Our Insights

The thought leaders at Herspiegel Consulting help you keep your finger on the pulse of what’s happening in the pharmaceutical and biotech industry by sharing our insights with our blog and white papers. From deciphering new healthcare reform policies to assessing market access challenges to evaluating novel marketing trends, we are constantly looking to find new healthcare trends that we believe will reshape the industry.

Make sure you check out our blog and white papers on a regular basis. They’re guaranteed to stimulate and challenge you!

Commercial Launch Readiness for Pharmaceutical and Biotechnology Start-ups

Pharmaceutical and Biotechnology start-ups are uniquely challenged when launching a new product because they are navigating a rapidly evolving regulatory and competitive landscape while building their internal organization and capabilities. Based on Herspiegel Consulting’s experience advising start-up clients, our whitepaper has defined four critical success factors that are crucial to achieving a successful first product launch.

DigiPharma Connect Recap – Debriefing DigiPharma Connect

Struggling with Digital Health Integration? You’re not alone! We recently met with senior leaders from across the industry at DigiPharma Connect and found most are struggling with the same questions. See the questions and responses in our newest whitepaper.

BMS-Celgene Merger: Worth It?

In January, Bristol-Myers Squibb (BMS) announced that they would acquire Celgene at the price tag of approximately $74B with a 58.6% premium paid by BMS over Celgene’s share price at time of acquisition. We have analyzed the deal to answer the question: Was it worth it? Read more to find out!

Copay Accumulators & Maximizers

This whitepaper outlines how copay cards were intended to address patient affordability concerns and how copay accumulators and maximizers impact that process. However, there are steps brand leaders can take to reduce exposure to these programs.

FDA Real-World Evidence Program Framework: Implications for Pharmaceutical Companies

The FDA is developing a framework for use of Real-World Evidence for approval of in-line indications. Pharma manufacturers will need to consider a new model of integrated decision making which evaluates traditional clinical trials, hybrid designs, and RWE in life cycle management planning. Read more!

FDA Guidances & Pilot Programs on Oncology Clinical Trials

This presentation focuses on recent innovations in Oncology Clinical Trials design and the Oncology NDA approval process. In October 2018, the FDA released several new Guidances, including one which covers the use of Minimal Residual Disease (MRD) in clinical trials for hematological malignancies, and another regarding clinical trials for rare genetic variants of a disease. The FDA also began two new pilot programs to increase the efficiency of the NDA process, the Real Time Oncology Review (RTOR) Pilot Program which allows for submission of data prior to submission of a complete NDA, and the Assessment Aid Pilot Program which provides a template for NDA submissions.