Given its new product development issues, Dura needed an R&D staff with a broad base of skills in fine particle technology and chemistry, drug delivery systems, and engineering. Dura's in-house staff was unable to meet these challenges simultaneously.

Accordingly, Dura began exploring alternative R&D options, including corporate alliances and contract development agreements. It concluded that an outsourcing R&D agreement with a contract lab offered greater flexibility and access to broad science and engineering skills. Dura selected SRI for its track record in advanced chemical and biological sciences, engineering, and innovative drug delivery systems.

Conquering Key Technology Milestones
Dura's non-chlorfluorocarbon inhalation device uses a blended powder formulation of an active drug ingredient mixed with a nonactive carrier. With slight inhalation from the patient, the dispenser is automatically activated, eliminating the awkward coordination of a metered dose inhaler that makes most devices difficult for children and seniors to use. The amount of drug inhaled into the lung from the Dura device does not depend on the respiratory capacity of the patient--which is a clear advantage for patients with respiratory diseases.

SRI used its expertise in drug milling to develop a customized method for producing the uniform fine drug powder required for delivery to the lung. Special blending techniques were then developed to ensure uniform concentrations of the active drug in the inert carrier. A new powder filler was invented and built at SRI that could produce uniform packaged doses. Stability tests were conducted to ensure the adequacy of the packaging and Good Manufacturing Practices (GMP) cleanroom protocols used in production of clinical trial packages. Dura later adopted these procedures for use in its own manufacturing facilities. SRI also developed new methods and gathered extensive laboratory data required by the FDA to estimate the amount of active drug the Dura device delivered to patients in clinical trials.

Other R&D Benefits
Dura leveraged its R&D outsourcing relationship and Dryhaler(TM) innovation to raise $13 million in additional funds. These funds were used to create Dura Delivery Systems Inc. (DDSI), a separate research corporation established to develop asthma drugs for use in the Dryhaler(TM).

With the help of outside R&D resources, Dura moved from product concept through Phase II clinical trials in just 18 months--significantly faster than average time-to-market cycles in the medical device industry. The goal of entering clinical trials by December 1994 was achieved through the joint development program.

The medical community's response to the new product was very favorable. Dura set new standards for others to match. The company is now exploring the effectiveness of its Dryhaler(TM) for pulmonary delivery of proteins, and area in which SRI's patented milling and micronizing technology may be beneficial.