Pointed Debate - Industry experts discuss the benefits and challenges of self-administration of injectable therapies. - BioPharm International


Pointed Debate
Industry experts discuss the benefits and challenges of self-administration of injectable therapies.

BioPharm International
pp. 42-48

Solid dosages are currently injected using a needle and trocar. This is a painful procedure and is not suitable for self-injection. Our solid dose injector technology differs in that a tiny rod of drug is produced with a point on one end so that it can be pushed into the skin without the need for a needle. When placed in the skin, the rod dissolves and releases the drug or vaccine into the tissue. Storing the drug in a solid dosage form offers stability benefits and may avoid the need for refrigeration. Solid dosages have been shown to dissolve quickly in clinical trials, providing bioequivalence compared with a subcutaneous needle and syringe injection. However, the formulations can also be designed to provide controlled release, if desired, by incorporating polymers in the formulation. The device is simple to use and could be used for self-injection. Most applications will comprise a small, lowcost, disposable cassette that will be prefilled with the drug or vaccine dosage, and a handheld, springpowered, reusable actuator. The cost per injection will be low and the technology will be suitable for a wide range of peptides, proteins and vaccines.

BioPharm: What is your overall assessment of the future of injectable drug delivery?

Kaufman (SHL Group): With the wave of biologics coming to market, several new devices, such as autoinjectors, will see increased competition. One clear way that companies will differentiate themselves will be in the choice of drug delivery device. Designing, developing, producing and launching a biologic in an innovative device will not only enhance patient compliance, but could result in more revenue. For biopharmaceutical companies, the trend is clear: find the right partner, and develop devices for your biologics and future biologics now. It takes time and money, but it will be well worth it.

Novara (BD): The future is very bright. There is a steady increase in chronic diseases, but therapeutic developments are keeping pace by offering very sophisticated treatments that can be used with self-administration and injectable systems. However, there is an increasing need for differentiation and customisation of self-injection delivery solutions to help customers strengthen brand loyalty and to increase patient adherence and compliance with therapy. Device manufacturers with a broad portfolio of differentiating devices, full-service expertise, a commitment to quality-by-design, and global scale are uniquely positioned to meet the needs of pharma and biotech customers, payers, and healthcare professionals. Most importantly, injectable drug delivery systems afford a unique opportunity to patients with chronic disease to optimally treat their condition with minimal disruption to quality of life.

Potter (Glide): Biologics is one of the key growth areas in the pharmaceutical industry. Biologic products typically need to be injected and injection technologies will be required for these products, whether they are new products or lifecycle management strategies of existing products. I believe that there is a fantastic future for injectable drug delivery technologies. In particular, those technologies that can deliver a range of drug and vaccines, and that are suitable for self-injection and have a low cost of goods, will be used to develop products for both existing drugs and new drugs in development.

Sadowski (Antares): Pharmaceutical pipelines are increasingly reliant upon biological products and the range of therapeutic applications for biologics is expanding to chronic conditions. We are also seeing improved cancer survival rates, in part due to improved, targeted biologic therapies, which mean that cancer will be treated more often as a chronic condition using self-injected biologic therapies. Cost pressures and patient preferences will drive pharmaceutical firms to shift the administration approach from higher cost settings, such as infusion centers, to self-administration. All of this will expand the range of therapeutic applications for self-injected products, leading to greater reliance upon and advances in technologies suited to meet the needs of increasingly diverse patient circumstances.

Roundtabe particpants include: Steven Kaufman, marketing director, SHL Group (Scandinavian Health Group); Mark Novara, worldwide director, Strategic Marketing, Self Administration and Injectable Systems, at BD; Charles Potter, chief technical officer at Glide Pharma; and Peter Sadowski, chief technology officer at Antares Pharma.

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