Dr. Bhawana Awasthy, a Clinical Oncologist with 30 years of experience in clinical practice and research, leads the India operations of a U.S.-based contract research organization. Specializing in women’s cancers, she is a published author and advocates for breast cancer awareness and empathetic leadership.
In an engaging interaction with Women Entrepreneurs Review Magazine, Bhawana shares her insights on how personalized medicine and global health trends are transforming oncology research and treatment. She emphasizes the vital role of women leaders in driving innovation amid global health challenges.
With rapidly advancing oncology research, how will the integration of emerging global health trends, like personalized medicine, reshape the future of oncology research and treatment strategies?
Translational research has revolutionized how we develop new treatments for cancer patients. The change from an organ-centric concept guiding treatment choice towards deep molecular analysis, driving a personalized approach, is one of the most important advances of modern oncology. This is not entirely a new concept; the first example of a molecular-based approach was the use of endocrine therapy for hormone-responsive breast cancer in the late 1970s. However, the revolution towards a precision medicine approach was recently seen in 1998 with the approval of imatinib in patients with chronic myeloid leukemia bearing the t (9,22) translocation that creates a BCR-ABL fusion kinase.
This approach has now been adopted to multiple malignancies, including breast, lung cancers, and melanomas. Tools such as next-generation sequencing (NGS) and RNA sequencing are being increasingly utilized to detect predictive and prognostic molecular alterations.
On the research front, we are seeing an increasing number of basket trials selecting specific molecular targets in different tumors, and umbrella trials where patients diagnosed with the same type of solid tumors are treated according to their molecular features.
Most trials with a personalized strategy led to a higher proportion of responding patients and longer survivals than trials with unselected patients.
However, the battle is far from won at this juncture. There are many unanswered questions and challenges- the complex ecosystem, inter-individual variabilities, limited clinician education, affordability, and accessibility of medications. I am hopeful that progress in the field of personalized medicine is going to be a game changer in the way we treat cancers. Improved quality of life and cure in advanced disease would be an achievable reality.
With your experience in both clinical research and leadership, how do you believe women in oncology research can influence the direction of emerging therapies in the face of global health challenges?
Cancer ranks in the top three causes of premature mortality among women in almost all countries of the world. Women interact with cancer in complex ways, as healthy individuals participating in cancer prevention and screening activities, as individuals living with and beyond a cancer diagnosis, as caregivers for family members and friends, as patient advocates, as health workers and health-care professionals, and as cancer researchers and policy makers.
Patriarchy dominates cancer care, research, and policy making. Those in positions of power decide which aspects of these areas are prioritised, funded, and studied.
Moving our focus to cancer research and treatment, I was surprised to hear the experiences of senior female oncologists and researchers in the US during a recent global conference. Their experiences of gender inequality and gender biased experiences while working in one of the most advanced nations- the US- were across the board, not related to race, color, or their immigration status. This was an eye-opener for me, as someone from India, where many women accept the inequality as a given. In India, we are now seeing a large percentage of women workforce in the research domain; however, the representation of women continues to decline in leadership positions. There are very few women leaders in this category who reach the boardrooms, where they can exhibit decision-making capacities.
Globally, men are over-represented in the leadership positions of hospitals, treatment centres, policy and research institutes. The same is true for editors-in-chief of cancer research journals and lead authors of cancer research papers.
We need to increase the representation of women in areas of decision-making, power, and thought leadership. There are many Women in the field of oncology as well as research, instilling a sense of self-pride, leadership, and assertive thought in each of these will help. Let each professional woman leader be an ally for two others, and the effect will multiply.
I would suggest the Lancet Commission report, published in December 2023, as a must-read for all women researchers and oncologists.
How have recent shifts in global health priorities, such as increasing cancer prevalence and access to healthcare, impacted the scope and direction of oncology research in India?
We have seen an increasing number of research articles, epidemiological studies, and novel research ideas being published from India in recent years. However, I would love to see this increase manyfold, and am certain that would be the case, as we continue to see the priorities shift towards research and healthcare.
Further, India has witnessed a large number of well-equipped large corporate hospitals, offering standard of care treatment facilities at a fraction of the cost compared to the Western world. Corporations, pharmaceutical companies have recognized the increasing purchasing capacity of the Indian population and the market potential of expensive anti-cancer drugs. The large population of the country, with the rising cancer incidence owing to multiple factors including urbanization, lifestyles, and unhealthy dietary habits, has highlighted India as a ‘market’ for cancer therapeutics.
