Tunnell's Quarterly Newsletter

What We're Saying...

Why Biopharma Startups Need to Proactively Design Their Organization

Many leaders and employees of startups have spent the bulk of their careers in Big Pharma. I think we all can agree that the business model that may work well for a large, complex, global company is not effective for a startup. Given the risk and uncertainty in a smaller company with a yet-to-be-proven product, most companies are designed to be largely virtual — with the goal of keeping costs down and creating flexibility.

Data Integrity Pirates; Preventing and Detecting Malicious Intent

Prevention is difficult, but it is typically accomplished through basic security controls, where the robustness of such controls is commensurate with risk (and regulation). The skill of the perpetrator may make detection very difficult. In this article, we will cover some basic recommendations for both prevention and detection of malicious intent. While these may seem obvious, very often the cause of data incidents is purely failure to cover the most basic elements in information security.

Kip Wolf

Principal

Kip brings to Tunnell more than 25 years of experience as a management consultant, during which he has also temporarily held various highly visible leadership positions at some of the world’s top life sciences companies. Kip has temporarily worked inside the life sciences industry on two occasions, both during periods of significant transformational change: first inside Wyeth, pre-Pfizer merger; and, again inside Merck, post-Schering merger. In both cases he led business process management (BPM) groups: at Wyeth, in the manufacturing division; and, at Merck, in the research and development division. In January 2015 Kip joined Tunnell Consulting where he brings his product development program management experience to bear to improve the probability of successful regulatory filing and product launch. He also leads the data integrity practice at Tunnell and consults, teaches, speaks and publishes regularly on topics of data integrity and quality systems.

His technical experience includes the fields of quality assurance and regulatory affairs, GMP and IT compliance, technical operations and product supply. His areas of expertise include business transformation, new business development, organizational change leadership and program / project management. Kip holds and maintains various credentials, including the Project Management Professional (PMP) credential and the Program Management Professional (PgMP) credential. He has also completed graduate studies in Drug Development at Temple University, and holds multiple business degrees from Eastern University: an MBA in Management and an undergraduate degree in Management of Information Systems.

In his spare time Kip explores the outdoors with his wife, plays Dungeons & Dragons and is a motorcyle enthusiast.