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Monthly Archives: October 2010

A side-comment at the Mid Atlantic Biotech conference really got me thinking. One of the panelists mentioned as an aside that she thought that more companies failed due to bad boards than due to bad management (she preferred not to be named).

The board of directors is more than a set of advisors to company management — they represent the shareholders of a company and have a fiduciary duty to ensure that shareholders interests are served. They have the power to replace executives, and can be held liable if they don’t do their jobs. As seen in the case of Dyadic, boards of directors can exert great control over companies.

I’ve regularly give talks on managing unexpected risks, and I’d love to find more examples of boards of directors actions leading companies astray — does anyone have any leads?

The next DCbiotech meeting will be at the Marriott Renaissance Washington DC Downtown Hotel on November 2nd  2010. The hotel is at 999 Ninth Street NW, and we’ll be meeting in the Mixx bar from 6:30-8:30pm. To facilitate finding the group, you may want to check out my photo on the about page.

Where: Mixx bar, Marriott Renaissance Washington 999 Ninth Street NW
When: November 2nd, 6:30-8:30

Positive reviews of the book, Get to Market Now! Turn FDA Compliance into a Competitive Edge in the Era of Personalized Medicine, have been appearing since the book’s publication earlier this year.  The BiotechBlog sat down with author John Avellanet for a discussion of the book’s appeal.

BB:   Why do you think the book is generating such buzz?

Avellanet:  The book is striking a positive chord with readers because it’s straightforward.  The book lays out the trends in new drug development and its regulation over the past twenty years, and then, as one reader put it, “Tells you exactly what you need to know and do.”

When I first thought about writing the book, I talked to a number of clients who’d mentioned how much I’d helped them think about product development and commercialization in a new light, as well as improve their compliance organizations.  They kept saying, “Write it like you explained it to us.”

So my goal in the book was two-fold:  first, to lay out the trend patterns over the past two decades so readers could see for themselves where things are going, and then second, show – with lots of examples and case studies – the new medicine development and FDA compliance strategies and tactics that are, and will continue to be, successful over the next two decades.  Thus, the advice in the book is particularly timely.

BB:  What’s driving the critical importance of the information and advice in Get to Market Now?

Avellanet:  The industry faces some significant, intertwined challenges that need to be overcome in the next few years:

  • Escalating costs of drug development
  • Ever-increasing complexity of drug development
  • Need to control healthcare costs
  • Globalization of both the marketplace and regulations
  • Desire to increase the personalization of medicines

In the book, I diagram a “21st century new medicinal product development funnel” that tackles these concerns head-on.  And I walk readers through how to put in place many of the aspects in this approach, from preclinical through the postmarket.

Given that average new medicine timelines now stretch to nearly ten years, the sooner executives get started using solutions like those in the book, the better for patients, for shareholders and investors, and for company employees.

BB:  Is there a downside to ignoring the advice in the book?

Avellanet:  At this point, those who ignore the insights and solutions like those in the book – solutions such as how to build in drug safety and efficacy from day one of development, how to take advantage of open collaboration models around the globe to speed development and lower costs, how to ensure flexibility and cost-effectiveness in quality systems and regulatory compliance – I don’t see those companies being around in the next twenty years.

Let’s remember that even the FDA realized this sea change was afoot back in 2002 with its publication of a concept paper on 21st century good manufacturing practices.  So now, eight years later, the time to “wait and see” is over.

BB:  So should investors, shareholders and venture capitalists read this book?  It would seem these groups would have a vested interest in the adoption of the strategies outlined in the book.

Avellanet:  That’s very true, although admittedly I did not write the book with investors in mind.  Shortly after Get to Market Now!’s publication, one of the early readers wrote me to suggest that the book should be required reading for all business analysts trying to follow and value biotech firms and for all business schools offering bio-entrepreneurship classes.  I’m not sure I would go that far, but the book does lay out the specific characteristics of a successful 21st century drug development pipeline and the compliance infrastructure necessary to support pipeline success.

Given that most investors are consumers of healthcare, then I think in that context it is fair to say that investors and business analysts should at least be familiar with the information in the book.

BB:  What’s an example of something in the book that consumers should know about?

Avellanet:  One of the tactics I discuss is how firms can harness the Voice of the Customer in new medicine development efforts:  how to learn from prospective customers what would improve a potential new product, what would help the customer decide to purchase the new medicine over a competing treatment, etc.

Consumers can help companies adopt this Voice of the Customer tactic by reaching out to company R&D executives, asking them to speak to patient advocacy groups, participate in an online Q&A type of chat in a patient forum, and other such mechanisms.  The goal is to drive drug development to incorporate customer needs beyond just “a cure.”  This is one way to help personalize medicine and improve healthcare.

