Evaluation of immunotherapy funding proposals and grant applications

Competitive intelligence on immunotherapeutic targets and therapies

Epidemiology and therapeutic approaches for rare diseases

Background scientific literature studies

Science writing and editing: research articles, reviews, web content, press releases, translations (English/French/Spanish)

Other communication pieces: posters, slide decks, patient information

Audience engagement: social media posts, newsletters, infographics

Live: graphic facilitation, graphic recording

Strategic Drug Discovery Guidance

Technology Integration and Innovation

Project Management & Team Leadership

Grant Writing and Funding Support

Scientific and medical communication (talks, posters, patient materials, etc.)

LinkedIn strategy and ghostwriting (posts and carousels)

Pitch decks, corporate presentations

Website contents

Promoting sustainable generation of higher quality and more consistent multi-parametric data sets

Driving transformational change in data health 

Supporting accelerated digital transformation 

Forging high value strategic collaborations

Target ID & validation package design & management

Scientific strategy and project / CRO / team management

Assay development & screening cascade design & troubleshooting

Translational study management

Scientific strategy and project management in life science

Consulting on innovative approaches and ideas in biomedical sciences and TechMed

Grant writing and funding support

Start-up pitch and value proposition preparation

Cell & Molecular Biologist

Biotech Technical Pre-Sales

Project Manager / Systems Optimiser/ Gap Analysis

Medical Writer

In Vivo and Pre-clinical Platforms, Technology and Tools - Strategy and Sourcing 

Genome engineering - In-house adoption and Outsourcing

Cross-functional team leadership, mentorship and integration

Complex stakeholder and partnership management

Medical and Scientific Writing

Medical communications 

Editing, proofreading, and fact-checking of medical, scientific, academic, and regulatory documents

Translation of documents from/to English, Italian

Scientific strategy and project leadership across Early discovery, preclinical and IND-enabling projects

Expertise in immunology and immunotherapy

Building/coaching teams and developing company culture

Training and mentorship for young scientists

Strategic R&D Planning

Experimental Design & Execution

Data Analysis & Interpretation

Scientific Writing & Communication

Process development: scale up and tech transfer of biologics for early and late stage manufacturing

Process characterisation, validation for commercial manufacture and pre-requisites for BLA filing

Use of microbial strains used for both early and late stage GMP manufacturing, strain characterisation (RCB, MCB, WCB) 

Experience of selecting and managing contract research organisations for outsourced work 

Lead early-stage clinical development initiatives.

Close collaboration with founders and leadership to align scientific goals with business growth strategies, ensuring alignment with investor and regulatory expectations.

Development of end-to-end clinical development strategy (CDP, TPP, ect.)

Designing and reviewing patient-centric clinical studies

Scientific strategy, Assay Development and Project/Team Management

Preclinical & Translational Drug Discovery Consulting

Due Diligence & Gap Analysis

Strategic Business Development & Partnership Strategy

Product Development Process design and implementation (ISO 13485, ISO 9001)

Strategic development planning

Independent review services

Training, coaching and mentoring

Customer Support strategy tailored to company size, products and sales forecast.

Building, scaling-up or optimising Customer Support teams and operations

Systems and AI assessment for Customer Support operations

Developing training plans and documentation related to Customer Support teams and operations

Leading and managing end-to-end Phase I-IV clinical trials for biotech and pharma companies.

Providing clinical strategy and operational efficiency consulting to streamline trial execution.

Building and developing high-performing clinical operations teams, including talent development and CRO oversight.

Advising on clinical development strategies across multiple therapeutic areas, including neurosciences and gene therapy.

GxP QA support and consultation 

Auditing and Inspection Readiness 

eQMS selection and implementation 

Sterility Assurance Assessments

Preclinical & Clinical Development Strategy – Guidance on preclinical efficacy, pharmacology, toxicology, and safety studies, along with biomarker and bioanalytics support for first-in-human (FIH) and early-phase clinical programs

CRO/CDMO Selection & Vendor Management – Identifying and managing contract research and manufacturing organizations to optimize biotech development workflows.

