Day 2 :
Objective Clinical, USA
Time : 09:00-09:25
Colleen is the CEO of Objective Clinical which is a clinical research strategy and management firm located in the Nashville Tennessee area that supports clinical research leaders in strategic and financial planning, regulatory compliance and optimization of research operations. She brings 25 years of experience in development, management and operational direction of clinical research organizations. She has held senior positions with international clinical research organizations (CROs) including specialty CROs. She served as a committee member for International Business Communications on their Speakers Board for healthcare administration topics, as a Biotechnology Advisory Member for Bates Technical College in Tacoma Washington, and a Board of Director member for Seattle’s Children’s Home. She has been a presenter at ACRP. Colleen is a graduate of the University of Tennessee, College of Business.
The primary focus of clinical research is advancing science and to improve health outcomes. However, for a site or network to have ongoing success and support across the enterprise, the research program also must support overall business goals. There is a methodology to choosing the right clinical trials and the right technologies that fosters efficiency, productivity and enhanced compliance. Optimal study mix selection examples based on the research program’s attributes and goals will be presented and we will discuss how current and emerging offerings can help. Case studies include:
eConsent: This technology offers higher efficiency, consistency and quality with improved participant empowerment and understanding. Success depends on well managed implementation and staff adoption and transition from legacy processes.
Mining EMR with Objective Criteria: The monitoring and analysis of records can help identify qualified patients with less co-morbidity. Understanding the potential to enhance study success through better matching of sites and sponsors by using carefully selected enrollment criteria, while recognizing the challenges of medical data input quality within the EMR.
Wearable’s & ePRO Data: These emerging technologies offer dramatic potential to capture timely research data remotely and continuously, reducing the facility and labor costs and the overall study time required for on-site trials.
Remote Monitoring: Embracing the time saving benefits for data collection by remote monitoring, while ensuring the clarity of the roles of the clinical study team, is key to making this technology and practice work well.
Independent Consultant, USA
Keynote: Liver Let Die – Challenges and Opportunities in Developing Interventions for Fatty Liver Disease (NAFLD/NASH)
Time : 09:25-09:50
Clayton Dehn is a research physiologist with expertise in metabolic disorders. He is the co-inventor of a process and substance for disturbing the inheritance pattern of ion-channelopathic disorders, and the sole author of the first publication cautioning against the risk of SGLT-inhibition inducing ketoacidosis in insulinopenic populations. He serves on the editorial board of four peer-reviewed journals, and has served by gubernatorial appointment on the Arizona Biomedical Research Commission.
Non-Alcoholic Fatty Liver Disease (NAFLD) is a chronic metabolic disorder marked by excessive fat accumulation in the liver that may affect as much as 30% of the population. It is not related to alcohol consumption or viral infection. NAFLD may progress to Non-Alcoholic Steatohepatitis (NASH) and hepatocellular carcinoma (HCC). NASH was first named and described in a 1980 review of 20 Mayo Clinic patients. NASH is expected to overtake all other indications as the leading cause of liver transplantation in the next ten to twenty years. Although this is a serious emerging health concern that has been described as the next global epidemic, there are currently no medications specifically approved for treating NAFLD/NASH. Until recently drug development in this space was stifled by the lack of a clear pathway to approval, necessitating outcomes trials. In 2015 the Food and Drug Administration (FDA) and the American Association for the Study of Liver Diseases (AASLD) published a manuscript of their joint workshop suggesting the acceptance of pragmatic surrogate biomarker endpoints such as the reversal of steatohepatitis with no evidence of progression to advanced fibrosis. Three years ago a Deutsche Bank report projected a peak NASH market opportunity of 35 - 40 billion dollars by 2025. Consequently, NAFLD/NASH interventions are becoming increasingly prevalent in drug development pipelines.
Ethicare Clinical Trial Services, India
Time : 09:50-10:15
Milan C Satia is a PhD in Pharmacology with more than 22 years of experience working across the local pharma majors and CRO industry, playing key leadership roles. He has led operations at R&D for a pharma major and CROs, setting up of a Pharmacokinetic cell within technology center, managed client relationship, and has led teams of expert and played important role in contributing to strategies, developing new business opportunities and to provide scientific knowledge base. He is having a wide knowledge base and experience of varied facets of pharmaceutical research including pharmacology, toxicology, bioavailability and bioequivalence studies, clinical trials, medical writing and exposure to various international audits. He is also a conversant with regulatory framework globally and a crucial Member for setting up of CROs in India. Currently, he is a CEO of Ethicare Clinical Trial Services since 2009 and located at Ahmedabad, India. He is providing services from Phase I to Phase IV clinical trials along with data management services.
