Bloemfontein Single Day Event - The Future of Data Science in the Changing CRO Environment - PHUSE Wiki
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Bloemfontein
Single Day Event
29th November 2019
Emoya Estate, Bloemfontein
The Future of Data
Science in the Changing
CRO Environment
phuse.eu
Bloemfontein | PHUSE SDE 2019 | 1
Your guide to the day
Agenda Thank you to
our sponsors
Time Title and Speaker(s)
08:00–08:45 Registration
08:45–09:00 Welcome
Chanelle Foster, IQVIA & Jaco van Blerk, Clindata
09:00–09:30 PHUSE Updates
Yvonne Moores, PHUSE Special Projects Director
09:30–10:00 Historical Data in Clinical Trials
Japie Lowings & Louise van Aswegen, MMS INTRODUCTION
10:00–10:30 In Rock We Trust, It's Rock or Bust! So Goes the Song by
Welcome to
AC/DC
Hentie du Plessis, IQVIA
10:30–11:00 Coffee Break
11:00–11:30 Randomized Control Trial (RCTs) Versus Trials Involving
the Use of Real-world Evidence (RWE)
Louise van Aswegen & Pieter Cloete, MMS
Bloemfontein
11:30–12:00 Ameliorated Subjects
Megan Carnell & Leon Lombaard, ICON
12:00–12:30 The ONLY Constant is Change Dear Single Day Event Attendees,
Eduan Cronjé, GCE Solutions
12:30–13:30 Lunch Break Welcome to the Bloemfontein SDE 2019. The aim of today is to discuss the future of data science in
the changing CRO environment.
13:30–14:00 A Practical Solution to Managing and Presenting Big Data
in Real Time
Conducting clinical trials today is a complex set of activities including huge volumes of data across
Jaco Smith, PAREXEL
multiple systems. As the clinical space grows at a rapid pace, with more trials and increasingly
14:00–14:30 Investigating Data Engineering, Extraction and Machine
strict protocols regulating those trials, the medical industry faces the challenge of having to quickly CHANELLE FOSTER
Learning Methods to Code MedDRA Dictionaries
and easily access real-time data. A large part of the medical industry relies on contract research IQVIA
Coenraad Bezuidenhout, ICON
organisations (CROs) to manage their trials and CROs, in turn, rely on data analytics software to
14:30–15:00 Our Industry: Technology-driven or Driven by Technology? facilitate their work.
Faheeza Rangunwala, GCE Solutions
15:00–15:30 Coffee Break The volume of data in healthcare is growing at a massive rate. As the industry enters the exciting
15:30–16:00 The Future of Clinical Trial Programming realm of genomics, historical control arms and high-frequency sensor data, the value of such data
Arnold van Aswegen, GCE Solutions will only be leveraged if it is properly integrated, standardised and analysed. In addition, there is
a lot of attention on machine learning, artificial intelligence (AI), deep learning, natural language
16:00–16:30 Q&A & Closing Remarks
processing and cognitive computing, which drive innovation and change.
Chanelle Foster, IQVIA & Jaco van Blerk, Clindata
JACO VAN BLERK
Given the influx of data and technology, data science is currently the most discussed topic on social Clindata
media and within the CRO industry. We hope you find the SDE both interesting and informative. We
look forward to a day of sharing ideas on this hot topic.
We would like to thank our sponsors for their support and our presenters for their time putting
together the amazing presentations we will see today.
Best regards,
Chanelle Foster and Jaco van Blerk JOHN SALTER
PHUSE Bloemfontein SDE Chairs PHUSE EMEA Director
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2 | PHUSE SDE 2019 | Bloemfontein Bloemfontein | PHUSE SDE 2019 | 3
Speakers and abstracts Speakers and abstracts
09:30–10:00 11:00–11:30
Historical Data in Clinical Trials Randomized Control Trials (RCTs) Versus Trials Involving
Japie Lowings & Louise van Aswegen, MMS the Use of Real-world Evidence (RWE)
Abstract Louise van Aswegen & Pieter Cloete, MMS
We live in a digital age where large amounts of clinical data get stored and accumulate on a daily basis. As a result, there is an increasing
tendency towards utilising this stored data in various productive applications. One such area is the usage of historical trial data as input Abstract
for a new clinical trial. We will be taking a look at some of the most prevalent ways in which historical data can currently be used in a new For a long time, randomised controlled trials (RCTs) represented the one and only gold standard for gaining scientific knowledge of drug
clinical trial, such as, for sample, size determination or actual control subject data. We will also touch on the basic concept behind each development and of medicine in general. In the last decade, a new method, generally referred to as real-world evidence (RWE) studies,
method, along with some of their strengths and weaknesses, in an effective and easy-to-understand presentation. has been discussed as a reasonable and more representative alternative to RCTs. This presentation will look at aspects surrounding the
main differences between the traditional randomised control trial (RCT) and trials involving the use of real-world evidence (RWE).
Biography
Japie Lowings is a senior biostatistician at MMS Holdings. He has 13 years’ experience in the CRO industry, with exposure to various Biographies
standards (CDISC, in-house and sponsor-specific). He holds a master’s degree in mathematical statistics from the University of the Free Louise van Aswegen is a senior biostatistician at MMS, with over 13 years’ experience in the CRO industry. She holds an honours degree
State. Japie has been involved in lead activities in various studies/programmes of studies, as well as innovation initiatives. in mathematical statistics from the University of the Free State. Louise has led multiple studies across various therapeutic areas, with
specific focus on tuberculosis.
10:00–10:30
Pieter Cloete is a Senior Clinical Programmer at MMS. He started his career in the clinical industry as a clinical data coordinator in 2009
before moving over to statistical programming in 2011. Pieter has over nine years of experience in the CRO industry and holds a bachelor
In Rock We Trust, It's Rock or Bust! So Goes the Song by of technology in electrical engineering, as well as a National Diploma in Computer Systems Engineering, both from the Central University
of Technology in South Africa.
AC/DC
11:30–12:00
Hentie du Plessis, IQVIA
Abstract Ameliorated Subjects
We all have our favourite tool/s to do our work, whether it is SAS, R, Python, UltraEdit, Sublime, VSCode, SAS DATA Step or SQL. However,
in the technology-driven world, saying “It’s SQL or bust” is the quickest way to go bust. Gone are the days where we had just one tool to Megan Carnell & Leon Lombaard, ICON
do it all. The evolution of statistical programming as a job role is ongoing, and with evolution comes change and likewise our tools. The
time has come to embrace the feast of tools at our disposal instead of building a wall to protect “my favourite tool”. There is a famous old Abstract
saying: “Test all things, retain the good.” We are no longer in the age of information, but of innovation. Living in an era where clinical trials have become an eminent part of
civilization, the question arises: Could In-Silico studies possibly lunge future clinical analytics, as we know it today, towards a completely
Biography re-established virtual playground for analysts? Considering near completion of the human genome sequencing, big data and the
Hentie du Plessis is a Statistical Programming Scientist at IQVIA. He has been working in the CRO environment for 13 years, most of it computational power we have available within the 21st century, bioinformatics allows for an extensive design of In-Silico simulated clinical
at IQVIA and all of it in biostatistics. Hentie is currently part of the Business Solutions group within Biostatistics and is passionate about trials. This presentation will consider the whats and whys of In-Silico clinical trials, where we are currently and the realistic prospects that
innovation and automation. the future holds.
Biographies
Megan Carnell is a statistical programmer at ICON. She has almost three years’ experience in the CRO industry, with exposure to in-
house standards and client-specific standards. She is currently pursuing her MSc in Mathematical Statistics at the University of the Free
State. Megan has mostly been involved in programming activities in oncology trials, including leukaemia, metastatic cancer, non-small-cell
lung cancer and solid tumour configuration.
Leon Lombaard is a medium-level Statistical Programmer at ICON DOCS, based in Bloemfontein. He has more than three years’
experience, with exposure to in-house and client-specific standards. He holds an MSc in Mathematical Statistics Risk Analysis from the
University of the Free State and is a certified SAS Base programmer. Leon has been involved in various programming activities, training
and lead activities across several cardiovascular, metabolic and haematology disease trials.
4 | PHUSE SDE 2019 | Bloemfontein Bloemfontein | PHUSE SDE 2019 | 5Speakers and abstracts Speakers and abstracts
12:00–12:30 13:30–14:00
The ONLY Constant is Change A Practical Solution to Managing and Presenting Big Data
Eduan Cronjé, GCE Solutions in Real Time
Abstract Jaco Smith, PAREXEL
In the CRO industry, change is inevitable. Some changes are small and easy to adapt to, while others are large and are more difficult to
process. No matter what kind of change arises, the industry needs to be able to adapt in order to survive. Abstract
Clinical trials today collect and store massive amounts of data and metadata. This creates a challenge in how to manage and present the
Contrary to belief, programmers in the CRO industry tend to be a group of diverse people (all of them fairly successful in non-computer data in order to make maximum use of it. Resource management is one of the areas that stand to benefit.
science fields as well), the majority of whom would agree that we were universally looked down upon as the "weirdos", the “geeks”, the
neckbearded nerds, the arrogant know-it-alls, etc. This is certainly not the case today! Why are we such a diverse group of people instead The management of big data becomes easier if sufficient attention is paid to the fundamentals of software development. Separation of
of stereotypical programmers? concerns, being an established principle of software architecture, seems well suited for application here. Separating the front and back
ends results in more freedom when it comes to software design, deployment, and usage.
ClinicalTrials.gov was first launched on 29th February 2000 with 1,255 registered studies. During this time, one would assume that
the workforce must have been relatively small compared to what it is today. Presently, the number of registered studies has grown The result is that data can be analysed and presented in real time, which enhances the user’s ability to find solutions and make decisions.
exponentially to 315,240, as of 29th August 2019. A system correctly designed and implemented should significantly reduce the difficulty in managing and presenting big data.
How are we handling this? What is changing and how should we adapt? The BIG question is: How do we adapt to these drastic changes Biography
and what other changes are we missing? Jaco Smith started his career in the information technology sector as a System Engineer at IQ Tech in 2013. In March 2014 he joined
PAREXEL as a Statistical Programmer, where he obtained experience and skills in ADaM and TFL programming. Jaco is also co-founder
”It is not the strongest of the species that survives, nor the most intelligent, but the one most responsive to change” – Charles Darwin of SL² Systems (sl2.co.za) and BitIntel (bitintel.ddns.net), whose systems offer a range of services including web design, web development,
(1809). customised applications and SAS solutions. As he is passionate about working in the technology field and creating solutions to innovate
business, Jaco is currently developing a system “StatTrack” which primarily focusses on analysing big data to benefit data-driven decision-
Biography making, greater accuracy, precision, efficiency and responsibility in the use of data.
Eduan Cronjé is a technical developer with a passion for software development. He has four years’ experience in the pharmaceutical
industry and has been active within the PHUSE Working Groups for almost a year. After completing his studies at the University of the
Free State, Eduan learned various programming languages including SAS, R, Python, C#, Java and C++. In his spare time, he enjoys
training, reading and travelling.
6 | PHUSE SDE 2019 | Bloemfontein Bloemfontein | PHUSE SDE 2019 | 7Speakers and abstracts Speakers and abstracts
14:00–14:30 15:30–16:00
Investigating Data Engineering, Extraction and Machine The Future of Clinical Trial Programming
Learning Methods to Code MedDRA Dictionaries Arnold van Aswegen, GCE Solutions
Coenraad Bezuidenhout, ICON Abstract
With so many data capturing techniques, integration of social media networks, live streaming data and new automation methods to
Abstract analyse vast amounts of data in this digital era, how can the design of clinical trials tap into these technological advances to improve
Since the 1990s MedDRA dictionaries have been used to code standard terminology. With advancement in technology and the growing patient participation and experience in clinical trials and still yield more accurate results contributing to the analysis. This presentation will
need for better worldwide healthcare, can machine learning and data manipulation methods be used to code MedDRA dictionaries? Machine explore a few of these concepts at high level and discuss how pre-clinical trial planning, set-up and programming can change the entire
learning models were created based on features extracted from phrases commonly used in three different languages, namely English, way we think of trial execution and analysis, and how the CRO environment can change to harness the power of future data science and
Afrikaans and Dutch. With high accuracy, the models were able to predict to which language the phase belonged. A similar approach can improve patient health through accelerated drug analysis.
be applied to MedDRA coding where terms are not a perfect match, the reviewer can review each prediction and choose the final match.
After each run, the selected data is added to the machine learning model, improving the exactness of the predicted MedDRA code. The Biography
possibilities are endless considering simple methods were applied to the language dataset riddled with grammar and spelling errors. The Arnold van Aswegen is a Principal Statistical Programmer at GCE Solutions. He has over 13 years’ experience in the CRO industry, with
quality of MedDRA dictionaries, combined with continuous efforts to improve data standards, creates a perfect environment to explore the exposure to in-house and client-specific standards, as well as CDISC SDTM and ADaM standards. He has been involved in compound
use of data science in MedDRA coding. group studies and analysis for the past few years and enjoys working in a team environment. Arnold holds a bachelor of science in
information technology management.
Biography
Coenraad Bezuidenhout is a senior statistical programmer at DOCS Global. He received his bachelor of technology from CUT and his
honours in mathematical statistics from Stellenbosch University. In his current role, his primary focus is exploratory exposure-response
analysis for oncology studies. Some of his responsibilities include producing high-quality and insightful programming specifications
documents, exploratory analysis datasets and reports for FDA submissions. Coenraad has a passion for machine learning and believes
pharmaceutical research can be a front-runner in the fourth industrial revolution. He enjoys spending quality time with his family, studying
and thinking of ways to improve the world one algorithm at a time.
14:30–15:00
Our Industry: Technology-driven or Driven by Technology?
Faheeza Rangunwala, GCE Solutions
Abstract
A certain level of innovation and technology is present in all industries. In fact, it has become necessary to facilitate growth, productivity and
competitiveness. With the focus on different technologies across industries, we are faced with some challenges regarding their adoption
and implementation. Where do we stand compared to other industries? Since pharmaceutical companies and CROs are research and
development organisations, it is imperative that we keep up with technological trends and use them to drive our outcomes.
This presentation will explore the timeline of our industry’s ability to adopt and implement trending technologies compared with other
industries, showing how these trending technologies have gone from conception to growth. It will deep dive into a few of these technologies
and how they should be playing an impactful role in our industry and how we can use technology to drive us forward.
Fun Fact
Biography
Faheeza Rangunwala is a Senior Statistical Programmer with about six years’ experience in the pharmaceutical and CRO industry. She Bloemfontein is popularly and poetically
holds a bachelor’s degree in IT and an honours degree in business informatics. She is a SAS certified programmer and has experience in a known as "the city of roses", for its
range of therapeutic areas. Faheeza has filled key positions as part of a global team, such as technical point of contact, lead programmer, abundance of these flowers and the
and mentor. She has also been involved in the PHUSE Working Groups since early 2019. annual rose festival held there. The city's
Sesotho name is Mangaung, meaning
"place of cheetahs".
8 | PHUSE SDE 2019 | Bloemfontein Bloemfontein | PHUSE SDE 2019 | 9Looking forward
EVENTS
2019 Dates
March April May June
India SDE US SDE China SDE Denmark SDE
Pune Foster City, CA Beijing Copenhagen
Germany SDE UK SDE US CSS
Heidelberg London Silver Spring, MD
India SDE
Hyderabad GenInvo is a dedicated software solutions company and
its foundation has been laid with a vision to provide
innovative technology solutions to life sciences clients
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India SDE Canada SDE Belgium SDE US SDE
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Bengaluru Ontario Beerse Cincinnati, OH
US SDE US SDE India SDE
Hoboken, NJ North Wales, PA Chennai
The Netherlands SDE
Utrecht
Shadow™ is the latest breakthrough in data and document
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China SDE US SDE comply with EMA 0070.
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South Africa SDE Japan SDE KEY FEATURES
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EU Connect Please note dates may • Risk Analysis
Amsterdam be subject to change • Multi-Policy Compliant – EMA 0070, 21 CFR
For dates and
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10 | PHUSE SDE 2019 | Bloemfontein
www.geninvo.com Ideas delivered intuitively Bloemfontein | PHUSE SDE 2019 | 11EU 2020
The Clinical Data Science Conference
8th–11th November
ACC Liverpool
phuse.eu
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