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Adaptive Designs in Clinical Trials
1 April - 2 April 2019
Adaptive Designs in Clinical Trials

SAE Media Group are proud to announce the 11th annual Adaptive Designs in Clinical Trials conference and exhibition will return to London from the 1st – 2nd April 2019. With the growing popularity in use and acceptance of adaptive designs in clinical trials - demonstrated most recently with the new  FDA  draft guidance on adaptive designs – there is a pressing need for a forum which explores this increasingly normalized medical methodology.


Hosting in depth presentations from regulatory agencies, researchers and biostatisticians, the meeting will cover how personalized medicine, platform trials, response-adaptive randomization, signature designs, estimand framework, bayesian methods and digital innovation are revolutionizing the drug development process both in Europe and North America.

FEATURED SPEAKERS

Alex Sverdlov

Alex Sverdlov

Director, Statistical Scientist, Novartis
Andrea Callegaro

Andrea Callegaro

Senior Manager, Biostatistician, GSK Vaccines
Beatrice Panico

Beatrice Panico

Medical Assessor , Medicines and Healthcare Products Regulatory Agency
Emma  Gray

Emma Gray

MS Society - Head of Clinical Trials, MS National Centre (MSNC)
Frank Fleischer

Frank Fleischer

Team Leader Clinical Biostatistics, Boehringer-Ingelheim
Heiko Goette

Heiko Goette

Biostatistician, Merck
Kaspar Rufibach

Kaspar Rufibach

Principal Statistical Scientist, F. Hoffman-La Roche AG
Macaulay Okwuokenye

Macaulay Okwuokenye

Syros Pharmaceuticals, Principal Biostatistician, Syros Pharmaceuticals
Paul Frewer

Paul Frewer

Early Clinical Development, AstraZeneca
Philip  Hougaard

Philip Hougaard

Vice President, Biometrics, H. Lundbeck A/S
Sandeep Menon

Sandeep Menon

Vice President, Pfizer Inc
Simon Wandel

Simon Wandel

Associate Director Statistical Methodologist, Novartis Pharmaceuticals
Sofia Villar

Sofia Villar

Senior Statistician, MRC Biostatistics Unit (University of Cambridge School of Clinical Medicine)
Tom Parke

Tom Parke

Director of Software Solutions, Berry Consultants, LLP
Vladimir Anisimov

Vladimir Anisimov

Principal Data Scientist , Amgen

Alex Sverdlov

Director, Statistical Scientist, Novartis
Alex Sverdlov

Alex Sverdlov has worked as a statistical scientist in biopharmaceutical industry since 2007. He has been involved in active research on adaptive designs for clinical trials to improve efficiency of drug development. He edited a book “Modern Adaptive Randomized Clinical Trials: Statistical and Practical Aspects” which was published by CRC Press in 2015. Alex’s most recent work involves design of proof-of-endpoint clinical trials evaluating digital technologies in neuroscience.

Andrea Callegaro

Senior Manager, Biostatistician, GSK Vaccines
Andrea Callegaro

Andrea Callegaro is a statistician working at GSK Vaccines (Belgium) on statistical innovation (trial designs, surrogate endpoints, high-dimensional data, exploratory analysis…).
Before joining GSK, he worked on the analysis of micro-arrays data (Bioinformatics – Padova University), on survival data analysis (San Gerardo Hospital, Milan) and he developed survival models with skew-normal frailties (post doc with Prof. A. Azzalini, Padova University).
For his PhD thesis, he worked on frailty models for gene-mapping (Prof. HC van Houwelingen, Leiden University)
 

Beatrice Panico

Medical Assessor , Medicines and Healthcare Products Regulatory Agency
Beatrice Panico

Maria Beatrice Panico is currently a Medical Assessor in the Clinical Trials Unit at the Medicines and Healthcare products Regulatory Agency (MHRA).
She is a medical doctor, fully qualified in Neurology with a PhD in Neuroscience. She has extensive experience in pharmacovigilance in the pharmaceutical industry.
 

