This document provides information about an upcoming conference on adaptive designs in clinical trials, including workshops, speakers, and program details. The conference will cover:
- The latest advances in adaptive designs from regulatory and industry perspectives.
- Two half-day post-conference workshops on the FDA's guidance on adaptive designs and designing digital technology trials.
- A program over two days addressing therapeutic applications of adaptive designs, regulatory outlook, and statistical approaches.
- Speakers from pharmaceutical companies, clinical research organizations, and regulatory agencies.
The document provides details on registration, speakers, workshop topics, and the overall agenda to give attendees an overview of the content that will be covered at the conference on adaptive designs in clinical trials
IBM Watson: Create the Future Today | Neil Sahota | Lunch & LearnUCICove
About UCI Applied Innovation:
UCI Applied Innovation is a dynamic, innovative central platform for the UCI campus, entrepreneurs, inventors, the business community and investors to collaborate and move UCI research from lab to market.
About the Cove @ UCI:
To accelerate collaboration by better connecting innovation partners in Orange County, UCI Applied Innovation created the Cove, a physical, state-of-the-art hub for entrepreneurs to gather and navigate the resources available both on and off campus. The Cove is headquarters for UCI Applied Innovation, as well as houses several ecosystem partners including incubators, accelerators, angel investors, venture capitalists, mentors and legal experts.
Follow us on social media:
Facebook: @UCICove
Twitter: @UCICove
Instagram: @UCICove
LinkedIn: @UCIAppliedInnovation
For more information:
cove@uci.edu
http://innovation.uci.edu/
Il processo di innovazione in atto: dalle strategie di brevettazione al fundr...Sardegna Ricerche
L'intervento di Rachele Berria (Global Vice President Primary Care Medical Unit Sanofi) in occasione dell'evento "Il valore della ricerca biomedica" che si è tenuto a Pula (CA) il 3 aprile 2019.
SPOTLIGHT ON THE PREMIUM CHANNEL – Bausch + LombHealthegy
Presentation from OIS@ASCRS 2016
Andrew Chang, General Manager & VP, US Surgical
Video Presentation:
https://www.youtube.com/watch?v=xxXQ5IKIMn8&list=PL1dmdBNnPTZJBhQxPOp0vdNg3s3wtN2yw&index=36
The Green Park Collaborative (GPC) has developed a new tool to help health care decision makers confidently and consistently use Real World Evidence (RWE) when making tough coverage and care choices. Called RWE Decoder, the spreadsheet-based assessment tool lets users review and evaluate all existing studies and evidence for both rigor and relevance. Informed by these factors, users can assess study quality, and generate a visual summary to help gauge the evidence under review.
Published RWE studies developed from data-rich electronic medical records or medical claims data are increasingly available from health care systems. However, the quality of this research can vary widely, and payers, clinicians and other health care decision makers often dismiss it out of hand. RWE Decoder and its associated user guide and framework, offer a thoughtful approach to helping these decision makers assess whether RWE studies address their questions and can appropriately guide their choices.
The tool, user guide, and supporting white paper are available here: https://goo.gl/AhbHUw
About UCI Applied Innovation:
UCI Applied Innovation is a dynamic, innovative central platform for the UCI campus, entrepreneurs, inventors, the business community and investors to collaborate and move UCI research from lab to market.
About the Cove @ UCI:
To accelerate collaboration by better connecting innovation partners in Orange County, UCI Applied Innovation created the Cove, a physical, state-of-the-art hub for entrepreneurs to gather and navigate the resources available both on and off campus. The Cove is headquarters for UCI Applied Innovation, as well as houses several ecosystem partners including incubators, accelerators, angel investors, venture capitalists, mentors and legal experts.
Follow us on social media:
Facebook: @UCICove
Twitter: @UCICove
Instagram: @UCICove
LinkedIn: @UCIAppliedInnovation
For more information:
cove@uci.edu
http://innovation.uci.edu/
IBM Watson: Create the Future Today | Neil Sahota | Lunch & LearnUCICove
About UCI Applied Innovation:
UCI Applied Innovation is a dynamic, innovative central platform for the UCI campus, entrepreneurs, inventors, the business community and investors to collaborate and move UCI research from lab to market.
About the Cove @ UCI:
To accelerate collaboration by better connecting innovation partners in Orange County, UCI Applied Innovation created the Cove, a physical, state-of-the-art hub for entrepreneurs to gather and navigate the resources available both on and off campus. The Cove is headquarters for UCI Applied Innovation, as well as houses several ecosystem partners including incubators, accelerators, angel investors, venture capitalists, mentors and legal experts.
Follow us on social media:
Facebook: @UCICove
Twitter: @UCICove
Instagram: @UCICove
LinkedIn: @UCIAppliedInnovation
For more information:
cove@uci.edu
http://innovation.uci.edu/
Il processo di innovazione in atto: dalle strategie di brevettazione al fundr...Sardegna Ricerche
L'intervento di Rachele Berria (Global Vice President Primary Care Medical Unit Sanofi) in occasione dell'evento "Il valore della ricerca biomedica" che si è tenuto a Pula (CA) il 3 aprile 2019.
