If that knocked your socks off, take a look at our next cool topic, coming soon. And if you want to peruse all of the previous sock-knocking blog entries, visit the Knocked My Socks Off archive.

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* Brené Brown, PhD, LMSW, has spent the past decade studying vulnerability, courage, worthiness and shame. Brown’s 2010 TEDx Houston talk, The Power of Vulnerability, is one of the most watched talks on TED.com, with over 8.6 million views. Brown has written several books, including Daring Greatly: How the Courage to Be Vulnerable Transforms the Way We Live, Love, Parent, and Lead (2012) and The Gifts of Imperfection: Let Go of Who You Think You’re Supposed to Be and Embrace Who You Are (2010).

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Felton E. How the taxman cleared the dance floor. The Wall Street Journal. March 18, 2013:A13. http://online.wsj.com/article_email/SB10001424127887323628804578348050712410108-lMyQjAxMTAzMDIwOTEyNDkyWj.html?mod=wsj_valettop_email. Accessed April 2, 2013.

Accelerating the translation of biological insights into new medicines requires developing powerful new scientific knowledge, methodology, and tools. Academic scientists tend not to pursue such work, because it is seen as ‘too applied’ and because it often requires multidisciplinary teams rather than individual academic labs.

I find it difficult to imagine how we are going to accelerate innovation unless we come to grips with the need to work in teams. When we talk about tools, more often than not we are referring to the technical aspects of research and development (R&D), such as new equipment for measurement of a phenomenon of interest. We do not speak of new tools for enhancing team work and knowledge synthesis related to the management aspects of R&D. Yet, a comprehensive, interdisciplinary synthesis of available data and experience should play a central role in the innovation that leads to new medicines. This knowledge synthesis is essential for the proper design, analysis, and interpretation of studies, and for the assembly and presentation of evidence in successful regulatory submissions. Unfortunately, cross-functional, interdisciplinary knowledge synthesis is lacking in many R&D programs. What often passes for “synthesis” is merely a collection of separate facts and study results from various disciplines. Without true synthesis of knowledge, erroneous assessments of the value of drug assets can be made, causing allocation of resources to unproductive development programs [2]. We will revisit the comment about academic scientists in my prediction below.

The other aspect of the report that I found interesting is a key recommendation from PCAST, which concerns the relationship between representatives from the US Food and Drug Administration (FDA) and the drug development teams. The report says (p. 46):

Sponsors need a clear, consistent, and timely understanding of FDA concerns about their drug development plan, yet they often express frustration that this understanding can be difficult to obtain for two reasons. First, FDA staff is stretched thin addressing formal PDUFA [Prescription Drug User Fee Act] milestones due to insufficient total funding from Federal appropriations and PDUFA. Second, the review process for each drug lacks a single high level individual tasked with responsibility for providing clear, consistent ongoing advice to the sponsor. As a drug progresses from the pre-investigational stage (pre-IND) to final consideration for approval (NDA), many staff across divisions and offices are involved in the review.

The solution proposed by PCAST would be for the FDA to designate, for each drug development project, a senior staff member to serve as “pre-market review leader.” This individual would have the authority and accountability for integrating the input, resolving conflicting opinions within the FDA and with other stakeholders, and communicating informally in a timely ongoing manner.

This solution is quite radical. As described in the report (p. 46):

This individual would be a ‘quarterback’ for the drug development project, with responsibility for providing sponsors with substantive, informal, clear, and timely advice, and for coordinating and leading FDA responses across diverse areas, including toxicology, trial design, manufacturing and clinical use, and for ensuring that timely decisions are made to resolve outstanding FDA review issues. Pre-market review leaders would be valuable for all sponsors, and could be especially helpful for small companies bringing their first product through a regulatory approval. Such a system could greatly improve regulatory certainty, timeliness of FDA decisions, and encourage innovators and investment in innovation.

