Lilly Shares Insights from Decade-Long Technology Transfer Experience

Eli Lilly and Company has published details of its long-standing technology transfer programme to increase the global supply of medicines for multidrug-resistant tuberculosis (MDR-TB). Begun in 2003, the effort included Lilly donating manufacturing technology and know-how for two antibiotics to pharmaceutical manufacturers in China, India, Russia and South Africa — all MDR-TB 'hot spots.' It also served as the foundation for the Lilly MDR-TB Partnership, the company's largest-ever philanthropic effort.

The technology transfer was Lilly's response to a dramatic global rise in MDR-TB cases in the late 1990s and early 2000s. Until that time, Lilly manufactured and supplied nominal quantities of two TB medicines — capreomycin and cycloserine. After independent researchers found that these two TB medicines were also effective in treating drug-resistant TB, Lilly doubled production and subsidised prices of the medicines. However, global demand was projected to quickly outpace manufacturing capacity, and Lilly sought a longer-term solution for people needing these medicines.

After close consultation with global TB experts, Lilly embarked on a novel approach: transferring its manufacturing technology and know-how for capreomycin and cycloserine to seven manufacturers. Lilly's experience and insights from this decade-long initiative are documented in a new white paper, Seeking Solutions to a Global Health Crisis.

"We thought bigger," commented John Lechleiter, Lilly's Chairman, President and CEO, in a video about the decision to undertake the technology transfer. "I am very proud of the fact that we looked beyond the question of can we supply these medicines. With a lot of Lilly people contributing their time and talents and working with multiple partners, it's been an extraordinary story and an extraordinary accomplishment."

The Lilly MDR-TB technology transfer sought to

• Establish a sustainable, high-quality supply of Lilly's two TB medicines
• Move manufacturing closer to where people needed the medicines most
• Increase global manufacturing capacity and volume
• Lower manufacturing costs to foster more affordable access.

"Sustainable access to quality-assured medicines has been our aim throughout this long initiative," said Evan Lee, Vice President of Lilly's Global Health Programs. "All seven of our partners have received regulatory approvals, including those from the World Health Organization's prequalification programme and other stringent regulatory authorities, to supply high quality versions of these two medicines to people with MDR-TB."

Lilly's experience generated several important insights that the company is sharing with governments, nongovernmental organisations, and other global health stakeholders involved in creating sustainable access to care. Among them are

• Technology transfers of medicines are highly complex and resource-intensive ventures requiring several years and substantial financial commitment.
• Evolving and variable regulatory requirements and changing customer preferences are critical considerations.
• The limitations and the potential of technology transfer should be fully understood before using this as a means of increasing access.
• Manufacturers should engage all personnel responsible for quality throughout decision-making and have a realistic market picture.

By sharing its experience, Lilly seeks to support decision-making by interested companies, public health entities, and other concerned parties, and to spur important discussions about: MDR-TB treatment and product supply; viability of the MDR-TB market for manufacturers; and the broader role of technology transfer in improving access to medicines for other global health challenges.