OUR SERVICES

• Situating your concept in the state-of-art and future perspective of medical and societal needs and expectations which may entail the elaboration of a very preliminary Target Product Profile
• Defining a pre-project and its preliminary specifications
• Conducting feasibility studies, interacting / validating with reliable experts (on an international basis), setting cost and time estimates, delineating options, and making simulations
• Defining or supporting the Global Development Strategy (including alternative options) up to Proof-of-Concept, or beyond as needed (Market Authorization, Pre-Launch, Launch), with costing, timing and definition of milestones and go / nogo decision points and criteria. This results in Development Plan writing

• Defining or supporting the Market Access Strategy, value-based pricing and alternative approaches
• Building SWOTs, driving competitive intelligence and analysis (marketed products /drugs in development), gathering the relevant epidemiologic data, building patient-trees
• Writing and updating the Target Product Profile, market positioning, and life cycle management plan.
• Supporting Business Plan development and/or validation
• 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 in the perspective of alliances, acquisitions, exit and partnerships

Operationalizing Development Activities

• Leading the declination and itemization of the Development Plan into detailed work packages
• 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 organizational structure and means
• Project steering, planning /priorities definition, development of KPIs and monitoring tools, risk management to support decision making and management or Board visibility on advancement

• 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 presentations and communications to the Executive Board, Partners, decision-making Committees, and other third parties

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 4 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 and filing authorization applications to the Ethics Committees and competent authorities
• Preparing, attending and following-up on meetings with the Authorities and other regulatory, Ethics, or scientific bodies in the EU and US territories, supporting as needed for other oversee applications (e.g. ensuring of consistency)
• Preparing and/or evaluating dossiers for Orphan Medicinal Product Designations (EU) / Orphan Drug Designation (US)

• Reviewing IMPD, IB, participating to Scientific Advice meetings
• Organizing and preparing for submissions to Health authorities (EMA)
• Seeking advice on scientific and technical regulations

• Helping companies or investors on strategic missions, project, product, and resource evaluations
• Developing or supporting applications for public subsidies and grants (H2020, EU, national or US public funds, specialized funds e.g. Carb-X)

• Supporting Due Diligence efforts (for both in and outlicensing)
• Supporting Funds Raising communication, attending and following-up on meetings with investors
• Supporting the search for adequate partnerships or collaborations