Two Labs Blog

Two Labs Blog

Two Labs Acquires Pennside Partners Ltd.

Posted by Two Labs on October 23, 2018

We’re excited to share today that as of  October 18, 2018, Two Labs has acquired Pennside Partners Ltd., a leading international provider of market insights, benchmarking, and competitive intelligence services for the pharmaceutical, biotech, and medical device sectors.

This acquisition enhances Two Labs’ suite of services with complementary competitive intelligence services and extends its capabilities into clinical product insights allowing us to better meet clients’ evolving needs.

At our core, Two Labs is committed to the patient. With the addition of Pennside’s services and expertise, we can now offer clients access to over 20 years of clinical product insights and strategic commercial issues. This will help uncover the most optimal pathways for pharma products, ultimately benefiting the patient. Matching Two Labs’ own commitment to client satisfaction, Pennside is dedicated to delivering an exceptional customer experience and, as a result, exhibits many similarities in customer loyalty and a reputation for delivering a high quality of service.

The combined capabilities of our companies will enable us to offer a wider and deeper suite of services. Through our joint expertise, we’ll be better able to support our clients throughout the product lifecycle from pre-launch through loss of exclusivity.

We are incredibly pleased to welcome Pennside Partners to the Two Labs family and look forward to adding their expertise to our suite of services. 

For more information:

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Topics: Pennside Partners, Acquisition, Two Labs

Everything You Need to Know About the DSCSA in 2018

Posted by Two Labs on September 24, 2018

By now, you’ve probably heard of the DSCSA. Since its passing in 2013, the act has been the talk of the industry as it continues to reshape the distribution landscape. However, because of the staggered roll out, varied enforcement dates, and multiple moving pieces, the DSCSA can be tricky. To help you keep track of the most important changes, we have mapped out the key things to know about the DSCSA in 2018 and beyond.

Background: Why was it created?

For the past 5 years, companies have been heads-down working on new processes and infrastructure to meet the requirements of the regulations. While hustling to adapt to a new system, it’s important to take a step back and remember the positive impact the act will have on the pharma industry. The DSCSA was created with a distinct goal in mind:

 Ensure a secure supply chain via:

1

Developing an electronic, interoperable system to identify and trace certain prescription drugs as they move through the supply chain

2

Establishing national licensure standards for wholesale distributors and third-party logistics providers

Through the pursuit of these objectives, the DSCSA is transforming the pharma industry, making it safer, more transparent, and more efficient. As the FDA enforces the regulations, the new system will:

  • Facilitate the exchange of information by trading partners at the individual package level
  • Improve efficiency of recalls
  • Enable prompt response to suspect and illegitimate products when found
  • Create transparency and accountability in the drug supply chain

What’s the timeline?

Though the DSCSA was enacted in November 2013, full implementation won’t be reached until 2023. To give companies ample time to comply, individual regulations are rolling out in stages over the course of the decade. To date, the timeline is:

January 2015: Transaction information must be provided by manufacturers, distributors, and repackagers

November 2017: Manufacturers must serialize product

November 2018: Repackagers must serialize product

November 2019: Wholesalers sell only serialized product and validate serialized returns

November 2020: Dispensers accept only serialized product

November 2023: Complete unit traceability

What’s happening in 2018?

While manufacturers were required to serialize product in 2017, enforcement has been delayed until November 2018. By this date, manufacturers must add serial numbers to their products that can be read, identified, and tracked by the FDA.

However, serialization is far from simple and as the industry interprets the new regulation, companies are realizing unanticipated extra resources are necessary. For example, manufacturers must select a system that will create, share, and store their product’s unique serial numbers to allow verification/validation. The system must also support EPCIS exchanges between their CMOs and their down-stream trading partners.

What does this mean? Budgets and timelines must be accurately planned out far in advance to avoid last minute surprises and costly delays. Project management becomes key.

What’s next?

In 2019, wholesalers must trade only in serialized products and must validate saleable returns. This can be accomplished in two different ways.

The first option is for the manufacturer to send aggregated purchased unit data to the respective wholesaler’s system to build their own database. For this option, the FDA selected EPCIS (Electronic Product Code Information Services) to establish a standard data communication protocol which will be used by all data trading partners.