Program & Operational Management – Overseeing global preclinical and clinical teams, ensuring smooth program execution and milestone achievement

Data Collection & Regulatory Submissions – Structuring and compiling data to support regulatory filings and clinical trial applications (CTA/IND)

Biomarker Strategy Development (PK/PD endpoints, candidates for CDx)

Expert advice in multicolour flow cytometry and XMAP Luminex proteomics

CRO selection and management supporting preclinical research and early-phase clinical trials

Regulatory compliance and Quality Assurance

Preclinical research: study design and project management for IND-enabling efficacy, safety, and toxicology analyses

Early discovery support: developing strategies for target ID and validation, MoA, and biomarker investigations

Technology evaluation: reviewing assets, scouting innovations, and exploring emerging technologies

Strategy & Business development: crafting growth strategies, conducting gap analysis, providing market insights, and facilitating CRO selection and strategic partnership

Regulatory Strategy

Regulatory CMC

Cross functional management 

Geographical expansion

Expertise in diagnostics (IVD, assays), biomarker development (auto-antibodies, protein production), and healthcare innovation

Strategic leadership to align scientific innovation with market and customer needs

A collaborative mindset that builds strong relationships with stakeholders to scale solutions globally

A passion for fostering team growth, promoting mental well-being, and empowering individuals to thrive within organisations

Lab automation strategy – developing tailored roadmaps for lab automation adoption aligned with scientific and business goals

Lab automation integration – analysing current experiment workflows to pinpoint areas for lab automation integration

Vendor & technology evaluation – assessing and selecting the best tools for your lab’s specific needs and objectives

Training & support – providing training and ongoing support to ensure smooth adoption and operation of lab automation systems

Strategic and operational solutions for Biotechs, Pharmas and CROs  

Clinical development, operations and project management leadership across several therapeutic areas

CRO selection and partnering

Organisational leadership: people management, team coaching, change management and process improvement

Clinical project management

Clinical trial management

Clinical operations management

Study and Vendor oversight

Biological data analysis and integration

Liquid biopsy, NGS assay development

Method development

Machine learning / artificial intelligence 

Market Insights

Market Access and Pricing

Value Evidence & Communication

Pathways to Access

Conducting scientific literature and regulatory information reviews and creating reports

Developing quality management audit and operations documents

Preparing and reviewing medical affairs slide decks and scientific PowerPoint presentations

Creating engaging white papers and educational content

Design and Development: Creation of CARs and other synthetic receptors, including novel receptor designs tailored to specific therapeutic needs

Strategic Guidance: Expert advice on experimental setups, realistic project planning, and comprehensive risk assessment

Laboratory Support: Troubleshooting and optimization of cell therapy workflows, including viral transductions, receptor expression, and related processes

CDMO or CRO vendor search, identification, negotiation, and qualification for Biotech/Pharma

Lead generation, negotiation and qualification for CROs/CDMOs

Regulatory consulting: MDR in Europe and NMPA in China

Investment pitch preparation and investor outreach

Design and implementation strategies to progress pipelines from discovery to IND-enabling studies

Expert guidance on HTA licensing and regulatory approval frameworks for human tissue research

Data integrity and compliance for regulatory submissions

Development of in-vitro 3D tissue models and in-vivo systems

Developing and executing biotech venture strategies to drive growth and investment readiness

Conducting due diligence and market analysis to assess opportunities and mitigate risks

Providing company-building expertise, including operational setup and scaling strategies

Supporting biotech companies with strategic leadership and operational oversight in a fractional capacity

Data stewardship and data management, specializing in R&D chemistry and small molecules data management.

Build efficient data strategies to unlock value for company and department, including change management.

Uncover and engage with all the teams involved to optimize data utilization and problem-solving in data management. 

Propose processes for data analysis and reporting to enhance decision-making

Provide tailored, end-to-end CMC technical development solutions to improve and accelerate the drug development journey

Support Biologics CDMO selection process

Oversee and manage tech transfer and cGMP manufacturing operations

Navigate the complexities of the CMC regulatory landscape

Commercial support for start up/small companies in the tech bio space. 

