OUR SERVICES

• Analyzing your concept with reference to the most up-to date scientific state-of-art and future perspectives, considering medical needs and expectations,
• Proposing  a  preliminary Target Product Profile
• Developing a draft development project and its specifications
• Conducting feasibility studies, interacting / validating with selected experts (on an international basis), setting cost and time estimates, delineating options, and making simulations
• Developing  the  Global Development Strategy (including alternative options) up to clinical Proof-of-Concept, or beyond as needed, with timelines, definition of milestones with go / nogo decision points and criteria, and costing,.

• Bringing scientific support to IP generation, issues, strength of patents, freedom to operate (FTO)
• Supporting Due Diligence preparation, organization and conduct
• Interacting with current or potential partners from a scientific perspective supporting  alliances, acquisitions, exit and partnerships

Operationalizing Development Activities

• Leading the declination and itemization of the Development Plan into detailed work packages
• Designing, supporting or leading the step-by-step execution of Operations with the company cross functional multidisciplinary expert team and/or vendor organizations, and other consultants, depending on company’s organizational structure and resource. This may entail study synopsis writing and validation, participation to writing developed protocols, scientific documents, study reports in the appropriate formats.
• Project steering, planning /definition of priorities / development of KPIs and monitoring tools, risk management to support decision making.

• Following-up on actions, decisions, building remediation plans
• Reviewing assessing project deliverables (based on multiple references), and checking alignment with strategy and planning.
• Managing or checking on Budget (internal and outsourced)
• Preparing or supporting scientific presentations and communications to all stakeholders.

Organization – Working Style

• Supporting, initiating or leading the switch into project mode (as necessary)
• Supporting Portfolio Management and interaction between projects, with resource arbitration where needed

• Project team coaching and training , support to the hiring process
• Coaching and mentoring of managers and colleagues in the development and execution of action plans, follow-up and evaluation

• Designing and overseeing the implementation of the clinical development plan, identifying the critical steps and roadblocks, defining alternative options
• Conducting bibliographic analysis, literature search and extractions, driving international expert mapping
• Writing / validating study synopsis, interacting with area experts
• Reviewing, amending, overseeing clinical and regulatory documentation preparation for phase 1 to 3 clinical trials (Investigator’s brochure, protocol, IMPD, ICF, CRF…)
• Hiring Clinical Team, and on a need basis training it to GCP, methodology, practical conduct of trials, safety, drug supply chain, etc…

• Selecting, contracting and overseeing pre-clinical or clinical vendors: CROs, SMOs, clinical supplies manufacturers, statisticians, data managers, regulatory or pharmacovigilance services
• Setting up Steering Committees, Advisory Boards, DSMBs, and managing contracts as appropriate
• Supporting, preparing, attending interactions with Regulatory Agencies and other entitled Authorities
• Developing clinical research contracts with investigators, hospitals and institutions and with multiple parties
• Managing, validating medical and clinical communication with stakeholders

• Preparation of the CMC development plan from Cell Line Development to Clinical Batch
• Selection of and contract with CMOs (RFP, Scope of work, Service Agreement…)
  – Drug Substance / Drug Product
  – Subcontractors for Viral safety, Fill & Finish, Packaging, Batch Release…

• Management of all CMC activities
  – Process Development
  – Formulation establishment
  – Process scale up and GMP material manufacturing
  – Establishment and qualification of analytical methods
  – Stability studies
  – Release of Drug Substance/Drug Product
• Preparation of tools and decision making process
• Transition to GLP toxicology studies and clinical

• Preparing the scientific and medical sections of  Clinical Trial Authorization applications to the Ethics Committees and competent authorities on various geographies
• Preparing, attending and following-up on scientific advisory meetings with the regulators,  and other  Ethics, or scientific bodies in the EU and US territories, supporting as needed for other oversee applications (e.g. ensuring of scientific consistency)
• Preparing and/or evaluating the scientific sections of dossiers for Orphan Medicinal Product Designations (EU) / Orphan Drug Designation (US)

• Reviewing IMPD, IB, and any information documents for investigators and patients
• Seeking advice on scientific and technical regulations

• Keeping scientific and medical documentation updated and valid for any audit or due diligence
• Developing scientific and/or medical rationale and supporting applications for public subsidies and grants

• Supporting the search for adequate partnerships or scientific collaborations