Pharmaceutical Consulting and Reports

New Survey: Market Access Trends in 2013

Cutting Edge Information team — Thu, 23 May 2013 14:27:01 +0000

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 [...]

It’s That Time of Year: Crunch Time for Medical Publications

Cutting Edge Information team — Wed, 22 May 2013 14:00:17 +0000

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 [...]

Less Is Definitely Not More for Counter-Generics Strategies

Cutting Edge Information team — Tue, 21 May 2013 14:29:51 +0000

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 [...]

Companies Broaden KOL Targeting, Found Recent Cutting Edge Information Study

Cutting Edge Information team — Thu, 16 May 2013 15:08:54 +0000

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 [...]

Health Outcomes Liaisons and Payers Talk Health Economics

Cutting Edge Information team — Wed, 15 May 2013 14:08:20 +0000

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. [...]

CDx Partnerships: What You Want and What You Don’t Want

Cutting Edge Information team — Tue, 14 May 2013 18:08:07 +0000

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 [...]

Advaxis’ Cervical Cancer Treatment Comes to ASCO

Cutting Edge Information team — Wed, 08 May 2013 14:22:01 +0000

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 [...]

Regulatory and Compliance Functions Within Medical Affairs Teams

Cutting Edge Information team — Tue, 07 May 2013 14:21:26 +0000

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 [...]

FDA Closer to Regulating Dr. Smartphone

Cutting Edge Information team — Thu, 02 May 2013 13:51:56 +0000

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 [...]

Product Launch: A Busy Time for Medical Affairs Teams

Cutting Edge Information team — Wed, 01 May 2013 13:25:37 +0000

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 [...]

Driving KOL Engagement Efficiency through Physician-Interaction Databases

Cutting Edge Information team — Mon, 29 Apr 2013 14:04:53 +0000

Cutting Edge Information recently conducted research among pharmaceutical medical affairs groups that looked at physician-interaction database ownership. The research revealed that ownership of these databases varies among the surveyed companies. Global groups at 60% of companies report responsibility for these internal databases. Companies that do not report global groups’ responsibility for an internal database (40%) [...]

New Clinical Trials Offer Promise for Melanoma Treatments

Cutting Edge Information team — Thu, 25 Apr 2013 14:29:34 +0000

Melanoma is the deadliest form of skin cancer. Although the World Health Organization estimates that melanoma accounts for only 5% of skin cancer cases — or 132,000 annual cases globally — it accounts for 75% of skin cancer deaths. However, compared with other cancer types, melanoma remains a small area of study. ClinicalTrials.gov shows that, [...]

Pharmacovigilance: Databases Support Adverse Event Reporting

Cutting Edge Information team — Wed, 24 Apr 2013 14:29:10 +0000

Drug companies’ increased pharmacovigilance activities highlight the importance of both clinical data and adverse events reporting. The World Health Organization (WHO) estimates that adverse drug reactions (ADRs) represent between the fourth- and sixth-leading causes of death in the US. The global organization cites that in the UK, among patients aged 16 and older, those experiencing [...]

Don’t Ditch the Tech If You Want Successful Speaker Programs

Cutting Edge Information team — Tue, 23 Apr 2013 13:28:57 +0000

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 the form of presentations, dinners and round-table discussions. New technology has recently expanded speaker programs into the online world, [...]

Minimize Phase 1 Delays through Early and Open CRO Communication

Cutting Edge Information team — Thu, 18 Apr 2013 14:16:59 +0000

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 planned and actual trial duration. It’s clear that most of these delays are during [...]

Promising Oncology Drug Receives Third Breakthrough Designation from FDA

Cutting Edge Information team — Wed, 17 Apr 2013 14:46:09 +0000

Pharmacyclics Inc. recently announced that the FDA granted an additional Breakthrough Therapy designation for its investigational oral agent ibrutinib as a monotherapy to treat patients with chronic lymphocytic leukemia or small lymphocytic lymphoma with deletion of the short arm of chromosome 17. For those keeping score at home, this is ibrutinib’s third breakthrough therapy designation. [...]

Projected Impact of ACA Legislation on Unpaid Hospital Bills

Cutting Edge Information team — Mon, 15 Apr 2013 13:45:25 +0000

According to the American Hospital Association, hospitals nationwide remain liable for up to $41.1 billion in unpaid healthcare costs annually. This cost is up from the recorded amount of outstanding costs in 2010 ($39.3 billion). Currently, Jack Hadley, senior health services researcher at George Mason University, estimates that the government ultimately foots the bill for [...]

DTC Ads Persuade AND Educate Consumers

Cutting Edge Information team — Wed, 10 Apr 2013 14:02:12 +0000

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 mix to include more Internet advertising, resulting in a decline in TV and print ads. Pharma is realigning [...]

Product Development Stage Dictates Medical Affairs Spending Patterns

Cutting Edge Information team — Mon, 08 Apr 2013 14:40:26 +0000

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. Understanding the science behind the product is increasingly important for market access functions as payers increasingly require [...]

Technology’s Role in Enhancing and Expanding Medical Information Teams’ Capabilities

Cutting Edge Information team — Thu, 04 Apr 2013 16:10:28 +0000

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 roles. Figure 1 shows the disparity across surveyed US companies’ medical information staffing teams. Groups range from less than a single FTE up to 20 FTEs at [...]