Solving the Patient-Centric Formulation Riddle

From an unlikely beginning as an apprentice-run print shop to a leading CDMO for transdermal, oral thin film, and unit dose semisolid drug delivery, Tapemark continues to evolve impressively. With a substantial expansion coming to fruition, the company is positioned to be the premier player for these drug delivery technologies. As part of Pharma’s Almanac’s  Road to 50 States campaign, Pharma’s Almanac Scientific Editor in Chief David Alvaro, Ph.D. met with Tapemark Senior Vice President and Chief Operating Officer Beau Garrett to discuss the macro trends shaping patient-centric formulation and these dosage forms and how Tapemark continues to innovate to reduce risk while increasing compliance. 

David Alvaro (DA): Beau, can you start by telling me about the genesis of Tapemark and how your business and vision have evolved over the years?

Beau Garrett (BG): Tapemark will celebrate a milestone 70th anniversary next year. Our founder Bob Klas, Sr., grew the company from truly humble beginnings — he was the sole apprentice in a printing shop, and the owner sold him the business and he gradually transformed it to support more and more complex printing, beginning with specialty adhesives, pressure-sensitive adhesives, and a variety of tapes. Approximately 30 years ago, Tapemark turned a corner and began making simple medical devices, including Breathe Right nasal strips and diagnostic strips for diabetes. From that point, we saw a tremendous opportunity to leverage our expertise further into medical adhesives and drug laminates to produce transdermal patches and oral thin films, products whose markets continue to expand. The company has truly experienced a renaissance in nearly every decade, bringing us from a one-room shop to a world-class CDMO working across the permeation space.

Our vision and goal is to be the premier CDMO for any kind of complex drug system as it relates to permeation: whether that means cutaneous delivery from patch, tape, or a semisolid topical or delivery through the oral mucosa via an oral thin film. Tapemark wants to lead the innovations and breakthroughs that happen in the space, which is why we’re adding or deepening capabilities to sustainably evolve the brand.

DA:  How is the increasing emphasis on patient centricity in drug development impacting and growing the market for these permeation-based dosage forms?

BG: From a market perspective, it’s a combination of both patients and clients driving demand. Tapemark operates largely in disease states where there’s an unmet need, like complex CNS disorders, metabolic diseases, addictions, and safer pain management treatments. Transdermal or oral thin film applications are often the most elegant solution to drug delivery considering ease of use and — as importantly — compliance.

I learned early in my pharmaceutical career one of the biggest plagues on the healthcare ecosystem is compliance. People don’t take their pills. Going by some of the best estimates, maybe 40% of prescriptions are adhered to, which means that nearly two-thirds go unfilled or are taken improperly by the patient. Transdermals and oral thin films present an easy solution to the complex problem of compliance and dosing. Take, for instance, a stroke patient, a patient that suffers from a heightened tremor, or has a tough time swallowing — a sublingual film can be placed under the tongue, giving patients the benefit of the therapy while eradicating issues with traditional consumption. There’s an old saying in medicine: ‘The most expensive drug is the one that’s never taken,’ and that’s very true if you reflect on its entire meaning.

DA: Considering that these dosage forms have mostly been applied to a subset of the possible indications, do you think there inherent limitations preventing them from expanding to a broader range of conditions, or do you expect to see expansion into more indications and applications over time?

BG: We’re starting to see innovation in transdermals as well as oral thin films for molecules that were traditionally delivered via oral solid dose (OSD). This has been largely prompted by the advent of the 505(b)2 regulatory pathway by the U.S. FDA and the many blockbuster drugs that have recently gone off-patent in the United States. These events are fueling opportunity and innovation, particularly in Tapemark’s domain. The great limiting factor for transdermal is really what can be absorbed across the skin. The skin is the largest organ in the body, but it’s also (by design) a great barrier, which can definitely be a challenge.

At the core of the Tapemark brand are scientists who also function as artists and craftsmen — being able to permeate the skin is as much a science as it is an art. Molecule size and attributes are limiting factors. You also always have to account for overall body chemistry and the response to the enhancers or fillers that might be in the formulation. Each of these elements can impact the feasibility of delivering a given drug through the skin. The industry has always defaulted to OSD because these formulations are easiest to create and manufacture; however, the active pharmaceutical ingredient (API) can often be lost during OSD administration, while side effects can be greater for the patient. By circumventing the GI tract and opting for direct absorption into the skin through mucosal administration — the lining of the mouth or the nasal cavity — these recurring issues are bypassed.

PA_Q321_R250states_Tapemark_Sidebar

DA: How active are current R&D efforts devoted to transdermals and buccal delivery to find new ways to allow molecules to cross that barrier?

