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Monthly Archives: October 2011

I often like to read books from technology-based companies outside of the biotechnology space because they can yield insights relevant to biotechnology business development. This book’s attention-grabbing title comes from the author’s experience working as a ranch hand prior to co-founding a computer hardware company.

How to Castrate a Bull describes the growth of NetApp, a disruptive entrant in the data storage business that developed a lower-cost data storage product and fought to gain customers from larger firms while simultaneously proactively defending themselves against other small entrants. The author’s style presents a compelling story, sprinkled with vignettes making analogies to his prior experience in raising cattle. One story, very relevant in any growing company, is the fate of an alpha bull who veers off path when leading a cattle drive: “… sometimes this leader had a tendency to veer off to the side, taking the herd with him. Getting the herd back on track was hard work for the cowboys, so if the lead steer swerved too often, there was no choice but to shoot him in the head.” A sentiment echoed in “When should you fire the founder.”

Another excellent story is when NetApp decided to aim for 100% growth. Hitz explains that failure to out-grow the competition can be detrimental, as a larger, faster-growing, competitor can effectively out-develop, out-sell, and ultimately eliminate a slower-growing company from a market. So, sometimes aggressive growth must be baked into business plans. This requires aggressive sales and R&D efforts to ensure sufficient revenues to support the growth. It also creates growth opportunities for employees. If a manager is promoted and is not able to effectively manage their larger team, an new manager can be hired to replace them and they can try their expanded management role again in a few months as their department continually grows.

The lessons in How to Castrate a Bull are relevant to most biotechnology companies. I recommend it highly for founders, managers, and new employees of growing companies.

Drug Patent Expirations in October 2011

*Drugs may be covered by multiple patents

TradenameApplicantGeneric NamePatent NumberPatent Expiration
ZOLINZAMerckvorinostat6,087,367Oct 4, 2011
ZORBTIVEEmd Seronosomatropin recombinant5,288,703Oct 7, 2011
NUTRESTOREEmmaus Medclglutamine5,288,703Oct 7, 2011
ATACANDAstrazenecacandesartan cilexetil7,538,133*PEDOct 18, 2011
ATACAND HCTAstrazenecacandesartan cilexetil; hydrochlorothiazide7,538,133*PEDOct 18, 2011
ATACANDAstrazenecacandesartan cilexetil5,705,517*PEDOct 18, 2011
ATACAND HCTAstrazenecacandesartan cilexetil; hydrochlorothiazide5,705,517*PEDOct 18, 2011
ELIGARDTolmar Therapleuprolide acetate5,324,519Oct 20, 2011
SYMBYAXLillyfluoxetine hydrochloride; olanzapine5,229,382*PEDOct 23, 2011
ZYPREXA RELPREVVEli Lilly Coolanzapine pamoate5,229,382*PEDOct 23, 2011
ZYPREXALillyolanzapine5,627,178*PEDOct 23, 2011
ZYPREXALillyolanzapine5,817,656*PEDOct 23, 2011
ZYPREXALillyolanzapine5,817,657*PEDOct 23, 2011
ZYPREXALillyolanzapine5,817,655*PEDOct 23, 2011
ZYPREXALillyolanzapine5,229,382*PEDOct 23, 2011
ZYPREXA ZYDISLillyolanzapine5,229,382*PEDOct 23, 2011

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

Courtesy of DrugPatentWatch.com

 This is a Guest Post by Prabhu Ram, General Manager- Healthcare Research & Advisory
 

The BioPharma industry faces some daunting challenges today. Faced by the surge in drugs going off-patent and with drying-up of their product pipelines, major pharmaceutical companies are facing an urgent challenge to reinvent their drug discovery and development models. An immediate opportunity for BioPharma is represented by the CRO industry in Asia. Asia represents a region that is now recognized more for its cutting R&D, scientific expertise, large patient population, in addition to the oft-quoted cost advantages.

The CRO industry has come a long way since its modest beginnings, growing strength to strength, while discarding the label of not being innovative tagged on them. The cross-functional, cost-conscious, global expertise of the CROs has now placed them at the centre of the bio ecosystem, and they are playing a pivotal role for resurrecting the global BioPharma industry.

The CROs provide the BioPharma industry with an excellent opportunity to leverage growth with lower R&D spends. As recent events have shown, some BioPharma enterprises consider the CROs as a strategic partner, and this trend is leading to changes in the business model for CROs – from transaction-oriented to strategic partnerships.

It is in this background that CMR conducted a comprehensive survey for BioSpectrum, Asia’s leading biotechnology journal and platform for knowledge exchange, in August 2011 to learn more about the trends in the clinical and contract research ecosystem in APAC market.

About the Survey

The survey included a mix of quantitative and qualitative questionnaire, administered through email, and direct telephonic interviews. Our survey respondents came from the following geographies: India, China, Malaysia, Singapore, Taiwan, South Korea, Australia, Ireland, Scotland, and North America.

According to our survey results, the CRO industry in Asia Pacific is expanding rapidly, parallel to the growth in the pharmaceutical sector. Powerhouses like China, India and Korea, as well as smaller markets like Malaysia and Singapore will drive this growth.

The business model will steer towards a collaborative partnership model wherein BioPharma would continue to focus on their core strengths, while leveraging the strengths of CROs. For instance, BioPharma would take the inputs from CROs for evaluating potential risks in the drug development pathway. CROs have vast experience and expertise in designing focused trials that accomplish the set goals for clinical, regulatory, and commercial considerations.

