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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 COACH

Reshma Kewalramani, M.D.

Dr. Kewalramani oversees clinical medical affairs, drug safety and other related functions and is responsible for developing, advising and driving execution of Vertex’s clinical development programs.

Executive Vice President, Global Medicines Development and Medical Affairs, and Chief Medical Officer
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.”

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 MARATHONER

Mary-Lynn Fulton

Mary-Lynn leads the Clinical Trial Management department, which is responsible for coordinating our clinical trials from start to finish.

Senior Director, Study Management
Mary Lynn Fulton

Motivation

A clinical trial is a marathon, not a sprint. Patients can be on treatment for more than six months during Phase 3, but the trial itself lasts much longer. During these longer-term trials, our teams often get the opportunity to see interim results and when they see that the potential medicines are actually working and helping patients, it’s really motivating.

“We’re all really fortunate to be here at this key point in Vertex’s journey.  The work we’re doing in cystic fibrosis (CF) is groundbreaking. We're working to change the course of the disease.”