At the root of humanity are the heroes in research and on the front lines, protecting, saving, and extending lives. A medical leader is someone who plays a critical role in guiding and overseeing the clinical development of new pharmaceutical products. The medical officer ensures patient safety with Principal Investigators and study teams to ensure the highest medical and ethical standards.
Identifying potential risks in early phase drug development, Dr. Gaetano Morelli provides scientific leadership and medical insights to the team at Altasciences—a CRO/CDMO that continues to be at the forefront of drug development, integrating the early phases of research and development under one organization.
Dr. Morelli’s expertise and leadership help his team bring sponsors’ potential new treatments to patients, faster, while upholding high medical and scientific integrity standards.
His expertise has drawn the attention of Insights Care, and thus we interviewed Dr. Morelli, Chief Medical Officer and Medical Monitor, to know more about his overall experience.
Below are the highlights of the interview:
Kindly tell us the source of inspiration. What led you to venture into healthcare?
Medicine is such a great path to so many roads and possibilities. Since I can remember, I’ve been interested in two things: going to space and clinical research. As Captain Kirk from Star Trek states, “Boldly go where no one has gone before.” Going to space didn’t work out for me, but clinical research for over 25 years has and continues to fulfil my dreams and aspirations. My years in drug development have been the most fascinating and engaging for me.
Clinical research is critical to the practice of medicine. With my history in medicinal practice, it made sense for me to join the forefront of development.
To be part of the development of medicines, and then witness, as a clinician, the administration of these life-saving drugs has been exhilarating and rewarding. Being part of the research and development has actually helped me become a better physician to my patients.
Brief us about yourself and shed some light on your journey towards becoming a part of Altasciences.
I have over 30 years of medical-clinical experience and over 25 years of experience in clinical research. Part of this experience has been in private practice, hospital positions, higher education, and clinical research.
I was previously the Director of Global Medical Affairs at MDS Pharma for about 12 years.
My journey with Altasciences began as a GI consultant in 2013 for complex and first-in-human studies, and to develop a program for studies in liver diseases, such as NASH and NAFLD. It didn’t take long to transition to the role of Clinical Principal Investigator in 2017 before becoming Chief Medical Officer in 2020. In parallel, I’m an Associate Professor of Medicine at McGill University, where I’m involved in training medical students, residents, and specialty follows. I am, in fact, still an active staff member at the McGill University Hospital Centre. In addition, I’m the Director of Gastroenterology/GI Endoscopy at one of McGill’s affiliated hospitals.
And here we are today—it’s been a fantastic journey!
Tell us about the variety of services that you are part of at Altasciences.
Altasciences is a full-service, integrated CRO/CDMO for early-phase drug development. What that means is that we provide sponsors with an adaptive, one-stop solution from late discovery to clinical proof of concept, and beyond. They can choose to partner with us for one study, an end-to-end program, or something in between—they have complete flexibility. These services include bioanalytical assay development and validation, preclinical safety evaluation, drug formulation, clinic-ready manufacturing, on-demand clinical pharmacy, clinical testing, as well as research support services such as program management, data management, biostatistics, medical writing, and regulatory guidance. What we do best as a team and one-partner solution is simplify and streamline solutions, to provide an integrated, seamless approach to early drug development that eliminates communication gaps between various development stages and departments. And as such, we’re able to centralize scheduling, finance activities, and overall communication for our clients, which is another huge burden relieved for our clients. We all champion this unique model called Proactive Drug Development. And with this model, we can reduce development timelines by up to 40%.
I am specifically involved with our clinical solutions. We offer biotechs and biopharma companies clinical support with first-in-human through end of Phase II, working with our clients to design the most robust clinical program, and conducting the testing that advances them through the phases with ease. Our clinical research services are available for a wide range of study types, routes of administration, and therapeutic areas. Altasciences is especially renowned for its expertise in CNS-active drugs, ethnobridging, and ophthalmological evaluations.
We have three clinical pharmacology units (one in Montréal, Canada, and two in the U.S.), where we have a combined total of over 500 beds and where we conduct over 285 clinical trials a year.
In what way do you consider technological advances to be a pathway in conducting your operations?