Emma Gray

MS Society - Head of Clinical Trials, MS National Centre (MSNC)
Emma  Gray

Emma is Head of Clinical Trials at the MS Society. She is responsible for developing and supporting the MS Society’s growing portfolio of clinical trials; collaborating with national and international funders (charity, government, other) to secure funding for MS clinical trials, the UK MS Clinical Trials Network; and more recently the Expert Consortium on Progression in MS Clinical Trials. Before joining the MS Society, she gained a PhD in molecular neuroscience and worked as a post-doctoral researcher at the MRC Centre for Neurodegeneration Research (Institute of Psychiatry, King’s College London) focusing on molecular and cellular processes associated with neurodegeneration in Alzheimer’s disease.

Frank Fleischer

Team Leader Clinical Biostatistics, Boehringer-Ingelheim
Frank Fleischer

Being a trained mathematician and statistician Frank has worked for more than 10 years in the pharmaceutical industry. He is heading a global team of statisticians at Boehringer Ingelheim focusing on statistical methodology and the implementation of innovative statistical designs into practice. In that role Frank and his team are considered with methodological questions regarding adaptive designs, statistical decision making, dose finding and Bayesian borrowing designs as well as with piloting these methods in clinical trials. Through this function several projects across different therapeutic areas and phases are supported. Formerly he has been a lead project statistician for different projects in oncology, immunology and the biosimilars.

Heiko Goette

Biostatistician, Merck
Heiko Goette

Heiko has been a Biostatistician at Merck KGaA in Germany since 2009. Before this he spent 5 years working as a research assistant at the Institute of Medical Biostatistics, Epidemiology and Informatics, Johannes Gutenberg-University Mainz, Germany. He graduated with a Statistics major, University of Dortmund, Germany in 2004 and received his doctorate in 2008 from Johannes Gutenberg-University Mainz, Germany.

Kaspar Rufibach

Principal Statistical Scientist, F. Hoffman-La Roche AG
Kaspar Rufibach

Kaspar Rufibach does methodological research, provides consulting to Roche statisticians and broader project teams, gives biostatistics trainings for statisticians and non-statisticians in- and externally, mentors students, and interacts with external partners in industry and the academic community in various working groups. Research interests are methods to optimize study designs, advanced survival analysis, probability of success, estimands, estimation of treatment effects in subgroups, and general nonparametric statistics. Before joining Roche, Kaspar received training and worked as a statistician at the Universities of Bern, Stanford, and Zurich.

Macaulay Okwuokenye

Syros Pharmaceuticals, Principal Biostatistician, Syros Pharmaceuticals
Macaulay Okwuokenye

Michael Proschan

Mathmatical Statistician, National Institute of Allergy and Infectious Diseases
Michael Proschan

Michael Proschan has been a Mathematical Statistician in the Biostatistics Research Branch at the National Institute of Allergy and Infectious Diseases since January of 2006. Prior to coming to NIAID, he spent about 16 years at the National Heart, Lung, and Blood Institute. He co-authored the books: Statistical Monitoring of Clinical Trials: A Unified Approach, with Gordon Lan and Janet Wittes (Springer, 2006) and Essentials of Probability Theory for Statisticians, (CRC Press, 2016) with Pamela Shaw.

Dr. Proschan received his Ph.D. in Statistics from Florida State University in 1989, M.S. in Statistics from Stanford University in 1982, and B.S. in Statistics and Mathematics (double major) from Florida State University in 1980. He became a Fellow of the American Statistical Association in 2005.
 

Paul Frewer

Early Clinical Development, AstraZeneca
Paul Frewer

Paul has been a statistician in the industry for over 20 years, working for Eli Lilly, GSK, Ipsen and AstraZeneca. He started working in post-marketing studies and slowly moved back through the phases to his current role in early clinical development. He joined AstraZeneca in 2012, and is a Associate Director, Statistics in the Early Clinical Biometrics team, supporting a number of different compounds in the oncology therapeutic area and has presented and published on the AZ decision making framework over the last few years.

Philip Hougaard

Vice President, Biometrics, H. Lundbeck A/S
Philip  Hougaard

Philip Hougaard is a biostatistician with a position as Vice President of Biometrics at Lundbeck in Denmark. He has a PhD based on a thesis on nonlinear regression and a degree as Doctor of Science based on a thesis on frailty models. He has worked in the pharmaceutical industry for 34 years, the last 16 years with Lundbeck. He is author of the book “Analysis of multivariate survival data” and more than 100 scientific papers. He is associate editor of Biostatistics and Lifetime Data Analysis. He has an honorary position as external professor at the University of Southern Denmark.

