By Srihari Gopal, senior director, head of development, psychiatry, Janssen Research & Development
From the boardroom to the laboratory, patients need a seat at the table.
The human brain is the most complicated structure in the universe. So it is no surprise that some of today’s most crippling healthcare challenges exist within the area of neuroscience. Neuropsychiatric and neurodegenerative disorders are complex diseases without a cure, and for some, there are few or no treatment options. Historically, pharmaceutical neuroscience investment and product development have been thwarted by the rich complexities of the central nervous system, causing many prominent companies to abandon neuroscience R&D altogether. But despite some progress that’s been made over the years, the global medical burden of mental disorders has surpassed all other diseases — amounting to 183 million disability-adjusted life years (DALYs)1 and an estimated $2.5 trillion dollars in direct and indirect costs by 2030.2
These statistics are staggering. Yet the true impact of brain diseases is even greater — for human suffering cannot be measured in numbers. Now more than ever, patients are speaking out and stepping up to take a more proactive role in their brain health. Technological progress has empowered patients to connect directly with others, from fellow patients and providers to pharmaceutical and service companies. Within R&D specifically, researchers are being challenged to embrace patient-centricity and integrate patient engagement activities with the product development process. We know that patients and caregivers are willing and eager to share their experiences and perspectives, in the hopes doing so will benefit others facing similar diagnoses in both the near and long term. From advisory boards, feedback loops, and partnerships with advocacy groups, incorporating the voice of patients and those who care for them is now a key to R&D success.
At Janssen, my colleagues and I have an ambitious goal ahead of us — to ensure a future where we can both predict and prevent psychiatric disorders and improve lives and society on a global scale. We realize that diseases as complex as those of the brain require an equally complex approach, centered on the unique needs, goals, and circumstances of the individual patients, as well as the loved ones who support them. It truly requires a patient-centric approach. Listening, empathizing, understanding — these basic human interactions will have a critical role in our ability to reach our goal and deliver transformational medical innovations.
Tackling Schizophrenia By Engaging With Patients And Caregivers
So how is this approach being turned into action — not only at Janssen but at large-scale research institutions and medical centers? Whether it’s in the board room or the laboratory, patients must have “a seat at the table” every step of the way.
Let’s take schizophrenia for example. Schizophrenia, which affects 20 million people worldwide,3 may cause extreme physical, emotional, and behavioral problems that affect every area of the person's life. But it also has a ripple effect on family, neighbors, and essentially the entire world around them. Examining all aspects of the personal impact of disease symptoms and quality of life implications is essential to improving real-world outcomes.
We have created opportunities to collaborate with those impacted by the disease in many ways and through multiple touch points. We regularly engage with both patients and caregivers to hear their open, honest opinions, counsel, and personal reflections.
- In recent clinical trials we surveyed and analyzed patient and caregiver perspectives of disease burden.
- We created a video series called “Healthy Minds” that features real life patients living with schizophrenia.
- We sponsored a podcast discussing serious mental illness in diverse communities.
- To help empower people living with schizophrenia to play an active role in their treatment plan, we educate patients and caregivers about treatment choice, including the benefits of long-acting injectable (LAI) medications. This year, we created several new resources created in partnership with patients and caregivers on OnceMonthlyDifference.com, including a personal preparedness plan, to help patients and loved ones plan ahead and take action when an episode strikes.
- To raise awareness of these resources for people who need them, Janssen partnered with Internet Personality and New York Times bestselling author Hannah Hart, who is a caregiver to her mother who lives with schizophrenia. Sharing real stories helps to normalize conversations about serious mental illness. We also partnered with The Mighty to share stories from people living with schizophrenia and their caregivers, including a recent post about how COVID-19 has impacted Jason,4 and how his treatment plan helps keep him on track during uncertain times.
- We also support patients and caregivers by partnering with well-known mental health advocacy organizations like Mental Health America (MHA) and National Alliance on Mental Illness (NAMI) and through our Choices in Recovery resources and programs, disseminated through our team of community mental health liaisons, who are active members of the mental health community in regions across the country.
The deep insights we uncover from these interactions impact everything we do, from designing and executing clinical trial plans to developing strategies that make innovations accessible to patients.
