DURHAM…Prominent cancer researchers from academia and industry meet with representatives from the U.S. Food and Drug Administration (FDA) this week for a two-day workshop seeking ways to speed testing and approval of new cancer drugs.
Chaired by the head of the Duke Comprehensive Cancer Center, the meeting is in Baltimore Wednesday and Thursday.
“Some of the very best scientists don’t necessarily have to tools or the training to develop their drugs and move them through the approval pipeline,” said H. Kim Lyerly, M.D., director of the Duke Comprehensive Cancer Center, chairman and sponsor of the two-day workshop.
The workshop’s primary goal is to encourage what is called “translational research” — transforming scientific discoveries made in the laboratory into viable treatments for patients, said Richard Pazdur, M.D. director, Division of Oncology Drug Products at the FDA. Pazdur said the sessions will provide insights into ways to facilitate and expedite drugs through the regulatory process.
Developing new drugs has been seen as a purely industrial enterprise in the past, but this scenario is changing, Lyerly said. Societal pressure is building to rapidly bring new drugs to patients — even for rare cancers — an endeavor that may not seem like good business.
Academic investigators can take the lead in developing drugs for these so called “orphan” diseases, he said. In addition, Lyerly said the strategies for battling cancer have changed, so must the methods of developing these strategies.
Removing barriers
“Decisions about how to proceed with testing a particular drug have often occurred in a vacuum, without input from the FDA,” he said. “We’re removing barriers to constructive dialogues by linking academics, early-stage drug developers and the FDA in a creative way to talk about new strategies for accelerating drug discovery.”
The workshop, “Accelerating Anticancer Agent Development and Validation,” provides an opportunity for seasoned cancer researchers from industry, academia, government and consumer groups to share their knowledge of drug development with 50 early-career cancer scientists from the U.S. and abroad. Each scientist will bring an agent or strategy with promising early-stage clinical data. Senior scientists will mentor them as they design strategic plans for fully developing and validating their anti-cancer agents.
Participants will refine and amend their strategic plans with the guidance of three mentors each — a representative from the FDA, a biostatistician and an academic or industrial clinical investigator. Scientists from the FDA, the National Cancer Institute (NCI), industry and academic institutions such as the Duke Clinical Research Institute will provide critical knowledge about designing and conducting clinical trials.
“We’ll be discussing the nuts and bolts of how to take great ideas and deliver effective and safe products to society quickly,” said Lyerly. “Our goal is to make the system work better, to make it more open and understandable to scientists who are trying to navigate their way through unknown territory.”
Pressure building
Dozens of new anticancer agents are discovered each year, but many of them fall short of reaching patients because of the painstaking process of drug testing and development. Scientists are trained to study the biologic basis of cancer or to treat patients, but they generally have not been trained to conduct multi-phase clinical trials or to negotiate the regulatory processes that lead to drug approval, said Lyerly.
The workshop’s primary goal is to encourage what is called “translational research” — transforming scientific discoveries made in the laboratory into viable treatments for patients, said Richard Pazdur, M.D. director, Division of Oncology Drug Products at the FDA. Pazdur said the sessions will provide insights into ways to facilitate and expedite drugs through the regulatory process.
Developing new drugs has been seen as a purely industrial enterprise in the past, but this scenario is changing, Lyerly said. Societal pressure is building to rapidly bring new drugs to patients — even for rare cancers — an endeavor that may not seem like good business. Academic investigators can take the lead in developing drugs for these so called “orphan” diseases, he said. In addition, Lyerly said the strategies for battling cancer have changed, so must the methods of developing these strategies.
“For the past few decades, most cancer drugs have been DNA poisons that kill the genetic machinery of the cancer cell and other healthy cells in their wake,” he said. “The newer anti-cancer agents tend to much more targeted: we attempt to block or activate a very specific pathway inside cancer cells that is critical to its growth or death. Drugs that target these pathways validate themselves as effective anti-cancer agents, but they also illuminate the pathway’s molecular role in the formation of cancer.”
In this manner, the development of new drugs is also contributing to the understanding of how cancer forms, grows and dies, said Lyerly. Participants in the workshop include the Duke Comprehensive Cancer Center, Duke Clinical Research Institute, FDA, NCI, American Association for Cancer Research, American Society of Clinical Oncology, National Institutes of Health, and Friends of Cancer Research.
