Our Network of Consultants

Senior Molecular Biologist with 35+ Years of International Experience (Europe/USA)
Expertise: Gene Therapy (rAAV & Lentiviral Vectors), Synthetic Biology, Molecular Biology, Biochemistry, and Cell Biology across Mammalian, Bacterial, Yeast, and Plant Systems
 Specialised in:
- Advanced Vector Engineering: Design and validation of custom plasmids for specific in vivo and in vitro assay requirements; expression cassette engineering by selecting promoters, enhancers, regulatory elements, and seqeunce optimisation (species-tissue optimisation); tailoring of cloning and assembly methods and validation; safety and manufacturability.
- Construct Stability: Troubleshooting DNA instability challenges such as repeated sequences, ITR, GC-rich sequences, and gene toxicity.
- Regulatory Practices: Design of GMP-compliant workflows, documentation, and manufacturing alignment.

Senior executive and consultant in Life Sciences focused on applying precision diagnostics to liquid biopsies to ascertain the molecular profile of single or multiple cells captured and enriched from blood and cerebral spinal fluid.

Experience:
- Ph.D. in molecular genetics, 20 plus years biotechnology experience in R&D, technology and product development, project and operations management, leading to the design, development, manufacture and commercial launch of RUO products, CE marked, and FDA PMA and 510(k) cleared molecular diagnostic assays.
- Broad knowledge focused on state-of-the-art technologies for application in human and molecular genetics, molecular/immuno-diagnostics, and cell biology, directed toward advancing personalized medicine in rare gene disorder and complex diseases through precision diagnostics.
- Application of strategic and tactical operations to reduce timelines and meet multi-million dollar milestones for the successful launch of multiple products from concept to commercialization.
- Managed R&D, product development, and a P&L for a $230M cell culture business.
- Developed 1 and 5 year strategic road maps for new and mature products.
- High level of interpersonal skills managing multiple disciplines for innovative cross-functional projects, which include R&D, computational biology, phase-gate product development, business and market development, clinical studies, tech transfer to manufacturing for RUO and IVD products under design control, FDA QSR and ISO 13485:2016 compliance in cGMP environments.
- “Roll up sleeves” management style to motivate, lead and mentor individuals, in small and large teams, in multi-national matrix corporations, building organizations from the ground up, and meeting project timelines and financial milestones.
- Presentations to executive management, company boards, scientific meetings, investors and multiple publications in top scientific journals
- 10 issued patents and receipt of $4.4M in NIH grants.
- Broad network of key opinion leaders in human and infectious diseases leading to collaborations and partnerships.

Capabilities:
- Transition research companies and their technologies into product development power houses, converting research projects or Research Use Only (RUO) products for use as Laboratory Developed Tests (LDTs) or In-Vitro Diagnostic (IVD) medical devices.
- Develop end-to-end processes, from feasibility to validation via the IVD (510k or PMA) or LDT route for molecular and cellular diagnostic tests.
- Serve at the intersection of assessing technology in M&As.
- Generate focused strategy plans from Marketing (VOC) to Product Development of VOC generated diagnostic assays, to the transfer of developed assays, to Manufacturing/Operations for the manufacture of medical devices under ISO13485.

My area of study is the intersection of clinical neuroscience, translational pharmacology, and computational biomarker discovery. I am a PhD candidate investigating how glymphatic and meningeal–lymphatic pathways relate to neuroinflammation in humans. I focus on immune-cell phenotyping and cell-free markers that may index inflammatory activity and neurodegenerative trajectories. Alongside sampling development, I contribute to assay and workflow optimisation for mass-spectrometry-ready proteomics, with an emphasis on automation, quality control, and reproducibility.

My pharmacology and drug-safety foundation was built through an MRes in Biological Science and Translational Medicine. I examined dose- and time-dependent paracetamol-induced kidney injury in renal cell models, differentiating apoptotic and necrotic mechanisms and linking experimental readouts to clinically relevant nephrotoxicity questions. I completed a systematic review on cilastatin as a renoprotective strategy and critically evaluated in vitro acute kidney injury models for translational validity. I also gained ward-level exposure as a Clinical Research Associate in nephrology, aligning laboratory findings with real-world clinical pathways and multidisciplinary decision-making.

From an industry and communications perspective, I have experience in medical affairs-adjacent work, including market analysis to support launch planning in an ophthalmic pharmaceutical company and the development of compliant training materials with medical teams. I have delivered conference and hospital presentations, tailoring complex findings to both clinical and public audiences, and I have completed structured projects on European compliance frameworks, which underpins my approach to regulatorily aware medical writing.

Computationally, I build end-to-end machine-learning workflows in Python and R for noisy, high-dimensional datasets, particularly proteomics and multimodal clinical data. My toolkit spans supervised learning, unsupervised clustering, and dimensionality reduction.

