Viewpoint: life science innovation companies compete to enter the field of cancer medicine

In recent years, cancer drugs have become a hot topic in the pharmaceutical industry The development trend of the pharmaceutical industry in 2020 is inseparable from the focus on cancer treatment drugs In recent years, the proportion of new drugs approved for cancer treatment has increased Since 2010, the proportion of new drugs approved for cancer treatment has accounted for 27% Innovative companies in the field of life sciences with different sizes and scales compete to enter the field of cancer medicine and increase investment in this field New companies in the field of treatment are taking a firm foothold and expanding their territory, while companies once famous as leaders in the field of popular medicine are also reshaping themselves in this field However, the field of cancer medicine is developing rapidly, and the competition for innovation in various cancer treatment fields is becoming increasingly fierce From car-t engineering immune cells, combination of checkpoint inhibitors, to vaccines, bring many expectations to the industry and stakeholders Companies are competing to become industry leaders focused on cancer treatment Photo source: pixabay According to the statistics in 2018, the number of cancer treatment drugs in the pipeline of advanced research and development increased from 711 in 2017 to 849 in 2018; 91% of them are targeted small molecule treatment drugs (40.3%) and biological products (50.3%) In addition to the unprecedented number of cancer treatment drugs under development, the annual investment scale of nearly 150 billion US dollars is also unprecedented In 2020, if this trend continues, it will continue to grow in double digits Cancer is currently the most widely concerned area of treatment, but for the clinical team, it is also the most difficult area At present, the investment risk and return in this field are very high As more and more companies increase investment, risks and difficulties will increase In addition, with the tight battle line of payers, resources are close to the breaking point; pharmaceutical enterprises must make a difficult choice in focusing on patients and signing a contract for collective procurement In 2020, the successful approved cancer treatment drugs will face new challenges In the face of patients' expectations, it has become the most practical way to solve the problem The pharmaceutical industry has been calling for a faster drug development cycle Regulators also hope to speed up the process from laboratory to approval Innovators in related fields are striving to shorten the R & D cycle of related new drugs to 5 years, which is only half of the time required for drug development in other treatment fields It makes sense that the pharmaceutical industry has to race against time for the unmet needs of people with fatal diseases ▲ routine drug R & D, approval and marketing processes in EU countries (data source: reference [3], content team drawing of Wuxi apptec) ▲ development and change of FDA accelerated approval (AA) and EMA conditional marketing authorization (CMA) (data source: reference [8] content team drawing of Wuxi apptec) Researchers are seeking to build a way to accelerate clinical development, from the traditional phase 1, 2 and 3 clinical research, to a more efficient and seamless research design that comprehensively considers all three clinical trial stages After the drug application is approved, other clinical trial arms can be used to continue to explore the variation of dosage, target and cancer type For the treatment drugs with the qualification of breakthrough treatment identification and priority review, the data set on which FDA Approves is becoming smaller and smaller The FDA approved less than 200 patients who were allowed to participate in clinical trials for the first really needed treatment drugs Drug regulatory agencies in other countries have also begun to allow the use of overseas clinical trial data for new drug applications These practices bring new expectation for conditional approval and clinical research budget There is a large degree of overlap between the relevant clinical research budget and the commercial budget; similarly, there will be overlap between the clinical trial timeline and the commercial promotion timeline Business teams used to expect two years, or more, to get ready for the market, but now, for cancer drugs, it could only take 12 months Once clinical trials show reliable scientific evidence, it is necessary to carry out relevant marketing education on new science, new access and new hope involved in drugs Data source: reference [4], content team drawing of Wuxi apptec Increasing changes and innovations may lead to mature cancer treatment drugs that are difficult to attract attention Once the growth of drug sales stagnates and enters the platform period, the management of pharmaceutical companies, as well as the stakeholders in the market, tend to focus on new products Tapping the potential of related molecules may involve current indications, prescription adjustments, or changes in labeling instructions We can maximize the molecular value through traditional clinical research, or identify new correlations and connections through data mining If it is determined that there is new and reliable scientific evidence for the relevant molecules, then the next step is to let the business team adopt common low-cost solutions to explore the potential vitality of the aging brand to attract attention In 2020, it is expected that you will see more mature brands, starting from the segmentation data, especially the segmentation data of new entry of real