Outsourcing in Clinical Trials UK & Ireland – Virtual Experience

Biography: Currently, working as Head of Clinical Operations for Mereo BioPharma, a small UK-based biopharma company specialising in rare diseases, Ian has approx. 20 years’ experience in clinical development. Working for small, medium, large pharma and CROs, including Takeda oncology, Shire, ICON, Sanofi in clinical science and operational roles he has a broad therapeutic and operations experience in early & late phase development which has supported successful registrations in US, EU and Japan. He has been successful in operationalising complex programs in orphan and specialty indications and has a PhD in Medical Microbiology from the University of Edinburgh and Queen Margaret University College.

Session Details: Adjusting To ‘The new normal’: will decentralized trials be the future for clinical trials? 30-03-2020, 10:00 am View In Agenda

Biography: John Shillingford, PhD is an experienced clinical researcher whose career in the Pharmaceutical, Medical Device and CRO industries has stretched over 40 years.  John has both lived and worked in a number of European Countries as well as the USA.   He is now lives in Germany. His wide experience of Drug and Medical Device Development in Europe and the USA has been acquired during the management of both Clinical and Data Operations for major Global Programmes. John has held senior positions in Management, Clinical Operations and Project Management for, Aptiv Solutions, Averion International (a Medical Device Research Company), PRA International and Imform GmbH. Currently John is Clinical Operations Director and a member of the Board of Afon Technology Ltd, a UK based Medical Device Company, Consultant to International Research Companies  and additionally continues to run a number of training courses in Vendor and Project Management.

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Biography: Barbara is Director, Quality and Risk Management, at GSK. This includes ensuring GSK’s global processes, procedures and training meet current and future regulatory requirements and GCP, and supporting GCP inspection readiness. She has recently taken on responsibility for quality at GSK’s phase 1 unit and for Human Biological Sample Management within clinical trials. Barbara has a PhD in Physiology and Pharmacology from the University of Nottingham. She started in clinical research 25 years ago as a Clinical Research Associate, subsequently working in clinical trial management, training, and various quality roles, for pharmaceutical companies including GSK and Roche. She is a visiting lecturer at Kings College London and an Honorary Fellow of the Institute of Clinical Research.

Session Details: ICH E8 Revision 1 General Considerations For Clinical Studies 30-03-2020, 12:30 pm View In Agenda

Biography: Andrew Thompson is the Director of Therapy and Analysis at GlobalData Healthcare, responsible for data collection and forecasting within the Medical Devices portfolio. Andrew is passionate about developing innovative approaches to the world of medical devices industry research. Andrew joined the team in 2012, following 20 years working within the academic and industry sectors, developing a specialty in advanced diagnostics for infectious disease. With multiple patents in molecular detection technologies, publications’ covering a breadth of topics and leading product development teams, Andrew has established a strong reputation within molecular diagnostics. Having worked on the frontline, Andrew can share a global understanding of the medical device industry, with both a highly developed understanding of the technologies, new and emerging, and of the business dynamics fueling medical device usage in healthcare. Responsible for the content and direction of global medical device portfolios, GlobalData forward-looking approach generates stimulating analysis and reports, to explore what these changes mean for GlobalData’s clients and their customers.

Session Details: Outlining The Fundamental Importance of Medical Devices In Tele Medicine 31-03-2020, 2:40 pm View In Agenda

