For formulation teams developing injectable biologics and other high volume drugs, new drug delivery technology may soon make development of stable, bioavailable, clinically relevant formulations easier, faster, and less costly. That should come as good news to pharmaceutical and biotech companies facing an ever growing backlash from payers and consumers who bristle at the price of new pharmaceutical products, particularly biologics. Despite their great promise in treating cancers, autoimmune disorders, rare diseases and a host of other conditions, many of the headlines focus instead on the fact that new drugs are expensive. Very expensive. As a CNBC host pointed out to a pharmaceutical company CEO on air recently, if the company’s newly approved biologic was prescribed for every eligible patient at the retail price, Medicare would go broke.

A new wearable high volume injector expected to soon hit the market could help take some of the pressure off. 

It brings to market a novel way to cut costs and add overall value to the healthcare system: enabling easy at home delivery of biologics by patients themselves. However, unique problems arise in developing formulations for at home delivery of biologics.
These include:

• More volume of product must be delivered;
• Much higher viscosities due to higher concentration of proteins, among other reasons; and
• Greater propensity to precipitate out of solution.

In addition, many of the biologics’ formulations are not stable at room temperature for long periods. This often necessitates the development of a lyophilized product, which then needs to be reconstituted for delivery.

Wearable high volume injectors are designed to precisely address the challenges faced by formulation teams working on developing high volume, viscous drugs such as biologics. Enabling a simpler method of product preparation in combination with providing a simple to use wearable injector for the patient could vastly improve patient acceptance of self-administered therapy.
But it doesn’t end there. Pharmaceutical and biotechnology companies must and do think well beyond drug formulation to drug delivery, and by extension, compliance.

As former U.S. Surgeon General C. Everett Koop famously said, drugs don’t work if patients don’t take them. And for pharma companies, that is the bottom line.

So in addition to their role in speeding or eliminating tedious, time-consuming formulation functions, wearable injectors shine most brightly in their major role, as patient-friendly, easy to use drug delivery devices that experts say will quickly revolutionize the pharmaceutical industry.

It is widely anticipated that the most sophisticated wearable injectors, those designed on the basis of multiple human factors studies and preferred by patient panels, will also perform these additional duties:

• Deliver high volume and/or viscous drugs subcutaneously;
• Increase patient compliance;
• Enable patients to inject easily at home, at work or on the go; and
• Replace some infusions, particularly those administered in a hospital setting, significantly reducing the high costs of  healthcare provider-mediated drug delivery at healthcare facilities

Wearable injectors: How to differentiate a pharmaceutical product
There is one more key advantage the wearable injector offers. It can differentiate one pharmaceutical product from another product targeting the same disease by providing patients with a brand new delivery option. Can’t get to the hospital for a scheduled infusion due to a snowstorm, hurricane, important meeting or a play at your daughter’s school? No longer a problem with at home or on-the-go delivery of even large volume—from 2 mL – 50 mL—or the most viscous drug.

Historically, the desired formulation for subcutaneous delivery has been high concentration and low volume, primarily due to the limitations of legacy injection systems such as syringes and auto injector pens. Today there are more than 900 biologics in development. Among them are today’s most promising drugs, tomorrow’s blockbusters. However, the majority of these molecules must be delivered in volumes greater than the 1 mL common to syringe delivery. In addition, many molecules are highly viscous and the force required to deliver them subcutaneously would be unacceptable to many patients. The new injection technology resolves these issues. For example, the wearable injector being developed by Enable Injections can deliver up to 50 mL (range 2-50 mL) subcutaneously at a customizable drug delivery rate and duration. It can deliver at a rate of 1 mL per minute of a drug as viscous as motor oil—125 cP (water has a cP of 1).

How will this affect patients? Intravenous administration of the drug Herceptin for the treatment of breast cancer currently takes 30-90 minutes in a healthcare facility, not including the travel time. Subcutaneous administration of the same Herceptin dose with a wearable injector would take just 2-5 minutes at home, work, etc. 

Delivering drugs: What patients want
The development of this entirely new class of drug delivery devices—wearable injectors—will facilitate the development and convenient delivery of higher volume formulations. This is a boon not only to the pharma industry, but also to patients frustrated with setbacks in bringing new drugs to market. 

Although patient advocacy has been around for a very long time, an article in the Wall Street Journal, “Patients’ Group Scores a Victory in Drug Research,” underscores the new reality. Patients, not pharmaceutical companies, are calling the shots. No longer willing to take a back seat, advocates are writing draft guidance for pharmaceutical companies—and even submitting directly to the FDA. The agency is listening “intently, intensively” to their demands.  

