Clinical Roundtable Forum 2020

Biography: Francesco Spoto – System Support and Information manager at Novartis, Basel (Switzerland). Life Science professional with vast experience in Engineering, IT and R&D projects for Pharma and Medical Device industries. In the recent years, he has been focusing more on the drug development domain with specific emphasis on IRT and global supply chain. In his current role, he works on creating value via optimization of the clinical system landscape and on early adoption of new technologies. Francesco is a blockchain enthusiast and a strong believer in the power of habits.

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Biography: A high-performing entrepreneurial GLOBAL SENIOR DIRECTOR with an exceptional track record of developing added value and patient centric solutions globally for Specialty, Orphan and Biosimilar medicines from clinical trials to commercialisation. Demonstrated strong strategy and leadership skills with commercial focus, in marketing, business development, and change management roles, such as identification and purchasing of new businesses, by driving value that exceeds forecasts.

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Biography: Abby Sener has B.A. from Juniata College in Marketing & Communication.  She holds a PMP certification and has a background in project management.  She has spent 9+ years with Almac and has experience in both the Clinical Supplies and IRT areas within the company.  Her current role as the Manager of Almac ONE involves responsibility for harmonized delivery of clinical trials operating in the Almac ONE model, using both Almac Clinical Technologies and Almac Clinical Services.

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Biography: With 11 years’ experience working in the pharmaceutical industry, Tom White has developed leading-edge expertise in comparator sourcing across various project management, sourcing, and business development roles. Amongst other accomplishments, Tom pioneered an onco-generic ‘on demand’ clinical supply model in direct response to the growing use of chemotherapy products in the clinical supplies industry. Tom currently leads the Strategic Sourcing team at Clinigen, which is responsible for managing and developing key supplier relationships, implementing and developing sourcing strategies, and providing market-leading comparator sourcing solutions.

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Biography: Progressive change agent with deep expertise in leading high performing teams, delivering innovative business strategy, and creating advocacy models transforming the way patients gain access to treatments. Proven innovator and trusted business partner who solves complex business, patient, and physician problems. Global pharmaceutical leadership experience spanning clinical operations, medical affairs, and research. Highly reputable advisor in the following therapeutic areas: Cardiovascular, Oncology, Immunoscicence, and Virology. Notable for designing and implementing global, disruptive integrated recruitment engagement strategies. Diversity thought leader and community advocate with a focus on advancing the careers of women.

Session Details: KEYNOTE EXPERT PANEL 10-12-2020, 8:45 am View In Agenda

Biography: Alan Yeomans has worked with the development of computerised systems for 40 years as hardware designer, programmer, system architect, project manager and in a number of management roles including CTO and QM. Alan has been at Viedoc Technologies since late 2008, where he is responsible for Quality Assurance of their EDC vendor business. From 2008-2014 he was also responsible for Quality Assurance for their CRO business, until that part of the company was organised as a separate entity. Alan has earlier worked as CTO for a Swedish CRO (CDC) and as CTO and QM for an international ePRO provider (Clinitrac). Alan worked at British Aerospace, Space and Communications Division from 1981 to 1984 as a hardware designer on control systems for communications satellites. While there he developed the first CPU-board used in control systems on their communications satellites. After moving to Sweden in 1984 Alan started working with software development, starting with hardware driver routines and moving up through the software architecture to all levels, including user interface software and database software.

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Biography: Julie Martin, M.Sc., MBA, Director, Clinical Operations, Scimega Research has developed an expertise in managing a wide array of oncology clinical trials set in early and late clinical development stages including collaborative efforts with larger CROs. At Scimega she is responsible for the strategic planning, conduct and oversight of oncology clinical trials across Canada, and for the development of project proposals. In addition, Mrs Martin serves as Director, Business Development, and is a member of Scimega’s managing Board of Directors. She received her Master of Science in Biochemistry from the University of Montreal and holds a Masters of Business Administration from Concordia University. Mrs. Martin is a member of the American Society of Clinical Oncology (ASCO) and the Society of Clinical Research Associates (SoCRA).

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Biography: Iain joined EastHORN in 2013 to play a key role in the next stages of EastHORN’s ambitious plans for growth. He has been managing CRO business development in Europe and North America for more than 15 years. Since the first tentative steps into Poland and Hungary in the 90’s he has enjoyed and been a key part of the spectacular growth in clinical services in this region and beyond. Senior management roles as European Head and Global VP of Business Development have enabled Iain to be at the leading edge of business and corporate development within the global CRO industry. Iain is based in the UK and graduated in Cell Biology from the University of Glasgow.

