From Idea to Approval:
Smart, Scientific and Lean
About
Ineke Jonker-Hoogerkamp graduated in Pharmacy at the University of Utrecht, followed by a PhD in Pharmacokinetic-Pharmacodynamic Relationships at Leiden University. She has over 30 years of experience in regulatory affairs, with substantial experience in the regulatory aspects of global drug development, market approval and regulatory compliance of medicinal products for human use. Ineke held senior regulatory positions in Organon and Genzyme and worked as director of the Regulatory Affairs division at consultancy company Xendo with her group of 20 RA consultants. Currently Ineke works as an independent consultant in regulatory affairs and drug development with her own company Eagle Pharma Consult. She combines consultancy with educational work, a.o. at the MSc course of TOPRA and as Assistant Professor at Paul Janssen Futurelab.
Consultancy
Choosing the right regulatory pathway is critical to the approval of your product idea both for clinical trial approval and market approval. Eagle Pharma Consult will help you design the appropriate regulatory pathway best suited to your product. Discussions with agencies worldwide are properly framed to reduce perceived risks of the chosen development plan. Using vast regulatory experience, scientific product knowledge and data bridging, Eagle Pharma Consult will prepare a lean, fit for use regulatory submission and guide your product through the approval process.
From Product Idea to Clinical Trial Approval
Want your product idea to fast forward into practice? Thorough scientific product knowledge, vast regulatory experience of minimum requirements and a clear view on the target product claims is the shortest route to clinical trial approval.
New Product Idea
First in Human
Proof of Concept
Confirmatory
Market Approval
New Product Idea
First in Human
Proof of Concept
Proof of Concept (2)
Market Approval
FIH for genetically-modified cell therapy: A product outside existing regulatory guidance
The company had the wish to enter the clinical phase as soon as possible. Product science was smartly used to fill the regulatory gaps. Advice meetings in EU and US were used to identify the main regulatory risks. Lean regulatory dossier writing (IMPD and IND) was applied to obtain fast approval while maintaining flexibility for future development.
COVID-19 therapy: A good product idea but not a perfect regulatory package
The company had the wish to enter the clinical phase in emergency situations, such as COVID-19, without having to do new experimental work. A well-organized national regulatory advice meeting, narrowing down the relevant issues and questions, provided clarity on the feasability of clinical trial approval. Smart regulatory writing using existing product data allowed the company to start a trial without being delayed with having to collect new data.
From Product Idea to Market Approval
A new idea for an existing product? Thorough scientific product knowledge, vast regulatory experience and smart bridging of existing data is the shortest route to market approval of that idea.
Market Approval
Product Idea
First in Human
Proof of Concept
Confirmatory
Market Approval
Market Approval
New Product Idea
First in Human
Proof of Concept
Proof of Concept (2)
Market Approval
Intranasal instead of intramuscular – a new route for improved patient compliance
The company had the wish to market an established active pharmaceutical ingredient in their proprietary intranasal formulation. A stepwise, lean product development plan was designed by bridging the new product with existing data from the intramuscular injection and from competitive intranasal products. Early regulatory advise was used to minimize regulatory and financial risks towards market approval and reimbursement.
Old product – New approval
The company had the wish to get their own market approval for a reasonably-priced old product for the treatment of a small group, otherwise untreatable patients. The company’s existing sourcing outside the EU was blocked by an EU orphan market exclusivity, granted to a company that used their exclusivity for a tremendous increase in price. By using publicly available data from decades of experience with this product, a lean market approval strategy was designed that did not require new nonclinical or clinical data.
Education
TOPRA – CRED MSc in Regulatory Affairs
Module leader – Module 1: Strategic planning in regulatory affairs
Paul Janssen Futurelab - Blended learning for entrepeneurial biomedical professionals
Course developer – Course: Market Approval
Quality Management in Pharma and Biotech
Module leader – Module 2: Drug development - from Quality by Design to Clinical Studies