Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare disease clinical trial designs. Perfectly structured, we provide full-service clinical development solutions for small and mid-size drug developers – headed up by a centralised leadership team.
With a focus on tailor-made and scalable solutions, we’ll adapt our delivery style, communications and operations to suit the demands of your project, helping you achieve your clinical and commercial objectives. Because our goal is the same as yours; to improve patients’ lives.
Our company culture is defined by our values: caring ambitiously, tight knit teams, dedicated to delivery, forward thinking, and radically honest.
Chairman of the Board
Anand qualified as a chartered accountant with Arthur Andersen in 2000. He worked in their Corporate Finance department for seven years, specializing in private equity and corporate transactions, before joining the CBPE Capital team. Anand has a degree in Mathematics from the University of Nottingham.
Non-Executive Director
Adam joined CBPE Capital as an Investment Manager in 2018, and shortly after he joined the board of Simbec-Orion.
Adam was formally part of Kester Capital where he focused on primary buyouts in the UK lower mid-market. Before Kester, he was an Analyst at Hawkpoint which is now part of Cancaccord Genuity. Adam has an MSc in Physics from the University of Cambridge.
Chief Executive Officer
Fabrice has been the CEO of Simbec-Orion since November 2019, before which he was appointed COO of Simbec-Orion upon completion of the merger of Simbec Research and Orion Clinical Services in June 2014.
In 1997, Fabrice and Dr Alan Irvine, founded Orion Clinical Services Ltd, an international CRO operating internationally and specialised in Rare and Orphan diseases, oncology and other indications with high medical need. In 1994, Fabrice founded Fournier Laboratories, a medium-size French pharmaceutical company and their UK International Clinical Development Unit, specialised in Gene Therapy and Immunotherapy. Previously, he was one of the directors of an international CRO based in Paris.
Non-Executive Director
Anita joined the board of Simbec-Orion in 2019 and has over 30 years of global business expertise.
Previously, she served as an Executive Officer and Senior Vice-President of PAREXEL. Anita’s broad leadership experience includes effective strategy development, governance, risk management, business start-up and process transformation. She has set up operations and business units across the world and has significant business, acquisition, integration and change-management expertise. Anita emphasizes integrity, strategy and excellence, as well as culture and talent development for diversity.
Anita holds an M.A. Honours degree in Psychology from St. Andrews University and a D.Phil. in Experimental Psychology from St. John’s College, Oxford.
Non-Executive Director
Chris brings a wealth of CRO Business Development experience to the board. Prior to becoming a self-employed business consultant in 2015 and joining the board of Simbec-Orion, Chris worked his way from VP International Business Development to Executive Vice President of Synexus Clinical Research between 2007 to 2016. Before this, Chris held roles at Kendle International (now part of Syneos Health) and Covance.
Chief Financial Officer
John joined Simbec-Orion as our Chief Financial Officer in 2019. John qualified as Chartered Account with KPMG, where over ten years he specialised in Transaction Service performing financial due diligence for corporates and venture capitalists. After KPMG, John joined GKN plc, a FTSE 100 company where he enjoyed eight years in senior financial and operational roles in Corporate Finance and the Driveline Division, including four years living in Singapore as GKN Driveline’s Regional M&A Director and Regional Finance Director of its £350m turnover Division. John has extensive experience of working in Asia and Japan.
John served for nine years as the Group Finance Director of Europe’s leading fire alarm and carbon monoxide detector business, FireAngel Safety Technology Group plc and led the Group’s IPO on AIM in April 2014. Prior to listing on AIM, John led a successful bid defence against a hostile takeover from a Fortune 500 company.
Managing Director, Clinical Pharmacology
Ceri has spent much of her career at Simbec-Orion and was appointed Managing Director, Clinical Pharmacology in December 2019. Ceri has over 20 years’ experience in operations, project management and team leadership in early phase clinical research.
Ceri is also a member of the Senior Management Team and has overall responsibility for the Clinical Pharmacology and Laboratory Services divisions at Simbec-Orion. Ceri’s responsibilities include operations, strategy execution and for ensuring client expectations are met by the team.
Chief Operating Officer
Aize joined Simbec-Orion as COO in September 2021, taking responsibility for Clinical Development Services, which include data sciences, clinical operations, medical affairs, pharmacovigilance, regulatory and project management. Aize has a 30-year track record of working in the Global CRO sector.
Prior to joining Simbec-Orion, Aize led and was part of several management teams in midsized CROs. He was CEO of Julius Clinical, an academic CRO based in the Netherlands, and also COO of Chiltern, prior to their acquisition by Labcorp. He truly enjoys the challenges in clinical development, as well as the need to innovate with all stakeholders to improve overall efficiency and to support sites/networks focused on Oncology and Rare Diseases.
Chief Executive Officer
Fabrice has been the CEO of Simbec-Orion since November 2019, before which he was appointed COO of Simbec-Orion upon completion of the merger of Simbec Research and Orion Clinical Services in June 2014.
