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Gene & Cell Ltd

A London-based, Globally-operating, Consulting Firm for the Gene & Cell Therapies

CGT Consultancy

Consultancy services for cell and gene therapies (CGT) play a crucial role in navigating the complexities of developing and bringing these advanced therapies to market. By leveraging the expertise of our specialized consultants/collaborators and contractors, companies can enhance their R&D efforts, ensure regulatory compliance, optimize clinical development, and develop effective commercial strategies.

Our consultancy services for cell and gene therapies are specialized services aimed at supporting companies, research institutions, and healthcare providers in the development, regulatory approval, and commercialization of cell and gene therapies. These services cover a wide range of activities, including scientific and technical support, regulatory guidance, market analysis, and strategic consulting.

Benefits of our CGT Consulting Services

Expertise: Access to specialized knowledge and experience in a highly complex field.

Efficiency: Streamlined processes and reduced time to market.

Compliance: Ensuring adherence to regulatory standards, minimizing risks of delays or non-approvals.

Innovation: Support for innovative approaches and technologies to stay competitive in the market.

Cost-Effectiveness: Optimizing resources and reducing costs through strategic planning and expert guidance.

Pricing for cell and gene therapy consultancy can vary widely based on several factors such as the expertise of the consultant, the scope and complexity of the project, the duration of the consultancy, and the specific services required. We are a small, specialized firm focusing solely on the CGT field and we offer competitive rates with deep industry expertise. We offer highly competitive hourly rates, project-based rates, retainer agreement fees and specialised services using specialised expert collaborators/contractors.

Why don't you try us:

The 1st hr of our CGT Consultancy is free! We can learn more about what you need, you can learn more about what we offer and we could discuss the requirements of your project under either a confidential (CDA) or a non-confidential framework.

What we offer:

Scientific and Technical Support

Research and Development (R&D): Assistance with preclinical and clinical research, including vector and study design, data analysis, and interpretation.
Process Development: Optimization of manufacturing processes for cell and gene therapies to ensure scalability, efficiency, and compliance with Good Manufacturing Practices (GMP).
Quality Control (QC) and Quality Assurance (QA): Development and implementation of QC/QA systems to ensure product quality and consistency.

Regulatory Guidance

Regulatory Strategy: Development of comprehensive regulatory strategies tailored to different markets (e.g., FDA, EMA, PMDA).
Regulatory Submissions: Preparation and submission of regulatory documents, including Investigational New Drug (IND) applications, Biologics License Applications (BLA), and Marketing Authorization Applications (MAA).

Compliance: Ensuring compliance with regulatory requirements throughout the product lifecycle.

Clinical Development

Clinical Trial Design and Management: Designing clinical trial protocols, managing trial logistics, and monitoring progress.
Clinical Data Management: Collection, management, and analysis of clinical trial data.
Biostatistics: Statistical analysis and support for clinical trials.

Commercial Strategy

Market Analysis: In-depth analysis of market trends, competitive landscape, and unmet needs.
Pricing and Reimbursement: Strategies for pricing and securing reimbursement from payers.
Market Access: Assistance with market access strategies to ensure successful product launch and adoption.

Strategic Consulting

Business Development: Identifying partnership and licensing opportunities, and facilitating collaborations.
Project Management: Managing complex projects from inception to completion, ensuring timely delivery and alignment with strategic goals.
Risk Management: Identifying and mitigating risks throughout the product development and commercialization process.
Pitch Decks Design to Investors

Training and Education

Workshops and Seminars: Providing training on the latest developments in cell and gene therapy.
Staff Training: Customized training programs for company staff on technical, regulatory, and commercial aspects of cell and gene therapies.

Gene & Cell Ltd: CEO & Founder

Takis Athanasopoulos

Dr Takis Athanasopoulos is currently the CEO & Founder of Gene & Cell Ltd. a Gene & Cell Therapy Consulting Firm, based in London. He has more than 25 years of expertise in the field of CGT. He has offered advice/offer consultation in CGT program deliverables and activities to various companies/start-ups/Biotechs (e.g. ViGeneron, TheraCell, Orgenesis, Octomera, Asgard Tx, Complement Tx, Genethon, Quethera), Consulting Firms (Dark Horse Consulting Group) & VC Partners (Sofinova). He was previously appointed as VP of Gene Therapy Research & Vector Technology, at Vigeneron GmBH, Munich, Germany. Prior to joining ViGeneron, Takis has previously held leadership positions at GSK, acting as Director & Head of various functional CGT GSK units i.e.Vector Innovation/Vector Development, Patient Operations, Transgene Delivery and Vector & Transgene Units, as part of Cell & Gene Therapy (CGT), Medicinal Science & Technology (MST) platform of GSK at Stevenage, UK. Before joining GSK, Takis was a Lecturer in Molecular Biotechnology at University of Wolverhampton and Academic Visitor/Research Consultant for the Gene Therapy Group at Royal Holloway University of London (RHUL). Before joining the Faculty of Science and Engineering at UoW, Takis has been a member of the Collaboration for AIDS Vaccine Discovery (CAVD)-an international network of scientists and experts dedicated to designing a variety of novel HIV vaccine candidates and advancing the most promising ones to clinical trials. He holds a BSc in Biochemistry from University of Patras, Greece, and a PhD in Biomedical Sciences from the University of London.