If they don’t use the first option, manufacturers must subscribe to the Verification Router Service (VRS). The HDA has established requirements to support a database query which will route serial number validation requests to the appropriate manufacturer serialization database. The catch? The VRS is currently in a testing phase and is not yet available.

Why should I bring in a DSCSA consultant?

In the pharma industry, so much relies on timing. Failure to comply with DSCSA regulations can result in expensive product delays. Unfortunately, not all of the regulations are easily interpreted, and there are still some major points of the DSCSA that need FDA clarification or final guidance. Researching the changes and interpreting how to comply takes valuable time – time that your team should be spending on product launch prep.

By working with a full service DSCSA consultant, you’ll have someone on your team who dedicates their time to understanding the regulations and creating tailored processes that ensure your company compliance. 

Two Labs has launched a DSCSA Consulting Service to help companies navigate the uncharted DSCSA waters. To make the process as smooth as possible, our team works with clients to:

  • Understand the regulations
  • Develop implementation strategies
  • Facilitate implementation testing
  • Plan and manage projects and timelines
  • Work with, and manage, data serialization vendors

By taking over the DSCSA management process, we free up your time to focus on things like product approval and launch. Click the button below to talk to one of our DSCSA experts about how we can help you.

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Topics: Two Labs, DSCSA, Trade

Two Labs Acquires MKO Global Partners

Posted by Rich Wartel on February 8, 2018

At Two Labs, we’re committed to staying at the forefront of the evolving healthcare market -- and to support our growth goals, we believe it’s invaluable to add insightful team members who have their own valuable perspectives.

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Today, we are pleased to share that as of February 2, 2018, Two Labs has acquired MKO Global Partners (MKO), a strategic global life sciences consulting firm focused on payer strategy, market access, and pricing in the pharmaceutical and biotech markets.

The union of Two Labs and MKO’s pharma services expands our total solution suite for market access, allowing us to provide many new services and areas of expertise. By combining our capabilities with MKO’s, we’re now able to guide clients on how to address value proposition concerns within the payer market, emphasizing all aspects of product pricing and payer segmentation.

Culture stands at the core of everything we do, and MKO exemplifies everything we look for in a partner. Their team is performance-driven and embraces the entrepreneurial mindset, seeking new opportunities for innovation and value creation. Most importantly, they have a passion for creating patient access through the products that they represent, highlighting the strong values alignment between our two organizations. Our principals have worked with and known the MKO principals for over 15 years, and they’ve exceeded our expectations for a partner with the same desire to grow and emphasis on culture. Each organization views the other as the logical extension toward the total solutions suite for pharmaceutical, biotech, and life sciences consulting solutions – and we believe our clients will be thrilled with the capabilities available through a single source.

Going forward our goals and commitment to the patient will remain unchanged: helping them better gain access to necessary pharma products. The pharma market is growing rapidly, and this acquisition will provide the support needed as we further invest in the expansion of our services to meet our clients’ evolving needs.

We are excited to welcome MKO, and look forward the impact their skills and expertise will have on Two Labs and the commercialization process.

Topics: Two Labs

Two Labs Marketing is Changing Its Name

Posted by Jessica Krauser on September 5, 2017

Two Labs Pharma Services Name Change

Two Labs Marketing is Now Two Labs

Two Labs Marketing, LLC is announcing our name change to Two Labs, LLC, a pharma services consulting company. To some it might sound like a small change, but to those who have been around Two Labs Marketing know that for over 14 years we have evolved into much more and we want our name to reflect that. Our company was established in 2003 with the idea to educate and train pharma product managers about the commercialization process. 

Since then, the Two Labs team consistently created new servic

es based on client needs:

  • PharmaLicense, LLC in 2007
  • Compendia expansion in 2009
  • eRx Solutions, LLC in 2013
  • Post-Launch Trade Management Services in 2013
  • Specialty Commercialization expansion in 2014
  • Patient (HUB) Services in 2016

Our name, Two Labs, allows us to brand all our services and affiliates under one umbrella in a more integrated, meaningful way.  For starters, every employee (PharmaLicense and eRx Solutions team included) will have a Two Labs email address. The second biggest change with any company rebranding is the website: www.twolabs.com.

Learn More About Our Services

Our goal is to become a full pharma services consulting organization. The re-branding is just the beginning.  

Topics: Two Labs