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The Life Sciences’ industry is undergoing fundamental changes as a result of the advent of genomics and proteomics. Combined with the current market and regulatory conditions, Life Sciences Organizations (LSOs) find themselves under an unprecedented set of industry, market, regulatory and competitive pressures that are creating significant challenges to the current “way of doing business” and driving for fundamental changes to its core business models and practices.
Currently there exist significant downward price pressures on the demand side. Price premiums are increasingly difficult to justify and will only be acceptable for first-to-market new drugs that are not “me too” in their benefits. The trend towards smaller target communities as a result of the transition to genomics is driving up the number of drugs that need to be successfully brought to market. Combined with the loss of patent protection for a number a key drugs, it will be extremely difficult to maintain revenue levels let alone build share value.
These factors are driving the need for a radically reduced time-to-market, a significantly lower drug development cost and a move towards a service-based therapeutic value proposition that requires knowing a great deal more about the customer than current norms. This cannot be achieved with the current paperbased, manual, semi-electronic and physical-world business models and processes. To maintain the status quo equates to decreasing profitability and its consequent reduced lower shareholder value. Accordingly, the transition to an electronic value chain is essential to the viability of the Life Sciences’ industry and the competitiveness and profitability of LSOs.
Enabling laws providing legal effect and validity to electronic records and signatures has been enacted around the world, effectively ensuring non-discrimination for being electronic. Regulations driving the adoption of electronic record and signature systems for medical information (HIPAA) and New Drug Applications (21 CFR Part 11) are in effect. Yet, the transition to an electronic value chain has been slow – Why?
This is due in large part to the difficulty and complexity of controlling and managing the business, technical, legal and regulatory risks of transitioning to and maintaining an electronic value chain. There is currently no enterprise-wide, multi-stakeholder and global strategy to manage the transition to an electronic value chain and there is no integrated and comprehensive method to control and manage the business, technical, legal and regulatory risks in making the transition from the “physical” to a more efficient and effective “electronic” value chain.
This white paper presents such a vision and strategy called Enterprise Digital Trust Management and outlines a risk mitigation and transition management method called the Digital Chain of Trust Methodology. This vision, strategy and methodology provides benefits to “C”- class executives, legal counsel, and senior executives by providing confidence for making management assertions to regulators, investors and business partners; to middle managers by enabling a controlled and measurable transition and a risk mitigation approach that enables the effective allocation of scarce resources; and to practitioners and internal auditors by providing a structured and automated method of performing audits. The overall organization will benefit from more effective control over risks, lower cost-of-compliance, greater “consistent intended performance” across the enterprise and a framework for continuous improvements. The end result – a Life Science Organization that operates an electronic value chain that brings new drugs to market in a significantly shorter time and lower cost while being demonstrably trustworthy and compliant (from both legal and regulatory perspectives).
1 The Electronic Drug Development, Approval, Marketing & Sales Value Chain
The adoption of Internet-based electronic business models and channels has the potential to dramatically reduce costs and revolutionize the speed, responsiveness, reach, efficiency, and effectiveness of each phase of the drug research, development, approval, manufacture and commercialization value chain. A number of creditable authorities including IBM Life Sciences 1, Tufts Center for the Study of Drug Development 2 and Cap Gemini Ernst & Young 3 have articulated strong business cases for the need to radically change how drugs are discovered, developed, approved, brought to market and administered to patients.
The gains require focus on delivering three main bottom-line outcomes – a shorter new drug development cycle, from an average of 10 - 12 years to 3 - 5; a lower pre-launch total cost of development of $200 million down from an average of $800.
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