What does a pharmaceutical CMO with an annual salary that is difficult to find look like? The scientific helmsman, the R & D façade, the argument with the big PI, the bag...

CMO in the enterprise, internally is the "helmsman" of innovation on the "ship" of R&D projects; External is the "façade" of the company's research and development, representing the company's clinical research and development style, and is also one of the "capabilities" to communicate with regulators, cooperate with other companies and be recognized by investors

In recent years, the domestic biopharmaceutical industry has shown a spurt of development, giving birth to thousands of Biotech companies, and many positions are in a state of scarcity of talents, especially the chief medical officer (CMO

The process of successfully bringing drugs from the R&D stage to the market requires cmOs to have different capabilities: when the project is about to enter the clinical phase, the CMO needs to develop a feasible clinical development plan for new drugs, which requires the ability to control strategy and direction and the ability to combine scientific research with clinical registration; In the early clinical stage, the CMO needs to have strong execution ability and be able to control the timeline of the clinical plan; In addition, CMOs also need to have the "insight" to find the right PI and talent, establish a network of communication between the company and experts, and build a small but refined team

It can be seen that high-quality CMOs need to have rich professional experience and have experienced the tempering of multiple "post ladders" before they can assume the heavy responsibility

In the eyes of the industry, what are the characteristics and capabilities of high-quality CMOs? What role does the CMO play within the enterprise, and who has the final say with the researchers? Under the globalization, what kind of challenges are faced by international multi-center clinical trials, and how should enterprises and CMOs resolve them? E-Drug Managers interviewed 13 CMOs and CEOs and gathered their views on these issues

CMO traits and abilities: not to "carry" the PI

How to identify and invite excellent CMOs to help drug research and development is a problem

First, rich clinical medical experience

Second, comprehensive knowledge reserves, including but not limited to familiarity with the drug development process, a deep understanding of translational medicine, a foundation in biology or molecular biology, and an understanding of how to design clinical trials

Third, leadership excellence

Fourth, "grounded", able to do practical work

Fifth, the vision and pattern

In addition, CMOs also need to have soft power such as continuous learning ability, innovative thinking ability, adaptability, and pressure resistance, as well as a sense of responsibility and mission

Of course, the ability of a high-quality CMO can not be practiced overnight, and it takes time to precipitate

The role of the CMO: helmsman, façade, bridge

What is the role of CMOs in the enterprise, and what role does it play between the enterprise and the researcher?

Some respondents believe that CMO is the optimistic and firm innovation "helmsman" on the "ship" of R&D projects in the enterprise; External is the "façade" of the company's research and development, representing the company's clinical research and development style, and is also one of the "capabilities" to communicate with regulators, cooperate with other companies and be recognized by investors

In internal work, the CMO, as the "helmsman" of research and development, largely determines the direction and speed

For startups, the CMO's first task is to lead the team to get the IND application for the new drug as soon as possible, and to push the company's pipeline assets to the clinic

In external work, CMOs need to communicate
with regulatory agencies in various countries at home and abroad.
This requires CMOs to have a deep understanding of the pharmaceutical research regulatory system, regulatory characteristics, and evolution trends in different markets, and can be implemented into the
communication and implementation of specific projects.

In addition, the CMO may also assume part of the BD business
.
In some transactions, whether the company's product development ideas, clinical data and future prospects can be clearly stated sometimes directly affects the success or failure
of cooperation.
CMOs with rich industry backgrounds and deep experience can increase their partners' "trust points"
in terms of persuasion and influence.

In addition to managing R&D internally and "speaking" externally, CMOs also play an "important bridge" role between enterprises and researchers
.

"An authoritative oncologist in China said: If one day the medical function of domestic enterprises can conduct scientific debates with domestic and overseas researchers, the level of local clinical development will jump to a higher level
.
" Wang Yu, CMO of Jinfang Pharmaceutical, gave
an example.

As a developer, the company presents cutting-edge technology and innovative therapies to the PI, providing the possibility of obtaining more treatment options for the clinic; PI provides the most tangible input and feedback
on the development strategy and execution of enterprises.
In the process of cooperation, the voices of both sides are very important
.

"CMOs need to ensure that the company's clinical strategy and plan are fully communicated and agreed with the PI, the direction is agreed without forgetting the confirmation of details, and when there is disagreement, it is also necessary to dare to discuss with the PI, work together to improve the development strategy and program design, optimize the operation process, and promote the smooth progress of
the trial.
" Liu Qing, CMO of Polar Biology, said
.

At the same time, the CMO should take into account the research requirements of the PI and do a good job in comprehensive evaluation and decision-making
.
"The communication between the CMO and the PI will be more like the communication between peers, rather than telling the PI what to do
from the perspective of the enterprise.
" Jiakesi CMO Wang Yi said
.

The biggest challenge of international multi-center clinical: product competitiveness

Under the pressure of collection and medical insurance policies, and under the increasingly serious homogenization competition in the same track, internationalization has almost become the only way
out for local Biotech companies.

As an important way for a new drug to accumulate global clinical trial data in the global research and development process, international multi-center clinical trials (MRCT) are one of the most critical steps for pharmaceutical companies to go global
.
But this is not an easy task for enterprises and CMOs
.

