Expertise

Contribution of Talentcy members during the last 12 months (July 2014-  august 2015)

  • One member has participate to several Scientific Advice Meetings with clients, has worked for the CMC preparation for a submission in late June 2015 of an IMPD, has prepared a Marketing Authorization Application (decentralized procedure)  as well as a US DMF type II (Sept. 2015) and support for multiple project groups for RA projects

 

  • Another TalentCy member is currently working in a temporary assignment management in Brazil, since August 2014 as Director of the transformation program Industrial and Supply Chain of the Brazilian subsidiary of Pierre Fabre Dermo-Cosmetics & Group Pharma, while another execute the same job for GSK Vaccines in Belgium.

 

  • A comprehensive analysis of pharma companies, biotech companies and start-ups in India active in 'small molecule' R & D has been made by another TalentCy consultant. Historical data of this analysis will be published as a review article, whereas recent information on current drug discovery projects in India are intended to be made available to interested clients.

 

  • Another TalentCy member is currently in charge at J&J Belgium of the implementation of a recent directive from the FDA namely "Continued Process Verification", an approach which is to demonstrate that a validated industrial process is still valid.

 

  • One of us continues a business Development for the company he co-founded in Amiens in 2011, Root Lines Technology. He also consults for the moment for Bio-IT companies, Dezyme and BaseClear (Next Gen Sequencing and Metagenomics ).

 

  • Another TalentCy member is working for projects of the European Commission, mainly the Horizon 2020 project and its components SME and  fast track to innovation, and as well as an auditor under the IMI project.

 

  • One of us is currently acting at the Administration Board of GenOway and also coach the Neolix Cy in terms of Business Development

 

  • Another TalentCy member is working on Chemically assisted distribution system for Oncology, on Dry Syrup Xyzal for UCB and act as counsel for Novinject and for Qualicaps (HPMC capsules for inhalation).

 

 

 

FROM  A  to  Z :  including...   Due diligence,...   In depth Analysis, ...  Outsourcing,...  Oncology, ....  Project Management,...  Supply Chain management & Project     

 

Access to an International network of Pharma biotech experts and « investors »,  

Assistance to Industrial Strategy Definition & Deployment,  

Audit and inspection for marketing authorizations of Cies manufacturing API according to ICH Q7A.,  

Biostatistics: Design, Analysis, Reporting, Interim-Analysis, IDMC Business Plan (drawing-up, presentation, implementation),   

Change Strategy and Management,  

Consulting and innovation in Patient-centric marketing Contacts /negotiations with regulatory authorities,

Creation of Spin Out and Spin Off,  

Data Management: Clinical Data Management Systems, Remote (Electronic) Data Capture Deals negotiations & Assistance for Due diligences,  

Deployment of Supply Chain Processes (S&OP, DRP,MPS, MRP,…),  

Deployment of Organization and Systems Design of Market Access strategy, Pricing & Reimbursement and Health Economics approach,  

Due Diligence,   Due Diligence in technical developments,

ERP Data Management,  ERP Implementation (SAP / APO),  

Expert opinion in drug licensing and participation in commercial drug diligence, esp. in CNS and inflammation,  

Facilitation of internal workshops on strategy definition and implementation, e.g.;  How to overcome cancer chemoresistance?,  

Identification & implementation of outsourcing opportunities, in emerging countries such as India,

Implementation of projects including: quality improvement, productivity increase, post implementation review,..,  

In depth analyses of research strategies in oncology: which cancer types to be targeted ?,  

In depth analyses of research strategies in oncology: which types of compounds?,  

Industrial Network Optimization assessment,  

Industrial implementation of chemical processes (scale-up Lab to pilot & industrial ),plus validation,  

Innovation Management in Developments and Manufacturing departments,  

Innovative screening processes of novel anticancer drugs (quantitative videomicroscopy),  

Investment / divestment plans assessment,   

Management of FP7 European project and of BioWin projects,  

Management of BioWin and EU/FP7 financed projects initiator and submission coordinator,  

Market surveys (drawing-up, presentation, implementation): alone or with specialized companies,  

Operational Marketing and Sales,  

Operational regulatory Support,  

Outsourcing Management,  

Outsourcing strategies for pre-clinical drug discovery research,  

Outsourcing Strategy & Implementation,  

Oncology Research & Development

Pre/post company creation audit (Cy/products, services positioning),  

Project & Program Management,   

Project management : coordination of multidisciplinary and multicultural teams,  

Project Management in technical developments (Pharmaceutical, Analyt, Chemical, Devices,..),  

Project Management: Clinical Trial Management Systems, 

Organization of Operational Teams,  

Project management: coordination of multidisciplinary and/or multicultural teams,   

Start up Coaching in the Healthcare Field,  

Strategic Marketing advice on drug launch and lifecycle management,   

Strategic regulatory consulting at all stages of lifecycle,  

Supply Chain, Development & Manufacturing Strategy & implementation,   

Supply Chain restructuring Team management Team management,  

Technical assistance in drawing up of regulatory files,  

Training in Regulatory affairs, 

Which types of pre-clinical models to be used ?