Lessons Learned in Preparing Nonclinical Programs Part IV:

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Lessons Learned in Preparing Nonclinical Programs Part IV:

Administrative Issues

Contracts: When outsourcing your work to a CRO, you need to ensure that you are protected from a legal standpoint.  There are two basic contracts that you will need.  The first is a confidentiality contract (also called a CDA or NDA), which will protect any conversations you have with the CRO as being privileged information. The other contract is a master agreement (also called an MSA or MA) that covers the work being done, including financial terms/payments, liabilities, proprietary rights, insurance, and other provisions.  Note that the negotiation of the terms, particularly in the MA, may take days or weeks to resolve.  Also note that the execution of an MA does not generally obligate you to the conduct of work at the CRO, but does allow work to initiate in a timely manner once a decision has been made to proceed with the work at the CRO.

Grant Funded Work: There are many sources of grant funding available for research in animals. Some funding sources may include: National Institutes of Health (NIH), National Institute for Allergy and Infectious Disease (NIAID), Public Health Service (PHS), Department of Defense (DoD) and many more along with private foundation funding and angel investors.  There are often legal reporting requirements and lengthy Requests for Proposals (RFP) required for grant submissions.  For any grant funded work conducted at a CRO, the funding agency will often require IACUC approval and other forms, such as the Vertebrate Animal Section (VAS) Worksheet, that will need to be completed by the CRO for submission with the RFP to the funding agency.  Allowing for additional time in the RFP process for the CRO to complete these tasks adequately will result in timely submissions.

Pre-IND Meeting: Before you initiate your first clinical trial and the nonclinical studies to support it, you have the opportunity to meet with the FDA to discuss your plan to support your Phase I clinical trial; this is called a pre-IND meeting.  This is your opportunity to get feedback on your approach.  This meeting covers all major aspects of the IND, your plans for manufacturing as well as nonclinical and clinical studies.  It should be used as an opportunity to outline your approach and engage the Agency in scientific discussion to determine if they agree that your planned nonclinical package is sufficient to support your clinical plan.  This is an opportunity for you to propose an alternative approach, but it must be with scientific justification, and not based on costs or timing.

Communications Expectations: The easiest issue to avoid is a lack of, or perceived lack of, communication.  Be sure to have conversations around communication expectations early in the process.  While it may seem obvious to some, the communication expectations from Sponsors can vary widely and issues can arise when the CRO is assuming one form of communication, and the Sponsor expects another.  With the increasing complexity of study designs, the number of personnel involved in study communications may need to be increased to include subject matter experts in different areas, including technicians, veterinarians, pathologists, and contributing scientists.  Establishing your preference early in the process will aid in avoiding any confusion and frustration throughout the conduct of your program.

Protocol Format: When drafting the study protocol it can be tempting to suggest some wording, alterations in format, or reordering of protocol sections based on your personal experience/preference, but keep in mind the CRO will be conducting the study.  It is best to allow the lab to use their terminology as this will help reduce deviations.

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By | 2017-07-04T10:26:32+00:00 July 7th, 2016|Lessons Learned: Nonclinical Programs|Comments Off on Lessons Learned in Preparing Nonclinical Programs Part IV:

About the Author:

MPI Research, with global headquarters in Mattawan, Mich., provides safety evaluation, discovery, bioanalytical and analytical services to the biopharmaceutical, medical device, animal health, and chemical industries. The company offers comprehensive imaging solutions including preclinical imaging, radiochemistry, and data analysis. Scientific knowledge and experience, responsiveness, integrity, trust, teamwork, and dedication to strong and enduring Sponsor relationships are the defining attributes that characterize MPI Research as a high-performance, high-quality organization that is committed to bringing safer and more effective products to the world.