From the 1st to 13th of March 2015, Scientific Malaysian organised an Ask Me Anything (AMA) session on their online discussion platform with Dr. Betty Kim Lee Sim (@bkimleesim), Founder of Protein Potential LLC and Executive Vice President of Process Development and Manufacturing at Sanaria Incorporated. Dr. Sim’s team at Sanaria Incorporated has developed the world’s first attenuated sporozoite malaria vaccine, the PfSPZ Vaccine, which is now in clinical trials in the United States, Europe, and Africa. In particular, the PfSPZ Vaccine has also been shown to be 100% protective in two clinical trials.
Throughout this AMA session, registered members of Scientific Malaysian were given opportunities to post questions directly to Dr. Sim. Here, we summarise the discussion that took place during the session.
Have you always planned to transition from academic research to joining a biotech company, and then to founding your own startup? What were the factors that influenced you to take this path?
Not at all. It was always my interest and intention to be in academia. After my post-doctoral fellowship at Harvard, I was an Assistant Professor at Johns Hopkins in Baltimore, which was about a 45 minutes commute one-way to work each time. After six years and when our youngest was born, and with my husband Steve traveling a lot, the distance and time of getting to work became a consideration. So when I was recruited for the position of Director of Molecular Biology at a new start-up biotech company, I resisted until it became clear that the labs were two minutes away from my home!
As a Malaysian scientist, have you been approached to contribute to, or help the local research community?
I just made it as a visiting Professor at the University of Malaya, my alma mater, in December 2015. During my last visit, I had the opportunity to lecture and meet and interact with the fabulous staff and students at the Faculty of Medicine. I am working on a nice collaboration with them now, linking with other institutions in the US and co-applying for grants with Malaysians in Malaysia. This is great and exciting!
Last year in the United States, pharmaceutical companies inflated the price of medication and vaccines way above the cost of making them. Considering that the PfSPZ vaccine is targeted at developing countries where malaria is most prevalent, what precautionary steps would you be expected to take after it is approved for use?
It is now estimated that it costs more than US$2.6 billion to bring a new drug or vaccine to market in the United States. In order to keep new drugs and vaccines coming, these costs must be recouped. Having said that, Sanaria’s goal is to bring a PfSPZ vaccine to market as soon as possible and to use it to halt transmission of and eliminate malaria through mass vaccine administration campaigns. This will only be possible if the vaccine is available at the lowest possible cost. We have already begun making agreements with African governments to assure this. That also means that the vaccine must be sold at a significant profit in the developed world for travelers to help fund the lowest possible cost in the developing world.
There appears to be little vaccine research and development in Malaysia. How could Malaysia build capacity in terms of research into vaccine research and development? What vaccines or diseases would you suggest to prioritise?
These are critically important questions, but not so easy to address, as this will represent a tremendous shift in perspective and national commitment backed up by investment. Singapore is probably a good model. Here are several suggestions,
(i) the government needs to set up a funding mechanism with significant amount of funds behind it to support this type of research (the Small Business Innovative Research [SBIR] program in the United States is a good example),
(ii) the government needs to work with excellent Malaysian physician scientists to establish a first rate Phase I and then Phase II clinical trials center like he Jenner Institute in Oxford, United Kingdom (we work at such a center in Tanzania),
(iii) the team at this clinical trials center needs to be fully trained in GxP (GMP, etc.) and have the personnel (quality, regulatory, clinical, laboratory) and infrastructure (IT, laboratory, etc.) to run clinical trials at a level acceptable to the entire world, and
(iv) a few diseases such as dengue, which is now devastating in Malaysia, need to be focused on to get the enterprise off the ground. With such a commitment and resource, I think the Malaysian investment community, which has a large international presence in biotech, could be convinced to invest in Malaysian enterprises.
Most clinical trials involving vaccines or drugs are very much based on western population. Studies have shown that several reasons (genetic predisposition, environmental factors, etc.) could contribute to the poor vaccines/drugs efficacy in non-western countries (i.e., developing countries). How can we address this issue to improve human health and to tackle diseases in the non-western countries?
We are quite mindful of these concerns, and in the context of the PfSPZ vaccine, we will soon be reporting on dramatic differences in immunological responses to immunisation with the exact same regimen of PfSPZ Vaccine in non-immune U.S. and semi-immune Malian (West African) subjects. For these reasons, and because of the importance of malaria worldwide, we are testing our PfSPZ vaccines simultaneously in multiple ethnic groups at multiple sites in the U.S., Germany, and six countries in Africa, and are working on getting studies going in Southeast Asia and South America. The answer is to assess products where they will be used.
What do you think is the best way we can shape this pharmaceutical industry to enable less profitable cures and vaccines to be researched and funded?
The only way to shape anything is to move forward to achieve your goals. Crowdfunding is a good way to bring attention to these diseases, and to get some seed money. However, the amount of money required to bring a new drug or vaccine to market (currently estimated to be $2.3 billion) cannot be raised through crowdfunding.
Have you ever felt that your gender played a role in your career progression, especially as you started during an earlier generation when there might have been more barriers for women? In relation to that, how have you coped with juggling a career and a family?
No. I have never felt that my gender inhibited my work or success in anyway. Perhaps it is an attitude. Yes, I did juggle my career and family, but in a happy way. I never distinguished my work from family life. Scientific discussions and discourse were often at the dinner table. My sons met and got to know our collaborators and friends in science and medicine from all over the world. I brought my kids into the lab even when they were young when I had to tend to experiments! Gone are those days when security and lab safety issues were non-existent.
Any words for Malaysians that chose to have a career in scientific research?
Research is a challenging career. But it selects for those who like the wild ride. Be bold and enjoy the ride!
Roti canai or nasi lemak?
Roti canai 🙂
Dr. Betty Kim Lee Sim hails from Kota Bharu, Kelantan. Dr. Sim did her undergraduate (B.Sc., Honors, First Class) and graduate studies (M.Sc., Ph.D.) at the University of Malaya, Kuala Lumpur. After a postdoctoral fellowship in molecular biology at the Harvard School of Public Health, she became a research assistant professor at the Johns Hopkins School of Public Health and worked with the Walter Reed Army Institute of Research in their malaria program.
In 2003, Dr. Sim founded Protein Potential LLC, a company focused on discovering, producing, and developing subunit recombinant vaccines, therapeutics, and diagnostics. Protein Potential’s core capabilities include the capacity to rapidly and efficiently take newly discovered molecules through all steps required to initiate and conduct clinical trials. Protein Potential’s platform technology includes recombineering foreign genes into Ty21a the attenuated Salmonella Typhi typhoid fever.
Dr. Sim is also Executive Vice President of Process Development and Manufacturing at Sanaria Inc., where she built the team and led the manufacturing effort for the PfSPZ Vaccine. Dr. Sim currently lives in Maryland, United States with her husband Dr. Stephen L. Hoffman, the founder, CEO and Chief Scientific Officer of Sanaria. Their three sons are pursuing careers in law, medicine, and science.
This interview has been edited for brevity and clarity. The original version of this interview can be accessed at http://www.scientificmalaysian.com/groups/general-research/forum/topic/ask-me-anything-ama-dr-betty-kim-lee-sim/. To find out more about Dr Sim, visit her Scientific Malaysian profile at http://www.scientificmalaysian.com/members/bkimleesim/
This article first appeared in the Scientific Malaysian Magazine Issue 12. Check out other articles in Issue 12 by downloading the PDF version for free here: Scientific Malaysian Magazine Issue 12 (PDF version)