The Current Dynamics at Play in the Life Sciences

Results are getting worse for Life Sciences R&D. Failure rates of experimental drugs are on the rise, with the number of products abandoned in late-stage Phase 3 trials having doubled to almost 40 in 2007-2009, compared with 2004-2006. Now it takes 12-13 drugs to enter the pre-clinical phase to gain one commercial success vs. 8 in the year 2000. Direct and indirect costs to achieve one commercial success have nearly tripled, going from $800 million in the year 2000 to $2.5 billion in the year 2010. Meanwhile, R&D cost growth has outpaced sales growth rates significantly. Only one in five marketed drugs manages to recoup R&D costs and new products developed over the last five years account for merely 7% of current revenue. Worse, the growth rate of R&D outlays has outpaced the growth rates of Gross Margins since 1996.

In addition to the financial dynamics outlined above, R&D operational performance is poor. Greater than 90% of all clinical trials are delayed due to over-ambitious timelines and difficulty with patient enrollment. Approximately one-third (35%) of trials are substantially delayed due to ‘Rescue Mode’ patient recruitment activities. Also, eighty percent of studies run over by 30-42%, an average of 6 months.

What are Life Sciences companies doing to address these issues? They are cutting people and costs. In the first three months of 2010, the pharmaceutical industry cut 25,857 jobs. Life Sciences companies have also cut back on R&D activities in 2010 to preserve funds, with aggregate spending to develop new drugs falling by 0.3 percent. Overall, cumulative investment as a proportion of sales has decreased to 15 percent across the pharmaceutical industry.

Unfortunately, these effectiveness and efficiency challenges have all led to the same result: staggering failure rates. An incredible 65% of product launches fail and 46% of product development resources are spent on products that either fail or never make it to market.

These results combined with the aforementioned financial and operational challenges clearly show one thing: an R&D transformation is needed.

See www.advancedclinical.com

Upcoming Brand Launch: Breaking the Mold

New Framework
Next week marks a vital time for Advanced Clinical (AC), as we will officially announce our new market and brand launch. On Tuesday, August 17th, we will be introducing our game-changing Industry-Leading R&D Performance (ILRDP) framework, unveiling our new website, as well as highlighting the new additions to our executive staff, social media platform, and our innovative service offerings.

Through our ILRDP model, AC is shifting the paradigm in the clinical research outsourcing (CRO) space, ensuring a positive, sustainable net profit impact for our clients. We have augmented our offerings and capabilities to better serve the needs of our life sciences clients in strategic effectiveness, clinical planning and clinical operations. While ILRDP will benefit all four of our core competencies: Consulting, Strategic Sourcing, Talent Management and Technology, our Consulting services will be impacted significantly. Through our Consulting services, we provide breakthrough performance with Portfolio Strategy, ILRDP Transformation, and Workforce Strategy. Below are examples of how our ILRDP framework will drive results:

• Our Portfolio Strategy offering provides complete analysis of company-wide business investments, through which we aim to restructure the overall investment portfolio to drive the best value for the client. Note that value is defined differently by each client (e.g., value could be either net profit, or top line growth, as well as other alternatives)
  Impact: This strategy ensures that clients are focused on the right initiatives and/or products solutions with the appropriate resource investment stance


• Our ILRDP Transformation identifies how R&D can become more effective and efficient; aligns clients’ R&D with the business strategy and identifies operational/maturity improvements, utilizing our ILRDP framework
  Impact: This transformation enables clients to embrace R&D to drive company-wide growth and create positive net profit impact, as well as contribute to business strategy and innovation


• Our Workforce Strategy approach determines core/context disposition for R&D functions. Assesses/benchmarks the current state workforce at the R&D level, clinical development level and/or the clinical trial level. Develops resource blueprint, plan and business case
  Impact: This offering provides a significant net-profit impact for clients by optimizing the mix of workforce for each element of the business. The outcome is a workforce blueprint, a roadmap as well as a P&L impact model

New Social Media Platform
In addition to our offerings and our ILRDP framework, we are excited to unveil our comprehensive social media platform, through which we can share up-to-date information more quickly and conveniently with our clients and consultants. Our new website provides opportunities for interaction and exploration regarding AC solutions, capabilities, experience and team members. You can find out the latest news and updates on our blog, Facebook fan page, LinkedIn group, YouTube page, and Twitter account.

New Leadership Team Members
We welcome two new members to our leadership team: Rosemarie Truman, executive vice president, and Julie Heneghan, vice president. Both leadership team members bring a wealth of knowledge and experience that will continue to evolve the future of Advanced Clinical.

Share in the excitement of our brand launch next week, as we continue to innovate and break the mold in the life sciences industry. Don’t forget to add us on Facebook, join us on LinkedIn or follow us on Twitter to view our latest news.

See www.advancedclinical.com

Database Development and Biostatistics: A Collaborative Process

If you could put a price on your clinical data in a given trial, how much would yours be worth? Millions, perhaps. With the ability to unlock discoveries, trends and relationships, you likely view this data as invaluable. It has all the potential of being either a perfectly packaged group of key findings – or a mass of erroneous variables.

The same group of variables that can reveal remarkable findings can also produce ceaseless headaches when handled incorrectly. When can you determine which path your data are headed down?

The Oracle Clinical database development and biostatistics teams at Advanced Clinical are standardizing the data upfront in a collaborative effort to streamline projects. By making the data CDISC compatible at the beginning of a trial, there is far less room for error and miscommunication throughout each project, from start to finish.

Typically, the database development and biostatistics teams are separate entities. Although they serve the same client, they often operate completely independently of one another. In the traditional paradigm, data inconsistencies are often discovered far along into the project. As a result, teams have to go backwards to see where the problem originated. The new process involves collaboration between the database development and biostatistics teams and implementation of CDISC standards early in the development life cycle.

What does this mean for a client? The teams now understand each other’s language, resulting in seamless workflow communication, increased data quality, easier transfer of data between teams and consistency across studies as well as time and cost savings. And, most important, there is more time to enhance your discoveries.

See www.advancedclinical.com