In the view of most respondents, the biggest challenge faced by Chinese pharmaceutical companies in carrying out international multi-center clinical trials is that their products must be sufficiently competitive
.

"To do internationalization, we must first require that this must be a good product
.
" Zhu Jun, president of Henlius, said
.

The absence of good products means that it is difficult to have a relationship
with "good" in the process of going to sea.
If the product is not competitive, it will be difficult to attract good researchers and patients, and the international multi-center clinical trial process will be blocked, the time and cost will be greatly increased, and the survival of the enterprise will also be threatened
.

In addition to having competitive products, communication with regulators is one of the most important tasks for CMOs in the process of going to
sea.
"It is not an empty phrase to communicate in advance with various regulatory agencies such as the FDA, EMA, PDA, KFDA, etc.
Enterprises must decide the strategy and content
of communication with regulators according to their own product characteristics and the development path of their products.
This requires CMO to conduct in-depth research on clinical resources, the latest scientific research results, a large number of targets, etc.
, and select a target and product that best reflects the value of the enterprise to promote clinical
practice.
Yituo Pharmaceutical CMO He Lijing said
.

Once the content of the communication is recognized by the regulator, the company's research and development work will also be more
effective.
The next challenge comes from the practical advancement of international multi-center clinical practice
.

First, the choice
of clinical centers.
Overseas, large hospitals and small hospitals, the level of doctors will vary greatly, which also determines whether a PI is experienced or not, and whether it can recruit enough patients, so it is important
to screen clinical centers.

Second, the choice of
CRO.
Because the practical level involves a lot of content, it is difficult to complete it independently for the first time or a small Biotech company, so it is necessary to consider choosing the right CRO
.
The selection and management of CRO is also a major test
of the leading ability of the clinical development team of pharmaceutical companies.

Third, the choice
of international multi-center.
In what country and in what region to carry out clinical trials are directly related to whether future trials can progress
smoothly.

Multi-site declaration strategy: first look at the road, work early

Going out to sea or not going out to sea, this is a problem
.

However, when companies answer "YES", they must start to consider whether to conduct international multi-center clinical trials and make multi-local declarations
.
If companies answer "YES" again, they must do two things: a global perspective; Do your "homework"
in advance.

When the enterprise determines the overseas strategy, the international multi-center clinical strategy either explores a balanced setting to meet the declaration and clinical practice of multiple places, or focuses on the optimal allocation
of resources to meet the drug regulatory requirements and clinical needs of the core market.
In this process, a global perspective is indispensable
.

International multi-center clinical research in the design, implementation, analysis and other aspects of more complex than only in the domestic clinical trials, requiring enterprises in the early stage of the international multi-center clinical trial plan need to consider the global patients as a whole, in the clinical trial design also need to consider the same global program, different regions of the patient enrollment ratio and other issues
.

In addition, enterprises should also consider the subsequent commercialization of products
.
When the product is close to commercialization, in addition to considering clinical and registration, enterprises also need to take into account product production, supply chain, quality system, financial and taxation, etc.
Only by considering the factors of different dimensions together can they make a more optimized multi-local declaration strategy
.

"If you lose your forward-looking global perspective, even if a drug is successful in China, if you want to promote it to overseas markets, you will face the problem of
constantly 'patching'.
" Zhu Jun said
.

With a forward-looking global perspective, in the actual implementation process, it is also necessary to do "homework" in advance, and step by step should be early
.

Mark Lanasa said: "It is worth noting that conducting global trials, particularly clinical phase III trials, remains a considerable challenge
for many companies.
Enterprises face many problems and uncertainties, including high clinical trial costs, different clinical practices, diagnosis and treatment status and ethical requirements in different countries, as well as communication and international collaboration
with different drug regulatory agencies.
”

This also means that enterprises must be fully prepared for
each link.

In the early stage of research and development, enterprises should think about whether the target is innovative, whether it can enroll subjects abroad in the future, whether the product has market potential, and whether clinical data can support global development
.

In the stage of selecting a market, enterprises should be familiar with and be able to make full use of the characteristics of different markets
.
"The FDA encourages innovation even more, so PLUSX products are generally first tested
in humans in the United States.
Relatively speaking, it is not particularly easy to do clinical phase I in Europe, and some requirements are more stringent than those of the FDA; But it is easier to conduct clinical trials in Europe after the early stages, because there is less competition than in
the United States.
Australia's drug regulatory agencies have a short approval time, the requirements for CMC are relatively simple, clinical trials start quickly, and the cost is reasonable, which is why many companies like to go to Australia
.
Wang Yi said
.

In the design of clinical trials, it is necessary to comply with the requirements of national regulatory agencies and treatment norms, and pay attention to regulatory trends and details
.
"For example, from the perspective of control group medication, the control group treatment for lung cancer patients abroad is generally 'PD-1 + chemotherapy', and domestic generic chemotherapy drugs may not be used
if they have not been approved abroad.
" CStone CMO Yang Jianxin said
.

In addition, the clinical trial plan also needs to take into account the patient population and socio-cultural characteristics of different regions, so as to reduce the difficulty of patient enrollment and the possibility of
shedding.

Going to sea is both an opportunity and a challenge for local enterprises
.
How to turn challenges into more opportunities, the answer lies in the "effort" of each step forward of the enterprise, but also in the ability and experience of the
CMO.