Although we work in an industry which is slow to adopt change I think we can all agree that change would be a good thing if it helped us improve in critical areas such as treatment risk-benefit bias, patient compliance and public perception.

So, if I were to close my eyes and travel through time, out a decade, perhaps this is what one (that would be me) would like to see occurring in the industry... (So here goes a broad brush, high level perspective. Starting of course at the beginning of the Pharma industry product lifecycle):

By 2018, I’d like the industry to be spending a higher percent of their revenues (currently 16%) on R&D. What the right percent is, is anyone’s guess, but I would contend that increases gradually over the next 10 years in the 20-25% range are appropriate . Of course, we’re not proposing throwing good money after bad here. The model needs to be substantially altered to maximize the return on this increase in investment. However, given that 2006 data suggests the average R&D cost/NDA was roughly $1.5B, I have to believe we can do better than that. While I don’t pretend to offer any formal expertise on this specific segment of the lifecycle, some potential solutions support this proposed new direction and associated investment in R&D.

Personalized medicine, in which treatment is tailored to an individual based on his or her genetic makeup¹, holds the most promise for improving R&D productivity. Using biomarkers to stratify patients with related but distinct conditions will enable Pharma to make different treatments for different patient populations². Genetic research (sequencing of the human genome) while not, thus far, the panacea for unlocking the secret code for personalized medicine, still holds the greatest potential for major breakthroughs in research. Understanding of the disease pathology and epidemiology and its relationship with molecular intervention will enable researchers to create a more precise and sensitive set of biomarkers for determining disease subtypes, patient subpopulation, safety and efficacy.

The results? Less trial and error and fewer hit-or-miss drugs will positively impact the risk-benefit ratio and make life a whole lot better for patients, physicians and the industry.

So how do these breakthroughs in research spill over into development? Rather dramatically. As patients now become genuine candidates for targeted treatments, the entire development cycle undergoes complete transformation. Fortunately we don’t have to wait a full decade to realize some of these innovations. In fact, at this year’s annual meeting of the American Society of Clinical Oncology insights into personalized medicine related to cancer care were given substantial attention. While numerous cancer related drug therapies have been introduced over the last several years, meaningful improvement in patient survival has been harder to demonstrate. At the meeting, researchers discussed advanced colon cancer and a gene called K-ras, a regulator of cell growth that researchers say plays a crucial role in several cancers. They discovered that 36% of patients with advanced colon cancer have a mutated form of the K-ras gene that all but assures they won’t respond to certain drugs¹. That leaves 64% of the colon cancer population who will! Integrating biomarkers into cancer drug development programs will give clinicians and patients much better outcomes and satisfaction.

Envisioning this type of breakthrough on a broader scale creates some very exciting visions for drug development. These visions do, of course, present some potentially intimidating consequences associated with drug development. Certainly having biomarkers available across disease categories should and will lead to smaller, more homogenous patient populations participating in clinical trials. And this of course will lead to approved drugs being targeted at smaller patient populations.

However, I believe the benefits associated with this transformation in drug development far outweigh the risk, and in the long run this is the only path for long-term success for the industry.

Focusing on small sub-sets of populations in clinical trials will be cheaper, faster and increase the likelihood of regulatory approval. If that’s not enough for you, the extension in useful patent life (down from 5.5 years in 1999 to less than 4 years in 2006) will increase the speed of getting drugs to the market³.

There are more innovations in the development cycle to look forward to that will have a significant impact on productivity. Technologies such as devices and diagnostic testing and techniques including combinatorial chemistry and high throughput screening will provide a major impact. The industry is already beginning to exploit the economic advantages of global expansion of clinical trials. Given that a top-notch academic medical center in India charges $1,500 to $2,000 for a patient case report, while a second-rate center in the US charges $20,000, the globalization of clinical trials is inevitable³.

So now as our vision comes to life, imagine that Pharma has produced a product that was cheaper and faster to build and bring to market, and has a much higher likelihood of working successfully on the targeted population for which it was designed. Not just a fantasy for idealistic dreamers, I believe this vision is well within the reach of this industry.

This momentum in innovation now spills out into the post-approval world of commercialization. The benefits for all parties will be significant. For patients, the most important recipients of Pharma product attributes, this will bring greater relief, less trial and error suffering, reduced drug safety concerns or adverse events and improved overall satisfaction.

For prescribing physicians, we will see a higher level of prescribing confidence, more job satisfaction, and a greater willingness to accept the Industry as a true partner in health care delivery.

For the Industry --- I know what some of you may be thinking: What happened to my blockbuster!! More targeted medications for smaller patient populations equates to less revenue. Seems logical, but wait just a moment. First, you brought that drug to market faster and cheaper; you’ve got more useful patent life to generate revenue; you’ve got a pitch to physicians and managed care that will increase uptake, provide better formulary placement and improve reimbursement; and last, but not least, you probably have a product that won’t blow up in your face 2-5 years out. Let’s also not forget the potential improvement in patient compliance with the product because of its personalized attributes.

Let’s face it, none of this is worth dreaming about unless all society benefits.

Drug R&D and commercialization that provide better health outcomes and lower the burden of high quality healthcare for society is a noble achievement. While some pretend this to be the case today, there’s just too much "noise," most real, some imagined, for this message to be persuasive.

One other by-product for the industry which can’t be underestimated is the restoration of that all-important customer requirement necessary for success in any industry, TRUST. Who can really measure the financial impact of customer trust? It’s one of those things you don’t always value until you’ve lost it.

The Pharma industry needs to transform itself from a reputation of being part of the problem to one in which they truly become part of the solution. They can only accomplish this through the creation and communication of a vision for change, in conjunction with a tangible, identifiable commitment.

I don’t know about you, but a decade from now (I hope sooner!) I want to be part of an industry that represents a positive force in global healthcare.

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