Overall, my expertise is translating complex biomedical and quantitative evidence into actionable deliverables, supported by an MBA in Clinical Leadership and a strong biochemistry foundation, including earlier research on TEX12 expression in somatic and cancer models.

During 16 years as a Ph.D. immunologist in the Life Science sector, I gained extensive expertise in the areas of inflammation/autoimmunity, immuno-oncology, MicroRNA therapeutics as well as vaccine platforms. I established a long-standing track record in lead identification and biomarker discovery work.

Working in the small-biotech environment, I embraced an entrepreneurial mindset and the necessity of wearing multiple hats across R&D, quickly adapting to an agile, fast-paced atmosphere to drive early-stage innovation. This hands-on approach and broad exposure to various functions, offered me a holistic view of the pipeline and the direct impact of my work. Transitioning to the corporate environment of a world-leading pharmaceutical company, I was able to utilize my diverse background while benefiting from the processes, resources, and expertise that define large organizations. In this highly impactful system, I was fortunate to lead and contributed to large-scale, international, high-priority projects with my work being instrumental to achieve set milestones.

As a consultant, I will be able to support activities across the full spectrum of the R&D pipeline, including, but not limited to:
• Identifying innovative new therapeutic concepts for immunological indications and pipeline expansion
• Developing mechanistic- and unmet-need-based research strategy to advance characterization of therapeutic targets and biomarkers
• Spearheading the development of novel in-vivo and ex-vivo animal and pathway models
• Supporting and guiding laboratory-based scientists in planning, execution and data analysis of in-vitro and in-vivo studies
• Bridging cross-functional/translational work with internal stakeholders as well as key external experts

KEY STRENGTH AND SKILLS
• Extensive expertise in early-to late-stage immunological research in the context of immuno-oncology and inflammation/autoimmunity
• Highly experienced in working cross functional within global project teams and with external partners/CROs
• Leadership experience by managing and mentoring teams and individual scientists
• Deep knowledge in cell- and molecular biology (with a vast array of in-vitro and in-vivo immune-bioassays), as well as characterization of disease relevant signaling pathways
• Extensive background in various animal models and multiple species
• Highly proficient in data analysis, -management, and -interpretation
• Excellent verbal and written communication- and presentation skills

Strategic Product Management/Marketing Leader with 25+ years of experience in life sciences, specializing in product management, new product development, developing global marketing strategy within the IVD, oncology, and infectious disease markets. Extensive experience leading multifunctional teams, building stakeholder relationships, and launching products involving advanced technologies, including NGS.

Over 35 years experience in life science research and the life science tools industry. 25+ years experience as a senior corporate executive in leading public and private life science tools companies, as well as board service and consulting over the past 10 years. A primary focus has been in corporate development and merger & acquisition.

Specialties: corporate development, merger and acquisition, and strategic planning in the life science tools industry

With over 25 years of leadership in the Life Sciences and Diagnostics market, I have built a proven track record of blending entrepreneurial vision with strategic business management expertise. Drawing from a wealth of experience across Business Development, R&D, Marketing, Sales, and Manufacturing, I have developed a deep technical foundation that drives a passion for revenue growth, market share expansion, and profit performance enhancement.

My leadership is defined by a commitment to innovation and a solution-oriented mindset, consistently helping businesses navigate complex challenges while fostering sustainable, high-impact partnerships across global markets.

Key Strengths:
• Building and scaling international distribution and sales channels
• Motivating and guiding teams to accelerate revenue growth
• Driving success in OEM and B2B sales strategies
• Leading contract negotiations, technology transactions, and licensing agreements
• Spearheading global business development across EMEA, APAC, LATAM, and Africa

By leveraging my expertise, global connections, and industry insights, companies can optimize their distribution networks, ensuring measurable results and maximizing revenue. With a focus on fine-tuning distribution strategies, together we can deliver sustainable growth across key regions.

With over 14 years of experience in the biotechnology and pharmaceutical sectors, I have established myself as a dynamic and results-driven leader, excelling in roles that demand strategic vision, scientific acumen, and exceptional project management skills. My career has been marked by significant contributions to drug discovery, innovation management, and business development, with a proven track record of driving growth and fostering client loyalty.

As Chief Business Officer in a CRO, I spearheaded business development initiatives, proactively engaging potential clients through targeted outreach campaigns. I successfully managed the entire sales cycle and secured contracts with biotech and major pharmaceutical companies. My ability to develop comprehensive proposals, aligning technical and financial aspects with client needs, ensured effective project management and client satisfaction. I represented the company's key assets at international congresses, further enhancing our market presence.

