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.

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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 Joins Global Celebration of Rare Disease Day

Posted by Jessica Krauser on February 28, 2019

DSC_0423Since 2008, Rare Disease Day has been on the last day of February – which every four years is a rare 29th of the month. The observance was created to drive awareness of the 6,000 existing rare diseases that affect 1 in every 20 of us.

As a way of demonstrating our support, we joined in on Rare Disease Day’s face-painting event at our offices, along with donations to Rare Disease Day and the National Organization for Rare Disorders to help further the amazing work.DSC_0416

Check out some photos from the event and join in to #ShowYourRare on social media! We’d also encourage you to check out some of the inspiring testimonials on Rare Disease Day’s website.

We're also supporting Mediaplant in the campaign for Rare Diseases by bringing awareness to the challenges manufacturers, regulators and payers face with orphan drug market access. 

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This year, the theme is “Bridging health and social care,” which is something that is extremely meaningful to us at Two Labs. In recent years, we’ve become increasingly involved in rare disease drug launches across the globe and we’ve seen how much support and assistance is needed by those suffering from rare diseases.  While the innovation and progress with rare diseases are very impressive, we can’t forget what our work is really about – improving people’s lives.

Topics: MKO, Pennside Partners, Rare Disease Day

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:

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

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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.

Request a Consultation

Topics: DSCSA, Two Labs, Trade

Key Learnings on Pathways of Care

Posted by Two Labs | MKO Global Partners on August 1, 2018

Oncology is a high cost and high management priority disease state for US payers, however, ability to control cost in this space is limited. MKO Global Partners, a Two Labs Company, conducted previous research that suggests oncology drugs are primarily managed to label and only occasionally are there policies in place to restrict or prefer certain agents.

1_mlHowever, new ways to control the cost of oncology care are emerging and are attracting attention. For example, pathways of care are considered a tool of growing relevance. Pathways, with or without risk sharing, are often mentioned as an oncology-specific cost containment tool, alongside other initiatives such as Oncology Care Models, changes in payment mechanisms for providers and, at least in part, value frameworks.

Despite the industry interest in pathways of care and other innovative oncology management tools, it is unclear what impact these new approaches will have on access at the local level. To explore this issue in-depth, MKO Global Partners organized a panel discussion with oncologists from different types of provider organizations.

Download White Paper

Learn about the three factors that emerged as key issues limiting payers' ability to manage oncology by downloading this paper.

 

Topics: MKO, Payers, ASCO

How a Trade Commercialization Team Makes Licensing Easier

Posted by Two Labs on June 26, 2018

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Licensing is a required step in the pharma industry, and unfortunately, it can be incredibly complicated. The consequences for not carrying the correct license can range from fines to an immediate stop in sales to felony charges – and that’s just the beginning.

We covered the basics in an earlier post, but while a general knowledge of the ins and outs is helpful, you’ll need more than an overview to navigate the various license types, regulations and state-specific laws.

Thankfully, you don’t have to handle it all on your own. A trade commercialization team can help you avoid detrimental licensing mistakes and set your company up for success from the start. Some of the benefits a trade partner can bring to the table include:

An ear to the (ever-changing) ground.

State licensing requirements change a lot and they vary from state to state. To make things harder, there’s no formal voting or amendment process to declare these changes and no central “hub” where you can see all updates from each state. It’s easy to miss an important change if you’re tackling licensing on your own, and unfortunately, the state boards don’t accept “I didn’t know” as an excuse.

But that’s where your  consulting partner comes in. It’s their job to stay on top of all the changes and keep you informed of the ones that will – and might – affect you.

At Two Labs, our PharmaLicense team works with these state boards on a routine basis and track all license requirement updates. We’ve built relationships with key players in the industry to make sure we never miss a change.

Deep industry knowledge.

Even after you’ve managed to successfully get your initial licenses, there are a lot of outside factors that can affect compliance throughout the life of your company. Some are unexpected (see above), but your license can be impacted due to known, consistent factors as well. For example, if your company moves, gets acquired, goes public or goes through a host of other changes, you’ll need to reevaluate your compliance and update your license ASAP.

Again, not all states are the same, and what works for some doesn’t necessarily translate to others. To make the process smoother, you’ll need a partner with a far-reaching knowledge of all regulations and industry quirks. The right trade partner will not only understand the requirements for your state, but for all states. And they’ll understand the licensing ins and outs for your company in its current form, and as it evolves.

Big picture strategy.

