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Medical Writing in Early Phase Studies
Is specialized knowledge needed for Medical Writers working on early phase studies? Based on the characteristics and needs of Phase 1, 1a, 1b, BA-BE...
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Gary Keeler : Jun 18, 2025 9:29:05 AM
Some ventures launch on clever tech alone. Most of those fade. The ones that stick seem to orbit three ideas that came up again and again when Dr Duane Pinto and Lisa Boyle spoke about their own path from cath lab to boardroom. Let’s walk through them.
Severe aortic regurgitation sits in that awkward space: too risky for the knife, too slippery for standard TAVR valves. Patients get pills and a shrug. That gap gnawed at founders who later developed the JenaValve Trilogy System. This device holds soft, non-calcified tissue, giving doctors a shot where they had none.
The pattern repeats everywhere. If pain is clear, buyers line up. If the pain is fuzzy, the pitch deck might win applause but not orders. So before CAD files or code, poke the wound. Make sure it hurts.
Picture Dr. Pinto on the Georgetown sidewalk, arriving as early as possible to make sure he was there before the dean, that’s persistence. Later he set up a three-person mentor circle: one for statistics, one for clinical sharpness, one for sanity checks.
A startup needs similar balance. An engineer who questions assumptions, a clinician who keeps things real, and a finance lead who guards the cash. Healthy debate is good. Silence is trouble. Rowing crews splash around before they hit their stride. Young companies do the same.
Curiosity nudged Dr. Pinto back to school for biostatistics because he was done summarizing other people’s trials. He wanted to design his own. Companies that survive take the same route. JenaValve pushed through formal studies and regulatory paperwork. It was slow and expensive, yet it bought them trust with regulators, payers, and surgeons.
Data may feel slow, but it closes deals faster than hype.
A sharp problem, a messy-honest team, and data the world can trust. Miss one leg and the stool tips. Catch all three, and even a small outfit can bend a treatment curve.
So if you’re sketching your own device on a bar napkin, pause. Name the hurt. Gather the right rowers. Then plan the study, however long it takes. Everything else is noise.
Ready to take the next step and push your goals forward? ↓
2 min read
Is specialized knowledge needed for Medical Writers working on early phase studies? Based on the characteristics and needs of Phase 1, 1a, 1b, BA-BE...
2 min read
In this installment of our “Meet the Team” blog series, we talk to Soma Sekhar Koramatla, Associate Manager, Statistical Programming, Biometrics...
In this installment of our “Meet the Team” blog series, we talk to Sakthivel Sivam, Senior Director, Biostatistics, about his industry experience,...