F. HOFFMANN-LA ROCHE | CASE STUDY
We need to radically change our process of getting new product to market
In the pharmaceutical industry, getting new drugs to market is a regulation intensive, highly specialised, cross-functional process. We helped Roche to build an experience for their filing teams that precisely replicated the complexities and challenges along the way, so they could access billion-dollar product opportunities in half the time, and get solutions to patients who need them.
"Benefitting from the very best learning expertise on the market today has really made an impact on the quality of leadership and level of business understanding right across the global organisation."
Estimated benefit to Roche for each drug filed 6 months faster
THE PROBLEM TO SOLVE
Pharmaceutical firms face unique challenges when bringing new drugs to market. The biggest issue is whether individual countries with their own differing rules and processes will grant a licence for the drug to be used, after reviewing the dossier of clinical evidence that the company “files”.
Developing a new drug can take ten years and cost $1 billion, but unless the “filing process” succeeds, it will never reach patients. Any delay in authorisation can cost the company $80 million a month, and delays are often caused by communication failures within the filing team or between the team and the health authorities. Regulatory work is extremely rigorous and demanding of company resources. Nevertheless, there is no room for error and Roche estimate that streamlining the process and reducing uncertainty for Health Authorities can cut 6 months off the process, gaining $480 million in revenues for each new drug.
A purpose-built filing team is drawn together from different countries and cultures for each filing application. With 17 key leaders taken from disparate specialities, multiple overlapping teams and governance structures, the potential for problems is limitless.
Roche wanted a simulation that could replicate and compress the 18 months of the filing process into a couple of days, giving participants an overview of the process, and helping them to develop world-class team behaviours that would influence how effectively the team would work.
Having partnered with Roche since the mid 90’s, we already had a deep understanding of their company culture, and how their business works. To meet the challenge, we interviewed more than 40 of their experts spread around the globe. These included Clinical Scientists, Drug Safety experts, Statisticians, Regulatory leaders, Project managers, Pharmacologists and so on. Each one of their roles could have dramatic effect on the outcome.
We produced a simulation that precisely mirrored the business challenge of submitting new drugs to the regulatory authorities, and gives immediate feedback on how participant behaviours affect their success. This award-winning course was so helpful to Roche we now deliver it regularly, and we are helping them to access billion-dollar product opportunities, in less than half the time.
After taking part in the simulation, the participants have a clear view of what to expect over the forthcoming months. They leave with a set of world-class teamworking skills, a deeper understanding of their teammates, the processes they must complete, and how the many roles fit into them. They are well prepared for both common and unexpected pitfalls.