Helen Morris Brown
"The Psychology of Communicating Effectively in a Digital World"
Helen Morris Brown is a business psychologist, TEDx speaker and performance coach who has helped hundreds of leaders, teams and CEOs of charities understand how to embrace change and optimise their performance.
Following more than two decades of experience in training and development, she now focuses on helping people to perform at their best through speaking, advising and coaching. Helen says: “I think our brains hold the key to our behaviour – good and bad – which is why I'm passionate about helping people to understand the ways in which it affects their performance at work. I prefer to entertain people, rather than lecture them, when talking about specific aspects of psychology and human behaviour.”
Helen knows how to bring psychology and neuroscience to life in her presentations. She keeps the audience engaged by combining comedy, sleight of hand and real-life stories to ensure that all the key points are memorable. She astonishes with illusions that challenge the way we think and enable people to see how the knowledge of neuroscience and psychology can benefit them at home and at work.
Wayne Kubick, HL7
“The Shortest Distance Between Two Points”
Wayne R. Kubick is Chief Technology Officer for Health Level Seven International, responsible for advancing HL7’s mission and vision, and helping HL7 work groups develop standards for health.
Kubick is an expert advisor and commenter at-large, focusing on improving clinical research through technology and data standards. He has spent more than 25 years in a variety of technology-focused roles related to the pharmaceutical industry, as first CIO of Parexel International and a senior executive at Lincoln Technologies (which developed advanced data mining and analytics software and was later acquired by Phase Forward and Oracle). He was a founding Board member, team leader and later Chief Technology Officer for CDISC. Mr. Kubick holds a B.A. from the University of Illinois and an M.B.A. from Boston University.
Representing a unique point of view from his roles as CTO of CDISC and HL7 International, Wayne will be looking at the past evolution of clinical research and a provocative future vision that thinks beyond the CRF. The increasing availability of electronic source digital healthcare data in standardized form, catalyzed by the emergence of the HL7 FHIR platform standard, creates an imperative to streamline the gap from initial patient experience or encounter to analysis, and points toward a radical reinvention of clinical research in the future.
Among the topics to be discussed are:
• Use cases for setting Clinical Research on FHIR in trial planning, data collection, drug safety and regulatory review
• Use of Real World Evidence and pragmatic trials, including a summary of results of the Tufts Center for the Study of Drug Development research project on RWE
• SMART-on-FHIR as a channel for patient interactions
• Genomics on FHIR to support precision medicine
• Devices on FHIR and the internet of things.
Gavin Hastings was one of the outstanding Rugby Union players of his generation.
Born in Edinburgh in 1962, Gavin was educated at George Watson's College before going on to study Land Economy at Cambridge University via Paisley College of Technology. He won two rugby blues at Cambridge and captained them in the 1985 Varsity Match. Five weeks later he won his first Cap for Scotland in the 1986 Five Nations Championship match against France, alongside his brother Scott. He kicked six penalty goals on his debut to give Scotland an 18-17 victory.
During his playing career, he captained Watsonians (in Scotland), London Scottish (in England), the Barbarians (in Hong Kong), the British Lions (in New Zealand) and Scotland (in South Africa), and he toured with various representative teams all over the world. Gavin played in the first three Rugby World Cups and was a member of the historic Scotland Team that won the Grand Slam in 1990. He also scored a memorable try that gave Scotland victory in Paris in 1995 – their first away win against France for 26 years.
He retired from International Rugby after the 1995 World Cup in South Africa with over 700 points having played 61 tests for his country (20 as Captain) and six for the British Lions. Upon his retirement from rugby, Gavin set up a company specialising in sports marketing and event management. Current clients include The Famous Grouse whisky, proud sponsors of the Scotland Rugby Team as well as BT Scotland, BT Cellnet and The Ladies European Golf Tour.
Gavin will share anecdotes and wisdom with his motivational keynote presentation.
Lilliam Rosario, FDA
"An Update on the Guidance of Standardized Study Data and Regulatory Review"
In December 2014, the FDA published the long-awaited binding guidance documents requiring the submission of study data in an electronic standardised format specified by the FDA beginning 24 months from the issuance of the document.
The Guidance on Standardised Study Data stated that all studies with a start date 24 or 36 months after the publication date must use the appropriate FDA-supported standards, formats and terminologies specified in the Data Standards Catalog for NDA/ANDA/certain BLA submissions and INDs, respectively. This presentation will update you and what has happened until now, and what is the impact of these changes in the way FDA conducts regulatory review in support of its mission to protect public health.