INDIANAPOLIS, Ind.—Through a new drug discovery initiative, Eli Lilly & Co. is hoping to engage researchers in searching for new drug candidates to treat Alzheimer's disease, cancer, diabetes and osteoporosis.
The initiative, called the Lilly Phenotypic Drug Discovery Initiative, or PD2 (pronounced PD-squared), uses Lilly-developed disease-state assays and a secure Web portal to evaluate the therapeutic potential of compounds synthesized in university and biotechnology laboratories. Findings from this initiative could ultimately form the basis for collaboration or licensing agreements between Lilly and external institutions.
Dr. William Chin, vice president of discovery research and clinical investigation at Lilly says over the last several years, officials at Lilly have looked for ways they as a company and as an industry can transform drug research and development.
"It simply costs too much and takes to long to get the drugs to the patients and that is something that we want to change," Chin said.
That line of thinking led Lilly to form the initiative in an effort to seek out new talent and ideas in the drug research arena.
"Each year, researchers throughout the world design and synthesize compounds in university and biotechnology laboratories that are never fully evaluated as potential drug candidates," adds Dr. Alan D. Palkowitz, vice president of discovery chemistry research and technologies at Lilly. "There's an untapped source of ideas and compounds in the greater scientific community that could ultimately impact patients' lives following further evaluation and development."
Collaborations between Lilly and external researchers are not new; however, the PD2 initiative is designed to provide a more convenient point of entry for global external researchers into Lilly's drug discovery and development process. By doing so, PD2 allows for the establishment of productive relationships with institutions and organizations that may not previously have worked with Lilly.
Chin adds that PD2 offers Lilly an opportunity to foster new relationships outside the company and is another step in the drugmaker's evolving transformation from a Fully Integrated Pharmaceutical Company, or FIPCO, to a Fully Integrated Pharmaceutical Network, or FIPNet.
"Our major impetus is trying to understand how we can have access to more of the ideas that are present in this world. It is a part of our transformation strategy," Chin adds. "We feel that by working with external partners, we can make this a win-win-win situation."
The winners, according to Chin, are the thought leaders in academia who can have molecules and other ideas tested; Lilly, which gains new relationships; and ultimately the patients, who will benefit from the development of new treatments.
Through the automated PD2 interface, researchers confidentially submit a structure of their compound for an initial computational evaluation using a set of proprietary Lilly algorithms focused on drug-like properties and structural novelty. If the compound structure meets certain specified criteria, the researcher is then invited to submit a physical sample for biological testing.
"This offers the opportunity to test molecules and ideas of others," Chin notes. "They will get to learn a great deal about their molecules and ideas that maybe they would never have known otherwise."
All testing by Lilly is free, and all intellectual property rights remain with the submitting researcher and/or institution at this stage. An objective of PD2 is not to promote a random, high volume submission of compounds, but rather to encourage the testing of molecules that represent novel structural diversity and hypotheses that are thoughtfully considered in light of the biology associated with each assay module.
The testing could lead to some moments of serendipity for those involved.
"The test will let the researcher know if their feelings about their molecules are bold claims of if there is something more to it," Chin added. "We might find out that a drug that they thought was good for cancer might actually have the potential to be a good treatment for diabetes. It may not have been tested for that otherwise."
After biological testing is completed, Lilly provides the external researchers a data report with a complete biological profile of the compound across the four assay modules mentioned earlier (Alzheimer's disease, cancer, diabetes and osteoporosis).
Palkowitz points out that because these data are derived from sophisticated and systematic in vitro model systems, they provide researchers with broader assessments of a compound's biological profile than what is generally available today in academic or government laboratories.
In return for these data, Lilly has first rights to exclusively negotiate a collaboration or licensing agreement with submitters of those compounds that demonstrate biological activity that Lilly would like to further explore. If there is no agreement within a defined time period, the researcher is granted no-strings-attached ownership of the data report and can choose to use it in publication or grant proposals, or to further refine structural hypotheses, all of which may advance scientific discovery.
Dr. Peter Wipf, professor of chemistry and professor of pharmaceutical sciences at the University of Pittsburgh, is one of the external experts to have consulted with Lilly on the development and testing of PD2. He said that, for researchers not employed at a pharmaceutical company, the major potential benefits of PD2 include the ability to test compounds in well-validated assays, the comprehensive nature of the data reports and the opportunity to exchange ideas and hypotheses with Lilly experts on compounds of interest.
"I'm looking for drug discovery experts who can critically evaluate the data on my compounds and engage me in discussing their immediate potential for optimization and perhaps their ultimate impact on specific areas of human health with unmet medical need," says Wipf.
The potential benefit for Lilly is increased access to top global research talent, novel therapeutic hypotheses and rich chemical diversity to amplify and leverage Lilly's work and expertise in these areas.
The success of the initiative will be measured in the victories for the parties involved— academia/researchers, Lilly and patients.
Chin points out that academic colleagues will learn more about their molecules and ideas.
"The bottom line is that if their molecules and ideas do work, you have something that may otherwise not have been on the path to becoming a drug candidate," Chin says.
While the company has a robust pipeline, Chin says Lilly can't rest on its laurels. Ultimately, Lilly's success in PD2 will be gauged by the number of new relationships it builds and the candidates that proceed through the pipeline.
