Scientific Affairs at Medical Device Firms: The Ongoing Challenge to Define Roles

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

Scientific affairs has evolved into a highly visible function throughout the life sciences industry. Companies look to these functions as the liaison between clinical-focused groups and the healthcare community.  However, some medical device organizations’ scientific affairs groups face ongoing challenges in defining their specific roles within the company.   Continue reading


Developing a Launch Sequence: Should Teams Build from Scratch or Repurpose Existing Sequences?

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

A product’s overall success may often depend on how well it does in its initial market debuts, meaning it is critical to launch the product first in markets where it is likely to succeed.  Teams develop a product launch sequence as a roadmap for when a product should reach particular markets.  These launch sequences typically take place in three waves, beginning with the most critical markets for the first wave and ending with the riskiest and/or nonessential markets in the third wave. Continue reading




Benefit-Risk Profiles: Pharmaceutical and Device Products’ Electronic Medical Records

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

Benefit-risk analyses help life science teams compare identified safety concerns with product efficacy outcomes.  Often, life science teams begin constructing risk-benefit profiles while products are in the preclinical or early clinical development stages.  After establishing their initial profiles, teams will update risk-benefit information as new data becomes available.  Much like patients’ medical records, products’ benefit-risk profiles remain associated with them for life. Continue reading


Companies’ Experiences with KOL Contract Negotiations Are Changing

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

Pressure on groups working with HCPs and other thought leaders has increased over the past five years with the rise of the Sunshine Act in the US and increased regulatory scrutiny around the world.  CEI has conducted extensive research on how companies should compensate thought leaders and what represents fair market value in the current healthcare landscape.  We are going to be leading a webinar on Thursday, May 19th at 2:00pm Eastern time to discuss a range of topics associated with KOL engagement by pharmaceutical companies. Continue reading


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 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