Every industry has a distinct set of obstacles to overcome, but it’s no secret that the life sciences industry encounters more speedbumps than most. Market cycles and product failures are expected, but companies also face economic challenges, advancements in technology, political and regulatory changes, escalating development costs, and lightning speed industry growth.
Innovation is the backbone of life sciences, with remarkable discoveries made in areas like genetic engineering, immunotherapy, cell and gene therapy, and precision medicine. As a result, we now have the possibility of curing diseases that we once thought were untreatable. Remarkably, the pandemic altered the way we get vaccines and treatments to market. As a result, there could be lasting effects on drug development: vaccines and other treatments were approved and to market in record time, companies that are usually competitors are now collaborating, and many are trying to make their supply chains more robust to deal with disruption. Some researchers and companies in the drug-development field say the system might never be the same again.
With these advancements come major changes in the way drugs are developed and manufactured. Standard manufacturing processes have shifted from traditional chemical synthesis to the genetic manipulation of living organisms and using the body’s own defenses to treat and prevent diseases. Additionally, a growing trend is the use of artificial intelligence and process analytical technology in drug discovery, development, and production. And considered by many as the biggest shift in the drug making industry, is continuous manufacturing processes.
These advancements have saved millions of lives and improved the health and safety of patients around the globe. Given the magnitude of these successes, it is easy to overlook one major problem that needs to be acknowledged and addressed by companies large and small – we have a resource shortage.
Facing a Serious Shortage
While there is no shortage of people trained to handle traditional pharmaceutical manufacturing, there is a skill set shortage of people to manage modern biopharmaceutical manufacturing processes and the recent breakthroughs in innovation. Factor in the difficulty professionals face to develop their skill set at the same rate of the industry as a whole develops. In an industry where the only constant is change, the people who do the work must also constantly change and evolve. And the rate of change is becoming more rapid every day.
In some countries such as the Netherlands, the government has stepped in to address these shortages and aims to improve the alignment between education and life sciences, as well as other industries.
Unfortunately, the rapid change in the industry does not allow for companies to wait for government to step in and fix the problem. This is an issue that requires broader and gradual change. In the meantime, there are steps companies can take in order to gain a competitive edge.
Bridging the Gap
Life science consultants are becoming increasingly in-demand; enabling biotech and medtech companies to access specialist skills easily.
Drug and device companies of all sizes encounter rigorous processes to bring a product to market. From painstaking research to clinical trials to product launch, these processes involve several skill sets, including data analysis, statistics, writing, and project management, to name a few.
Many companies – domestic and global, large and small – have engaged the services of a consulting company. Even companies with in-house resources need additional help with many tasks and areas that require specialized expertise across the organization.
One of the top five biotech contract services offered by experts is life science consulting services. Qualified industry experts can help with services ranging from protocol design, analytical and scientific services, regulatory, preclinical, and clinical services to commercialization.
Here’s a quick look at areas where life science consultants can help:
Compliance – maintaining and elevating the stature of quality systems, ensuring compliance standards are met:
- Quality Management Systems
- Remediation
- Quality Assurance
- Qualified Person (QP) and Responsible Person (RP)
- Pre-Approval Inspection and GxP Audits
- Quality Investigations
Product and Process Lifecycle Management – mitigate project costs, accelerate timelines, and improve commercial probability:
- Technology Transfer
- Process Optimization
- Program and Project Management
- Process and Product Development Management
- Third-Party Selection Services
Commissioning, Qualification, and Validation – develop continuously reliable and compliant production services, to meet the highest GMP standards:
- Process Validation
- Cleaning and Sterilization Validation
- Good Manufacturing Practices (GMP) Product Lifecycle Methods
- Computer System Validation
- Equipment and Facility Engineering
Engineering and Project Management – managing projects of various scale, complexity, and importance:
- Bioprocess Engineering
- Process Architecture and Facility Design
- Equipment and Facility Engineering
- Process Automation
Clinical Services – ensuring safe and effective clinical conduct and support for patient health and safety:
- Medical Monitoring
- Data Safety Monitoring Board
- Safety Management Plan (SMP) Development
Specialized Life Science Strategy Consulting – new and developing market segments:
- Cannabis and CBD
- Cell and Gene Therapy
Pharma consulting teams will work onsite with the client’s cross-functional experts to lead critical projects and to ensure goals are achieved – efficiently, economically, and on time. Consultants will work individually or as a team, bringing a wealth of industry experience, valuable leadership, and problem-solving skills. Based on years of experience and working with a variety of clients, consulting firms will apply state-of the art project management best practices. Many consultants hold advanced degrees (PhDs, MBAs, MS) and other certifications, and have worked for government agencies such as the FDA and EMEA.
Consulting an expert directly helps organizations save precious time and money, while building a reliable team of go-to experts under one roof. And, eliminating one more obstacle – lack of people resources.
Need help with research, regulatory strategies, or product development? Contact the experts at ProPharma Group.
