Two Labs expands product launch services with the addition of Risk Evaluation & Mitigation Strategy (REMS) offerings

To further support pharma manufacturing partners and ensure launch delays are avoided, the company has deepened its expertise with REMS Strategy and Project Management solutions

COLUMBUS, Ohio, Jan. 12, 2023 /PRNewswire/ -- Today, Two Labs, an industry-leading pharma services company, is announcing the launch of its REMS strategy and program management offerings, which will be provided by its Shepherd Safety Services team.

REMS are FDA-mandated, post-marketing safety programs that can be required to appropriately balance a drug's benefits and risks to support safe use. These safety programs are most often required during the New Drug Application (NDA) or Biologic License Application (BLA) process to address risks identified in development. When not planned for, a drug launch could be delayed months, or even a year, depending on the complexity of the REMS requirements. Manufacturers often lack the in-house REMS experience and knowledge to navigate this small niche of the drug safety world.

"We've deepened our bench of experts by adding some of the most experienced REMS professionals to our team, including Melissa Landers," said Howard Miller, CEO of Two Labs. "Melissa joins the Two Labs family as a preeminent expert in the design, FDA approval, and ongoing consultative management of REMS programs. We've always been committed to the patient, and the addition of REMS and Melissa's deep expertise will provide immense value to our clients that need these programs to ensure a timely and successful launch."

Two Labs specializes in both working with clients who are bringing their first product to market as well as mature manufacturers as they prepare for product launch. For pharma leaders and risk management professionals who need strategic guidance and/or project management office (PMO) support for a new or existing REMS program, the expert team at Two Labs has the experience, technology, and know-how manufacturers need to efficiently plan, implement, and manage their REMS programs to support safe use and maximize patient access.

"Two Labs has a proven track record of quality client service that meets the evolving needs of pharma manufacturers," said Melissa Landers, Senior Principal of Shepherd Safety Services at Two Labs. "Having the opportunity to collaborate with the broad array of service lines at the company has already made me proud of the impact I can have with the added value I bring to the team and our partners."

Two Labs officially launched its REMS offerings in October 2022. Additional information on Two Labs' REMS Strategy and Project Management offerings can be found here.

Two Labs is a leading pharmaceutical services company that partners with pharma/biotech companies, providing integrated and customized commercial solutions. We help chart the path from clinical to commercial for a new product launch and provide strategies for continued market viability for drugs on the market. Since its inception in 2003, Two Labs has led 280+ new product launches and more than 300+ in-market projects from pre-launch to loss of exclusivity. For more information, visit www.TwoLabs.com

SOURCE Two Labs, LLC