Biography: Professor of Clinical Diabetes and Metabolism, Cardiff University School of Medicine. Professor of Endocrinology and Diabetes, University of Bristol. Colin Dayan trained in medicine at University College, Oxford, and Guy’s and Charing Cross Hospitals in London, UK before obtaining a PhD in the immunology of Graves’ Disease in Laboratory of Marc Feldmann. He then spent a year as an endocrine fellow at the Massachussetts General Hospital in Boston, USA before completing his specialist training in diabetes and endocrinology as a Lecturer in Bristol. He became a consultant senior lecturer in medicine (diabetes/endocrinology) at the University of Bristol in 1995 and Head of Clinical Research at the Henry Wellcome Laboratories for Integrative Neuroscience and Endocrinology in Bristol in 2002. In 2010, he was appointed to the Chair of Clinical Diabetes and Metabolism and Head of Section at Cardiff University School of Medicine. He served as Director of the Institute of Molecular and Experimental Medicine in 2011 – 2015. In 2017 he was appointed to the post of Professor of Endocrinology and Diabetes at the University of Bristol, UK as a joint post with Cardiff. He has a long established interest in translational research in the immunopathology of type 1 diabetes and is currently conducting early phase clinical trials in the development of antigen specific immunotherapy as well as leading multicentre phase 2 studies. His clinical interests in diabetes include management of poor compliance in type 1 diabetes, public health measures in the prevention of type 2 diabetes and models of community care in diabetes. He is the lead for diabetes in the Cardiff whole pancreas transplantation programme and with colleagues leads an All Wales anonymised data linkage programme for monitoring childhood type 1 diabetes. He has been part of 2 major EU FP7 programme grants in type 1 diabetes (and coordinator on one), a member of the Juvenile Diabetes Research Foundation Medical and Scientific Committee and the Welsh Diabetes Research Unit. Prof Dayan currently leads the Clinical Engagement and Training Core of the Diabetes UK funded type 1 diabetes UK immunotherapy Consortium which aims to coordinate and support combined efforts to bring immunotherapy for type 1 diabetes into clinical practice. He also chairs the UK Clinical Studies Group for the prevention, targets and therapies in type 1 diabetes.

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Biography: Having graduated from University with a degree in biochemistry , I have worked in the pharmaceutical industry for 30+ years most of these in clinical development. For the last 10 years I have had the role of Director of clinical operations within the anti-infectives portfolio first at AZ then latterly at a small biotech company F2G. I have also had a similar tole within the oncology and CNS portfolio and have worked across all phases of development from FTiM to phase 4 and post approval commitment studies. I am very interested in the difference between small and large pharma and the way these different entities interact and partner with CROs.

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Biography: Nick Rich joined Novotech business development in March 2017. With a strong passion for Business Development, and a results orientated approach, he brings over 25 years of experience across the life science space. Nick’s specialty is clinical full service outsourcing of pharmaceutical and biotechnology products across Asia Pacific. In his previous roles, he has managed a team of account directors in Asia Pacific based in India, China, Singapore and Japan. Nick holds a Bachelor of Science with Honours from the University of Warwick.

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Dave is an entrepreneur and technology innovator. He is known for pioneering the fields of A.I.-based medical decision-support, Training Analytics, and Virtual Clinical Simulation (VPS).

When he was Founder and CEO of TheraSim, Dave launched the world’s first successful online VPS system for physicians and trained over 1,000,000 doctors in every country on Earth. He also built the world’s largest network of computer-based clinical simulation sites in Africa in support of the USAID and the CDC’s HIV-treatment effort.

Since then, he has focused his passion for technological innovation and learning systems in the field of clinical trials, helping sponsors make their studies more accurate and efficient through finding the right technology mix such as virtualization, performance management and applied behavioral sciences to produce the most effective, lasting, and engaging results for clinical trials.

Dave is passionate about building performance management systems that are fun to use, predictive, adaptive, and measurably effective, producing lasting changes in a quickly changing field. Dave has always valued the interconnectedness of our vastly changing world and has traveled to over 70 countries for global health work and with cultural development outreach through music.

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More than 25 years of hands-on experience and working knowledge in clinical development and operations in both diagnostics and therapeutics at the Senior Director and Vice President capacity.  Track record includes delivering supportive clinical data culminating in multiple NDA/BLA and PMA/510(k) product approvals in the US and EU.  Experienced in leading highly motivated in-house clinical and cross-functional teams, vendors and CROs in strategic planning and execution of early to late phase clinical trials in oncology, immunotherapy, CNS, CVD and upper respiratory disorders in a cost-effective and timely manner.  Experienced in planning and executing complex, hard to recruit, large global studies across 5 continents.  Authored publications, protocols, study documents, training material and mentored direct reports.

