THE ATXA TEAM

Prof. Therese Kinsella, PhD, MRIA

Inventor, Founder, Chief Executive Officer and Director

Therese is a leading expert in the field of prostanoid biology, focusing on the vasculature and, more recently, on cancer. She has published extensively in this area, as the lead author, in top peer-reviewed journals, has extensively patent protected including on the discoveries that underpin ATXA, has acted as an expert CV consultant to both large pharma and life-science venture capital funds. In recognition of her contribution to her research field, she has received a number of awards during her professional career including: in 2000, awarded the Royal Irish Academy Medal in Biochemistry; in 2006, elected as a Member Royal Irish Academy (MRIA); in 2008, awarded the Biochemical Society (IAS) Gold Medal. Having begun her research career in industry (Guinness) as a post-doctoral experimental scientist, Therese has a strong appreciation of the underlying processes of product/drug development, including the associated challenges. She has extensive expertise in securing R&D funding and in company management. As Founder and Chief Executive Officer of ATXA Therapeutics Ltd (ATXA), Therese is the lead inventor on an extensive portfolio of patents based on the discovery of novel Thromboxane Receptor (TP) antagonists in clinical development for treatment of PAH and other clinical indications. Therese also serves as Chief Scientific Officer (CSO) and Chief Operations Officer (COO) at ATXA.

Helen Reid, PhD

Co-inventor, Program Manager & Scientist

Helen is the Program Manager at ATXA Therapeutics and has acted as Research Fellow in Prof. Therese Kinsella’s lab, SBBS, UCD during the early discovery phase of the drug development program prior to company spin-out. Prior to joining Therese’s lab initially as a postdoctoral researcher (2001), Helen graduated with a PhD from the University of Ulster, Coleraine (2001), holds a MRes in Subjects Allied to Medicine (UUC, 1997) and BSc Hons in Biomedical Sciences (UUC, 1996). Helen has acted as lead biologist and as program manager at all stages in the development of the TP antagonists from discovery to candidate selection and development and is co-inventor on each of ATXA’s granted patents and pending patents to date. She has >18 years’ experience in the field of prostanoid biology with numerous publications in top peer-reviewed journals in prostanoid biology area. In addition, Helen has 5 years’ experience in the cancer/oncology field.

Eamon Mulvaney, PhD

Senior Scientist & Analyst

Eamon joined ATXA in January 2016 as Senior Scientist. He graduated with a B.Sc Hons (First class) and PhD (2012) from UCD and prior to joining the company, was a postdoctoral research fellow in Therese’s lab in, UCD. Eamon has dedicated his PhD and postdoctoral research career to the role of the prostanoid receptors in health and disease. For ATXA, he has been instrumental in undertaking detailed morphometric and histological analyses of lead drugs NTP42 (as well as back-up drugs NTP48 and TP20) in two preclinical models of PAH, namely the Sugen-Hypoxia (SuHx) and Monocrotaline (MCT) models. He has extensive expertise as a data analyst, biostatistician and in information technology.

Andy Baxter, PhD

Product Development

Andy has held senior technical and management positions in major pharmaceutical companies (Glaxo and Pfizer, where he was involved in the initial development of Sildenafil), emerging biotech companies (Chiroscience - Celltech) and, most recently, early-stage/small pharmaceutical companies (Arakis, Serentis and Altacor). Andy has acted as product development advisor to ATXA since spin-out in 2015 and continues to advise on all aspects of product development associated with the relevant technical work packages. Andy has >28 years’ experience in the biotechnology and pharmaceutical industry, including in discovery and development from early research through to mid-stage clinical trials. His approach is to undertake extensive portfolio review during candidate selection, lead ID and optimisation (chemistry, strategy and screening), advice on IP innovation and diligence, to early development (pre-clinical, CMC, regulatory and early clinical) and product/pipeline due diligence. Andy has a broad knowledge of most therapeutic areas and experience of many therapeutic targets. He is an inventor or co-inventor of over 60 patent applications. Andy has developed products as solid dose forms (including modified release), parental, topical, inhaled, intra-nasal, sub-lingual and transdermal patches. Andy has been successfully involved in both in-licensing and out-licensing projects and has managed collaborations between biotech and major pharmaceutical companies on a multidisciplinary level.

Adriaan Fruijtier, M. Phar.

