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.

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.

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.

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

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.

A distinguished life science professional with over 33 years of extensive experience in research, leadership, and innovation, adeptly navigating the complexities of the biotech and life science sectors as the founder of LMF Biosciences and currently holding key executive positions at Biosensis Pty. Limited, Symansis Limited, as well as previous roles at EMD-Millipore and Chemicon. I have demonstrated exceptional prowess in driving organizational growth, developing strategic partnerships, and leading high-impact projects across various scientific disciplines from Cell Biology and Neuroscience to Molecular Biology, Cancer, and Metabolic Disease.
My career is highlighted by significant contributions to technical and customer service excellence, playing a pivotal role in the success of major companies like Millipore and Chemicon International. My expertise encompasses a wide range of technical skills, from the basics of immunohistochemistry and western blot, DNA/RNA manipulation, molecular cloning, and PCR to a comprehensive knowledge of cell culture techniques and protein analysis, making me a respected educator and trainer in the life science community.

With a solid track record of leading multi-person teams and directing technical service organizations, I have consistently delivered world-class service, support, and scientific assistance crucial to business success in the life science reagents sector. My strategic vision and innovative approach have been instrumental in product development, customer engagement, and identifying future growth areas, enabling companies to better anticipate and meet the diverse needs of their customers.

Beyond technical expertise, my leadership roles have showcased my ability to effectively manage and expand life science markets, achieving and surpassing sales targets while fostering sustainable growth. My entrepreneurial spirit, scientific understanding, and business insight make me an invaluable asset to any organization aiming to excel in the competitive biotech and life science research reagents landscape.

In summary, I offer a unique blend of scientific excellence, strategic business management, and visionary leadership, making me an ideal candidate for roles that demand depth of knowledge, innovative thinking, and a proven track record of success in the life sciences sector.

Senior technical expertise on antibodies and immunoassays

With a thorough background of molecular cell biology and biochemistry, I have accrued multi-disciplinary knowledge and experience while working in both academic and commercial environments with an emphasis on antibodies and immunoassays. During my CSO appointment at an antibody manufacturer, I have gained global recognition on my knowledge of commercial antibodies and their validation through meetings and publications. During my time involving drugs discovery I have developed several assays and filed for patents. I have tutored and trained assistants to very high standard, and many of them have moved on the career ladder since then. After I have written SOPs in a GLP-audited CRO and many technical and managerial SOPs for a fast-growing research antibody manufacturer, my focus has been on protein biomarkers and antibody validation to industrial standard. This focus led to a thorough understanding of etiologies at protein level and of diagnostics and medical interventions. My understanding of physical, chemical, and pharmacological principles made me ready to move on as an independent consultant to aid antibody manufacturers and in vitro diagnostics industries. My interest in strategic planning has helped me thinking creatively thus providing valuable inspirations to move biotech/pharma companies forward.
Based on the above, I was in the opportunity to set up my own company to introduce a long sought after quality standard for commercial tool antibodies. This concept may ultimately also work for the early discovery of candidate therapeutic antibodies.
My expertise is now available to assist in technical or strategic hurdles when complementary experience is required. When assistance is needed for a start-up or for a well-established company, confidentiality is guaranteed, and NDAs can be exchanged when required.

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.