Lifecycle Mgmt Pharmaceutical Bwp 070014
Improving clinical development & manufacturing processes in pharmaceutical R&D organizations
Product Lifecycle Management for the Pharmaceutical Industry
An Oracle White Paper
Author: Todd Hein, Oracle Life Sciences
Key Contributors:
i.
ii. iii. Arvindh Balakrishnan, Oracle Life Sciences
Hardeep Gulati, Oracle Product Strategy
Michael Winkler, Oracle Life Sciences
Oracle Pharmaceutical Solution Set
Page 1
Improving clinical development & manufacturing processes in pharmaceutical R&D organizations
Introduction:
In recent years the pharmaceutical industry has faced declining R&D productivity, a rapidly changing healthcare landscape and fierce competition from generics resulting in lower growth and profit margins. Historically, drug development focused on clinical trials management and outcomes. Now however, the industry is looking at more holistic approaches to improve processes of bring new products to market that can accelerate product development while lowering operational costs. This is challenging because of the complex value chain and business processes required in this highly regulated environment. Additionally, it has proven difficult for the industry to effectively adapt as many pharmaceutical companies are simply not optimized for cross functional collaboration which is so desperately needed to support these changing market conditions. One meaningful and holistic approach to today’s current challenges within the pharmaceutical industry is to focus on Product Lifecycle Management (PLM), which is a business transformation approach to manage products and related information across the enterprise. In recent years PLM has provided many pharmaceutical organizations with the ability to increase their ability to get products to market quicker, ensure greater regulatory compliance and efficiencies while reducing development costs.
This article identifies some key business metrics that benchmark a company’s performance and key strategic business processes
Product Lifecycle Management for the Pharmaceutical Industry
An Oracle White Paper
Author: Todd Hein, Oracle Life Sciences
Key Contributors:
i.
ii. iii. Arvindh Balakrishnan, Oracle Life Sciences
Hardeep Gulati, Oracle Product Strategy
Michael Winkler, Oracle Life Sciences
Oracle Pharmaceutical Solution Set
Page 1
Improving clinical development & manufacturing processes in pharmaceutical R&D organizations
Introduction:
In recent years the pharmaceutical industry has faced declining R&D productivity, a rapidly changing healthcare landscape and fierce competition from generics resulting in lower growth and profit margins. Historically, drug development focused on clinical trials management and outcomes. Now however, the industry is looking at more holistic approaches to improve processes of bring new products to market that can accelerate product development while lowering operational costs. This is challenging because of the complex value chain and business processes required in this highly regulated environment. Additionally, it has proven difficult for the industry to effectively adapt as many pharmaceutical companies are simply not optimized for cross functional collaboration which is so desperately needed to support these changing market conditions. One meaningful and holistic approach to today’s current challenges within the pharmaceutical industry is to focus on Product Lifecycle Management (PLM), which is a business transformation approach to manage products and related information across the enterprise. In recent years PLM has provided many pharmaceutical organizations with the ability to increase their ability to get products to market quicker, ensure greater regulatory compliance and efficiencies while reducing development costs.
This article identifies some key business metrics that benchmark a company’s performance and key strategic business processes