SPOTLIGHT ON THE PREMIUM CHANNEL – Bausch + LombHealthegy
Presentation from OIS@ASCRS 2016
Andrew Chang, General Manager & VP, US Surgical
Video Presentation:
https://www.youtube.com/watch?v=xxXQ5IKIMn8&list=PL1dmdBNnPTZJBhQxPOp0vdNg3s3wtN2yw&index=36
The Green Park Collaborative (GPC) has developed a new tool to help health care decision makers confidently and consistently use Real World Evidence (RWE) when making tough coverage and care choices. Called RWE Decoder, the spreadsheet-based assessment tool lets users review and evaluate all existing studies and evidence for both rigor and relevance. Informed by these factors, users can assess study quality, and generate a visual summary to help gauge the evidence under review.
Published RWE studies developed from data-rich electronic medical records or medical claims data are increasingly available from health care systems. However, the quality of this research can vary widely, and payers, clinicians and other health care decision makers often dismiss it out of hand. RWE Decoder and its associated user guide and framework, offer a thoughtful approach to helping these decision makers assess whether RWE studies address their questions and can appropriately guide their choices.
The tool, user guide, and supporting white paper are available here: https://goo.gl/AhbHUw
About UCI Applied Innovation:
UCI Applied Innovation is a dynamic, innovative central platform for the UCI campus, entrepreneurs, inventors, the business community and investors to collaborate and move UCI research from lab to market.
About the Cove @ UCI:
To accelerate collaboration by better connecting innovation partners in Orange County, UCI Applied Innovation created the Cove, a physical, state-of-the-art hub for entrepreneurs to gather and navigate the resources available both on and off campus. The Cove is headquarters for UCI Applied Innovation, as well as houses several ecosystem partners including incubators, accelerators, angel investors, venture capitalists, mentors and legal experts.
Follow us on social media:
Facebook: @UCICove
Twitter: @UCICove
Instagram: @UCICove
LinkedIn: @UCIAppliedInnovation
For more information:
cove@uci.edu
http://innovation.uci.edu/
Design is to do good not just be and look good: Bad Design is Smoke, Good Des...Ajaz Hussain
Design is to do good not just be and look good. "Design means being good, not just looking good." ~ Clement Mok. "A small change at the beginning of the design process defines an entirely different product at the end." ~ Jonathan Ive. "User-centered design means understanding what your users need, how they think, and how they behave - and incorporating that understanding into every aspect of your process." ~ Jesse James Garrett.
Compared to “one factor at a time” experiments, increased experimental efficiency, accounting interactions, multivariate predictive capability, minimization, maximization, optimization, graphical illustration for enhanced communication of complex topics.
"Design is intelligence made visible." -- Alina Wheeler
Opportunities and Challenges Associated with Novel Companion Diagnostic Techn...L.E.K. Consulting
L.E.K. Managing Director Alex Vadas spoke at a BDA workshop on "How to Mature Emerging Technologies into Companion Diagnostics?" See his presentation here.
Scott Johnson - Myelin Repair Foundation, Speaker at the marcus evans Discovery Summit Fall 2011 in Las Vegas, delivers his presentation on Carving a New Niche for Non-Profits: Filling the Translational Gap for Novel Treatments for Diseases with Unmet Needs
Critical Path Initiative Challenges: FDA ACPS Meeting 19 October 2004Ajaz Hussain
Each section within P2 can have an impact on the other P2 sections and similarly other sections of a submission and to CGMP’s By recognizing this as a complex design system that involves multiple attributes, goals, constraints, multidisciplinary design teams (subsystems), different degrees of uncertainty, risk tolerance, etc., we wish to find opportunities to identify robust designs and design space that provides a sound basis for risk assessment and mitigation
Structure-Based Drug Design Facts & Figures InfographicJames Prudhomme
Among 32 pharma and biotech companies surveyed, structure-based drug design is the most prevalent activity with the most players emphasizing the fragment-based variation.
PAREXEL's Matt Neal joins experts from Microsoft and Allergan to discuss how innovations in technology can help patients by reducing the time and expense of bringing life-saving treatments to market.
Getting Results through Data-driven ProcurementDan Traub
2018 NAEP Annual Meeting panel presentation, delivered in Orlando, Florida
Procurement teams are facing increased calls from leadership to bring documented value and accountability to their institutions. Many are finding that an analytical approach is an effective way to deliver relevant insights and focus limited resources on the most pressing challenges.
In this panel discussion, learn how leading organizations are embracing analytics not simply as another technology to deploy, but as a transformative way of doing business. The session will use real-life examples to show attendees how to build a business case for change, foster analytical thinking in staff, and develop and communicate meaningful conclusions from procurement data.
Presenters: Lauren Leonard, University of Pittsburgh. Ron Moraski, Rensselaer Polytechnic University. Shannon Wampler, University of Virginia. Dan Traub, FinVantage Solutions LLC.
With cancer being the fastest growing healthcare priority in the pharmaceutical industry, IBC Asia announces the region's first ever strategic oncology conference focusing on clinical development and market access.
Download the brochure <link> now to identify new trends and opportunities in development and commercialization in the region.
