The BioSpace 40 Under 40 honoree helped steer Forge’s sale to Ajinomoto. Now, Samantha Piteri-Molina sees opportunities in AI-driven analytics and Ohio’s gene therapy ecosystem—with a responsibility to patients worldwide.
As vice president of business and strategy at Forge Biologics, Samantha Piteri-Molina is focused on more than just growing the manufacturing business—it’s about getting gene therapies into the hands of waiting patients, she told BioSpace.
Piteri-Molina, a BioSpace 40 Under 40 honoree, helped guide the contract development and manufacturing organization through its $620 million acquisition by Ajinomoto in late 2023. Now operating as a subsidiary of the Japanese multinational food and biotechnology corporation, Forge has been able to accelerate its commercial manufacturing ambitions, expanding to more than 425 employees while maintaining a retention rate above 92%, she said. That’s up from the 327 Forge employees as of July 2023, according to an Ajinomoto presentation.
As the CDMO grows, Piteri-Molina sees opportunities to improve how the sector works—from analyzing complex manufacturing data to drawing on the specialized talent surrounding Forge’s Ohio home.
The CDMO supports adeno-associated virus (AAV) gene therapy development and commercial manufacturing. Just last year, the cell and gene therapy arena achieved three new blockbuster products—Bristol Myers Squibb’s Breyanzi, Johnson & Johnson and Legend Biotech’s Carvykti and Sarepta Therapeutics’ Elevidys—bringing the total number of drugs with blockbuster status in the space to five, according to the Alliance of Regenerative Medicine (ARM).
Piteri-Molina said she is seeing more programs advance through the clinical pathway than ever before. And “we’re seeing more drug approvals, she continued,” adding that more can still be done to improve manufacturing efficiency in the sector.
Finding AI’s value beyond ChatGPT
For Piteri-Molina, one near-term opportunity is using artificial intelligence to improve the data that gene therapy manufacturers already produce.
“There’s so much data in gene therapy manufacturing, and so I think there’s a real opportunity in how we collect it, how we analyze it, how we interpret it, that can create a lot of efficiencies,” she explained.
As manufacturers get better at making more of the vectors used to deliver gene therapies, they also need faster, more sophisticated ways to understand the product and perform quality checks. With AI, “I think that that is very achievable near-term and very valuable,” Piteri-Molina said.
Drawing on her past experiences working at PTC Therapeutics and Agios Pharmaceuticals, Piteri-Molina also sees a lot of potential for AI on the drug development side. Whether that be construct optimization or developing unique assays to pair with programs, she’s keeping her eye on how AI improves that side of biopharma.
Meanwhile, she thinks the myriad variations of Claude or ChatGPT are overhyped, drawing a distinction between tools that tackle technical challenges and the proliferation of general bots.
“There’s more diversification in those platforms that can add value, but that’s where I think: Is that the most bang for our buck in this space right now?”
Forge’s Ohio advantage
Technology is only one part of the equation. Location is another.
Forge is based in Columbus, Ohio—a hotspot for cell and gene therapy. A 2023 ARM report featured Columbus as one of 10 U.S. hubs for the sector, highlighting the city’s strong education system, low cost of living and cheap land.
“We’re really fortunate to be part of an ecosystem that grew out of the research at Nationwide Children’s Hospital, which is here in Columbus, and that a lot of that research in spun-out companies directly contributed to four FDA-approved gene therapies,” Piteri-Molina said. Those therapies are Sarepta’s Duchenne muscular dystrophy treatment Elevidys; Novartis’ spinal muscular atrophy treatments Zolgensma and Itvisma; and, most recently, Ultragenyx’s Fayuvi for Sanfilippo syndrome type A.
“That research has helped attract a lot of really specialized talent in the area that really understand the complexities of gene therapy development and manufacturing, and Forge has been able to capitalize on that talent and that ecosystem,” Piteri-Molina said.
Being located in the Midwest also gives Forge a supply chain advantage, she added.
“We’re a one-day drive for most of the U.S. population major cities along major transportation distribution networks,” Piteri-Molina explained. Those factors play a significant role in gene therapy manufacturing, which uses specialized raw materials that require temperature-controlled shipments and tight timelines.
“There are a lot of really good reasons to invest in domestic manufacturing capabilities, and Forge is a part of that,” she added.
But she also emphasized that people all around the world are impacted by the rare diseases that cell and gene therapies treat.
“Rare disease patient populations aren’t concentrated in any one country,” she said. “These are small communities; they’re distributed globally. For most of the diseases our clients are working on, the patients who need that therapy are spread across many geographies.”
While encouraged by ongoing discussions at and with the FDA about cell and gene therapy, Piteri-Molina cautions the industry against letting the case for domestic manufacturing narrow the industry’s perspective.
“The patient communities we’re ultimately serving are global ones,” she said, adding that the more stakeholders align, the better patients will be served.
“There are patient groups out there who every day are waiting to see . . . how quickly we get a treatment to them,” the Forge leader concluded. “It’s important for us to keep that in mind: what a privilege it is to do what we do, but also the responsibility that carries.”