Sales Leadership

Business Development

Market development

Marketing strategy on social media

Content creation adapted to your audience

Audience and customer understanding

Personal branding for scientist leaders or CEO

CMC development strategy and project management

Process design and optimization, gap assessment, qualification and validation, facility fit, 

New technology evaluation, benchmark and implementation strategy

Training and mentorship for young scientists/Engineers

Strategy development and M&A support, including diligence and asset integration

Commercial product launch and go-to-market strategies, including CMO/CPO/3PL selection

Business transformation, Supply Chain & Operations, including S&OP, Lean programmes, etc

Non executive director / board support

Finance support from day to day support to special development projects

Experience in building best in class internal control infrastructure

Can assist with fundraising

Ability to help scale organisations

Medical and scientific writing

Health literacy campaigns and educational content creation

LinkedIn strategy for science communication and professional branding

Training and mentorship in medical writing and freelance career development

Supporting Start up biotechs in organisation development, R&D Operations

Clinical Operations Leadership and development, CRO Selection and Oversight

Project Management development including Board presentations

Clinical Operations review for Venture Capital Investment

Business development and lead generation

Tender bid writing

Sales mentorship for early career account managers

Cell therapy platform development 

Immuno-oncology assay development

In-vivo model development and study design

Flow Cytometry

Due Diligence – Assessing the scientific, technical, and commercial viability of biotech projects

Licensing & Investment Support – Evaluating assets, partnerships, and funding opportunities to inform strategic decisions

Gap Analysis – Identifying inefficiencies in R&D, regulatory, and operational strategies and providing clear solutions

Accelerating Development Pathways – Optimising workflows, regulatory readiness, and clinical integration to streamline biotech innovation

Software Regulatory & Quality Compliance Support

Bioinformatics & Clinical Software Development

Strategic Business & Operational Support

Risk Management & Process Optimisation

Therapeutic antibody strategies, discovery, lead optimisation & engineering

Pre-clinical development, assay design & in vivo models

R&D management, guidance of in-house & outsourced projects

Scientific & technical writing, data overviews, development plans, or (pre-)IND dossiers

Interim management for biopharmaceutical companies and CROs

Clinical research support in Europe

Supporting biopharmaceutical companies in contracting and partnering with CROs

Process improvement, change management, team building, team engagement, project rescue

Development and translation of adoptive immunotherapies for solid and haematological malignancies

Preclinical and clinical strategy for biotech companies and research institutions

Scientific and clinical expertise for immune-oncology innovation and therapeutic development

Strategic Clinical Program Leadership

Clinical Operations Oversight

Vendor and Stakeholder Management

Early-Phase Expertise

Scientific consultancy in AAV gene therapy, stem cell therapies, and bioengineering

Expert advisory and support for securing research funding

Strategic proposal reviews for competitive UK and EU funding schemes

Coaching, training, and workshops for researchers and teams

CMC process development: end-to-end support in process development, scale-up and tech transfer to accelerate biotech CMC development and commercialization

Strategic support for GMP manufacturing for biologics

Strategic implementation of process optimization, tech transfer, and GMP compliance for early and late-stage biologics

Scientific strategy and project management

Gap analysis for regulatory strategy

Biweekly mentoring to navigate regulatory challenges

Development of a structured roadmap to advance toward the clinic

Hands-on support to accelerate First in Human success

Delivering Global Strategic Solutions

Clinical Development & Operations

Project & Programme Management

Fractional Leadership & Strategic Advisor

Laboratory, clinical and manufacturing operational consultant

Works with pre-seed, small to large biotech startups to implement legally required Health and Safety systems, Quality Systems, GMO submissions and HTA requirements

Design, build, operate and relocate global laboratories

Establish procurement, supply chain and global logistics

Employment legislation & compliance

Strategic & operational partner for all your people needs

Establishing & maintaining great cultures

Enhancing engagement & internal communications

Organisation Development

Restructuring

Start-up

RemCom support

Bioprocess development from concept to commercialisation

Start-up technical strategy and design

Research guidance in microbiology, biological safety and compliance

Document generation within Health and Safety and compliance