Sandeep Menon

Vice President, Pfizer Inc
Sandeep Menon

Dr. Sandeep Menon is currently the Vice President and the Head of Early Clinical Development at Pfizer Inc. and also holds Adjunct faculty positions at Boston University, Tufts University School of Medicine and Indian Institute of Management (IIM). He is the elected fellow of American Statistical Association. He currently reports to the President of R&D and part of the World-Wide Research and Development Leadership Team. He is currently leading a multi- functional global team which includes Biostatisticians, Clinical Pharmacologists, Clinicians, Precision Medicine Scientists and Digital Medicine Scientists.
Sandeep has extensive experience in late phase studies and with regulatory interactions especially with the FDA (US Agency), EMA (European Agency) and PMDA (Japan Agency). He is internationally known for his technical expertise especially in the area of adaptive designs, personalized medicine, multi-regional trials, and small populations and has participated in the core review of draft version of the regulatory guidance documents. He has co-authored and co- edited six books and contributed to influential papers in this area. He has taught short courses internationally and is a regular invited speaker in academic, FDA, Industry forums and Business Management institutes.
 

Simon Wandel

Associate Director Statistical Methodologist, Novartis Pharmaceuticals
Simon Wandel

Simon Wandel holds a master in Statistics and a PhD in Medical Statistics/Epidemiology from University of Bern. In 2010, he joined Novartis as statistician. In 2013, he co-founded a start-up specialized for Bayesian statistics (Cogitars GmbH), before rejoining Novartis as Expert Statistical Methodologist in 2014.
Simon Wandel has a particular interest in application of Bayesian statistics for clinical trials. He has worked as responsible or consulting statistician for more than 30 fully Bayesian phase I/II/IV trials. He regularly provides talks and trainings at meetings of professional societies and academic institutions and contributes to scientific sessions organized by regulatory agencies.
 

Sofia Villar

Senior Statistician, MRC Biostatistics Unit (University of Cambridge School of Clinical Medicine)
Sofia Villar

I am a senior statistician in the clinical trials methodology group at the MRC Biostatistics Unit (University of Cambridge School of Clinical Medicine). I lead a team of statisticians at Papworth Trials Unit Collaboration. I was awarded the first Biometrika post-doctoral research fellowship in 2014. Before that I was in the Department of Mathematics and Statistics of Lancaster University, yet working from the MRC Biostatistics Unit, as part of a joint research project on the design of multi-arm multi-stage clinical trials. I did my Ph.D. thesis on designing tractable and nearly optimal solutions to computationally infeasible constrained sequential estimation problems.

Steven A. Gilbert

Senior Director Statistics, Pfizer
Steven  A. Gilbert

Steve Gilbert is a Senior Directors at Pfizer in Cambridge, MA. He has worked in clinical trials since 1998, first in CROs and then in Pharma, supporting all phases of drug development in numerous therapeutic areas. Steve started at Pfizer supporting the Inflammation and Immunology Research Unit in early phase programs before joining the Statistical Research and Innovation group. Steve is a member of the ASA, ENAR and DIA; he served on the DIA missing data working group and is a member of the DIA study endpoints committee. Steve holds a PhD in statistics and a Bachelor’s in Biology.

Tom Parke

Director of Software Solutions, Berry Consultants, LLP
Tom Parke

Tom Parke is Director of Software Solutions for Berry Consultants. Tom joined Berry Consultants in 2016 having previously worked at Tessella, a UK scientific software company where he first met and worked with Don Berry. In 1998 Tom managed the development and running of a software system to support Pfizer’s ASTIN Stroke trial – a ground breaking response adaptive randomization dose ranging trial designed by Don Berry and Peter Mueller.
Following that he managed multiple projects to support different aspects of many adaptive clinical trials, mostly designed by Berry Consultants, and projects to develop clinical trial simulators, first with Pfizer, then Wyeth, and finally with Eli Lilly to develop FACTS. Latterly, as well as managing the continuing development of FACTS, Tom has researched the estimation of expected Net Present Value of development programs leading to the development of the QUOTES software package.
Tom originally graduated with joint First Class Honors in Maths and Computer Science from Bristol University, and enjoyed two decades in the software industry (inmos, Imperial Software Technology and then Praxis - which became part of Deloittes) before stumbling upon the wonderful world of adaptive clinical trials.
 