world data, or the segmentation data of earlier clinical trials These data can show which types of patients, or subgroups of concern, are most likely to benefit from relevant treatment methods, help doctors and payers, and maximize the application of relevant segmentation data Photo source: pixabay Although there are still doubts about the rationality of "data mining", the FDA will open the door to the use of quartiles, forest charts, information on comorbidities, and other ways to reveal the far-reaching benefits of the product as long as it does not involve the expansion of indications beyond the scope of drug label description Submitting the summary basis of approval to FDA, as well as all the registration data of the submitted brand, is a very useful resource, but it is often ignored Case studies may play a greater role in mature companies After the drug is put on the market, with the passage of time, more useful real world experience databases will be accumulated, making the voice of patients become the focus of attention of all parties By working with doctors with more prescriptions and patient rights organizations, we can help pharmaceutical companies understand the situation of patients and medical care personnel, and listen to their true stories After that, the information can be shared through sales promotion materials, webcasts, corporate websites, social channels, and even mass media These case studies will increasingly lead brands to reconsider their value proposition These value propositions may stay in the listing mode before, but do not keep pace with the changes of experience, competitive environment or the real world The overall business of pharmaceutical companies is changing from managing drugs and their datasets to managing customized processes and treatments for patients Once the brand is established, the referral network becomes very important Mature molecules can map out the referral network and find key nodes, thus affecting the daily behaviors of the prescribers that the brand owners are most concerned about Photo source: pixabay The biggest challenge for drug clinical trials is the difficulty in recruiting patients It is not uncommon that clinical trials cannot be carried out due to recruitment difficulties It is more common for complex diseases, rare diseases, and cancer treatment drugs where multiple companies are seeking to conduct clinical trials at the same time As innovation emerges, finding patients who have not previously been treated with checkpoint inhibitors, or car-t therapy, can become difficult As 2020 approaches, different research teams will continue to use data to determine who can prescribe and how to treat the right patients But at the same time, these teams will use another type of data to reconsider the identity of the right patient At the ASCO annual meeting in 2019, there are many dialogues about increasing the use of medical record data to understand the real world population situation, and the goal is no longer limited to those who initially meet the inclusion criteria Using the real world approach, it is possible to shift the recruitment from 20% to 30% of the patient population to only 5% to 10% of the patient population It is also important that the relevant data can better reflect the response of the relevant population to the treatment Photo source: pixabay For the clinical trials of cancer drugs, basket test, adaptability test, and the use of synthetic control arm method, the significance is not small In a positive regulatory environment and the expectation of patients' rights and interests groups, the relevant team will be in a favorable position to persist in trying new clinical trial design methods If the relevant elements have convincing value, but they have not been given due attention, it is necessary to formulate a plan for three to five years, and take the long view Accelerating the review and evolving competitive environment makes it more important to actively and consistently use real world evidence (RWE) and real world data (RWD) Disclaimer: This article is only for the purpose of information exchange The views in this article do not represent the position of Wuxi apptec, nor do they represent the support or opposition of Wuxi apptec reference material: [1] Sept 12, 2019 Retrieved Jan 2, 2019 from https://med.sina.com/article detail 103 2 71470.html [2] Patricia Van Arnum Gauging the Opportunities in the Oncology Drug Market June 5, 2019 https:// [3] EC The financing of biopharmaceutical product development in Europe Jan 15, 2014 Retrieved July 12, 2019 from http://ec.europa.eu/DocsRoom/documents/1416/attachments/1/translations/en/renditions/pdf [4] Philip Pallmann, Alun W Bedding, Babak Choodari-Oskooei, et al Adaptive designs in clinical trials: why use them, and how to run and report them BMC Medicine (2018) 16:29 https://doi.org/10.1186/s12916-018-1017-7 [5] FDA CDER APPLICATION NUMBER: 761097Orig1s000 MULTI-DISCIPLINE REVIEW Sept 28, 2018 Retrieved Dec 26, 2019 from https:// [6] Bill Clinton, Al Gore Reinventing the Regulation of Cancer Drugs: Accelerating Approval and Expanding Access 1996 Retrieved Dec 29, 2019 from https://books.google.com/books?id=URm7D02FhUQC&pg=PA7&lpg=PA7&dq=Reinventing+the+Regulation+of+Cancer+Drugs:+Accelerating+Approval+and+Expanding+Access&source=bl&ots=2a4EoQnfxI&sig=ACfU3U2tZyRhuqjdF6kn6fmJJksStqrpGQ&hl=zh-CN&sa=X&ved=2ahUKEwiSxpeHt_DmAhXyxlkKHcZ2BNUQ6AEwA3oECAkQAQ#v=onepage&q=Reinventing%20the%20Regulation%20of%20Cancer%20Drugs%3A %20Accelerating%20Approval%20and%20Expanding%20Access&f=false [7] Elizabeth A Richey, E Alison Lyons, Jonathan R Nebeker, et al Accelerated Approval of Cancer Drugs: Improved Access to Therapeutic Breakthroughs