Defined as “the making up or composition of a whole by adding together or combining the separate elements or parts”, integration is the new strategy in the active pharmaceutical industry.
Instead of working with many companies which offer particular services, the industry giants are now focusing on working with fewer companies which offer a large range of services. This reduces labor costs and time, as well as the required management work.
This outsourcing model includes a cluster of a few companies situated in a small region, compared to a larger number of companies situated across the globe. The co-location strategy leads to increased effectiveness in external and internal communication, as well as knowledge sharing.
For this article, we’ll be considering three integration areas:
- Integrated services
- Integrated technologies
- Integrated project teams
Every API, needs a particular technology for its manufacturing but not all the technologies are needed. Many successful companies have established themselves on the basis of a single technology.
For a CRO, to provide the proper technology for client’s active pharmaceutical ingredient, is an important ability.
The perfect example for this technology is Biocatalysis. Compared to chemocatalysis, it produces no heavy metal waste and works with nature friendly solvents. Also, it doesn’t require no deprotectional steps and functional group protection. When applied correctly, it provides high yield, scalability, and stereo control.
Analysis, chemistry and physical form services are the ones which are responsible for the development of a drug. It should be noted that it’s their proper combination that has the maximum impact.
An early study on understanding the form (physical) of an active pharmaceutical industry, can guide a company towards the study of the API’s isolation and purification. This can also lead to a path for best FIH formulation.
A truly integrated model can have the following solutions:
Early toxicology scope definition
It includes identifying and controlling potential genotoxic impurities (GTIs).
The synthesis path can be modified to remove GTI’s risk, if the nature of the GTI is known. Other than that, an early start can be started to develop an analytical method to quantify low levels of the genotoxic impurities.
Effective active pharmaceutical ingredient batch strategy
In this model, the manufacturer of the API and the clinical testing site work with each other, to determine how much API is needed and when it is needed. Once this information is available, the chemistry team can identify strategy to produce the required amount, and create a flexible plan which can be changed according to the project’s needs.
This strategy makes the clinic, client and API manufacturer communication openly and regularly. It’s the kind of strategy that allows an aggressive timeline to be followed without an increase in risk.
Avoiding repeat activities
The problems with the analytical method can be resolved early. The API analytical method may end up being transferred several times but only one time in the integrated model.
When the integrated model is applied, the prime company has to work with fewer companies which leads to increased effectiveness in communication, team building, and strong project management.
The integrated model saves money, and time. As the model removes duplicate activities, and join up program planning, the time and costs required to develop a drug can be reduced.
Mainly, the model reduces the number of companies the client company is required to work with, and as they are co-located, the complete benefits of the model can be achieved.
This leads to more face-to-face communication between the client company and the other companies. At the end, this helps in the reduction of time required by the program manager/director, to spend on coordination activities, resolution of critical project issues, and allows faster escalation.
Integrated Project Teams
As Michael Jordan once said, “talent wins games, but teamwork and intelligence wins championships”.
The pharmaceutical business, at the core, is driven by the people involved, where services and technology must be firmly established in the strategies of the outsourcing company and the other companies.
There are two challenges involved: focus on the ownership of all the program and clear communication among all the parties involved, as long as the project works.
The following three components lead to effective teamwork on active pharmaceutical ingredient development projects:
A skilled and experienced program manager
Program managers are at the core of the success of any program and the ones whose effective management and coordination skills lead to efficiency. Now, the manager shouldn’t only have soft skills but should have experience of working in the field, to get a gist of the troubles and issues one might face during the devising process or the implementation of the plan.
The individual should also be able to handle the impact of any delays caused, or any required delays.
The person should be able to maintain a good relationship between the client and outsourcing company, which is a leading factor in the success of any projects.
Clear communication practices
While the lack of communication can lead to severe impacts on the project, too much communication can also cause troubles in the project.
Asymmetric communication in which one party communicate properly, and the other poorly, can also lead to problems in coordination.
Establishing clear roles for all the team members
Every team member should have a clearly defined role. If the roles aren’t clear, it can lead to the delay in work.
Not only that, but in some serious cases, the team members might end up blaming each other for any losses or issues faced by the team. This will not only waste time but also decrease the communication among team members, and ultimately result in the failure of the project.
In the coming times, true communication will affect a company’s standing in the charts marginally. The integrated model is the future of the industry. We believe that the companies failing to follow this model, or come up with a better strategic model, will end up losing out on many great opportunities.