The “Therapeutics Discovery: From Bench To First In-Human Trials” conference, held at the King Abdullah International Medical Research Center (KAIMRC), Ministry of National Guard Health Affairs (MNGHA), Kingdom of Saudi Arabia (KSA) from October 10–12, 2017, provided a unique opportunity for experts from around the world to discuss advances in drug discovery and development, focusing on phase-I clinical trials. It was the first event of its kind to be hosted at the new research center, which was constructed to boost drug discovery and development in the KSA in collaboration institutions such as the Academic Drug Discovery Consortium in the United States of America (USA), Structural Genomics Consortium of the University of Oxford in the United Kingdom (UK), and Institute of Materia Medica of the Chinese Academy of Medical Sciences in China. The program was divided into two parts. A pre-symposium day took place on October 10, during which courses were conducted on clinical trials, preclinical drug discovery, molecular biology, and nanofiber research. The attendees had the opportunity for one-to-one meetings with international experts to exchange information and foster collaborations. In the second part of the conference, which took place on October 11/12, the clinical trials pipeline, design and recruitment of volunteers, and economic impact of clinical trials were discussed. The Saudi Food and Drug Administration presented the regulations governing clinical trials in the KSA. The process of preclinical drug discovery from small molecules, cellular and immunologic therapies, and approaches to identifying new targets were also presented. The recommendation of the conference was that researchers in the KSA must invest more fund, talents and infrastructure to lead the region in phase-I clinical trials and preclinical drug discovery. Diseases affecting the local population, such as Middle East Respiratory Syndrome and resistant bacterial infections, represent the best starting point.
On behalf of the King Abdullah International Medical Research Center (KAIMRC) and Ministry of National Guard Health Affairs (MNGHA), Dr. Bandar Alknawy, Chief Executive Officer of the MNGHA, and Dr. Ahmed Alaskar, Executive Director of KAIMRC, welcomed the speakers, presenters, and attendees to the conference. Dr. Alknawy and Dr. Alaskar stated that this event is in alignment with Saudi Arabia Vision 2030, the plan to reduce dependency on oil, diversify the economy, and develop public service sectors such as health, education, infrastructure, recreation, and tourism in the Kingdom of Saudi Arabia (KSA). Accordingly, KAIMRC is leading a transformation in biomedical research in the KSA to convert basic research into tangible products that impact health and economy. Dr. Alknawy and Dr. Alaskar then stated the aims of the conference: to showcase the research discoveries of KAIMRC and MNGHA with the intention of creating a platform and opportunity for exchange and collaboration between local and international researchers on therapeutics discovery and phase-I clinical trials.
The opening ceremony was followed by a short presentation of the different sessions making up the scientific program of this 2-day event by the Conference Chairman, Dr. Mohamed Boudjelal.
On the first day of the conference, the presentations focused on the settings, regulation, and ethical aspects of phase-I clinical trials. In addition, several international and KAIMRC clinical trials programs were presented, followed by round table discussions to provide expert recommendations.
On the second day of the conference, preclinical drug discovery process for small molecules and cellular and immunologic therapies were discussed. The speakers gave an overview of the current most promising drug targets and latest validation approaches under consideration. In addition, several KAIMRC projects were showcased during the sessions
- Over the years, the goals of phase-I clinical trials have moved away from classical objectives by merging phase-I and -II trials, creating larger phase-I trials and basket trials. The success of these trials is largely dependent on both preclinical development and clinical trial design.
- Phase-I clinical trials should not only be designed to test toxicity or dose adjustment, but must also consider the therapeutic benefit to the patient. The investigators should rise above personal conflicts of interest related to securing funding, academic publicity, and career growth, and adopt a “patient’s physician first and scientist second” approach.
- Apart from solid scientific experience and infrastructure, trust, discovery, and decision-making are key to the successful establishment of phase-I clinical trials. It is essential that society should be convinced about the beneficial contribution of these trials to society and medical anthropology.
- During clinical trials, investigators need to choose between “idealism”, which demands following the best possible ethical practices, and “utilitarianism”, which requires the maximum utility of clinical trials.
- As a result of overlapping studies, competition between companies leads to a very expensive drug discovery program. This may be controlled by the coordination of these companies.
- A shift from a one-size-fits-all approach to a personalized medicine strategy has increased the focus of drug development programs on small molecular inhibitors.
- To enhance collaboration between academia and industry, it is essential to have an “Early Drug Development Unit” that will strengthen the program and resources investment.
- Precision medicine requires characterization of genomic and immune changes to tailor therapies to achieve the best response and highest safety for the patient.
- Strategies to develop biologic modifiers, involving advanced technologies such as quantum optics, methylation of DNA with next generation sequencing, and bioinformatics with supercomputers, may be useful to characterize dynamic diseases such as breast cancer.
- A good understanding of a disease, in combination with the use of suitable techniques that include phenotypic assays and a proper drug delivery system, is key to a successful drug discovery program.