Yang Jianxin: From the CMO perspective to see the challenges of domestic clinical development in the next 5-10 years!

Introduction: "Chijin hard to find CMO" in the domestic and foreign biopharmaceutical industry is no secret. it is no secret that the
"CMO is hard to find" in the biopharmaceutical industry at home and abroad. How expensive is the Chief Medical Officer (CMO) of
? According to public information shows: Today, most pharmaceutical companies on the basic annual salary of CMO has been mentioned more than 2 million, and even the industry has spread some Of the value of CMO has been fired to tens of millions.
is true, joke, after all, reflects the importance of CMO in innovative drug companies and the scarcity of professional clinical development talent in China. Dr.
Yang Jianxin, Chief Medical Officer of Keystone Pharmaceuticals, CMO: BiopharmaceuticalS. Ed Fleming, senior partner at McKinsey, explained to CMO: "For pharmaceutical companies, CMO has two key functions: one is to deliver the voice of the patient to the highest level of the company, and the other is to represent the company's external activities.
"In general, the main work of foreign CMO can be summarized as: control product pipeline development, adjust product development strategy, communication KOL (key opinion leader, Opinion Key Leader).
Therefore, CMO not only has a deep scientific background, but also has a wealth of clinical experience.
said that cMO, the leading clinical research and development in China, has more than 25 years of experience in academic research and biopharmaceutical research and development, from basic research to clinical development stage of the 100-year-old Dr. Yang Jianxin is an important member.
Yang Jianxin is currently the chief medical officer of Keystone Pharmaceuticals, taking the lead in forming the cornerstone clinical development and registration team, leading the clinical development of more than 10 cancer projects. What qualities should
a superior CMO? What are the differences in the definition and demand of CDOs at home and abroad? What role does CMO play in drug development? At the beginning of the interview, Mr. Yijun threw these questions at Dr. Yang.
the role of CMO in large multinational pharmaceutical companies is not exactly the same as that of CMO, a small and medium-sized biotech company.
the former is mainly the combination of the company's product strategy and market demand.
the latter is primarily leading the clinical development and successful listing of drugs. Most of the CMOs in
foreign pharmaceutical companies are transformed by clinicians.
abroad, doctors not only enjoy superior treatment also have a very high social status, so clinicians transition to the pharmaceutical company as CMO will is not very strong, which is also a foreign CMO shortage of a major reason.
the shortage of CMO abroad has a long history, and the domestic biopharmaceutical companies on the cMO talent demand has increased sharply in the last 5 years has become more and more serious.
the reason, on the one hand, the lack of talent accumulation, on the other hand, the sharp increase in demand.
Yang Jianxin believes that The CMO of Chinese pharmaceutical companies must first have a broad global perspective, but also must be very familiar with China's national conditions, culture and clinical trial environment and domestic treatment practice;
so excellent CMO often has a dual background of clinical medicine and basic research.
Yang Jianxin admitted that CMO's work is very complicated and thin ice, excellent CMO also needs to advise the company's product line.
so, large to the product policy development, small to project clinical trial data are CMO need to be checked.
in order for the company's products to go to market successfully, The CMO must look further, while maintaining independence and authority, to make decisions for all critical projects, and even to press the pause button when necessary.
in China, an excellent CMO is not only responsible for the development strategy of all the company's products, the clinical trial design program to control, but also the implementation of clinical trials to carry out co-ordination planning.
in terms of clinical design, the project clinical trial design needs to be discussed in depth with PI.
in this process, the CMO and PI stand from the angle is sometimes not exactly the same, the need for repeated communication.
PI may want to add more exploratory research, such as biomarkers, to clinical trials, but these exploratory trials increase the difficulty and complexity of the trial operation and increase the cost of the study.
, the refore, CMO should consider the product and the company's interests as an important test design consideration, while respecting PI's recommendations.
, the domestic CMO should also be familiar with the policy, investment and financing, marketing and other fields, with the management team to promote the company's development.
the challenges faced by clinical trials in China in the next 5-10 years In recent years, with the acceleration of drug collection and the sharp decline in generic drug prices, the pattern of China's pharmaceutical market is accelerating changes.
previous years, the me-too/fast follow strategy has become a widely used path for many pharmaceutical and biological companies to develop new drugs.
Although this is a shortcut to drug development, but ultimately is not a long-term solution, China's biopharmaceutical enterprises finally have to go to their own original new drug development road.