This type of system is commonly used in the defense and aerospace industries and is long overdue in the biomedical innovation ecosystem. The representative of the Department of Defense or relevant funding agency is an integral member of the project team and is involved in all aspects of design and decision-making, especially in ensuring that all relevant stakeholders are properly represented.

Which leads me to my audacious prediction — I predict that the company or academic institution that embraces the strategy of forming comprehensive interdisciplinary teams with representatives from all stakeholders, including the FDA, and that puts into place innovative management strategies to ensure the proper functioning of these teams, will, over time, come to dominate the drug discovery and development landscape in their chosen technical competence areas.

One final point. The comment in the report about academic scientists (p. viii); namely, “Academic scientists tend not to pursue such work, because it is seen as ‘too applied’ and because it often requires multi-disciplinary teams rather than individual academic labs” describes a malfunctioning innovation environment that we can ill-afford. This lack of interdisciplinary collaboration has important implications for the success of biomedical research that originates in academia and is, in fact, a key obstacle to accelerating innovation.


Are you hooked? Check out the previous Pharma of the Future℠ blog entry, The drama in drug development. Or visit the Pharma of the Future archive to catch up with the future of pharmacometrics.

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[1] Executive Office of the President, President’s Council of Advisors on Science and Technology. Report to the President on propelling innovation in drug discovery, development, and evaluation. http://www.whitehouse.gov/sites/default/files/microsites/ostp/pcast-fda-final.pdf. Published September 25, 2012. Accessed April 1, 2013.

[2] Grasela T, Slusser R. Innovation ecosystems in pharma: collaboration at the boundaries between disciplines. AAPS Newsmagazine. 2012;Dec:22-25.

1. Planet Money, Episode 446: The Invisible 14 Million
2. This American Life, Episode 490: Trends With Benefits
3. All Things Considered, March 22, 2013: Millions Of Americans Don’t Work Due To Disability, And The Number Is Growing
4. Planet Money, Online Story, 2013. Unfit for Work: The startling rise of disability in America

Of course, there have been comments in the blogosphere about the piece. Here are two examples:

• Hall W. Govt. Spends More on Disability than Food Stamps, Welfare Combined. Breitbart. March 25, 2013.
• Davis L. NPR Reporter Chana Joffe-Walt Gets Disability Wrong. The Huffington Post. March 29, 2013.

If that knocked your socks off, take a look at our next cool topic, How a tax begat bebop. And if you want to peruse all of the previous sock-knocking blog entries, visit the Knocked My Socks Off archive.

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* Chana Joffe-Walt has been a reporter for Planet Money on NPR since 2009. Previously, she was a reporter for the public radio station KPLU in Seattle. Her favorite part of working with Planet Money is those nagging economic questions. What are the economic incentives for pirates? What is the business model of recycling? What does an FDIC takeover actually look like? How do our tiny, day-to-day purchasing decisions affect the global economy?

Worry About Internet Drivel. If we have a million photos, we tend to value each one less than if we only had ten. The internet forces a general devaluation of the written word: a global deflation in the average word’s value on many axes. As each word tends to get less reading-time and attention and to be worth less money at the consumer end, it naturally tends to absorb less writing-time and editorial attention on the production side. Gradually, as the time invested by the average writer and the average reader in the average sentence falls, society’s ability to communicate in writing decays. And this threat to our capacity to read and write is a slow-motion body-blow to science, scholarship, the arts—to nearly everything, in fact, that is distinctively human, that muskrats and dolphins can’t do just as well or better.

Read his full answer here. A version of this article appeared Feb. 25, 2013, in some U.S. editions of The Wall Street Journal.

If that knocked your socks off, take a look at our next cool topic, coming soon. And if you want to peruse all of the previous sock-knocking blog entries, visit the Knocked My Socks Off archive.
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[1] David Gelernter is a professor of computer science at Yale University. His research centers on information management, parallel programming, and artificial intelligence.
[2] According to Kevin Horrigan, Edge is a website where really smart people write about subjects that make most people’s heads hurt. This year’s question was suggested by the technology historian George Dyson. Dyson’s premise: “[P]eople tend to worry too much about things that it doesn’t do any good to worry about, and not to worry enough about things we should be worrying about.”