So, thinking about Voice of the Customer, let’s take Pfizer’s Exubera, the inhaled version of insulin.  According to a recent article, Exubera was one of pharma’s ten biggest flops.  Pfizer spent billions of dollars bringing Exubera to market only to see diabetics could shun it.  Why?  Well, the major reason given by diabetics was that the Pfizer version required carrying around a big can-sized delivery mechanism.  In other words, Exubera was not the little asthma-like inhaler that consumers originally envisioned.  This canister concept did not fit with consumer needs or desires.

Early on, under the Voice of the Customer model, prospective consumers of Exubera could have informed drug developers that carrying around a delivery mechanism the size of a Foster’s beer can was a considerable downside to the product; a downside that would likely outweigh the desire to stop injecting oneself with tiny needles. Developers would then have had three options:  stop development, engineer to solve the size issue, or continue development but in a less costly manner so that costs could be recouped by the 1% segment of the diabetic population that was willing to cart around the delivery mechanism.

If companies are not reaching out to prospective patients to discover this type of information, we – as consumers of healthcare and as investors in healthcare companies – need to take the initiative:  visit company websites and send in comments, visit company social media sites, and so on.  The goal is to try to encourage the Voice of the Customer to be heard to encourage personalization of medicines in the development phase.  Consumer communication can help remind executives to take advantage of new information and new tactics to develop better medicines.  Sometimes we all get so stuck in the day-to-day that we forget a better way exists.

When I talk to organizations and executives, I tell the story of the guy running down the road pushing a bicycle alongside him.  A bystander sees him and asks what he’s doing – the guy responds that he’s late and trying to get somewhere fast.  The bystander asks why he doesn’t ride the bike.  The guy responds he doesn’t have time to stop and get on.  That, I think, captures a moment that all of us have; we know in our minds that there is a better way, but we keep trying the same way we’ve been doing things, just faster.  So in the book, I try to offer very concrete, practical steps to take with examples that show how these steps will help.  I want to encourage even just small changes.

BB:  Can you give an example of how biotech and pharma executives can take advantage of some of the tactics in the book like Voice of the Customer?

Avellanet:  Well, I provide over a hundred tactics, examples and case studies in the book, and so for the moment, let’s stick with gathering Voice of the Customer information during development. One tactic is for executives, preferably at the preclinical stage, to go beyond market analyses for new drug candidates, and canvass potential patients and physicians to determine what they’d like to see in terms of a new treatment.  Now, to clarify, I don’t mean paying physicians to recommend drugs or anything of that sort.  Rather, developers can poll potential future customers to ascertain what typical medications the target population is on (so that clinical trial dosing regimens can be developed that address potential interaction issues, for instance), which current downsides or side effects of a potential new drug are “deal killers” as far as prospective patients or physicians are concerned, and so on.

Starting to gather this type of consumer preference information may seem a bit premature at the preclinical stage, we need to recognize the larger picture – the need to address consumer desires to increase the cost-efficiency of treatment and the personalization of medicine.  The sooner developers can identify product characteristics that provide a marketplace edge – less side effects, more cost-effective treatment from increased drug efficacy, etc. – the better the chances of the new drug in the market and the easier the path of development.  Further, some of these product characteristic advantages might also be reliant upon proprietary manufacturing processes which, in turn, can help fend off competition from generics.  This helps us move beyond the “develop it and they will come” mentality that results from just following the science.  And companies can do so with many of the tactics I advocate in the book.

BB:  And yet Get to Market Now! isn’t just directed toward speeding time to market with better medicines – part of your book focuses on the role of the modern compliance organization.  How does that play into this?

Avellanet:  Quality assurance and regulatory affairs have often been afterthoughts in the traditional development cycle.  Let’s face it:  compliance with FDA regulations is not top of mind when first developing a new medicine.  Thus, with my clients, I’ve worked to position both quality and regulatory affairs as more value-adds to the bottom line as early as possible.  The book provides three chapters-worth of these tactics for readers to adopt in their own organizations.

So, for instance, with regulatory affairs, I advocate developing what I term a “clinical regulatory integrated strategic plan” early on in the drug development cycle.  This strategic plan then serves as a guide tying each functional area’s activities (the clinical department’s Phase I clinical trials, the purchasing department’s qualification of the contract research organization, etc.) together in order to identify dependencies and regulatory timelines.  Now, this goes beyond a big meta-project plan that some folks initially picture when I discuss this.