In fact, it was insights from the schizophrenia community that led to Janssen’s currently available and upcoming schizophrenia innovations. As we continued to learn more from patients taking prescribed antipsychotic medications, we recognized that, despite an important role in schizophrenia treatment and symptom control, nonadherence issues were leading to greater risks, including relapse and hospitalization. With these serious consequences in mind, Janssen developed a three-month injectable medication for the treatment of schizophrenia administered once every 12 weeks that provides long-term symptom control. And perhaps more importantly, this medication gives patients greater flexibility by enabling them to focus less on taking their medication and more on other aspects of their treatment plan without having to refill prescriptions or go into a doctor’s office monthly.5 But our efforts don’t stop there. We’re continuing to explore extended dosing options to give patients even more flexibility when it comes to treatment choices.
Beyond Drug Development
Of course, we understand that it is not enough to develop these medicines; they must be widely available to those who need them, when they need them — safely and cost-effectively. Our market access strategy is focused on delivering clinical and payor value through evidence generation, innovative payor partnerships, and private market options. We offer financial assistance options and provide ongoing support to help patients stay on therapies that are effective for them. And these efforts have ramped up in recent months, in response to the economic challenges brought on by COVID-19. In the U.S., Janssen has set up a comprehensive program to assist patients in need called Janssen CarePath, through which eligible patients can apply for assistance to receive medications. Outside the U.S., Janssen works with governments, payers, and insurers to provide evidence to support the reimbursement of Janssen antipsychotic medications. In many of these countries, patients may use Janssen medications at no cost.
Patients also continuously remind us of the need to shine a spotlight on mental health by breaking down stigmas and supporting a more holistic, personalized approach to healthcare. It’s time to radically reframe conversations about mental health. For that reason, we are active in stigma-reducing endeavors — from our own initiatives to meaningful collaborations with nonprofits, and we advocate for continued investment in mental health to address the massive prevention, care, and quality gaps that exist around the world.
The neuroscience community has a tremendous opportunity before us to make a meaningful impact on mankind’s most devastating brain disorders, while also reducing the stigma associated with them. We must continue to focus our efforts on leveraging data, science, and technology, while also discovering innovative ways to collaborate with patients. As my colleagues and l work toward our ambitious goal, we’ll aim to uncover the root cause of these diseases to develop novel interventions, rather than incremental medicines. And, every step along the way, we’ll listen, empathize, and understand — we’ll give patients a “seat at the table.”
- Whiteford, H., et al. Global burden of disease attributable to mental and substance use disorders: findings from the Global Burden of Disease Study 2010. The Lancet. 2013 Nov 9;382(9904):1575-86. Available at: https://pubmed.ncbi.nlm.nih.gov/23993280/.
- Trautmann, S., et al. The economic costs of mental disorders. EMBO Reports. 2016 Sep; 17(9): 1245–1249. Published online 2016 Aug 4. Available at : https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5007565/.
- World Health Organization. Schizophrenia. Key Facts. Available at: https://www.who.int/news-room/fact-sheets/detail/schizophrenia.
- Jason has been diagnosed with schizoaffective disorder.
- INVEGA TRINZA® (paliperidone palmitate), a 3-month injection, is an atypical antipsychotic indicated for the treatment of schizophrenia in patients after they have been adequately treated with INVEGA SUSTENNA® (1-month paliperidone palmitate extended-release injectable suspension) for at least four months. Prescribing Information, including Boxed WARNING, and Important Safety Information available at: http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/INVEGA+TRINZA-pi.pdf
About The Author:
Srihari Gopal is senior director, head of development, Psychiatry, for Janssen Research & Development. He leads a worldwide team focused on the clinical development of medications for the treatment of mental disorders. Dr. Gopal received his M.D. degree from Rutgers University and a master’s degree from Duke University. Prior to Duke, he completed his residency training at the Baylor College of Medicine in Houston. A prolific scientific writer, he has authored more than 150 peer reviewed publications, posters, abstracts and books, and has been published in journals including American Journal of Psychiatry, JAMA Psychiatry, and Nature.