APRIL 2023LIFE SCIENCES REVIEW 19CXO INSIGHTSBy Simon McErlane, Medical Director Asia Pacific, Amicus TherapeuticsCould 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 70­80 years have seen the development of several medical treatments, technologies, devices, tests, and prosthetics. Now medical research focuses heavily THE PATHWAY TO PEOPLE-CENTRIC HEALTHCARE Simon McErlane
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