Experience

Actelion (now Janssen Pulmonary Hypertension)

• Switzerland
• Pharmaceutical Manufacturing
• 500 - 600 Employee

• Clinical Project Physician

  • Oct 2013 - Present

  Providing medical leadership, oversight and guidance on clinical development projects under responsibility (macitentan in Fontan; macitentan tadalafil fixed dose combinations) from concept generation to design, implementation, execution, and submission/approval. Assumes the role of the Clinical Indication Lead of the assigned project in a matrix environment with key global development contributor's sciences. Medical lead for the assigned projects in the Clinical Teams and in the Life Cycle Teams • Provide medical leadership internally for all Clinical Science responsible project activities (e.g. to clinical science teams and clinical operation teams, regulatory & safety aspects), through a comprehensive understanding of the science, medicine, product environment and competitive landscape relating to a disease area. • Provide medical leadership externally based on thorough scientific review of macitentan / Opsumit® and tadalafil / Cialis ; Adcirca data and consultation with internal and external experts. • Maintain personal knowledge base of medical treatment of congenital heart diseases and, especially Fontan, and also of medical treatments of pulmonary hypertension and pulmonary arterial hypertension, especially combination medications, in adults and adolescents. Show less



Thierry Briand Consulting (Huningue, France)

• Huningue, France

• Founder and Managing Director

  • Oct 2005 - Sep 2013

  Thierry F. Briand is Founder and Managing Director of Thierry Briand Consulting created in 2005. Performed multiple, recurring senior interim development program management missions for bio-pharmaceutical and biotech companies in EU, USA, and India. • Designed, guided, and oversaw complete development plans with scientific, strategic, and medical aspects of clinical trial protocols (Phase 2, Phase 3, and Phase 4). • Experienced with compounds (New Chemical Entities (NCEs) or New Biological Entities (NCEs)) in multiple disease areas, e.g., cardiovascular, metabolic diseases, oncology, and infection diseases,... • Liaised between Key Opinion Leaders (KOLs), Contract Research Organizations (CROs), and client companies to design programs • Prepared and attended health authority meetings. Acted as development expert for clients Conducted multiple due diligences for bio-pharmaceutical, biotech companies, and investors. Clients were international small to mid-size biopharmaceutical or biotech companies, international institutional investors (private equity, venture capitalists), and private high-net-worth individuals • Performed multiple, thorough evaluations of in-licensing investment candidates in different specialties areas. Wrote assessment reports and recommendations for decisions • Trained and coached teams on strategies and hands-on practices of, in- and out-licensing due diligences. Presented scientific, medical, and regulatory assets • Provided assessment of company achievements, operational capacities, technical, scientific, regulatory, compliance, risks, and relevance of mobilized resources. Show less



Speedel

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Project Director. Member of Management Team

  • Dec 2000 - Sep 2005

  • Led and managed avosentan (SPP301) from Phase 0 to Phase 3. Explored hear failure, diabetic nephropathy, glaucoma, and asthma, etc. indications. Led and ensured progress of a PEG-hirudin recombinant protein project (SPP200; a biological) into Phase 2, in USA. • Guided development strategies of cardiovascular projects (endothelin receptor antagonist, anticoagulant). Reported projects progress to CEO and Board of Directors. • Created and assured the Drug Safety Officer (Integrated Clinical Safety Reports handling) function. Developed the company's pharmacovigilance Standard Operating Procedures (SOPs) from scratch. • Championed projects and conducted due diligences and road shows • Managed outsourced capacities in a semi-virtual company with scarce resources Show less



Novartis

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Global Project Leader

  • 1995 - 2000

  • Led and managed projects in Infectious Diseases, Immunology/Transplantation, Dermatology, Oncology, CNS, and Rheumatology/Arthritis therapeutic areas • Integrated cross-functional operational activities of Novartis International Project Teams • Contributed to developing the Dermatology and Immunology/ Transplantation strategies, evaluating in-out licensing opportunities and assessing cross-sector synergies • Led project teams through the preparation and conduct of interactions with key health authorities (e.g., EMEA, FDA, etc.) • Refocused and re-energised projects at risk. Re-designed and re-focused strategies of projects. Led projects from late research through registration and successful commercialization. Successfully transitioned projects from Research to Development • Trained and coached newly appointed project managers in Project Management Department • Post Ciba-Sandoz merger, created key project information and tool sets, which were used as benchmarks Show less