This month we turn the medical spotlight on one of our market areas, Clinical Development, and spoke with Senior Medical Director at Akeso Biopharma, Inc. Dr Kwek Kon Yew about this vital area.
Kon Yew is a physician with broad industry experience in drug development, particularly in early Clinical Development. At Akesobio, he manages the global Clinical Development programs of the company’s therapeutic monoclonal antibodies outside China and contributes to the Clinical Development Plan of all Akesobio’s assets. He is also tasked with managing relationships with international Key Opinion Leaders in Oncology.
Prior to joining Akesobio, Kon Yew was the Head of Phase 1 and Drug Development Safety for the Asia Pacific region at IQVIA, where he chaired the IQVIA Asia Pacific medical safety governance committee; and served as a member of the global Medical Safety Review Group. Primarily, he advised sponsors and internal teams on the preparation of protocols and investigator’s brochures (IB) for both oncology and non-oncology early phase clinical studies. He also supported the regional business development and therapeutic strategy teams in their engagements with clients. His other responsibilities at IQVIA included assessing and developing IQVIA’s network of Phase 1 Sites in the Asia Pacific region, reviewing sponsors’ requests for IQVIA to act as their ‘Local Representative’; and medical monitoring of oncology studies.
Kon Yew began his career in the industry as an investigator at a Phase 1 Clinical Research Unit, where he delivered high-quality early phase studies safely and in minimal time. He completed his undergraduate medical training at Oxford Medical School; and read for a doctorate in Molecular Biology on an EP Abraham Research Studentship at Oxford University. He also holds graduate diplomas in Family Medicine and Palliative Medicine from the National University of Singapore; and a Certificate in Human Pharmacology from the Faculty of Pharmaceutical Medicine, Royal Colleges of Physicians (UK).
So let’s start with what Clinical Development actually is?
Clinical Development is a very broad term that covers the whole process of getting a drug or medical device from the lab into humans for the first time and eventually approval by regulatory authorities so that doctors can prescribe the drug or use the device.
From my perspective of developing medicines (not devices) and for the purposes of our discussion, it might be helpful to think about Clinical Development in 3 dimensions. The first is the ‘length’ of the clinical development process, which on average is about 10 years but with innovation these days, it can be remarkably shorter. This includes preclinical testing in the lab, Phase 1 trials where the first human receives the drug, Phase 2 trials and then bigger Phase 3 trials, which are generally needed to support applications for drug approval. The second dimension is the breath of Clinical Development. By that, I mean the different functions that come together to develop a drug. Besides the medics, we need project managers, biostatisticians, data managers, clinical pharmacologists, PK scientists, and the list goes on. Even among the medics, there are different roles too. The third dimension is ‘depth’. There are different layers to Clinical Development in that beyond the biotech or pharmaceutical company (a.k.a. “sponsor”) that owns the drug, we have contract research organisations (CROs) that sponsors engage to run the clinical trials. Also, it is not uncommon for biotechs to engage independent consultants to advise us on a variety of matters.
What do you like about your job in Clinical Development?
There are many things I enjoy about my job, but I will focus on two here – one applies to Clinical Development in general and the other more specific to biotechs.
What gets me out of bed in the early morning (and sometimes stops me from getting into bed late at night) is the intellectual stimulation and sense of purpose in bringing innovative medicines to patients, especially newer treatments for cancer. This involves understanding the science of the drug and disease, the therapeutic landscape and health economics; then using the knowledge to design a plan that would help us to get a new drug candidate from the lab to marketing approval in the shortest possible time with the least risk. And beyond the intellectual fulfilment, it is emotionally rewarding to know that at the end of the process are patients who would benefit. For example, one of our bispecific antibodies just received Fast Track Designation for cervical cancer from the FDA last month; and I’m hopeful that we will finish our registration trial soon and it wouldn’t be long before doctors can start prescribing this drug to patients. I hope that tomorrow we will have more effective and safer therapies than we have today.
The other thing that I like about my job is specific to working for biotechs, which are usually more nimble than bigger organisations. This means we can move very swiftly whenever the need arises. For example, based on the data that the world has been rapidly accumulating on COVID-19, it has become apparent that one of our drug candidates might be effective in reducing the risk of COVID patients developing severe disease. As soon as I raised this with the senior management at Akesobio, they began to evaluate the evidence; and within a week, gave me the go ahead to take this drug into a Phase 1 trial. And just 2 months after I received the initial go ahead, we have a study approved by Ethics and a regulatory authority. We begin dosing at the end of the month. I guess the speed at which things happen in biotechs is something that one either loves or hates. I love it!
What triggers the transition from being a physician to Clinical Development?
I have always been interested in research. That’s why I read for a doctorate in molecular biology but after 3 years decided that an academic life wasn’t my cup of tea. Strangely, it never crossed my mind to join industry. But after 8 years in clinical practice and having done my post-grad exams, I was looking for something new. A job in clinical research with a pharmaceutical MNC was available and I thought ‘let’s see what this is about’. I applied, got the job and never looked back. So, you can say that I fell into Clinical Development serendipitously. And I have been very happy about this ‘fall’!
How do you know if Clinical Development is suitable, why not Medical Affairs?
As I alluded to earlier, I fell into Clinical Development as a pleasant accident. If I had fallen into Medical Affairs instead, you might be asking me ‘why Medical Affairs, why not Clinical Development’. LOL! On a more serious note, I did explore options in Medical Affairs when I was newer to the industry but somehow the opportunities for career progression have always been in Clinical Development for me. So, I guess like everything in my life, it has been ‘man proposes, God disposes’. And I am very thankful for this. To know if Clinical Development is something for you, as a first step it would be helpful to speak with people in Clinical Development to get an idea of what it is like – the good, the bad, and the ugly. But the most reliable way to find out if you will like it is to try it. People tend to get a feel very quickly about whether this is their cup of tea.
How would you go about getting a job in Clinical Development?
Given that there are not many entry-level Clinical Development positions in Singapore with sponsors, I would suggest working overseas, where most of these positions are, for a few years if your personal circumstances allow. Living and working abroad for a period of time can be very fun! Alternatively, CROs do advertise for jobs in Singapore from time to time and these positions would be a great place to start. Some people enjoy working with different sponsors across a wide variety of studies, so they remain with a CRO throughout their career. Others prefer to experience a different aspect of Clinical Development, so they join a biotech or pharmaceutical company from a CRO later. Another way is to take up a Medical Affairs position, which would also give one varying degrees of exposure to Clinical Development, then look out for direct Clinical Development opportunities within the company later. For anyone who is keen to give it a go, try asking a friend who’s already in the industry to refer you for a job opening. Some big companies have internal processes which prioritise referrals from their staff. Also, it is important to work with a recruiter that is experienced and has direct contacts with hiring managers in the industry. A competent recruiter will be able to help open doors for you.
So there you have it, a snapshot of working in Clinical Development. If this is something that interests you or you are looking to progress your career in Clinical Development then get in touch with our team.
All views expressed in this article are solely those of Dr. Kwek Kon Yew in his personal capacity as an expert and in no way reflect the opinions of Akesobio or any affiliations.