Starting in the Clinical Research area 30 years ago as a study coordinator I have worked my way to being senior director of clinical operations of AM-Pharma through roles in clinical Pharmacology, different CNS areas in midsize Pharma. CNS, Leukemia and now Acute Kidney Injury in Biotech companies. The Biotech has really stolen my heart and sole because of the creativity you have to use in these small companies and the close cooperation with every department. Regulatory Inspections are not a threat but I actually have to say I like them. Partially because I like to be challenged but also because I believe you can constantly work towards a good outcome. There are always findings but they are also a recipe for improvement.
Archives: Speakers
Tanja Ouimet
Tanja holds a PhD in Neurosciences from the University of Montreal. She then moved to Paris to persue her research on metalloproteases as drug targets in academia before joining Pharmaleads in 2006 as Head of Biochemistry, characterizing metalloprotease and inhibitor activity in vitro and in vivo, through the design of specific assays. Her work was essential in selecting Pharmaleads’ drug candidates, Dual development in the treatment of severe pain.
In 2014, Tanja was appointed Head of Clinical Operations overseeing all operational aspects of the DENKIs clinical trials and was names Director of Clinical Development in 2017.
Efe Egharevba
Pharma & biotech professional with 16 years’ experience in clinical trial set-up, monitoring, management and in program leadership. My work experience to date includes a number of indications including oncology, paediatric rare diseases, cardiovascular disease, CNS and rheumatology across all phases in small, medium and large biotechnology and pharmaceutical companies. I am experienced in vendor, budget and matrix project team management and possess a sound understanding of the drug development process gained both professionally and academically.
Marta Garcia
Originally graduated as a Pharmacist in Madrid, and later completed my academic education with an MBA and a Master in Public Health from Liverpool University.
Over 25 years of international experience within the pharmaceutical industry in Regulatory Affairs, Medical Affairs, Marketing, Scientific Communications and Clinical Operations in global and local positions in areas from cardiovascular to oncological diseases.
In the last 2 years my main professional interest has shifted towards Patient centricity within clinical development, recently taking on new responsibilities as R& D Chief Patient Officer.
My current responsibility is the incorporation of patients´ voice across the research and development process of new medicines. This covers the development and coordination of project and study patient centric plans, identification of best-practises and development of KPIs in a cross-traversal manner with patients partners and internal stakeholders.
Matt Cullen
Matt Cullen is the ABI’s Assistant Director, Head of Strategy, Data & Analytics. As Head of Strategy he provides thought leadership on the long term strategic challenges and opportunities facing the insurance industry, and works with policy and executive colleagues to incorporate this thinking into planning and policy development. Much of his time has been spent building the ABI’s policy agenda and public profile in three key emerging areas: technological change and data, cyber risk and climate change.
As Head of Data & Analytics, Matt leads the team of analysts collecting industry data from ABI members to produce the ABI’s market statistics and insight, and is driving a modernisation programme to ensure that the Data & Analytics function adds maximum value internally and externally.
Matt joined the ABI in September 2010 as Policy Adviser, Flooding, and became Manager, General Insurance in 2013. In these roles, he led the development of Flood Re, building stakeholder support for the model, working on its negotiation, and leading the project team implementing the scheme.
Matt began his career in the UK and US nuclear industries – with roles at the Nuclear Decommissioning Authority, the Department for Energy and Climate Change, and the US Department of Energy – after reading Geography and Management at Cambridge University.
Sathyanarayanan Krishnamurthy
Sathya is an artwork and packaging expert, and specialist with over 15+ years of experience in Life Sciences Industry that spans across, Operations Management; Client Servicing and People Management for Biopharma (Innovator and Generic) and Consumer Business. Satya has enabled and assisted a number of Pharmaceutical clients and demonstrated a key role in Large Outsourcing initiatives that involved 25,000 + artwork changes a year, artwork process harmonization, global implementation of systems and processes across 40 countries.
Kripa Patel
Kathleen O’Brien
A 15-year veteran of the translation industry with a background in linguistics, Kathleen has held various roles in the translation business: vendor, project and account management, as well as new business development. Her experiences have positioned her with a unique perspective into both translation operations and how translation impacts the globalization needs of clients in the pharmaceutical and medical device industries. Kathleen proactively collaborates with her Life Sciences client partners on a daily basis to help them set their localization strategies.
David Gwyn
With more than 25 years of experience in the Life Sciences industry, David is a seasoned executive with extensive experience delivering solutions to customers, with a particular focus in the areas of regulatory information management (RIM), content management and collaboration. His main focus is aligning customer needs with the capabilities of the company’s Life Sciences Suite and ensure that the solution meets the needs of the customer. David also leads the DIA EDM Submission Reference Model team that developed a document architecture for use when designing and building content management solutions.
