Uniquely delivered drugs have great potential, including playing a role in curing cancer. However, development of these technologies is challenging — fortunately, contract service providers are delivering these capabilities, as well as the emerging delivery technologies and breakthrough therapies needed to be effective.
For optimal pharmacokinetics, sometimes it’s about getting the right amount of a drug to the right place at the right time. Whether a drug is delivered orally, parenterally or through some other method like inhalation, bioavailability might be greatly enhanced when a drug is combined with certain types of nanoparticles in development today. These nanoparticles, when attached to smallmolecule drugs, often act as vehicles to get the drug where it needs to go, sometimes by getting it to where it might not ordinarily be allowed to go. Thus, medications that could help alleviate central nervous system (CNS) disorders such as Alzheimer’s disease and Parkinson’s disease are given the opportunity to work more efficiently.1
Nanotechnology’s pharmaceutical potential In a recent article appearing on Phys.org, Sam Gambhir, MD, Ph.D., professor and chair of radiology at Stanford School of Medicine said, “Nanotechnology offers an exquisite sensitivity and precision that is difficult to match with any other technology.”2 The U.S. government has recognized these medical advantages and deemed it necessary to help fund research in nanotechnology. The president’s budget for the National Nanotechnology Initiative was $1.5 billion. That money inevitably trickles into greater opportunities and resources for research and development for medical companies such as drug owners and CDMOs, nationally as well as internationally.2
Cancer’s role in design of unique delivery
It is in the area of cancer research where the most interesting unique drug delivery breakthroughs seem to be happening. Many patients already receive treatments with liposomes that carry drugs in lipidnanoparticles. Other forms of treatment await their fate in the clinical trials pipeline. There are many different ways that particles are being tested to specifically target and treat the cancer, from binding gold onto certain drug molecules to using specifically sized nanoparticles and reading their sound frequency, or “tune,” in order to locate cancer cells.2 The marriage between biologics and small molecules in the form of antibody drug conjugates (ADCs) has also been a growing source of unique deliveries within the cancer realm. According to the 2016 Nice Insight CDMO Outsourcing Survey, 57% of North American CDMOs currently list an ADC in their pipelines.3
The FDA and nanotechnology
However, more efficient drugs, uniquely delivered and microscopically refined, mean nothing if they cannot reach the right people and places on a macro level. It is often through assistance or by coordinated effort and/or partnership with the public sector that private companies have the ability to get drugs into the hands of the right patients. Regulatory agencies like the FDA are facilitators in the process. But they are also the main barriers for a drug’s entry into the marketplace, and thus to doctors, hospitals and patients. Yet, despite its enforcement mission, FDA continues to evolve in a way that advances along with technology in order to take advantage of it. For instance, Dr. Leonard Sacks, the former acting-director for the FDA’s office of Critical Path Programs, noted that the use of “novel scientific tools in the service of medical product development has been a central priority for FDA.”4
In the U.S., several broad measures have recently been adopted that may add extra regulation but are designed to facilitate the development of uniquely designed drugs. In 2012, congress passed the Food and Drug Administration Safety and Innovation Act (FDASIA). As most know, the act gives the FDA authority to enforce certain measures to ensure safety of the market on a global level (for example, policing of counterfeit drugs). According to the FDA’s website, this act also “accelerates patient access to new medical treatments and breakthrough therapies.”5
CLO’S to smooth the supply chain
When the public and private sectors are working in tandem to deliver drugs safely and efficaciously to market, the supply chain is most effective. But the drug supply chain can sometimes be a chaotic and arduous road for a company to navigate alone. Clinical logistics organizations (CLOs) are equipped to partner with drug owners in order to facilitate trials and help lessen the obstacles of getting a drug from discovery to market. CLOs, such as Marken, use interactive response technology (IRT) to deliver drugs to depots in the EU, and often navigate import regulations to get some of those drugs into certain countries such as Russia and Ukraine.6
The future of uniquely delivered drugs
It’s likely that due to the nature of these drugs, given their complicated design, there will be more hurdles for companies to bring them to market in the future. FDA’s 2013 Nanotechnology Regulatory Science Research Plan promises more oversight into the use of nanoparticles, with the agency overseeing how safe drugs of unique delivery will be.7 Yet, measures like the National Cancer Moonshot Initiative may pump some needed speed and efficiency into FDA’s pipeline. The Cancer Moonshot Task Force looks to break barriers and silos (silo mentality being the lack of sharing and transferring of information from one agency to another) and to facilitate partnerships, in order to hasten the cure for cancer.7 Were it to happen, that cure may very well come about with the help of drugs in their own kind of partnership with nanoparticles.
References
- Kreuter, Jörg. “Drug Delivery to the Central Nervous System by Polymeric Nanoparticles: What Do We Know?” Advanced Drug Delivery Reviews 71 (2014): 2-14. Web.
- Conger, Krista. “Small Wonder: How Nanotechnology Could Detect and Treat Cancer.” Stanford Medicine. 17 May 2016. Web.
- The 2016 Nice Insight Contract Development & Manufacturing Survey.
- “Food and Drug Administration Safety and Innovation Act (FDASIA).” U.S. Food and Drug Administration. Web.
- “2013 Nanotechnology Regulatory Science Research Plan.” U.S. Food and Drug Administration. Web.
- Wheeler, Wes, and Ariette Van Strien. “Clinical Logistics – Meeting The 21st Century Cures Challenge.” Pharma’s Almanac. Jan. 2016. Web.
- FACT SHEET: Investing in the National Cancer Moonshot. The White House: Office of the Press Secretary. 1 Feb. 2016. Web.