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


Pharma New Product Planning Challenges

No longer can companies wait until Phase 3, or even Phase 2, to begin commercializing their developing brands.  Today, the pharma industry sees increasingly competitive markets and payers who require more convincing before reimbursing products.  Companies must begin shaping their brands very early in their development for the greatest chance of success.  For most companies, the group charged with commercializing developing brands is new product planning. Continue reading


The Appeal of Authorized Generics

To combat the era of patent cliffs, pharmaceutical companies have long been planning strategies to extend the lives of their blockbuster drugs.  Some companies look to preserve their spot in the market by introducing new indications and new formulations.  Others opt to conduct pediatric testing to gain an extension, however short, of the product’s market exclusivity.  Still others would rather create a generic version of their own drug and prevent competition from pulling the rug out from under their sales.  By creating its own authorized generic, the company’s looming patent cliff may not look so precipitous. Continue reading


Portfolio Management an Important Part of Pipeline Planning

The recent news that bapineuzumab, a treatment for Alzheimer’s disease, failed to meet two primary endpoints in a recent Phase III study isn’t great for development partners Pfizer and Johnson & Johnson. The new results show the drug fails to produce clinical significance in treating carriers of the APoE4 genotype. The drug had not performed up to expectations for this patient population in Phase 2 either. Bapineuzumab will continue through trials in other patients who are more likely to show a strong response to the drug, according to pharmaceutical industry expert Ed Silverman in a recent Forbes piece. Continue reading


Driving Counter-Generics Strategies

With patents expiring right and left, pharmaceutical companies are looking for every possible tool to slow revenue losses. Counter-generic strategies are one method to maintain market share, however temporary. Even a period of six months when no generic versions can enter the market, as pediatric exclusivity grants, can mean a difference of millions or even billions of dollars. Continue reading


Alliance Management Communication, Relationships are Key Factors

Eric Bolesh, commercialization and alliance management expert
By Eric Bolesh,
Senior Director

In collaborations among pharmaceutical and biotech companies, conflicts inevitably arise — and they can spring from a host of different factors. Here are several of the most common issues that we hear about in our research:

  • Unrealistic clinical/commercial goals
  • Limiting market factors
  • Lack of staff buy-in
  • Clashing corporate cultures
  • Science that does not meet endpoints
  • Poor patent protections
  • Unclear deal structure
  • Limited communication and coordination
  • Lack of leadership involvement

Some of these problems might be addressed through — or even prevented by — effective alliance management. Continue reading



Communicating the Value of Innovation through Health Economics Analysis

By Shaylyn Pike,
Senior Research Analyst

Once upon a time, a brand team’s quest ended at marketing approval; revenues would take care of themselves. Fast forward 20 years, and the industry faces a much more challenging road to brand success. Receiving marketing authorization has become just another stage to complete. The more crucial step now is gaining and keeping the desired level of reimbursement.

A growing reliance on insurance companies and government payers to cover the cost of therapy has led to increased scrutiny of drug and device prices and benefits. With increases in patient populations and disease prevalence, payers no longer turn a blind eye to rising prices necessary to recoup product development costs. To successfully maintain their business model, they must find ways to cut their required expenditures or place more of the burden on patients. With the latter either forbidden (countries such as the United Kingdom and Canada) or severely frowned upon (the United States), they look to trim their expenses. To accomplish this, payers have begun limiting access to and decreasing the payments for new drugs and technologies. Continue reading


Pfizer Aims to Retain Lipitor Patients for a Little Longer Despite Generic Atorvastatin

After years of nurturing its global blockbuster and trying to prepare for patent expiration, Pfizer’s Lipitor is finally open to direct generic competition in the United States. Ranbaxy, which has 180 days of exclusivity on the market due to a settlement with Pfizer, recently launched its generic atorvastatin. During this period, the only other atorvastatin products on the market will be branded Lipitor and an offering from Watson Pharmaceuticals, which is selling an authorized generic version on behalf of Pfizer. Continue reading