Two Labs Blog

Two Labs Blog

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 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

Current and Future Oncology Management in the United States

Posted by Jessica Krauser on February 1, 2019

The cost of treating cancer patients is high and rising in the United States. Payers are exposed to cost through doctor visits, laboratory tests, imaging tests, radiation treatment, drugs, hospital stays, surgery, home care, transportation and travel, and caregiving. This study focuses on the cost of medication from the viewpoint of U.S. payers. Although new tools for managing these costs have been gaining attention, prices continue to rise, and challenges to managing costs remain high. Innovative tools are necessary for controlling the cost of care in oncology, but their effectiveness is still unclear.

Read full article published at the JMCP (Journal of Managed Care & Specialty Pharmacy).

Innovative Access Agreements

Posted by Jessica Krauser on January 1, 2019

A potential payer solution for Cell & Gene Therapies

A US and European perspective

Payer concerns over increasing cost of therapies and uncertainty of clinical data have led to a growing interest in market access tools. These tools have many names and definitions, often referred to as innovative (IAA) or alternative access agreements (AAA). For the purpose of this review we will refer to them collectively as IAA. The agreements can be split into two key categories: finance-based, designed to reduce uncertainties over budget impact and cost; and outcome-based, designed to reduce clinician uncertainties over drug performance.

Download White Paper

Failure to Launch: Five key reasons that biosimilars have failed to gain traction in the US market

Posted by Jessica Krauser on November 1, 2018

Although biosimilars have taken off in Europe, they have yet to gain significant traction in the United States. More than thirty biosimilars have been approved and twenty-six are marketed in Europe. In the US, there are only eleven biosimilars approved with only five marketed: Zarxio, Fulphila, Retacrit, Renflexis, and Inflectra.

Read the full report by downloading this paper.

Download White Paper

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