Yang Jianxin introduced that the current domestic in the first echelon of biological pharmaceutical companies in the quality of clinical trials has been in line with international standards, but the overall level of clinical trial design in China, the promotion of translational medicine and the use of clinical resources, these may determine the next 5-10 years of China's innovative drug development level. "I think the biggest challenge for China's next step in first-in-class drugs is clinical trial design and commercial returns, "
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the level of clinical trial design, capital's anti-risk ability and the market prospect of innovative drugs have to be tested.
" Yang Jianxin stressed. the promotion of
translational medicine is the second clinical development difficulty that makes Yang Jianxin worry.
previously, in an interview with Professor Xiao Ruiping, He learned that in 2003, NIH first realized that it wanted to solve human health problems, and one of the keys was the translation of basic research into clinical practice.
however, however, the transformational medicine work in our country is difficult to land.
Yang Jianxin saw the pain point of the development of translational medicine in his daily work: the difficulty of collecting samples, the low degree of patient cooperation, and the high detection cost.
from the quality and safety control of the sample library to the integration and sharing of information resources, there is a large gap between domestic and foreign countries.
is more concerned about the low utilization of clinical resources in China.
on this issue, Yang Jianxin said: "China's clinical resources utilization is not high, and fierce competition."
, although the number of patients is large, but can be innovative and high-quality clinical trials are few.
", for example, cri published a clinical study review of PD-1 and PD-L1 in Nature at the end of 2019, summarizing the current clinical trials of PD-1/PD-L1 immunosuppressants in terms of the number of trials, targets, tumor types and patient recruitment.
notes that PD-1/PD-L1 and chemotherapy drugs, among others, have been conducted in 1,716 clinical trials involving 240 different targets.
and a major feature of China's clinical research is that an academically influential PI often undertakes multiple repeatable clinical trials, which Professor Lu called "the ability to work more."
there are eight PD-1/PD-L1 products available in China today.
clinical trials of PD-1/PD-L1 are all over the place, how can The Core Product snr. PD-L1 inhibitor CS1001 impress PI? Yang Jianxin believes that the most important thing about the big PI is the efficacy of the drug and the design of the experiment.
the current PD-1/PD-L1 research and development homogenization is serious, clinical trial design without bright spots is difficult to attract PI attention. How do
do it to the top of the ladder? Yang Jianxin's answer is fast layout big indications.
is different from some large multinational pharmaceutical companies, cornerstone pharmaceutical industry for the current high incidence of China, and there is a huge lack of meet the demand for cancer development, such as lung cancer, stomach cancer, esophageal cancer, liver cancer and colorectal cancer. At the same time,
, clinical development of treatment gaps for rare and difficult-to-treat cancer species, at present, CS1001 has 6 registered trials in the smooth progress.
"Cd-L1 of Keystone Pharmaceuticals entered the clinical time only ranked 12th in the domestic PD-1/PD-L1 products, but with lung cancer, a large indication, we are expected to successfully enter the field of lung cancer treatment in the first tier.
" Yang Jianxin is proud of it.
today, Keystone Pharmaceuticals has built an internationally qualified clinical development team of nearly 200 people, most of whom have contributed to the clinical development of several of the world's best-selling cancer drugs.
written for more than three years, and with the need to ensure high quality, Keystone has moved five products, including three co-products, into a critical registration pilot phase.
so far, Keystone Pharmaceuticals has completed the successful submission of four NDAs for two drugs in Greater China(ivosidenib and avapritinib).
next, two other heavyweight drugs, THE RET inhibitor Pralsetinib and CS1001, will each publish their findings in a registered study of non-small cell lung cancer.
Yang Jianxin is confident about the future of Keystone Pharmaceuticals.
in Yang Jianxin's view, biopharmaceutical companies are increasingly competitive, want to take a higher level can appropriately borrow from foreign large pharmaceutical companies.
is the so-called "bird with phoenix flying far, people with good and good products from high."
For some innovative pharmaceutical companies in China, it seems difficult to open up the international market, the smarter pharmaceutical companies will choose to work with multinational companies to promote their own projects, improve international market share.
to attract the interest of multinationals on the premise that the project itself is good enough.
as chief medical officer, Yang Jianxin's next task is to the cornerstone pharmaceutical industry in the clinical stage of the product, continuous high-quality, high-speed forward, maintain and open up a global strategic partner, and ultimately benefit Cancer Patients in China and the world, with practical therapeutic effect, quickly realize product value.
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