SEPTEMBER 2009 NEWSLETTER

Welcome to the Life Science Strategy Group (LSSG) complimentary e–newsletter, keeping you up–to–date with the latest life sciences news and consulting insights.

In this issue, we highlight Brand Planning, Biosimilar Strategy, Cancer Biomarkers and insights from our new 2009 Molecular Diagnostic Testing Trends, Opportunities & Outlook report.

If there are other specific Life Science topics you´d like LSSG to provide insights on in subsequent e-newsletter editions, please let us know. If you are not interested in receiving our complimentary e–newsletter in the future, please notify us below.

With best wishes,
Life Science Strategy Group

BIOPHARMACEUTICAL BRAND PLANNING DIAGNOSTIC

Are You Getting the Most Out of Your Brand?

Brand managers today face an increasing set of challenges as they work to maximize the value and performance of their brands. Despite a struggling economy, an increasingly competitive marketplace and mounting regulatory pressures, expectations of brand performance continue to grow. For brand managers, this translates into pressure to meet ever increasing revenue and growth targets, while maintaining product profitability levels and return on investment. As a result of these growing brand performance expectations, brand managers are now driven to focus efforts even more critically on the day-to-day management of their brands. While this can provide near-term improvements in performance, often times, the resulting compromise is inadequate attention given to the brand plan – the key to sustained (mid- to long-term) performance of the brand.

The brand plan is the roadmap that details the goals, objectives, strategies and tactics for a brand. It tracks past performance and the market environment, competition, customer and regulatory dynamics impacting the brand. To be truly effective, the plan needs to be a “living” document that is continually “refreshed” and refined as brand and environmental factors evolve.

As you think about your brand, do you feel you are getting the maximum performance and ROI? Have you considered how effective your brand plan is? Is there room to improve upon the performance of your brand by improving the effectiveness of the brand plan? To assess the effectiveness of your brand plan, consider the following questions:

    Questions to Assess Brand Plan Effectiveness
  • Does your brand plan provide a credible, objective assessment of the brand, its up-to-date performance versus competitive products and key issues?
  • Does your plan include current market research and insight from key brand stakeholders?
  • Does your plan clearly define key issues, risks, objectives, and actionable strategies for the brand?
  • Does your plan formalize brand tactics, metrics, and budgets for the year?
  • Does your brand plan capture current lifecycle management strategy necessary to sustain the long-term performance of the brand?

If your answer is “no” to any of the above questions, it is likely there is room to improve the effectiveness of your brand plan and corresponding product’s performance.

Life Science Strategy Group is uniquely positioned to provide its pharmaceutical clients with exceptional brand planning value. Our brand planning services include diagnosis of existing plans, brand planning process development, and expert strategic and tactical plan development. Our services are highly flexible and customized to our clients’ particular business needs. We are able to leverage more than 20 years of pharmaceutical industry product and therapeutic area expertise, allowing us to provide support across a wide range of therapeutic areas. Finally, the combination of our customized, cost-effective process with extensive content expertise allows us to add affordable strategic insight to brand planning, which ultimately translates into value to our clients. To learn more about LSSG’s brand planning services or to request a detailed case study, please contact LSSG.

Download Life Science Strategy Group´s complimentary brand planning white paper.
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BIOSIMILARS AND FOLLOW-ON BRANDED BIOLOGICS

Planning Your Follow-on Biologics Strategy: Minimizing Risk and Maximizing your Opportunity

As the United States waits with bated breath for healthcare reform legislation to pass, one of the items on the minds of drug manufacturers, contract research/service organizations, physicians, payers and patients is biosimilar and follow-on branded biologic regulation. When will this inevitable regulatory pathway be defined? What definitions and limitations will it entail? Will a biosimilar regulatory pathway create a niche market opportunity for those with the accredited facilities to manufacture biosimilars/follow-on biologics or those with capacity/capabilities to perform BA/BE testing, a likely requirement of any future regulation? What pricing strategy will drive strong physician and formulary adoption whether or not a biosimilar has an AB substitutability rating? How should you shape your company’s biosimilar strategy? How can your company minimize the risk and maximize the opportunity biosimilars and follow-on biologics pose?

With the FDA’s recent guidance for pen, jet and related injectors intended for use with drugs and biological products, which some experts interpret to help facilitate the conversion of biosimilars into higher-value follow-on branded products, and the Federal Trade Commission’s projection of 10-30% cost savings from the utilization of biosimilars, which some analysts doubt to be enough of a price differential to encourage switching patients, it is obvious that the dynamic topic of biosimilars and follow-on biologics will continue to evolve. However, once the regulatory impasse is resolved, domestic and global market expansion (increased product volume, value and competition), product expansion (introduction of second generation products addressing high unmet medical need) and clinical acceptance (overcoming bioequivalence concerns) will be the key issues for biosimilars and follow-on biologics.