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Biography: Meghan has over 20 years of clinical research experience in Phase 1 to 3 Clinical trials in oncology, ophthalmology, immunology, neurology, and infectious disease.  Her vision includes developing strategies to drive greater inclusion of racial and ethnically representative patient populations in clinical research and to support the optimal use of Genentech medicines.   Gaining patient insights early in program development is integral to developing what is important to patients but just as important is getting access to medicines and treatments for all patients, regardless of race/ancestry, sexual orientation, gender identity, socioeconomic status and ability/disability.   Her prior positions include Clinical Program Director. Clinical Program Leader, Trial monitor, Data manager, Research Coordinator and NASA Research associate. She has a Bachelor's degree in Behavioral Economics from UNC-Chapel Hill and a Master's degree from San Francisco State University in Human Biology.

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Biography: Romiya Glover Barry is recognized for outstanding leadership in clinical research by a project manager by the ACRP, and is the winner of the silver award in the PharmaTimes Clinical Researcher of the Year competition. She is an MGHIHP 'Forty for 40' alumna making a difference in the world of health care and beyond. Romiya has worked in various roles of progressive responsibility in the IVD and medical device industries. She has built a capability framework of technical, analytical, and interpersonal skills from her years of experience in product development, technical marketing, clinical trial project management, regulatory affairs, organisational leadership, and community health.

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Biography: Reggie Hooks has been active in clinical research since 2004. Being a native Oklahoman, he graduated with an MPH in Epidemiology from the University of Oklahoma Health Sciences Center and an MS in Forensic Science from the University of Central Oklahoma. In addition to his education, his perspectives on clinical research are further derived from his prior work experiences in the laboratory, at research sites, with a CRO, and with non-profit and for-profit sponsors. Reggie has managed the conduct of clinical trials across multiple therapeutic areas in over 15 countries and specializes in expedited site activation, and the development and implementation of creative study rescue activities. Reggie enjoys teaching at professional conferences and volunteering his time as a career development mentor for junior research professionals

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Dr. Treiber is a CRO industry veteran with 28 years of clinical development experience. Most recently, Dr. Treiber was Chief Operating Officer at Elligo Health Research. Before that, he was Executive Vice President, Biopharmaceutical Development and GM at Chiltern. Dr. Treiber has expertise in clinical operations, clinical development, medical affairs, data management/statistics, pharmacovigilance/safety and quality. He has broad therapeutic expertise in neuroscience, oncology, infectious disease, pain, gastroenterology, respiratory and women’s health.

Scott has a BA in biology from the University of Iowa, a PhD in neuroscience from the University of California Santa Cruz and an MBA from New York Institute of Technology.

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Biography: Eric has been designing, developing, hosting and maintaining award-winning, small and largescale education portals for healthcare and science organizations for more than 25 years. As the General Manager of Consent Solutions, Eric works with his team, sponsors, sites, patients, IRB’s and regulatory authorities to continually develop and enhance a comprehensive informed consent platform and services for clinical trials, registries, biobanking and hospital procedures to a rapidly growing network of pharmaceutical companies and healthcare providers. Recently, eConsent celebrated its 200th trial and has worked with over 2000 sites, 50,000 patients, and in 51 languages. Eric was named to the PharmaVoice 100 list of most inspiring and influential people in 2017.

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Biography: Behtash Bahador is an Associate Director at the non-profit organization CISCRP, and holds a Master of Science in Health Communication from the Tufts University School of Medicine. Since 2014, he has collaborated with a range of stakeholder groups to establish and implement patient- and public-centric initiatives across the life-cycle of drug and treatment development. This has included supporting the development of regulatory and cross-disciplinary best practice guidelines, operationalizing key elements of evidence-based public health programing into research engagement activities, and always keeping the needs of patients, participants and the public at the forefront of his work.

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Biography: As Chief Product Officer at AiCure, Michelle Marlborough is responsible for the product direction, definition and delivery of the company’s award-winning artificial intelligence platform. With over 24 years of experience in life sciences and software development, Michelle has been at the forefront of transforming clinical trials through innovative technology and analytics and previously held the positions of Vice President of Product Management at Veeva and Vice President of Product Strategy at Medidata Solutions. Before making the shift to the technology sector, Michelle worked in data management roles at GlaxoSmithKline and AstraZeneca. There she experienced firsthand the industry’s struggle with outdated processes and systems. Michelle earned her bachelors of science degree in biology and mathematics from Coventry University.

