Black Yongjie: The field of cancer and cardiovascular disease, fun from scratch.

Guide: I think young people should be whole-hearted, down-to-earth work, it is best to be able to do a thing from beginning to end, do not rush.
think young people should be whole-hearted, down-to-earth work, it is best to be able to do a thing from beginning to end, do not rush.
to be a successful clinical director is critical to your company's and project choices, which have a direct impact on your ability to receive good exercise.
do our business, the most value of fame, credibility, our core value is creditibility.
, talk to the facts, don't know not to talk nonsense, guess what not to say.
Dr. He Yongjie has worked in the clinical development and medical aspects of oncology drugs for 17 years in multinational pharmaceutical companies such as ShiGuibao, Roche, Novarma and Amjin, and has extensive practical experience and expertise in clinical trial design and implementation, and has been responsible for Xeloda, Zometa, motesanib, conatumumab, Vectibix and other development projects or listed products, specializing in clinical data analysis and research and development of product benefits/risk assessment.
he was the first executive medical director of Anjin China, forming a clinical medical team from start to until.
is currently the Chief Medical Officer of Ambrx corporation in the United States.
-jaw necrosis (osteonecrosis of the jaw) is a dental disease associated with phosphate, first abbreviated as "ONJ" by He Yongjie in a brief document for an FDA ODAC meeting.
"At the time, I led the safety issues at Zometa, including clinical scientific analysis and evaluation, communication with oral maxillofacial surgeons, expert meetings to design treatment options, and helped write a white paper on ONJ.
", the word ONJ has been used by the FDA and other companies.
later, when He Yongjie went to work, he found that everyone was using the "ONJ" he had first activated, and pride came into being.
: Shi Guibao, Roche, Novarian, Anjin 1983, He Yongjie University graduated from the university, the first time out of Xinjiang, to Huaxi Medical University graduate students.
In that era of waste, as his mentor's first graduate student, relying on a "pharmacological experiment program" slowly groping, He Yongjie from scratch to establish a variety of experimental model system, after graduation to stay in school teaching.
Soon, he went to Canada to study pharmacology, in Vancouver's pharmacology laboratory, He Yongjie from scratch to introduce a new set of FPLC protein purification system, "from the application of funds to the purchase of equipment, installation and commissioning and system optimization, is a zero-based creation."
"In 1996, He Yongjie saw a job opening in science magazine.
because of his experience in using molecular biology to design and analyze animal results, he emerged from a wide range of candidates as a researcher at Segeo.
entered Sguibo, He Yongjie, who passed the U.S. doctor's license exam, was no longer motivated to become a doctor.
If Shi Guibao opened the door to pharmaceutical research for He Yongjie, so that he chose to abandon medicine, then the future work experience at Roche is more determined to do medicine in the end.
Black's first job at Roche was as a medical liaison officer, "and it showed a completely different world, a world I had never known before."
" Black Yongjie describes the feeling of first-time Roche.
drug research and development is a huge system, if the past work content at the beginning, now at the end, the closest to the real society.
"a lifetime of drug discovery may not be the same.
that my post-market product support at Roche can directly affect patients, which makes more sense to me.
", who was in charge of Xeloda's products, often discussed clinical trial design with doctors, and because of his scientific and medical background, coupled with a serious and positive attitude, he quickly became Hiroda's head of biomarkers in the United States.
In order to promote collaboration between Roche's Department of Medical Affairs and the Medical Device Diagnostics Department, "I have also been to Roche Diagnostics Headquarters in Germany to discuss how to strengthen research on Hiroda biomarkers in the United States.
the medical liaison officer had just emerged and was free to do a lot of things, and it was hard to have that opportunity now.
" He Yongjie concluded that the identity of the medical liaison officer is equivalent to a soldier on the front line, is a very important training before becoming a general.
"When we design clinical trials, disagreements with doctors often occur.
will complain that their opinions were not fully accepted at the expert meeting.
, " said He Yongjie, which is a matter of balance.
the point of view of an expert doctor on the design of clinical trials for the development of new drugs is important because she/she has a lot of clinical experience and is a specialist in disease, but their focus is not necessarily on the requirements for the registration and listing of new drugs.
focus on new drug developments that meet registration regulations and enable them to be marketed to meet the needs of patients.
"We should try our best to respect the views of our doctors and stick to our correct position, " he said.
