News

Avoid Launch Delays By Planning For An FDA-Required REMS

2023-01-18T14:48:04+00:00January 18th, 2023|Categories: News|

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 NDA or biologics license application (BLA) process to address risks identified in development. If not planned for, this one requirement can set the launch back months, possibly a year, depending on the complexity of the REMS. This reality hits [...]

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

2023-03-03T14:20:10+00:00January 12th, 2023|Categories: News|

"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 [...]

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Why Emerging Manufacturers Need Specialized Communications That Are Built To Scale

2022-10-10T20:36:12+00:00October 10th, 2022|Categories: News|

Emerging manufacturers have a strength in how close to and how passionate they are about the science they are developing. But because they are hyper-focused on the groundbreaking science they're working on, it can be hard to come up from the weeds to put together the launch support that their product needs. And often, one of the most underestimated parts of that launch plan is medical communications. Read our recent article [...]

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Effective Medical Communications During CGT Clinical Trials

2022-10-06T20:04:51+00:00October 6th, 2022|Categories: News|

As the cell and gene therapy market has exponentially grown in recent years — with some reports predicting it will reach $24.4 billion with 54 to 74 approvals by 2030 — many manufacturers are learning the hard way just how complex it can be to launch these products, and that’s after already making it through the arduous development and clinical trial process. Among the many things to navigate, a manufacturer [...]

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Achieving Launch Excellence in Oncology

2023-03-08T16:39:41+00:00October 3rd, 2022|Categories: News|

It’s no surprise that putting together a successful launch strategy for an oncology product is a complex process. And we’ve heard from many of our emerging pharma clients that it’s intimidating to see how saturated and competitive the landscape is. To cut through the noise and deliver a message that resonates with healthcare providers, payers, and patients, it’s important to recognize that strategic and integrated medical communications should be [...]

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Two Labs Adds Medical Affairs & Communications to Suite of Services

2022-07-13T15:09:11+00:00July 13th, 2022|Categories: News|

In a market where most medical affairs and medical communications service providers are built to support large pharma, Two Labs is aiming to fill the gap for small and emerging biopharma and biotech manufacturers with the launch of Medical Affairs & Communications. Read more here.

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Adding State Licensing to Your Cell and Gene Launch Strategy

2021-07-06T14:21:39+00:00July 16th, 2021|Categories: News|

The main question that sits at the center of the most common licensing questions and obstacles for cell and gene strategies: how do companies license a product that is often never touched by the parties that need to hold the license? Ryan Fields, Sr. Vice President of Regulatory Services at Two Labs answers this question and more in his article featured on Pharmaceutical Outsourcing. Read more here.

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Two Labs, an Envision Pharma Group company Acquires Riparian

2021-07-06T13:52:51+00:00July 7th, 2021|Categories: News|

The partnership expands Two Labs’ suite of services and broadens its integration competency to include government price reporting COLUMBUS, Ohio (7/7/2021) -- Two Labs, an industry-leading pharma services company and part of Envision Pharma Group, today announced that it has acquired Riparian, a pharma consulting and SaaS company that helps manufacturers navigate pricing regulations, reporting, strategies, and program operations. The acquisition expands Two Labs’ suite of pharma services, allowing the [...]

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US Value-Based Management of Oncology Drugs

2022-04-01T15:32:13+00:00July 2nd, 2021|Categories: News|

Oncology and other specialty therapies continue to get more and more expensive for payers, placing immense financial pressure on the HCP. The percentage increase in worldwide spending on oncology medications went up by double digits every year between 2013 and 2018, and reached nearly $150 billion in 2018. Modern cancer therapies significantly improve disease outlook, but with a tremendous cost of treatment. Read more from Two Lab’s Senior Consultant Anne [...]

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Envision Pharma Group and Portfolio Company Two Labs Pharma Services Launch MSL Solutions

2021-06-28T03:16:51+00:00June 28th, 2021|Categories: News|

With the new offering, Envision and Two Labs are poised to deliver more options and innovation to the Medical Science Liaison (MSL) Space. Two Labs Pharma Services and its parent company Envision Pharma Group – organizations that are deeply engaged in providing Medical Affairs services to biopharmaceutical companies – are proud to announce an exciting new, combined offering: MSL Solutions. Designed to grow and enhance both organizations’ ability to deliver [...]

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