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Biography: Andrea is a senior-level strategic leader with 19 years of experience spanning clinical research, global quality assurance, strategic alliance management and business process optimization. She is responsible for driving strategic-level decisions that enable Teckro to challenge today’s status quo in the conduct of clinical trial research. She is also responsible for ensuring that Teckro products meet all regulatory requirements, including GCP and data privacy. Andrea holds a Bachelor of Science degree from the University of Tennessee.

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Biography: Rita brings a decade of customer relationship experience. In her current role as Customer Success Manager, she provides strategic guidance to Teckro customers so they get the most value from their investment. Prior to Teckro, Rita was the project manager involved in the creation of the Health Research Institute at the University of Limerick, which conducts research to enhance health and wellbeing. Earlier in her career, Rita was a project manager for the National Treasury Management Agency, which manages the assets and liabilities of the Irish government.

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Cayce brings more than a decade of clinical research experience, working at sponsor companies, CROs, and investigative clinical trial sites. Cayce has worked on numerous Phase I-IV trials across therapeutic areas. She has undergraduate degrees in Biology and Mental Health and holds two Master’s Degrees in Microbiology and Clinical Research.

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Jason Valentine is a chemist by training with an honours degree in In-organic chemistry.  He was the first analytical scientist employed by Faulding Pharmaceuticals in 1994 to support the establishment of the Faulding drug studies unit bioanalytical facility.  Faulding was the forerunner to CMAX, the first Phase 1 unit established in Australia. 

In 1999, Jason transitioned to the University of South Australia to manage the Centre for Pharmaceutical Research Bioanalytical capability.  Jason lead the expansion of the Centre to add CRO services to support the biotech and pharmaceutical industry and in 2009 drove the fund raising to spin off  of the private company CPR Pharma Services out of the University.  As the Founding CEO of CPR Pharma Services, Jason grew this entity to be a significant CRO with national relevance in early phase clinical trial activities.  In 2018, CPR Pharma Services was acquired and split to form Agilex Biolabs (Bioanalytical Services) which Jason Leads as CEO.

With 25 years’ experience in Tandem Mass Spec Bio-assay development and validation coupled with FDA and EMA regulatory requirements for bioanalytical assays, Jason is a leader in the field of regulated bioanalysis.  He is also a Graduate of the Australian Institute of Company Directors (GAIC).

Session Details: Panel: Partnership Opportunities Between Non-Profit & Industry Leaders To Enhance Clinical Trial and Patient Efficiency 30-03-2020, 10:30 am View In Agenda

Biography: Holding a Master of Science in Clinical Research from the Danube University Krems and a diploma in Business Administration and Computational Sciences from the Academy of Public and Business Administration in Munich Patrick is bringing more than 12 years of experience in Business Development in the CRO business. During his career, he gained a solid understanding of all aspects of clinical trials and deep knowledge in Business Development. He held several leading positions in the area of Business Development in mid-size CROs.

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Biography: Gowri Sukumar is the Director, CMC and Regulatory Affairs for Iterion Therapeutics, Houston, TX. Unique to her experience is leading all the technical disciplines of CMC development as well as regulatory Affairs. She has broad responsibilities that include process development, Drug Substance and Drug Product manufacturing from the CMC side. From the Regulatory affairs perspective, she provides regulatory leadership and expertise for regulatory strategy, liaises with the regulatory agencies including FDA, Health Canada and other Health authorities. For her leadership approach, she brings a strong focus beyond the necessary technical disciplines and regulations, looking at the interplay of culture and teamwork for successfully advancing programs in an effective and efficient manner.  Gowri holds a master’s Degree in Biosciences as well as the prestigious Regulatory Affairs Certification (RAC) awarded by the Regulatory Affairs Professional Society.  She is the author or co-author of several peer-reviewed research publications as well as book chapters. Gowri has breath of experience spanning R&D, CMC and Regulatory affairs. She also serves as a reviewer for several international Bioscience Journals for providing Scientific and technical expertise.