Life Science Strategy Group can help your company interpret the evolving landscape and assess the competitive threat biosimilars/follow-on biologics may pose to your branded product’s lifecycle planning and tactical marketing initiatives. LSSG can also help formulate an effective market entry strategy for biosimilars/follow-on biologics, or evaluate the opportunity for contract biosimilar/follow-on biologic services, manufacturing needs or drug delivery technologies. Life Science Strategy Group has completed numerous biosimilar/follow-on biologics engagements ranging from margin analyses of generic injectable oncology drugs to market entry strategies for follow-on biologics. LSSG diligently monitors evolving healthcare reform and the implications to biosimilars and follow-on biologics. We also leverage our deep life science engagement experience and our proprietary contact database of regulators, policy makers, industry professionals, physicians and payers to provide data-driven, actionable, and affordable consulting solutions. As the landscape for biologics continues to evolve, LSSG can help ensure that your company is informed and prepared to maximize its opportunity.

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MOLECULAR DIAGNOSTIC REPORT

2009 Molecular Diagnostic Testing Trends, Opportunities & Outlook – Surprising Trends You May Not Have Expected

MRSA has rapidly become the second most prevalent molecular diagnostic test used in laboratories today with volumes second only to Chlamydia & Gonorrhea, which are well established in the molecular diagnostic market. However, the size of the institution that drives the majority of MRSA diagnostic test volume might surprise you. According to new research conducted by Life Science Strategy Group, LLC with over 150 diagnostic laboratories in the US, Europe and Asia Pacific regions, the largest weekly test volume for MRSA is not generated at the largest (1000+ hospital bed) institutions.

The report goes on to further explore centralized versus decentralized molecular testing trends and drivers. After years of molecular diagnostic companies working to decentralize laboratory testing, Life Science Strategy Group’s report takes a critical look at current perceived trends toward centralized and decentralized testing and the key drivers influencing those trends.

"As hospitals and facilities merge, there’s greater need for all specialized testing to be performed at one site for economic reason. However, as technology becomes more accessible, near-patient testing becomes more and more feasible."
-Laboratory Director, Academic Hospital Lab

LSSG´s report provides an in–depth analysis of market trends and utilization of 30 infectious disease and non-infectious disease molecular diagnostic assays to identify top areas of growth by test volume, centralized vs. decentralized testing trends, test barriers to entry and opportunities for new molecular diagnostic tests. The report profiles current and future test utilization, volume growth, pricing, regulatory levels, vendor preferences, and laboratory setting segment differences.

"An affordable and data–rich report."
–Marketing Manager, Diagnostic Company

You can learn more about these and other molecular diagnostic test findings in LSSG´s 2009 Molecular Diagnostic Testing Trends, Opportunities & Outlook Report.

To download complimentary sample pages or to purchase the full comprehensive report, please visit: www.lifesciencestrategy.com/publications/reports-diagnostic.shtml.

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CANCER BIOMAKERS

Do you have a biomarker selection and commercialization strategy?

Today biomarkers are an integral component of oncology therapeutic development because of their ability to improve treatment outcomes, streamline research and development activities and maximize the market potential for new therapeutics. First and foremost, cancer biomarkers improve treatment outcomes as they are used to manage the care of cancer patients, directing courses of treatment and predicting recurrence of the disease. Currently, BCR-ABL and Her2neu testing identify patients most appropriate for Gleevec® and Herceptin® treatment respectively. Furthermore, biomarkers can improve and streamline drug development activities by validating targets early in development, both improving product portfolios and reducing costs by focusing developmental pipelines and target patient populations. Indeed, biomarkers used to identify appropriate patient groups can be an important component of successful development of cancer therapeutics. An example of a successful oncology biomarker development occurred when the FDA cleared the test, EGFR pharmDx that identified colorectal cancer patients eligible for treatment with the cancer drug, Erbitux® (cetuximab).

While some of the initial groundwork has been laid, the Obama administration is expected to provide additional resources to encourage the development of biomarkers and personalized medicine. The FDA has clearly realized that current guidance for biomarker development is insufficient to address industry concerns, and has formed collaborations such as the CBC (Cancer Biomarkers Collaborative) and OBQI (Oncology Biomarker Qualification Initiative) to help address these concerns and to develop guidance that will encourage biomarker development.

Given the benefits cancer biomarkers provide to patients and pharmaceutical product development, and with the regulatory landscape set to encourage biomarker development, now more than ever, companies need a formal process to strategically and objectively craft their biomarker portfolios. Leveraging its therapeutic and diagnostic strategy consulting experience, Life Science Strategy Group can assist companies with a biomarker selection and commercialization strategy including:

  • Formalizing processes to identify, evaluate and select new biomarkers
  • Establishing frameworks to shape optimal biomarker portfolios
  • Support services for development and commercialization decisions that involve team members from different parts of the organization
  • Development of strategic insights grounded in rigorous research that will challenge, refine and/or validate previous assumptions
  • Delivery of cost effective and reliable results leveraging extensive industry experience, contact networks and proven methodologies

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Copyright © 2009. Life Science Strategy Group, LLC.