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!

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.

IO Landscape

IO Landscape Over 50,000 cancer patients needed for IO trials, but will it make a dent?We are in the midst of an explosion of clinical targets within the immuno-oncology field which has resulted in impactful advancements in cancer care.

Highly Anticipated Drug Launches in 2017

All medicines in this list have the potential to be gamechangers.

Getting the Most of Consulting Engagements

A consultant should be someone who provides expert advice professionally. Engaging a consultant provides access to deeper levels of expertise than would be financially feasible to retain in‐house on a long‐term basis. Organizations can control expenses and risk by purchasing as much service as desired at a given time, sometimes flexing up and down as need or budget dictates.

Innovation in Pharma

Innovation in the pharmaceutical industry has a dramatic impact on the health, wellness, and pocket books of millions of people. It improves quality of life, extends life time, saves lives, and can spur vigorous political debate. Historically, innovation has meant drug or treatment development. Due to increasing challenges in gaining drug approval and aggressive pricing pressure, pharmaceutical manufacturers have sought new routes of innovation and revenue growth.

Performance Metrics Point of View

A robust data strategy is essential to optimal commercial performance. However, most companies use dashboards that provide only a limited set of lagging indicators of performance with little information to guide diagnostics. A new approach to performance metrics can provide both predictive and diagnostic information for actionable insights.