Organizational Culture Leaks Outside the Company
― The hollowing out of pharmaceutical research organizations as seen through cancer drug discovery support projects ―
When looking at job postings and outsourcing projects for pharmaceutical companies, one can sometimes see right through to the company's "organizational culture."
What I encountered this time was an external support project in the field of cancer drug discovery.
The content itself is not unusual.
* Cancer drug discovery
* Organization centered on young staff
* Lack of senior staff
* Evaluation system support
* Third-party perspective
* Educational purpose
* Mechanism understanding support
This is a composition often seen in the pharmaceutical industry over the past few years.
However, what was impressive about this project was that "knowledge reinforcement" and "education" were more prominent than "research support."
In other words, the organization lacks the "empirical knowledge" that should naturally be there.
They are trying to fill that gap with external personnel.
This seemed to condense many of the problems faced by Japanese pharmaceutical research organizations.
Drug discovery is an industry of "failure experience," not "knowledge"
Especially in cancer drug discovery, judgments are required regarding:
* How to design the evaluation system
* Which model to use
* What to look for in PK/PD
* Where the mechanism of action ends and artifacts begin
* To what extent in vitro results can be connected to in vivo
* How to position biomarkers
* How to design differentiation from existing treatments
* Which patient population to assume
These are parts that cannot be filled by mere knowledge, but only by "experience."
It is not a world you can understand just by reading papers.
Experimental systems hold a massive amount of failure before they are published as papers.
And originally, that knowledge of failure is something that the senior layer of an organization passes on to the younger generation.
However, recently, that middle and senior layer has become extremely thin in many pharmaceutical companies.
There are various reasons for this.
* Restructuring
* Early retirement
* Development cancellation
* Department reorganization
* Foreign ownership
* Short-term results-oriented culture
* Pipeline reduction
* Research organizations that have only progressed toward "becoming management"
The result is a state of:
"There are young people. But there is no one to teach them."
Research organizations that have started outsourcing "education"
So what happens to the organization?
They start outsourcing "education."
In this project as well, while it is written as "research support" on the surface, in reality, the following are expected:
* Evaluation system review
* Provision of judgment criteria
* Research discussion
* Mechanism understanding
* Young talent development
* Third-party perspective
In other words, it is a story of:
"We want to replenish from the outside the knowledge system that is no longer growing within the company."
Of course, using external experts is not a bad thing in itself.
Drug discovery is dangerous when it is a closed world.
External perspectives are necessary.
However, the problem is whether the organization itself understands "why an external perspective became necessary."
Originally, third-party reviews should be "supplementary."
However, recently, there are cases where they are starting to depend on the outside for:
* Decision-making
* Evaluation design
* Hypothesis formation
* Data interpretation
* Education
This is not just a shortage of manpower.
It is the collapse of organizational learning.
Cancer drug discovery is a field where "knowledge connection ability" is questioned
Cancer drug discovery cannot be discussed solely by simple cell growth inhibition.
* Validity of target molecules
* Biological background for each cancer type
* Resistance mechanisms
* Tumor microenvironment
* Drug sensitivity
* Biomarkers
* Selection of patient groups
* Positioning relative to existing treatments
* Balance between safety and efficacy
Connections between pharmacology, molecular biology, clinical practice, and development strategy are necessary.
Furthermore, just because it works in vitro, works in animal models, or shows PK, does not lead to clinical success.
Which patient group are you targeting?
What is the differentiation from existing drugs?
How do you view resistance?
How do you incorporate biomarkers?
What are you proving in clinical development?
This kind of "translation of drug discovery" is necessary.
In other words, it is a field that requires not just experimental technicians, but "people who can understand drug discovery as a structure."
However, that layer is rapidly thinning in Japanese companies.
The culture of "you can just buy expertise from the outside"
What is even more troublesome is that this culture spreads outside the research laboratory.
"If you don't know, just ask someone outside."
"You don't have to grow expertise in-house."
"You can just buy empirical knowledge."
This culture eventually spreads to:
* QA
* CMC
* PV
* Regulatory affairs
* Manufacturing
* DX
* Statistics
* Medical
Then, the "backbone of knowledge" no longer remains within the organization.
What ultimately happens is a state where "only meetings increase, and there is no one left who can make decisions."
Drug discovery is originally a very gritty job.
Evaluation systems, animal models, PK, and biomarkers are all actually built upon a massive amount of failure and trial and error.
When the number of people who understand that decreases, the organization gradually enters a state of "doing experiments, but not being able to do research."
Job postings reflect the "symptoms" of an organization
Job postings are surprisingly honest.
They contain what the company is truly struggling with right now.
And sometimes, you can see not just the problems of that company, but the problems of the entire Japanese pharmaceutical industry.
The project I saw this time was not just a recruitment for external outsourcing.
It directly displayed the problems that Japanese drug discovery research organizations face, such as:
* Absence of seniors
* Lack of empirical knowledge
* Over-reliance on young staff
* Organizational learning failure
* Black-boxing of evaluation systems
* Dependence on external knowledge
Organizational culture does not end within the company.
Eventually, it appears in job postings, outsourcing structures, and how research is conducted.
And finally, it leaks out into society as a whole.
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References and Related Materials
1. Scannell JW, Blanckley A, Boldon H, Warrington B. Diagnosing the decline in pharmaceutical R&D efficiency. Nature Reviews Drug Discovery. 2012.
2. DiMasi JA, Grabowski HG, Hansen RW. Innovation in the pharmaceutical industry: New estimates of R&D costs. Journal of Health Economics. 2016.
3. Paul SM et al. How to improve R&D productivity: the pharmaceutical industry’s grand challenge. Nature Reviews Drug Discovery. 2010.
4. Morgan P et al. Can the flow of medicines be improved? Fundamental pharmacokinetic and pharmacological principles toward improving Phase II survival. Drug Discovery Today. 2012.
5. Kola I, Landis J. Can the pharmaceutical industry reduce attrition rates? Nature Reviews Drug Discovery. 2004.
6. Workman P, Collins I. Probing the probes: fitness factors for small molecule tools. Chemistry & Biology. 2010.
7. Begley CG, Ellis LM. Drug development: Raise standards for preclinical cancer research. Nature. 2012.
8. Prinz F, Schlange T, Asadullah K. Believe it or not: how much can we rely on published data on potential drug targets? Nature Reviews Drug Discovery. 2011.
9. Japan Pharmaceutical Manufacturers Association "Pharmaceutical Industry Vision" related materials
10. Ministry of Economy, Trade and Industry "Bio Policy/Drug Discovery Capability Strengthening" related materials
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#PharmaceuticalIndustry #DrugDiscovery #CancerDrugDiscovery #Oncology #DrugDiscovery #PharmaceuticalResearch #R&D #PKPD
#TranslationalResearch #Biomarkers #DrugDiscoveryCulture #OrganizationalCulture #ResearchOrganization #OrganizationalLearning #ExternalPersonnel #Expertise #CMC #GxP #QA #MedQualis #PharmaceuticalArchitecture