SELECTION AND DEVELOPMENT:
identification of a potential drug target, VDDI Pharmaceuticals will form a due
diligence team which will work closely with VDDI Pharmaceuticals management during
the diligence assessment process. The team will be responsible for
'scoring' each target according to a filter and sieving process.
A product will be considered based upon the following criteria:
Established: In Phase I studies, safety and initial dose selection
is explored to determine the maximal tolerated dose. In addition,
initial estimates of efficacy can be determined. This is especially
true with "fast-track" products. For example, in the
case of cancer therapies Phase I clinical studies for "fast-track"
products can often be conducted with cancer patients instead of
normal volunteers. VDDI Pharmaceuticals will focus on product opportunities where
the pharmacology has already been established.
Development Time and Cost: There are three distinct phases
of clinical testing of pharmaceutical products and each has a
specific purpose. In Phase I clinical trials, the drug is administered
to a small number of typically healthy volunteers (approximately
50 to 100) in order to determine a drug's safety, metabolic effects
and tolerable dose levels in humans. During Phase II studies,
the drug is administered to patients who suffer from the disease
the drug is intended to treat. Approximately 100 to 300 patient
volunteers are given the drug to determine how effective it is
against the disease and to identify doses that are both effective
and well tolerated. After a drug completes Phase II trials, it
enters larger Phase III clinical trials. During this phase, the
drug is administered to 1,000 to 3,000 patient volunteers in order
to confirm its efficacy and long-term effects. The use of larger
numbers of patients also helps detect infrequent side effects.
If the results of the preclinical studies and clinical trials
are positive, a drug company will file a New Drug Application
(NDA) and submit it for FDA review. The NDA contains all the research
data on the drug obtained thus far. Clinical trials are conducted
within a two-to-seven year time period. Simultaneously, the Marketing
Authorization Application (MAA) is prepared for non-US markets.
A key factor in VDDI Pharmaceuticals' consideration of product
opportunities will be the target population and indication. For
example, in many orphan cancer indications it is only necessary
to complete Phase II to obtain marketing approval. This directly
translates into reduced time and cost for commercialization, with
the clinical program often competed in 2 years In contrast, for
a hypertension drug, clinical studies may take 7-10 years and
include between 2000 and 3000 patients along with special populations
like the elderly, and patients with kidney and liver complications.
- Fast Track
FDA Approval: "Fast track" is intended to facilitate
development and expedite review of drugs that treat serious and
life-threatening conditions so that an approved product can reach
the market expeditiously. VDDI Pharmaceuticals will look for product opportunities
eligible for "fast-track" approval.
- Good Preclinical
Studies: During the selection process VDDI Pharmaceuticals will examine the
following areas relative to preclinical issues: Acute and multiple
dose (subchronic), Chronic and/or carcinogenicity, genetic toxicology
(in vitro/in vivo), reproductive toxicity (segments I, II &
III), specialized studies (inhalation, phototox, arthropathy,
allergenicity), safety pharmacology, absorption, distribution,
metabolism and excretion (PK), and toxicokinetics (TK).
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