Are you hooked? Check out the previous Pharma of the Future℠ blog entry, Insight. . .Inspiration. . .Innovation. Or visit the Pharma of the Future archive to catch up with the future of pharmacometrics.

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*Mamet is a Pulitzer Prize-winning playwright, screenwriter, and director who was the creator and executive producer of the TV show The Unit, which aired on CBS from 2006 to 2009. The Unit was “an action drama that followed a covert team of Special Forces operatives as they risked their lives on undercover missions around the globe, while their families maintained the home front, protecting their husbands’ secrets.”

To read more about the use of drama in corporate leadership, see Daniel Goleman’s recent LinkedIn blog entry: Effective Leaders Are Effective Storytellers. Goleman quotes Howard Gardner: “I’m absolutely certain that a very important part of any new invention, whether it’s mechanical or literary or artistic, is a narrative vehicle which helps people relate to that. It helps them understand the ways in which it is complementary to, or consistent with or directly in clash with, what you did before.”

Welcome to the beginning of 2013. Most of us, I bet, had a challenging 2012, certainly it was stressful, but there is so much to be grateful for and, if one is optimistic, there are many opportunities that are full of promise for the New Year.

Personally, I have much to be grateful for, not the least of which are the relationships we have with one another here at Cognigen and also with our clients. These relationships stem from our shared sense of purpose in helping to bring new and important medicines to patients. I have been thinking a lot about these relationships, and I want to share a few thoughts about what I have learned in working on projects this year and provide a few ideas for advancing Pharma of the Future in 2013.

Frustrations about the challenges of bringing new drugs to the marketplace sometimes seem greater than the rewards. Science is a fickle friend; it reveals our genius and our ignorance with equal ease. Further, the economic realities of our collective failures at drug development make the future of the pharmaceutical industry sometimes seem in doubt.

Keep in mind, though, that we as scientists are, in fact, merchants of hope. Each time we uncover a new insight, we open up possibilities to see issues in new ways that can be the inspiration for solutions and innovations for addressing important problems. The possibility of fostering innovation is the motivation that we need to remember whenever the challenges of drug development seem overwhelming.

Over the past 20 years, Cognigen has made great strides in advancing the science and engineering the systems for model-based drug development. The systems we have built and the science we employ enable us to perform remarkably complicated model-based analyses efficiently. Personally, I derive the greatest sense of accomplishment from working with very smart and inquisitive development teams who seek to understand the causes and implications of unexpected findings as the pharmacometric analyses unfold.

In 2012, Cognigen performed model-based analyses for 28 new medicines in 12 different therapeutic areas. These analyses were the basis for 14 Clinical Pharmacology syntheses of the determinants of drug safety and efficacy that were included in New Drug Applications submitted to regulatory agencies. Our work has a direct impact on the product labels and instructions-for-use to patients and healthcare providers world-wide.

We are quite proud of our accomplishments, and we are looking forward to the next steps in building upon what we have already achieved to create the Cognigen of the future. The question we have to answer, though, is what comes next?

This question can’t be answered by any one person because we will be creating the future together with our clients based upon our past experiences, the knowledge and expertise we have gained from these experiences, and the evolving scientific and technical environment around us.

While we have a free hand in envisioning the Cognigen of the future, we do have three requirements that must be satisfied. First, Cognigen must focus on our clients’ needs for analyses that provide insight and inspiration. Second, our pursuit of excellence must balance the strategic, operational and technical aspects of each problem. Third, anything that we call an “innovation” must reflect the goals and needs of the larger R&D ecosystem we seek to influence.

I look forward to talking with you, our existing and future clients, to continue the development of new capabilities and new innovations that will improve the productivity and effectiveness of Pharma R&D.

Are you hooked? Check out the previous Pharma of the Future℠ blog entry, The Worst Job in Pharma. Or visit the Pharma of the Future archive to catch up with the future of pharmacometrics.