Gaby Anthonijs, Early Development and Alliance Suppliers Strategy Lead I BRQC Janssen Quality Planning & Strategy, Janssen Pharmaceutical
Gaby Anthonijs brings over 30 years of pharmaceutical experience as she began her career at Solvay as a Scientific Associate (CRA) and subsequently held global management positions at Glaxo, Astra Pharmaceutica, Janssen Pharmaceutica, Yamanouchi Europe, Medtronic (medical devices), Farma Research, MSource, Astellas and Johnson & Johnson. She served as the VP/General Manager at a full-service CRO in the Netherlands with a 40-bed Phase I unit. Gaby received a Bachelor of Medicine and her M.Sc. from the Free University Amsterdam in Medical Sciences.
Gaby Anthonijs re-joined Janssen Pharmaceutical Companies of Johnson & Johnson in November 2011 whereby she was globally responsible to develop and establish an E2E Vendor Lifecycle Management strategy, process and oversight including Performance Management of the various vendors (or vendor types) through mutually agreed Key Performance Indicators (“metrics”) as well as issue capturing, tracking, resolution and escalation. Since Jan. 2014, Gaby Anthonijs is in the position of CRO Q&C Liaison, responsible for ensuring effective harmonization, central coordination, implementation and maintenance of activities associated with Quality & Compliance oversight associated with global CRO vendors to ensure Inspection Readiness. Since Nov. 2016, Gaby Anthonijs is in the position of Alliance Suppliers Strategy lead, Strategic Sourcing Network Quality Lead at BioResearch Quality & Compliance Janssen (BRQC) Janssen Quality Planning & Strategy. In May 2017 she was asked to also take the responsibilities of Early Development ESP Oversight as a Lead.
Martine Westendorp M.Sc., Director Clinical Operations, Merus N.V.
Martine bring over 25 years of experience in clinical research working within both CROs and Pharma companies including Sanofi, Covance, Genzyme, Kendle, Analytico and many more. Her achievements include completing phase 2 and 3 programmes with proven pre-approval inspection readiness preparation for FDD among others.
Amer Alghabban, GXP Quality Assurance, Karyopharm Therapeutics
Amer has over 26 years of experience in the pharmaceutical industry. Prior to joining Karyopharm, he was the Managing Director of GxP Compliance and Training Partners (GCTP) helping pharmaceutical companies and aca¬demic institutions to achieve compliance with GCP, GVP and GLP. Prior to that, he was Global Director, Head of Quality Assurance & Audit Management at Merck Serono. Mr. Alghabban has published 2 references books, Pharmaceutical Medicine Dictionary and Dictionary of Pharmacovigilance. He was Assistant Editor for 11 medical journals and an invited Course Director for Pharmacovigilance Auditing at the UK RQA.
Henrik Torp Nielsen, Head Medical Affairs Finance, Novartis
Finance professional with more than 20 years of international experience including different finance roles in Fast Moving Consumer Goods and Pharma (Novartis) while living and working in Denmark, UK, US, Italy and Switzerland.
Medical Affairs focus since 2012 working with scientists from across the world and engaging with scientific community in collaborations, clinical trials, medical activities and increased financial transparency.
Véronique Freund, Quality Head Europe & APAC, Sanofi
Currently Head of Europe & APAC Clinical External Parties Quality Management (CEPQM) and Deputy Global Head at Sanofi.
CEPQM department is in charge of development and deployment of the outsourcing strategy and model for Clinical Operations.
I am also Leader of a group of Subject Matter Experts ensuring the quality and integrity of Interactive Response Technology (IRT) for all R&D studies.
I have 20 years of experience in Clinical Quality Assurance with extensive expertise in the audit strategy and methodology in GxP domains and process optimization.
Expands expertise for 10 years in services providers governance and oversight.
Michele Marzola, Chief Executive Officer & Founder, Interceptin
Founder & Investor in Life Science companies, with more than 20 active projects; previously General Manager, IBM Global Services EMEA and Principal, Booz Allen & Hamilton. MBA Columbia University, MS Università di Bologna.
Katrien Reynders, M.Sc., PMI PMP, Celyad
Fifteen years of experience in clinical research in several leadership roles within both the pharmaceutical and CRO industry. Last year, she joined Celyad as a program director where she oversees the program strategy and execution of the allogeneic lead compound NKG2D CAR-T. Currently, the product is in clinical development phase in both solid and hematologic cancer indications. Outsourcing of critical executional aspects of clinical trials have been more common over the last decade, allowing sponsors to focus on their core business, giving flexibility in resourcing and transferring risks to the CRO. The demands towards CROs have increased, yet the selection process of engaging the right partner is crucial. Sponsors have limited time to dedicate to the search and selection, CROs are often brought in late in the process and with limited information and the chance of succeeding a project is multifactorial. The management of a CRO requires a high level of expertise which is not always available at the sponsors side yet with high financial repercussion.
Martin Rodriguez, Rod Head of Transversal Expert Service, Sanofi
Martin has a Biochemist degree and started in basic research and worked clinical research for more than 20 years.