For instance, the clinical regulatory integrated strategic plan needs to document how the company will address specific concerns the FDA might have raised with similar or competitor products:  in which part of what trials will those concerns be addressed?  Will it be in Phase 2 trials so that at the end-of-Phase 2 meeting with the FDA, the company can answer questions related to those concerns?  Or, should it be earlier, as a part of a Phase 2A trial, in case something goes wrong and further study is needed before requesting an end-of-Phase 2 meeting with the agency?  How will Voice of the Customer and Quality by Design aspects be incorporated into trial planning and prototype production?  At what point will should a firm outline or draft a preliminary post-market risk evaluation and mitigation strategy (REMS) in case the agency requests one?  What global regulatory concerns need to be addressed (and when) in our clinical trials to ensure the least amount of repeat clinical trials or studies possible for the global marketplace?  Answers to all of those are built into this clinical regulatory integrated strategic plan, and regulatory affairs professionals are perfect to drive this plan.  Certainly in my experience, they’ve eagerly taken it on, as this type of early cross-functional planning and coordination adds real value, right away, to the bottom line.

And that’s just one of the examples in the second half of the book on how compliance professionals can play a more proactive, cross-functional and collaborative role to support new medicine development success.

BB:  Several reviewers made specific mention of the book’s dedicated resource website for readers.  What was the impetus behind the site?

Avellanet:  Well, when I read nonfiction, whether it’s a history book, a business process improvement book, or something compliance-related, I’m often surprised at the lack of online resources associated with a book published in this day and age.  I usually end up at Wikipedia or going online to search out various items, so I thought a good way to help readers quickly implement the advice in the book was to put up a dedicated resource website with checklists, templates, mini-tutorials on some of the tactics in the book, lots of helpful links, downloads, and so on.

And I try to keep the book site constantly updated as new information comes available so readers always have access to the latest and greatest.  I want to make sure that readers succeed.

The book is titled Get to Market Now! Turn FDA Compliance into a Competitive Edge in the Era of Personalized Medicine, by John Avellanet and published by Logos Press.  It’s available through Barnes & Noble, Amazon.com, the publisher, and hundreds of other bookstores.

Associations and organizations interested in having Mr. Avellanet come speak at an event or run a workshop on some of the tactics in the book can contact him through his author speaking page at:  www.get2marketnow.com/presentations-and-talks/

Drug Patent Expirations in October 2010

*Drugs may be covered by multiple patents

TradenameApplicantGeneric NamePatent Number Patent Expiration
ORGARANOrganon Usa Incdanaparoid sodium5,164,377Oct 3, 2010
MIRAPEX ERBoehringer Ingelheimpramipexole dihydrochloride4,886,812Oct 8, 2010
MIRAPEXBoehringer Ingelheimpramipexole dihydrochloride4,886,812Oct 8, 2010
CLIMARA PROBayer Hlthcareestradiol; levonorgestrel5,770,219Oct 12, 2010
CLIMARA PROBayer Hlthcareestradiol; levonorgestrel5,252,334Oct 12, 2010
MENTAXMylanbutenafine hydrochloride5,021,458Oct 18, 2010
NUVIGILCephalonarmodafinil4,927,855*PEDOct 22, 2010
CETROTIDEEmd Seronocetrorelix5,198,533Oct 24, 2010
TRITECGlaxosmithklineranitidine bismuth citrate5,256,684Oct 26, 2010
INVEGA SUSTENNAJohnson And Johnsonpaliperidone palmitate5,254,556Oct 27, 2010
COMTANOrionentacapone5,135,950Oct 31, 2010
STALEVO 125Orioncarbidopa; entacapone; levodopa5,135,950Oct 31, 2010
STALEVO 200Orioncarbidopa; entacapone; levodopa5,135,950Oct 31, 2010
STALEVO 75Orioncarbidopa; entacapone; levodopa5,135,950Oct 31, 2010
STALEVO 100Orioncarbidopa; entacapone; levodopa5,135,950Oct 31, 2010
STALEVO 150Orioncarbidopa; entacapone; levodopa5,135,950Oct 31, 2010
STALEVO 50Orioncarbidopa; entacapone; levodopa5,135,950Oct 31, 2010

This information is also available in an email newsletter: Subscribe to the DrugPatentWatch Patent Expiration Bulletin. Courtesy of DrugPatentWatch.com

The panel on applying Design Thinking to biotechnology was well received, and I look forward to writing up my observations.

I’m now in Japan for a workshop on developing a biotechnology cluster. The U.S. biotechnology industry – the largest in the world – was basically developed with  strong  support from Japanese pharmaceutical and brewing companies. I look forward to developing new insights on what Japan can do to bolster its biotechnology industry.