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


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



HEOR Data Needs to be Tailored to Match Market Needs

Jacob Presson, pharmaceutical market access researcher
By Jacob Presson,
Senior Research Analyst

When health economics groups are working on developing HEOR data, they need to keep in mind the different gaps that the research may be needed to fill.  Depending on the market, whether right at launch or years afterwards, payers may see product’s position significantly strengthened by the appropriate HEOR data.  Developing the right information can require customization based on geography or based on the competitive landscape. Continue reading



Keep Health Economics Groups Out of Information Silos

Jacob Presson, health economics groups researcher
By Jacob Presson,
Senior Research Analyst

One of the major organizational challenges presented by health economics groups is the fact that they need data from the clinical and scientific side of the organization in order to make an effective case for payers that may be used to speaking with the commercial side of the company.  This issue is part of why many health economics groups report into medical affairs so that they can preserve their scientific expertise and credibility while bridging the gap to payers as needed. Continue reading


Proactive Communication Key to Managing Challenging Regulatory Agencies

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

Dealing with regulatory agencies to earn product approvals can prove quite difficult for life sciences companies.  Some representatives can be quite passionate about their therapeutic area which can affect their judgment, for instance.  In other instances, one investigator can simply prove more difficult than others.

To respond, pharmaceutical and other life sciences companies use several strategies to handle working with difficult regulators, according to Cutting Edge Information’s conversations with regulatory affairs executives.  Open communication with the regulator assigned to a product is absolutely essential — and should begin early in the development process. By openly communicating with agencies early on in the development process, companies can seek input from the individual responsible for reviewing the product. This communication ensures that there are no surprises on either side and that potential misunderstandings can be addressed promptly. Continue reading