Two Labs Blog

Two Labs Blog

New regulation requirements impacting your license

Posted by Two Labs on June 4, 2019

In the pharmaceutical industry, state licensing requirements can change at a moment’s notice. Though no central “hub” exists listing all licensing updates for each state, our team of experts works with state boards on a routine basis to track all license requirement updates.

Recently, we’ve notified our clients and partners of changes that affect virtual manufacturers specifically in Arizona, Vermont, and New Hampshire.

Government agencies in these states have implemented a new requirement that Contract Manufacturer Organizations (CMO) must hold their own license in these states. This is a prerequisite for virtual manufacturers to obtain a new and/or renew a current license in these states. Let us help you determine how these, or other licensing changes, affect you. 

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Arizona:

Effective in 2019, the Arizona Board of Pharmacy has amended their qualification requirements for Virtual Manufacturers. A CMO located in the United States must hold a Manufacturer License with the Arizona Board of Pharmacy. If a CMO is located outside of the country, they will be required to provide an unredacted FDA inspection report dated within the last 2 years.

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New Hampshire:

The New Hampshire Board of Pharmacy has recently moved to require licensure of all the following entities: “Virtual Manufacturers, Virtual Distributors, Contract Manufacturers (repackager/relabelers), and Brokers/Intermediaries.”

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Vermont:

Effective for 2019, the Vermont Board of Pharmacy moved to require licensure of all entities that are engaged in the “dispensing, delivery, or distribution of prescription drugs.” Specifically, the board is now requiring CMOs located in the United States to hold a VT license. If a CMO is located outside of the United States, VT now requires an unredacted FDA inspection report dated within the last 2 years.

At Two Labs, keeping a pulse on these changes is at the core of our best-in-class service offering. We proactively monitor for changes in state regulations, government agency statue interpretations, and compliance requirements which affect manufacturers.

We work closely with our clients to not only update them on these changes, but to explain their impact on operations and provide detailed guidance on next steps.

Curious how these or other licensing changes might affect you? Not sure what action to take with your CMO? Click the button below to get in touch with our PharmaLicense expert team!

Click Here to Schedule Time

or visit Two Labs Contact Us page.

 

Topics: PharmaLicense, Two Labs

Doug Troy Joins Two Labs as New Chief Operating Officer

Posted by Two Labs on May 2, 2019

At Two Labs, we value partnership. We work hard to make sure our clients view us as an extended part of their team, and not just another vendor. As the pharma market continues to evolve, we are excited to expand our team so that we can provide even more value to our clients as they navigate the path of bringing their products to market.

Troy, Doug

Two Labs welcomes Doug Troy to the team as our new Chief Operating Officer. As we continue to expand by acquiring new partners and elevating our current services, Doug’s expertise in scaling entrepreneurial companies will become essential to our continued success in providing unmatched client service. He will work to prepare Two Labs for future growth, while ensuring smooth integration with regard to Two Labs’ recent acquisitions.

“Bringing Doug on board is an intentional step towards maximizing our value and efficiency as a company,” said Rich Wartel, founder and CEO. “In his new position, he will be responsible for the growth and success of Two Labs as we continue to expand our suite of services.”

Doug comes to Two Labs after spending the last 12 years with Lake Capital, a $1.3 billion private equity firm based in Chicago, and its family of companies. He held multiple C-suite positions at Lake Capital’s companies, where he guided their operations and finances.

Doug earned his Bachelor of Science in accounting from Indiana University and an MBA from Northwestern’s Kellogg Graduate School of Management. In 2012, he won CFO of the year in the private company category in Los Angeles County.

Doug has extensive experience in private equity for portfolio companies, having worked both as a company executive and as an investor. He will bring this knowledge with him to help Two Labs bridge the gap between executive management and private investors, a role that Two Labs has never had before.

"Two Labs is doing great things,” said Doug. “I’m excited to contribute my skills in an operations capacity so that Rich, Howard and the rest of the leadership team can keep working with the entrepreneurial spirit that has made the company so successful. Two Labs is on a path of tremendous growth and I’m excited to join the team and do work that truly impacts the clients, the employees, the business and the operations.”

Doug is hitting the ground running in his new role, already upgrading back-office systems and creating a scalable platform for us as we continue to grow.

Team photo in kitchen

Topics: Two Labs, New Hire

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:

Learn More About Our Services

Topics: Two Labs, Pennside Partners, Acquisition

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: DSCSA, Two Labs, 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