The Ask

As part of its diversification strategy to combat sales erosion from drugs facing cheap generic competition, a global pharmaceutical company acquired two subsidiary companies – one is a vaccines company, the other is a biotech company.

Each was left to run autonomously for a number of years until the Chief Medical Officer challenged why there wasn’t one drug safety system instead of three.

The parent company and the two acquisitions each had their own drug safety systems supported by different organizational structures, different processes and procedures, different IT systems operating in different geographical locations.

This project was designed to simplify and harmonize the client’s end to end PV business processes into a single process and to integrate the subsidiaries into the parent PV, regulatory and quality departments.

Objectives

To meet corporate capabilities;
To meet the needs of affiliates;
To comply with all current and upcoming regulations;
To adopt pharmaceutical industry best practices;
To improve efficiency;
To reduce cost; and
To take advantage of advancements in technology.

Challenges

How to reorganize three Pharmacovigilance departments into one;
Resources we defensive about their jobs, processes and technologies;
How to develop one process workflow that met the needs of three different companies;
How to integrate three different product families into one safety database;
How to train resources to be competent and proficient in the use of new processes, procedures and systems; and
How to comply with regulations in three different countries.

Implications

None of the three databases could accommodate all of the products from all three companies;
Regulations differed country to country;
Following the creation of one PV department there may be over staffing as a result.

The Approach

Initially, work was conducted separately with the staff in each company to understand the specific requirements and nuances of their operations pertinent to the type of company and its product families:

Mapping the client’s current “As-Is” processes;
Design and development of the re-engineered “To-Be” processes;
Workshop organization and facilitation;

The process maps were compared to identify commonality and gaps and used to determine best practice.

A data analysis was undertaken in each of the drug safety systems to identify commonality and gaps to determine what changes might need to be made at field level to accommodate the product types.

Then a systems analysis was completed to see which, if any, of the three drug safety systems could accommodate all product types.

An integration road map and time-table was developed and deployed.

The implementation project encompassed a PMO and 15 different project teams.

Results and benefits

Three Pharmacovigilance departments were reorganized into one;
One process workflow was developed that met the needs of three different companies;
Three different product families were integrated into one safety database;
The new drug safety system complied with regulations in each country;
Pharmaceutical industry best practices were adopted;
Efficiency and productivity improved;
Costs reduced; and
An updated IT system took advantage of advancements in technology.

Integration of two acquisitions into a global pharmaceutical company