Regulatory Affairs

Adriaan has held senior and management positions at Global Regulatory Affairs at Bayer AG, Wuppertal, Germany & Bayer Corporation, West Haven, CT, USA; Micromet AG, Munich, Germany; European Medicines Agency (EMA), London, UK; Novartis AG, Basel, Switzerland; Ciba-Geigy, Netherlands, Glaxo, Netherlands. Adriaan graduated as a pharmacist at the University of Utrecht, The Netherlands. Adriaan has acted as regulatory affairs advisor to ATXA since spin-out and was instrumental in advising ATXA when filing its application for orphan medicinal product (OMP) designation from the EMA and FDA for NTP42 for treatment of pulmonary arterial hypertension. As a regulatory affairs expert, Adriaan has extensive knowledge of regulatory compliance and safety assessments in Europe and the USA. In addition, having previously worked at senior level at the EMA, Adriaan brings his vast experience and invaluable insight into all matter relating to regulatory approval by the EMA to ATXA.

Mark Maginn, PhD

Regulatory Affairs, Safety Pharmacology & Toxicology

Mark is an experienced safety pharmacologist & toxicologist, with extensive knowledge and expertise in managing preclinical development programmes for both small molecules and biologics gained in both contract research organizations and the pharmaceutical industry, from small start-ups to mid - large Pharma. In this, he has held senior positions at Huntingdon Life Sciences Ltd (Team Leader, 1997 – 1999); H. Lundbeck A/S Denmark (Academic Associate, 1999-2004); AstraZenica AB, Sweden (Assoc. Principal Scientist, 2004-2008); PanGenetics UK Ltd, UK (Preclinical Development Manager, 2008 – 2010). In 2010, Mark founded Pharm Tox Consulting Ltd, UK and is currently serving as an independent consultant to large and early-stage biotech companies such as ATXA. Mark’s experience includes developing early discovery efficacy models to screen lead candidates, late discovery safety screening and all areas of preclinical development and early clinical development. Furthermore, his experience extends to regulatory submission, including preparation of formal responses to regulatory questions. He has worked in safety assessment across many therapeutic areas including cancer, cardiovascular, gastrointestinal, CNS, Immunology and Inflammation/Pain research areas. Mark has a keen interest in the development, validation and introduction of new models to aid drug discovery and the drug development process with particular focus in immunology, cardiovascular and CNS safety assessment. In Sept’ 2019, Mark joined ATXA as a consultant safety pharmacologist and toxicologist, advising the company on its ongoing late-stage preclinical development path, particularly in relation to the safety pharmacology and toxicology program as well as ensuring regulatory compliance.

Dr Mike Perkins, MB CcB MRCP FRCP, FFPM

Consultant Chief Medical Officer

In September 2019, Mike joined ATXA as an advisory chief medical officer (CMO). Mike has extensive experience in CV & respiratory medicine, academia, large pharma (e.g Pfizer), start-ups (Oxygen Ltd, UK) and has held various CMO consultancies since 2004. Dr Perkins is an experienced pharmaceutical physician in CV & respiratory medicine having worked in the large pharmaceutical for more than 30 years. He previously held senior positions in Clinical and Regulatory at AstraZeneca and Pfizer. Whilst at Pfizer, as Vice President Regulatory Affairs, he was a member of the world-wide exploratory development forum (EDF) overseeing many projects including the Sildenafil programme in pulmonary hypertension which was delivered from the Pfizer Sandwich Laboratories Development research hub. He also has extensive experience in academic medicine, including acting as an experienced appraiser for General Medical Council physician revalidation for the Faculty of Pharmaceutical Medicine and a Medical Appraisal Lead. In 2004, Dr Perkins transitioned successfully from large Pharma into biotech and has managed preclinical and clinical programmes to proof of mechanism and proof of concept in pain, allergy and inflammation. He has been CMO for several biotech companies. He was previously CMO for Oxagen Ltd (an Oxford University spin out) where he devised and managed a clinical programme from preclinical to first-in-human, Phase II POC and Phase IIb for a novel CRTH2 antagonist. Prior to this, he was Chief Development Officer for Ionix Pharmaceuticals in Cambridge where he devised and ran a clinical programme for intranasal buprenorphine in the USA including filing an IND and managing a pre-submission IND meeting involving three FDA divisions. As advisory CMO at ATXA, Mike’s main responsibilities includes advice on finalizing the design of the FIH Phase I clinical trial and selection of the clinical trial unit, as well as liaising with key clinical advisors and with the national competent authority where the FIH trial will be carried out (e.g. the MHRA, UK or HPRA, Ireland).

