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Webinar Recap: The 3 Questions to Consider In Your New Product Launch

2023-03-23T17:08:16+00:00March 21st, 2023|Categories: Blog|

If you haven’t had a chance to watch the on-demand webinar, “Top 3 Questions Facing New Launches,” but are curious about where to start with the pharmaceutical commercialization process, we’re giving you a recap of the highlights. Based on Two Labs' experience supporting 280+ pharmaceutical new product launches, our experts will walk you through the most critical questions to answer when planning a pharma launch strategy. Question [...]

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Public Policy Strategy Helps Realize Clear Access Path for Patients

2023-03-06T17:04:09+00:00March 6th, 2023|Categories: Blog|

We’ve entered a new era in the U.S. healthcare system with the passage of the Inflation Reduction Act’s (IRA) landmark policy changes. And whether you are an emerging manufacturer bringing your first drug to market or more seasoned about the whole launch process, it’s important to make sure that your strategy includes a focused public policy element. A focused policy strategy is especially important for drugs that will [...]

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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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Post-Launch Optimization

2023-02-28T17:10:13+00:00November 4th, 2022|Categories: Pending Review|

Whether you’re an emerging manufacturer putting the finishing touches on a new product launch or a small to mid-sized company whose products are outgrowing the post-launch support infrastructure you have in place, Two Labs provides expert consultative services to ensure your product can keep pace with constantly changing market dynamics. Additional indications, formulation changes, altered patient populations, and labeling changes are a few of the catalysts that can obsolete [...]

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Two Labs’ New Medical Communications Service was Built with Emerging Pharma in Mind

2023-03-06T13:42:16+00:00October 20th, 2022|Categories: Blog|

Given the complexities that an emerging manufacturer is managing when developing a new product for launch, it might sound like medical communications is just one more thing on the list. But this couldn't be further from the truth. This is especially true for products with novel products with complex science, like cell and gene therapies. Strategic Medical Affairs & Communications is about delivering the right scientific data at [...]

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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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Cell & Gene Therapies: How the Industry is Innovating & What Emerging Manufacturers Need to Know

2023-03-06T13:43:33+00:00October 6th, 2022|Categories: Blog|

Thousands of rare diseases affect hundreds of millions of people globally, and hope for treatment is on the rise in the form of cell and gene therapies. While only 9 cell and gene therapies are currently FDA-approved in the U.S., that number is soon expected to grow exponentially. With such drastic change on the horizon, the industry needs to be prepared. In this white paper, Kyle Felmet, Vice [...]

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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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