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Forge's Piteri-Molina: AI's gene therapy value is manufacturing data

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Forge's Piteri-Molina: AI's gene therapy value is manufacturing data

3 Key Points

  1. What happened

    Forge Biologics VP Samantha Piteri-Molina told BioSpace that gene therapy manufacturing generates so much data that better collecting, analyzing and interpreting it with AI is a near-term, high-value opportunity, while calling general chatbots overhyped.

  2. Why it matters

    Faster, more sophisticated quality checks on the vectors used to deliver gene therapies could ease a manufacturing bottleneck as more programs advance through clinical trials, she said.

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Context & Analysis

Forge's position changed materially with the $620 million acquisition by Ajinomoto in late 2023, which Piteri-Molina credits with accelerating its commercial manufacturing ambitions. The headcount figures she cites—more than 425 employees now versus 327 as of July 2023—illustrate that build-out, and she says retention has stayed above 92%.

The broader backdrop she describes is a cell and gene therapy field that added three new blockbuster products last year: Bristol Myers Squibb's Breyanzi, Johnson & Johnson and Legend Biotech's Carvykti, and Sarepta Therapeutics' Elevidys. That brought the total number of blockbuster drugs in the space to five, per the Alliance of Regenerative Medicine. Piteri-Molina says she is seeing more programs advance through the clinical pathway than ever before, which is the context for her argument that manufacturing efficiency is the next constraint to address.

Her caution cuts in two directions. She draws a distinction between AI tools that tackle technical challenges and the proliferation of general bots, questioning whether the latter are the best use of resources in this space. She also warns against letting the case for domestic manufacturing narrow the industry's view, noting that rare disease patient populations are distributed globally rather than concentrated in any one country.

FAQ
What does Piteri-Molina think AI should be used for in gene therapy?
She points to collecting, analyzing and interpreting the large amounts of data gene therapy manufacturing already produces, and to faster, more sophisticated quality checks on the vectors used to deliver therapies.
How has Forge changed since Ajinomoto acquired it?
Forge was acquired by Ajinomoto for $620 million in late 2023 and now operates as its subsidiary. It has grown to more than 425 employees, up from 327 as of July 2023, with a retention rate above 92%.
Why does Forge's Ohio location matter?
Piteri-Molina said Columbus research spun out companies that contributed to four FDA-approved gene therapies, attracting specialized talent. She also cited a one-day drive to most major U.S. cities for temperature-controlled shipments.
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