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Two Labs

Two Labs is a leader in all facets of pharma industry services, working with clients who are in Phase II through product launch and post-launch commercialization. Two Labs is entrusted by pharma and biotech companies, providing services across multiple stages of drug development and commercialization process for a wide array of therapeutic areas.
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Recent Posts

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: 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.

Request a Consultation

Topics: Two Labs, DSCSA, Trade

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

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

The Basics of Licensing: In & Out, Drug, & Facility

Posted by Two Labs on January 5, 2018

When you conduct a quick online search using the following phrases, a vast array of answers will cross your screen:

  • "License a Drug or Facility"
  • "Pharma Licensing"
  • "How to start my own Pharma Company"

The results of these searches tend to center around licensing: in-licensing, out-licensing, drug licensing, and facility licensing. How does all of this relate to launching a drug? Here are the basics:

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In-Licensing

When you hear the term "in-licensing," simply think of the word "investor". In-licensing is the process of creating a contract that allows another firm to provide capital to the development and launch process, thus taking on financial responsibility. This is a very popular licensing process for small bio-pharma start-ups to get their drug off the ground. There are pros and cons to this type of licensing; for example, it can provide the capital a company needs, but then the profits need to be shared once the drug enters the market.

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Out-Licensing

Out-licensing is more focused on opening up the delivery pipeline to assist you with getting your drug "out the door." Out-licensing encompasses finding a partnership, or partnerships, that will help identify your target market and assist you in getting your product into the right hands. This process may include working with marketing firms or legal firms. The financial relationship is very different in this type of licensing than the one outlined in the in-licensing section above.

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Drug Licensing

Only one entity in the United States "licenses" a drug, and that is the Food and Drug Administration (FDA). The FDA must approve all drugs before they can enter the market, and consequently, FDA approval is paramount before the drug actually leaves your facility and heads to the patient.

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Facility Licensing

Facility licensing may entail more than you would initially expect. Of course, if you are manufacturing your own drug, your facility must be inspected and licensed by the FDA. However, the state where your facility is located may also require a license which may or may not include an inspection. In addition to your resident state, there are other states that have requirements for a license, certification to do business, or deliver drugs within their borders. Each business location must have its own set of licenses. A company with multiple facilities may end up with dozens of facility licenses and only have one drug.

Do you have all the licenses you need?

Let Two Labs  Conduct an Analysis

Or visit www.twolabs.com to learn more.

Topics: PharmaLicense

3 Entities That Can Change Your State Licensing Strategy

Posted by Two Labs on November 9, 2017
Pharmaceutical State Licensing ChangesIn the Pharmaceutical industry, licensing is never a static process. There are many changes that can alter your licensing strategy: 
 

1. Your Company

This one is pretty obvious. There are a number of different business changes that could direct the strategy of your licensing, or the maintenance of your state licenses. Some of the most common occurrences are: a change of business entity (i.e. LLC to INC), a change of officers, or moving. These are the more common instances, but there is a wide variety of scenarios that may affect your company's licensing strategy.  Remember, each state interprets business changes differently according to its own statutes.
 
Are you making any strategic business changes? Fill out this form and let us check to see if it will affect your Licensing.
Fill Out the Form Here

2. Contract Manufacturing Organization (CMO)

If your CMO moves, it might affect your state licensing more than you would expect. States are now asking for your CMO's license number on applications, and to provide a copy of the FDA's inspection report. If any pharmaceutical manufacturer opens a new facility, they have to go through the rigmarole of an FDA inspection all over again to get an updated license. This can adversely impact your licensing if the required states aren't updated with the change.
 

3. Third-Party Logistics Provider (3PL)

Similar to the CMO, if a 3PL changes locations or opens up a new location, this may alter your state licensing. The states vary on the requirement of a 3PL's license: several states allow a company to piggyback off of its 3PL's license, a handful require your 3PL's state license to be listed, and a few print the 3PL's location on your license. In each scenario, your 3PL's business activities may adversely change your state licensing strategy and the process of maintaining your state licensing.
 
If any of these situations sounds like something your company is faced with now or potentially in the future, contact the Two Labs PharmaLicense team and let us determine if your future plans will alter your licensing strategy.
 
Fill Out the Form Here
 
For more information about Two Labs, visit www.twolabs.com
 

Topics: PharmaLicense, 3PL

Consequences Pharmaceutical Companies Can Face for not Carrying the Correct State License and Being Noncompliant

Posted by Two Labs on October 20, 2017

Anyone who is engaged in manufacturing, preparing, propagating, compounding, processing, packaging, marketing, selling, shipping, repackaging, or labeling a prescription drug, or wholesale distribution of a prescription drug...must obtain a license/permit in certain states to be in compliance.

Discover the ins and outs of State Licensing

"But I didn't know!"

This is a response that is never accepted by a government agency for a pharmaceutical company's inaction to remain in compliance with state licensing.

In analyzing the costs of being compliant, remember these consequences for not carrying the correct state licenses and being noncompliant:

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  1. If you are found to be noncompliant by your resident state licensing board, you may have your business license suspended or revoked.

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  1. The state board, depending upon the infraction, may also impose civil penalties ranging from a flat fine (up to $250,000 in some states, such as North Carolina¹) to charging your company per violation or per day. At worst, there could be misdemeanor or felony criminal charges that include jail time.
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  1. Being punished by your resident state board may only be the beginning:
    1. Once you have come to a resolution with your resident state board, it must then be reported to all of the other state licensing boards.
    2. Your company could then go through the same board actions with other states you are licensed with, and incur more license revocations, fines, and criminal charges.

Once the dust settles from all of the boards, there is still one final hurdle to face: how will your company recover from license revocation?

Every state board application asks if your company was ever denied a license or faced disciplinary action. This could potentially prevent your company from continuing to do business without expensive alternate strategies.

As you can see, in the pharmaceutical industry, falling out of compliance with state boards can be very costly. Consequences can include anything from license suspension by multiple states, up to felony charges and time spent in jail. Is running your own company's risk for noncompliance worth it?

Let the state licensing experts at Two Labs help! To learn more about licensing and other important topics related to launching a pharmaceutical drug, subscribe to our blog below or request a free consultation from the Two Labs PharmaLicense experts.

Request a Free Consultation Today!

¹North Carolina Wholesale Prescription Drug Distributor Laws: Chapter 106 Article 12 A § 106-145.6.  Denial, revocation, and suspension of license; penalties for violations. http://www.ncleg.net/EnactedLegislation/Statutes/HTML/ByArticle/Chapter_106/Article_12a.html

Topics: PharmaLicense