Tom Parke

Director of Software Solutions, Berry Consultants, LLP
Tom Parke

Tom Parke is Director of Software Solutions for Berry Consultants. Tom joined Berry Consultants in 2016 having previously worked at Tessella, a UK scientific software company where he first met and worked with Don Berry. In 1998 Tom managed the development and running of a software system to support Pfizer’s ASTIN Stroke trial – a ground breaking response adaptive randomization dose ranging trial designed by Don Berry and Peter Mueller.
Following that he managed multiple projects to support different aspects of many adaptive clinical trials, mostly designed by Berry Consultants, and projects to develop clinical trial simulators, first with Pfizer, then Wyeth, and finally with Eli Lilly to develop FACTS. Latterly, as well as managing the continuing development of FACTS, Tom has researched the estimation of expected Net Present Value of development programs leading to the development of the QUOTES software package.
Tom originally graduated with joint First Class Honors in Maths and Computer Science from Bristol University, and enjoyed two decades in the software industry (inmos, Imperial Software Technology and then Praxis - which became part of Deloittes) before stumbling upon the wonderful world of adaptive clinical trials.

 

Vladimir Anisimov

Principal Data Scientist , Amgen
Vladimir Anisimov

Dr Anisimov is working in pharma industry since 2002. Currently he is Principal Data Scientist, Center for Design & Analysis, Amgen, based in London, UK. Prior to this, he has been working in GlaxoSmithKline and Quintiles (IQVIA) and led the development and implementation of the innovative analytic methodologies for modelling clinical trials, in particular, patient enrolment and drug supply modelling. Has got world-wide recognition in this area. He also has been granted the status of Honorary Professor in the School of Mathematics and Statistics, University of Glasgow, UK.
Prof. Anisimov started his career in academia. Prior to switching to pharma industry, he served for 20 years as Professor & Head of Applied Statistics Department established by himself at Kiev National University, Ukraine. Received Ph.D. and Sc.Dr. (Hab) degrees and diploma of Professor in Applied Statistics, published about 200 papers and several books, supervised 24 Ph.D. theses. Led a numerous number of various projects and some EU and UK grants.
 

sponsors

Conference agenda

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8:30

Registration & Coffee

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9:00

Chairman's Opening Remarks

Tom Parke, Director of Software Solutions, Berry Consultants, LLP

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9:10

An industry outlook on adaptive designs in clinical trials

Tom Parke, Director of Software Solutions, Berry Consultants, LLP

  • Innovations of adaptive designs in clinical trials
  • How has the use of adaptive designs in clinical trials developed?
  • Views on the draft FDA guidance on adaptive designs
  • Heads of Medicines Agencies: Clinical Trials Facilitation Group practical implications
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    9:50

    Adaptive designs in multiple sclerosis clinical trials

    Emma Gray, MS Society - Head of Clinical Trials, MS National Centre (MSNC)

  • Initiative to establish platform trial
  • The practicalities of setting up platform trials
  • Methodological challenges in MS trial design
  • Ethical and patient perspective on adaptive designs

     

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    10:30

    Morning Coffee

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    11:00

    Adaptive signature designs for cancer vaccines

    Andrea Callegaro, Senior Manager, Biostatistician, GSK Vaccines

  • Mage-A3: a double-blind, randomised, placebo-controlled, phase 3 trial
  • The practical and operational considerations of immunotherapeutic adaptive designs
  • Futility for subgroup analyses in adaptive signature design
  • The future of adaptive designs for cancer vaccines
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    11:40

    The European Prevention of Alzheimer’s Disease platform trial

    Philip Hougaard, Vice President, Biometrics, H. Lundbeck A/S

  • EPAD is a public-private partnership running two connected trials:
  • A longitudinal cohort study identifying subjects with biomarker evidence of early Alzheimer’s
  • An adaptive platform trial for Proof-of-concept testing of new preventive treatments, recruiting from the first trial
  • Advantages and disadvantages of testing drugs in this setup compared to classical one-drug trials
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    12:20

    Networking Lunch

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    13:20

    Forecasting and adaptive adjustment of trial operational design

    Vladimir Anisimov, Principal Data Scientist , Amgen

  • The problems and uncertainties in the operational design of adaptive trials
  • Forecasting trial operational characteristics at interim look and the impact of stochastic variation on the operational design
  • Risk-based monitoring of different metrics of trial performance
  • Interim data-driven re-projection and adaptive adjustment of trial operation
     
