By Michelle Vitko,
Senior Research Analyst

In today’s pharmaceutical market, which is riddled with austerity measures and healthcare reform, securing favorable reimbursement rates is more difficult than ever.  Cutting Edge Information is kicking off a new benchmarking study designed to assess current challenges and trends facing market access teams.  Our previous market access study completed in 2011, showed that teams were growing in importance even then,  as demonstrated by stable — and in some cases, increasing — resources.  Market access teams were responsible for a variety of vital functions, from pricing and reimbursement to outcomes research and account management. The new study aims to measure how things have changed in this evolving pharmaceutical landscape and how those changes impact drug companies’ structures and strategies. Continue reading “New Survey: Market Access Trends in 2013” »


By Jacob Presson,
Research Analyst

In light of the coming American Society for Clinical Oncology (ASCO) annual meeting, many companies are scrambling to get their medical publications out by the conference deadline. One of the biggest contributions a pharmaceutical company can make — beyond the manufacturing of drugs — is to sponsor physicians’ research to further therapies and techniques. This sponsorship represents a valuable component of how pharmaceutical companies engage their thought leaders. Continue reading “It’s That Time of Year: Crunch Time for Medical Publications” »

Christie Shilling
By Christie Shilling,
Research Analyst

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.  Companies should begin to 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 “Less Is Definitely Not More for Counter-Generics Strategies” »


By Sarah Ray,
Research Analyst

Drug companies are reaching beyond specialists when targeting medical leaders to further develop their existing products.  Among 36 companies recently surveyed, nearly four-fifths targeted multiple types of key opinion leaders (KOLs): from specialists and subspecialists to primary care providers, preventative medicine practitioners and nurses.  The takeaway?  Companies’ understanding of the movers and shakers in the healthcare community is growing and no longer bound by the traditional understanding of who holds the most sway in the medical community. Continue reading “Companies Broaden KOL Targeting, Found Recent Cutting Edge Information Study” »


By Nicole May,
Research Analyst

The burden of proving drugs’ cost-effectiveness data falls in part to health outcomes liaisons (HOLs) who work between pharmaceutical companies and payers to get their company’s drugs onto formularies.  HOLs rely on comparative effectiveness and health outcomes data to convince payers that a new drug is clinically and financially favorable. Continue reading “Health Outcomes Liaisons and Payers Talk Health Economics” »

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 why a drug manufacturer may need to outsource biomarker development.  A companion diagnostic (CDx) program is a valuable asset for any pharmaceutical or biotech company seeking to improve health outcomes and ensure that their products are provided to patients who are most likely to benefit from them.  Continue reading “CDx Partnerships: What You Want and What You Don’t Want” »

The American Society of Clinical Oncology’s (ASCO) annual meeting is fast approaching, scheduled for May 31st to June 4th in breezy Chicago.  One of the many to present data this year is Advaxis, a biotechnology company that develops cancer and infectious disease immunotherapies.  The company’s keystone product, ADXS-HPV, is based on technology developed at the University of Pennsylvania and is currently being tested in five clinical trials.  The product targets HPV-related diseases, including cervical, head and neck and anal cancer.  The company will give presentations on two Phase II trials of the drug next month: one in the treatment of recurrent/refractory cervical cancer in Indian women and the other in the treatment of persistent or recurrent cervical cancer. Continue reading “Advaxis’ Cervical Cancer Treatment Comes to ASCO” »

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 been a complete shift either. Fewer than 40% of surveyed companies in a recent Cutting Edge Information study put compliance functions under the medical affairs department’s supervision. Continue reading “Regulatory and Compliance Functions Within Medical Affairs Teams” »

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 with patients and doctors.  Mobile health (mHealth) apps are on the rise.  And with an estimated 3.4 billion smartphone or tablet users with access to mobile health apps by 2017 (according to Research2Guidance), this market represents an enormous opportunity for pharma.  The market will continue to increase as smartphone use spreads into developing countries and as baby boomers age, two groups that could particularly benefit from improved healthcare information and access. Continue reading “FDA Closer to Regulating Dr. Smartphone” »

Marketing and commercial teams get a lot of the credit for a successful product launch, but medical affairs teams are typically buzzing with activity in the months (sometimes even years) preceding drug approval.  As the official communication channel between a pharmaceutical company and the scientific community, the medical affairs department plays a critical role in successful product launches.  Each of the medical affairs subfunctions plays its own unique part to play to properly support a new drug. Continue reading “Product Launch: A Busy Time for Medical Affairs Teams” »