Dry! From scratch, how can project management help new drug research and development?

In recent years, with the improvement of the national requirements for the quality and quantity of innovative drugs, new drug research and development has become an indispensable part of

New drug development process

First, let's talk about new drug development

Taking Class 1 chemical drugs as an example, the discovery and development of new drugs has experienced the discovery of emerging compounds, the discovery and optimization of pilot compounds, the identification and development of drug candidates, the preclinical pharmacodynamic pharmacology, IND declaration, clinical phase I (human pharmacology), clinical phase II (therapeutic effect exploration), clinical phase III (confirmation of therapeutic effect), NDA declaration, listing, and clinical phase

The above time point is already an important node in the process of new drug development, but if you want to get further milestones, you can narrow the scope to: IND, confirmatory clinical, NDA, and listing (as shown in the following figure).

Figure 1: Characteristics of the life cycle of innovative drugs Image source: Research and development model and value assessment of innovative drugs in China.

Early-stage project flow for new drugs

Based on the above-mentioned new drug research and development process, domestic new drug research and development enterprises are also working around the whole life cycle of new drug research and development

➣ Project initiation

Early new drug projects, the technical level, more to see the field and pipeline, based on the simplest mathematical statistics can be carried out

➣ Planning

The formulation of the plan can further determine the scope, schedule, and funding of the project, and can present a rough outline of the project, which is the basic condition

➣ Implementation

After the project is established and the plan is approved by the superior leader, it enters the implementation stage

➣ Monitoring

After the project is implemented, it must be effectively controlled, and it is generally necessary to organize meetings at various key time and space nodes, as far as possible to avoid all subjective risks that can be avoided, and at the same time minimize the objective risks as much as possible

➣ Closure

It is necessary to make a decision tree based on the initial project plan, and eventually point to the final project, whether it is success or failure

New drug development project process

The project enters the development stage, because there are too many disciplines and departments involved, the processing method is different, and the technical department and the management department need to intervene and discuss at the same time, and form a technical plan, and then implement

➣ Overall project plan

Once the project enters the development, it is necessary to formulate strict progress nodes and execution contents to determine the overall framework of the project, key quality assessment indicators, and time node tasks

➣ Quality compliance control

Innovative drug development projects, according to different guidelines at different stages, the basic guidelines are ICH technical guidelines, which can be divided into Q series, S series, E series, M series; At the same time, under the premise of the large box, it is also necessary to follow the pharmacopoeias of various countries, the relevant technical guidelines of sub-projects, etc

➣ Risk management

Risk management can be combined with an effective project management system to control

➣ File management

The data files in the R&D process are important proof materials for the safety, effectiveness and quality control of the new drug project, and a good document management system can ensure the traceability of the project R&D life cycle

Project management professionals are involved

Item management is a part of management, from a professional point of view, the project, item management is defined as follows:

1) The so-called project refers to the one-time effort to create a unique product or service under the constraint of certain resources, which has the characteristics
of integrity, one-time, uniqueness, life cycle and constraint.

2) The so-called project management refers to the effective management
of all the work involved in the project by the project manager under the constraint of limited resources, using systematic views, methods and theories.
It is typically suitable for the management of one-off tasks with large investments, complex relationships, and limited time and resources
.

The specific content of project management can be composed of scope management, schedule management, cost management, quality management, resource management, procurement management, communication management, risk management, integration management, etc.
, and has been widely used in new drug development projects
.
Now focus on the introduction
of schedule management, cost management and quality management.

Figure 2 Key knowledge areas of project management Image source: Research on project management optimization of new drug R&D.
CNKI

➣ Schedule management

Schedule management, the role of the project management process is very important
.

The development of new drugs is cyclical, the shorter the cycle, the greater the room for future benefits, and the current development of innovative drugs is also in the speed of the fight, and the completion of phased tasks has been calculated on a monthly basis, not years
.
New drug development progress management, on the basis of work decomposition, quickly determine the stakeholders, appropriately adopt the CRO management mode, reasonably formulate the development schedule plan, use Gantt chart, decomposition chart, fish thorn diagram, network diagram, etc.
, to monitor the project progress at all times, and adjust the associated sub-projects at the same time to achieve the effect of
obtaining the fastest progress.

➣ Cost management

Cost management is as important
as schedule management.

In the process of innovative drug development, the cost can be divided into labor cost and capital cost
.
Funds are a necessary condition for the implementation of the project, and project management can effectively control input costs and improve output value, which is very critical
in the development and management of new drugs.
Labor cost is an important condition that determines the success of the development of new drug projects
.
How to balance these two costs and ensure that the project continues to run on schedule requires comprehensive consideration
.
The establishment of a scientific fund management system, matching the cost of project development schedule has an important role in promoting the progress of new drug development projects
.

➣ Quality management

Quality management is as important
as schedule management and cost management.

All sub-projects after the project has been decomposed and split require strict quality control
of the final data result conclusion.
The ICH Guiding Principles emphasize that quality comes from design, and implementing quality control through project monitoring can effectively reduce risks
in the new drug development process.
For example, through standardized CRO services to improve the quality of new drug development projects, the use of continuous quality improvement system in the new drug development cycle, from the level of awareness, organization and operation to implement quality design and continuous improvement, the implementation of the whole process of quality management, full quality management and all-round quality management, the new drug development project process to carry out PDCA management cycle, and then avoid potential quality events and efficiently solve quality events
.

In addition to the above key management projects, in the implementation of new drug research and development projects, pharmaceutical companies also need to establish a sound project quality evaluation system, a sound mid-term evaluation system, a perfect project document management plan, a sound process management system, and so on
.

Stage thinking on the fusion of two dimensions

The project management in the process of new drug development, one is the technical level, the other is the management level, and the two are forced to "mix and mix", which is bound to produce a certain chemical reaction
.

First, it's people
.
The person in charge of the innovative drug project focuses on solving technical problems, while the person in charge of the project management focuses on the management
of the project.
Therefore, one is charging on the front line, and the other is constantly updating the Gantt chart, and the consequences can be imagined
.

Second, there is the organizational model
.
In the study of patterns, the frequency of matrix-type tissues appearing is relatively high
.
Although it is possible to concentrate technical efforts on solving tasks and support multi-tasking at the same time, the disadvantage is that the expenditure is large, the scale is large, and it is not conducive to controlling costs
.
And in reality, resources are extremely limited, if many companies really do this organizational model, then other projects can be stopped
.

Again, it's responsibility
.
The success and failure of new drug projects are usually most relevant to the project leader, but many companies have seen the phenomenon of seizing power and skimming responsibility in recent years, of course, this is also one
of the reasons why many cattle people have fled.

Finally, there is the point
.
No matter what the organizational model, its core, its focus, or the project
.
A good project deserves the most suitable organizational model equipped; A good project deserves to be joined by a group of scientific researchers; A good project is worth working
around the clock.
On the contrary, a project that is alive but has died buries not only the cost of funds, but also the irreparable cost of labor and time, which is the top priority
that is worth reflecting on.
I understand everything
.

Resources:

1.
A brief analysis of project management in the process of new drug development.
CNKI

2.
Application of project management in new drug development projects.
CNKI

3.
Application of project management in new drug research and development.
CNKI

4.
Application of project management in the research and development of new drugs.
CNKI

5.
Application of project management in the research and development of new drugs in pharmaceutical enterprises.
CNKI

6.
Research on project management optimization of new drug R&D.
CNKI

7.
Basic considerations and problems of innovative pharmacognostic research.
CNKI

8.
Characteristics and technical considerations of innovative pharmacognostic research.
CNKI