ONCOLOGY ASIA focuses on the clinical development and effective market access for cancer drugs in Asia. It will cover strategies for developing oncology products and businesses from innovative pipelines, commercializing products, sales and marketing strategies to capture opportunities in Asia’s markets.
Featured sessions from top industry thought leaders:
Market Trends and Drivers in the Region
• James Garner, Head Unit Development Operations, Asia R&D, Sanofi, Singapore
What You Need to Know When Marketing Oncology Drugs
• Dr Paul Cornes, Clinical Oncologist, Bristol Oncology Centre, UK
Successful Market Access Strategies for Oncology Drugs
• Sameer Agarwal, Senior Vice President, Business Center Strategic
Marketing, Fresenius Kabi Deutschland GmbH, Germany
Clinical Engagement for Successful Oncology Products
• Dr Anish Desai, Director Medical & Clinical Affairs, Johnson & Johnson, India
http://www.oncologyasia.com
Real World Evidence - getting value from volume with metadataAnn Kelly
Anne Lapkin from Smartlogic and Bill Fox from MarkLogic webinar on Real World Evidence; the value, the opportunity, the problems and the platform of the future
Design is to do good not just be and look good: Bad Design is Smoke, Good Des...Ajaz Hussain
Design is to do good not just be and look good. "Design means being good, not just looking good." ~ Clement Mok. "A small change at the beginning of the design process defines an entirely different product at the end." ~ Jonathan Ive. "User-centered design means understanding what your users need, how they think, and how they behave - and incorporating that understanding into every aspect of your process." ~ Jesse James Garrett.
Compared to “one factor at a time” experiments, increased experimental efficiency, accounting interactions, multivariate predictive capability, minimization, maximization, optimization, graphical illustration for enhanced communication of complex topics.
"Design is intelligence made visible." -- Alina Wheeler
Opportunities and Challenges Associated with Novel Companion Diagnostic Techn...L.E.K. Consulting
L.E.K. Managing Director Alex Vadas spoke at a BDA workshop on "How to Mature Emerging Technologies into Companion Diagnostics?" See his presentation here.
Scott Johnson - Myelin Repair Foundation, Speaker at the marcus evans Discovery Summit Fall 2011 in Las Vegas, delivers his presentation on Carving a New Niche for Non-Profits: Filling the Translational Gap for Novel Treatments for Diseases with Unmet Needs
Critical Path Initiative Challenges: FDA ACPS Meeting 19 October 2004Ajaz Hussain
Each section within P2 can have an impact on the other P2 sections and similarly other sections of a submission and to CGMP’s By recognizing this as a complex design system that involves multiple attributes, goals, constraints, multidisciplinary design teams (subsystems), different degrees of uncertainty, risk tolerance, etc., we wish to find opportunities to identify robust designs and design space that provides a sound basis for risk assessment and mitigation
Structure-Based Drug Design Facts & Figures InfographicJames Prudhomme
Among 32 pharma and biotech companies surveyed, structure-based drug design is the most prevalent activity with the most players emphasizing the fragment-based variation.
PAREXEL's Matt Neal joins experts from Microsoft and Allergan to discuss how innovations in technology can help patients by reducing the time and expense of bringing life-saving treatments to market.
Getting Results through Data-driven ProcurementDan Traub
2018 NAEP Annual Meeting panel presentation, delivered in Orlando, Florida
Procurement teams are facing increased calls from leadership to bring documented value and accountability to their institutions. Many are finding that an analytical approach is an effective way to deliver relevant insights and focus limited resources on the most pressing challenges.
In this panel discussion, learn how leading organizations are embracing analytics not simply as another technology to deploy, but as a transformative way of doing business. The session will use real-life examples to show attendees how to build a business case for change, foster analytical thinking in staff, and develop and communicate meaningful conclusions from procurement data.
Presenters: Lauren Leonard, University of Pittsburgh. Ron Moraski, Rensselaer Polytechnic University. Shannon Wampler, University of Virginia. Dan Traub, FinVantage Solutions LLC.
With cancer being the fastest growing healthcare priority in the pharmaceutical industry, IBC Asia announces the region's first ever strategic oncology conference focusing on clinical development and market access.
Download the brochure <link> now to identify new trends and opportunities in development and commercialization in the region.
ONCOLOGY ASIA focuses on the clinical development and effective market access for cancer drugs in Asia. It will cover strategies for developing oncology products and businesses from innovative pipelines, commercializing products, sales and marketing strategies to capture opportunities in Asia’s markets.