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    14:00

    A regulatory perspective of adaptive design trials

    Beatrice Panico , Medical Assessor , Medicines and Healthcare Products Regulatory Agency

  • Initial Clinical Trial Authorisation (CTA): points to consider
  • Regulatory points to consider for submissions with substantial amendments
  • Safety considerations
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    14:40

    Afternoon Tea

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    15:10

    Using Estimand Framework in Adaptive Designs: The implication of ICH E9 R(1)

  • ICH E9(R1) and adaptive clinical trials
  • Using estimand framework in adaptive clinical trials
  • Design challenges that ICH E9(R1) might bring to adaptive designs
  • Impact of ICH E9(R1) on the analysis of adaptive clinical trials
  • Steven A. Gilbert, Senior Director Statistics, Pfizer

    Macaulay Okwuokenye

    Macaulay Okwuokenye, Syros Pharmaceuticals, Principal Biostatistician, Syros Pharmaceuticals

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    15:50

    Chairman’s Closing Remarks and Close of Day One

    Tom Parke, Director of Software Solutions, Berry Consultants, LLP

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    8:30

    Registration & Coffee

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    8:50

    Chairman's Opening Remarks

    Alex Sverdlov, Director, Statistical Scientist, Novartis

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    9:00

    Statistical and design considerations in personalised medicine

    Sandeep Menon, Vice President, Pfizer Inc

  • Identifying genetic, genomic and clinical characteristics to predict patient susceptibility
  • Biomarkers and the challenges in their use for diagnostics
  • Selecting appropriate designs to determine biomarker performance, reliability and regulatory acceptance
  • Case studies for biomarker driven trials
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    9:40

    Implementing cost-efficient randomization designs in clinical trials with heterogeneous treatment costs

    Alex Sverdlov, Director, Statistical Scientist, Novartis

  • Optimal allocation designs minimizing study cost under statistical efficiency constraints
  • Restricted randomization procedures to implement optimal allocation in practice
  • Statistical inference following these procedures, using population-based and randomization-based approaches
     
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    10:20

    Extrapolation in clinical trials and beyond

    Simon Wandel, Associate Director Statistical Methodologist, Novartis Pharmaceuticals

  • Basics of extrapolation: when is it applicable - and when not
  • Extrapolation from adults to children: “adaptive” borrowing
  • Bridging studies
  • Beyond individual studies: extrapolation via mixture models for meta-analysis
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    11:00

    Morning Coffee

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    11:30

    Considerations and Experiences in a Randomized Clinical Trial for Treatment of Ebolavirus Disease in Western Africa

    Michael Proschan, Mathmatical Statistician, National Institute of Allergy and Infectious Diseases

    • Bayesian design to seamlessly accommodate adaptations through calculation of posterior probability of superiority
    • Skeptical prior distribution to prevent a self-fulfilling prophecy of benefit, yet less conservative than Fisher’s exact test at interim analyses
    • Resistance to Bayesian presentation among clinical trial community: “But what was the p-value?”
    • Why alternative designs such as the triangular test were not used
     

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    12:10

    Applying adaptive designs in industry

    Frank Fleischer, Team Leader Clinical Biostatistics, Boehringer-Ingelheim

  • Overview of adaptive designs at BI
  • Joint escalation models in oncology dose finding
  • Early phase basket designs and GoNoGo decision making
  • Blinded sample size reassessment – is there a future?
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    12:50

    Continuous decision making within a clinical trial

    Paul Frewer, Early Clinical Development, AstraZeneca

  • Overview of Decision Making in Early clinical development at AstraZeneca
  • Incorporating continuous decision making into the framework
  • Standardizing tools/ figures to convey the information
  • Statistical risks and considerations in adopting this approach
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    13:30

    Networking Lunch

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    14:30

    Response-adaptive designs

    Sofia Villar, Senior Statistician, MRC Biostatistics Unit (University of Cambridge School of Clinical Medicine)

  • The benefits of forward looking response-adaptive randomisation in adaptive designs
  • Trials for rare diseases & finding treatments that work subgroups
  • Type 1 error inflation due to an unknown time trend over the course of the trial
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    15:10

    Panel Discussion: Bayesian vs. frequentist designs incorporating multiple treatment arms