"When He Yongjie was medical director at Roche's headquarters, Novart's new product, Zometa, was just on the market, "You're in the U.S. at Roche, you're in charge of the world here."
" Black Yongjie at Novaral's invitation, joined Novaral Oncology's International Department of Medicine, established a global medical strategy program to actively expand the clinical trials initiated by researchers over a four-year period, from more than 30 to more than 140.
, Black Yongjie came to Anjin and stayed for ten years.
In the second year of Anjin's growth, He Yongjie experienced a major restructuring of the company closely related to himself, the merger of the Department of Medical Affairs and the Department of Clinical Development, and he also became one of the project leaders of the global clinical development department from the Director of the Medical Affairs Department, which gave He Yongjie important training in comprehensive leadership improvement, and he began to learn to integrate different styles, different disciplines of the team, leading the development of products together.
", I learned to think about multiple solutions when dealing with any problem, and to sort out each option, and then communicate with my superiors to get support.
" when leading the Product Strategy Group and the global development team to do Motesanib (AMG 706) on non-small cell lung cancer adaptation, they completed a large international multi-center clinical trial of more than 1,500 patients, encountering a variety of Challenges, the team led by He Yongjie made innovative changes to the trial design, successfully solved the risk management of patient safety in clinical trials, and after overcoming great internal resistance, introduced biomarkers accompanying the diagnosis in the program change, which was approved by the FDA.
this experience provided valuable experience for He Yongjie to return to China to form a clinical development and medical team.
back to China, the medical department was on my own, and it was a process from scratch.
" In Anjin China, He Yongjie established Anjin's Chinese medical team and is responsible for managing Amjin's overall strategy for product development in China.
"I rely on years of accumulation and in the establishment of the credibility of Anjin, word-of-mouth.
the ability to analyze things and absorb information from all sides over the years is important to my achievements in China.
" in China, He Yongjie quickly opened the situation, established and led the oncology and cardiovascular field product development strategy, clinical project management, scientific affairs and drug registration and other excellent team, with the CFDA and clinical experts to establish a good relationship, but also experienced the initial water and soil, "to get clinical approval after clinical trials into the group is very smooth, but in the registration environment at that time to get clinical approval is very difficult, we also experienced three reports and three batches of challenges."
, " said He Yongjie.
in order to get new drugs approved for the market, to meet the needs of the regulations is the key, not good drugs must be given the green light.
the first anti-cancer drug approved in Europe, oxalipari, was considered OK when the application was filed in the United States because it had been shown to be effective, but the FDA did not approve it.
"Dr Pazdur, the FDA's director of oncology, has said that the FDA approved not the drug, but the application (NDA).
medicine is good, if the information submitted is defective, can not meet the requirements of the FDA, the drug is good may not be able to batch, of course, the medicine is not good, the information is no good is useless.
, China must comply with Chinese regulations and meet China's requirements and procedures for the approval of new drugs.
news in 2015: A coalition of Shanghai Fosun Pharmaceuticals Group, Hopu Investment, Everbright Holdings Healthcare Fund and Pharmaceutical Mingkang acquired Ambrx.
, a biotech company in the clinical research and development phase, focused on developing protein concedes at the forefront of innovation, requiring a Chief Medical Officer (CMO) with experience in both clinical development in China and the United States.
ambrx found Black Yongjie, after several months of communication, Black Yongjie decided to join Ambrx.
for big companies like Amjin and Roche, the division of responsibilities is more detailed.
CMO is more to consider the entire product line, as far as the specific implementation of the programme is supported by other departments.
for small companies like Ambrx, CMO is even more challenged.
in addition to developing the company's product development strategy, clinical programming, but also need to act as a company spokesman, with the outside world, and with the company's management team to plan the company's long-term development.
can I become a CMO? In addition to his medical background and experience in product development, as well as his familiarity with product registration regulations and clinical trial design, he believes, leadership is needed, including keen insight, judgment, analytical skills, and coordination between different departments.
"We must have a clear understanding that the development and clinical of a product requires people from many disciplines to do it together, not just medicine."
, for example, I think statisticians are my left arm and right arm, and without their help, I wouldn't have been in a good place to design a good experiment.
" "However, " said He Yongjie, "now many large and small companies are beginning to do clinical development, mixed."
need to consider the direction and overall strategy of clinical trial design in many ways.
to meet unsoponsed needs is always fundamental, and products that others don't want are meaningless.
"