Featured sessions from top industry thought leaders:
Market Trends and Drivers in the Region
• James Garner, Head Unit Development Operations, Asia R&D, Sanofi, Singapore
What You Need to Know When Marketing Oncology Drugs
• Dr Paul Cornes, Clinical Oncologist, Bristol Oncology Centre, UK
Successful Market Access Strategies for Oncology Drugs
• Sameer Agarwal, Senior Vice President, Business Center Strategic
Marketing, Fresenius Kabi Deutschland GmbH, Germany
Clinical Engagement for Successful Oncology Products
• Dr Anish Desai, Director Medical & Clinical Affairs, Johnson & Johnson, India
http://www.oncologyasia.com
Real World Evidence - getting value from volume with metadataAnn Kelly
Anne Lapkin from Smartlogic and Bill Fox from MarkLogic webinar on Real World Evidence; the value, the opportunity, the problems and the platform of the future
SMi Group are thrilled to announce the launch of the Ophthalmic Drugs Conference, being held on the 28-29 November 2017 at the Copthorne Tara Hotel in London, UK. www.ophthalmicdrugs.com/slideshare
P 141 pre-filled syringes america revisedAlia Malick
The global prefilled syringe market is estimated to reach $6.9bn by 2018. This figure is reflective of manufacturers striving to improve their technologies to meet the increasing number of biologic drugs reaching the market. The rising demand for prefilled syringes is driving the manufacturers to introduce improvements in technology and with the focus still on the safety for the user, innovation improvements for device development and ease of use for the patient are key areas to be addressed.
SMi’s leading prefilled syringes conference will focus on a number of hot talking points that will no doubt cause controversy and debate and on reflection open the floor to discussion in our breakout sessions. In addition, with a new competitive market just around the corner for biosimilars we look at this new session for 2015 in addition to the vision and benefit of lyophilisation in a prefilled syringe.
Will I see you in Philadelphia next week? In case you don’t already know, I’ve been invited to speak at CBI’s Risk-Based Trial Management and Monitoring Conference.
I’m going to be sharing real world, pragmatic guidance that you can implement immediately to effectively influence your clinical trial performance.
My presentation, Practical Usage of KRIs and QTLs in Clinical Trials, will take place next Thursday, November 14th at 9:45am. I’m going to share with you:
• How to identify and close the gaps between risks and KRIs
• What the difference is between KRIs and QTLs, and how to use them effectively
• Useful examples of Centralized Monitoring findings from open data
• How to detect, combat and prevent fraud and sloppiness at an early stage
• How AI and ML advance risk-based approaches
So I can’t wait to see you at this informative and fun-filled industry expert forum,
– Artem Andrianov, CEO Cyntegrity
Instructions for Submissions thorugh G- Classroom.pptxJheel Barad
This presentation provides a briefing on how to upload submissions and documents in Google Classroom. It was prepared as part of an orientation for new Sainik School in-service teacher trainees. As a training officer, my goal is to ensure that you are comfortable and proficient with this essential tool for managing assignments and fostering student engagement.
Unit 8 - Information and Communication Technology (Paper I).pdfThiyagu K
This slides describes the basic concepts of ICT, basics of Email, Emerging Technology and Digital Initiatives in Education. This presentations aligns with the UGC Paper I syllabus.
How to Split Bills in the Odoo 17 POS ModuleCeline George
Bills have a main role in point of sale procedure. It will help to track sales, handling payments and giving receipts to customers. Bill splitting also has an important role in POS. For example, If some friends come together for dinner and if they want to divide the bill then it is possible by POS bill splitting. This slide will show how to split bills in odoo 17 POS.
2024.06.01 Introducing a competency framework for languag learning materials ...Sandy Millin
http://sandymillin.wordpress.com/iateflwebinar2024
Published classroom materials form the basis of syllabuses, drive teacher professional development, and have a potentially huge influence on learners, teachers and education systems. All teachers also create their own materials, whether a few sentences on a blackboard, a highly-structured fully-realised online course, or anything in between. Despite this, the knowledge and skills needed to create effective language learning materials are rarely part of teacher training, and are mostly learnt by trial and error.
Knowledge and skills frameworks, generally called competency frameworks, for ELT teachers, trainers and managers have existed for a few years now. However, until I created one for my MA dissertation, there wasn’t one drawing together what we need to know and do to be able to effectively produce language learning materials.
This webinar will introduce you to my framework, highlighting the key competencies I identified from my research. It will also show how anybody involved in language teaching (any language, not just English!), teacher training, managing schools or developing language learning materials can benefit from using the framework.
Operation “Blue Star” is the only event in the history of Independent India where the state went into war with its own people. Even after about 40 years it is not clear if it was culmination of states anger over people of the region, a political game of power or start of dictatorial chapter in the democratic setup.
The people of Punjab felt alienated from main stream due to denial of their just demands during a long democratic struggle since independence. As it happen all over the word, it led to militant struggle with great loss of lives of military, police and civilian personnel. Killing of Indira Gandhi and massacre of innocent Sikhs in Delhi and other India cities was also associated with this movement.
Palestine last event orientationfvgnh .pptxRaedMohamed3
An EFL lesson about the current events in Palestine. It is intended to be for intermediate students who wish to increase their listening skills through a short lesson in power point.
Read| The latest issue of The Challenger is here! We are thrilled to announce that our school paper has qualified for the NATIONAL SCHOOLS PRESS CONFERENCE (NSPC) 2024. Thank you for your unwavering support and trust. Dive into the stories that made us stand out!
Welcome to TechSoup New Member Orientation and Q&A (May 2024).pdfTechSoup
In this webinar you will learn how your organization can access TechSoup's wide variety of product discount and donation programs. From hardware to software, we'll give you a tour of the tools available to help your nonprofit with productivity, collaboration, financial management, donor tracking, security, and more.
