Bill Martin is the head of N’s global therapeutic areaEuropean Science in In an interview, he shared some promising developments in the field of neuroscience, such as the rise of neuroimmunology, new methods for measuring and monitoring the likelihood of recurrence of schizophrenia, and the industry’s adoption of digital health tools to support drug development .
Bill Martin
Given that Janssen’s neuroscience pipeline is relatively small compared to other departments, how do you see this part of the company’s growth and becoming a key driver in Janssen’s portfolio?
We view neuroscience as one of Janssen’s main growth engines. We have a long history of 60 years in the field of neuroscience. In fact, our eponymous Dr. Paul Janssen developed a breakthrough treatment for schizophrenia, which completely changed the standard of care at the time. During his career, he has developed more than 20 treatments for various neurological diseases.
Today, the true golden age of neuroscience is emerging, and its definition is an increase in accuracy. We are using more precise methods to determine the goals and patients that are most suitable for a particular treatment. We can also adjust these targets more precisely and measure treatment response.
Our growth strategy is to go beyond our core focus on psychiatry to take advantage of scientific advances in human genetics, data science, biomarkers, and neuroimmunology (the intersection of neuroscience and immunology). We plan to expand our global business portfolio by launching new therapies for people suffering from neurological diseases, neurodegenerative diseases and autoantibody-driven diseases.
What is an example of how Janssen works in the field of neuroimmunology?
A recent example is Johnson & Johnson’s acquisition of Momenta Pharmaceuticals in August 2020. This transaction gives us the opportunity to expand our leadership position in the field of immune-mediated diseases to drive further growth. As part of the acquisition, we acquired all global rights to molecules that treat autoantibody-driven diseases. Although there are many immunological indications in this field, there are also many neuroscience indications. For example, we are studying patients with myasthenia gravis, an autoimmune neuromuscular disease that is difficult to diagnose.
This investigative treatment recently received the U.S. Food and Drug Administration’s (FDA) fourth orphan drug designation for the treatment of chronic inflammatory demyelinating polyneuropathy or CIDP, a rare peripheral nervous system disease It is characterized by a gradual increase in sensory loss and weakness and loss of reflex.
In March of this year, your medicine was used to treat relapsing multiple sclerosis in adults Obtained FDA approval. Can you talk about the importance of this approval and how it affects Janssen’s general drug development methods, especially neuroscience methods?
The importance of our multiple sclerosis (MS) treatment approved by the FDA and the European Commission this year is based on more than 10 years of accumulated clinical research. The study included a head-to-head study that found that our product is superior to another oral disease improvement treatment in reducing the annual recurrence rate of patients with relapsing MS. These results show why research shows that patients can benefit from additional treatments to control their disease.
I think that in addition to the molecule itself and what it can provide for patients, it is important to realize that this represents our re-entry into the field of neurology and reinvigorates our commitment to developing solutions throughout the field of neuroscience. By helping us expand our global clinical footprint beyond psychiatry, this milestone is also in line with our overall strategy.
Do you see licensing or acquisition as a way to promote the Janssen neuroscience pipeline?
Licensing, when it makes strategic sense, is a means of growth. In fact, Johnson & Johnson has a long tradition of cooperating with companies, whether through cooperation or acquisitions, to help expand our product line. Compared with some of our internally developed assets, we are still willing to explore other opportunities to help us strategically enter into patient groups that we may not be able to access, and enter a deeper stage of clinical development.
What is your plan for the treatment of neurodegenerative diseases?
We are very concerned about Alzheimer’s disease, including projects focused on tau protein. It is a small protein mainly found in brain cells and accumulates in genetic diseases. We have two ongoing plans. One is passive immunotherapy-a monoclonal antibody that targets the middle domain of the tau protein. It is the most advanced therapy for Zhongyu because it recognizes the epitope in the pathological area and is specific to the phosphorylation of this epitope that occurs in Alzheimer’s disease. We also have a tau vaccine program, which is currently in phase 1b/2a, and we are running it in cooperation with AC Immune.
exist , You said that Janssen is closing the conversion gap that hindered industry development in the past. How do you do it?
Historically, the lack of understanding of brain diseases is indeed an obstacle to the development of new therapies. Today, we see an opportunity to close the conversion gap by systematically incorporating data science and biomarkers into all stages of development. We are advancing our understanding of these diseases and using biomarkers to achieve better patient stratification and more accurate response measurement. This is a key factor in revealing the complexity of the disease. We believe that patient heterogeneity is a major obstacle to advancing treatment. These conversion opportunities may be stronger and better than ever before.
In the same interview, you talked about using digital tools that you and other pharmaceutical companies apply to neuroscience. Can you elaborate on the digital tools you are referring to and how they can give a company like yours an advantage?
Let us first realize that digital health solutions have been successful in the entire healthcare field.exist Neuroscience, The potential impact is great because digital tools directly interact with the output and input of the human brain. We and others have discovered that, for example, voice and video contain disease-related information. By using smartphones to collect data based on digitally deployed tasks, we can put this information in the context of everyone. These data sources can help to fully understand individual patients.
In one example, we have been working with data science and digital health companies to collect digital phenotype data on a large scale in the real world. We are co-developing an application that enables digital data to be combined with electronic psychiatric medical records.I would also like to draw your attention to the many examples where these digital tools are at work, such as the European Innovative Medicine Initiative’s The plan aims to develop new methods for monitoring major depression, epilepsy and multiple sclerosis using wearable devices and smartphone technology. We are also working to measure and monitor the likelihood of relapse in patients with schizophrenia.
Is the data you collect using digital tools used in the development phase or to support the drugs you currently sell on the market?
Both. Let’s take a look at recurrence prediction. As you know, people with schizophrenia are discharged from the emergency room or hospital. What if we could really provide them with smart phones with health wristbands or watches? By capturing this continuous physiological information, we hope to be able to evaluate or identify features that predict recurrence, and then intervene before recurrence occurs. Our goal is to predict and prevent or intervene treatment very, very early to maximize the patient’s treatment effect.
Does the growing trend of decentralized clinical trials make it easier/faster to recruit patients for neurodegenerative disease research?
Compared with traditional methods, decentralized clinical trials clearly have several potential advantages. Their positioning is to help increase patient participation. By meeting with patients on the spot, clinical research can be made easier and more convenient. It also provides an opportunity to expand the representation of all patient groups in clinical trials.
Decentralized clinical trials also provide an opportunity to standardize the use of these digital technologies in disease measurement and treatment response. The idea is that decentralized trials may be faster and more effective than traditional site-based research.
But I think people are cautiously optimistic for these reasons. First, we need to ensure good clinical research practices (GCP)-data privacy, integrity and quality throughout the process. We also need to cooperate with networks and companies that are innovating in this field. More specifically, I think the challenge of recruiting clinical trials for neurodegenerative diseases is still high, and scattered clinical trials alone cannot solve these challenges.
When you start using these remote monitoring tools, there will inevitably be a higher screen failure rate, which is almost intentional. Therefore, digital technology and low-friction pre-screening methods can help reduce this burden and identify suitable patients for registration.
However, what I want to say is that the price of improved accuracy today is that it takes longer for clinical trials to start and run normally.There are many benefits to decentralized experiments, but it’s important to note that although they are certainly part Solutions, they are not All solution. We need to continue to ensure that clinical trials are executed at a faster rate and at a lower cost, so that we can get the advantages we want to experience in terms of recruitment. This will bring us closer to our goal at Janssen-to change personal lives and fundamentally change the way diseases are managed, interpreted and prevented.
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