A drug’s success isn’t determined solely by its efficacy: exceptional commercialization also plays a critical role. At a recent BIOLINK fireside chat, Mark Soued, Senior Vice President and Head of U.S. at Alnylam Pharmaceuticals, shared some crucial insights. Mark was instrumental in the 2025 launch of Amvuttra, a therapy for ATTR cardiomyopathy, which exceeded revenue expectations. 

Moderating the discussion was Ramsey Homsany, Co-Founder and President of Octant, a biotech tackling protein misfolding diseases. Ramsey brought a founder’s lens to the conversation, asking the hard questions that early-stage companies face as they grapple with how early business decisions can influence access, pricing, and launch success.

Adding to the conversation was Hassan Jaroudi, Senior Vice President & Head of International at BridgeBio which has a competing ATTR cardiomyopathy drug that was approved at the end of 2024. 

The Three Pillars of Launch Success

Mark identified three criteria for a successful launch:

Physician Education and Share: Entering a market where Pfizer had dominated and BridgeBio was gaining ground required demonstrating unique value to cardiologists, in this case. Mark invested heavily in educating physicians about Amvuttra’s new mechanism of action as an “RNA silencer,” and positioning it as the optimized choice for newly diagnosed patients.

Payer Access: Great clinical data means little if payers won’t cover the drug. Mark emphasized securing first-line access with payers, in order to prevent physicians from encountering formulary barriers when prescribing a new therapy.

Health System Access: Because Amvuttra is administered as an injection, it moves through a different benefit path than an oral treatment. It requires physicians or health care systems to purchase inventory and bill back to insurers, a financial risk that Alnylam needed to solve. 

Baking the Cake Takes Years, Not Months

Ramsey asked Mark how far in advance of a launch everything needs to be in place. Mark’s answer was unambiguous: you cannot win a drug launch in the last few months before FDA approval. The foundation must be laid two to three years in advance.

Mark emphasized that designing a Phase 3 clinical trial with endpoints that appeal to both physicians and payers is 80% of the cake, and once baked, hard to undo. Preparing stakeholders to understand a new mechanism of action takes time. Payer conversations should begin in a compliant manner two to three years before approval, by sharing data and discussing the “value story” and pricing strategy.

Nine to 12 months before launch, companies should start hiring and training the field organization to ensure they’re ready once they receive FDA approval.

Commercial Should Have a Seat at the Table

At younger science-driven biotechs, commercial can unfortunately be an afterthought. However, to earn trust, business folks should also do their homework to understand the science. “Celebrate the win commercial got, but it’s only the very last point in this long chain of events that started in the lab and ultimately ended up in a patient’s hands,” said Mark.

Practical Advice for Early-Stage Companies

• Find seasoned professionals or consultants, such as ClearView Healthcare Partners or LEK, that have repeat experience commercializing a therapy to a target audience of specialists and payers. 
• Think globally from the start, especially when the patient pool can be bigger than in the U.S. “Payers in Europe have a clear process on what your endpoints need to be to accept and reimburse your product,” said Hassan.

The Bottom Line

Launching a drug demands that R&D, clinical, regulatory, and commercial teams work in concert years before.