We all have good and bad thoughts from time to time and situation to situation. We are bombarded daily with spiraling thoughts(both negative and positive) creating all-consuming feel , making us difficult to manage with associated suffering. Good thoughts are like our Mob Signal (Positive thought) amidst noise(negative thought) in the atmosphere. Negative thoughts like noise outweigh positive thoughts. These thoughts often create unwanted confusion, trouble, stress and frustration in our mind as well as chaos in our physical world. Negative thoughts are also known as “distorted thinking”.
Chapter 3 - Islamic Banking Products and Services.pptx
SMi Group's Adaptive Designs in Clinical Trials 2019
1. PLUS TWO INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPS
WEDNESDAY 3RD APRIL 2019, HOLIDAY INN KENSINGTON FORUM, LONDON, UK
HIGHLIGHTS FOR 2019:
• See how the regulatory environment for adaptive drug
design is shifting across the continent with insights from the
MHRA, Amgen, AstraZeneca and Berry Consulting
• Explore the therapeutic potential of adaptive designs with
real-world examples from H.Lundbeck, GSK Vaccines, Pfi zer
and Novartis
• Listen to how the latest platform trial case studies, such as
that of the EPAD project and the MS Society initiative, are
impacting pharmaceutical development
• Delve into the long-standing discussion of Bayesian vs.
frequentist designs
• Discover the latest research in response-adaptive designs:
trials for rare diseases and looking forward
CHAIRS FOR 2019:
• Alex Sverdlov, Director, Statistical Scientist, Novartis
• Tom Parke, Director of Software Solutions, Berry Consulting
FEATURED 2019 SPEAKERS INCLUDE:
• Sandeep Menon, Vice President and Head of
Early Clinical Development, Pfi zer
• Simon Wandel, Associate Director, Statistical
Methodology and Consulting, Novartis
• Solange Corriol-Rohou, Senior Director Regulatory
Affairs and Policy, EU, AstraZeneca
• Christine Fletcher, Executive Director Biostatistics, Amgen
• Philip Hougaard, Vice President Biometrics, H. Lundbeck
• Beatrice Panico, Medical Assessor, MHRA
• Kaspar Rufi bach, Principal Statistical Scientist, Roche
• Andrea Callegaro, Senior Manager, Biostatistician,
GSK Vaccines
• Sofi a Villar, Senior Statistician, MRC Biostatistics Unit
Holiday Inn Kensington Forum, London, UK
www.adaptivedesigns.co.uk
Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
ACADEMIC & GROUP DISCOUNTS AVAILABLE @SMIPHARM
#smiadaptivedesigns
REGISTER BY 14TH DECEMBER AND SAVE £400
REGISTER BY 31ST JANUARY AND SAVE £200
REGISTER BY 28TH FEBRUARY AND SAVE £100
SMi Group Proudly Presents the 11th Annual Conference...
CONFERENCE:
1ST - 2ND
WORKSHOPS: 3RD
APRIL
2019
Adaptive Designs
in Clinical Trials
The latest advances to enhance the precision,
effi ciency and ethical aspects of your clinical trials
B: Design and analysis of clinical trials
evaluating novel digital technologies
Workshop Leader:
Alex Sverdlov, Director, Statistical Scientist, Novartis
Yevgen Ryeznik, PhD, Uppsala University
13.30 - 17.30
A: The FDA – a new guidance
on adaptive designs
Workshop Leader:
Tom Parke, Director of Software Solutions, Berry Consulting
08.30 - 12.30
2. 08.30 Registration & Coffee
08.50 Chairman’s Opening Remarks
Alex Sverdlov, Director, Statistical Scientist, Novartis
THERAPEUTIC POTENTIAL OF ADAPTIVE DESIGNS
OPENING ADDRESS
09.00 Statistical and design considerations in personalised medicine
• 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
Sandeep Menon, Vice President and Head of Early Clinical
Development, Pfi zer
SPOTLIGHT SESSION
09.40 Adaptive designs in multiple sclerosis clinical trials
• MS Society 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
Emma Gray, Head of Clinical Trials, MS Society
10.20 Morning Coffee
10.50 Adaptive signature designs for cancer 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
Andrea Callegaro, Senior Manager, Biostatistician, GSK
Vaccines
DEEP DIVE
11.30 The European Prevention of Alzheimer’s
Disease platform trial
• 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 fi rst trial
• Advantages and disadvantages of testing drugs in this
setup compared to classical one-drug trials
Philip Hougaard, Vice President Biometrics, H.Lundbeck
12.10 Networking Lunch
REGULATORY OUTLOOK OF ADAPTIVE DESIGNS
KEYNOTE ADDRESS
13.10 An industry outlook on adaptive designs in clinical trials
• 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
Christine Fletcher, Executive Director Biostatistics, Amgen
13.50 The evolution of adaptiveness
• Recent updates in European guidance
• The MAPPs engagement process
• Critical questions to be asked
• Adaptive approaches to bringing drugs to the market
Solange Corriol-Rohou, Senior Director Regulatory Affairs
and Policy, EU, AstraZeneca
14.30 Afternoon Tea
15.00 A regulatory perspective of adaptive design trials
• Initial Clinical Trial Authorisation (CTA): points to consider
• Regulatory points to consider for submissions with
substantial amendments
• Safety considerations
Beatrice Panico, Medical Assessor, MHRA
15.40 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
Macaulay Okwuokenye, Associate Director Biostatistics,
Syros Pharmaceuticals Inc
16.20 Chairman’s Closing Remarks and Close of Day One
Adaptive Designs in Clinical Trials
Day One | Monday 1st April 2019 www.adaptivedesigns.co.uk
Register online at www.adaptivedesigns.co.uk
SPONSORSHIP AND EXHIBITION OPPORTUNITIES
SMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to complement your company’s marketing strategy. Prime networking
opportunities exist to entertain, enhance and expand your client base within the context of an independent discussion specifi c to your industry. should you wish to join
the increasing number of companies benefi ting from sponsoring our conferences please call: Alia Malick on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk
Supported by
LETTER FROM THE CHAIRS:
Dear participants,
It is eleven years since the start of SMi’s series of conferences
on Adaptive Designs in Clinical Trials and twenty years since I
started working on adaptive trials. There are now multiple threads
that continue to drive the development of adaptive designs,
their acceptance and their use. These threads include the
radical “Platform Trial” design, the impact of advances in digital
technology, the increased potential of personalized medicine and
the attitude of regulators.
