Eugene Polini, Technical Key Account Manager at Datwyler examines the challenges drug developers are facing to speed up production lifecycles and what solutions are available to them.
While people around the world hope to never see another global pandemic in their lifetimes, it is the responsibility of pharmaceutical manufacturers to prepare for the next one by applying key learnings of the past two years to fortify and streamline supply chains. Amid today’s increasingly complicated global marketplace, drug manufacturers stand to benefit sooner rather than later in taking measures to speed the drug development and production lifecycle.
A Landscape of Trials
Drug development comes with challenges from intensive and often expensive clinical and pre-clinical tests—sometimes for highly specialised drugs that yield little to no profits—to the pricing pressures created by generics, which often end the market exclusivity period. Additionally, material and personnel shortages, transport delays, quickly changing marketplace dynamics, and evolving regulations further complicate supply chains. After product launch, pharmaceutical companies must observe and act on evolving patient needs through new indications, improved formulations, and new drug delivery systems that can improve patient experience. Indeed, it is an evolving mission, and the ability of drug companies to quickly deliver is necessary both to support public health and maintain credibility.
To accelerate the drug lifecycle management process, maximise value of a product’s life and discover new opportunities, pharmaceutical industry suppliers must come together. By doing so and applying best practices that simplify and speed up the process to deliver safe, effective, and high-quality drugs to communities in need of care, everyone wins.
Challenges and Opportunities
It is critical for the pharmaceutical industry to be proactive about challenges that may affect their workflow, and most importantly, patients. Pharmaceutical product lifecycle management is about maximising the value of drug products to customers – from the discovery and development stage all the way to FDA post-market drug safety monitoring. This includes new indications, improved formulations, new delivery systems and packaging as well as IT solutions that help expand the utility and improve upon efficacy, safety, and patient experience.
One must consider how to improve the effectiveness of a lifesaving drug in a vial, the drawbacks, and the drug delivery process. In an emergency scenario where the difference between life and death could be determined in seconds, every detail matters. For example, one must flip the plastic dust cover off the vial, clean the stopper surface with alcohol, prepare a disposable syringe, withdraw the medication, make sure the proper dose is contained in the syringe, clean the injection area on the patient, and then administer the injection. The patient population benefits from a drug that can be delivered quickly and safely.
The Five Stages
There are five stages in the drug lifecycle management process:
- Discovery and development – The first step, discovery and development, consists of researchers assessing the disease so that they can design a product that can prevent or treat that particular illness. From there, researchers can conduct experiments to gather information on how the drug will be absorbed, distributed, broken down and eliminated. During this stage, researchers also explore potential benefits and side effects, ideal dosage, and how the treatment interacts with other medications. They also consider its effectiveness against other drugs.
- Preclinical research – The second step in the drug development process is preclinical research, which includes in vitro and in vivo trials. During this stage, researchers determine who qualifies to participate, how many people will be a part of the study, how long the study will last, among other considerations. They also determine what assessments will be performed and how the data will be reviewed.
- Clinical research – During the clinical research stage, trials are then conducted in individuals. Drug developers must submit an Investigational New Drug (IND) application to the FDA before even beginning this stage, however. In this application, developers must include manufacturing details, data from prior human research, what the planned clinical protocols are for these trials and more. Within this stage there are four different phases to measure dosage, efficacy, and safety as well as any potential side effects and adverse reactions to the drug.
- FDA drug review – During this fourth step, pharmaceutical companies submit a New Drug Application, which the FDA then reviews for approval and an FDA advisory committee gives their input. The next and last stage is the post-market drug safety monitoring, in which the FDA reviews reports of any issues with the drug. This allows the FDA to add cautions to the dosage or usage information and advise on any other measures for more serious issues.
- FDA post-market drug safety monitoring – The most complex and difficult portion of this process, next to discovery and development, is the regulatory pathway. This requires a highly complex and specialised body of knowledge practiced by professionals that specialise in regulatory science. Even though all these stages provide valuable evidence on a drug’s efficacy and safety, it is virtually impossible to have a full picture on the safety of a drug once approved. Due to that limitation, the FDA continues to monitor its impact over the months and even years that make up a product’s lifetime even after it hits the marketplace.
Drug Development Lifecycle: Solutions
With so many stages in the drug development lifecycle, there are also many opportunities for hiccups. To effectively bring a new drug to market and improve cycle time, pharmaceutical companies can begin by outsourcing research and development activities to increase efficiency and allow their internal team members to focus on other valuable tasks in the drug development process. Mergers and acquisitions are also becoming more common so companies can have more capital, production resources, and a wider clientele. This allows them to develop more complex drugs and delivery systems. Specialisation is another strategy where companies become the market leaders in things like large molecules, biologicals, recombinants, and even small molecule specialties.
Challenges will never cease to exist, so it is important to be prepared. If the choice is to work with a partner, choose one that is innovative, has a strong global industrial presence, and most importantly, is reactive to everyday needs, strategic questions, and tasks with a short turnaround time.
There are no cutting corners in the drug development process. When the industry comes together, it is stronger than when one company operates in isolation. By keeping the ultimate goal in mind – which is to deliver safe and effective treatment for patients around the globe – pharmaceutical companies can come together and implement best practices to push the process forward and bring excellent healthcare to those in need.