  • Response-adaptive randomisation
  • Triangular tests
  • Dropping poorly-performing arms in multi-arm multi-stage designs
  • Flexibility in Bayesian vs. frequentist designs
  • Michael Proschan, Mathmatical Statistician, National Institute of Allergy and Infectious Diseases

    Kaspar Rufibach, Principal Statistical Scientist, F. Hoffman-La Roche AG

    Alex Sverdlov, Director, Statistical Scientist, Novartis

    Sofia Villar, Senior Statistician, MRC Biostatistics Unit (University of Cambridge School of Clinical Medicine)

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    15:50

    Afternoon Tea

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    16:20

    MIRROS: Phase 3 trial with time-to-event endpoint, cure proportion, and futility interim analysis using response

    Kaspar Rufibach, Principal Statistical Scientist, F. Hoffman-La Roche AG

  • Phase 3 trial in AML with overall survival as primary endpoint which is currently running
  • Sample size based on a cure proportion model
  • Operating characteristics of futility interim analysis explored based on mechanistic simulation model
  • Discussion of statistical and operational aspects of this trial
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    17:00

    Defining decision rules based on simulated development programs

    Heiko Goette, Biostatistician, Merck

  • Go/no go decision after phase 2 and futility analysis in phase 3 trials based on estimated probability of success
  • Probability of success is estimated using simulations taking into account observed association between short-term and long-term endpoint from phase 2
  • Simulation of complete phase 2 and 3 development program allows to define appropriate decision boundaries
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    17:40

    Chairman’s Closing Remarks and Close of Day Two

    Alex Sverdlov, Director, Statistical Scientist, Novartis


    Director, Statistical Scientist
    Novartis
    Senior Manager, Biostatistician
    GSK Vaccines
    Medical Assessor
    Medicines and Healthcare Products Regulatory Agency
    MS Society - Head of Clinical Trials
    MS National Centre (MSNC)
    Team Leader Clinical Biostatistics
    Boehringer-Ingelheim
    Biostatistician
    Merck
    Principal Statistical Scientist
    F. Hoffman-La Roche AG
    Syros Pharmaceuticals, Principal Biostatistician
    Syros Pharmaceuticals
    Mathmatical Statistician
    National Institute of Allergy and Infectious Diseases
    Early Clinical Development
    AstraZeneca
    Vice President, Biometrics
    H. Lundbeck A/S
    Vice President
    Pfizer Inc
    Associate Director Statistical Methodologist
    Novartis Pharmaceuticals
    Senior Statistician
    MRC Biostatistics Unit (University of Cambridge School of Clinical Medicine)
    Senior Director Statistics
    Pfizer
    Director of Software Solutions
    Berry Consultants, LLP
    Director of Software Solutions
    Berry Consultants, LLP
    Principal Data Scientist
    Amgen

    Sponsors and Exhibitors

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    Workshops

    The FDA – a new guidance on adaptive designs
    Workshop

    The FDA – a new guidance on adaptive designs

    Holiday Inn Kensington Forum
    1 April 2019
    London, United Kingdom

    Design and analysis of clinical trials evaluating novel digital technologies
    Workshop

    Design and analysis of clinical trials evaluating novel digital technologies

    Holiday Inn Kensington Forum
    3 April 2019
    London, United Kingdom

    VENUE

    Holiday Inn Kensington Forum

    97 Cromwell Road , London, United Kingdom

    Holiday Inn Kensington Forum is perfectly situated in one of London’s most luxurious and beautiful areas within South Kensington. 

    The hotel is just 2 minutes walk from Gloucester Road tube station for convenient travel to Hyde Park, London Eye, Tower Bridge plus more of London’s top attractions. There are also easy and direct links to some major transport hubs including Victoria, Kings Cross St Pancras, Paddington and Heathrow. 

    This distinctive hotel in south London has so much to offer to make all guests really feel at home. The latest Holiday Inn relaunch is not just about the new look and feel for the hotel but to offer guests more benefits during their stay including a pillow menu for extra comfort during their sleep and a curved shower rail for more spacious feel. 

    In addition to our 906 rooms, all business guests can take advantage of our meeting and conference facilities including High Speed Internet Access and unlimited Starbucks coffee at The Academy. Our hotel’s professional event planners are on board to help take the hard work and stress away from planning your next event. 

