Scientific Program

Conference Series Ltd invites all the participants across the globe to attend 4th International Conference on Clinical Trials San Antonio, Texas, USA
(10 Plenary Forums - 1 Event).

Day 1 :

Keynote Forum

John P. Neal

PCRS Network, LLC, USA

Keynote: The Future of the Clinical Research Industry
Clinical Trials 2017 International Conference Keynote Speaker John P. Neal photo
Biography:

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.

Abstract:

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.

Keynote Forum

Diana L Foster

Society for Clinical Research Sites,USA

Keynote: The Site Landscape
Clinical Trials 2017 International Conference Keynote Speaker Diana L Foster photo
Biography:

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.

Abstract:

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 

Clinical Trials 2017 International Conference Keynote Speaker Ayad Abdul-Ahad photo
Biography:

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

Abstract:

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.

Keynote Forum

Nicki Norris

Symphony Clinical Research, USA

Keynote: Novel techniques for improving clinical trial subject retention
Clinical Trials 2017 International Conference Keynote Speaker Nicki Norris photo
Biography:

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).

Abstract:

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. 

  • Sessions / Tracks:
    Clinical Research & Clinical Trials | Conducts of Clinical Trials | Patient-Centric Clinical Trials | Research and Trials on AIDS / Cancer / Diabetes | Clinical Trials on different Diseases | Clinical Data Management and Statistics | Innovations & Future of Clinical Trials | CRO/ Sponsorship Clinical Trials | Pharmacovigilance and Drug Safety
Speaker

Chair

Oleg V Tcheremissine

Carolinas HealthCare System, USA

Speaker

Co-Chair

Sarah Attwood

IntegReview IRB, USA

Speaker
Biography:

Oleg V. Tcheremissine, MD, is a Professor of Psychiatry and Research Director for the Carolinas HealthCare System Department of Psychiatry and Behavioral Sciences. He is a board-certified Psychiatrist and Clinical Investigator with more than 25 years of medical and more than 20 years of research experience in human behavioral and clinical psychopharmacology. Dr. Tcheremissine has successfully combined his research interest, teaching, clinical, and administrative responsibilities while focusing on eliminating external and internal barriers to development of novel and innovative treatments with the overall goal of reducing health disparities, improving access to care and increasing the generalizability of clinical trials results.

Abstract:

Alzheimer’s Disease (AD) is a progressive neurogenerative disorder with a wide range of symptoms affecting memory, concentration, volition, and almost all aspects of human behavior. The prevalence of patients with AD is increasing due to an aging population. There is real possibility that without medical breakthroughs, the current 5.3 million Americans diagnosed will triple to 13.8 million by 2050. Delivery of compressive care is facing a crisis stemming from a combination of factors -- a growing demand for such care, insufficient number of those specialized in this therapeutic area, rising costs of care, the complexity of the diseases and lack of effective treatment. Despite massive research efforts in recent decades, new treatments for AD remain elusive. Since 1998, there have been more than 100 attempts to develop new pharmacological agents, and all have failed. Patient population included in these clinical trials typically suffered from mild-moderate AD. Most of them were initially diagnosed and treated by their primary care providers. Early identification of a cohort of those who will benefit from clinical trial participation by is a strategic priority. CHS has made an investment in developing a comprehensive dementia care though a collaboration of different service lines including Neurosciences, Behavioral Health, Primary Care and Geriatrics. This bidirectional reciprocity allows to align the process of drug development with information derived at the “point of care”, and provides an opportunity to further breech the “efficacy-effectiveness” gap, commonly defined as the differences between two populations of patients, those enrolled in clinical trials and those who will be treated in real clinical settings.

Speaker
Biography:

David is a well-known leader and change agent in the clinical research industry.  He lives outside Nashville, TN where he involves himself in work, family life and other charitable and entrepreneurial opportunities.

Abstract:

Over the past several years there has been a resurgence of efforts to gain access to investigational products outside of clinical trials.  Previously failed attempts a decade or so ago at the federal judicial level has turned advocates’ strategy to pushing states to pass variants of so-called “Right To Try” laws in an effort to circumvent the FDA’s Expanded Access policies.  Over the past several years, a majority of states have now done so.  While ethicists debate the battle of the good vs. the good of this kind of access, and lawyers debate the state’s rights to have these kind of laws, the FDA and the advocates debate their respective track records.  Nevertheless, the issue has gotten the attention of the federal legislators through passed acts (evidenced by certain section in the 21st Century Cures Act) as well as putting forth proposed legislation for a national Right To Try Act.  With the current congress and the executive branch leaning towards the advocates’ position, it is likely that we will see continued movement.  This session provides a comparison of the varying state “Right To Try” laws and summaries of the most recently passed and proposed federal laws related to this topic.

Speaker
Biography:

Valerie G Sams completed her fellowship in trauma and surgical critical care at San Antonio Military Medical Center (SAMMC), San Antonio, Texas in 2015. She is a trauma and general surgeon at SAMMC and an extracorporeal membrane oxygenation (ECMO) provider. She has published more than 15 papers in reputed journals and is active in multiple funded research projects.

Abstract:

Hyphema is blood that is grossly visible in the anterior chamber of the eye and can cause permanent vision loss. It is a rare complication that usually occurs after ocular trauma. Spontaneous or nontraumatic hyphema may result from underlying bleeding disorders, anticoagulation or antiplatelet medications, vascular malformations, ocular abnormalities, closed-angle glaucoma, sickle cell anemia, acute leukemia, rheumatologic disorders, or lymphoma. Rarely, spontaneous hyphema may present after non-ophthalmic surgery due to intra-operative heparin administration, coagulopathy, severe hypertension, or during emergence from anesthesia. Here we present a case of a man with acute respiratory distress syndrome (ARDS) as a result of Influenza B infection who underwent lung protective mechanical ventilation strategy, sedation, paralysis, and prone positioning to assist with oxygenation. This is the first reported case of non-traumatic hyphema in a patient undergoing prone positioning as part of the management of ARDS. We postulate that the patient’s thrombocytopenic state coupled with the increased venous drainage pressure in the eyes from the face-down prone positioning likely led to his development of bilateral spontaneous hyphemas. Positioning his head to the side normalized venous drainage pressure and allowed rapid reabsorption of the anterior chamber blood. Hyphema should be considered a potential complication of prone positioning in patients with ARDS, especially in patients with a concomitant bleeding diathesis. In our patient, early recognition and medical intervention led to complete resolution. Ophthalmology evaluation and management is important for successful recovery. 

Speaker
Biography:

Richard Entsuah is a Fellow of the American Statistical Association. He completed his PhD from University of Michigan. He was an Assistant Professor of Biometry at University of Illinois in Chicago. He joined Wyeth Research from 1988 to 2007 and left as an Assistant Vice President of Global Biostatistics and Programming. He joined Merck Research Labs as Executive Director of Late Development Statistics and is the Research Group 4 Head for Neuroscience and Respiratory of and Immunology. 

Abstract:

In the area of pharmaceutical drug safety, one of the primary goals in analysis of adverse events (AEs) is to detect any signal of a difference between the treatment and control groups. Traditionally, crude incidence rate, chi-square test or Fisher's exact test, and Miettinen and Nurminen are the useful methods in analysis of single AE data depending on what level of importance it belongs to, such as Tier 1, Tier 2, or Tier 3, which were defined by Merck. Actually, the occurrence of AEs is very complicated. Simple measurement of AE data without enough information including duration effect, severity effect, or recurrent event, the estimation and inference could be biased. Moreover, multiple AEs within the same system organ class (SOC) are usually correlated with each other. So analysis of single AE over simplifies comparison among treatment arms in drug safety. In this presentation, we would like to propose a new class of distribution-free approaches to address the effects of duration, severity, and recurrence of AE data by using a new measurement within certain specified class. The good asymptotic properties and robustness for the proposed models have been shown in this study. The numerical simulation studies and a case study example are provided for illustrations. 

Joann Pfeiffer

Arizona State University, USA

Title: Management of clinical trial agreements
Speaker
Biography:

Joann Pfeiffer completed her Doctorate of Science, in Regulatory Science from the University of Southern California. She is currently the Director and an Associate Professor, in the Clinical Research Managment Graduate Program at Arizona State University. She has published several books related to managing contracts and budgets in clinical trials, conducting clinical trials at study sites, as well as articles in peer reviewed journals. Her expereince includes over 20 years in the management of clinical trial operations in both academic and non-academic settings. 

Abstract:

Clincal trial agreements are legal and binding, forming the foundation for a successful partnership between study sites and sponsors. Not understanding the legal language and the terms of the contract can lead to financial and legal ramifications for the site, the investigator, and study staff. Terms and language of the contract will be reviewed focusing on risk areas and protecting the site. Through interactive activities participants will review and revise contract language to meet the needs of the site. Proper management of contracts includes knowing what you are agreeing to, prioritizing site needs, and utilizing site metrics and successful strategies to negotiate a fair and balanded contract. Strategies include redlining contracts with preferred language, naming and version control, reviewing related study documents for consistency, contract definitions, addressing the responsibilities of the contract parties, and asking questions for clarification. The session will finish with contract tips.

Speaker
Biography:

Manuel Castro has been with Carolinas Healthcare System for 9 years and serves as the Vice-Chief Department of Psychiatry, Medical Director of Behavioral Health Integration, and Assistant Medical Director of outpatient medication services. In 2016 he was honored to become a Fellow for the American Psychiatric Association. He leads the Behavioral Health Integration team in servicing ambulatory care practices across the healthcare system through a virtual platform. He is Board certified in adult psychiatry. He is the recipient of the Brian R Nagy MD teaching award at CMC-Randolph and is an adjunct Associate Professor of psychiatry with UNC-Chapel Hill. 

Abstract:

In March 2014, the Behavioral Health Service Line within Carolinas HealthCare System launched a transformative integrative care model utilizing virtual and population health management tools to reach out to patients with behavior health symptoms through ambulatory care settings (primary care, internal medicine, and pediatric clinics). The goal of the collaborative care initiative is to improve access to behavioral health services by providing evidence-based, innovative, timely, seamless and coordinated care that meets patients’ individual needs; by increasing the detection of mental illness through appropriate screening; increasing access to behavioral health coaching; providing treatment and medication oversight, improving clinical outcomes; strengthening relationship with ambulatory care providers; decreasing avoidable healthcare utilization and achieving higher rates of treatment adherence; while decreasing the overall cost of care overtime. In 2016, the program achieved a dramatic 43% decrease in depression (PHQ-9) and 38% decrease in anxiety (GAD-7) symptoms scores. 49% of the patients achieved 50% or more reduction in their raw depression scores as a result of telephonic health coaching. Over 80% of the program participants with suicidal ideations at baseline denied suicidal ideations at the completion of the program. Through implementation of the virtual model, ambulatory care clinics have immediate access to behavioral health services via video technology and other resources. Thus, assessment and treatment planning can begin immediately, and follow-up care can be coordinated between the behavioral health team and medical providers all in one visit. 

Speaker
Biography:

Sarah brings to IntegReview IRB over 20 years of experience in Operations and Business Development in clinical research and is currently Director of Client Services. Prior to joining IntegReview, Sarah was the Vice President for a research site organization. She was responsible for the clinical operations of their multiple Phase I – IV clinical research sites and developing the CRO business to provide project management and monitoring services. Prior to management, Sarah has held various positions including Clinical Research Coordinator, CRA, Project Manager and Consultant for CROs and Sponsors and has a background in hospital research, pharma, medical devices, nutraceuticals and biotech. 

