Evolving Medical Information Team Abilities to Collect Unsolicited Requests More Efficiently

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

Thanks to evolving technology, medical information teams must also update their methods for receiving and answering unsolicited inquiries.  Medical communications teams have already begun looking to web portals and other Internet-enabled request modalities, as well as considering how to best monitor social media.  However, teams should also adjust their communications with field forces such as medical science liaisons (MSLs). Continue reading


Looking for IIT Performance Metrics? Try the Percentage of Evaluated Proposals that the Committee Approves

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

Like all sub-functions in medical affairs, investigator-initiated trial (IIT) teams are being pressured to provide upper management with performance metrics to demonstrate team value.  The underlying purpose of these metrics is to show team activity, efficiency and success.  Useful IIT performance metrics include the number of submissions received and approved, the number of resulting publications and the length of time it took the evaluation committee to approve a proposal and negotiate the clinical trial agreement (CTA) with the vendor. Continue reading


Majority of Global Health Economics and Outcomes Research Teams Begin Working with Developing Products in Phase 2

David Richardson, pharmaceutical commercialization and launch expert
By David Richardson,
Director of Research

In our most recent study examining health economics teams, 64% of responding global health economics and outcomes research teams revealed that they begin working with developing products during Phase 2 — though most desired an even earlier start.  HEOR directors and managers want early involvement to help them understand payers’ hot-button issues as early as possible. Continue reading


Following Finalization of EMA Guidance, Clinical Data Transparency Continues to Surge

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

Clinical data transparency continues to reflect a growing theme across the life sciences industry.  Over the years, many life sciences organizations, including Janssen and Novartis, have established initiatives allowing physicians and other scientific researchers to access clinical research findings through online portals.   Regulatory agencies in the US and Europe alike have also worked to expand existing public access to clinical trial outcomes. Continue reading


What Are Patients Saying? Using PRO Instruments to Impact Product Marketing Claims

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

As the pharmaceutical industry transitions to more patient-centric marketing, companies are looking to patient-reported outcomes to inform product labels.  Often, clinical or PRO teams will implement PRO instruments during Phase 2 or Phase 3 trials to collect end-user feedback.  This feedback is particularly useful as companies look to prove a product’s comparative effectiveness and product label claim approval.  While PRO endpoints are becoming increasingly popular, companies still find gaining approval for these findings is a complex process. Continue reading


Can’t Reach Physicians? Time to Implement Customer-Centric Strategies

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

In recent years, pharmaceutical companies’ commercial teams have faced a growing number of challenges in the market.  These organizations have already faced two major patent cliffs, both of which filled the market with a number of generics and biosimilars alongside an increasing contingent of branded competitors.  Now, sales representatives are seeing more and more doctors close their doors to pharma’s commercial forces in response to the Physician Payment Sunshine Act.  In the wake of these challenges, pharmaceutical sales teams have had to evolve their traditionally product-centered commercial models to better meet their customers’ demands. Continue reading


Don’t Call it a Comeback: mHealth Never Went Out of Style

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

Across the life sciences industry, global not-for-profit partnerships and pharmaceutical manufacturers alike have become increasingly active in the mobile health space.  In 2012, projections indicated that the global smartphone application market would reach up to $718 million. Already, mobile technologies had helped pharmaceutical and device teams facilitate heightened medical awareness and encourage patient adherence.  Continue reading