The merits of accelerating time to market through innovations in formulation design and drug delivery systems was the focus of a panel discussion as part of the 4th Peptide Drug Design and Delivery Summit in Philadelphia, Pennsylvania, on August 27. Panelists deliberated why innovation is slow in the field of drug discovery and what they see in the future of commercially available peptide drug products. Moderator Rakesh Dixit, PhD, president and CEO of drug development consulting firm Bionavigen, opened the discussion by addressing concerns about peptide drug formulations for the next generation of drug products.
Peptide drugs have unique challenges regarding solubility and viscosity profiles, particularly in high-concentration formulations. Dr. Dixit mentioned that nanotechnology delivery systems may help advance peptide drug design in this aspect by allowing scientists to modify and stabilize these profiles. For example, a product on the market now, DEP, a dendrimer, conjugates peptide drugs along with targeting moieties and excipients. But how do these new drug formulations impact the regulatory burden for pharmaceutical companies? Many scientists are concerned that the use of novel active pharmaceutical ingredients (API) with peptides will belabor the FDA approval process.
There are a number of complicating factors unique to peptide drugs that need further characterization and standardization to convince regulators that these products are safe. Among these factors are toxicity concerns. David Owen, PhD, vice president of research at Starpharma, a developer of dendrimer products, believes that it is crucial to strip out as many unnecessary things as possible from peptide drug products and to keep products simple in design. Scientists have found that excipients and additional components can have unwarranted impacts on the bioavailability of the API in peptide drug products. Therefore, the safety of each component added to drug products needs to be qualified and defined for regulators. This requires a huge expense to find out what effect each component is having on the API and in patients. Structural characterization is not enough in these cases. Toxicity studies in animal models will be required for the approval process.
What role does nanotechnology play in the future of peptide drug design? This is a hot topic among materials scientists and drug formulation chemists around the world. An opposing view is that investments in these technologies would be better spent in other research areas that are leading to commercially available products, whereas others argue that innovation and technology development takes time but is well worth the wait. Xialong Li, PhD, professor and associate dean of the University of the Pacific and CSO at specialty pharmaceutical firm Triastek, suggests that if you look at the comparison between the funding in nanotechnology research, the number of academic papers published and the number of products coming to market, there is a great disparity. Is this investment better spent in an area that can be employed more efficiently to improve patient outcomes? Alternatively, Dr. Dixit offered the examples of cell therapy and gene therapies, which were concepts that scientists worked on for decades before any products became commercially available.
The panel also debated the main challenges in nanotechnology, which are the scalability and reproducibility of products. Currently, researchers are struggling with batch-to-batch consistency of API bioavailability. Because of the novelty of this technology, Dr. Owen suggested that a new approach needs to be established for classification and characterization of nanoparticles for drug use. The industry must develop the tools and techniques for analytical and synthetic chemists to improve reproducibility, an iterative process that may take years. Despite difference in the path forward for nanotechnology, there was a generally optimistic outlook among panelists that nanotechnology will eventually become a standard in peptide drug design.
It is an exciting time for innovation in drug design and patients. Panelists debated how long certain products might take to reach the patient, but these products are coming nonetheless. Keep an eye out for new products featuring nanotechnologies and other innovative technologies soon!
Samantha Black, PhD, is community manager and editor of the Science Advisory Board, an international community of science and medical experts. The Science Advisory Board is part of Science & Medicine Group.