Our Network of Consultants

As a strategic life sciences leader with over 14 years of experience in oncology, immuno-oncology, and cell and gene therapy, I am passionate about advancing innovative therapies that improve patient outcomes. My journey in biotech has been defined by a hands-on approach to discovery research, product development, and regulatory strategy, taking concepts from the lab bench to clinical trials.

Throughout my career, I’ve had the privilege of leading and contributing to groundbreaking projects. At TC BioPharm, I played a pivotal role in the FDA approval of an allogeneic gamma delta T cell therapy and the preclinical development of next-generation CAR-T products. My expertise in developing complex assays and driving exploratory clinical analyses has been critical in achieving key milestones, including advancing a phase 2/3 AML clinical trial.

As a consultant, I leverage my experience to guide biotech companies in refining development strategies and bridging preclinical and clinical efforts. From conducting due diligence for investments to streamlining development pathways, I provide actionable insights that reduce timelines and costs while maintaining scientific and regulatory rigour.
Collaboration is at the heart of this effort. I thrive in cross-functional teams, ensuring seamless integration across R&D, clinical, regulatory, and manufacturing functions. I also enjoy mentoring, developing talent, and fostering team innovation and resilience.

I actively contribute to the scientific community, having presented at international conferences such as the Gamma Delta T Cell Therapies Summit and the Allogeneic Cell Therapies Summit. My academic foundation, with a PhD in Medicine from the University of Glasgow, further underpins my technical expertise and commitment to translating research into impactful therapies.

Joining this network aligns with my drive to connect with like-minded professionals with a vision for transforming healthcare. I am eager to contribute my knowledge, learn from peers, and explore opportunities for collaboration that can accelerate therapeutic development and benefit patients worldwide.

With over a decade's experience in Life Sciences, Biotechnology Commercialization and Law, I have developed a broad scope of skills in various fields, ranging from sales and marketing, to regulatory and logistic affairs. During my time as business developer, I assisted companies in establishing global distribution networks, raised global awareness through marketing campaigns, and increased sales revenue three-fold within 18 months. I have substantial experience in biotech commercialization and have successfully overseen the commercial release of more than 80 products into the global market.

I specialize in assisting companies to develop and expand their business in South Africa and other African countries. This process entails the development and implementation of a commercial strategy that is tailored for the specific territory of interest, as well as the establishment of customer and distributor networks, and guidance as to regulatory compliance and logistic considerations. I have an aptitude for relationship building, strategic planning and target customer profiling, which forms the foundation of my business development capabilities.

I own a Ph.D. in molecular biology from Max Planck Institute for Infection Biology and have accumulated more than 12 years of industry experience. Having worked in different life science industries spanning from biotech to animal feed legislation. My main experience is the start-up culture and this is what I am mostly interested about and where I see the greatest fit with my consultancy proposition. My aim is to use my expertise and professional network to support the product development and marketing in small to medium sized life science companies with scientific services such as data analysis, scientific writing and competitive research. I follow a pragmatic approach combining hands-on work and strategic impulses. I am passionate about science and innovation and always eager to learn and being surprised by the multitude of outstanding ideas in the life science sector.
My positions were:
- PhD student (flow cytometry, cell culture, infection biology, confocal microscopy)
- Postdoc (flow cytometry, infection biology)
- Project manager at Mologen AG (preclinical safety studies of a DNA vaccine, developing new concepts for platform technology)
- Manager Scientific Cooperation at Zaluvida Corporate (innovation management, scientific expertise for CSO)
- Director Scientific Affairs at Mootral SA (R&D in animal feed, stakeholder management, competitor watch, scientific communication)
- Scientist at Federal Institute for Risk assessment (safety of feed additives, scientific writing)

Our consultants have extensive experience of working within start-up and small company environments and have developed their skills and expertise across a variety of disciplines within the IVD industry including, quality assurance, regulatory affairs, design and development, innovation, manufacturing and Notified Body lead auditing.

Our credentials include the preparation and management of international regulatory submissions, QMS implementation and maintenance in compliance with global regulatory requirements and the successful development and commercialisation of IVD products within entrepreneurial settings.

Noteworthy former senior leadership roles within pioneering IVD companies include Head of Quality Assurance and Regulatory Affairs, Chief Technology Officer, Head of Site and Director of Innovation and New Technologies.

We offer a range of pragmatic, flexible and customised consulting and training services covering regulatory, quality, product development and innovation to support our clients from product concept to commercialisation and beyond. These include:
• Person Responsible for Regulatory Compliance (PRCC).
• Product classification and regulatory strategy.
• Performance evaluation planning and reporting, including scientific validity, analytical performance and clinical performance.
• Risk management (ISO 14971).
• Preparation of regulatory submissions in compliance with the UK MDR, EU IVDR and other global regulations.
• Technical documentation review and remediation.
• Review of marketing, product packaging, labelling and instructions for use to ensure compliance with global requirements.
• Post-market surveillance and vigilance guidance.
• Gap analysis.
• Identification of applicable standards.
• QMS implementation, remediation and maintenance in conformity with ISO 13485, MDSAP and other global requirements.
• Quality planning guidance, including quality objectives and management of changes to the QMS.
• Quality impact assessment of design and development activities.
• Manufacturing and QC documentation guidance.
• Supplier control, including the control of critical outsourced processes.
• Equipment and QMS software validation guidance.
• Control of nonconformities, including root cause analysis, corrective action and preventive action.
• Management review.
• Internal auditing and gap analysis.
• Innovation input to new product concepts.
• Evaluation of novel technologies for IVD applications.