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Gayle |
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Hamilton |
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Director, RBQM, Digital Trial Management Suite |
IQVIA Technologies |
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Gayle Hamilton is an experienced Risk-Based Monitoring project advisor and project lead with a strong background in clinical operations and project management. She has supported study trial teams and IT development in RBQM implementation across all phases and therapeutic areas, driving the development of processes, tools, and systems. Gayle is also experienced in assuring high-quality business performance of clinical operations within global projects. |
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Eric |
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Klaver |
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DCT Regulatory Director – IQVIA Decentralized Clinical Trials |
IQVIA |
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Eric brings almost 30 years of clinical research experience to IQVIA in roles varying from data management to post-trial access. His focus has been on compliance in clinical trials, through training and auditing. Eric has trained clinical research staff literally around the world and has audited, supported audits and inspections on an international stage as well. Currently, Eric focuses on the continued compliance of the IQVIA DCT strategy and platform. |
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Kate |
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Godwin-Smith |
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Director, Solution Engineering |
IQVIA Technologies |
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Allan |
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Van Konynenburg |
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Senior Director, Global Depot Network |
SanaClis |
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Allan van Konynenburg has more than two decades of experience in Business Development and Operations in the pharmaceutical arena, specifically in specialty logistics and supply chain. He brings with him a wealth of knowledge and experience across the pharmaceutical ecosystem, extending to Warehousing, Fulfilment, Distribution, CTSM, Logistics, Direct-to-patient, and Cell & Gene therapy. Allan is responsible for SanaClis vendor relationships, identification of specialized Clinical Trial Depots, formalization of business relationship with current and new vendors and establishing and negotiation of unified pricing models. His knowledge and experience play a key role in managing innovative approaches to existing and new business challenges and work with teams across SanaClis to deliver customer-centric products and services that support SanaClis’ mission statement. |
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Zuzana |
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Baťová |
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Director of Regulatory Affairs |
SanaClis |
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Zuzana Batova brings years of regulatory experience and has a highly successful track record. Most notably, she was the Executive Director of the National Competent Authority in Slovakia (State Institute for Drug Control). For over 5 years, Zuzana was responsible for the final decision making in the field of human pharmacy such as granting marketing authorization, authorization of clinical trials and drug recall. She also represented the agency on national and international level (V4 Presidency, SK Presidency and EMA Management Board).
Prior to that, Zuzana was heading the Drug Registration Department at the State Institute for Drug Control and took charge of the activities associated with the marketing authorization of human medical products, ensuring that approved medicines meet appropriate standards of quality, safety and efficacy coming from the ICH, EMA and WHO guidelines. |
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Ash |
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Rishi |
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CEO and Co-founder, Founder |
COUCH Health, Demand Diversity and COUCH Academy |
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In his own words, Ash is a ‘failed neuroscientist’. Ash is a passionate, supportive leader – one who truly eats, sleeps and lives our mission to make healthcare more human. Ash shares over 15 years of experience in creative communications, patient engagement, and patient recruitment strategies for clinical trials, with a key focus to improving diversity in clinical trials. Ash is driven to make a difference, and is inspired to defy the odds, always standing up for what’s right. It’s why he set out to make COUCH Health what it is today. |
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Matt |
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Marano |
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Chief Commercial Officer |
Rosa & Co. LLC |
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Alex |
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Guillen |
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Director of Sales – Life Sciences and Pharma Europe |
TIVE |
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Alex Guillen is an established executive with a proven record in global business and market development, with well-rounded experience in multicultural sales management and brand building. Alex has extensive experience and expertise in cold chain; as SME – Life Science and Pharma at Tive, Alex leads sales and business development within the company’s rapid-growth Life Science division. Previously, Guillen served as a Board Member and leader of Corporate Strategy at SWITRACE S.A, a developer of temperature and humidity data loggers compliant to the Pharma and Biotech industries. Alex’s extensive experience also includes serving as Global Cold Chain Director of Fisher Clinical Services, CEO of Escort Cold Chain Solutions SA, and Director for Commercial Operations for Novartis Vaccines. |