"We believe open collaboration with a network of scientists will create new venues to deepen our understanding of complex biological processes and eventually to discover novel therapeutics that benefit patients," adds Chin. "Ultimately, our hope is that the patient will be the biggest winner of all."
The initiative, called the Lilly Phenotypic Drug Discovery Initiative, or PD2 (pronounced PD-squared), uses Lilly-developed disease-state assays and a secure Web portal to evaluate the therapeutic potential of compounds synthesized in university and biotechnology laboratories. Findings from this initiative could ultimately form the basis for collaboration or licensing agreements between Lilly and external institutions.
Dr. William Chin, vice president of discovery research and clinical investigation at Lilly says over the last several years, officials at Lilly have looked for ways they as a company and as an industry can transform drug research and development.
"It simply costs too much and takes to long to get the drugs to the patients and that is something that we want to change," Chin said.
That line of thinking led Lilly to form the initiative in an effort to seek out new talent and ideas in the drug research arena.
"Each year, researchers throughout the world design and synthesize compounds in university and biotechnology laboratories that are never fully evaluated as potential drug candidates," adds Dr. Alan D. Palkowitz, vice president of discovery chemistry research and technologies at Lilly. "There's an untapped source of ideas and compounds in the greater scientific community that could ultimately impact patients' lives following further evaluation and development."
Collaborations between Lilly and external researchers are not new; however, the PD2 initiative is designed to provide a more convenient point of entry for global external researchers into Lilly's drug discovery and development process. By doing so, PD2 allows for the establishment of productive relationships with institutions and organizations that may not previously have worked with Lilly.
Chin adds that PD2 offers Lilly an opportunity to foster new relationships outside the company and is another step in the drugmaker's evolving transformation from a Fully Integrated Pharmaceutical Company, or FIPCO, to a Fully Integrated Pharmaceutical Network, or FIPNet.
"Our major impetus is trying to understand how we can have access to more of the ideas that are present in this world. It is a part of our transformation strategy," Chin adds. "We feel that by working with external partners, we can make this a win-win-win situation."
The winners, according to Chin, are the thought leaders in academia who can have molecules and other ideas tested; Lilly, which gains new relationships; and ultimately the patients, who will benefit from the development of new treatments.
Through the automated PD2 interface, researchers confidentially submit a structure of their compound for an initial computational evaluation using a set of proprietary Lilly algorithms focused on drug-like properties and structural novelty. If the compound structure meets certain specified criteria, the researcher is then invited to submit a physical sample for biological testing.
"This offers the opportunity to test molecules and ideas of others," Chin notes. "They will get to learn a great deal about their molecules and ideas that maybe they would never have known otherwise."
All testing by Lilly is free, and all intellectual property rights remain with the submitting researcher and/or institution at this stage. An objective of PD2 is not to promote a random, high volume submission of compounds, but rather to encourage the testing of molecules that represent novel structural diversity and hypotheses that are thoughtfully considered in light of the biology associated with each assay module.
The testing could lead to some moments of serendipity for those involved.
"The test will let the researcher know if their feelings about their molecules are bold claims of if there is something more to it," Chin added. "We might find out that a drug that they thought was good for cancer might actually have the potential to be a good treatment for diabetes. It may not have been tested for that otherwise."
After biological testing is completed, Lilly provides the external researchers a data report with a complete biological profile of the compound across the four assay modules mentioned earlier (Alzheimer's disease, cancer, diabetes and osteoporosis).
Palkowitz points out that because these data are derived from sophisticated and systematic in vitro model systems, they provide researchers with broader assessments of a compound's biological profile than what is generally available today in academic or government laboratories.
In return for these data, Lilly has first rights to exclusively negotiate a collaboration or licensing agreement with submitters of those compounds that demonstrate biological activity that Lilly would like to further explore. If there is no agreement within a defined time period, the researcher is granted no-strings-attached ownership of the data report and can choose to use it in publication or grant proposals, or to further refine structural hypotheses, all of which may advance scientific discovery.
Dr. Peter Wipf, professor of chemistry and professor of pharmaceutical sciences at the University of Pittsburgh, is one of the external experts to have consulted with Lilly on the development and testing of PD2. He said that, for researchers not employed at a pharmaceutical company, the major potential benefits of PD2 include the ability to test compounds in well-validated assays, the comprehensive nature of the data reports and the opportunity to exchange ideas and hypotheses with Lilly experts on compounds of interest.
"I'm looking for drug discovery experts who can critically evaluate the data on my compounds and engage me in discussing their immediate potential for optimization and perhaps their ultimate impact on specific areas of human health with unmet medical need," says Wipf.
The potential benefit for Lilly is increased access to top global research talent, novel therapeutic hypotheses and rich chemical diversity to amplify and leverage Lilly's work and expertise in these areas.
The success of the initiative will be measured in the victories for the parties involved— academia/researchers, Lilly and patients.
Chin points out that academic colleagues will learn more about their molecules and ideas.
"The bottom line is that if their molecules and ideas do work, you have something that may otherwise not have been on the path to becoming a drug candidate," Chin says.
While the company has a robust pipeline, Chin says Lilly can't rest on its laurels. Ultimately, Lilly's success in PD2 will be gauged by the number of new relationships it builds and the candidates that proceed through the pipeline.
"We believe open collaboration with a network of scientists will create new venues to deepen our understanding of complex biological processes and eventually to discover novel therapeutics that benefit patients," adds Chin. "Ultimately, our hope is that the patient will be the biggest winner of all."
