Sentry BioPharma Services is a wholesaler and third party logistics provider of prescription and investigational drug products, medical devices, and active pharmaceutical ingredients (APIs) for the pharmaceutical and medical device industry.

Sentry’s founders created the contract service organization (CSO) to meet the rapidly growing demand for dedicated and highly-specialized contract GXP storage, labeling, packaging and supply chain management services.

Tim Mitchell is principal founder of the company and has been at its helm for the past fourteen years. As president and chief executive officer he has guided Sentry from inception through start up and onto profitability and mature growth. Contract Pharma recently had the chance to discuss Sentry’s beginnings and most recent business highlights as well as wider industry trends with Mr. Mitchell.

Contract Pharma (CP): Since founding Sentry, how has the company evolved from its roots?

Tim Mitchell (TM): When we began business in May 2007, we approached the market with three validated temperature ranges: +2°C to +8°C (REF); -15°C to -25°C (FRO20) and +15°C to +30°C (AMB) for management and distribution of temperature sensitive biologics, pharmaceutical materials, finished drug product and medical devices. Today we manage products within 9 separate validated temperatures from +20°C to +25°C (CRT) to <-135°C LN2.  The product profiles include finished drug product, APIs, excipients, as well as master cell banks. Further we label, kit and perform secondary packaging on drug products for distribution into 34 countries.

CP: What are some of Sentry’s most recent business highlights?

TM: This last 12 months have been crucial to Sentry. Our year-over-year growth rate for the last five years has averaged 34% annually. However, during 2020 we are experiencing a 56% growth in revenues over 2019.

Highlights include the completed validation of the new Controlled Room Temperature, +20°C to +25°C (CRT) addition with 1,500 pallet spaces, which will grow to 2,000 spaces by 2021, including active relative humidity control. We also added a former DEA caged, continuously monitored, enhanced security Ultra-Low Temperature freezer storage offering as well as custom steel mezzanine and infrastructure for up to 320 x Ultra-Low Temperature (ULT) upright freezers (-50°C, -70°C, -75°C and -80°C), which will be completed in November 2020.

We are also completing infrastructure build within a new second site for 50 x -80°C ULT freezers in Copenhagen, Denmark by the end of the fourth quarter 2020 and in Indianapolis, construction has commenced on a second 250 x pallet -20C walk in freezer, doubling site capacity and redundancy. Validation is to be completed by the end of first quarter of 2021.

CP: In which area(s) of Sentry’s business is it observing the greatest growth?

TM: The Ultra-Low Temperature (ULT) upright freezers with a validated set point of -50°C, -70°C and -80°C represent the greatest growth area. This has been driven by additional large molecule drug approvals and development.

CP: What are some of the crucial issues impacting pharma manufacturing and supply and logistics providers like Sentry in particular? 

TM: Crucial issues include the ready supply of -80°C ULT freezers.  Sentry’s normal experience is to receive new units within 3 business days. Today, because of short supply the time for delivery has extended to more than 10 business days.

In addition, the lack of international airline flights brought about by COVID-19 significantly impacted global drug distribution in the second quarter of 2020. Additional resources brought to bear by international freight carriers has somewhat alleviated this supply disruption.

CP: Are you seeing more business growth from new ventures or established organizations?

TM: A majority of Sentry’s growth is coming from its existing client base which stands at 130 pharmaceutical companies. Although some of these clients are small to medium virtual companies, many are large multi-nationals which seek out Sentry’s expertise in managing extremely cold supply chains. We continue to offer a white glove, customized, customer service-oriented experience to all clients, providing support in the areas of most crucial importance, on a per client basis.

CP: What are some trends in today’s pharma logistics market to keep an eye on?

TM: Pharmaceutical supply chain infrastructure is experiencing its own stress test, within this newest market trend of COVID-19 vaccine development. Upon commercialization of one or more promising vaccine candidates, the true extent of the effects on market supply and demand for pharma logistics will be clearer. Some things to consider include, end user (hospital, clinics, etc.) infrastructure for reasonable deployment of a finished vaccine, whether at standard or more exotic temperatures, which may not be readily available in the clinic.

All other commercial and clinical supply chains are vying for the same resources that were available, prior to COVID-19. This has caused a vacuum in certain markets, which Sentry is working to mitigate. Sentry expects to meet and exceed all client needs, though continues to rely upon our trusted qualified vendors for additional support in fulfilling global logistics on time and in temperature. We expect the next 18 months to yield a better picture on the logistics market, going forward.

CP: How is technology evolving to help logistics providers like Sentry serve clients?

TM: Sentry continues to utilize cutting edge technologies to mitigate risks associated with movement of high value temperature sensitive materials, globally. Some of these technologies include: advanced manufacturer qualified shipping systems to maintain temperatures for days at a time and active cellular/GPS based temperature logging systems with multi-variable alarming (light, pressure, shock, humidity, location and temperature) to track shipments in real time.

Technologies such as these, have allowed Sentry to open shipping lanes into the far corners of the globe, with the highest assurance of successful shipment fulfillment, in time and in temperature. We continue to invest in advanced supply chain infrastructure, to ensure Sentry’s clients are receiving best-in-class service and quality.

CP: What are some of Sentry’s plans for the near future? How about long-term growth plans?

TM: Sentry’s plan is to closely monitor our clients’ developing needs and seek avenues to fulfill these needs. In 2021 and 2022 we will be adding stability chambers and services to support client research and development; a secondary facility in the U.S. for the repository of ultra-high value material, as risk mitigation; and we’ll continue to build out services in Copenhagen to meet our clients’ EU and ROW service requirements.

On our longer-term plans, we intend to evaluate additions of further global depots, in support of ROW operations; evaluate the addition of laboratory services for pharmaceutical development; increase Sentry’s consulting capabilities to further assist our clients with regulatory support; and further expand the Indianapolis site to meet market demand.

CP: Please add anything else you would like to share with our audience about Sentry and/or the markets it serves.

TM: Sentry is a smaller company that continues to grow, with a nimble and knowledgeable team. We continue to add resources to meet the ever-expanding biologic pharmaceutical supply chain market. We do so with the utmost care, while ensuring all client needs are met with the appropriate response. This allows Sentry to service organizations including the smallest of pharmaceutical development companies, as well as the largest organizations in the world. 

Tim Mitchell functions as President and Chief Executive Officer for Sentry BioPharma Services. Mr. Mitchell is an attorney, proven entrepreneur and business leader with more than 35 years of expertise in financial planning and management, investment strategy and business development. His professional accomplishments include a documented track record of helping both new ventures and established organizations attain and accelerate profitability. In his role as Chief Executive Officer at Sentry, Mr. Mitchell is responsible for day-to-day management decisions including oversight of all business operations including shipping/receiving, storage, recordkeeping, and quality, and for implementing Sentry’s long and short-term strategic plans. Further, Mr. Mitchell acts as a direct liaison between the Board of Directors and Sentry’s management team.