Bright SPARK

Many academicians will, no doubt, be able to attest to the fact that years of research can seem to fall by the wayside as pharmaceutical companies refuse to take their novel discoveries for further development into therapeutics, creating barriers to the progression of translational research. It’s well known that out of 10,000 new drugs developed at the bench, only one will often make it to the bedside, but are fixed ideas about what the drug development process should look like preventing this from changing? Aware that the starkly obvious cultural divide between academia and industry can create roadblocks to biomedical innovation, Daria Mochly-Rosen, George D Smith Professor in Translational Medicine, and Professor in Chemical and Systems Biology at Stanford University, set out to create a new initiative to help academics take their inspiring work further. Daria is the founder and co-director of SPARK at Stanford and president of SPARK Global.
 
 
What is the story behind SPARK?
 
I believe we, in academia, have a part to play if we want to serve patients worldwide. In 2006, I founded SPARK as a not-for-profit program at Stanford University to take promising advances in biomedical research and help translate them into new therapeutic options for patients. The campus-based program is based on collaboration between industry experts and academic investigators in the pursuit of novel drugs and diagnostics for all diseases, with a special emphasis on pediatric, maternal and neglected diseases areas. While being of significant clinical relevance, these disease areas are often left untouched in terms of drug development. The regulatory challenges and ethical issues associated with maternal and pediatric pharmaceuticals have perhaps left many in the industry with the feeling that the stakes were too high when it came to the development of new treatments for these areas of unmet clinical need.
 
For us, it is a moral imperative to address these issues. The needs of these patient populations are just as severe as any other patient group and they cause a significant burden for healthcare organizations worldwide. In 2017, it was estimated that over one billion people worldwide were affected by a neglected disease – one-sixth of the world’s population!
 
By focusing on filling in the white spaces around these therapeutic areas, SPARK gained the attention of the Lucile Packard Children’s Hospital at Stanford University’s School of Medicine. They recognized the importance of what we were trying to achieve through the program and offered us funding. While the program is primarily funded by the university’s medical school, the fund it receives from other philanthropic organizations and the National Institutes of Health have helped the program grow into what it is today – a research center with a success rate of over 50 percent when bringing potential therapies to the clinical trial or to a licensing stage. In comparison, the industry’s success rate is 10 percent for projects at the same stage of development. A major aspect of SPARK’s ethos is to operate effectively without commercial incentives, as funding derived from these types of channels would create a conflict of interest for the dozens of industry volunteers in the program.
 

How has your previous experience influenced the development and evolution of SPARK?

Four years before the commensal of SPARK, I set up KAI Pharmaceuticals with my student, Leon Chen. KAI was a biotech venture focused on the development of novel therapeutics for cardiovascular diseases. The experience overhauled my perception of pharma and I gained a new appreciation for the complicated and intellectually stimulating work carried out by an industry, which I must confess I had previously viewed with a certain sense of scepticism! With SPARK, I wanted to provide other academic inventors the opportunity to learn from industry experts and push forward early ideas to benefit patients, in the same way I had at KAI.
 
Our aim is to provide our SPARK Scholar project teams (academicians whose projects we support) with enough exposure and insight from experienced pharma experts to help enhance their chances of success. Open to professors, clinicians, postdoctoral scholars, and graduate students, SPARK also offers graduate level courses on drug development, helping academics with a blue-sky approach to research to understand the highly regimented and regulated aspects of the commercial pharma industry.
  
How can established pharma experts also contribute to SPARK?
 
We have experts from the pharmaceutical industry who volunteer their time to the program, by sharing their stories of success and failure with our SPARK Scholars. While they have no rights to the inventions developed through the program, their mentorship is crucial in helping move ideas from the bench to solutions at the bedside. SPARK hosts meetings, on a weekly basis, where the process of drug development and commercialization is taught to our SPARK scholars, and every fortnight, our project teams receive feedback on their work from advisory panels whose expertise lie in pharmaceutical drug development. Fostering these types of healthy working relationships, where ideas are shared between academics and many industry experts without the concerns or focus on financial return, defines SPARK and helps move translational research in a positive direction.

How does SPARK work with scholars?
 
Championing talent whose work goes unnoticed is integral to SPARK’s DNA. Each year, SPARK selects between 10 and 15 Scholars who are mentored under the program for two years. The selection is carried out by a committee consisting of SPARK’s team, pharma industry experts, and Stanford faculty members. The proposed projects are assessed on their ability to:
 
●      Address an unmet clinical need
●      Utilize a novel approach
●      Be moved to clinic or be commercialized within a two year time frame
 
Scholars who join the program can only be described as powerhouses. So far, SPARK has launched over 30 companies, licensed 48 technologies, and led to 25 clinical studies – a great feat for both our Scholars and the patients who will ultimately benefit from their work.
  
One of SPARK’s Scholars, Teresa Purzner, conducted research on medulloblastoma – the most common form of pediatric brain tumor. She has developed a potential therapy for the condition. Traditional treatment options for this form of tumor involve surgery, whole brain radiation and/or chemotherapy. This can result in intellectual and social impairment and deterioration of quality of life. Doing major basic research, Purzner identified that drugs which block CK2 – a protein kinase – may benefit children with this malignant cancer. One of these inhibitory drugs (and others from other project teams) are currently under clinical trial, but highlight the potential of SPARK Scholars for transforming the clinical landscape and disrupting the conventions that having seemingly been set in stone by industry players.
 
What have been some of SPARK’s biggest success stories?
 
2015 marked the official launch of SPARK Global. As universities across the globe began to replicate the SPARK model within their own institutions, the need to properly organize became apparent. Currently, over 50 different institutions on all continents are involved in SPARK, forging partnerships to improve upon the number of therapeutics available for unmet clinical needs.
 
As just one example of how SPARK Global facilities connections in different countries, consider the Zika crisis, which drew public attention in 2016, and remains a major threat for children born to mothers bitten by the insect that carries this virus. The profound effects of this viral infection on the fetus results in microcephaly (small heads) and many other severe developmental issues. In an effort to help, researchers at SPARK Stanford are collaborating with SPARK Brazil and Brazilian scientists to develop a novel vaccine to combat the disease.

How do you think the work from SPARK could shift the drug development landscape?

Our aim is to encourage unconventional solutions to drug development. As academicians, out of the box risk-taking is what drives our progress and underpins our successes. Here at SPARK, we are developing creative approaches that are improving upon the current efficiency of the drug design process. Our academic and non-for-profit status facilitate us to enter meaningful conversations with organizations like the FDA about transforming the drug development landscape. We also aim to work with regulatory affairs bodies in Europe and Asia. We hope that these activities will allow regulators to hear alternative modes as to how novel therapeutics can be brought to patients faster.
 
My colleagues and I want our impact to be far-reaching – beyond the scope of academic publications. I believe that it is part of our social responsibility as scientists. We, as academicians, have the capacity to make a difference to patient lives and to complement other work that is strongly tied to the conventions of the pharma industry. We are two sides of the same coin and only by investing time in having serious conversations about the future of drug development and working together can we fulfill our mutual goal – to help patients.