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Could you trace your career trajectory and share your current role and responsibilities?
I have a wide experience of over 22 years in the healthcare industry. I was initially in an emergency medicine position by training and started my first role in the industry with Schwarz pharmaceutical. Soon after, Allergan recruited me to drive their European R&D for a Botox product.
After two years with Allergan, I worked for Pfizer on their respiratory infectious diseases, oncology, and rheumatology portfolio, with hundreds of drugs, many of which were tail products. I also got to work on exciting medicines like Sutent, Spiriva, and Celebrex during the whole Vioxx withdrawal, which was a fascinating experience to defend one product and withdraw another product from the market.
Moving back to the UK for new opportunities, I joined Takeda and was promoted to vice president and the head of R&D for Asia Pacific. I am currently with Amicus Therapeutics. After the FDA approved the launch of Galafold for a rare genetic disease in most of Asia Pacific, I was responsible for managing their medical affairs. I oversee distributor firms to ensure they make patient-centric decisions and adhere to best medical practices.
How do you bring the patient-centric approach to health organizations?
I graduated with a diploma in health economics from Deakin University in Australia and worked in a variety of different therapeutic areas. I've learned that for value-based development, one must ingrain patient centricity in our behavior, and it must be made central to decision-making. It is fascinating to get a different perspective when you measure how patient-centric you've been by the type of data you have while completing the regulatory submission and reimbursement activities.
People with a medical background have a critical role in ensuring better health and healing of patients. We must keep this in mind from the beginning until the end of clinical development. Repurposing the same medicine in multiple forms and expecting people to pay a premium is not adding new value. For instance, at Amicus, one of our medicines is an oral alternative to long-hour infusion treatments. Consuming a tablet is more convenient and less time-consuming for patients and medical professionals, and we need to focus on the interface between medical professionals and the clinical environment. It will quantify the value of spending millions of dollars on a development program and represent value for patients, insurance companies, and other stakeholders in healthcare systems.
What are the challenges in charting value-based development?
It becomes a struggle to overcome regulatory hurdles and get a license in most countries if you can't justify to a health technology assessment group that your product represents an additional value over the existing standard care in a smarter and more data-driven world than before. In terms of challenges, we have governments, investors, and healthcare stakeholders rightly demanding to see value-based development. It has to be core to our thinking on how to demonstrate value and analyze that internally before spending millions of dollars on a phase three trial.
A significant amount of time, money, and brain power is spent managing cardiovascular and cerebrovascular risk, particularly in countries with functioning healthcare systems, and the reduced death rates are a tremendous success story. But diseases like Malaria took around 30 years of research to find the approved vaccine. Despite enormous research for complex psychological and neurological diseases being carried out, medical scientists are still unsuccessful at finding treatments for Alzheimer's. About 8 percent of humans have a rare genetic condition for which there were no treatments up until recently, and the challenge is that fewer patients and higher costs per patient make it difficult to show value.
Could you highlight the leading trends that you see within the marketplace?
The last 70–80 years have seen the development of several medical treatments, technologies, devices, tests, and prosthetics. Now medical research focuses heavily on rare genetic diseases and oncology, but I believe the most challenging medical problems involve the human brain or neurology because we don't fully understand the complexities of the human brain. This challenge will require more innovative solutions, as there is a higher failure rate with medical tests and clinical development processes, which will cost the industry money.
We require a more systematic method for determining which programs will succeed as a high percentage of even the largest pharmaceutical companies fail, and unpredictable things can happen during experimental drug trials. This makes the global steering committee to be critical of the programs due to law cases or issues with side effects, which might hinder the health of millions. To minimize failure rates, an accurate method for predicting scientific tests or trials is needed to develop and critically analyze the process, even if it takes place in the same manner as 50 years ago.
Could you discuss the kind of leadership strategy that you utilize to guide your team for successful projects and implementations?
There is great learning about leadership from Ancient Greeks: to know oneself. Knowing your strengths and weaknesses is the bedrock of how you build your leadership style. For example, some people tend to lead through their ability to speak to groups of people and convince them through their charismatic personalities. Also, recognizing if this isn't one of your strengths is the first step to finding a different way of leading. My strengths are my scientific temperament and interpersonal skills. Between these two, I can choose to engage in cold, irrational discussions with someone who values that or engage in a more people-based conversation with another who values that.
Leadership is to align people behind a common united purpose, and in organizations, different people will come from various countries. And there are significant cultural differences even between countries as similar as the UK and Australia, so leaders have to lead accordingly. For instance, our communication will be different if I am with a team of biostatisticians or a group of HR professionals. In medicine and clinical trials, we encounter people from various industries with different roles, such as HR, legal, finance, scientists, governments, and health technology assessment groups. A leader in that position must engage differently with everyone to work toward the same goal of improving human health, which includes all of us.
Where do you envision the industry in the coming years, and what advice would you give regarding future disruptions?
Disruptions are hard to predict, but some patterns could hint toward future disruptions. Therapeutic vaccines and gene therapy are two of the potential disruptions, but with the advent of CRISPR's gene editing technology, there's a real potential to have durable cures that will completely replace routine medicines.
People with a medical background have a critical role in ensuring better health and healing of patients. We must keep this in mind from the beginning until the end of clinical development
Clinical business models and health development programs will disrupt if we have, for example, therapeutic vaccines for hypertension for people taking an antihypertensive pill for an entire lifetime. That brings up the question of how payers are going to pay for that.
Cost-effective models and structures will have to be devised and implemented with governments and insurance companies so that patients can afford gene therapy and therapeutic vaccines and move to models that can cure rather than treat.
The interesting thing is we have to interface with government regulations, tech device companies, or digital content creators, which didn't exist before. For instance, when Apple decides that it is aiming to become a healthcare company or online bloggers are creating medical content, we have to ensure that the treatments or tests that we develop work with those innovations rather than counter them.
Another disruption here would be waiting for prospective results of the vaccines because there is no long-term evidence that the clinical trials will last a lifetime. The potential solution could be a payer-for-performance model where you subscribe to treatment and the payer keeps paying until the medicine stops working or after a stipulated number of years agreed by both stakeholders, which is not something that any company is doing. It is not going to be disruptive even if a host of successful therapeutic vaccines or gene therapies remove the need for chronic therapies but come at a hefty price. The clinical trial models in use and the health technology appraisal techniques that we use to justify value need to change and that could be potentially be a huge disruption.