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Executive Summary (Chapter 1) In this article, we illustrate how personalized medicine will change the pharmaceutical industry.  When one contemplates the complexity of the future environment, it becomes quite clear that existing discovery, development, regulatory, commercialization, and reimbursement frameworks are nowhere near prepared for the changes coming with personalized medicine. It is imperative that pharmaceutical …

Drug Discovery (Chapter 2) Over the years, research and discovery teams have deployed numerous techniques to identify “trial-worthy” compounds.  Some discovery was pure serendipity (e.g. penicillin) while others were the result of decades of research in molecular pathways (e.g. lovastatin).   Some drug discovery techniques have included: Combing the rain forests and oceans to find bacteria, …

Drug Development (Chapter 3) In drug development, a series of preclinical safety, toxicity and efficacy studies are performed in vitro and in animals prior to administering these drugs to humans.  Clinical trials are designed to first addressing safety, then dosing, then efficacy, and finally larger Phase III trials to look at efficacy and other endpoints …

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 …

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 …

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 …

Lifecycle Management (Chapter 7) Historically, drugs are approved for an initial indication; then the lifecycle management team pursued additional indications.  Rarely were indications revoked by regulators, so the potential market usually increased indication by indication.  Within each indication, companies competed for market share. Personalized Medicine Implications As our understanding of genomics increases, it is likely …

Summary and Recommendations (Chapter Eight) Personalized medicine has arrived, and its impact has only begun to be felt across the healthcare ecosystem.  In this article, we have illustrated how personalized medicine is likely to change the pharmaceutical industry, historically one of the riskiest yet most profitable parts of the healthcare ecosystem. When one contemplates the …

Every day there seems to be something in the News about Personalized Medicine. Many people tune it out thinking, “Really? How is our life better? For 20 years, we’ve been hearing the Human Genome Project is going to revolutionize medicine. During the same time, Steve Jobs* revolutionized the music, telecommunications, and computer industries.“ FACT: Personalized …

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