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Technical Audit (Strategic Inventory Consulting)

The objective assigned to Technical Audits is to study future trends and competitive drugs developments in a therapeutic area prior to committing to the design of a clinical / marketing program.

For one given candidate-drug, a Technical Audit addresses the scientific, business, and marketing issues relative to the development and best possible clinical positioning in one (or a set of) country(ies).

Prepared for the exclusive usage of a Company with the help of data supplied by this Company, a Technical Audit / this Strategic Inventory Consulting is a professional tool for a better development & marketing positioning of a given candidate-drug.

Objective

• For the pharmaceutical Developer and Marketeer, Technical Audits are an opportunity to challenge opinions and to secure decisions.
• Each technical audit is a “creative” work specifically designed for aiming at the best possible clinical positioning for one given candidate-drug.
• Technical Audits address the scientific, business, and marketing issues relative to the development and best achievements of a given candidate drug in one or several countries.
• With their final aim of developing and marketing better-designed drugs, Technical Audits should also contribute to an overall improvement of human life. It is Bouée Research Institute’s corporate philosophy to comply to this ethic, hence to work for the progress of human well-being.

List of Contents

➀Medical aspects
Medical update,
Future epidemiologies, including disease-management foreseen evolutions,
Review of the candidate-drug profile & SWOT analysis.

➁Competition (Macro & Direct)
Current market,
Foreseeable future,
Players’ strengths & weaknesses.

➂Clinical development & business factors; pricing
Clinical research in the field,
Clinical requirements & pitfalls,
Timing & cost of development,
Pricing issues.

➃ Opinion leaders & media flow of information

➄ Clients’ expectations
Governmental authorities, patients, doctors, pharmacists, nurses, wholesalers, etc.

➅ Positioning Recommendation

➆ Adequacy of the envisioned candidate-drug positioning with the company global strategy

➇ key-information on the candidate-drug
Appraisal of the candidate-drug potential,
Profit-events graph.

➈ Issues which need to be addressed (to do)

Experience:

Mode of action	Targeted Indication
ACE-inhibitor	hypertension
angiotensin-II-antagonist	hypertension, arrhythmia, cardiotonic, peripheral vascular disease
calcium antagonist	dementia
noötropic	dementia
steroid inhaler	bronchial asthma
beta2 agonist	bronchial asthma
RT inhibitor	HIV CD4≤500
5HT3 antagonist	nausea & vomiting associated to therapies anti-histaminic asthma, rhinitis, atopic dermatitis, urticaria wounds skin healing
alkylating agent	bone marrow transplantation, chronic hepatitis B
immunopotentiator	chronic hepatitis B
immunopotentiator	HIV / AIDS
interferon alpha	hepatitis, liver cancer treatment
sodium blocker	epilepsy
antiviral agent	herpes...
pyrolid	gastro/duodenal ulcer
H2-antagonist	gastro/duodenal ulcer
neuraminase inhibitor	influenza
5HT3	migraine / cluster headache, stomach / colorectal cancer, adjuvant therapy
5HT3	irritable bowel syndrome
RT inhibitor	HIV/AIDS
tribactam	infections, cytomegalovirus, anti-infective, anti-fungus, anti-viral, gram-positive anti-infective, septic shock
sodium blocker	acute pain
analgesic [systemic]	pain, PTCA/CABG renostenosis (cardioprotection)
glycin antagonist	within 12 hours after stroke, stomach/colorectal cancer
alpha1a antagonist	begnin prostatic hypertrophy
NSAID	rhumatology, sleep disorders, anxiolytic, sleep inducer, anti-depressant
anti-metabolite	cancers
immunomodulator	cancers
hormone replacement	osteoporosis
hormone	oral contraception
topical antibiotics	rosacea
retinoid	acne

Note: until we have a mutually agreed and honored contract with our client or prospect on the concerned topic, our Documents, Research Proposals and the relevant Research Procedures are the sole property of Bouée Research Institute & L207. They cannot be used, directly or indirectly, partly or as a whole, without the prior written consent of an authorized person from Bouée Research Institute or L207.