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VOICES OF VERTEX

From Drug Discovery to the Clinic

Each day, Vertex researchers push the boundaries of science to develop innovative molecules and compounds that form the building blocks of new cystic fibrosis (CF) medicines. But in order to reach the next stage of the drug discovery and development process, the baton is passed to the clinical team. Our Global Medicines Development & Affairs (GMDA) group – comprised of physicians, clinical trial coordinators, project managers, and regulatory specialists – works synchronically to determine how compounds discovered in the lab will translate to a clinical setting. Fueled by the needs of patients, families, doctors, and nurses, our CF “Translators” share their thoughts and stories about what motivates them to take part in the relentless pursuit of fighting for a cure.

THE EXPLORER

Mario Saltarelli, M.D., Ph.D.

A neurologist by training, Dr. Saltarelli heads up the Early Development and Neurology Group, an area that addresses the early clinical stage of the drug development cycle, as well as development of all of our potential neurological medicines.

Senior Vice President, Early Development and Neurology
Mario Best

AH-HA! Moment

As soon as you walk in the door, you feel why Vertex is a special place. We have not only the resources, but also a strategy to tackle high unmet medical needs and to develop novel therapeutics that address them. Everything we do is dedicated toward patients and bringing them new medicines as quickly as possible.

“You can think of early development as the experimental phase. We’re not in the lab with test tubes, but we conduct experiments and test hypotheses as if we were scientists in a lab. Having strong pre-clinical models allows us – at a very early stage – to predict how the medicine will perform in a patient. It’s much less of a shot in the dark.”

THE PROTOCOL MASTER

Charlotte McKee, M.D.

Dr. McKee, a former lung transplant pulmonologist, leads a team of physicians who are experts in clinical study protocols.

Vice President, CF and General Medicines
Charlotte McKee

Motivation

My experience as a former lung transplant pulmonologist has inspired me to work toward creating a world where no cystic fibrosis (CF) patient will ever need another transplant. Before switching to industry, I never thought I’d be doing something like this – it’s more meaningful than I could have ever imagined.

“I lead a specialized team of experienced and motivated physicians who are the experts in designing, monitoring and progressing the clinical studies supporting approval of our medicines. I feel lucky to lead such an enthusiastic “band of zealots” who work relentlessly to drive innovation throughout our drug development engine.”

THE COACH

Reshma Kewalramani, M.D.

Dr. Kewalramani is responsible for the Late Development group, where she leads the Cystic Fibrosis and General Medicine Clinical Development therapeutic areas, Clinical Development Execution, Medical Writing and Medical Affairs.

Senior Vice President, Clinical Development and Medical Affairs
Reshma K

AH-HA! Moment

Vertex captured my heart and imagination when I saw the opportunity to help create medicines that could potentially have a huge impact on people’s lives. I was especially impressed with our model of working in serious diseases where we have an excellent understanding of the underlying biology, because it gives us a higher chance of success when making the leap from the lab bench to a patient.

“Drug discovery is like a relay race – a race against time. Even before the Research team is ready to pass the baton to the clinical team, we are doing everything we can to clear the road ahead and remove obstacles so the transition is as fast and seamless as possible. For example, we include a small cohort of cystic fibrosis patients in our first-in-human studies to ensure what we see in healthy volunteers is recapitulated in patients. Throughout the race, we have strategically-placed “runners” – our subject-matter experts - where their skills and expertise can have the most impact.”

THE ADVOCATE

Robert Reyes

Robert has been leading clinical research programs for more than 25 years.

Senior Director, Clinical Development Support & Site Advocacy
Robert Reyes

Motivation

Every group I’ve worked with in my 25+ years in this industry has been passionate about helping patients. But that passion is over the top at Vertex – it’s not just talk. On top of their day job, people here not only donate hundreds of personal hours volunteering, some even donate their weddings gifts to the cystic fibrosis (CF) community. I’ve never seen anything as strong as the passion of people at Vertex.

“I had the privilege of building Vertex’s Regional Site Advocate function, which is a new yet increasingly critical component to ensure our clinical trials operate smoothly. This team is spread across the globe to provide front-line support to trial sites and share insights with our team. They also help us understand the perspective of our sites and patients enrolled in our trials – something that is so important to consider when designing and managing our studies.”