In this article, Alan Shortall, Chief Executive Officer, Unilife Corporation, describes a new paradigm now driving the pharmaceutical market for advanced drug delivery systems, where the composition of clinical development pipelines is being increasingly dominated by complex injectable drugs, such as biologics, with specific molecular and formulation requirements that are targeted for patient self-administration. He argues that in many cases the combination of these large-molecule drugs with delivery systems comprised of commodity components sourced from conventional device manufacturers can constrain or diminish their commercialisation and marketability across highly competitive therapeutic classes. Instead, pharmaceutical companies are seeking to build long-term partnerships with a new generation of device manufacturers who specialise in the design, development and commercial supply of innovative delivery systems that can enable the commercialisation of pipeline drugs, enhance or extend product lifecycles and generate strong brand differentiation.
1. DIFFERENTIATION WITHOUT DISRUPTIONIn this article, Alan Shortall, Chief Executive Officer, Unilife Corporation, describes a newparadigm now driving the pharmaceutical market for advanced drug delivery systems, wherethe composition of clinical development pipelines is being increasingly dominated by complexinjectable drugs, such as biologics, with specific molecular and formulation requirements thatare targeted for patient self-administration. He argues that in many cases the combination ofthese large-molecule drugs with delivery systems comprised of commodity components sourcedfrom conventional device manufacturers can constrain or diminish their commercialisation andmarketability across highly competitive therapeutic classes. Instead, pharmaceutical companiesare seeking to build long-term partnerships with a new generation of device manufacturers whospecialise in the design, development and commercial supply of innovative delivery systems thatcan enable the commercialisation of pipeline drugs, enhance or extend product lifecycles andgenerate strong brand differentiation.Pharmaceutical companies with access to best- fied portfolio of delivery systems, an advancedin-class delivery systems that can enhance array of operational capabilities and the flexibil-patient care, protect healthcare workers or ity to respond to the needs of the pharmaceuticalimprove therapy compliance are well posi- customer with speed, agility and reliability.tioned to succeed across therapeutic classes fac-ing heightened levels of competition amongst UNILIFE AN EMERGING GLOBALnovel, generic or biosimilar drugs. LEADER FOR ADVANCED DRUG The development of these strong long-term DELIVERY SYSTEMSpartnerships between pharmaceutical compa-nies and device manufacturers are ultimately Unilife is a fast-growing US-based devel-focused on the development of the right device oper and commercial supplier of advanced drugto deliver the right drug to the right patient. delivery systems. In direct response to the unmetCollaborations between device manufacturers needs of pharmaceutical companies, healthcareand pharmaceutical companies can commence workers and patients, Unilife has developed oneearly during the clinical development of the of the most complete and customer-focused port- folios of injectable drug delivery devices on the market. A rich UNLIKE CONVENTIONAL DEVICE portfolio is led by the Unifill MANUFACTURERS THAT SUPPLY range of ready-to-fill syringes Alan Shortall with integrated safety features Chief Executive Officer ME-TOO COMMODITY (Figure 1), and also includes T: +1 717 938 9323 patient self-administration sys- COMPONENTS, UNILIFE SERVES AS tems such as auto-injectors and Unilife Corporation A TOTAL SOLUTIONS PARTNER FOR subcutaneous pump infusion sys- 633 Lowther Road tems, as well as other specialised Lewisberry, PA 17339ADVANCED DRUG DELIVERY SYSTEMS. devices for targeted organ deliv- USA ery. The size and scope of this T: +1 717 938 9323 F: +1 717 938 9364drug and span the entire commercial lifecycle unique portfolio, the depth of our operational E: firstname.lastname@example.org the combination product. capabilities and our unparalleled capacity for To succeed under this new industry paradigm device innovation together enable Unilife to www.unilife.comrequires device manufacturers to have a diversi- address the specific molecular, formulation andCopyright 2011 Frederick Furness Publishing www.ondrugdelivery.com 13
2. patient requirements of injectable drugs suppliedin either a liquid-stable or lyophilised form forreconstitution at the point of delivery. Unlike conventional device manufacturersthat supply me-too commodity components,Unilife serves as a total solutions partner foradvanced drug delivery systems. Our centre ofoperations is a state-of-the-art manufacturingfacility located in York, PA, US (Figure 2). Thismodern $32 million (20 million) facility wasopened in late 2010 and serves as an integratedcentre for device innovation. At York, Unilife hasbrought together the people, production systems,design expertise and quality processes necessaryto design and develop best-in-class drug deliv- Figure 1: The Unifill syringe, shown here before and after use, is the first and onlyery systems targeted for use across a range of known prefilled syringe with safety features fully integrated within the glass barrel.therapeutic classes. Designed by pharmaceuticalarchitects to be ahead of the curve in the design, ilised drugs and vaccines targeted for delivery All Unifill components within the fluidproduction and supply of medical devices, the US in a prefilled format. Unifill syringes function path feature USP Class six-compliant materi-FDA-registered site plays a key role in ensuring as a primary drug container, a safety device and als sourced from established suppliers, withthat we comply with stringent internal and indus- a needle containment system all rolled into one. the devices designed for customer supply astry standards for quality and reliability. Available in both single and multiple cham- per standard handling systems for equivalent The 165,000 square-foot (15,300 m2) facility ber formats with either a staked or an attach- syringes for integration into fill-finish systems.includes 11 cleanrooms, a product development able needle, Unilife syringes feature a unique As a primary drug container with integratedcentre, quality labs, machine shops and a fully automatic needle-retraction mechanism that is safety features, Unifill syringes can streamlinesegregated warehouse. Activities undertaken atthe site include device design, rapid prototyping,pilot and commercial production, bio-analytical UNIFILL SYRINGES ARE ALSO SIMILAR IN SIZE TO ANtesting, packaging, quality assurance and sup-ply chain. All activities at Unilife are guided by EQUIVALENT PREFILLED SYRINGE AND SIGNIFICANTLYadvanced business systems, such as SAP ERP SMALLER THAN THOSE ATTACHED WITH AN ANCILLARY(SAP AG, Walldorf, Baden-Wrttemberg,Germany), that complement those of our phar- SAFETY PRODUCT TO REDUCE PACKAGING, TRANSPORTmaceutical partners. Our Quality Management System is fully AND STORAGE VOLUMES BY UP TO 60-70%.certified to ISO 13485, and in compliance with21 CRF 210/211 for pharmaceuticals and 21 activated upon full-dose delivery. With activa- pharmaceutical industrial processes and signifi-CFR 820 for medical devices. tion of the safety mechanism signaled by an cantly reduce transport, packaging and storage audible, tactile click, Unifill syringes have a true costs associated with the attachment of ancillaryUNIFILL PLATFORM OF PRIMARY end-of-dose indicator. Operators can control the safety products.DRUG CONTAINERS WITH speed at which the needle is withdrawn directlyINTEGRATED SAFETY FEATURES from the body into the barrel of the syringe. The UNIFILL SYRINGE plunger is then automatically locked to prevent We have developed a full platform of Unifill the re-use of the device, circumvent product The Unifill syringe is the worlds first andready-to-fill syringes that are designed for use tampering, and encourage its convenient and only prefilled syringe with automatic safety fea-with a broad range of liquid-stable and lyoph- compact disposal. tures fully integrated within the glass barrel. It isFigure 2: Unilifes Centre for Operations in York, PA, US, Designed by Pharmaceutical Architects and Purpose Built to be Ahead ofthe Curve.14 www.ondrugdelivery.com Copyright 2011 Frederick Furness Publishing
3. generate brand differentiation for drugs mar- keted within competitive therapeutic classes to