BG: It is definitely an active area of research, and I feel that it’s an area that the FDA needs to modernize from a regulatory perspective in terms of how enhancers are classified. Seemingly obvious regulatory changes would likely fuel new discovery. Tapemark has formed a strategic partnership with a company that has patented technology with a chemical system that facilitates the transfer of larger molecules. Another option is to physically change the skin, as with a solid microneedle. If you abrade the skin just a little bit, you’re able to get a lot more drug across, which has generated renewed interest, including recently for a COVID-19 drug, and that’s another exciting area we are watching closely. This is why we established a strategic partnership with a solid microneedle company.  

DA: What do you see as the strongest differentiators for Tapemark compared with other companies working in this space? 

BG: Some of the other players are really large conglomerates, and what we often hear from prospects and clients is that working with companies of that kind can be very slow, methodical, and sometimes frustrating, as they often feel that their voice goes unheard and there isn’t always sufficient flexibility to really create solutions tailored to their needs.

That is definitely not the client experience at Tapemark. We combine world-class expertise and facilities with full integration in an accessible, CDMO setting. Very few companies can formulate a product like we do while also offering full-scale commercial manufacturing in the same site. We take on the early development work, including developing clinical supplies and then logically offering the scaling of a program leading up to agency submission. We then commercially manufacture the product at the same site post-approval, which is a highly streamlined (and largely unheard of) approach to the supply chain. We also take pride in our client relationships — all of our clients have my personal cell phone number and are encouraged to use it, day or night, weekday or weekend. That accessibility and the trust that comes with it is another huge differentiator and has been key to our success.     

DA: What kinds of customers have you’ve been most successful in working with, and is there a profile of the kind of company that could reap the most benefits from collaborating with Tapemark?

BG: If I had to generalize the type of client that’s historically best for Tapemark, it’s the customer that wants a premium experience. We are not a low-budget, low-cost shop, but, because we do it right the first time, we often maximize our clients’ spend. As an example, many of our repeat customers are Japanese, and my experience in that market is that quality is prioritized well before expense — and the fact that they return at the pace they do speaks volumes about the quality of our work and service.

Of course, our clients run the gamut. Over the last 24 months, we’ve signed contracts with four of the top 20 pharma companies in the world, including two in the top ten. We also work with midsize generics, small/medium branded players, and virtual pharma. The common element connecting each client is an emphasis on, and respect for, quality and a premium experience.  

DA: Beyond the constantly evolving technology, have things at Tapemark evolved recently that have changed or enhanced the overall service offering?

BG: Tapemark has offered a full-service formulation since 2018, which I think a lot of people are unaware of, despite our industry-wide reputation. More recently, we added our newest lab, which enables us to offer full analytical release testing on raw materials or a finished product — on-site. We’ve always had this as an offering on the R&D side. Now, we're excited about this brand-new lab dedicated exclusively to commercial analytical services. This site has generated a tremendous response, because it truly simplifies the supply chain and reduces time, cost, and (most importantly) risk.

Tapemark has invested in growth and nearly doubled capacity over the last 18 months. We’ve increased our client base as a result, and we’re continuing to do a lot of innovative work — including a program for a Coronavirus treatment, as well as many other illnesses. This represents our trajectory overall, especially at a time when the world has been largely idle.

DA: What can you share about your current vision for Tapemark and where you see the company positioned five years or ten years in the future?

BG:  Tapemark is poised to accelerate. As I mentioned, we’ve just doubled our capacity. To keep up with this growth, our staff has increased from 115 to 191 employees within three years. Spurring this expansion is our pipeline, which is no doubt one of the most exciting in the industry. We currently have 23 active development programs across formulation, early development, scale-up, and precommercial encompassing many clients, as well as 10 current commercial programs. We predict that these programs will lead to an 70–80% approval rate, which is a near unprecedented track record that we attribute to our discerning partner selection process.

All things considered, we plan to more than double our commercial activity in the next three to four years. Ultimately, the more business we do and the more commercial opportunity we have, the more benefits our clients will continue to receive as the depth of our competency evolves. Despite our growth, Tapemark maintains the close-knit culture upon which the company was built, which our employees liken to a family. Growth will also not dilute our accessibility — the personal connection we’ve forged with our clients is a huge differentiator and something we’re committed to sustain for years to come. No matter our size, our clients will always have my personal cell number.  

Beau Garrett

As Sr. Vice President & Chief Operating Officer at Tapemark™, Beau Garrett has nearly 20 years of pharmaceutical expertise and thoroughly understands the needs of the pharmaceutical maker. He understands the value and innovation through pharmaceutical therapies to the United States’ most complex integrated healthcare delivery systems. Beau has experience with more than two- dozen therapeutic areas, has sold and marketed 14 branded therapies, and has launched 6 NDAs of which 4 became blockbuster products. Beau received his undergraduate degree in economics from The Colorado College and completed his MBA while attending The Carlson School of Management and The Gore School of Business.

Q: