PSI Webinar: Master protocols - theory, application and regulatory considerations
For this webinar, PSI brings together experts on master protocols from the pharmaceutical industry, academia, and regulatory agencies.
Lucy Rowell, PSI Chair
Lucy has been engaged in the PSI Scientific Committee for 8 years. She was the Conference Chair (2017 & 2018) and has sat on the Board since July 2016. She is driven by advancing the role of statisticians within healthcare and breaking down perceptions of what a “statistician” is.
Lucy is the Group Head for Affiliate Partnerships, within the Personalised Healthcare Data Science team at Roche with over 16 years industry experience and is the PSI Chair since 4th July 2019! Lucy has worked as a clinical statistician across early and late stage and many therapeutic areas, performing varying roles. She spent 3.5 years being a Global Development Team Leader, leading a cross functional team (clinical science, regulatory, statistics, operations, safety, clin pharm ….) to deliver complex development programs and has spent a year rotation as a medical manager/commercial brand manager in the Roche UK Affiliate.
Outside work Lucy loves doing anything adventurous, traveling the world and going to see live bands. To relax she likes to read, meditate and is experimenting with being a vegan (since Jan 2019).
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Chrissie Fletcher, Vice Chair and Secretary
Chrissie is passionate about her profession as a statistician and the significant value statistics has in development and commercialisation of new medicines in the Pharmaceutical Industry.
Chrissie is the VP of Development Biostatistics at GSK and previously held various roles in the Biostatistics at Amgen and SmithKline Beecham.
For nearly 30 years, she has supported a wide range of associations where she is widely recognised for her expertise and leadership in shaping her profession and broader industry initiatives. PSI was the first association Chrissie joined back in 1991 and she has supported ITIT/Training, Scientific, Treasurer and Regulatory activities. Chrissie has also supported a variety of SIG’s, including the HTA SIG, for the last ten years. She was awarded an Honorary Membership in 2019 for her services to PSI.
Jurgen Hummel, Regulatory Chair
Jürgen has 25 years of experience in the industry, where he has held a variety of technical and managerial positions, predominantly within the CRO industry. He has been at PPD in Bellshill (near Glasgow) since 2006, where he is Senior Director of Statistical Science and heads up the Statistical Sciences group. In addition, he provides statistical consultancy both internally and externally.
Jürgen has been a member of PSI/EFSPI Regulatory Committee since 2006 and during that time he has been meeting with MHRA and EMA statisticians and attending EMA workshops on many occasions.
Jürgen earned a Diplom (German equivalent of a Master’s Degree) in Mathematics and Economics at Augsburg University, Germany, and is a Chartered Statistician with the Royal Statistical Society. Outside of work, he enjoys running (which has included two marathons, as well as several half-marathons), hill walking and travelling.
Alexander Currie, Commercial Director
Since completing his MSc in Statistics with Applications in Medicine at Southampton University in 1999, Alex has been employed as a Biostatistician in the CRO and pharmaceutical environment based in the UK and US.
He has been an active member of the PSI including 5 years organising courses on the Training Committee followed by 2 years as Commercial Director. Alex currently works for GSK managing a team of statisticians in the Infectious Diseases therapeutic area. Alex’s hobbies include going to music gigs and visiting art exhibitions.
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Amanda Darekar, Careers and Academic Liaison Committee Chair
Amanda Darekar has over 20 years’ experience in the industry and has worked at Pfizer since 2003. Prior to that, Amanda worked for Pharmacia (later acquired by Pfizer) and Quintiles (now IQVIA). During her career, Amanda has been the lead statistician on many projects across various phases and therapeutic areas and in 2007 she also undertook a year-long secondment to Mumbai to manage the Pfizer statistics group there. She is currently a director within the Internal Medicine statistics group, where she is a Statistics Lead on late-phase projects.
Amanda has been a member of PSI CALC since 2010 and in 2019 took on the role of committee chairperson and is committed to ensuring that through CALC, PSI is well-placed to publicise the value of studying maths and statistics to both school and university students and to promote careers in medical statistics.
Amanda has a BSc in Statistics from the University of Reading and an MSc in Statistics with Applications in Medicine from the University of Southampton. Outside work Amanda has an interest in art, architecture and enjoys doing pretty much anything creative.
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Mary Elliot-Davey, Training Committee Chair
Mary started working at Amgen after graduating from LSHTM with an MSc in Medical Statistics. She is currently principal statistician working on both early and late phase Cardiovascular clinical trials. She is also involved in providing training to non-statistical colleagues. The thing Mary enjoys most about her work is that she is helping to make a difference to patients with serious diseases.
Early on in her career, Mary got involved in PSI. She joined the training committee and helped to organise several training courses on topics such as Adaptive Designs and Cross-over studies. In 2016 she joined the PSI Board of Directors and became chair of the training committee. She really enjoys planning training courses to meet the educational needs of the PSI membership, and in recent years the committee have worked to put on more soft skill based courses as well as the traditional technical courses. She also enjoys being on the Board and helping drive the strategic aspects of PSI as a whole, to ensure the organisation meets the needs of the members.
Outside of work Mary likes to spend her time walking her dog – a black Labrador called Jet.
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Stephen Jones, External Affairs Chair
Stephen has been a PSI member since 1988, when he joined the Pharmaceutical Industry as a Statistician after graduating with an Msc in Biometry. His current interests fall more under data science and using his statistical knowledge to guide predictive modelling for investigator site and overall study performance.
Stephen has been involved with the running of PSI ever since in many roles, including Scientific Committee Chair, Conference Chair, SPIN Editor and most recently, External Affairs.
Stephen is passionate about promoting the importance of data and the correct use of statistics in decision making but in a way that is not off-putting to those who claim not to understand (something he refers to as ‘statistics by stealth’).
Rachael Lawrance, Scientific Committee Chair
Rachael is a Principal Statistician at Adelphi Values Patient Centered Outcomes team, focused on the analysis and interpretation of PRO data, particularly in the context of clinical trials (3-days a week). She also occasionally works part-time as a freelance statistical consultant, with a focus on statistical work for small healthcare companies. Rachael previously worked at AstraZeneca for sixteen years; most recently as a lead project statistician in oncology projects, including those with companion-diagnostics. Rachael has a slightly unusual career route to becoming a statistician in the pharmaceutical industry, as she has a BSc Biochemistry and Genetics - she started at AZ as a molecular geneticist -- but has gradually been drawn into the world of statistics and enjoys the application of statistics in practice.
After leaving AZ Rachael was keen to stay connected to Pharma Statisticians and therefore joined the PSI Scientific Committee member in 2016. Rachael enjoys organising events and has been co-organising one-day meetings, webinars & PSI conferences and joined the PSI Board as scientific chair in June 2019.
Rachael loves the outdoors and is a keen fell runner and is also slightly infamous for completing long races (marathon distance and beyond). She has two boys who are currently at primary school so family life keeps her busy too!
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Kate Tsirtsonis, Membership Chair
Kate has over 15 years of experience in the Pharmaceutical Industry, working as a Statistician and a Statistical Programmer across early and late stage therapeutic areas, performing varying roles. She is currently European Statistical Lead for General Medicine within Amgen.
Before joining the Pharmaceutical Industry, Kate obtained a Bsc in Maths with Actuarial Studies and an Msc in Medical Statistics from the University of Southampton.
Kate has been involved in PSI for many years but is now enjoying taking an active part in the PSI Membership Committee, focusing on widening out the PSI community.
Outside of work, Kate is a keen, yet distinctly average, runner. She also has two active young boys, so family life keeps her very busy.
Alexander Schacht, Commercial Director
I have studied mathematics and received my PhD in biostatistics on non-parametric statistics from the University of Göttingen in Germany. I authored more than 70 scientific manuscripts in peer-reviewed journals and regularly speak at international conferences – both statistical ones like PSI and medical ones like EADV. During my career at university and within the pharma industry, I have collected more than 20 years of experience. My career focused mostly on phase III and IV (RCT, observational studies, HTA submission, commercialization work) with some regulatory work as well as some experience in the early phases of clinical development.
I’m interested in a broad range of methodological areas but specifically on making better decisions based on data. As such, I was the chair of the EFSPI/SPI SIG on benefit-risk for some time. PSI provided my with many more opportunities, which I’m happy to work on. At work, I supervise a small but mighty team of statisticians in a large pharma company. The virtual work environment requires me to adjust my communication style and focus on my ability to deliver results effectively.
I’m a happy husband and father of 3 wonderful kids, who I love to spend time with. In the rest of my time, I love running and listening to podcasts.
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Paul Terrill, Conference Chair
Paul has been working as a statistician for over 20 years, primarily in the Pharmaceutical Industry. As a member of Cytel’s Strategic Consulting Team, Paul provides statistical consultancy and advice to trial sponsors on optimising their development strategy and applying appropriate study designs and analysis.
Early in his career, Paul was a statistician at in the Agrochemical Industry at Jealott’s Hill, Berkshire, before becoming a statistical trainer for SAS. He moved into the Pharmaceutical Industry in 2005.
Paul has been on the PSI Scientific Committee since 2014 and took the role of Scientific Committee Chair and PSI Board Member in October 2017. In 2019, Paul took on the role of Vice-Chair for the annual conference. He has co-organised many webinars, one-day meetings and sessions at the annual PSI conference. He was awarded the Mick Godley Award in 2017, the PSI annual award for input into the organisation.
Adam Crisp, Special Interest Group (SIG) Director
Adam is Head of Infectious Disease Statistics at GSK with 25 years’ industry experience across all phases of drug development and multiple therapeutic areas. Educated and based in the UK, Adam has extensive experience in the design and conduct of cardiovascular outcomes trials and in working with the associated external groups. Adam is a member of GSK’s “Global Safety Board” and is a GSK Senior Fellow. Adam has previously served on the PSI Scientific Committee and joined the Board in December 2019.
Adam has a range of statistical interests, with recent publications on topics such as use of assurance to support decision making in drug development, the changing landscape of Data Monitoring Committees and a wide-ranging overview of blinding in clinical trials; recent external presentations have included contributions as a keynote speaker at the Indian Association for Statisticians in Clinical Trials 2018 conference (on Go/No-go criteria), as panellist at the 2017 ISBS Conference session “Data Monitoring Committees – Scope, Expectations and Challenges” and as speaker at the 2016 ASA Biopharmaceutical Workshop on “Futility assessments in late-phase drug development: a novel two-stage outcomes trial in Acute Coronary Syndrome”.
Adam received his PhD in Statistics from University College London and has a Diploma in Mathematical Statistics from Cambridge University.
Markus Elze, Contracts and Finance Director
Markus Elze is Biostatistician at Roche with a focus on late stage Oncology, based in Basel. He works mainly in cancer immunotherapy, including some early phase and paediatric trials, as well as in biomarker work. His interests include computational tools (especially R for the generation of valid outputs), decision-making in early phase settings and paediatric studies.
Markus has been an active member of PSI for several years, including presentations at the conference and membership in the PSI AIMS SIG. He is an active member of RSS and was also a Young Statisticians Section Committee member in 2016.
Markus obtained his PhD in Statistics from the University of Warwick with a thesis on joint modelling of time-to-event and longitudinal processes and did a PostDoc at The London School of Tropical Medicine.
Markus’ hobbies include technology, space, travelling and food.