The Journey of Moutih Rafei: Driving Innovation in Healthcare

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Dr. Moutih Rafei is an accomplished immunologist with a diverse educational background and extensive experience in the healthcare industry. Dr. Rafei holds an Honors Bachelor’s degree in Immunology from McGill University, where his passion for medical research and innovative therapies first took root. This passion led him to pursue a PhD at McGill University, focusing on novel fusion proteins for autoimmune diseases and exploring the potential of mesenchymal stromal cells in cell therapies.

Following his doctoral studies, Dr. Moutih Rafei undertook post-doctoral training at Université de Montréal, delving into T-cell development and cytokine-based therapies. This comprehensive training in translational immunology laid the foundation for his hybrid academic/industrial career, where he has excelled in bridging the gap between cutting-edge research and practical applications in biotech and pharma. In 2019, Dr. Moutih Rafei founded Axiom Services Inc., a consultancy dedicated to providing guidance and support across various stages of drug development, from pre-clinical studies to regulatory submissions and clinical trial design. His leadership in the company has been instrumental in driving forward innovative projects and achieving significant milestones in the healthcare sector.

Educational Background and Preparation for Business Role

Dr. Moutih Rafei is an immunologist by training, having received his Honors Bachelor in Immunology from McGill University in 2004. Dr. Rafei pursued his PhD training at McGill University from 2004 to 2009, where he focused on investigating the use of novel fusion proteins (fusokines) as potential immunotherapy for autoimmune diseases. During this time, he also delved into the application of mesenchymal stromal cells for developing cell therapies targeting catastrophic illnesses. Following his PhD, he completed post-doctoral training from 2009 to 2013 at Université de Montréal, where he studied various aspects of T-cell development and cytokine-based therapies. This diverse training background provided him with extensive experience in translational immunology, motivating him to pursue a hybrid academic/industrial career. In this capacity, he has been involved in multiple translational programs in academia while also assisting industrial clients in developing their own program pipelines across pre-clinical, manufacturing, regulatory, and clinical trial design aspects.

Entry into the Healthcare World and Career Inspiration

Dr. Moutih Rafei was initially fascinated by modern medicine, with his early thoughts on healthcare shaped by movies on pandemics and medical research during his teenage years. While his initial objective was to become a medical doctor, he realized that his calling was in research, seeking a cure rather than providing palliative care. This decision led him to fully dedicate his time to research.

Establishment of Axiom Services Inc. and Unique Offerings

Axiom Services Inc. was established in 2019 to provide guidance for the Biotech and Pharma industry. Since his expertise spans from pre-clinical to clinical work, Dr. Moutih Rafei was able to provide a much larger scope of services without relying on third parties like most consulting groups do. For example, they can help in the design of pre-clinical and GLP studies, support CMC activities or contribute to IND submissions to the FDA, Health Canada or MHRA.

Roles and Responsibilities as CEO and Founder

Dr. Moutih Rafei serves as the main and senior consultant in the company, meeting with clients to identify their needs and develop plans and timelines to achieve their set goals. Additionally, Dr. Rafei can be hired on a contract basis to drive pre-clinical or scientific programs as a senior advisor  Head of Discovery,  VP Research and Development or in specific long-term cases as a Chief Scientific Officer . He also has experience serving as a board member for several companies and regularly interacts with decision-makers, bankers, investors, and venture capitalists for due diligence on technologies before funding decisions are made.

Challenges Faced and Overcoming Them

Dr. Moutih Rafei highlights funding and speed as two main challenges in the scientific and clinical operations field. He notes that funding can be a global issue but emphasizes the feasibility of raising funds even from foreign countries with the right network and introductions. He also discusses the challenge of finding suitable service providers like CROs and cell processing centers, which can lead to delays of 6-18 months depending on the needs. He stresses the importance of being consistent, patient, and prepared for challenges while navigating these complexities.

Major Accomplishments and Milestones

Besides working on various academic translational projects, which ended-up expanding with years, Dr. Moutih Rafei was involved in many industrial projects. One notable achievement was his work on a diagnostic device for infectious diseases. He also collaborated with a digital healthcare company to enhance an AI-based program for logistics in medication management. Additionally, he has worked on cancer immunotherapy, specifically modifying Interleukin-2 to exhibit higher therapeutic potency than the parental molecule, which is currently in Phase I trials. Currently, he is working on several biologics-related projects, including small injectable molecules for solid tumors, cancer vaccines, antibody-drug conjugates (ADCs), and mRNA vaccination, with two Phase I trials starting this year. He has been involved in designing five Phase I trials, three of which have already been initiated.

