Subject Matter Expert Opinion

For companies that don’t have an in-house diagnostics development program, especially those not focusing on therapeutic areas optimized for companion diagnostic (CDx) development, outsourcing to a diagnostic firm is a great solution.  There are many reasons...

Over the past several years, we have seen a slow shift among regulatory affairs and compliance groups in the pharmaceutical industry as these groups move under medical affairs oversight. This hasn’t been a surprise among many industry observers, but it hasn’t...

Pharma has been quick to take up its share of social media — companies have already staked out their space on Facebook, Twitter and even Pinterest.  Television ad spending is down as drug companies have increased their use of these new platforms to interact...

The pharmaceutical industry has begun to dabble in online business communication, especially around speaker programs aimed at informing healthcare providers of new research and medicines.  Of course, pharmaceutical speaker programs have existed for a while in...

Staying on schedule with planned timelines is both essential to maximizing a product’s potential and monstrously difficult to achieve.  New data that we’ve compiled in a recent study (see Figure 1) show an average of more than five months’ difference between...

Direct-to-consumer (DTC) advertising in the pharmaceutical industry is changing.  From 2011 to 2012, money spent on DTC ads by pharmaceutical companies declined by 22% to $3.1 billion, according to Cegedim Strategic Data.  Companies are shifting their marketing...

Although marketing and market access functions may not support a developing drug until Phase 2 or even later, companies need to coordinate between several different teams as products move through different development stages beginning in the pre-clinical stage....

Within companies’ medical affairs groups, medical information subfunctions disseminate information quickly across consumer and healthcare practitioner audiences alike.  However, US companies rely on different-sized medical information teams to fulfill these...

Among other responsibilities, pharmaceutical compliance teams need to make sure all internal departments are up-to-date on regulations and practices.  Tracking each employee’s training also falls under the compliance team’s umbrella, but companies are often...

Regardless of company size, establishing operations to support expansions in new territories has a big impact on existing organizational structures.  The question often rests on how the subsidiary will be connected to the headquarters. Will it be a centralized...