Day 1 :
PCRS Network, LLC, USA
Time : 09:00 - 09:25
John has over 30 years of experience as an entrepreneur and has provided services to biotech and pharmaceutical companies via his various businesses since 1985. He is the Founder and Chairman of PCRS Network, LLC, a leading independent research site network. John is a frequent speaker at industry conferences, writes the PCRS blog, and serves on the Board of Trustees of the Association of Clinical Research Professionals, the industry’s largest professional membership organization.
Prior to founding PCRS, John served as the COO and CFO of a multi-site clinical research company, which he helped grow from a single site in 2004 to 5 sites in 2007 by establishing privately operated Clinical Trial Offices at community hospitals.
From the make-up of the study pipeline to how studies are conducted, the Clinical Research industry is changing. Pressure to reduce the time and costs required to take new drugs and devices from the lab to market, patients advocating for quicker access to novel new treatments, and technology advances are driving changes in systems, processes, and strategies. Based on discussions and interviews with numerous Senior Executives with Drug and Device companies, CRO’s, IRBs, and the FDA over a the last eighteen months, Mr. Neal will provide insights and predictions of some disruptive changes coming to the clinical research enterprise. Mr. Neal will address the primary drivers of the changes that are coming, share quotes from notable figures involved in Clinical Research, including Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER), and elaborate on eighteen specific predictions of changes coming, and shed light on what the changes mean for study sponsors, CROs, IRB, and the Investigators and clinical research staff employed at Sites. Since he first presented his predictions in April 2016 at the ACRP Annual Expo and Conference, many of his predictions have already come true. The changes coming will affect everyone from the lab to the clinical research Site, and everyone in between. Many positions will change dramatically; others will simply disappear. Mr. Neal will address all this and more in this timely presentation.
Society for Clinical Research Sites,USA
Keynote: The Site Landscape
Time : 09:25-09:50
Diana is a consultant to the Society for Clinical Research Sites as their Vice President of Strategy and Development and in that role is responsible for building relationships with industry that help amplify the voice of the clinical research site. Diana has addressed audiences across five continents, published multiple papers and articles, and written five authoritative industry books including global issues in patient recruitment and retention, the highly anticipated sequel to international patient recruitment: Regulatory guidelines, customs and practices. The books serve as teaching tools for colleges and universities, along with her earlier works: A guide to patient recruitment, a guide to patient recruitment and retention and 50 ways to cope with arthritis. Her personal honors include recognition by the Global EXEC Women’s International Council as a 2009 International Woman of Influence, being named a finalist for Ernst and Young’s Entrepreneur of the Year Awards in 2008, and an induction into the 2006 PharmaVOICE “100 Most Inspiring People in the Life-Sciences Industry.
Gain insight to new site trends and metrics to position sites for success. Current data related to sites’ financial health, reimbursement, and cost of doing business will be unveiled. Learning from big data sets on site performance is not previously available. This information will enable sites to understand how they measure up and to make meaningful
A3 Pharma Counselling Ltd, UK
Keynote: Towards more Clinically relevant outcome measures in Cancer, multi-system syndromes and Patient Safety
Time : 09:50-10:15
Dr Ayad Abdul-Ahad, MD, PhD, FRCPath, is a physician specialised in Oncology, Immunology and Haematology. He trained in various teaching hospitals in the United Kingdom. He has spent the last 25 years in drug Development and Medical Affairs. Ayad has built and led teams across the Pharmaceutical and Biotechnology industries in the US and Europe that managed the clinical development and medical affairs for several drugs in Oncology, Neurology, Pain, and Immunology
More clinically relevant outcome measures are greatly needed to allow physicians, health authorities, Healthcare providers and patients to make robust therapeutic choices. 21st Century therapeutic decisions need to into account many factors such; increasing complexity of drugs, personalised medicine, and the demands of Healthcare providers for proof of cost effectiveness, the impact on the quality of life, & patient reported outcomes. Rapid scientific advances are leading to the development of new drugs that are usually more expensive, thus increasing the pressure on budgets and demands for more evidence based medicine. Hence, the increasing the need for more clinically relevant outcome measures to assist in choosing the right drugs. These outcome measure should take into account; the impact on the Natural History of Cancer and other conditions, & the burden of drugs on patient safety and quality of life. Clinical trials data are the basis for therapeutic decisions. However, some outcome measures do not provide the robust basis to make these decisions In Cancer, time to clinical progression, MRI progression, surrogate marker progression are analysed separately. No collective impact on the Natural History of Cancer is measured. The data collected after progression, is not usually presented. Safety data are reported as an absolute list or summary with the number of patients with a specific AE. No identification patients who experience more than one AE contemporaneously, consecutively or the combination of incidence and severity and their impact on patients. I will present a new outcome measure utilising collected data that that aims to help these needs.
Symphony Clinical Research, USA
Time : 10:15-10:40
Nicki Norris is the CEO of Symphony Clinical Research, a provider of specialized in-home and alternate-site clinical services. She has more than 30 years of experience as a Healthcare Executive. She has spent 20 years at Baxter, lead a high growth dialysis company; a blood collection/processing organization; and a Gold-Standard Laboratory accrediting organization. She has an MBA from the UofI Urbana-Champaign, passed the CPA exam, and serves as a VP of the Chicago chapter of the HBA. She has spoken at dozens of industry conferences (DIA, Outsourcing, Innovations in Clinical Trials, Center Watch, Site Solution Summit, SCOPE, CBI Rare Disease and NORD conference on Rare Diseases).
Each year thousands of patients drop out of clinical trials for any variety of reasons. Though some dropouts are a result of uncontrollable circumstances, many others are preventable. With over 85% of trials failing to retain enough patients, it is clear, more can be done to boost subject retention. This session will outline a few of the many reasons to subject drop-outs occurring. We will identify innovative approaches for improving subject retention, and risk mitigating strategies for minimizing its impact on study validity. This session will also discuss techniques used within phase 2, phase 3 and open label extension studies to decrease the number of missed visit time-points. Lastly, this session will offer metrics demonstrating the impact of in-home and alternate site clinical services on the number of missed visits, subjects lost to follow-up and overall retention.