Head of US Operations
Wilfred's key areas of expertise include: Large program design and implementation management, Global safety strategy and operations design, and Business development and senior client relationship management. Over the years Wilfred has been engaged in helping many of the top 100 Pharma and Biotech companies develop and implement their overall Safety and Risk Management strategies across the US and Europe.
Meet the Expert
Wilfred Gilich, Vice President and Head of US Operations, Insife
“We are witnessing a huge shift in the adoption of technology and automation in the Pharma industry, significantly changing the way Clinical and Pharmacovigilance functions are organized, managed and run.”
Wilfred Gilich – or just Wilf – joined Insife in 2019, with the directive of setting up Insife’s US presence so as to facilitate quick and easy access to Insife’s Services and Solutions, in particular Insife’s HALOPV application, for our US customers. Wilf has a long history of working with Pharmacovigilance (PV) functions in the Pharma and Biotech industry. Ever since 1994, when he started working at WCI Consulting (WCI), his focus has been on global transformation programs, with the implementation of best-in-class PV processes, organizations, and technology solutions. To him the fantastic trajectory of PV operations and what he characterizes as exponential development, is exciting:
“The last few years have shown us that the optimization of available technology solutions to support and accelerate the development of drugs and products, is a real imperative. We are seeing it already and I am optimistic, that the future holds great promise both in terms of the number of new treatments and the speed at which these become available.”
From Small to Huge to Innovative
Back when Wilf joined WCI in the UK in 1994, WCI was a relatively small boutique consultancy, focused primarily on operations and process improvements. Over the years WCI worked with many of the world’s top Pharma and Biotech companies, specifically in the areas of PV and Regulatory Affairs (RA), becoming one of the leading PV and RA advisory firms in the industry. WCI also set up the hugely successful PV Nets forums, an industry membership focused on benchmarking and developing best practices within PV and RA environments. In 2015 TAKE Solutions acquired WCI and over time merged WCI with other acquisitions and rebranded the new entity as Navitas Life Sciences (NLS). NLS also shifted its focus from PV more towards the needs and opportunities within Clinical Development. This change in focus and reorganization brought about many changes within the business:
“We went from being a nimble, well-organized team working closely together with easy paths of communication and decision making to being a large organization with many functions and different expectations.”
Several years later, Wilf ran into Martin Holm-Petersen, who had also previously been a colleague at Navitas Life Sciences. Martin had recently set up his own company – Insife, and developed a cutting-edge technology solution - HALOPV, to address many of the areas within PV, which were not supported by any other solutions on the market at the time.
“What I saw was a progressive and innovative company, offering a unique solution through the integration of all the different platforms within and around the PV technology landscape. With the digital transformation in full swing, many groups within the Health Care and Life Sciences industry realised that they needed to follow suit. Unfortunately, there were few common standards between technologies and companies ended up with a long list of point solutions, which did not always communicate with one another. These were exactly the issues and opportunities Insife was aiming to address in the most effective and efficient manner. Martin had a vision of global PV Operations being able to orchestrate and automate where possible, all of their worldwide PV processes, by integrating disparate systems, using a cloud infrastructure, giving easy access and usability, no matter how big or small the company”.
Wilf was impressed with and shared Martin’s vision for Insife, and it also brought him back to the centre of PV, which is where he really wanted to be. Not long after, Wilf agreed to join Insife and take the lead in establishing Insife’s US branch. The prospect of a more agile, fast-moving, and entrepreneur-minded environment, together with Insife’s amazing technology solution – HALOPV, was too good to pass up.
3 Elements of Advisory
“Managing PV is always about three things: people, process, and technology. Capable people with best practice processes and supported by the best available systems, is the key. Technology systems that support PV must really be fully integrated and to do so, you need to first understand and ensure that the people, the processes, and technologies used, are completely aligned. This is why my first priority is always to understand what our clients have today, help them map out where they need to be in the future to be successful, and then support their journey in implementing the changes they wish to make”.
A promising Future
According to Wilf it is this integrated approach together with the best available technologies, that gives him the optimistic view of what we have in store for the future:
“We see it both up and down-stream of PV. Throughout Clinical Development, Post-marketing and Signal Management and Regulatory Affairs. Speed and precision of relevant information are improving impressively, increasing the ability to ultimately both help and safeguard patients. When you look at the growing availability of easy-access cloud solutions and digital communication, I’m hopeful that the great advances experienced in one country can be quickly available and accessible all around the world as well.
Wilfred Gilich has a BSc in Microbiology & Genetics from Stellenbosch University and an MBA from the University of Cape Town.
Before joining Insife Wilfred Gilich worked at:
Navitas Life Sciences (US)
WCI Consulting Limited (US)
Byrne Flemming Consulting (South Africa)