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Written by Steve Scribner on 25/01/16

Agility has become the magic word symbolizing Nirvana. To be ‘agile’ is a capability or state that everyone in business wants to achieve. Companies struggle to get their minds and their hands around it. They feel that if they cannot achieve ‘agility’, then they cannot successfully compete in our fast-moving market.

 There are two definitions for Agility in the dictionary:

  • The power of moving quickly and easily; nimbleness
  • The ability to think and draw conclusions quickly; intellectual acuity

 The capability to be Agile is becoming necessary because of rapidly occurring changes that affect the Life Sciences business. These changes are surely making the conduct of business more challenging. In this context, there are three areas of concern that I will address:

Organizational change

Every organization is challenged to respond as best as possible to these conditions:

  1. Mergers & Acquisitions – Life Science companies find rejuvenation and renewed life, and are reinventing themselves through the merger of separate organizations. Value is improved. Teams are combined and then filtered to result in a more streamlined and efficient organization. One very large company has stated publically that they have been and will continue to follow a pattern of one large acquisition every two years and a smaller purchase on the alternate years. That amounts to major organizational dynamics each and every year.
  2. Outsourcing – In order to smooth out the dynamics of critical activities such as Clinical Trials or perhaps Regulatory Publishing, it will be financially advantageous to contract with outside organizations to supplement your own staff for specific activities. The model usually employed is to find an easy division of tasks by specific Clinical Trials or specific Products. These contractual partners are members of a Virtual Team and the overall process flow must bridge the gap between companies (also may be known as Virtual Teamwork). A difficult challenge you will have is the constant and continuous communications needed. How are handoffs handled across your organizational boundaries?
  3. Resources – Many of the tasks performed within the organization require specific talent and training. The training can be cumbersome and/or lengthy. When new employees are hired or transferred to perform these labors, these people must receive training and perhaps even become certified to perform the new tasks. Turnover in your organization can be crippling. When new systems are introduced or changed, you have a significant change management challenge.
  4. Geography – When there are differences in the conduct of business between geographic locations, as there usually will be for diverse organizations, harmonization of process and systems, implementation and training will always be a challenge. The better the harmonization, the more smooth it will be for changes to be accepted.


Both industry organizations and governmental regulators are constantly trying to improve the drug development and approval process. These changes are often implemented through new regulatory guidance. Life Sciences companies must be aware and respond to these changes in order to remain compliant. The timelines are never convenient and they force companies to think ahead towards the integration of process and systems to make these changes smoothly across the following conditions.

  1. Emerging regulations/implementations – the pending guidance for the Identification of Medicinal Products (IDMP) is an excellent example of anticipated change that is/will greatly impact all Life Sciences organizations in a significant and pervasive way, crossing many internal organizations.
  2. Industry adoption – Some regulatory requirements have been presented in a soft way. Historically, when regional agencies supported eCTD formats and revised their own internal systems to receive and process these submissions, they recommended that Life Science sponsors adopt this new format. However, the FDA would not require it of all sponsors because of a sense of fairness. For years, they felt that small firms would not have the resources to implement internal systems to support the eCTD standard. Eventually, it would become a hard requirement, and it has now become so.
  3. Changing priority – Some regulatory developments will be taken through a series of priority steps. It can be seen as a progression, from suggestions (draft) or voluntary, to recommended to required

Process change

In a never-ending trail of changes to the process of development of medicinal therapies, companies will reconsider and revise their standard operating procedures to better achieve one or more of the following:

  1. Efficiency
  2. Satisfy changing regulations
  3. Serve the changing organization
  4. Adoption of new/changed systems
  5. Periodic, cyclical or seasonal process streams and SOPs


Often, the dynamics within your organizations can be a combination of the causes noted above. Usually, change will not be the result of just one cause, or at least, each organization will want to take advantage of change to satisfy several root causes. Change, however, may be synthetically limited to a subset of the business along the lines of either:

  1. Products
  2. Clinical trials (or Phases)
  3. Divisions
  4. Locations
  5. Partners (both outsourced (process) and in/out-licensed (products))

 The actions taken may be limited for a time by one of these characteristics in order to limit the risk of making such a change. Implementation is sometimes called a ‘pilot’.

So, Agility means to me that we must look for systems that are adaptable to the above conditions, allowing you to reconfigure it without software programming, modifications, process redesign or lengthy purchase processes that could cause you lost time, revalidation, cost or otherwise ‘grief’ when trying to comply with the change. We all want to be ‘nimble’ and adapt change with ‘intellectual acuity’ but often it is not that easy. People are as much of the equation as is the software. It is time that you build a comprehensive solutions strategy that anticipates the potential risks for change that I have enumerated here. It is NOT simple; but it is surely WORTH IT.

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Agility, Regulatory, eCTD, IDMP

Steve Scribner

Written by Steve Scribner

Steve is a Consultant with 45 years of experience in computer solutions implementation in business. For the past 22 years, he has focused on electronic document/content management systems in the Pharmaceutical / Life Sciences industries. Steve has an extensive experience with managing multinational projects and looks for circumstances where his understanding of diverse cultures can help projects be successful. He has lived and worked in US, Western Europe and Asia.

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