Features

Robert Wollin – MeiraGTx

The legal DNA to expanding gene therapy on a global scale

During the COVID-19 pandemic, MeiraGTx, a biotechnology company headquartered in New York City and London, acquired two buildings in Ireland to expand its manufacturing capabilities. This was to ensure sufficient capacity for its clinical, pre-clinical and commercial programs upon receiving regulatory approval.

In September 2022, the clinical-stage gene therapy company celebrated the official opening of Ireland’s first commercial-scale gene therapy manufacturing facility. In combination with its site in London, this one in Shannon, Ireland, increased MeiraGTx’s total dedicated manufacturing space to over 180,000 square feet, allowing it to research, develop and manufacture potential cures and treatments for serious diseases, such as Parkinson’s and inherited retinal diseases.

Robert Wollin | General Counsel and Secretary | MeiraGTx

Robert Wollin | General Counsel and Secretary | MeiraGTx

The space allows for the six manufacturing steps of gene therapy: plasmid development and production, cell expansion, plasmid transfection, viral vector production, purification, and the last step of fill and finish.

“This has significantly increased our capabilities to develop and deliver potentially curative treatments for patients living with serious diseases while decreasing regulatory and supply chain risks and costs,” says General Counsel and Secretary Robert Wollin, who has been with the company since August 2019 and oversees its legal matters.

For this project, he immersed in Irish real estate law and helped set up a new operating subsidiary in Ireland.

“I was more than a little surprised when the chief financial officer called me about this project in the spring of 2020, shortly after the world shut down due to the pandemic,” Wollin tells Vanguard with a laugh.

Ireland was just the beginning

Despite the state of the world at the time, Wollin saw the many advantages, including the open warehouse layout of the adjacent buildings and the ability to fit out the facilities to the company’s specifications, creating a first-in-class manufacturing campus.

Over the course of 18 months, MeiraGTx was able to purchase and install equipment in these blank slates—now, Ireland is home to over 70 MeiraGTx employees, adding to the more than 200 in London, 50 in the U.S. and several more in Amsterdam and Belgium.

Robert Wollin | General Counsel and Secretary | MeiraGTx

According to Wollin, Ireland was a perfect choice for other reasons, such as the country’s development authority awarding the company a grant for investing in the country and creating job opportunities. During a lull in COVID-19 cases and once he felt comfortable traveling, Wollin finally had a chance to visit Shannon for the grand opening celebration and, during the event, had the honor of meeting the Irish Taoiseach, also known as the prime minister.

Wollin had limited real estate experience before this deal but says the role of general counsel has a lawyer constantly dipping and delving into different legal areas, even if they are well outside their comfort zone.

He took the knowledge and expertise he gained on this project and has been using it to help MeiraGTx expand its global footprint.

Robert Wollin | General Counsel and Secretary | MeiraGTx

In the past few years, this has included setting up an entity in Belgium, for which he advised on setting up compensation programs, reviewing contracts with administrative vendors and leasing a flexible workspace allowing employees to have a centralized office to work and hold in-person meetings. He also assisted MeiraGTx in acquiring a company based in the Netherlands and negotiating a lease for new lab space in Amsterdam.

“Our teams are working hard to discover new advancements in gene therapy to help people everywhere, and I’m glad to be a part of these efforts to expand our capabilities and global footprint,” Wollin says.

Commercialization and compliance

According to Wollin, these international sites are critical in helping MeiraGTx create its first gene therapy commercial products. Now, the company runs multiple gene therapy programs to address diseases such as Parkinson’s and xerostomia, also known as dry mouth. It’s currently enrolling patients in phase two studies for both programs.

It is also in the middle of dosing patients in the pivotal Phase 3 LUMEOS clinical trial of botaretigene sparoparvovec, or bota-vec, for the treatment of X-linked retinitis pigmentosa, an inherited retinal disease with onset in early childhood and rapid progression to blindness generally by the time patients reach 30 to 40 years old. MeiraGTx is developing bota-vec with its partners at Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Robert Wollin | General Counsel and Secretary | MeiraGTx

Wollin says Janssen’s collaboration and initial $100 million investment have been imperative in developing the product—but it’s not the only funding source for MeiraGTx. In fact, he helped the company raise $100 million in 2022 through debt and equity financing—and the company raised approximately $60 million in May 2023 to help further its pipeline and extend its cash runway.

Despite this rapid growth, Wollin says MeiraGTx still views itself as a small company. It’s why he’s been implementing new processes for efficiency and compliance—and recently helped roll out the first code of conduct training across the company, which employees can complete online.

He’s also implementing a new contract management and database system, so contracts can exist in one, centralized space. The platform will allow his team to tag, classify and track contracts. It will also help them better assist the business team by sending automated notifications when renewals are coming up instead of waiting until a contract is almost expired.

“I worked with something more basic at my prior company, but even that was useful to keep track of agreements and amendments by vendor,” Wollin says.

Robert Wollin | General Counsel and Secretary | MeiraGTx

His legal experience has run the gamut from a traditional law firm to working in-house for a large pharmaceutical company and a global financial technology firm.

“My law firm practice really prepared me to move in-house, as I supported numerous public companies by assisting them with whatever they were working on, and I’m pleased my years of expertise are proving valuable to MeiraGTx,” Wollin says. “Gene therapy is the future, and I’m thrilled to be supporting my colleagues as we advance our late-stage clinical programs to develop potential treatments to help patients around the world.”

View this feature in the Vanguard Fall II 2023 Edition here.

Published on: October 22, 2023

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