All of this has collectively brought India to the forefront of conducting quality clinical research, and we are witnessing many multinational and national pharmaceutical companies in the healthcare sector utilizing workforce from India, including bench and clinical research.
As an expert in clinical research and medical management, what innovative strategies do you think are crucial for tackling solid malignancies amidst evolving global oncology trends and treatment models?
Speaking about clinical research - While the traditional human interface of experienced clinicians and medical monitors would continue to be important, the use of AI, ML algorithms for data review, designing and developing new drugs, identifying new druggable targets, genomics, are being increasingly utilised.
On the clinical management front - approaching the treatment of solid tumors in a precision-based manner, advances in surgical techniques, with the discussion shifting to minimal surgical techniques and organ preservation rather than clearance, have added new dimensions to the way we approach the treatment of solid tumors.
The rising treatment cost of cancer necessitates approaches where cost-effectiveness needs to be incorporated in care decisions. I think this is one aspect that we need to do better. We will see AI-supported pathway concordant care models to reduce unwarranted variation in cancer care across the world. Advancements in technology should be directed towards affordability and ease of delivery.
I am hopeful that we will witness a shift in the way we approach cancer treatment, making it more personalized to each patient, more patient-friendly, and hopefully more affordable too.
How have needs for collaborative global research models changed the landscape of oncology trials, particularly in the context of FDA registration and new product development in emerging markets?
Data from all countries, including India, have been historically accepted by the FDA for registration of drugs since the late 1990s. So I do not see FDA acceptance as a challenge.
India has seen major changes in the regulatory approval processes, which continue to evolve, though there is always scope for further improvement, especially towards a pro-industry and innovation approach. We have well-equipped corporate hospitals in India, but there is a need to develop infrastructure, manpower, processes, and strategy to create state-of-the-art government institutions, which cater to the patients, and also to the needs of academic and industry drug development. We have only seen baby steps in the field of early drug development in the clinics in India. There is still a large gap that needs to be filled to be able to conduct phase 1 First in Human (FIH) studies in India for innovative products.
If we were to just look at numbers for India- of oncology hospitals, patients, doctors- it appears to be impressive. However, if we were to compare these numbers with the number of global oncology clinical trials that have been conducted in the country, the reality is evident. We are one of the options, but not the preferred destination for oncology clinical trials.
I see a limited interest among clinicians to be involved in industry trials- mainly due to conflicting priorities, excessive time needed to ensure documentation for administrative and legal tasks, extra time needed for clinical documentation and patient communication, time expectations of the sponsors and CROs, and often with noadditional compensation, especially in the government sector.
At the sponsor’s end, limited published data, (perceived) lack of consistency in regulatory guidelines and processes, quality concerns quoted from a few historic examples, and general inertia- all contribute to a very limited outreach for India and other emerging countries. The geopolitical situation across many nations also impacts decisions around the conduct of trials in these countries.
On the other hand, we are seeing the Indian Pharmaceutical companies having a renewed interest in novel drug development in oncology. Many of these companies are leaders in the generic space and have a vision and appetite for innovation. I am hopeful that this would work as a catalyst towards improving the climate, infrastructure, and processes in India as a destination for drug development. We are seeing innovator start-ups in oncology in India, many of them independently funded. This is an exciting phase, and I am sure we will see drugs developed from these accepted by global regulatory agencies and markets in the near future.
How can more women be empowered to lead cutting-edge oncology research? Which critical skills and support structures are needed to foster this leadership in a global health context?
I am proud that in India, women have been consistently shining as compared to their male counterparts in the field of Science and medicine. Quoting a recent news article in TOI- “Indian women started to outnumber men in admissions to medical colleges and the trend continues to grow stronger by the year: over the last five years, India has produced over 4,500 more female doctors than male ones”. We see a healthy proportion of women entering research and the clinical research industry. However, women need to consistently stay in their careers to be able to climb the ladder to leadership. I have not seen published data on these numbers, but in our daily interactions, we have all seen examples of women opting out of their jobs, or de-prioritizing their jobs and careers along the way. I feel that it is the responsibility of each woman (and male) leader to support these bright women as allies, especially at that vulnerable spot in her career. Organisations need to align towards women-friendly policies too, and we need to have these conversations more often in the boardrooms and at policy decision forums in the industry, political, and academic settings.