The survey points to radical changes to the business model and strategy for outsourcing firms, and points to an exciting phase of growth ahead. The level of outsourcing is set to increase, and strategic partnerships are likely to overshadow the transactional project-to-project approach that has been the norm.

19 percent of CROs have revenue size of $ 26-50m

Revenue size of CRO companies19 percent of the survey respondents of the BioSpectrum-CMR Asia Pacific Survey for Clinical and Contract Research Organizations Survey 2011 indicated that they operate in the revenue band of $26- 50m. An equal percentage of respondents indicated that they operate in the $16-20m band.13 percent of the respondents operate in the revenue band of $ 1-5 m and $6-10 m respectively.

Only 10 percent of the respondents have a revenue size of $ 101-500 m, while another 3 percent has revenue size greater than $ 500m.

CRO Assessment of Market Opportunities

83 percent of the survey respondents indicated that the market opportunities would increase for full-service and niche operators, while 11 percent of respondents opined that the market opportunities would remain the same. Surprisingly, 6 percent felt that the market opportunities would decrease over the next 3 years.

CRO market opportunitiesOur survey respondents indicated many different factors for their assessment and confidence in increased market opportunities. Some of the key factors that respondents indicated include: current global economic realities, cost pressures for sponsors, growing regulatory burdens, the daunting challenges in operating in the West, marketplace globalization, significant increase in outsourcing levels. Some of our survey respondents indicated that geographical and market expansion by sponsors is driving the outsourcing trend.

Measuring CRO Performance

The optimism shared by CROs on their assessment of the market and the opportunities therein for their strategic growth leads us to the question on how they measure their own performance. Identifying and implementing metrics can help improve and maximize clinical trial performance. Also, metrics provide sponsors with the key they need to work together to run clinical trials efficiently.

Some of the other highlights of the survey include:

  • How contract research organizations measure their performanceThe average contract size for CROs in Asia-Pacific is under $ 50 million. Most of the enterprises operating in the APAC region are small and medium-sized.
  • The top five therapeutic areas of focus for CROs include Oncology, Cardiovascular diseases, Dermatology, Neurology, and Respiratory.  According to our survey respondents, India and China are the hotspots for patient recruitment and clinical trials.
  • 34 percent of the respondents indicated that the revenue range of the Sponsors is in $101-200m range. Sponsors originate from North America while a majority of the mid and small Sponsors originate from APAC region, and predominantly from India.
  • According to our survey respondents in the Sponsor category, over the next three years, the outsourcing budget is likely to increase. When assessing a CRO/CMO, the primary and key strategic consideration is quality and reliability. This takes precedence over other critical factors such as pricing, regulatory compliance, and productivity.

 About Prabhu Ram

Prabhu Ram is General Manager-Research and Consulting, and heads the Healthcare Research and Advisory Practice at CyberMedia Research (CMR) at New Delhi, India. Email:pram@cmrindia.com

CyberMedia Research is a premier research and consulting firm from Asia offering its clients, strategic and tactical insights in the form of market intelligence, market sizing, market ecosystem mapping and go-to-market services. CMR has over 24 years of rich research experience that provides clients with well-informed strategic insights on emerging investment and R&D trends.

CMR offers an integrated suite of market information gathering services from a wide range of sources, advanced information management tools, sophisticated analytical systems and methodologies and dedicated professional client servicing for client advantage. CMR Healthcare Research and Advisory works on the entire value chain from idea generation to commercialization and market delivery

Key Services include:

  • Market Intelligence
  • Strategy consulting focusing on growth
  • Go-to-market services
  • India-entry Strategies

Web: www.cmrindia.com

To discuss your specific requirement, please write/call Prabhu at pram@cmrindia.com or call at +91 9899440380.

Founders at Work provides a rare glimpse into the early thinking that spawned many of today’s most prominent start-ups. Going beyond the glam articles found in many other sources, Founders profiles founders who have achieved sufficient success that little time needs to be spend justifying their inclusion. Rather, the focus is on how they conceived of their ideas and how they were able to implement them.

Author Jessica Livingston is a founder at Y-combinator, which helps explain how she was able to obtain access to so many accomplished founders. An interesting feature of this book is that she spends little time trying to identify themes or best practices between the individual profiles. As a reader I enjoyed this exclusion, as it enabled me (and forced me) to draw my own conclusions.

The depth of the investigation is what truly sets this books apart. For example, in profiling Steve Wozniak’s role in founding Apple, the reader learns that young Wozniak was a relentless optimizer, continuously striving to find ways to eliminate costly chips and circuits from early computers. His contributions were driven by a desire to own a then-unaffordable computer, and eventually gave rise to the personal computer industry. In another example, one learns that the founders of PayPal started with the goal of developing high speed encryption-decryption technology, not on developing an e-commerce platform as might be fairly (but incorrectly) assumed. It was only after refining the technology that the founders began to seek out applications and found themselves in the payment business.

This focus on developing core technologies, and only then searching for market opportunities, is a central theme in the book and seems well suited to biotechnology companies. The strong technology-development component of biotechnology business necessitates a business model that accommodates a technology push while still enabling market demands to help refine development paths and enable profitable sales.

I really enjoyed this book, and would encourage it for anyone seeking to ‘take a step back’ and look at the underpinnings of successful companies — many of the founders acknowledged that strategic positioning, excellent execution, and a measure of good fortune were key to their success.