Petra Cavallaro is the Head of Regulatory Affairs CMC Biologics at Just - Evotec Biologics. In her role, she oversees the regulatory strategies and compliance for the biologics products the company manufactures, ensuring they meet all necessary guidelines and standards for clinical and commercial use.

Petra brings extensive experience in regulatory affairs, particularly in the field of biologics. Her expertise includes navigating complex regulatory environments and leading teams to successful product approvals. Before joining Just-Evotec Biologics, Petra held various leadership positions in regulatory affairs for companies such as Lilly, Merck and Takeda contributing significantly to the development and approval of multiple biologic therapies, including mAbs and vaccines.

In this interview, Petra describes how her team works with partners that are taking their biopharmaceutical candidate into the clinic for the first time and helps ensure their successful Investigative New Drug (IND) or Investigational Medicinal Product Dossier (IMPD) application.

Just – Evotec Biologics' integrated development and manufacturing services for FIH biologics will provide all the CMC IND- or IMPD- enabling studies needed for a FIH trial. The Regulatory Affairs team help guide partners on what data and information from these studies should be provided in Module 3 of the Common Technical Document to meet their strategic objectives. We ensure our partners’ success through extensive experience and a detailed understanding of the regulatory requirements of different health authorities. Examples of some studies that are required to be include in the initial IND or IMPD include Cell Line Development studies, Cell Bank Qualifications, Reference Standard Qualifications, Method Qualifications, Stability Studies and Viral Clearance Studies.

We typically meet with clients right at the beginning of a first-in-human CMC project and align on a strategy together based on the specific needs of their program. We can prepare all the Module 3 components, and we can also manage health authority interactions, including meetings as they relate to CMC topics. Somewhat unique for a CDMO we also have experience of filing our own complete INDs (Modules 1 – 5), as we are the sponsor for various Just – Evotec Biologics internal programs; we really know what it takes to be successful.

As we pull the submission together, the sponsor can be there every step of the way (if that’s the preference) or just during the various reviews of each document within the submission. I typically run a weekly Authoring Team meeting which partners can attend if they so choose. The relationships are always collaborative and I’m very flexible on how we work with clients depending on their needs and preferences.

One thing to consider is whether they want to have health authority meetings such as a pre-IND, a Type C and/or a scientific advice meeting . We can advise on when the best time to schedule and have these meetings. We can help prepare the meeting requests and briefing documents and support the partner organization at the meeting. I recommend clients have the Pre-IND/Scientific Advice meeting to present their protocol or synopsis, show the pre-clinical plans and data they have generated to date and provide information on the proposed CMC strategy. It’s a great opportunity to confirm that the agency agrees with the approach, create awareness to the agency that an IND or CTA will be submitted, as well as gain additional advice that the agency may provide.

I would usually advise starting working on Module 3 of the regulatory filing four to six months before the partner’s preferred filing date. This allows plenty of time for the sponsor to engage in the process and create high quality CMC content.

Authoring starts prior to all data being available with placeholders for drop-in data to be populated. Typically, drug substance and drug product stability data are the last pieces that we need to wrap up the content. One requirement for finalizing each section is to have approved source documentation to perform data integrity checks against. Once this is done, the Module 3 can be routed for final approval.

Upon completion of Modules 1 – 5, the sponsor can submit the IND or CTA and dosing of subjects can start after the IND is in effect, which in the US is 30 days after the FDA receives the IND application or when the is CTA approved.

I would say that they should work with us because first and foremost we know their product. With that we have the knowledge to complete all their Module 3 documents efficiently with minimal direction and we have a track record of little or no questions from the regulator regarding CMC. We can provide them with a quality Module 3 package and run the whole process for them. Within Just – Evotec Biologics and the broader Evotec Corporation we have tremendous experience of filing INDs in a wide range of different territories with different health authorities.