market
How to
Market
Design Deliver Communicate
Regulatory
Penetration
Pipeline Analysis
Cipla SWOT
Affordability
KOL Opinion
Reimbursement
Something for Day
After Tomorrow
Conceptualization
Geographies
Positioning
Case of Cancer
Therapeutic Arsenal Against Cancer
Surgery Chemotherapy Radiotherapy
Targeted
Therapy
Tyrosine Kinase Receptor Inhibitor
Angiogenesis Inhibitors
Proteasome Inhibitors
Biological Response Modifiers
Monoclonal Antibodies
Small Molecules: Imatinib, Gefitinib, Erlotinib
Bevacizumab
Bortezomib
Denileukin Diftitox
Reference:
Monoclonal antibodies: Targeted therapy
N Gupta, A Srivastava
Intas Biotechnology/Oncology, Plot No. 423/P/A/GIDC, Sarkhej Bavla Highway, Moraiya, Tal: Sanand, Ahmedabad-382 210, India
Monoclonal Antibodies
Objective: To harness specificity of immune mechanisms against tumor cells
Arise from a single cell type
Act by recognizing the protein on the surface of the cell and then lock into it
Produced in lab from a single clone and recognize only one antigen
Made by fusing a normally short-lived antibody producing b-cell to a rapidly dividing cell, such as
cancer cell (Often referred to as immortal cell)
The resulting hybrid cell, or hybridoma, multiplies rapidly; creating a clone that produces a large
quantity of antibodies
Inhibition of allo-immune reactivity: In case of organ transplantation, MAbs are used to provide
immunosupression by antagonism of IL-2 or by the elimination of activated T-cells.
Inhibition of autoimmune reactivity: Infliximab is used in the treatment of Crohn's disease and
rheumatoid arthritis. Rituximab is also used in the treatment of rheumatoid arthritis.
Antiplatelet activity: Coronary intervention in ischemic cardiac disease disrupts the intimal layer of
the vessel and aggravates platelet aggregation, leading to thrombosis. Glycoprotein IIb/IIIa
receptor blocker is a clear target for MAbs, in the prevention and treatment of this disease.
Infectious diseases: MAbs is being used for the treatment of respiratory syncytial virus (RSV) infection
in premature infants with bronchopulmonary disease. Several drugs are in the pipeline for the
treatment of infective diseases.
Cancer therapy: MAbs that bind cancer cell-specific antigen induce an immunological response
on the target cell. Another strategy for antitumor therapy is to target the receptors of growth
factors like EGF and VEGF.

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Other Targeted Therapies
Tyrosine Kinase Receptor Inhibitor
Gefitinib for non-small cell lung cancer
Erlotinib for metastatic renal cell carcinoma
Imatinib in gastrointestinal stromal tumors, lung cancer, prostate cancer, breast
cancer, gliomas and seminoma
Angiogenesis Inhibitor
Bevavcizumab in metastatic colorectal cancer, metastatic renal cell carcinoma,
multiple myeloma, and prostate cancer
Proteasome Inhibitor
Bortezomib in multiple myeloma patients on whom other therapies failed
Biological Response Modifier
Denileukin is diftitox used in non-Hodgekins lymphoma

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