Magazine Article | March 7, 2018

Is Your CDMO Listening To Your Small-Company Needs?

Source: Life Science Leader

By Paul Maffuid, Ph.D., Executive VP R&D, MabVax Therapeutics

Small companies can often encounter situations in which contract organizations devote their best people to their larger sponsors. Therefore, to ensure you get the attention your small-company project deserves, you need to take some proactive steps.

For example, you will need to reflect on and most likely refine your management style: A small company that is very organized and communicates effectively with a CDMO will do quite well even when competing with large organizations that have many FTEs with a contractor. Because, large or small, the project is your project, and ultimately, you are delegating responsibility to the CRO or CDMO.

The best way to be heard is to be proactive with the organization that you have contracted with to meet your program goals. To be successful, take the time to get to know who you are working with and understand the internal dynamics and systems of the CRO. The first step is scheduling a site initiation visit and a kick-off meeting to establish relationships, assess the maturity level of the staff you will work with, establish their program goals, and set the groundwork for the frequency of future interactions. Detailed meeting minutes with clear action items from this first meeting will set the stage for your future interactions.

Treating the CRO team as you would new members of your company is important, and understanding what leadership style to use and how you will delegate responsibility to the CRO will be critical. We all would like to move immediately to a delegative style, but the situational leadership theory suggests that you will need to adapt your leadership style to the situation at hand. This includes the style of leadership and the strategies needed to complete the project. The most-effective leaders are able to adapt their style as needed and evaluate the situation to understand the tasks, potential roadblocks, the nature of the group, and other factors that might contribute to getting the job done.

Your site initiation meeting is a great opportunity to begin evaluating whether your team can simply take on a full delegation of responsibility. If your style is “hands-off,” consider how this style could be interpreted by your new team and whether it is appropriate at this early stage of the relationship. You can “pressure test” this early on by assuming you can fully delegate completion of a noncritical task and then analyze the result. As very few companies have time and money for failure, there will unlikely be a significant appetite for this approach. Instead, you can learn from your site initiation meeting and work toward moving from a directive to a delegative style as quickly as possible. Hopefully, the maturity and competence level at your CRO will allow you to move quickly!

The situational leadership theory, or Hersey-Blanchard Situational Leadership Theory, was developed by Paul Hersey, author of The Situational Leader, and Ken Blanchard, author of One Minute Manager.

Following are some guidelines to a meaningful site initiation and kick-off meeting:

This is potentially your best opportunity to provide the necessary background and establish expectations for your new team. It also provides you with an opportunity to introduce yourself, your background, and your role and experiences at your company. This should be both personal as well as detailed, with technical information that provides the basis for the work requested of the CRO. Share how you became involved in the project, what you find interesting, and what the expectations are for success. Let them get to know you and what you are expecting right at the start and that you hope to move to a delegative style with them quickly. Asking the team what they need from you to make this happen is a good way to understand what they are thinking and how much support from you they are expecting.

Share with your new team where the project is going and how their activities fit into your development program. Next, take time to review the contract and statement of work, as well as the process for completing any change orders. This is a good time to obtain their feedback on other studies that may add value to your program. Keep an open mind to these ideas, as you do not need to immediately agree to add these to the program, and you may find that these become useful future budget considerations as the program matures. Find out if they see any bottlenecks to meeting the program deliverables. During a tour of the laboratory and manufacturing areas, look for unforeseen bottlenecks or risks, and make sure these are identified. You may not be able to come up with a plan to resolve these during the kickoff meeting, but having a plan to resolve these will be important to ensuring success.

Sharing an organization chart that includes your company’s team will be an important part of the meeting. It is important that you have key members from your organization with you or include them by teleconference. Work closely with the CRO’s project manager, and develop a communication plan to establish roles and responsibilities for staff from each organization, how they can communicate with each other, and how to escalate topics that require management resolution. The plan should clearly align the staff from each company by functional area responsibilities and should contain their contact information. Discuss and agree to the use of email correspondence and who needs to be copied on the correspondence. I have found that working with the project manager to draft a communication plan prior to the kick-off meeting is an effective way to ensure the plan is finalized during the meeting. Having a plan in place will eliminate most if not all of the communication gaps that can hinder program progress.

The kick-off meeting is a good time to obtain resumes and understand backgrounds. Consider the type of questions you would ask during an interview and get some dialog going. Typically, the experience level of staff at the CRO is far beyond what is noted on their resumes, and you can expect this to be a learning process. This can be difficult at times if CRO management is in the room, so you may want to hold a few questions for later when you have a more relaxed environment. This will be critical to understanding the maturity level of the staff on your project and the type of leadership style that you will need to be effective.

"Having a well-organized site-initiation visit and kick-off meeting will ensure your voice is heard regardless of the size of your company."

The site initiation visit should be the first of many positive interactions. Establish the logistics for future meetings and for information transfer. Most CROs will have a cloud-based means to organize project files, and your company may have one, too. Consider how this project fits within the requirements of your company’s planned regulatory submissions, and set up the file structure in a manner to expedite information transfer to support these submissions. I have found that CROs are quite flexible and are amenable to meeting your needs. Define how to measure success, and discuss how to incorporate these evaluations into future meetings.

Try to work this into your schedule as a means to work through the final detailed points that were discussed during the day. Having a more relaxed environment can make a difference.

Having a well-organized site initiation visit and kickoff meeting will ensure your voice is heard regardless of the size of your company. This meeting will help you begin to understand the background and experience of your new team and how this experience overlaps with the needs of your project. Being at the site provides you with an opportunity to identify potential bottlenecks and risks that could impact success for both organizations. This meeting will help you understand what type of leadership style you will need initially and how quickly you can move to a delegative style. Your CRO will appreciate that you came well-prepared and established the groundwork for a successful relationship.