Coordinating Lifecycle Management Techniques: Involving the Right Functions at the Right Time

Natalie DeMasi, clinical development and medical affairs researcher
By Natalie DeMasi,
Research Analyst

Orchestrating lifecycle management (LCM) techniques can be a complicated, and — as with any strategic operation — different players contribute to the process over time.  Life sciences companies optimize lifecycle management by involving the right functions at the right time throughout development and commercialization.  For example, R&D is far more important in the early years of product development.  On the other hand, market access plays a major role closer to product launch. Continue reading

Using the Buddy System: Finding a Quality Partner for Generics and Counter-Generics Strategies

Victoria Cavicchi, pharmaceutical social media researcher
By Victoria Cavicchi,
Research Analyst

Ending product patents and generic competition are very real challenges in the pharmaceutical landscape. With limited counter-generics strategies, partnerships with generics companies can be an effective solution for organizations looking to maximize lifetime revenue for their branded products.  While these tactics can have great returns, they do require a high-level of investment and foresight—making them difficult to execute. Continue reading

Pharmaceutical Leaders Seek Focused Product Portfolios

Ryan McGuire, lifecycle management tactics expert
By Ryan McGuire,
Research Analyst

There is a surge in portfolio management activities going on in big pharma right now. Several CEOs have announced plans to rework their investigational pipelines, create focused product portfolios and divest marketed product lines that no longer fit the new company strategy. Some companies, such as Bayer AG, have sought to strengthen the core business through large-scale mergers. (Bayer purchased oncology specialist Algeta in December for $2.9 billion). Some of the biggest companies, however, are using divestitures and asset swaps to accomplish their goals. Continue reading

Lifecycle Management: A Love Story

In this age of blockbuster drug patent cliffs, pharma has focused its attention on optimizing lifecycle management of its drugs.  Companies are adding dedicated LCM teams and cross-functional committees to better plan and execute LCM strategies.  Tactics are aimed not just at prolonging exclusivity at the end of the lifecycle, but at maximizing sales while still under patent protection. Companies surveyed in an upcoming LCM report explain below how to embrace an LCM strategy this February 14th.  Continue reading

New Year’s Resolutions for Pharma Teams

Victoria Cavicchi, pharmaceutical social media researcher
By Victoria Cavicchi,
Research Analyst

As 2013 comes to a close, the Pharmaceutical and Life Science industries are gearing up for new challenges and new opportunities in 2014. Cutting Edge Information is pleased to present a snapshot of our 2014 Forecasting Guide. Every team will have unique New Year’s resolutions to meet challenges and embrace opportunities. Cutting Edge Information’s research team offers options for deepening key opinion leader engagement, boosting health economics investment, listening more closely to the Voice of the Patient, refining drug development plans earlier and forecasting clinical costs more accurately, among others. Continue reading

Sandoz Aims to Launch Biosimilar Version of Enbrel

Sandoz, a generic subsidiary of Novartis and an industry leader in the development of follow-on biologics, is launching a Phase III clinical trial of a biosimilar version of Enbrel (etanercept) – one of Amgen’s biggest sellers.  Enbrel fights autoimmune diseases by acting as a tumor necrosis factor (TNF) inhibitor to treat inflammatory conditions like rheumatoid arthritis and psoriasis.  Generic production of biologics is tricky because biologics are proteins derived from cells of living organisms and cannot be perfectly duplicated.  Instead, Sandoz hopes to demonstrate the biosimilarity of its product to Enbrel. The new clinical trial will investigate the ability of the molecule to elicit the same immune response in patients with moderate to severe plaque-type psoriasis.  Safety and efficacy will also be determined. Continue reading

New Product Planning Teams Ramp Up Staff and Budgets for Successful Development

Jacob Presson, pharmaceutical market access researcher
By Jacob Presson,
Senior Research Analyst

New product planning teams are an important part of the product development cycle and portfolio management.  Assisting in the transition from an investigational product to a fully marketed one is vital for the success of a potential drug. One of the most important aspects of working with a new product group is getting them involved as early as possible and then scaling up involvement appropriately as the product progresses through clinical trials. Continue reading

Pfizer-Sun Settlement: Bad Omen for Aggressive Generics Launches

Once upon a time, a generics pharmaceutical company launched a generic version of another company’s branded product before patent expiration. Many years passed, with both companies in court fighting over the patent’s validity, until one summer day they finally reached a settlement. The generics company was dismayed at the amount it would have to pay the branded company, but it agreed anyway for fear that a full court decision would demand even more money. From that day forward, generics companies were on notice that they must be cautious in attempting aggressive generics launches. Continue reading

New Product Planning Teams: A Tale of Three Companies

It’s tempting to steer clear of considering a compound’s commercial potential early in a drug’s development.  After all, market and regulatory forces could all change drastically in the years required to bring a product from pre-clinical testing to launch.  However, avoiding the hard work that comes with commercial planning early in development is not the best approach. To achieve the best results from early commercial work for a product, the right group needs to be doing the work.  Often, the group for the job is new product planning.  But companies often include new product planning teams at different times or involve a different team earlier in the process.  Figure 1 shows examples of companies’ different approaches to involving new product planning in clinical development. Continue reading

Counter-Generics Start Early: Less is Not More

We have a running joke among the researchers at Cutting Edge Information.  Many of the key findings from our research can be boiled down to one phrase: Start Early.  Our usual advice for pharmaceutical companies is to start planning as early as possible for all tasks.  Planning for patent expiration and generic market entry is no exception.  Counter generics start early: companies should plan as early as possible — even as far out as 7 to 10 years prior to loss of exclusivity — to successfully counter the threat of generics.  Yet teams in charge of counter-generic strategy consistently wait until only two years before patent expiry to start planning.  Waiting this long, however, means that many companies won’t have time to implement some of the best tactics before generics hit the market.  Continue reading