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Biography: Rosemary Coates is an Expert Witness for legal cases involving global supply chain matters. She is also the President of Blue Silk Consulting, a Global Supply Chain consulting firm and Executive Director of the Reshoring Institute. She is a best-selling author of: 42 Rules for Sourcing and Manufacturing in China and Legal Blacksmith - How to Avoid and Defend Supply Chain Disputes  Ms. Coates lives in Silicon Valley and has worked with over 80 clients worldwide

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Frank Leu is a Co-Founder and CEO of Novapeutics at Philadelphia, PA - a biopharma spun-out from the University of Pennsylvania, developing a first-in-class small molecule beta-cell restoration curative for type 2 diabetes. Prior, Frank was at a specialty pharma Verto Institute, developing biologic therapeutics for treating the neuroendocrine cancer. Frank graduated with a Pharmacology Ph.D. from Weill Cornell Graduate School of Medical Sciences in 2001, and then post-doc in a Howard Hughes Medical Institute laboratory at the Rockefeller University in molecular enzymology. He has served as an adjunct instructor at the Rutgers Cancer Institute of NJ, and is an adjunct professor at the pharmacology department of the Thomas Jefferson Medical University. Frank also founded BioPharMatrix developing blockchain solutions to lifescience innovations at all phases, and serves as advisor to the Pennovations center working with 1776 / Benjamins Desk. Frank is a thought leader in the blockchain architecture innovations in the life-sciences and drug development, Frank serves on multiple advisory boards and frequently served as chairman, speaker, moderator, and facilitator for many life-sciences and drug development events.

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Biography: Tormey has more than 44 years of Sales and Marketing, and Executive experience in the global pharmaceutical market. 2017-2020, Mr. Tormey held the position of Chief Executive Officer at Kibow Biotech, where the company developed product a novel treatment for Chronic Kidney Disease. Prior to Kibow, he was a Member of the Board, and Vice-Chairman of Prevention Pharmaceuticals Inc, where he previously held the position of President/CEO beginning July 2010. From 1985 to 1990, Tormey lead Medical/Hospital/Industrial Sales with Wyeth. From 1990 to 2003, Tormey was with Nelson Communications Worldwide. First, as VP at PDN, and then as President of The Medical Phone Company®, and later as President/COO of Nelson Communication’s flagship company, Nelson Professional Sales (later known as Publicis Selling Solutions), Publicis, S.A., Paris. From 1976 to 1985, Mr. Tormey held Sales & Sales Management positions at Ortho Pharmaceuticals, and then as Director of Sales Staff Management with McNeil CPC (Johnson & Johnson).

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As Founder & Chief Executive Officer of Axiom, Andrew Schachter provides the visionary leadership integral to the company’s more than 17 years of eClinical technology and managed services success.

Axiom’s Fusion eClinical Suite, the leading unified eClinical platform, has been used to run hundreds of studies across a wide range of therapeutic areas, from Phase I to global Phase III studies and registries.

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Biography: Seth A. Kaufman, MSHCA, CCRA, is the Sr. Director, Clinical Affairs at Axonics Modulation Technologies. Axonics Modulation Technologies, Inc. (NASDAQ:AXNX) is a medical technology company focused on the design, development, and commercialization of innovative and minimally invasive sacral neuromodulation (“SNM”) solutions. SNM therapy is primarily used to treat patients with overactive bladder (“OAB”), fecal incontinence (“FI”) and urinary retention (“UR”). Axonics currently has marketing approvals in Europe, Canada, and Australia for OAB, FI, and UR. He has 20+ years of life science industry experience focusing on clinical research. He has worked for numerous sponsors as well as consulting for a “Big 4”. He also has past experience with epidemiological research with the US Department of Defense. He has deep knowledge and demonstrated experience with: Good Clinical Practices; ICH; and 21 CFR Parts 50, 54, 56, 312 and 812 as well as established practice with key tools, processes and procedures for clinical operations of many therapeutic areas for complex clinical trials.

