Pharmaceutical Pricing and Market Access
Lecture Notes
Lecture 1:
• the lifecycle of a drug
• challenges facing the pharma industry
History of Drug Discovery:
— Herbs and natural ingredients; coincidental discoveries, i.e. penicillins - 1900
— Psychotropics: 1950s
— Receptors (NSAIDS): 1960s
— Enzymes (beta blockers): 1970s
— Genetic engineering: 1980-2000s
— Cell and Molecular Biology: 2000s-2020s —> biologics
Precision medicine (nowadays)
— Pharmaco-genetic guided treatments
— Germline DNA testing to obtain info that influences effects and side-effects of drugs in order
to inform the treatment or its dosing
— Target therapies
— Gene therapy: drugs that target/alter genetic profiles.
Lifecycle of a drug include:
1. Development: before sales
Synthesis of compounds, perform safety studies,
identification of core components
Animal testing (pre-clinical)
Then, human studies:
PHASE I (small pool, healthy)
PHASE II (bigger pool)
PHASE III
Obtain registration and reimbursement
Commercialization: PHASE IV (safety, real life patients)
Lecture Notes
Lecture 1:
• the lifecycle of a drug
• challenges facing the pharma industry
History of Drug Discovery:
— Herbs and natural ingredients; coincidental discoveries, i.e. penicillins - 1900
— Psychotropics: 1950s
— Receptors (NSAIDS): 1960s
— Enzymes (beta blockers): 1970s
— Genetic engineering: 1980-2000s
— Cell and Molecular Biology: 2000s-2020s —> biologics
Precision medicine (nowadays)
— Pharmaco-genetic guided treatments
— Germline DNA testing to obtain info that influences effects and side-effects of drugs in order
to inform the treatment or its dosing
— Target therapies
— Gene therapy: drugs that target/alter genetic profiles.
Lifecycle of a drug include:
1. Development: before sales
Synthesis of compounds, perform safety studies,
identification of core components
Animal testing (pre-clinical)
Then, human studies:
PHASE I (small pool, healthy)
PHASE II (bigger pool)
PHASE III
Obtain registration and reimbursement
Commercialization: PHASE IV (safety, real life patients)