Altasciences is always up to date with the latest software, equipment, and technologies to enable our team to deliver data to our clients as accurately and timely as possible, to help them make the right decisions faster. And when we can’t find a system that meets our needs, we create one! One of the biggest technological advances at Altasciences that has truly made a difference is comprised of two pieces: Ask Albert and a centralized scheduling system. Ask Albert is a proprietary communication tool we built to facilitate efficient, timely information transfer between internal teams at Altasciences, no matter the research phase, location, or department. As a client’s molecule advances from one milestone to the next, their information moves as well, eliminating the need to repeat themselves, which naturally reduces the bottlenecks and the chances of communication errors. Our exclusive centralized scheduling system allows for all Altasciences’ projects—again, regardless of phase or location—to be scheduled using a single software. This gives everyone at Altasciences, and more importantly, our project and program managers, full visibility, enabling them to actively manage client timelines; and when the unexpected happens, find ways to optimize delivery through parallel scheduling. Both Ask Albert and the centralized scheduling system help our teams move in unison, providing a seamless outsourcing experience for our clients, and ensure we can react quickly and effectively in progressing our client’s new drugs.
What endeavours are you currently pursuing to improve service measures at Altasciences?
Altasciences has recently implemented Foundry Health’s ClinSpark eSource Platform to automate our Phase I clinical trials for clinical development. Phase I trials often face challenges relating to study site, data collection, and transcription processes. ClinSpark is designed to automate the complete study process, including recruitment, screening, data collection, and data export. This web-based electronic data capture platform uses real-time electronic data and remote data tracking that will decrease documentation errors. Sponsors have instant access to critical trial information required to monitor the progress of their trial from anywhere. ClinSpark helps simplify trials for the sponsor, regulators, and our study participants.
What are some of the challenges you face when conducting operations and how do you turn them into opportunities for growth?
Conducting a clinical trial from an operations point is similar to conducting an orchestral symphony. There are many parts and players involved: the sponsor, the preclinical teams, the pharmacologists, the clinicians, the regulators, the protocol developers, the quality teams, and so on. These all have to come together and work as a cohesive team, understanding expectations and limitations right from the start. Communication is key here. Everyone has an expertise to bring to the discussions. These exchanges are great learning opportunities for continued growth. Our proprietary communication tool [Ask Albert] is an excellent example of how Altasciences embraces these challenges and turns them into a great opportunity for growth for the company, and, in return, bring incredible value to our clients.
What advice would you like to give to budding physicians and clinical researchers who desire to venture into the sector?
I can probably best explain this through personal experience. During the COVID-19 pandemic, there was a huge shift in drug development. Most pharma and biotech companies pivoted to developing COVID-directed therapies. I was fortunate to be able serve as an Altasciences Principal Investigator on many of these trials. During the pandemic it was all hands-on-deck at hospitals across the country. I spent many days and nights attending hospital wards and ICUs, caring for COVID-infected patients. One cannot imagine the sense of intense gratification when, on numerous occasions, I had the opportunity to administer some of the life-saving medications, to patients with severe acute illness, for which I was part of the development. As a medical practitioner and clinical researcher, seeing all this come together is exhilarating, rewarding and fulfilling. It just doesn’t get any better than that.
How do you envision scaling your services and operations in 2023 and beyond?
Over the last five years, Altasciences has continued to increase capacity and expand our comprehensive service offering through acquisitions and organic growth. Our growth has been based on client feedback; what they wanted and needed from us. From 2020 to 2023, we added five locations: a CDMO facility in Philadelphia, a third clinical unit in Los Angeles, and three more preclinical facilities, which are located in Sacramento, Scranton, and Columbia. We also expanded many of our facilities, some of which is ongoing.
We pride ourselves on offering multiple points of entry with complete flexibility, according to where our clients are in their drug development program. As for the future, we will continue to grow our relationships with clients, partnering with them for more services and even more end-to-end programs. This is where clients can experience the greatest benefits of partnering with a single CRO/CDMO like Altasciences.
2023 has been, and will continue to be, a challenging year for some of our clients, and for many industries. We will help our clients through it, ensuring that we still work closely with them to get better drugs to market. People are depending on us and the therapies we help develop.