    So whether you in London on business or pleasure, make the Holiday Inn London Kensington Forum your first choice of hotel and book your accommodation for our lowest internet rate guarantee. 

    A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SMi Group. SMi Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.
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    2019 ATTENDEES

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    Interview with Dr. Sandeep Menon, Pfizer

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    Interview with Alex Sverdlov (Chair)

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    Letter from the Chairs

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    Interview with Heiko Goette, Merck

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    Interview with Kaspar Rufibach, Principal Statistical Scientist, F. Hoffman-La Roche AG

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    An interview with Sofia Villar, MRC Biostatistics Unit

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    Speaker Line-up

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    2018 ATTENDEES

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    2019 Programme

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    Workshop B

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    Workshop A

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    Presentation by M.Beatrice Panico, Medical Assessor, MHRA

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    Presentation by Professor Sue Todd, University of Reading, UK

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    Presentation by Bob Clay, Managing Director, Highbury Regulatory Science

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    Presentation by Dr. Frank Fleischer, Boehringer Ingelheim

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    Presentation by Christine Fletcher, Amgen

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    Sponsors and Exhibitors


    GCE Solutions

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    Since 2006, GCE Solutions has operated as a biometrics-focused CRO. We are a global clinical research services and solutions organization specializing in all aspects of clinical data. Innovation is the company’s key driver as GCE’s Innovation Team continues developing processes, tools, and technology that accelerate data gathering, analysis, and the submission phases.

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    Drugdevelopment-technology.com covers every aspect of the drug development and research process, from conception to pre-FDA approval. Our global network of journalists updates the site with the latest and most significant industry developments. This coverage allows us to provide everyone - from senior management through to research and QA staff – with in-depth reviews of the latest projects, advance notice of new product releases and analysis of the latest procedural and legislative developments.


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    Founded in 2000, Technology Networks is established as the leading news provider for life science and drug discovery professionals. In addition, we provide unique content including webcasts, videos, application notes and posters from recent conferences. Our portfolio now includes around 30 focussed scientific communities, all of which are accessible free of charge within TechnologyNetworks.com


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    The Swiss Biotech Association (SBA) is the national industry association for biotechnology, including pharmaceuticals, diagnostics, agriculture, food, cosmetics, environmental biotechnology, and specialty chemicals. Members are companies active in modern biotechnology, such as R&D, Production, Marketing and Sales, Finance, Services and Consulting. SBA provides a networking platform for Life Science clusters, academic and federal institutions the like. Founded in March 1998, the Association grows steadily.


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    Pharmaceutical-technology.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production. Pharmaceutical-technology.com brings you the latest in industry projects and updates, along with the news, views and trends that leading professionals – from senior executives to manufacturing managers and heads of procurement – require to stay on top of their field.

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    Holiday Inn Kensington Forum

    97 Cromwell Road
    London SW7 4DN
    United Kingdom

    Holiday Inn Kensington Forum

    Holiday Inn Kensington Forum is perfectly situated in one of London’s most luxurious and beautiful areas within South Kensington. 

    The hotel is just 2 minutes walk from Gloucester Road tube station for convenient travel to Hyde Park, London Eye, Tower Bridge plus more of London’s top attractions. There are also easy and direct links to some major transport hubs including Victoria, Kings Cross St Pancras, Paddington and Heathrow. 

    This distinctive hotel in south London has so much to offer to make all guests really feel at home. The latest Holiday Inn relaunch is not just about the new look and feel for the hotel but to offer guests more benefits during their stay including a pillow menu for extra comfort during their sleep and a curved shower rail for more spacious feel. 

    In addition to our 906 rooms, all business guests can take advantage of our meeting and conference facilities including High Speed Internet Access and unlimited Starbucks coffee at The Academy. Our hotel’s professional event planners are on board to help take the hard work and stress away from planning your next event. 

    So whether you in London on business or pleasure, make the Holiday Inn London Kensington Forum your first choice of hotel and book your accommodation for our lowest internet rate guarantee. 

    HOTEL BOOKING FORM

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@saemediagroup.com

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    Contact SAE Media Group

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SAE Media Group , Ground Floor, India House, 45 Curlew Street, London, SE1 2ND, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smgconferences.com Email: events@saemediagroup.com
    Registered in England - SMi Group Ltd trading as SAE Media Group




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