During a recent drug development seminar held in Tel Aviv with a group of 40 C-level executives, Ken Phelps, president and chief executive officer of Camargo Pharmaceutical Services, addressed Israeli pharma executives on the 505(b)(2) development process as an important tool that can reduce costs and shorten the timeline for approval of new drugs.
“Israel is known for innovation, and Israeli developers offer a wide range of drug candidates with good market potential and an opportunity to gain FDA approval through 505(b)(2),” said Mr. Phelps. He added that development under 505(b)(2) is ideal for drugs making a change from a previously approved drug because it allows utilizing selected data from studies in the public domain.
“For new indications, drugs that enhance some aspect of an existing drug, drugs with dosage changes or new active ingredients, prodrugs, combination drugs or drug-device combinations, 505(b)(2) can be an attractive alternative,” Mr. Phelps said.
Camargo Speaks at Israeli Drug Development Seminar
By Kristin Brooks
Published December 18, 2013
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