Obtaining your state licenses is only one step in the process of launching your product. Looking at it in a silo can cause problems for your distribution down the road. Instead, a trade commercialization partner can look at your licensing as part of the larger whole, develop a strategy that gets it approved on time and make sure it aligns with your overall launch plan.

At Two Labs, we understand how to bring a product to market, and use that industry knowledge to guide our licensing strategies. We have the tools to help you before and after licensing, and can flag opportunities for your company as we work through the process.

For many companies, licensing tends to be an afterthought, but it can delay a launch or stop shipment all together. Instead of risking it, let us help! Our PharmaLicense experts are ready to dive into your overall commercial launch plan and get hands on with licensing. Below is a link you can click on to schedule time with James, one of our PharmaLicense experts! 

Click Here to Schedule Time

Topics: PharmaLicense

Two Labs Hires Anita Dopkosky as Vice President of Specialty Pharmacy

Posted by Two Labs on May 10, 2018

At Two Labs, we value partnership. Our clients view us as an extended part of their team, not a vendor. And as the pharma market continues to evolve, we are excited for the growth we can experience by incorporating additional insightful team members.

During Asembia’s 2018 Specialty Pharmacy Summit earlier this month, Two Labs welcomed Anita Dopkosky, a pharmaceutical industry executive, as Vice President of Specialty Pharmacy. She is just one of six new hires in the past 18 months, which speaks to the ongoing growth of the Two Labs Specialty team.

Anita knows Anitathere is no one-size-fits-all distribution model – she believes it’s essential to fully understand the patient’s journey and the unique attributes of the product. In her role, Anita will be responsible for helping solution-hungry pharma and biotech manufacturers develop efficient, cost-effective distribution models to serve patients, caregivers and prescribing physicians. Additionally, she will work with trading partners to identify areas of collaboration within the specialty pharmacy and distribution space, supporting our broader purpose in helping patients get access to life-altering drugs and services.

Before joining Two Labs, Anita served as an organizational leader for specialty pharmacy business development and implementation at Walgreens Boots Alliance – where she helped secure access for biopharma’s limited distribution products that required strategic and tailored high-touch services. Prior to Walgreens, Anita held ascending and complementary positions at McKesson and Thermo Fisher Scientific.

We are thrilled to welcome Anita to Two Labs. Our culture is centered around the drive to support patients, and we believe that her experience, leadership and commitment to our core values will position her as a great asset for our clients.

Interested in joining Anita and starting a career with Two Labs? We’re looking for talent to grow and thrive right along with us. Take a look at our open positions

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

How DSCSA Changes the Licensing Landscape for Third-Party Logistics

Posted by Two Labs on January 10, 2018

The Drug Supply Chain Security Act (DSCSA), passed in November 2013, has become a buzzword in the pharma industry in the past few years, and will continue to be until the completion of the implementation in 2023.  DSCSA describes creating an electronic, inter operable system that stores transaction information and history of a drug from the time of manufacture to when it is dispensed to a patient.

The big license earthquake came when the FDA defined what a Third-Party Logistics (3PL) company should be.  Before the passage of DSCSA, 3PL companies could be licensed as a wholesaler. The Wholesale and 3PL business models are similar: both company types accept products from manufacturers into their warehouses and then distribute them to customers. However, there is one major difference: the 3PL does not own the products that they are distributing. 

Because the 3PL does not take ownership of the product, the FDA decided that the 3PL should have its own category and can no longer be licensed as a wholesaler. As Federal law supersedes any state requirement, all 305 Third-Party Logistics locations listed by the FDA had state licenses that were now considered nullified.  

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The big question is: How are the 3PLs able to continue to do business in a state when all their licenses are no longer valid? This is an issue plaguing the industry.  Even the National Association Boards of Pharmacy (NABP) has been trying to help clarify. Feel free to check out their November/December issue of their publication, Innovations, page 7 where NABP leads a discussion forum to provide guidance to the wholesale industry.

As of December 2017, there are only 14 states that have established a specific license for a 3PL. This means the 3PL may continue to do business in the other 36 states (in addition to Washington, D.C.) without the requirement of a license. The state legislatures must decide for themselves whether a state will require a 3PL to hold a license, what the requirements will be, costs, etc. That small number of 14 states will both continue to grow and continue to change the landscape of licensing for pharmaceutical distribution over the next few years as the states make these decisions

Which 14 States  Require a License?

Click on the button above or visit www.twolabs.com to learn more.

Topics: 3PL, PharmaLicense, DSCSA