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Cost, complexity pose barriers to new drug development

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TORONTO — Notwithstanding recent U.S. FDA approvals of anti-VEGF therapeutics, the path to new drug development is complex and costly, according to a speaker here.

“The path to development begins when the target is identified,” Jeffrey S. Heier, MD, said to colleagues at the American Society of Retina Specialists meeting. “And the target has to be understood, both in terms of diseased and normal state.”

Jeffrey S. Heier

After the target is identified, an agent must be identified that can alter the action of the target molecule, he said. After this point, the barriers blocking development are complexity and cost of the process, with complexity entailing choice of controls, feasibility, regulatory control and duration of subject follow-up, and cost involving time and risk.

“There’s a great deal of discussion and debate about what the actual cost of bringing new drugs to market are,” he said. Estimates range from $500 million to $2 billion, not including failures.

Innovation and collaboration are key to minimizing the barriers to new drug development, Heier said.

“Without such efforts, diseases such as neovascular AMD and central retinal vein occlusion would have remained essentially untreatable,” he said.

Disclosure: Heier is an advisory board member for and/or receives research funding from Acucela, Aerpio, Alcon, Alimera, Allergan, Bayer, Forsight Vision, Fovea, Genentech, Genzyme/Sanofi, GSK, Kala, Kanghong, Liquidia, Lpath, Novartis, Ohr, QLT, Regeneron, Stealth Peptides, ThromboGenics and Xcovery.