Amidst the sea of Big Pharma executives jumping ship to start highly regarded and attention-grabbing biotech companies, bolstered by the huge influx of capital, the opening of stock exchanges in first Hong Kong and subsequently Shanghai to pre-profit biotech companies that meet certain criteria, as well as the reformation and harmonization of China’s regulatory processes, global industry veteran Dr Lingshi Tan has decided to take the road less travelled by establishing a CRO, dMed. dMed was established in 2016 after Tan’s retirement from Pfizer, where he spent nearly 20 years in various positions, including head of global biometrics for multiple regions, vice-president of Worldwide Development Operations, and chairman and GM of Pfizer China R&D Co. (CRDC).
When people talk about R&D, it conjures up the common image of drug breakthroughs miraculously emerging from laboratories. However, so much of the heavy lifting comes after that, during the clinical phase
Lingshi Tan, dMed
He recounts, “My passion has always been innovative drug development. Nothing can replace the satisfaction of launching a new innovative drug! Therefore, I debated the options for quite a while following my retirement from Pfizer.” But upon reflection, he realized that “people like me, who have spent many years in the field, know well how difficult it is to develop a novel drug or therapy. Chinese biopharma innovators have launched journeys that typically last more than a decade and cost billions. I was excited about this turning point but also concerned about the challenges Chinese biotech firms face. When people talk about R&D, it conjures up the common image of drug breakthroughs miraculously emerging from laboratories. However, so much of the heavy lifting comes after that, during the clinical phase.”
When China joined the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) in June 2017, it heralded new opportunities for China to play a bigger role in global clinical research as well as accelerate domestic regulatory approval of global innovations into the Chinese market. Nevertheless, Tan assesses the current clinical research landscape in China frankly. “Chinese medical practice, the local standard of care and the entire Chinese clinical ecosystem are fundamentally different from the American or European systems. Clinical development involves an additional dimension of complexity that goes beyond science. Much of the ‘value’ of clinical development expertise comes from systems, processes and infrastructure. It is the well-orchestrated collaboration – of doctors, patients, regulators, clinical centers, CROs and even payors – that determines the quality of clinical development.”
This is why he emphasizes, “to succeed, emerging Chinese biotech companies must have access to world-class clinical development core competencies in the form of experts with extensive clinical development experience who can work as an integrated team. It is very difficult for an early stage biotech company to build a complete clinical team of its own.”
A responsible CRO in China must be able to execute critical tasks but also be capable of performing ‘brain functions’ that, in mature markets, normally reside in the sponsors
Lingshi Tan, dMed
With the mission to support local biotech companies to take their innovations into the clinic, dMed takes it as a point of pride that they are ‘more than just a CRO’. Tan sheds light on the situation: “A responsible CRO in China must be able to execute critical tasks but also be capable of performing ‘brain functions’ that, in mature markets, normally reside in the sponsors. Given the early stage of development of the Chinese biotech industry and clinical development in particular, we do not simply ‘do studies’. We help emerging companies establish the framework for a new function; we help facilitate communication between the US licensor and the China licensee to instil confidence in the US partner that critical areas such as safety and pharmacovigilance (PV) are being managed to global standards. We second our people to head key functions within client firms until they have their own leadership in place” – all until the client has fully developed these capabilities in-house! He points out, “This is a very unique value proposition and is only possible because of the trust our clients have in us.”
Having grown rapidly in the past two years, Tan is now focused on growing for the future. He strategizes, “My top priority this year is to formalize the management of dMed. We need to ensure the platform we create this year will sustain our growth. We have made the development of our relationships with Western biotechs a priority for 2019 and are developing novel ways to help bring them to China.”
