Archive for the ‘Pharma Sales & Marketing’ Category

2010 was a lean year for new drug approvals. The FDA granted permission for only 21 new medications…below both the 2009 and 2008 levels. Some of the most eagerly awaited approvals have been delayed.  Many see the low numbers as a trend

Courtesy of the WSJ

reflecting an increased focus on safety concerns but the FDA states there has been “no systemic change…” in the process of granting approval. Nonetheless, change is most certainly underway when it comes to evaluating safety & effectiveness for proposed and existing medications. 2010  also saw a significant number of drug recalls by the FDA and the agency used its enhanced authority to address issues of labeling and advertising throughout the year as well.

Armed with more legal power through the passage of the FDA Amendments Act (FDAAA) and moving towards improved data management technologies, the agency is targeting changes aimed at improving the drug approval process, responses to adverse events and other key safety segments with its Sentinel Initiative.

The FDA’s Deputy Commissioner Dr. Joshua Sharfstein, (a strong advocate of more stringent safety regulations, who has just recently announced his departure from the Agency) gave a significant update to the House Subcommittee on Health in Spring 2010.

“…FDAAA requires the HHS Secretary to develop methods to obtain access to disparate data sources and to establish a postmarket risk identification and analysis system to link and analyze health care data from multiple sources. On May 22, 2008, FDA launched the Sentinel Initiative with the ultimate goal of creating and implementing the Sentinel System—a national, integrated, electronic system for monitoring medical product safety. The Sentinel System…will enable FDA to actively gather information about the postmarket safety and performance of its regulated products—a significant step forward from our current, primarily passive safety surveillance systems.   The law sets a goal of access to data from 25 million patients by July 1, 2010, and 100 million patients by July 1, 2012…”

Lofty but achievable goals when the right data management technologies are brought to the task. The challenges are significant but with almost half of the population taking at least one prescription drug the value of transforming the FDA from an agency that reacts to adverse events to one that proactively prevents them cannot be overrated.

The nascent trend of five years ago is rapidly becoming the model of today. More & more pharma research is focused on joining forces with universities. The rationale is simple and brilliant; With the ever escalating costs of R & D and the ‘patent cliff’ fast approaching, the merger of resources is a natural wellspring of mutual benefits.

Big pharma needs new drug discoveries and more cost effective ways of discovering them. 80% of all FDA approved drugs have generic counter-parts, according to the 2010 Kaiser Foundation report on prescription drug trends. Add to this the fast approaching edge of the “patent cliff” (2011-2015) when dozens of brand name drugs go off patent, including six of the ten largest medicines in the U.S. and you get a good idea of the challenges facing the ‘business’ of big pharma. Viagara, Actos, Symbicort, Crestor and Avandia are just a few major brands to face generic competition soon.

Partnering with universities will offer big pharma alternate approaches to their on-going research…access to new and experimental technologies, creative thought processes indigenous to the university environment…more cost efficient continued development of in-license drug candidates…fresh stimulus for stalled projects…the potential of discovering multiple, new applications for existing drugs…all in an arena that could offer new, more rapid research platforms for the discovery and release of better medicines.

In this win-win collaboration, universities will be able to analyze pharma’s extensive and diverse data…and data is what it’s all about in the research and development of new drugs. An example of this trend is Sanofi’s recent announcement to collaborate with Harvard in diabetes and cancer research.  As pharma gleans new & improved information from institutional partners, so too do those institutions gain precious access to pharma’s previously locked treasure chest of health science research.

It’s a natural collaboration, taking place on a global scale. A marriage of necessity expected to bring forth a new generation of blockbuster progeny.

The community vectors receiving value from electronic health records (EHR) is broad.  EHR data has uses from epidemiology and populations at one end of the spectrum, and genotyping in computational biology for specific proteins at the other.  EHR is prominent in healthcare legislation, issues of interest to governments vis-à-vis personalized medicine and genetic testing, and the number of lives represented is growing.

At some point soon – if it has not happened already – the patient will realize the value of EHR is not as much “Wow, my doctors are talking to each other and sharing my medical record,” but rather “My daughter was not prescribed x because EHR data mining showed the chance of an adverse reaction was lower for kids like her when they take y.”  This ‘behind the curtain’ intelligence that invariably pulls medicine-and society-toward deeper personalization as an index of the increase in mine-able data will save more lives than relieve headaches of coordinating care.

But what about ‘Big Pharma’?  As the innovators and distribution centers of the drug interventions, are there compelling value propositions for them to analyze EHR data?  Most certainly, and these areas give just a start:

  • Pharmacovigilance.  This concept has been around for some time, seems the most obvious, and EHR seems to have a critical value proposition in drug safety and interactions.   And the model is so simple and direct, the data sizes so large and rich, that – for example – the European Union (through its executive body, the European Commission) proctored a study identifying the most important adverse events to search for in the EHR pool.   The question is not how to use it, but how to use it best.
  • In Clinical Trials.  Dr. Michael Kahn of Children’s Hospital, Denver, presented a paper to the National Institute of Health () and the first benefit listed was “Query EHR database to establish number of potential study Candidates”.  The ability to use EHR databases to save time during participant selection and recruitment seems compelling.
  • Comparative Effectiveness.  Earlier this year, Steven Labkoff, MD, FACP formerly of Pfizer presented at the National Academy of Science conference “Electronic Health Records: Where Do We Go From Here?”  Labkoff discussed the benefits Big Pharma can receive by aggressively using EHR data.  A key mention by Labkoff is that new players-payors, PBMs, US government- are now in the market asking for “pharmacoeconomic justification” that a drug is better and cheaper than something on the formulary.  Geisinger Health Network weighed in simply on how EHR can help on comparative effectiveness.
  • Marketing & Branding.  Bringing all the insights together from these areas tied to a single drug make a much stronger case that prescribing it has increased therapeutic value.  As consumers and prescribers have more channels of data-centric information on their treatments, sound, large sample EHR-type data backing up claims of a drug’s benefits become critical.

Taken together, the EHR as our collective health repository and ‘effect’ database can make the pharma expenditures drop noticeably in many silos from picking the compounds to bring to market, testing and validating them, and ensuring they are used well once in the market.