Life Sciences Blog

Focused on the Business of Healthcare and Healthcare Innovation

Regulatory Submission (Chapter 4) The FDA and other regulatory agencies are conservative by design.  Drugs are approved based on their safety and efficacy (historically their ability to address a particular disease or patient condition) regardless of a patient’s genomic profile. Pharmaceutical companies have attempted to follow proven regulatory pathways as opposed to proposing or negotiating …

Read more »

Marketing & Sales (Chapter 5) Pharmaceutical marketers use the classical 4Ps of marketing (product, price, place, promotion) to market therapeutics to the key stakeholders:  prescribers, payers, and patients.  Tactics deployed depended largely on the size of the market, the number of competitors, the number of prescribers and payer ability to influence access/coverage. Primary Care Drug …

Read more »

Coverage and Reimbursement (Chapter 6) The market access/reimbursement teams at pharmaceutical companies work closely with payers, advocacy groups, commercial copay programs, and 501(c)(3) patient assistance foundations to help ensure approved medicines are covered by public and private payers.  Once coverage has been established, these groups focus on understanding the payer-to-payer differences in processing and paperwork …

Read more »