With so many evolving themes it is hard, even for an avid practitioner
of adaptive designs, to stay current across all of them which is why
conferences such as this are so useful. With a diverse program and
experienced speakers the conference presents a vibrant and up
to date cross-section of current practice in adaptive clinical trial
design.
As the chairs of this event, we look forward to personally welcoming
you to this must-attend conference in London this April.
Tom Parke, Alex Sverdlov,
Director, Director,
of Software Solutions Statistical Scientist,
Berry Consulting Novartis
3. 08.30 Registration & Coffee
08.50 Chairman’s Opening Remarks
Tom Parke, Director of Software Solutions, Berry Consulting
CLINICAL APPROACHES OF ADAPTIVE DESIGNS
OPENING ADDRESS
09.00 Digital therapeutics: an integral component of digital
innovation in drug development
• The potential for reducing current costs of medical care
• The unmet medical needs addressed by digital therapeutics
• Emerging pathways to regulatory approval
• How innovative business models are enabling further
growth in digital therapeutics
Alex Sverdlov, Director Statistical Scientist, Novartis
09.40 Applying adaptive designs in industry
• 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?
Frank Fleischer, Expert Statistician Methodology,
Boehringer-Ingelheim
10.20 Morning Coffee
10.50 Extrapolation in clinical trials and beyond
• 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
Simon Wandel, Associate Director, Statistical Methodology and
Consulting, Novartis
11.30 Continuous Decision Making within a Clinical Trial
• 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
Paul Frewer, Early Clinical Development, AstraZeneca
12.10 Networking Lunch
STATISTICAL APPROACHES OF ADAPTIVE DESIGNS
SPOTLIGHT SESSION
13.10 Forward looking response-adaptive designs
• The benefits of forward looking response-adaptive
randomisation in adaptive designs
• Trials for rare diseases and finding treatments that
work subgroups
• Type 1 error inflation due to an unknown time trend
over the course of the trial
Sofia Villar, Senior Statistician, MRC Biostatistics Unit
Panel Discussion
13.50 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
Moderated by:
Michael Proschan, Mathematical Statistician,
National Institute of Allergy and Infectious Diseases, USA
Panellists:
Kaspar Rufibach, Principal Statistical Scientist, Roche
Alex Sverdlov, Director, Statistical Scientist, Novartis
Sofia Villar, Senior Statistician, MRC Biostatistics Unit
14.30 Planning a phase 3 trial with time-to-event endpoint
• The MIRROS phase 3 trial
• Futility interim analysis using a mechanistic simulation model
• Sample size planning
• Exploration of operating characteristics of the futility interim
analysis
Kaspar Rufibach, Principal Statistical Scientist, Roche
15.10 Afternoon Tea
15.40 Defining decision rules based on simulated development
programs
• 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
Heiko Goette, Biostatistician, Merck KGaA
16.20 Chairman’s Closing Remarks and Close of Day Two
Adaptive Designs in Clinical Trials
Day Two | Tuesday 2nd April 2019 www.adaptivedesigns.co.uk
Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
MARKETING OPPORTUNITIES
Want to know how you can get involved? Interested in promoting your services to this market?
Contact Jinna Sidhu, SMi Marketing on +44 (0) 207 827 6088 | Fax +44 (0) 207 827 6089 or email: hsidhu@smi-online.co.uk
Supported by
4. The FDA – a new guidance
on adaptive designs
Workshop Leader:
Tom Parke, Director of Software Solutions, Berry Consulting
HALF-DAY POST-CONFERENCE WORKSHOP A
Wednesday 3rd April 2019
08.30 – 12.30
Holiday Inn Kensington Forum, London, UK
Overview of the workshop:
The new FDA draft guidance on Adaptive Trials is a signifi cant
change from the 2010 version of the draft guidance. This
workshop will look at the changes and what it means for
submitting proposals for adaptive trials to the FDA.