Evolution of Leadership Style

Dr. Moutih Rafei leadership journey began during his graduate studies, particularly as a PhD student, where he collaborated with numerous academic groups and students. This experience allowed him to share ideas and offer solutions to various challenges. By the midpoint of his PhD, he was already supervising graduate students and providing guidance to research assistants and project managers, many of whom had more experience than him in their roles. This early exposure to leadership roles sparked his realization that he was well-suited for such positions. As he progressed to become a principal investigator (University professor), his leadership skills continued to develop. However, it was his entry into the Biotech industry that truly accelerated his growth as a leader. In various capacities such as board director, senior consultant, Head of Discovery, VP research and development, and ultimately Chief Scientific Officer, he managed and guided multiple scientific groups, honing his leadership abilities significantly.

Prioritization and Time Management

Dr. Moutih Rafei receives a considerable number of requests for consultations, reflecting his expertise and reputation in the industry. However, due to capacity constraints, he cannot take on multiple projects simultaneously, although he envisions expanding his business in the coming years to accommodate more clients. To prioritize competing demands, he closely monitors trends in the pharmaceutical industry. This involves staying updated through extensive reading of reviews and articles, both scientific and business-related. Additionally, he places significant importance on attending the yearly Immuno-Oncology 360 meeting in New York City, where pharmaceutical leaders converge to exchange ideas and define the top 10 fields of interest for the upcoming year.

Building Strong Relationships

Establishing contact with clients was initially a challenging task, requiring strategic thinking and differentiation from competitors. It took Dr. Moutih Rafei three years to secure his first significant contract, primarily relying on a “mouth-to-ear” approach facilitated by networking. Over time, he realized the importance of showcasing his expertise and success in ongoing projects to attract more clients, including competitors who recognized his value in driving business success. He emphasized the significance of marketing efforts, such as press releases, investor meetings, and interactions with key opinion leaders (KOLs), coupled with charisma and a knowledgeable persona. His experience taught him that success in client acquisition is not just about knowledge but also about building strong relationships and leveraging networks effectively.

Problem-Solving and Decision-Making Approach

When addressing the question of problem-solving and decision-making, Dr. Moutih Rafei emphasizes the importance of returning to the fundamental question: what is the initial problem to be resolved? He believes that this approach is not limited to business but is applicable across various fields and daily activities. He advises individuals facing challenges to continuously ask themselves this question, as it leads to clearer and easier problem-solving. Additionally, he stresses the significance of having a broad knowledge base, not just in science but also in understanding the perspectives of businessmen, investors, and scientists. He highlights the need for a balance between scientific innovation, market viability, and efficient manufacturing processes in the biotech industry, which is crucial for achieving set goals and attracting investment.

Opportunities for Growth in Healthcare Industry

Dr. Moutih Rafei observes significant shifts in the healthcare industry, from regenerative medicine to stem cell-based therapies, biologics, and most recently, immunotherapy. He notes the growing interest in advancing immune-oncology therapies, often referred to as “immune-oncology 2.0,” with a focus on specificity and personalized treatments for greater effectiveness. He highlights the potential of cancer vaccination but acknowledges the need for breakthroughs to reinvigorate global attention in this area, drawing parallels to the developments in CAR-T therapy and mRNA vaccination, which was recently catalysed by the COVID-19 pandemic. He expresses optimism about the future of universal off-the-shelf cancer vaccines, mRNA vaccination, CAR-T therapies (especially with new solid tumor targets), and biologics such as monoclonal antibodies, bi- or trispecific engagers, and antibody-drug conjugates, as fields poised for significant growth and innovation.

Upcoming Projects and Initiatives

Dr. Moutih Rafei primary career aspiration revolves around bringing a life-saving therapy to fruition in clinical settings. Among the various projects he’s been engaged in, one stands out as particularly promising: a universal off-the-shelf cancer vaccine adaptable to different cancer types. Recognizing the revolutionary impact of vaccines, exemplified by the recent success of mRNA vaccines against COVID-19, he emphasizes the underappreciated potential of cancer vaccines in the pharmaceutical industry until recent times. Over the past two decades, he has dedicated his efforts to finding alternatives to overcome challenges faced with dendritic-cell-based vaccines. Through rigorous research and identifying gaps in knowledge and manufacturing limitations, he developed a research program centered on reprogrammable stem cells as antigen-presenting cells. His experience has underscored the importance of collaboration with the industry to address manufacturing challenges early in the development process, ensuring a smoother transition from preclinical to clinical stages. Currently, he is deeply involved in advancing a cancer vaccine project to swiftly deliver effective solutions to cancer patients.

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