WORK.
Flexible, hands-on support for the development of biopharmaceuticals throughout all development phases, from the idea to product approval and beyond.
Your partner for all things biotech.
GLOBAL DEVELOPMENT STRTATEGY.
01 Establishing Your Strategy
Preparation of integrated development strategy and definition of key development milestones for CMC, non-clinical, clinical, regulatory
Preparation of global regulatory strategy till approval including strategic considerations and requirements for EU and US
Assessment of options and scenarios to accelerate product development
Target product profile (TPP) definition
Competitive landscape analysis and regulatory intelligence
02 Plans for CMC, Clinical, and Nonclinical Development
Preparation of functional project plans for CMC, clinical and nonclinical develop ready for execution
Technical gap analyses incl. proposals for remediation
Comprehensive time and budget planning for complete development program
Planning of development project scenarios for decision-making
Planning and execution of tech transfer projects
Writing of biosimilarity assessment report
03 Effective Execution and Leadership
Leadership of cross-functional teams for development programs, complex projects, and multi-project portfolios
Project tracking and reporting (timelines, quality, costs)
Implementation of project management processes and tools
CMO and vendor management
Crisis and change management
Management of grants and public funding
Operational support for clinical trials in CTIS
REGULATORY AFFAIRS.
01 Interactions with Regulatory Authorities
Preparation and management of scientific advice meetings and regulatory interactions including meeting request and briefing documentation, organization and management of procedure (EMA, FDA, EU national competent authorities, Health Canada)
Writing and preparation of applications for grants and public funding
EU representative and primary contact in all dealings with EMA
02 Acceleration and Increasing Value Strategies
Preparation of requests for regulatory expedited programs such as PRIME, breakthrough, RMAT designation
Preparation of applications for orphan drug designation (ODD) and humanitarian use device (HUD) designation
Preparation and management of SME applications to EMA
Acting as Interim Regulatory Affairs Professional in your team
03 Clinical Trial Documents
Writing of investigational medicinal product dossier (IMPD), investigational new drug (IND) applications
Writing of Investigator's Brochure
GMO documentation for clinical trial applications in the EU, environmental risk assessment (ERA)
04 Support for Marketing Authorization Applications
Writing of marketing authorization application (MAA), biologics license application (BLA)
MF BIOTECH’s Accelerator Model
Holistic support for emerging biopharma startups, development programs and ventures in early stages.
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Strategic and scientific-technical hands-on support to bring your product development strategy to the next level.
Address key development issues in areas for CMC, nonclinical, and clinical development.
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Complement the leadership team with required biopharmaceutical development know-how and resources.
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Comprehensive review of development strategy and product features in combination with analysis of market and competitive landscape to ensure product-market fit.
Identification of scientific, technical, regulatory, commercial risks and definition of appropriate risk mitigation strategies.
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Enable teams with hands-on knowledge and best-in-class tools to establish product-specific development strategy and to execute development plans effectively.
Tailor-made coaching and training workshops for biopharmaceutical professionals, startups, development teams, academia and entrepreneurs.
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In-depth evaluation of scientific data and refinement of development plans to facilitate investment and funding.
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Authoring of high-quality applications for grants and public funding to secure financing for your development program.
Management and monitoring of funded projects.
SELECTED PROJECTS.
Advanced Therapies
Genetically Modified Organism
Development support for project transitioning from pre-clinical to clinical development stage, EU national scientific advices, IMPD
IB, IMPD
US and EU clinical-regulatory development strategy and regulatory interactions with FDA and EMA
PRIME designation
CAR T
Regulatory support for MAA procedures in EU and UK
CRISPR/Cas9
National scientific advices in EU and Canada, IMPD
mRNA
Project planning and management of personlized mRNA oncology therapy
mRNA
Program management of mRNA COVID-19 vaccine development program and other mRNA drug development projects
Leadership of cross-functional project team for clinical, regulatory, CMC development and manufacturing
Project planning of all development phases till product launch
MSCs
Orphan drug designation
Bacteriophage
EU development strategy
Biologics
Monoclonal antibody
Program lead of cross-functional development team comprising CMC, Clinical, Regulatory, IP, Commercial, Quality
Regulatory interactions with EMA and FDA
Monoclonal antibody
Program management of biosimilar development program
Comprehensive development strategy for a global biosimilar development program
National scientific advices in EU
Co-development agreement
Monoclonal antibody
MAA and Day 120 responses
Immunogenicity assessment report
Recombinant Protein
Project management of inhaled protein drug
Recombinant Protein
US and EU biosimilar development strategy
Oromucosal immunotherapy
IMPD
Monoclonal Antibody
IMPD
Monoclonal Antibody
EMA scientific advices and development support for biosimilar development program
Biosimilarity assessment report
Recombinant Protein
MAA and QOS/Module 3
Fusion Protein
EMA scientific advice
Recombinant Protein
EMA scientific advice
Synthetic peptide
CMC gap analysis
Small Molecules
Small Molecules
Program management of tech transfer portfolios for new manufacturing plant in Asia
Established a comprehensive project organization, including project management tools and processes
Created a technology transfer SOP and a blueprint of a lean technology transfer organization
Small Molecule
EU and US development strategy, orphan drug designation strategy
IND
Small Molecule
Regulatory support for MAA/ BLA procedures
Small Molecule
EU national scientific advices, IMPD
Active Pharmaceutical Ingredients
Project management office for process optimization initiative to establish a new CDMO business
Medical Devices
Combination product
US development strategy and regulatory interactions with FDA
Classification of product and orphan drug designation
Medical device
Development strategy for EU and US, orphan drug designation
Combination product
Facilitation of Notified Body process
Let’s work together.
INSIGHTS.