The workshop will cover:
• How to submit adaptive designs to regulators
• What the contents of the documents should be
• What simulation details need to be submitted
• What problems to expect
• How to submit simulation results
• How to submit simulation software
Why you should attend?
• Attend this workshop if you would like to understand:
• How the new guidance refl ects changes at the FDA
• How to justify the use of an adaptive design to the FDA
• How to document an adaptive design
• How to organise, perform, and report the clinical trial
simulations necessary to support an adaptive design
• How to report the results of an adaptive design
Programme
08.30 Registration and Coffee
09.00 Opening remarks and introductions
09.10 A look at the draft guidance in detail
• Changes to the detailed principles
• Classes of adaptive designs
• Operational details and considerations
• Regulatory interaction and submission guidance
09.50 Describing and justifying a proposal to perform
an adaptive trial
• Statistical effi ciency
• Ethical considerations
• Operational considerations
• Broader questions the trial might address
• Stakeholder fl exibility
10.30 Morning Coffee
11.00 Trial simulation necessary to support
a complex trial design
• How to simulate trials
• The art of simulating clinical trials – choosing
scenarios choosing operating characteristics
• Avoiding doing too much
• Showing type-1 error control
11.40 Submitting the results of an adaptive trial
• Analysis of results and analysis code
• Interim analyses and results
• Interim communications
12.20 Closing remarks
12.30 End of workshop
About the workshop leader
Tom Parke is Director of Software Solutions for Berry
Consultants. Tom joined Berry Consultants in 2016 having
previously worked at Tessella, a UK scientifi c software
company where he fi rst met and worked with Don Berry.
In 1998 Tom managed the development and running of a
software system to support Pfi zer’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, fi rst with Pfi zer, then Wyeth, and
fi nally 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.
Berry Consultants
Berry Consultants is a statistical
consulting company specializing in
the Bayesian approach to medical
statistics, an approach that is radically
changing the way research is done
throughout the medical industry in
both device and drug development.
Berry Consultants employs world renowned experts in
Bayesian statistics and strives to set the standard for innovative
clinical trial design and analysis in the statistical and medical
communities.
5. Design and analysis of clinical trials
evaluating novel digital technologies
Workshop Leader:
Alex Sverldlov, Director, Statistical Scientist, Novartis
Yevgen Ryeznik, PhD, Uppsala University
HALF-DAY POST-CONFERENCE WORKSHOP B
Wednesday 3rd April 2019
13.30 – 17.30
Holiday Inn Kensington Forum, London, UK
Overview of the workshop
Digital technologies (such as wearable devices, smartphone
apps) are increasingly used in clinical research and
development. Despite numerous pilot clinical studies
evaluating merits of digital technologies, there is still little
knowledge on how to properly design and run such studies,
and how to analyse the collected experimental data. The
current course will cover several important statistical aspects
of clinical trials evaluating digital technologies.
Why you should attend?
Attend this workshop if you would like to understand:
• Potential challenges and benefi ts of utilizing digital
technologies in clinical research
• What trial designs are available for evaluating digital
technologies
• How to analyze data generated by digital technologies
• Current regulatory pathways to the approval of digital
therapeutics
Programme
13.30 Registration and Coffee
14.00 Opening remarks and introductions
14.10 Innovative designs for developing mobile
health interventions
• Micro-randomized trials
• MOST and SMART designs
• Choice of sample size
• Data analysis aspects
14.50 Digital biomarkers as screening/diagnostic tools
• Challenges and opportunities
• Classifi cation problems
• Building predictors of clinical outcomes
15.30 Afternoon Tea
16.00 Digital therapeutics
• Addressing unmet medical need
• Emerging business models
• Clinical trials to develop digital health
interventions
16.40 Current regulatory landscape for digital health
technologies
• Pathways to regulatory approval of a device
• Existing regulatory guidelines
• Examples of successful approvals
17.20 Closing Remarks
17.30 End of Workshop
About the workshop leaders
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 effi ciency 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.
Since 2014, Yevgen Ryeznik is a Ph.D. student in Uppsala
University, Uppsala. Before that, he had a 2-year experience
of working as a SAS programmer and clinical data analyst in
the Ukrainian department of Quartesian LLC, a CRO located
in Princeton, NJ. For the last ten years, he has been actively
involved in research on optimal designs and adaptive
randomization for clinical trials, mainly, trials with time-to-
event outcomes. Yevgen’s most recent research interests are
digital therapeutics and mobile health, and applications of
deep learning for biopharmaceutics.
6. ADAPTIVE DESIGNS IN CLINICAL TRIALS 2019
Conference: Monday 1st Tuesday 2nd April 2019, Holiday Inn Kensington Forum, London, UK
Workshops: Wednesday 3rd April 2019, London, UK
4 WAYS TO REGISTER
www.adaptivedesigns.co.uk
FAX your booking form to +44 (0) 870 9090 712
PHONE on +44 (0) 870 9090 711
POST your booking form to: Events Team, SMi Group Ltd,
Ground First Floor, 1 Westminster Bridge Road London, SE1 7XW, UK
EARLY BIRD
DISCOUNT
□ Book by 14th December to receive £400 off the conference price
□ Book by 31st January to receive £200 off the conference price
□ Book by 28th February to receive £100 off the conference price
VAT at 20% is charged on the attendance fees for all delegates. VAT is also charged
on Document portal and literature distribution for all UK customers and for those EU
Customers not supplying a registration number for their own country here.
