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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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Two Labs a Best Place to Work in Central Ohio

Posted by Two Labs on November 14, 2019

Two Labs is proud to be named as one of Columbus Business First’s 2019 Best Places to Work in Central Ohio.TwoLabs_Best Places to Work_191101-02

The Best Places to Work program, which is now in its 15th year, invites companies with at least 10 full time employees in Central Ohio to apply for the program by conducting an employee survey to assess satisfaction and happiness on the job.

The winners of the Best Places to Work program are solely selected based on survey results that measure employee engagement and other workplace factors. The survey scores items across six categories including:

  • Communication and Resources
  • Individual Needs
  • Manager Effectiveness
  • Personal Engagement
  • Team Dynamics
  • Trust in Leadership

Team Picture #GoGold

Two Labs was recognized in part as a great place to work because of the flexible vacation and scheduling policies, our collaborative nature, a culture of giving, and an environment that encourages teamwork.

Here is what some of our team members had to say about working at Two Labs:

 

“No policies. We hire adults and treat them as such by limiting policies and rules to just those required by law.”

“Flexible work schedules and locations. Our culture is built on trust. In most cases, employees can choose to work from home or the office and can create a schedule that works best for their personal lives and their clients.”

“No vacation policy. We encourage employees to take time to re-energize and enjoy life outside of work.”

“Quarterly engagement surveys. Two Labs conducts quarterly engagement surveys because keeping a pulse on our organizational health is a company priority. We have fun, often having Friday afternoon happy hours and team lunches.”

“Office environment. Our office is open and inviting and encourages collaboration."

Our team works hard to move us toward one goal: serving our clients in the most collaborative, passionate and engaging way possible. That’s why we hire for experience and talent but also for dedication and attitude.

Two Labs will be honored along with the rest of the honorees at an awards luncheon on Nov. 14.

Topics: Two Labs, Pharma Consulting, Best Places to Work

Michael Rowe Joins Two Labs as DSCSA (Serialization) Compliance Services Manager

Posted by Two Labs on September 3, 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. 

Two Labs welcomes Micheal Rowe to the team as our new Serialization Services Manager.

Michael Rowe

As we evaluate the ways that we can best grow and serve emerging pharmaceutical manufacturers, we realize that there is a great need and opportunity to advise clients on the Drug Supply Chain Security Act (DSCSA) regulations and timeline.

Michael comes to Two Labs after working at Cardinal Health for 11 years, most recently serving as the Manager of Operations Technology, where he oversaw Cardinal Health’s track and trace serialization program and advised on DSCSA requirements. His new position at Two Labs will expand the scope of our serialization services to work with more clients as well as downstream with all trading partners.

“There are few people who can understand and advise on the many complexities of DSCSA like Michael can,” said Rich Wartel, Founder and CEO of Two Labs. “His serialization expertise, combined with his experience in project management, sales analytics, operations and customer service in the pharmaceutical manufacturing industry will offer our clients unmatched guidance as they navigate through the DSCSA and bring their new drugs to market. Beyond his skills, he has a true passion for teaching and communicating on the subject, which is extremely valuable in our industry.”

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Michael is well-known for his DSCSA expertise and has spoken at several industry conferences and events, including the Healthcare Distribution Alliance’s Traceability Seminar and their Distribution Management Conference, Pharma IQ’s Pharmaceutical Traceability Forum and DSCSA seminars with GS1. He has also participated in several industry task force groups.

 

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Along with helping clients meet the current requirements, Michael is looking ahead to future challenges and opportunities of the DSCSA, including the saleable returns requirement and how to efficiently handle the mass amount of necessary communication and serialization checks; how blockchain’s information storage capabilities could benefit manufacturers and wholesalers; and the analytics possibilities that exist when the kinks have been worked out and the industry is equipped with mass amounts of serial data. 

“The opportunities at Two Labs, both for the industry and for me personally, are so exciting,” said Michael. “I am also excited to work alongside so many innovative and intelligent people with the common goal of helping emerging manufacturers bring their medicines to patients who need them.”

Topics: DSCSA, Two Labs, Trade, Pharma Consulting

What manufacturers need to know about Minnesota House Bill 400

Posted by Two Labs on July 30, 2019

We recently notified our clients and partners of several regulatory changes that will affect manufacturers and wholesalers doing business in Minnesota. In May 2019, Minnesota Governor Tim Walz signed House Bill 400, which created an Opioid Stewardship Advisory Council to confront the opioid addiction crisis and overdose epidemic.

Parts of the law are already in effect as of July 1, 2019, and more pieces of the bill will be felt within the next year, including significantly increased licensing application fees for all drug manufacturers and wholesalers, as well as new reporting requirements and registration fees for opioid manufacturers.

Below, we have summarized the new fees and requirements for manufacturers doing business in Minnesota, however the implications may vary by company.

To see exactly how these new regulations will impact your company and for help navigating the changes, contact our team of experts.

Application Fees for Non-Opioid Manufacturers & Wholesalers

On July 1, fees for non-opioid manufacturers and wholesalers increased from between $150-$325 to a flat fee of $5,260.

Requirements & Fees for Opioid-Based Controlled Substance Manufacturers & Wholesalers

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Annual Licensing Fees

Effective July 1, manufacturers of opioid-based controlled substances now face a $55,260 annual licensing fee. Regardless of how a product arrives in Minnesota or whether or not the manufacturer holds the product title when it arrives, the Minnesota Board of Pharmacy (MN BOP) states that the law applies to all manufacturers whose products end up in Minnesota.

If a company has multiple facilities that require a Minnesota license, it must pay the $55,260 annual licensing fee for the first facility, and then $5,260 for each additional facility. Distributing an opioid-based drug into Minnesota without the correct license can result in a civil penalty of up to $10,000 per violation, which can be defined as a single shipment of a single dose.

The state of Minnesota could also suspend or revoke licensing, prohibiting a manufacturer’s product from entering the state at all. Additionally, the manufacturer would be required to report the violation to every other state that it conducts business in, which may result in additional loss of state licenses.

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Registration Fee by Volume

There will also be an annual $250,000 registration fee for any manufacturer that sells, delivers or distributes at least 2 million units of an opioid into or within Minnesota. The MN BOP will notify manufacturers on April 1 of each year to inform them if they will be required to pay this fee. The first registration fee will be due June 1, 2020, for products sold in the 2019 calendar year.

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Required Distribution Reporting

Opioid manufacturers and wholesale distributors are now required to record and report every sale, delivery or other distribution within or into Minnesota, beginning with reporting all 2019 distributions by March 1, 2020. The penalty for failing to report sales by the March 1 deadline will be a $500 per day administrative fee.

Additionally, the bill created the Opioid Stewardship Account Fund to support prevention and treatment programs for opioid addiction and abuse. This fund will be financially supported by MN BOP, as well as federal aid and grants. Another provision to note is that Minnesota may drop the requirement that a Virtual Manufacturer must hold both a wholesale and manufacturer license, a rule that has been historically upheld in the state.


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!

Contact our PharmaLicense Experts

Topics: PharmaLicense

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.

Request a Consultation

Topics: DSCSA, Two Labs, 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