Imagine the clamor when drug delivery devices that allow patients to subcutaneously self-inject biologics easily and comfortably at home hit the market. Many patients with cancer or Rheumatoid Arthritis or parents of a child with hemophilia or a rare diseases may no longer need or want to take a trip to a healthcare facility for an infusion. Instead, the patient or caregiver will be able to prepare and deliver the injection in minutes taking these simple steps:

1. Insert any standard vial or syringe into a container that automatically warms any refrigerated drug while the injector fills;
2. Where mixing is required, no action required. It occurs automatically as the injector fills;
3. When the injector is filled, in less than a minute, patient adheres the injector to skin under clothing; and
4. Push one button to begin the injection

An infusion that today would require a trip to a healthcare facility could be completed in minutes at home at much lower cost and far greater convenience, with never a needle in sight. 

This development is particularly noteworthy since wearable injectors such as the Enable Injector, the size of small yo-yo, can, for the first time, deliver up to 50 mL subcutaneously at a customizable drug delivery rate and duration with minimal patient discomfort. 
Human factors play a prominent role in patient demands. Just as Amazon changed consumer buying habits, so patient-friendly wearable high volume injectors have the potential to change patients’ injection regimens. They are widely expected to boost compliance, which may lead to improved patient outcomes, the ultimate goal of any treatment. The route to blockbuster biologics lies in addressing these human factors.

A major technological innovation
There is a growing sense that the pharmaceutical industry’s traditional cost-cutting and productivity enhancement methods have largely run their course. Facing the challenge of finding the right balance between volume and viscosity while maintaining quality and stability, formulation teams can save millions of dollars as budgets shrink by adopting new drug delivery technology that not only enhances patient convenience, but removes much of the added cost and effort of developing large molecule biologics when compared to developing small molecule pharmaceuticals.

Operating in this ever-harsher environment, pharmaceutical companies that survive and prosper will be those that are already responding by re-inventing to meet the challenges that lie ahead. In fact, a recent Price Waterhouse Cooper survey of pharmaceutical executives in 13 countries found that the most innovative players are growing faster than their less pioneering competitors.

“I have never been able to say this about a class of novel (pre-approval) drug delivery systems with such certainty before, but wearable bolus injection devices will change the pharmaceutical industry forever, and they will do it relatively soon,” says drug delivery expert Guy Furness. “This is a major technological innovation.”

Partnering with a drug delivery company
As global drug maker CSL Behring considered its pipeline, the specialty biotherapeutics giant looked for new drug delivery technology that would differentiate their products and the company squarely at the forefront of patient-focused companies. 
For its promising large volume biologic formulations, the company sought to make every effort to improve the patient experience and quality of life. Patient panels considered a number of drug delivery options. Injection comfort and convenience were among their key preferences.

Consequently, the company decided to offer patients more individualized options, which included potential new delivery devices. One of these was the wearable injector for subcutaneous delivery. A development deal was struck with Enable Injections, whose injectors were engineered based on more than 60 Human Factors studies and whose novel technology was compatible with the company’s products.

Enabling the biologic drug market
At lightning speed, wearable injectors are becoming the single largest driver of the rapidly evolving pharmaceutical and biotechnology markets. It’s no wonder:

• Interest in novel parenteral drug delivery technology is growing as more biopharmaceutical companies seek to differentiate their products;
• High volume biologics cannot be delivered with today’s legacy injection systems;
• Injectable drugs are projected to be the largest drug delivery growth category in the next 10 years;
• The majority of the new injectables are biologics, which now account for $161B in sales are predicted to grow to $221B by 2017, accounting for 19-20% of the total market value; and
• Analysts predict that by next year, 50% of the top 100 drugs will be biologics.

More than 900 injectable biologic drugs are currently in development or on the market. These promising new drugs and future blockbusters have the potential to advance treatment of cancer, autoimmune deficiencies, blood disorders, rare diseases and a host of digestive, infectious, cardiovascular, respiratory, neurologic and musculoskeletal diseases. As soon as next year, biologics are expected to account for approximately half of top drugs in utilization, and considerable more in sales. 

But these large dose, viscous biologics, monoclonal antibodies and immunoglobulins will only fulfill their full potential if formulations are developed in partnership with new drug delivery devices in a collaboration that speeds time to market, reduces costs and pleases patients. 

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Michael Hooven is the president and chief executive officer of Enable Injections.