Abstract:

Have you considered how the revisions to the common rule may affect your next research project? There are a number of questions circulating on how these changes will be implemented effectively and efficiently within the academic communities and other institutions, but also the impact that they may have on all industry sponsored research. Important elements in the final rule issued include: The requirement for consent forms to provide potential research subjects with a better understanding; requirements, in many cases, to use a single institutional review board (IRB) for multi-institutional research studies; for studies on stored identifiable data or identifiable biospecimens, researchers will have the option of relying on broad consent obtained for future research as an alternative to seeking IRB approval to waive the consent requirement; the establishment of new exempt categories of research based on the level of risk they pose to participants; removal of the requirement to conduct continuing review of ongoing research studies in certain instances where such review does little to protect subjects and requirement that consent forms for certain federally funded clinical trials be posted on a public website. This session will look at the changes and discuss the impact on human subject protection, informed consent for research sites and IRBs.

Speaker
Biography:

As the Vice President of Compliance, Melanie is responsible for the daily leadership, management and full responsibility for the Company’s compliance program. Melanie has worked in the IRB industry since 1999 and has been with IntegReview since 2001. Prior to leading the Regulatory Compliance Department, her main focus for 9 years was spent providing training to IRB staff and IRB members to ensure compliance with Federal Regulations, ICH Guidelines, IntegReview IRB Standard Operating Procedures and standards of the AAHRPP.

Abstract:

Have you considered how the revisions to the common rule may affect your next research project? There are a number of questions circulating on how these changes will be implemented effectively and efficiently within the academic communities and other institutions, but also the impact that they may have on all industry sponsored research. Important elements in the final rule issued include: The requirement for consent forms to provide potential research subjects with a better understanding; requirements, in many cases, to use a single institutional review board (IRB) for multi-institutional research studies; for studies on stored identifiable data or identifiable biospecimens, researchers will have the option of relying on broad consent obtained for future research as an alternative to seeking IRB approval to waive the consent requirement; the establishment of new exempt categories of research based on the level of risk they pose to participants; removal of the requirement to conduct continuing review of ongoing research studies in certain instances where such review does little to protect subjects and requirement that consent forms for certain federally funded clinical trials be posted on a public website. This session will look at the changes and discuss the impact on human subject protection, informed consent for research sites and IRBs.

Speaker
Biography:

Chris Chan is Executive Director of R&D Finance at FibroGen, Inc, and has over 25 years industry experience, including 20 managing clinical trial and R&D finances for biopharmaceutical companies of various sizes. He holds an MBA from UC Berkeley’s Haas School of Business and is a Certified Management Accountant (CMA) and Certified Financial Manager (CFM). He has served as speaker and chair at numerous industry conferences, and has authored multiple published articles on clinical trials budgeting, accruals, and outsourcing.

Abstract:

Like many marriages, the sponsor/CRO relationship is often fraught with strife and adversity. These conflicts typically center around issues including lack of good communications, misaligned expectations, and other common challenges. This presentation explores common pet peeves frequently observed and experienced by both sides. Real-life case studies/anecdotes from various companies will be used and respective conflicts and resolutions will be examined in detail. Common lessons learned that may be applied to current and future sponsor/CRO relationships will be discussed.

Speaker
Biography:

Brian is principal and vice president at Tanner-Ibbotson, Inc, an insurance brokerage located in the Northeast part of the United States. With a focus on providing insurance solutions for pharmaceutical and medical device companies, he brings over a decade of experience in the industry. His practice helps companies procure insurance both domestically and internationally. Brian hold bachelors’ degrees in business administration and polical science from Pepperdine University in Southern California. 

Abstract:

A key component of international clinical trials that is often overlooked is insurance considerations for the country where the study will be performed. Failure to comply with jurisdictional or IRB insurance requirements can delay approval for the start of a trial. In drug development, any delay could cost the sponsor millions of dollars. Having the proper insurance program structure is also critical to avoid any gaps in protection.  Working with a qualified insurance broker that has key relationship with global insurance companies is critical.  A proactive approach and understanding of the parameters of insurance procurement for global clinical trial will produce a well managed clinical trials insurance process as it relates to efficiency, affordability, protection and ease of administration.  

