Project Management and CMO–Sponsor Relations - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Project Management and CMO–Sponsor Relations
Using basic project management tools and ideas in the transfer process saves time and money and ensures high success rates.


Pharmaceutical Technology


Whether it is the kick-off meeting or a routine meeting, take time to develop and distribute an agenda. This single basic tool will maximize the effectiveness of your meeting. Send the agenda out at least one full day in advance to allow all team members to be as prepared as possible for a productive meeting. As important as agendas, meeting minutes are critical to the documentation trail of the project. Use them to document decisions, discussions, and potential issues. Distribute the meeting minutes to those who are not part of the actual team (affected departments and management). This allows everyone to have the opportunity to keep in touch with the project's progress from their own desk.

Key points to remember

Define your corporation's terminology. Not all companies define a demonstration lot, a development lot, and a commissioning lot in the same way. Do not assume that these definitions are industry standards.

Do not wait for the routine meetings to communicate with your peers on the other side. Email allows small details to be addressed quickly. Establishing the parameters for an emergency or rush situation up front prevents false alarms throughout the process, resulting in a relationship with a high level of trust. Crying wolf erodes trust. Both sides must be courteous in setting realistic timelines for responses to questions, document reviews, approvals to procedures, and so forth. Moreover, communicate when replies are required because it helps set priorities, and remember to set realistic goals.

Project leaders and team members must work together to maintain and control the project scope. With the project scope finalized at the kick-off meeting and communicated in the project schedule, routine updates become critical in project management. The timeline shouldn't be static—it is a living document that must be updated and published with meeting minutes. If a new task is needed and inserted in the schedule, determine whether it is a clarification of a previous task or a new activity. If the task alters the scope, let the business development department know.

Avoid unnecessary mid-course changes during the project. Surprises are inevitable, but consider carefully whether a significant change mid-project is needed or whether other options exist. Change orders can be costly and threaten not only the project schedule, but also your budget. Moreover, keep an eye on "walk-up" business. A simple request for another document or another study may seem inconsequential, but over the course of the project, the extras actually take time away from the critical tasks. Sometimes there is a business need for the add-ons, but there may be other options.

Minimizing scope creep is essential in project management. These changes drive up costs and lengthen the project schedule. Although most scope-creep changes are small, added together they can endanger a project. A method to minimize or compensate for scope creep is factoring contingency into the project schedule. Both the sponsor company and CMO have limited resources, so the earlier something is known and communicated, the better. Modifications to the project schedule or a delay on an important decision can't always be handled without adverse impact. Consider what happens if the project leader is out for a period of time. What is the effect on the overall project timing? Who on the project team will step in and chair routine meetings? Who will follow up on key decisions that must be made? Where are the data held, and can others access electronic files? Is there a system in place to provide "human contingency planning"? Taking the time to plan for knowledge management is better than insurance and costs less, too.

Finally, hold a wrap-up meeting to celebrate and review the project. Take time to learn from each project. Have both sides evaluate not only their contributions but the other side's as well; communicate in an honest and direct manner. The goal is to improve the system. Determine what was done well and what could have been done better. Don't let this become only a notetaking session. Rather, use it as an opportunity to strengthen your project-management system.

Managing quality in contract manufacturing

Often the most challenging aspects of managing projects within the contract-manufacturing arena are those activities that fall under the realm of the quality unit. These include quality assurance, quality control, and regulatory functions.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
27%
Oversee medical treatment of patients in the US.
14%
Provide treatment for patients globally.
8%
All of the above.
41%
No government involvement in patient treatment or drug development.
11%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Source: Pharmaceutical Technology,
Click here