Clinical trials using human subjects are an integral part of the approval of new drugs and biologics. About 40% of clinical trials out of total trials registered in USA took place in emerging nations of Asia, Latin America and Africa. At the same time, clinical trials have become increasing costly ventures apart from its complex conduction, adding to the overall cost of developing a drug and, ultimately, the price that patients pay for drugs. The requirement of large sample sizes and the potential for fast recruitment leading to a speedy completion of clinical studies are probably the most important factors that have fueled globalization of studies. While an enlarged clinical trial universe certainly benefits patient recruitment and diversity, it also multiplies the operational and strategic obstacles that clinical trial professionals must circumvent. In addition to inexperience in conducting trials and differing quality standards, there are wide spread differences from country to country in customs knowledge, experience and laws. Other challenges include the need to manage logistics complicated by countries with limited infrastructure as well temperature sensitive biologics, especially outside major cities. There are regional idiosyncrasies -- differences of language, both spoken and unspoken, working patterns, culture and religion -- that add another layer of complexity. Above all, a high level of co-ordination between participating centers across the globe is a different level of challenge one has to handle. Big pharmas and small biotechs alike are looking for innovative ways to improve trial outcomes and, in turn, lower trial costs-this means increasing the efficiency in which they recruit patients, monitoring more closely how drugs are supplied and being more flexible about trial design. Pharmaceutical companies and some academic cooperative groups have been conducting challenging, large pivotal registration studies with multinational participation. Most importantly, the process of expanding the network of clinical research sites also fosters the integration and the development of closer relationships among investigators at a global level. Reduced operational costs and the ability to expedite the regulatory approval of drugs in various countries or regions are also important drivers. Some of the tools that are optimizing clinical trials today and help in overcoming current challenges will be discussed.
Harvard Medical School and VA Boston Healthcare System, USA
Keynote: Streamlining Clinical Trial Conduct in a National Healthcare System – Towards Pragmatic Cardiovascular Clinical Trials
Time : 10:15-10:40
Dr. Jacob Joseph is an Associate Professor of Medicine at Harvard Medical School and faculty in the Cardiovascular Divisions of Veterans Affairs Boston Healthcare System and Brigham and Women’s Hospital. He has published over 80 articles and edited a book. Dr. Joseph is a clinical trial leader of national VA consortia for major international clinical trials; and a member of the Executive Committee of the NIH-funded Influenza Vaccine to Effectively Stop Cardio-thoracic Events and Decompensated Heart Failure (INVESTED) trial, and the Steering Committee of the international Pemafibrate to Reduce cardiovascular OutcoMes by reducing triglycerides IN patiENts with diabeTes (PROMINENT) trial.
Pragmatic clinical trials (PCTs) aim to reduce the burden on patients, investigators and the clinical research ecosystem, without losing effectiveness compared to traditional or explanatory clinical trials. Various elements of a clinical trial can be “pragmatized” depending on the therapeutic hypothesis being tested. The Veterans Affairs Healthcare System (VAHS) offers unique resources for conduct of cardiovascular clinical trials including a large patient population with cardiovascular disease, a nationwide database with advanced search capabilities to identify eligible participants at participating sites, a pool of highly experienced investigators and study coordinators, established support services including research pharmacists and research administration, and a strong institutional commitment to conduct of research. We are leading an effort to streamline the conduct of traditional clinical trials in the VAHS by a focus on centralization, pragmatization, and innovation. We are pioneering a centralized approach to identifying sites, contracting and payments, and regulatory approvals to streamline trial onboarding for sites and trial sponsors. We have utilized the national VA database to identify lists of potential subjects at each VA site to enhance recruitment. In addition, a fully pragmatic trial funded by the VA with centralized patient recruitment and follow-up is also underway. Overall, a national healthcare system with a comprehensive and connected patient care database has the potential to revolutionize clinical trials and make them more pragmatic and less costly without losing effectiveness to answer key therapeutic questions. In addition, the Million Veteran Program also offers the opportunity to conduct trials of personalized medicine based on genotype-phenotype correlations.