In my concurrent role as Chief Innovation Officer, I secured substantial funding for R&D projects through programs like Eurostar. My expertise in providing scientific and technical guidance to stakeholders has been instrumental in driving innovation and maintaining high standards of project execution.

Prior to these roles, as Chief Project Officer, I spearheaded drug discovery research projects, evaluating the efficacy, mechanism of action, and proof of concept for various candidates, including viruses, antibodies, small molecules, and vaccines. I managed cross-functional teams, budgets, timelines, and deliverables, ensuring project completion and regulatory compliance. My ability to analyze data and my deep expertise in flow cytometry, in vitro assays, immunology, mouse models and preclinical pharmacology evaluation allowed me to present comprehensive reports to clients and ensure project success and client satisfaction.

My academic foundation includes a PhD in immuno-oncology and a tenure as a Research Scientist at INSERM. I secured two post-doctoral grants and authored several peer-reviewed publications, further solidifying my scientific expertise.

Throughout my career, I have demonstrated a strong commitment to leadership, team collaboration, and client-centric approaches. My ability to fuse scientific knowledge with strategic business acumen has enabled me to drive impactful projects and foster long-term client relationships. I am eager to bring this unique blend of skills and experiences to new challenges, continuing to innovate and deliver exceptional results in the biotechnology and pharmaceutical sectors.

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.

Senior Life Sciences Executive and Technical Expert with 15+ years of experience driving innovation in biotechnology. Proven track record in building and scaling successful ventures, specializing in cell biology, automation, and AI-powered solutions. Currently serving as CEO of an iPSC technology company, while offering strategic consulting to emerging life science ventures.

Technical Expertise:
- Cell culture and cell line development (CLD)
- Extensive experience with cancer, CHO, HEK, cultured meat and iPSC cell lines
- Developing and validating automation and high-throughput AI-based imaging instrumentation
- Cell line optimization, immortalisation, engineering and characterization

Molecular & Synthetic Biology:
- Gene editing and genetic engineering
- Vector design and production
- Protein expression systems

Leadership Experience:
- Founded and scaled an iPSC quality control company from concept to market
- Led cross-functional teams of scientists, software engineers and engineers
- Developed and implemented automated laboratory workflows
- Successfully navigated multiple funding rounds and strategic partnerships

Industry Applications:
- Drug discovery and development
- Diagnostic platform development
- Viral vector manufacturing
- Stem cell technologies
- Vaccine development
- Recombinant protein production

Consulting Services:
- Strategic Planning
- Scientific advice
- Market entry strategy
- Technology road-mapping
- IP portfolio development
- Laboratory Operations
- Design and construction optimization
- Workflow automation

A PhD consultant in the biotechnology and life sciences industry with over 17 years of experience working internationally. Specializing in customer insights, market-driven product development and strategic marketing, with expertise in genomic medicine, gene therapy, cell therapy, nanomedicine, NGS, molecular diagnostics, oncology, and more. Held leadership positions in biotech and life sciences companies in Canada, US and UK, including Abcam, STEMCELL Technologies, Thermo Fisher Scientific, Cytiva/Danaher.

I have a a D.Phil. in Biochemistry from the University of Oxford with first author publication in Nature Immunology; an MSc from University of Toronto and a BSc (Honours) from University of British Columbia.

Consulting Services include:
Voice of Customer/Customer Insights
Market Driven Product Requirements
Value Propositions and Product Positioning
Product-Market fit
Competitor Landscape Assessments
Pricing Strategies
Go to Market Strategies

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)

With more than 10 years of R&D experience in biochemistry and infection biology, I am a Senior Scientist for Surface Chemistry in Biotechnology at e-Proteins, the world leader in avidin derivatives production. I have been applying my expertise and skills to develop innovative binding protein solutions for diagnostic, biotech, and pharma industries, addressing the main challenges of streptavidin-based applications.

As a team leader and co-founder of Sapoto, I have also been managing and coordinating a team of 30 employees, integrating external service providers, and overseeing the quality management activities for other test centers. I hold the credentials of QMB Manager and Internal Auditor, which enable me to ensure compliance with GMP, GLP, and GCP standards. My mission is to contribute to the advancement of biotechnology and improve the quality and reliability of binding protein products.

I consider myself an "all-rounder," but as a consultant, I focus on helping clients with their marketing, bringing my experience from the last 25 years working in a range of commercial roles at top life science companies. After a Ph.D. and post-docs, I started my first non-lab role in tech support, then developed my business skills in sales and business development before progressing to senior management positions in marketing, product management, and business unit management, where I founded and led international teams.

I've worked with commercial and technical teams at >200 life science companies - distributors, manufacturers, and OEM resellers in public companies, private companies, and startups. As a consultant, I take on a range of commercial projects, mainly in the marketing/product management realm, specializing in writing engaging content to attract and convert customers, including websites and sales tools.

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.