Drug Development Advisory Board



The Drug Development Advisory Board (DAB) at Simbec-Orion was established to offer our clients additional support and guidance in their drug development journey. All members of our DAB are independent of Simbec-Orion, and each are hand-picked as experts in their chosen fields.
These respected scientists utilise their individual areas of expertise to offer specialist insights to our clients, including supporting with aspects of study design and protocol development, regulatory advice, and interpretation of emerging study data.
Our DAB members include leading authorities in our core therapeutic areas of oncology and rare disease. Other individuals bring their extensive experience across all stages of the pharmaceutical development process, including non-clinical, first in human, drug metabolism, and pharmacokinetics.
Drug Development Advisory Board
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Pierre Attali
Member of Drug Development Advisory Board
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Simon Hutchings
Member of Drug Development Advisory Board
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Art Gertel
Member of Drug Development Advisory Board
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Jörn Klinger
Member of Drug Development Advisory Board
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Marco Schmidt
Member of Drug Development Advisory Board
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Alan Philips
Drug Development Advisory Board
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Geoff Kitson
Vaccines & Infectious Disease Expert
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Kirsty Wydenbach
Regulatory & Pharmaceutical Medicine Expert
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David Jones
Pharmaco-toxicology Expert
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Sarah Blagden
Oncology Scientific Advisory Board
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Samson Fung
Oncology Scientific Advisory Board
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Ahmad Awada
Oncology Scientific Advisory Board
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Carlos Camozzi
Chair, Rare & Orphan Scientific Advisory Board
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Alain Thibault
Chair, Oncology Scientific Advisory Board
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Pierre Attali
Member of Drug Development Advisory Board
Pierre Attali is a highly experienced hepatologist, acting as Senior consultant in hepatology (Paul Brousse Hospital, Villejuif, France) since 1976, where he was recently an active coinvestigator of several phase 2 and phase 3 clinical trials (HCC, NASH, HBV HCV).
Pierre was appointed as an expert for hepatology projects at the European Commission in 2020 and has acted as Principal Investigator of several Phase I-III clinical trials in hepatology since 2000.
During his career, Pierre has held positions as Chief Medical Officer, Chief Operating Officer and Head of R&D across several Biotech companies including Sensorion, Bioalliance Pharma/Onxeo and Selexel; and is currently working as Head of R&D and/or CMO for several biotech companies since January 2019.
Pierre has experience overseeing development of programmes from preclinical research to late phase clinical trials, including the definition and implementation of the medical strategy. Pierre also has experience in the management of Medical Affairs, including pharmacovigilance, and Strategic Marketing, including market access, export activities and competitive intelligence.
Simon Hutchings
Member of Drug Development Advisory Board
Simon has over 15 years of experience in the drug development process, including pre-clinical pharmacology/toxicology, phase I (including first-in-human) pharmacology/PK studies and investigator-led phase II and phase III trials. His practical experience and deep scientific knowledge of the design, management and reporting of early clinical development and human pharmacology trials will help our clients optimise their trial designs to maximise the data generated
Art Gertel
Member of Drug Development Advisory Board
Art has over forty years of increasingly senior management-level positions in the Pharmaceutical Industry. Particular expertise in the preparation of large, complex corporate and regulatory (NDA/BLA/MAA/PMA/510(k)) documents and thorough familiarity with relevant US, Canadia, EU, and ICH guidelines. He is a Registered Agent with US FDA, guiding ex-US companies through the regulatory processes required to initiate clinical trials and file successful applications for commercialization.
His additional expertise includes encompassing clinical, preclinical, promotional, and medical educational aspects of all phases of product research, development, and registration.
Jörn Klinger
Member of Drug Development Advisory Board
Joern is Chief Executive Officer and Co-Founder of AI-enabled causal modelling company, biotx.ai. Prior to his focus on utilising AI technology to enhance clinical research, Joern explored how humans learn – first as a linguist and then as a computational psychologist scientist during his Masters at Oxford, where he created deep learning models of the brain.
Marco Schmidt
Member of Drug Development Advisory Board
Marco is Chief Scientific Officer and Co-Founder of AI-enabled causal modelling company, biotx.ai. Prior to his focus on utilising AI technology to enhance clinical research, Marco had an exceptional academic career, winning Best PhD of the year award in Chemistry in his home country Germany before doing a Post-Doc at the University of Cambridge.
During his time at Cambridge, Marco received a Marie-Curie fellowship, as well as a stipend from the Gates Foundation to do his own research. Working with people like Chris Abell and Tom Blundell opened his eyes to the possibilities of launching his own company, as well as to the limitation of traditional approaches to drug development: The inability to predict clinical efficacy. Solving this problem became the mission of biotx.ai.