Speaker
Biography:

With over 30 years experience in scientific and business computing Michael is a recognized leader in visualization technology worldwide. He created the oil industry’s first commercial 3D visualization center. He received the Carnegie Mellon and American Management Institute Award for Innovation in Information Technology. His work was honored with a permanent position in the Archives of the Smithsonian Institution. He founded Magic Earth, LLC. in 2000, and as Chairman and CEO, achieved profitability in three months and was acquired by Halliburton that same year for $100 million. Michael holds a B.Sc. in Earth and Space Sciences and M.Sc. in Marine Environmental Science from the State University of New York at StonyBrook.

Abstract:

TBD

Speaker
Biography:

Amanda Brock has completed her Master of Bioethics and Master of Science in Nursing at the University of Pennsylvania. She has ten years’ experience in direct patient care including inpatient and outpatient, nursing administration, and clinical research.  She is experienced in leading committee work and creating nursing policies. She is a firm believer in systems thinking and the importance of clear and thoughtful communication in clinical care.

Abstract:

Integration of Palliative Care into oncology care has been a challenge since the inception of palliative care programs. Phase 1 oncology clinical trial participants are considered a distinctly vulnerable population. They are at high risk for lack of follow through by the healthcare system after being withdrawn from the clinical trial. In addition, they are at risk for therapeutic misconception and major challenges associated with dual enrollment on the trial and hospice programs. Patients with dual enrollment in palliative care and phase 1 trials could live longer lives, remain on trials for longer, have higher rates of advance directive completion, and may be more likely to die comfortably at home.  Palliative Care consultation upon Phase 1 trial enrollment can could improve the quality of the research being conducted as well as improve Quality of Life for trial participants.

Speaker
Biography:

Lauren Ballina has a degree in Psychology and Masters in Biomedical Science. She is a SOCRA-certified CRC. She coordinated clinical trials at the University of North Carolina at Chapel Hill and The Mayo Clinic Arizona. She is currently the National Program Director at Clinical Research Fastrack. She is a natural educator and passionate about making the field of clinical research a respectable profession and not just a job

Abstract:

The varying level of knowledge, competency, and professionalism of clinical research coordinators at the site level is problematic in clinical research. The role of clinical research coordinator (CRC) is a technical position requiring working knowledge of ICH GCP and the Code of Federal Regulations. CRCs are required to collect and document data appropriately and accurately. Their work can have direct impact on the efficiency and quality of a trial. Of 60 current clinical research professionals surveyed, 4 (7%) reported purposefully seeking a position in clinical research. The remaining 56 reported that they “fell into clinical research” and stayed because the field is so rewarding. All reported on the job training in their entry-level position as inconsistent and incomplete. Many felt overwhelmed in their first position and that experience and mistakes have been their best teachers.

Clinical Research Fastrack (CRF) has sought to standardize entry-level training for CRCs. By delivering a robust curriculum focused on ICH GCP, Code of Federal Regulations, protocol, good documentation practices, adverse events, protocol deviations, clinical trial operations, participant recruitment and retention, responsibilities of study team members including PI, informed consent, and research skills all coupled with a hands-on internship at a clinical trial site, CRF is re-inventing the entry-level CRC. Through training standardization, and utilizing an innovative educational approach of “massed practice” CRF is helping transform the role of coordinator to a profession and not just a job. As more well-trained individuals obtain positions in the field, the industry as a whole will benefit.

Xichun Sun

Virginia Commonwealth University School of Medicine, USA

Title: Cancer Metastasis: Enactment of the Script for Human Reproductive Drama
Speaker
Biography:

Dr. Xichun Sun is a practicing surgical pathologist and cytopathologist.  He graduated from medical school in China.  He completed his Ph.D, postdoctoral and residency training and fellowships in the USA.  His current research interest centers about cancer diagnosis, carcinogenesis and cancer metastasis.  He is the author of one monograph and has proposed a new theory on cancer metastasis.

