A Framework to Assess Opportunities

Size of Prize Per Indication, Per Geographical Market

Incidence & Prevalence

% Diagnosed% Treated

AffordabilityHealth

InfrastructureReimbursement

Market Size Estimation

Landscape AnalysisNo. of existing Solutions

Penetration of These

Determining the Unmet Need

Likely New Entrants

KOLsAbove Analysis

Pipeline Analysis

Commercial EstimatePricing 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

ObjectiveWhere I want to

be

Environmental Analysis

Industry Analysis

Company Analysis 

Customer Analysis

Where to Market

How to Market

Design Deliver Communicate

Regulatory

PenetrationPipeline Analysis

Cipla SWOT

AffordabilityKOL Opinion

Reimbursement

Something for Day After Tomorrow Conceptualization

GeographiesPositioning

Case of CancerTherapeutic 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 therapyN Gupta, A SrivastavaIntas 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.

Appl

icat

ions

Other Targeted TherapiesTyrosine Kinase Receptor Inhibitor

Gefitinib for non-small cell lung cancer Erlotinib for metastatic renal cell carcinomaImatinib in gastrointestinal stromal tumors, lung cancer, prostate cancer, breast cancer, gliomas and seminoma

Angiogenesis InhibitorBevavcizumab in metastatic colorectal cancer, metastatic renal cell carcinoma, multiple myeloma, and prostate cancer

Proteasome InhibitorBortezomib in multiple myeloma patients on whom other therapies failed

Biological Response ModifierDenileukin is diftitox used in non-Hodgekin’s lymphoma