In 1997, Fabrice and Dr Alan Irvine, founded Orion Clinical Services Ltd, an international CRO operating internationally and specialised in Rare and Orphan diseases, oncology and other indications with high medical need. In 1994, Fabrice founded Fournier Laboratories, a medium-size French pharmaceutical company and their UK International Clinical Development Unit, specialised in Gene Therapy and Immunotherapy. Previously, he was one of the directors of an international CRO based in Paris.
Chief Commercial Officer
Melissa joined Simbec-Orion in April 2019 as Chief Commercial Officer. Melissa previously headed the commercial group at Synexus Clinical Research whilst it was an independent private equity held company through to its successful acquisition by PPD and subsequent integration.
Melissa has led commercial teams at Synexus, Premier Research and Kendle International through significant growth and expansion periods meeting strategic & corporate goals.
Melissa has significant business development & account management experience from her tenure at IQVIA. Melissa started her career within clinical operations at Innovex, which was later acquired by IQVIA in 1996.
Chief Information Officer
Jim was appointed CIO of Simbec-Orion in January 2019 to leverage technology, data, people and process as strategic enablers to deliver Simbec-Orion’s growth strategy.
Most recently Jim was VP Technology for the Michael & Susan Dell Foundation responsible for delivering the overall vision and operational execution for the Foundation’s technology strategy in order to accomplish their philanthropic goals globally.
As VP Technology for IQVIA Jim was focused on local UK and Global technology delivery in Commercial and Clinical Business Units, managing annual IT investment strategy and creating the go-to-market strategy for the IQVIA Infosario product at its inception. For 7 years up to IPO in 2013, Jim was a key part of the leadership team that grew the IT group from 300 to over 1000 employees, won several business innovation awards and was consistently recognized as one of the ‘Best 100 Places to Work’ by Computer World.
Chief Financial Officer
John joined Simbec-Orion as our Chief Financial Officer in 2019. John qualified as Chartered Account with KPMG, where over ten years he specialised in Transaction Service performing financial due diligence for corporates and venture capitalists. After KPMG, John joined GKN plc, a FTSE 100 company where he enjoyed eight years in senior financial and operational roles in Corporate Finance and the Driveline Division, including four years living in Singapore as GKN Driveline’s Regional M&A Director and Regional Finance Director of its £350m turnover Division. John has extensive experience of working in Asia and Japan.
John served for nine years as the Group Finance Director of Europe’s leading fire alarm and carbon monoxide detector business, FireAngel Safety Technology Group plc and led the Group’s IPO on AIM in April 2014. Prior to listing on AIM, John led a successful bid defence against a hostile takeover from a Fortune 500 company.
Managing Director, Clinical Pharmacology
Ceri has spent much of her career at Simbec-Orion and was appointed Managing Director, Clinical Pharmacology in December 2019. Ceri has over 20 years’ experience in operations, project management and team leadership in early phase clinical research.
Ceri is a member of the Senior Management Team and has overall responsibility for the Clinical Pharmacology and Laboratory Services divisions at Simbec-Orion. Ceri’s responsibilities include operations, strategy execution and for ensuring client expectations are met by the team.
Chief People Officer
Ana joined Simbec-Orion in 2019 as Group Head of Human Resources, before being appointed as Chief People Officer in December 2019. At Simbec-Orion, Ana is responsible for leading the function to support the end to end employee life cycle including talent acquisition (recruitment), performance management, learning and development, compensation and employee relations.
Prior to joining Simbec-Orion, Ana was head of HR at AstraZeneca between 2015-2019, prior to which she worked primarily as an HR Business Partner between 2007-2014 leading for restructuring, change and transformation at AstraZeneca.
Ana graduated from Reading University with 2:1 LLB (Hons) Law in 2000.
Senior Director, Group Head of Quality Assurance
Enrique joined Simbec-Orion in September 2020 as Senior Director, Group Head of Quality Assurance. Enrique has over 24 years’ experience in Clinical Research from early to late phase trials. Having studied for a BA in Chemistry at the University of Pennsylvania and an MSc in Chemical Research at Imperial College London Enrique joined the industry as a CRA and has spent the last 20 years in Quality Assurance within Global CROs.
Enrique has a passion for developing quality systems whilst promoting a culture of quality across diverse global organisations. He has significant experience in leading quality assurance teams globally, working in partnership with operations to implement risk-based strategies, simplify process, and embed fit-for purpose quality systems that focus on patient safety, data integrity and regulatory compliance. Enrique has held senior QA roles at Covance, i3 Research, Pharm-Olam International and Medpace.
Chief Operating Officer
Aize joined Simbec-Orion as COO in September 2021, taking responsibility for Clinical Development Services, which include data sciences, clinical operations, medical affairs, pharmacovigilance, regulatory and project management. Aize has a 30-year track record of working in the Global CRO sector.
