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Pharmaceutical and Life Sciences companies are experiencing a period of unprecedented change. Shifts in age and demographics, the entry of new technology platforms and solutions, increased government regulations and aversion to risk; and the call for lower prices from the market along with rocketing operating costs, are changing the face of the industry. Moreover, increased scrutiny of operational and research practices together with difficult questions over the safety of marketed drugs have created uncertainty in what has traditionally been considered a stable and highly profitable business. The patents on many of the medicines launched in the 1990s will expire over the next few years, leaving many companies very exposed; only four out of ten companies have enough products in their pipelines to fill the impending revenue gap.
These factors raise a number of specific operational issues that companies should address in order to succeed in this changing environment:
The need to successfully develop innovative drugs and enhance R&D productivity.
Companies need to move new products into existing and new markets quickly to obtain sufficient benefit from a limited patent life and to compensate for development costs which can exceed $800 million per drug. Effective R&D is a complex mix of science, organisational ability to invest, choice of location based on cost-base or skills availability, recognition of opportunity; and compliance with stringent regulations and strategic decisions on mass-market medicines or speciality therapies. These have a profound bearing on the business models and mix of skills needed to support the company's ability to succeed.
The need to address the conflicting pressures of pricing and shrinking margins.
As R&D increases the range of treatments available to treat the nation's illnesses and, as the economy and budgets are squeezed ever tighter, healthcare providers across the UK struggle to budget for an increasing range of costly treatments. Despite the fact that only a small proportion of overall healthcare costs are due to the cost of drugs, pharmaceuticals companies are a relatively easy target for healthcare providers trying to get more out of their budgets. Faced with spiraling operating costs in addition to shrinking margins, it is vital for companies to have efficient control over these costs.
Public perception of pharmaceutical manufacturers has been impacted by a number of recent product recalls. Quality assurance processes and regulatory requirements may become even tighter in order to satisfy demand for the return of public confidence.
The need to demonstrate regulatory compliance.
Heightened regulatory scrutiny will challenge the industry to demonstrate regulatory compliance and evidence a comprehensive strategic approach that builds compliance into the fabric of the business.
The implications for the industry are that it must embrace new business models that focus on adapting to the risks and choices available.
Vetasi Solutions for Life Sciences
Vetasi understands the challenges faced by Life Sciences companies in developing new business models to enable strategic partnerships and acquisitions, improve organisational flexibility and speed of response, develop new R&D models, build closer collaboration with regulators and healthcare providers and utilise different channels to market. Vetasi solutions can provide the basis for the transformation by helping to build compliance into core processes, enabling operational excellence from the supplier to the customer and facilitating innovation with partners worldwide to accelerate new product and process development.
Vetasi consultants have extensive experience in the life sciences sector from the management of critical assets to integrating core processes, controlling costs, increasing operational efficiency and ensuring regulatory compliance. Certified in GAMP 5, they understand industry-specific requirements such as:
- FDA compliant to 21CFR part 11
- Calibration and Mobile Calibration functionalities
- Support (asset-related) CAPA
- Compliance Assistance Documentation (in Validation projects)
For information about our customers in the Life Sciences sector, please contact firstname.lastname@example.org