He joined Sanofi in 1998 and had different position such as Clinical Research Associate (CRA), International Clinical Trial Manager including Quality roles in Process Improvement.
team in the Clinical Platform within Trial Operations and is in charge of supporting activities to the conduct of clinical trials. These activities include, but not limited to, Interactive Response Technology (IRT), Central Laboratory, electronic Patient Reported Outcomes and Clinical Outcome Assessment (ePRO/eCOA), study management outsourcing, vendors management, Quality and Training and Communication.
Roxana Drake, Head Medical Programs Clinical Science, Santhera
Therapeutic areas: rare diseases, vaccines, infectious diseases (antivirals / antibiotics), mmunology, respiratory, neurology, critical care/perioperative bleeding, cardiovascular, coagulation/hematology, medical devices. Hands on experience in Clinical Development, Clinical Operations, Medical Affairs, managing clinical trials phases I to V, across planning - implementation - close out cycle. Integrated experience at local, regional and global level, in small to large companies, US and EU clinical development, including pediatric and rare diseases studies. Currently: Santhera Pharmaceuticals Basel, Switzerland Oct 2017-present.
Head Medical Programs Clinical Sciences/Clinical Development. Novartis Basel, Switzerland Nov 2013-Sep 2017. Global Medical Director Clinical Development Infectious Diseases (Hepatitis, TB).
Stefan Georgiev, General Manager Bulgaria, Premier Research
Stefan Georgiev is general manager for Bulgaria and a Senior Manager Technical Operations for Premier Research Functional Services global department. Stefan has more than 10 years’ experience in the Clinical Trials Custom Sourcing Solutions and is leading various project as an FSP in North America and Central and Eastern Europe.
Andrey Larionov, MD, MSc, Clinical Lead, Hal Allergy
Professional with more than 15 years of expertise in the industry of clinical development. Management positions in both CROs and Pharma companies.
Frederike Sieders, Vendor Management, Danone Nutricia Research
Frederike Sieders is responsible for the coordination of vendor selection and management for clinical studies at Danone Nutricia Research. After graduating in Human Nutrition at the Agricultural University in Wageningen, the Netherlands, she started as CRA in 1989, and continued her career in clinical research as project manager and in several line management positions, both in the pharmaceutical industry as well as for a local and global CRO.
The clinical studies at Danone Nutricia Research relate to early and later phase development projects in Medical Nutrition (e.g. sip and tube feeds, to meet specific nutritional needs) and Early Life Nutrition (e.g. infant formulas). Specific challenges are faced in collaborations with CROs, having especially experience with pharma/device industries.
Her role is to support the clinical study teams to make the best choice in the selection phase and to cope with issues in the collaboration thereafter.
She combines this function with the responsibility as Global Quality Manager for clinical studies at Danone Nutricia Research.
Tania Snioch is Director Healthcare at Global Standard 1
Tania supports the healthcare user community and GS1 local Member Organisations with the aim to enhance the level of GS1 System adoption.
Prior to starting at GS1, Tania worked for the Australian GS1 organisation, GS1 Australia. Tania and her team assisted the Australian Healthcare industry to implement the GS1 System; having the dual aims of helping to improve patient safety and supply chain efficiency. Tania has participated in a range of government initiatives working with both Australian state and territory governments and federal regulators.
Tania has an Honors degree in Biomedical Science from Monash University.
Dr Dorothy Bray, CEO, ImmunoClin
Dr Dorothy Bray is a Senior Executive and Entrepreneur in biopharmaceutical industry with over 25 years experience in healthcare. She is an inventor and holds multiple patents. Dr Bray works with multiple biotechnology and nutraceutical companies helping to develop the commercial and clinical development strategy. In the past she served as a Global Director of HIV Research and Senior Clinical Program Head of HIV and Opportunistic Infections for GlaxoSmithKline and also as Senior Medical Strategy Head, International Medical Affairs, Glaxo Wellcome Inc, USA and as Principal Clinical Research Scientist at Antivirals, Glaxo Wellcome, UK and USA. Dr Bray has extensive network of collaborations and contacts with pharmaceutical companies, governments, and non- government organizations in key developed and emerging markets. She is the European Commission's Scientific Expert and acts as a business advisor to investment companies in USA and Europe.
Since 2012 Dr Bray has been involved in helping companies, research institutions and governments to establish legal hemp and cannabis programs, from industrial applications like fiber production and building materials, fuels and plastics to developing novel formulations for pure compounds and crude extracts to deliver precise oral dosing of cannabinoids in the multiple therapeutic applications.
In addition to her industrial activities she served as a Member of the Scientific Staff and the Head of Scientific Business Development of The UK Medical Research Council Clinical Trials Unit, currently holds an honorary Senior Lecturer position at the University of London and serves as a reviewer for a number of scientific journals.
Specialties: Business development, pre-clinical and clinical strategy to develop novel pharmaceuticals, nutraceuticals and functional food products, solutions for conditions related to aging, including inflammation.
Frank Verheggen, MSc, Clinical Research Professional
Biochemist by training. Started in biotech R&D and has more than 20 years clinical development experience in both early and late phase up to registration, as business development manager, as study manager and as clinical program lead for various indications including paediatrics