Abstract:

In parallel to the appearance of primordial germ cells during early embryogenesis, the cancer reproductive saga starts with the separation of metastasis initiating cells (MICs) from cancer initiating cells when the primary cancer is still in its infancy.  Prime MICs embark on a journey to the host bone marrow where they undergo further development and regulation.  Migrating MICs are guided by the same CXCR4/CYCL12 axis as used in the migration of primordial germ cells to the genital ridge.  Like the ovary, the host bone marrow features immune privileges, coolness, hypoxia and acidity which are essential for stemness maintenance and regulation. Opportune activation of the MICs via fusion with bone marrow stem cells triggers a frenzy of cellular proliferation and sets them on the move again.  This scenario is akin to oocyte fertilization in the Fallopian tube and its subsequent journey towards the decidum.  Just as the human reproductive process is plagued with undesirable outcomes so is the cancer metastasis highly inefficient.  The climax of the cancer metastatic drama (colonization) is reached when proliferating MIC clusters attempt to settle down on decidum-like premetastatic sites.   Successfully colonized clusters blossom into overt macrometastases only after the execution of sophisticated immunomodulation, angiogenesis and vascular remodeling.  Similarly, the implanted blastomere needs to orchestrate these feats before flourishing into a new life.  What is more, the cancer reproductive drama seems to be directed by a primordial Hypothalamus -Pituitary -Gonad axis. Pursuing this reproductive trail could lead to new frontiers and breakthroughs in cancer research and therapeutics. 

Speaker
Biography:

Abstract:

In 1972, Charles Fried, in Medical Experimentation: Personal Integrity and Social Policy asserted that physician-researchers have an ethical obligation to be in a state of equipoise during all stages of randomized clinical trials. Fried’s equipoise requirement dictates that a physician engaged in research must not believe that one experimental arm of a randomized clinical trial is better or more efficacious than the other arms (must be in a state of equipoise). Although the equipoise requirement has been modified over the course of the last 45 years, the equipoise requirement is currently the fundamental or guiding principle concerning the ethics of enrolling patients in randomized clinical trials. In this talk I will discuss the ethical foundation for the equipoise requirement, what is the current equipoise requirement and ethical/practical problems associated with the equipoise requirement.

Speaker
Biography:

Raj Bandaru heads a data analytics and knowledge management function in Translational Informatics at Sanofi Pasteur. He is championing the adoption of cloud and big data analytics at Sanofi, bringing advances in clinical research together with big data and digital technologies. Over the past two decades, he has led data management and analysis across research and clinical development at various pharmacy and biotech companies and most recently led a data and analytics consulting practice. He has an MBA from Babson College, with a focus on clinical informatics and operations research and also holds graduate degrees in statistics and genetics.

Abstract:

Like much of the pharmaceutical industries, we at Sanofi are also experiencing a shift in clinical development strategies to adopt more digital technologies and analytics placing greater emphasis on data and model driven approaches. We have set up a strong integrated capability across quantitative systems models, disease progression models and empirical models driving a rigorous clinical trial simulation process to inform design and key decisions in our clinical research. To this end, access to historical clinical trial data has been central. However, using clinical study data for broader clinical research use has several limitations and challenges. We are implementing several processes and intelligent informatics solutions to enable easier access to clinical study results and conducting integrated analytics using state of the art methods and tools. Here we describe some of the informatics solutions we are developing and how these could eventually be applied to support trial submission activities. One example is in the use of a machine learning methods to index data and make it searchable without compromising data security or patient privacy. We are also applying intelligent approaches to data de-identification and harmonization across multiple studies to support meta-analysis. A pilot effort using a learning based approach to data harmonization has shown significant promise and we are exploring other applications including management of metadata and terminologies using machine learning approaches. Some challenges however still exist primarily in the governance of data access and patient privacy issues. We are working on developing clear rules and guidelines that will eventually also help with automating data governance activities. Another challenging area will be in handling genomic and digital health data and we foresee an opportunity for automated machine learning algorithms to help in not only managing the data, but to also discover patterns and associations to clinical outcomes.