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Haider |
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Alleg |
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Global Head of Digital |
Ferring Pharma |
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Haider is an entrepreneur, who blends commercial and marketing innovation into brands. He is specialized in business transformation and product launches within regulated industries such as pharmaceuticals. Developing a natural obsession for creating new customer experiences, Haider disrupts the way global organizations adopt emerging marketing and technology trends. |
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Christian |
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Biberger |
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Head, Clinical Center of Excellence |
CSL Vifor |
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Christian Biberger, PhD, is Head of Clinical Center of Excellence at CSL Vifor (previously Vifor Pharma), and is based in Glattbrugg, Switzerland. In this role, his key focus is to ensure Vifor’s clinical development processes and systems are state-of-the-art and enable the teams to deliver efficiently, in full compliance with regulations and, last not least, with a patient-centric mindset. Christian’s development tenure spans more than 25 years. During that time, he has held various management and leadership positions in both pharma and the CRO industry. His development experience comprises studies in all phases as well as numerous indications. |
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Michal |
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Konstacky |
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Senior Director, Clinical Development |
Luzsana Biotechnology |
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Dr. Michal Konstacky, is currently employed at Luzsana Biotechnology, since June 2021, holding the title of Senior Medical Director for Innovative Medicines Clinical Development. Previously, Michal held global medical positions at Roche, Takeda, Aegerion or Almirall in Switzerland, UK, Spain, Sweden. Michal completed a Master of Business Administration – MBA • General management degree from City University of Seattle, he holds MD and PhD titles from Charles University in Prague and he also studied international business law at Salford Uni (UK) and negotiation at Harvard Business School. Michal is author of two published books: Nejezte hříbata! and The Predictive Value of Fortune Cookies and advisor to the Czech Senate, Ministry of Education and former advisor to the Ministry of Foreign Affairs. Since 2009 Michal has lived in Switzerland and currently he is the president of Sokol Zuerich Club (founded in 1867). |
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Domenico |
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Merante |
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VP Clinical Development Nephrology & Orphan Diseases |
CSL Vifor |
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Domenico Merante graduated in Medicine at University of Pisa/Italy in 1988. He specialized at the same University in 1993 and practiced at the main Pisa city hospital of St. Chiara whilst specializing in endocrinology and diabetes. His practice experience is 20+ years, including working as emergency doctor for 12 years in the NHS in Italy. During the compulsory military service, he also worked for three years as Medical Officer and subsequently as Chief Medical Officer of a ship unit named “Ammiraglio Magnaghi” in the Italian Navy. Domenico focus is on diabetic neuropathy, neuropathic pain and diabetic wound treatments.
In addition to his medical practice experience, so far Domenico has developed 26 years’ experience in global clinical development, half of which spent with Japanese organizations (Daiichi Sankyo, Shionogi and Sosei Heptares) within the pharmaceutical and biotechnology environment. The other half of his career was with Lab. Guidotti, Novo Nordisk, Eli Lilly and GSK in Italy and in the UK. In this context, Domenico has worked in global clinical development programs (phase 1,2 and 3) in pain area, infectious diseases, type 1 & 2 diabetes and diabetic complications (including painful diabetic neuropathy), severe hypertension, metabolic and endocrine area. To date Domenico has produced 103 publications as main or co-author among full papers, abstracts and oral presentations. |
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Anja |
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Urban |
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Head of Clinical Operations DEU |
Immatics |
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Anja Urban, Director Clinical Operations at Immatics Biotechnologies GmbH has been working all her professional life in the medical field and started her career in clinical research in 2002. She started off at a niche provider for Medical Imaging and moved to a global international CRO before joining Immatics Biotechnologies GmbH in 2021. Anja has worked in a number of different positions in clinical research on which she gained a high level understanding of ICH-GCP and hands-on experiences in all operational aspects of clinical trials in all phases and a number of indications including Oncology. |
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Jean-Philippe |
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Kunz |
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Co-Founder & CEO |
Gnubiotics Sciences |
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Jean Philippe is a serial Entrepreneur with international experiences in strategy and business development for added value products, having leadership credentials in bridging brands with their markets to make an edge for sustainable growth. Partner at Kainjoo Group SA and co-founder of GNUbiotics Sciences, Swiss biotech start-up with mission to improve health by unlocking the benefit of the microbiome. |
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