Kerry af Forselles, PhD

Regulatory Affairs and Scientific Writing/Communication

Kerry is a consultant pharmacologist with significant expertise in medical/scientific writing and communications in the pharmaceutical industry. She possesses excellent interpersonal and project management skills, with extensive expertise in the preparation of regulatory documentation and submissions for both drugs in clinical development and/or the delivery of new or repurposed medicines to market. She has extensive pharma industry experience having worked for over 10 years at Pfizer Global R&D, Kent, UK (1999 – 2011) where she served as Biology Team Leader in small molecule drug development in the Genitourinary field. She then served as Publications Writer at ApotheCom ScopeMedical (UK, 2012-2013) before starting a consultancy company afPharmative Insights Ltd (UK, 2014 – present). In this, Kerry serves as a pharmacology advisor to early stage pharma, particularly in putting in place quality management systems, as well as in assisting in the preparation and submission of regulatory documentation, ensuring regulatory compliance. At ATXA, Kerry has assisted in putting a quality management systems (QMS) in place and will be expected to lend support in scientific writing of key regulatory documents including the Investigator Brochure (IB), Investigational Medicinal Product Dossier (IMPD) and the Clinical Trial Application (CTA).

Audrey Murray, BComm, FCCA, LIB

Finance and Administration Manager

Audrey joined the team in October 2018. She previously acted as Project Manager on a large scale EU Interreg project (Ireland Wales Programme 2014-2020) within University College Dublin. Prior to this, Audrey has over 20 years’ experience in a banking environment in finance, relationship management and project management roles.

Lucia Bialesova, PhD

Research Scientist

Lucia has over 8 years experience in cell biology and in cancer research. After completing her PhD on nuclear receptors in breast cancer, she continued as a postdoc at the prestigious Karolinska Institute, Stockholm where she worked in the fields of epigenetics and DNA methylation in metabolic diseases, and on the  role of Estrogen Receptor in breast cancer. After several years of experience in academia and public medical health, Lucia joined the R&D team at ATXA Therapeutics recognizing the collaborative and challenging opportunity that this role offers.

Fabiana Renzo, MSc

Research Scientist

Fabiana joined ATXA Therapeutics as Research Scientist in January 2020. In 2019, she graduated with a M.Sc. (First Class) in Pharmaceutical Chemistry and Technology from the University of Modena and Reggio Emilia (Italy), with a program equivalent to a 4 year B.Sc in Pharmacy followed by 1 postgraduate year toward a M.Sc. As part of her M.Sc, she completed a 6 month research project at the FOCAS Research Institute of TU Dublin where her studies focused on the applications of spectroscopy technologies to stem cell biology and clinical use. Fabiana is an experienced pharmacist and practiced in both the hospital and community pharmacy setting.

Viviana Salvatore, PhD

Research Scientist

Viviana completed her PhD in oncology at the University of Bologna, Italy in 2016, specializing on the role of the tumour microenvironment in cancer development and progression. She then took up a post-doctoral fellowship there, further enhancing her background in cell micro-environment interactions in cancer development and tissue regeneration. In Jan 2017, Viviana moved to Dublin to work as a post-doctoral scientist on the comparative proteomic analysis of milk-derived exosomes in human, bovine and infant formulas at the School of Pharmacy & Pharmaceutical Sciences, TCD and, later, joined An2H Discovery Ltd working on novel strategies to screen small-molecule therapeutics in neurology and oncology. Prior to joining ATXA Therapeutics Ltd in March 2020 as Research Scientist, Viviana held a research fellowship at Trinity Translational Medicine Institute, TCD, where she worked on the therapeutic development of clinically relevant radiosensitising miRNAs for the treatment of oesophageal cancer.

CLINICAL TEAM

ATXA’s clinical advisory team includes Dr Luke Howard (Consultant Respiratory Physician, Imperial College and Hammersmith Hospital, London, PAH specialist), Dr Alex Rothman (Sheffield University Hospital, Cardiologist, with special clinical interest in PAH) and Dr Sean Gaine (Consultant Respiratory Physician, Mater Misericordia University Hospital in Dublin & Director of the National Pulmonary Hypertension Unit, with a special interest in biomarker development).

© 2020 by ATXA Therapeutics Limited.

Dublin, Ireland

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