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August 14, 2011 · 10:15 pm

Drug Development from Binary to Gradient Model

Earlier this year a study by the Center for the Study of Drug Development at Tufts University placed the cost of developing a new drug at $1.3 billion [1].

Distribution of Development Funding

Though the number is contested by other researchers [2], it is well within the trend of pervious studies and has now been widely accepted as an industry wide average. Exacerbating the issue is the all or nothing nature of drug development, where failure during any phase of clinical trials can cause the termination of a project. It is therefore advantageous to consider technologies that will reduce the risk of this binary success/failure model and transition to a gradient definition of therapeutic efficacy.

Trending Costs of Drug Development

Much of the high costs come in during phase 2 & 3 trials, where patient care, clinical production and regulatory leg-work consumes funds at an alarming rate. With everything riding on the individual trial subjects, their well-being directly linked to success. Undesirable reactions to experimental treatments is unavoidable and the margins for serious adverse events is kept tight by regulatory agencies to protect healthcare consumers. Often however, ground-breaking treatments have to be shelved because they affect 10-15% of trial subjects detrimentally.

RD costs of new chemical entity (NCE)

This makes any ability to view trial subjects with increased resolution and discern subtle correlations with their reactions to consumer demographics key in cutting risks of total-loss. Here I hope a story about my own experience is helpful, as I know it better than what anyone else has had to dealt with. My time at Novartis began when I was brought on-board to help with the development of a drug entering a repeat Phase IIB trial, as the first time around approximately 15% of subjects showed an adverse reaction of note.

Draft FDA Guidance on DNA Sequencing & Clinical Trials

Soon however folks began to get cold-feet, do we dump further resources behind this project or cut our losses and iterate to the next project. A third option now becoming available is that perhaps there was something specific to those 15% of patients that caused the unwanted reaction. Identifying this would allow the drug to move along its pipeline with contraindications that covered the failing demographics. No longer limiting projects to pass/fail while hedging development risks.

Citations:
DiMasi et al,(2003) The price of innovation: new estimates of drug development costs
Ernst & Young Global Pharmaceutical Industry Report (2011) Progressions Building Pharma 3.0
Tufts Center for the Study of Drug Development (2011) Outlook 2011 report

Industry & Academia, part 2: Ex Mod Op

Infamous Exubera Insulin Disaster

Opening restrictions of what a guided problem is allows us to achieve greater results. A simple rendition of this can be seen with consumers perception of what “cures” or medicine is. The lay public expects a pill to solve our problems. Which inversely effects the professionals own vision of what their goals are. Any cure that a researcher imagines is heavily influenced by what they perceive the consumer will accept, overwhelmingly a pill or vaccine. When new forms of delivery are brought to the edge of market they are often marred internally as “untested” or the cost of implementation by an older method is brought to attention. Exubera was developed when predictions throughout the healthcare industry pointed to a diabetes epidemic, which of course we are smack in the middle of now. In that climate a non-invasive inhalable insulin seemed like it would pay its weight in gold, it didn’t.

Today, the oracles in their glass towers predict a surge in respiratory illness. Rightfully pointing to developing nations, i.e. China, India and their falling air qualities & rising numbers of healthcare consumers. Guiding research towards COPD, cystic fibrosis and others, all of which are significant causes of suffering. Chasing after the dollar often is the best method for innovation; healthcare however, has often demonstrated to be a more complex system requiring greater foresight than simply following consumers pocketbooks and wants. Adding to this are the already strict standards which government agencies apply and by so doing hinder the progress of medicine.

This often brings up the fear that the regulations were placed to keep the public safe and still to-date so many dangerous drugs make it to market every year; a moot point, in that many of the addictive, high risk drugs which make it to market are often brought about by public want. Pain-killers & anti-depressants, all poster ads for substance abuse and hollywood over-doses. Truly increasing life span and quality significantly, requires a new paradigm of for-profit research and public perception of medicine. Extinctus Modus Operandi.