PRECLINICAL RESEARCH & CLINICAL TRIALS - DRUG DEVELOPMENT

Preclinical research 

 After validation----> Drug molecule is noted for its

                                   ✅ Affinity and selectivity 

                                   ✅ ADME properties 

                                   ✅ Pharmacokinetic properties 

Potency of drug is checked in 

    ☆Rodents 

    ☆Non Rodents (usually Rabbit)

  《Unwanted effect --- off-Target effect 

    Desirable effect   --- on-Target effect》

    

Before testing in Humans 

●File an application  called Investigative new drug(IND) to FDA seeking permission 

●The efficacy, pharmacology, toxicity & plan to conduct trials in Humans should  be submitted 

Role of FDA 

FDA is a federal agency that ensures public health by regulating the foods,human &Vetrinary drugs,biological products and medical devices etc.

1906 - Only associated with interstate  transport

1938 - Elixir sulfanimide caused deaths in children - Regulated laws for safety 

1962 - Thalidomide caused fused limbs in new born - Efficacy

                                                 

Conduct of clinical trials

US National Institute  of Health describes 7 ethical principles 

⊙ social and clinical values

⊙scientific  validity 

⊙Fair selection of subjects 

⊙Informed consent

⊙Favorable risk benefit ratio

⊙Independent review 

⊙Respect for enrolled and potential subjects (NIH 2011)

After initial phase of phase III clinical trial - New drug application(NDA) or Biological license Application(BLA) should be filed for marketing of the drugs

PRESCRIPTION DRUG USER FREE ACT(PDUFA) enacted in 1992 speeds up the drug approval process by providing enough resources 

FDA takes 6-10 months to complete the review

Both Marketing company and the FDA should agree on the Label

Insurance companies do not finance for the off-label use of the drug

PHASES OF CLINICAL TRIALS 

DRUG DEVELOPMENT & COST

Introducing a new drug in the market is a humungous process, typically takes 10-20 years for a drug to be available for patients-use. This also results in heavy investment since a drug developing process requires lot of scientific clinical trials and inevitable errors.

source:https://www.toptal.com/finance/valuation/biotech-valuation

source:https://www.toptal.com/finance/valuation/biotech-valuation