______________________________________________________________________________________
If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email events@smi-online.co.uk
Unique Reference Number
Our Reference LVP-282
VAT
DOCUMENTATION
I cannot attend but would like to Purchase access to the following Document Portal/
Paper Copy documentation. Price Total
□ Access to the conference documentation
on the Document Portal £499.00 + VAT £598.80
□ The Conference Presentations – paper copy £499.00 - £499.00
(or only £300 if ordered with the Document Portal)
Payment must be made to SMi Group Ltd, and received before the event, by one of
the following methods quoting reference P-282 and the delegate’s name. Bookings
made within 7 days of the event require payment on booking, methods of payment:
□ UK BACS Sort Code 300009, Account 00936418
□ Wire Transfer Lloyds TSB Bank plc, 39 Threadneedle Street, London, EC2R 8AU
Swift (BIC): LOYDGB21013, Account 00936418
IBAN GB48 LOYD 3000 0900 9364 18
□ Cheque We can only accept Sterling cheques drawn on a UK bank.
□ Credit Card □ Visa □ MasterCard □ American Express
SMi Group will apply surcharges to commercial cards
Please tick here □ if the card provided is not a commercial card
Card No: □□□□ □□□□ □□□□ □□□□
Valid From □□/□□ Expiry Date □□/□□
CVV Number □□□□ 3 digit security on reverse of card, 4 digits for AMEX card
Cardholder’s Name:
Signature: Date:
I agree to be bound by SMi’s Terms and Conditions of Booking.
Card Billing Address (If different from above):
PAYMENT
CONFERENCE PRICES GROUP DISCOUNTS AVAILABLE
I would like to attend: (Please tick as appropriate) Fee TOTAL
□ Conference 2 Workshops £2697.00 + VAT £3236.40
□ Conference 1 Workshop A □ B □ £2098.00 + VAT £2517.60
□ Conference only £1499.00 + VAT £1798.80
□ 2 Workshops £1198.00 + VAT £1437.60
□ 1 Workshop only A □ B □ £599.00 + VAT £718.80
PROMOTIONAL LITERATURE DISTRIBUTION
□ Distribution of your company’s promotional
literature to all conference attendees £999.00 + VAT £1198.80
The conference fee includes refreshments, lunch, conference papers, and access to the
Document Portal. Presentations that are available for download will be subject to distribution
rights by speakers. Please note that some presentations may not be available for download.
Access information for the document portal will be sent to the e-mail address provided
during registration. Details are sent within 24 hours post conference.
Please complete fully and clearly in capital letters. Please photocopy for additional delegates.
Title: Forename:
Surname:
Job Title:
Department/Division:
Company/Organisation:
Email:
If you would like to continue to receive email updates about our
events, please tick □
Company VAT Number:
Address:
Town/City:
Post/Zip Code: Country:
Direct Tel: Direct Fax:
Mobile:
Switchboard:
Signature: Date:
I agree to be bound by SMi’s Terms and Conditions of Booking.
ACCOUNTS DEPT
Title: Forename:
Surname:
Email:
Address (if different from above):
Town/City:
Post/Zip Code: Country:
Direct Tel: Direct Fax:
Payment: If payment is not made at the time of booking, then an invoice will be issued and must
be paid immediately and prior to the start of the event. If payment has not been received then
credit card details will be requested and payment taken before entry to the event. Bookings within
7 days of event require payment on booking. Access to the Document Portal will not be given until
payment has been received.
Substitutions/Name Changes: If you are unable to attend you may nominate, in writing, another
delegate to take your place at any time prior to the start of the event. Two or more delegates may
not ‘share’ a place at an event. Please make separate bookings for each delegate.
Cancellation: If you wish to cancel your attendance at an event and you are unable to send
a substitute, then we will refund/credit 50% of the due fee less a £50 administration charge,
providing that cancellation is made in writing and received at least 28 days prior to the start of the
event. Regretfully cancellation after this time cannot be accepted. We will however provide the
conferences documentation via the Document Portal to any delegate who has paid but is unable
to attend for any reason. Due to the interactive nature of the Briefi ngs we are not normally able to
provide documentation in these circumstances. We cannot accept cancellations of orders placed
for Documentation or the Document Portal as these are reproduced specifi cally to order. If we
have to cancel the event for any reason, then we will make a full refund immediately, but disclaim
any further liability.
Alterations: It may become necessary for us to make alterations to the content, speakers, timing,
venue or date of the event compared to the advertised programme.
Privacy policy / Opt Out: For full details on our privacy policy please go to
http://smi-online.co.uk/privacy-legals/privacy-policy. If you no longer wish to receive email
updates you can opt out by going to the following webpage http://www.smi-online.co.uk/opt-out
Terms and Conditions of Booking
DELEGATE DETAILS
VENUE Holiday Inn Kensington Forum, London, UK
□ Please contact me to book my hotel
Alternatively call us on +44 (0) 870 9090 711,
email: events@smi-online.co.uk or fax +44 (0) 870 9090 712