Prior to joining Simbec-Orion, Aize led and was part of several management teams in midsized CROs. He was CEO of Julius Clinical, an academic CRO based in the Netherlands, and also COO of Chiltern, prior to their acquisition by Labcorp. He truly enjoys the challenges in clinical development, as well as the need to innovate with all stakeholders to improve overall efficiency and to support sites/networks focused on Oncology and Rare Diseases.
Chair of the Oncology Scientific Advisory Board
As Chair of our Oncology SAB, Alain Thibault is a leading oncologist with over 25 years of oncology drug development experience across phase I-IV clinical studies, including small molecules and biologics; cytotoxics, targeted therapy and monoclonal antibodies, including regulatory submissions; translational medicine and biomarker discovery.
Alain’s previous experience includes positions as Chief Medical Officer, (arGEN-X BVBA), Vice President Clinical Services, Oncology, (Regeneron Pharmaceuticals), Senior Director, Oncology, (Gemin-X Biotechnologies), Senior Director, Oncology, (Johnson & Johnson Pharmaceutical Research & Development), Director, Clinical Services, (Hoffman La-Roche Laboratories)
Chair of the Rare & Orphan Scientific Advisory Board
Dr. Carlos Camozzi, a leading expert in rare and orphan diseases, is an experienced Chief Executive and Corporate Governance in the Biopharmaceuticals and Health Technology with over 30 years C-level expertise/experience of the orphan drugs, gene-therapy, biopharma, and medical devices industry.
Carlos has generated innovative solutions to the design and the execution of non-clinical, translational, and clinical development projects for several orphan drugs, paediatric, and oncology clinical trials. He successfully led several clinical development programmes, regulatory interactions, consultations, submissions and approvals of Orphan Drug Designations (ODD), Paediatric Investigational Plans (PIP) and Marketing Authorisations Applications (MAA) by both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). Outstanding regulatory achievements such as the FDA approval of Carbaglu™ in NAGS deficiency and EMA approval of the first ever gene-therapy (Glybera™) in the western world. He played a key role in the implementation of relevant Market Access and Early Access Programmes in Europe and USA for orphan drugs and products with high unmet medical need.
Dr Awada is Head of the Oncology Medicine Department at Jules Bordet Cancer Institute Brussels, Belgium, where he has worked extensively in the study of solid tumours and breast cancer. Experienced in the clinical drug development of cytotoxics, molecular-targeted therapies, and immunotherapy, Dr Awada has over 25 years’ experience in oncology clinical development.
Dr Awada also holds the position of Head of the Oncodistinct Network, which works to develop innovative strategies for clinical studies and accelerate the development of anti-cancer drugs in solid tumors, especially in areas of high unmet medical need.
We have the expertise and facilities to deliver exceptional clinical services, with a full-service unit dedicated to clinical pharmacology. We perform a range of pharmacology studies, including First-in-Human (FIH), food effect, drug-drug interaction and pharmacokinetic studies, at our dedicated Clinical Pharmacology Unit. Our facility also includes an Investigational Medicinal Product management capability as well as an on-site Bioanalytical and Clinical Pathology Laboratory service, enabling rapid turnaround times and eliminating sample shipment costs.
Established for over 45 years, we boast one of the most experienced Clinical Pharmacology Units in the UK, having successfully delivered over 2,000 Phase I/IIa studies in a wide range of therapeutic indications and routes of administration.
Throughout its history, Simbec-Orion has played a pivotal role in accelerating the progress of numerous groundbreaking medical therapies within the US and Europe. We are a specialised global CRO with in-depth experience of the most complex clinical studies in the challenging therapeutic areas of oncology and rare disease. Our expertise also includes trials to support patients with unmet clinical needs in a range of indications in the fields of CNS, respiratory, dermatology and anti-infectives.
Our clients are globally located, and with the leadership and expertise of the Simbec-Orion project teams, we conduct and deliver key clinical studies which support their submissions for FDA, EMA, and MHRA approval.
In working with our established teams across the UK, Europe and the USA you will benefit from our in-depth and extensive industry and scientific experience and a comprehensive service you can trust, delivered with the highest level of quality, agility, and responsive customer service.
Designed exclusively for the biotech pharmaceutical industry, Simbec-Orion’s full service solution provides central laboratory analyses for Phase I–III trials conducted at investigators sites across the world.
Our combination of expertise, experience and investment in infrastructure enables us to deliver a rapid, responsible, and reliable service, so you can make critical decisions, fast.
The clinical research organisation with wide therapeutic experience, specialising in rare disease and oncology clinical development solutions.
For the last four decades, we have been providing clinical trial management services across a wide range of therapeutic indications and phases. Our passion is rare diseases and oncology.
Responding to the needs of our clients has made us the CRO we are today; a partner, offering full-service clinical development with the size, agility and structure to respond rapidly when needed.
From Phase I clinical pharmacology studies through to Phase III rescue studies and post-marketing, we are here to take on the challenge – whatever the indication or compound you are passionate about, wherever you are in your clinical development journey.
