Providing Strategic Regulatory Guidance/Advice to Pharmaceutical
and Biotech Companies Via Online
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Project Examples

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Typically a strategic regulatory representative in a project team faces regulatory questions from various functions like pre-clinical, clinical, CMC or safety pharmacology during the course of drug development, more so at critical regulatory milestones stage such as pre-IND stage, planning for future development stages, end of phase one or two, pre-NDA/MAA stage etc. The regulatory advice/or response to these cross functional questions is key in terms of expediting drug development, avoiding unnecessary expenditures or costly blunders which may lead to delay or cutting the programs prematurely. This is where GRSA will play a pivotal role for the companies who need or would like to add to their staff a complimentory regulatory advice online tool/resources in providing strategic regulatory development advice/recommendations for regulatory development of your new or establsihed drugs. Or simply use GRSAOnline for a second opinion or to double check your already established regulatory drug development strategy. 

The following actual real life examples provide a glimpse of what GRSAOnline can be of help to you in a quick and cost effective manner:

Early Stage of Drug Development

Early Phase: 1st scenario/ Issue
Question: What would be one of the key questions to be raised during a pre-IND meeting with the FDA that would indicate a potential clinical hold situation

“Does the FDA endorse the proposed phase I clinical study design (FIH-First in Human) specifically regarding proposed starting dose,inclusion/exclusion criteria, dose escalation scheme and the safety monitoring schedule (see sections xxx, yyy…in the protocol)?

Advice: Based on the real life experience, some of the clinical hold issues from the FDA were raised specifically focusing on the above underlined sections of the phase I protocol. So the FDA’s response to your question would indicate as to whether or not your phase one trial design might contain a hold issue that you could avoid when you file your initial IND.

Early Phase: 2nd scenario/Issue

Question: "From a regulatory perspective, is multiple ascending dose (MAD) acceptable for a new monoclonal antibody in FIH phase one trial?"

The response/recommendation from GRSAOnline might be along the lines as follows:

Advice: We would strongly recommend including a rationale/justification in your IND supporting the necessity of multiple dose studies during initial FIH (First-in-Human) phase one trial for a new monoclonal antibody. This is because your proposed multiple ascending (MAD) study design conflicts with the FDA's guidance entitled "Points to consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use."  

The guideline recommends that the phase 1 initial studies of a therapeutic mAb should generally be escalation studies of single-doses of the NBE mAb.

Early Phase: 3rd Scenario/Issue

Question: Certain steps of a FDA requested non-clinical safety study, due to a novel toxicity seen with a new investigational compound, were not conducted under GLP conditions. Would this be a problem with the regulatory authorities in general? How can we mitigate the risk so that the study need not be repeated to be GLP compliant since certain steps of the study were not conducted per GLP?

Advice: GRSAOnline will undertake all the regulatory guidance review, FDA’s pre-clinical safety regulations/guidance, past precedence situations from industry experts/or GRSA own experience and will provide an outline of arguments that one could use to mitigate the risk for the type of situation described above.

For example, GRSA will provide advice on what types of studies that should be GLP compliant and those that  may be deemed eligible for an exemption.  A typical response to the above situation may require one to two hours of work and the response will be provided in a short period of time.

Late Stage-Drug Development (End of Phase II to Phase III Registration Stage) 

Personalized Medicine Drug Development (Companion Diagnostic Test/Therapeutic Drug Development)

Points To Consider

Additional Typical Questions Facing Small Biotech or Start-Up Companies