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• Clinical trials:
• Coordination of Clinical Trial Material / Investigational Product supply to clinical sites according to Local legislation, Sponsor’s SOP and GCP / GDP / GMP
• Coordination of Clinical Trial Material / Investigational Product use on clinical trial sites according to Local legislation, site’s SOP and GCP
• Training of clinical / pharmacy personal on all aspects of drug accountability (including preparation of treatment)
• Training of clinical personal on use of medical devices (when applicable)
• Quality control:
• QC laboratory team leadership
• Organization of QC laboratory according to GMP
• Planning and execution of Development and Validation of Analytical and Biochemical methods according to GMP, USP and PhEur
• Auditing of QC laboratory methods and results
• Preparation of regulatory required documents according to GMP (SOP, methods, reports...)

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Biography: Professor of Clinical Biochemistry the Lily and Avraham Gildor Chair for the Investigation of Growth Factors, Head of the Elton Laboratory for Molecular Neuroendocrinology, Department of Human Molecular Genetics and Biochemistry, Sackler Faculty of Medicine, Sagol School of Neuroscience and Adams Super Center for Brain Studies, Tel Aviv University. Former Director, the Adams Super Center for Brain Studies & the Edersheim Levie-Gitter Institute for Functional Brain Imaging. Serves as Editor-in-Chief of the Journal of Molecular Neuroscience. The inventor of CP201 and CP102. Holds a B.Sc. from Tel Aviv University and a Ph.D. from the Weizmann Institute of Science.

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Biography: Mrs. Erlich is a senior regulatory, clinical trials, and compliance expert for the health-care and medical device industry. She has served as a senior management member and held VP positions in national startups and international health-care companies since 2003. As part of her job, she managed large company teams, delineated the regulatory and compliance strategy and led its implementation, leading to multinational market clearance, including the EU, USA, South America and the Japanese market. She also designed and managed multinational multisets clinical trials and submissions. In addition, since 2001, she also served as a senior consultant in the PushMed group and N.G.I.T, for more than 70 medical device companies in miscellanies clinical fields. As a consultant she established quality systems, lead the design control process to support successful regulatory submissions, supported the company during CE audits and FDA inspections, and tailored regulatory and clinical strategy. She also held meetings with regulatory bodies, including notified bodies and FDA, and managed clearance file submissions, such as a Technical File, 510(k) notices and post market activities. Tsvia Erlich joined ConTIPI Medical, as Regulatory and Clinical Affairs officer in 2007. She holds a BSc. degree (cum laude) in Biochemistry and Food Engineering from the Hebrew University in Jerusalem. Later, she graduated the Technion Institute of Technology, Haifa and received her M.Sc. degree (cum laude) in Biotechnology and Food Engineering, in 1993.  During that time she completed her research in the field of protein engineering at the laboratory of Professor Yuval Shoham, at Technion Institute. She holds CQE and CQM certificates since 1999 and is an active member of RAPS and she lectures at national and international conferences.

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Biography: Jessica Cordes studied Molecular Life Science in Luebeck and started her business career for 2 years at the Central Lab MDS Pharma Services as project manager. She moved then to GlaxoSmithKline where she worked as country project leader for 4 years. In 2013, she moved to MorphoSys, working for four years in an international role as clinical trial leader. 2017 she moved to Medigene headquarter as clinical trial manager and is now leading the Clinical Operations group since 2018

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Biography: Zach Hales is a driven solutions provider with more than a decade of experience revolutionizing the manufacturing, payments and software landscapes.  As a Product Manager at Greenphire, Zach is responsible for ensuring the business strategy and software development consistently evolve to meet market demand while working closely with clients to facilitate change.  Exceeding customer value in the clinical research continues to be his primary focus in building Site Centricity and Patient Convenience.

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Biography: Trishna Bharadia is a multi-award winning health advocate and patient engagement champion. From the UK, she has worked across Europe and the world with multiple stakeholders to get the patient voice heard louder, stronger and more effectively throughout the entire healthcare journey. Her work includes health information, patient support programmes, disease awareness campaigns, improving the clinical trial experience, engaging with BME communities and development of patient-centred strategies, among many other things. She is a regular conference speaker, advisor, writer and media spokesperson. Among her accolades, she was recognised by the UK Prime Minister's Office with a Points of Light Award in 2018, for her work with patient communities.

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