Speaker
Biography:

Mohsin Shaikh has completed his MD from M.S. University, Gujarat and postgraduate studies from AAPS Toronto. He is a lead clinical data manager at Axiom Real-Time Metrics, a premier clinical data management service organization providing expert solutions into the EDC/DM/IWRS sector. He has published more than 15 papers in reputed journals and has been serving as an editorial board member of Repute. Mohsin is an international medical graduate with more than 8 years of experience in Clinical Research Industry mainly in Clinical Data Management. 

Abstract:

An Effective eCRF design is always key to the successful outcome of a clinical trial.

The main objective is to offer improved data quality, online discrepancy management, faster database lock and at the same to time preserve and maintain quality and integrity of the data. eCRF design should be standardized to address the needs of all user roles enrolled within the Clinical Trials. Data should be organized in a format that facilitates and simplifies data analysis for submission. Review of the primary and secondary study end points as well as well-planned study design and safety/efficacy outcomes will assist the process of effective eCRF designing. Use of CDISC standards variables will also enhance the process of effective eCRF building. Effective measures taken while conducting eCRF design as well as post production changes (changes deployed on production environment of the eCRF design) will result in reduced query generations and improved data integrity. This presentation will also describe the methods of CRF designing in clinical research and discusses the challenges encountered in this process.

Speaker
Biography:

Thiago M. Sakae has completed his PhD at the age of 32 years from Federal University of Santa Catarina, South Brazil and postdoctoral studies from University of Southern Santa Catarina – UNISUL, Brazil. He is the anesthesiologist and epidemiology professor at UNISUL, an University in Southern Brazil. He has published more than 130 papers in reputed journals and has been serving as an editorial board member of repute. 
 

Abstract:

Objective: The purpose of this study was to evaluate the effect of intravenous or perineural dexamethasone added to ropivacaine on the duration of ultrasound-guided interscalene brachial plexus blocks (BPB).

Methods: Randomized Clinical Trial. Setting, Patients and Interventions: Sixty ASA physical status I−II patients with elective shoulder arthroscopic surgeries under interscalene brachial plexus blocks were randomly allocated to receive 20 ml of 0.75% ropivacaine with 1 ml of isotonic saline (C group, n = 20), 20 ml of 0.75% ropivacaine with 1 ml (4 mg) of perineural dexamethasone (Dpn group, n = 20), or 20 ml of 0.75% ropivacaine with 1 ml of isotonic saline and intravenous 4 mg dexamethasone (IV) (Div group, n = 20). A nerve stimulation technique with ultrasound was used in all patients.

Measurements: The onset time and duration of sensory blocks were assessed. Secondary outcomes were pain scores (VAS) and postoperative vomiting and nausea (PONV).

Results: The duration of the motor and sensory block was extended in group Dpn compared with group Div and group C (P<0.05). In addition, within 24 h, group Dpn presented lower levels of VAS and lower incidence of PONV as compared with the other groups. Moreover, there was a significant reduction on onset time between group Dpn and the other groups.

Conclusions: Perineural 4 mg dexamethasone was more effective than intravenous in extending the duration of ropivacaine in ultrasound-guided interscalene BPB. Moreover, Dpn has significant effects on onset time, PONV, and VAS.

  • Special Session:
    An Open Dialogue With Sites About Streamlining The Startup Process
Speaker

Chair

David Vulcano

HCA Healthcare, USA

Session Introduction

Diana L Foster

Society for Clinical Reseaarch Sites (SCRS), USA

Title:
Speaker
Biography:

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.

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JoAnn Pfeiffer

Arizona State University, USA

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Speaker
Biography:

Joann Pfeiffer completed her Doctorate of Science, in Regulatory Science from the University of Southern California. She is currently the Director and an Associate Professor, in the Clinical Research Managment Graduate Program at Arizona State University. She has published several books related to managing contracts and budgets in clinical trials, conducting clinical trials at study sites, as well as articles in peer reviewed journals. Her expereince includes over 20 years in the management of clinical trial operations in both academic and non-academic settings. 

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Colleen Hoke

Objective Clinical, USA

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Speaker
Biography:

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