The Building Blocks of a Successful Launch Sequence: A Strategic Regulatory Affairs Perspective

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

Developing, refining and coordinating a complex pharmaceutical launch sequence can be a significant challenge for even large global groups.  There are a myriad of market considerations on top of commercial priorities that come into play when setting the launch sequence. Bringing a strategic regulatory affairs function into these discussions is also key in order to keep the license cascade in line with the proposed launch sequence. Continue reading


Supplementing Patient-Reported Outcomes: How Accurate Are Patient-Reported Data Online?

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

The pharmaceutical industry’s interest in patient-reported outcomes (PROs) has steady grown since the FDA and EMA released their respective guidances on the subject.  Now, pharma and device companies seek out the best ways to infuse their product support with the patient voice.  For many companies, this can mean looking not only to clinical trials which use PRO measures, but also to available pharmaceutical Big Data. As the patient population becomes more tech savvy, more and more patient data is available online. Continue reading


Medical Device HEOR Groups Use PROs to Support Reimbursement Conversations

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

Health economics groups are facing more competitive reimbursement processes worldwide.  To navigate these increasingly difficult negotiations, many medical device HEOR groups are looking to patient-reported outcomes (PROs) to improve their value propositions. One interviewed HEOR consultant explained, “Before PROs, you had a lot of clinician-completed measures and clinician rating scales. Now the FDA and stakeholders want to see how treatments are actually impacting patients, and PROs give the patients a voice in the trial.” Continue reading


Health Outcomes, Patient-Reported Outcomes and Real-World Data Most Preferred Forms of Big Data

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

Because of the varied nature of pharmaceutical Big Data, companies have access to information capable of supporting a number of goals throughout products’ lifecycles.  Teams companywide are able to implement prospective studies to support clinical trials, impact reimbursement conversations with payers and demonstrate product effectiveness.  Data usage for these prospective studies varies depending on the teams’ goals and available information. 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





Biosimilars, Biobetters and Captain America: The Future of Biosimilars in a World of Biobetters

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

After being untouchable for decades, US biologics companies are finally facing biosimilar competition.  Well, sort of.  Cutting Edge Information’s report on counter-generics strategies found that the high cost of biosimilar production will not allow companies to price biosimilars substantially below that of the original product – meaning they may not have the same market impact that a typical generic would.  Instead, biobetters may be the next biggest thing to rock the biologics world. Continue reading