Alan Philips
Drug Development Advisory Board
Dr Philips provides statistical consultancy services to the Pharmaceutical Industry based on 35+ years of experience working in the Pharmaceutical and Clinical Research Organisation (CRO) industries. Alan has experience of regulatory submissions in many therapeutic areas such as Biosimilars (Rituximab, Herceptin), CNS (depression, insomnia, Generalized Anxiety Disorder), Cardiovascular (Hypertension), Oncology (Breast Cancer) and Women’s Health (Hormone Replacement Therapy, Oral Contraceptives). For example, Alan developed and justified the sample size and statistical analysis strategy for managing missing data for a biosimilar development program for the FDA. He have also recently provided statistical support for clinical development plans in Osteogenesis Imperfecta, Sarcopenia and Chronic active antibody-mediated rejection (AMR) in Kidney transplant recipients. He represents clients at FDA and EMA regulatory meetings, as well as being an expert statistical member on DMCs.
Geoff Kitson
Vaccines & Infectious Disease Expert
Geoff has over 34 years’ experience in the pharmaceutical industry, with a broad-based international perspective on drug development, from phase I to phase IV, experience of pre-clinical work, and regulatory requirements. He has been involved in the preparation of INDs, CTAs, MAAs and other regulatory documents. He has experience in the development of individual clinical studies, clinical trial programmes, multinational clinical trials and developing clinical strategies.
In the last few years he has taken 5 products including 5 vaccines through to first-in-man studies and progressed products through to Phase II/III.
Kirsty Wydenbach
Regulatory & Pharmaceutical Medicine Expert
Dr Kirsty Wydenbach is Head of Regulatory Strategy at Weatherden. With over 13 years’ experience as an Expert Medical Assessor at MHRA within the Clinical Trials Unit (CTU), Kirsty has been involved in the UK regulation of clinical trials across all therapy areas and all phases of development, including ATMPs and many first-in-man studies. Kirsty has also been involved in European discussions aiming to establish an EU harmonised approach to clinical trials and was an EMA expert for the update of the First-in-Human guideline.
Kirsty’s other work has included collaboration with external industry groups and regulators regarding adaptive and novel trial designs, including several publications. She led the MHRA work on novel trial design for the Life Sciences Industrial Strategy as well as through the new MHRA Innovative Licensing and Access Pathway (ILAP), leading the novel methodologies tool.
Kirsty also oversaw the clinical trials work for COVID-19 and provided regulatory expertise on vaccines both within MHRA but also as part of the Government Vaccine Taskforce
David Jones
Pharmaco-toxicology Expert
David is a European Registered Toxicologist and a Fellow of the British Toxicology Society as well as a Chartered Biologist and a Fellow of the Royal Society of Biology. David lectures at the University of Surrey and the University of Wales.
With a background in pharma and contract research, David then joined the MHRA (formerly the Medicines Control Agency) in 1996, where he was recently working as an Expert Nonclinical Assessor, responsible for assessing the nonclinical data for Clinical Trial Authorisation Applications and chairing over a hundred scientific advice meetings every year.
Sarah Blagden
Oncology Scientific Advisory Board
Sarah trained as a doctor in London before undertaking her Medical Oncology specialist training in Cambridge and the Royal Marsden Hospital. In 2003 she completed a PhD at Cambridge University in fruit fly genetics followed by a Clinical Fellowship at the Institute of Cancer Research’s Drug Development Unit.
From 2006-2015, Sarah was a Senior Lecturer at Imperial College London and led their Early Cancer Trials Unit. In 2015 she moved to the University of Oxford where she is now Professor of Medical Oncology, Director of Oncology Clinical Trials Office (OCTO), lead for Oxford Early Cancer Medicine Centre (ECMC) and runs a molecular biology laboratory exploring protein synthesis in cancer.
Sarah has been chief or principal investigator for a number of national and international cancer studies. She has worked with the MHRA/NICE to develop guidance for their new pathways to approval and advises biotechnology and pharmaceutical companies on cancer drug development.
Samson Fung
Oncology Scientific Advisory Board
Dr Fung has over 25 years of oncology practice as well as global Pharma and biotech experience across Hematology, Immunology, Gastroenterology and Nephrology. He has extensive experience in Translational Medicine, including the seamless transition of product candidates from preclinical research into early phase development until Proof-of-Concept (Phase IIb), biomarker expertise, the implementation of clinical operations plans and clinical development strategy.
Dr Fung has experience in EU markets, particularly Germany (AMNOG), and Orphan Drugs.
Ahmad Awada
Oncology Scientific Advisory Board
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.
Carlos Camozzi
Chair, Rare & Orphan Scientific Advisory Board
Dr. Carlos Camozzi 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- and cell-therapy, biopharma and medical devices industry.
Carlos has generated innovative solutions to the evaluation, 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 programs, regulatory interactions, consultations, submissions and approvals of orphan drug applications (ODA), 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).
Alain Thibault
Chair, 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)
Navigating the Regulatory Journey from Nonclinical to Early Phase Clinical Trials
Two-part webinar series: Two of our Scientific Advisory Board members presented a webinar series examining the transition from nonclinical to early clinical from a regulatory perspective and highlighting the key areas where your program can benefit from some forward thinking and planning for your next steps.