Managing Time and Cost of Health Technology Assessments

Jacob Presson, pharmaceutical market access researcher
By Jacob Presson,
Data Product Team Leader

As pharmaceutical companies continue to work to prove the value of their products to payers around the world, they are encountering health technology assessments (HTAs) in many markets around the world. These HTAs require companies to submit value dossiers that follow specific guidelines — often including health economics and comparative effectiveness work.  Our research has shown that different HTAs consume varying amounts of raw resources in terms of working hours and budgetary expenditure.  However, most companies’ proportions of timing and spending following similar patterns across regions and company types.  Continue reading


Right-Size Risk-Based Monitoring Activities by Evaluating Individual Site Data

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

Risk-based monitoring is a highly individualized practice among life sciences companies.  Each organization’s clinical trial team may have a different threshold of risk with which they are comfortable.  Teams also employ a different mixtures of remote and centralized monitoring techniques. As such, firms must continually evaluate incoming data for factors that indicate a need for increased risk-based monitoring activities. Continue reading


Physician Fair Market Value: KOL Travel Compensation Across Different Tiers

By John Sweeney,
Statistical Analyst

In light of the Sunshine Act and the restrictions that are being placed on the pharmaceutical industry, there is much more scrutiny placed on these companies for overcompensating key opinion leaders for business and travel. Some life sciences companies are starting to adopt policies that highlight exactly how KOLs may be compensated and by how much and/or to what degree. Of these policies, most pharmaceutical companies provide a very vague overview explaining that travel provided to thought leaders must be reasonable and not excessive (i.e. below first class ticket). Continue reading


Clinical Outsourcing Decision-Making at a Glance

Sarah Ray, regulatory affairs and safety researcher
By Sarah Ray,
Senior Research Analyst

To provide continuous support throughout the product development process, life science companies may seek additional assistance from third-party solution-providers. Research and development (R&D) teams may lack necessary in-house capabilities—be it limited staffing or insufficient technology—to fulfill their preclinical and clinical trial needs.  For example, not all companies have full service labs in-house.  Consequently, these organizations look to clinical outsourcing options for diagnostic or other test types.  Continue reading


The New Age-Old Question: How to Prove Medical Science Liaison Value?

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

It’s a common question at conferences, business meetings and even on social media: What key performance indicators (KPIs) should medical science liaisons (MSLs) track to prove value?  When I ask medical affairs executives this question, I get a variety of answers, but they usually begin in the same way – with a sigh and “that’s a good question.”  Through all of this muddle, however, some MSL teams have devised satisfactory methods to prove their worth to upper management. Continue reading


The Heightened Ease of Mobile Accessibility Creates a New Era for REMS

Sarah Ray, regulatory affairs and safety researcher
By Sarah Ray,
Senior Research Analyst

As part of its 2013 drug safety research, Cutting Edge Information explored the advantages of internally-leveraged mobile applications.  At the time, one senior vice president described her company’s foray into mobile drug safety development.  To support drug safety activities, the business technology team at her small pharmaceutical company teamed up with an outside vendor.  Together, these groups developed a drug safety application that allows field forces—including sales teams and medical science liaisons (MSLs)—to transmit adverse events to the organization’s drug safety teams.  Continue reading


Recap: Medical Affairs Launch Planning Webinar

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

Medical affairs is on the front lines of a product launch.  During this crucial launch window, medical affairs is responsible for raising awareness, educating stakeholders and all-around readying the healthcare community.  These tasks make medical affairs a cornerstone of product success.  However, medical affairs teams are only as effective as their product launch plan, as poor timing or a sub-par strategy can diminish their impact. Continue reading


Create Pharmaceutical Commercial Boards to Meet Developing Brand Needs

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

Launching and commercializing new pharmaceutical products is a complex process.  A successful launch requires input from experts across the organization, as well as meticulous timing and coordination of activities.  “Just about every function at one point or another is going to be involved in the brand launch,” explained one interviewed associate director of new products. To combine an array of expertise, pharma companies develop commercial boards to support their emerging products.  However, these teams must evolve over time to match growing brand needs. Continue reading



Taking Mobile Health Applications One Step Further with Smart Shoe Wearables and More

Sarah Ray, regulatory affairs and safety researcher
By Sarah Ray,
Senior Research Analyst

As part of its research into life science teams’ digital marketing practices, Cutting Edge Information has studied the development and uptake of mobile platforms.  Cutting Edge Information’s previous pharmaceutical digital marketing report delves into how corporate and brand teams alike develop mobile applications—combined with how targeted physician and patient audiences use them. Examples of the types of mobile applications that life science organizations develop range from those that are effectively lifestyle trackers to applications that function as medical devices.  Continue reading