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Biography: Business Development professional with 10 years experience working in clinical research. Passionate about improving patient education and outcomes, boosting the industry reputation amongst the general public, increasing efficiency and quality in clinical trials and ultimately bringing more effective and safer treatment options to patients. Currently working for Novotech - a rapidly growing, fast paced and agile, full service CRO covering exclusively APAC with an aim to be the CRO of choice for the region.

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Biography: Business Development professional with 10+ years experience working in Healthcare and Clinical Research. Established track record of closing complex multimillion dollar deals. Skilled in strategic relationship development, clinical research, prospecting, development of proposals, budgets and presentations, as well as contract negotiation and management. Strong communication, leadership and analytical skills with a BS in Chemistry and Human Physiology from Monash University. Currently working for Novotech - a rapidly growing, fast paced, full service CRO, covering the Asia Pacific region.

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Neta Bendelac, 4G Clinical Senior Director of Strategy, has over 10 years of experience in Clinical Supply Chain Management. She headed the Clinical Supply Chain department at Teva Pharmaceuticals, where she established new and innovative approaches to managing IMPs in clinical trials, designing them with a highly acclaimed and unique patient perspective. Prior to Teva, Neta worked as an international Supply Chain consultant, providing simulations and optimization tools to clients worldwide. Neta holds a BS in Industrial Engineering  and a Master of Business Administration (MBA) from Tel Aviv University, Israel. Neta is always focused on execution, finding joy in creative solutions to help patients around the world.

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Biography: Mr. Schliebner is a clinical strategist with a 25+ year background in clinical drug development focused on rare diseases, orphan drugs, and advanced therapeutics.  He develops innovative solutions and strategic considerations to help overcome the operational, logistical, and ethical challenges inherent to conducting research in challenging patient populations.  Mr. Schliebner’s efforts are focused on patient-centered approaches to drug development; reducing the burden of clinical trial participation; and leveraging virtual and de-centralized paradigms to bring new therapies to patients faster.  Mr. Schliebner also serves as the Co-Chair of Global Genes’ Corporate Alliance, and serves on the Board of Uplifting Athletes.  He holds a Master’s Degree in Public Health (MPH) from the University of Utah School of Medicine, and completed a Graduate Research Fellowship at The National Institutes of Health.

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Biography: Irena Seredina has medico-economic background. She graduated with honours as a medical doctor. When practicing as a medical doctor, she has carried out a doctoral research. Then, she received Master in Economics and studied management and marketing. Irena has more than 20 years of experience in clinical trials. At S-Clinica, Irena manages business development, partnerships and client relationship.   

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Biography: I am a people oriented, active and sensitive change agent leading the R&D efforts to help serve more Patients around the world. My international experience and transferable skills helped me change careers after more than 14 years in Commercial roles, finding a match in Clinical Operations, expanding the opportunity to help medically underserved populations. My business acumen and customer focus have been key to demonstrate results in different roles, but more importantly to engage with key stakeholders. I hold a Masters in Human Capital, and am fluent in Spanish, English and Portuguese. I believe in the value of connecting others and am proud of building this connections and helping whenever is needed. I am an inclusion advocate.

Session Details: KEYNOTE EXPERT PANEL 10-12-2020, 8:45 am View In Agenda

Biography: Physician-Executive with clinical experience and expertise in all phases of CNS drug development, global medical strategy, business development, and innovations in lifecycle planning.

Session Details: KEYNOTE EXPERT PANEL 10-12-2020, 8:45 am View In Agenda

Biography: Experienced Director Of Technology with a demonstrated history of working in the clinical development technology area. Strong professional in IT Strategy and System Business Process.

Session Details: KEYNOTE EXPERT PANEL 10-12-2020, 8:45 am View In Agenda

Biography: Experienced leader within the pharmaceutical industry in the US and EU with demonstrated experience producing results in new drug development and drug approvals across global markets. Skilled driver of strategic Global Regulatory Affairs, Drug Development across multiple indications including Oncology, Hematology, Cardiovascular, medical Dermatology, across R&D and Commercial. Global and commercial minded with strong clinical/medical, business, P&L understanding and interpretation as well as ability to seamlessly transition between therapeutic areas, transversing comfortably between R&D, commercial, and cross regionally

Session Details: KEYNOTE EXPERT PANEL 10-12-2020, 8:45 am View In Agenda

Biography: Experienced health outcomes researcher with an expertise focused on technology driven data capture. Passionate about developing the science of COA and driving the industry forward within the burgeoning field of technologically supported outcomes in clinical trials through research, publications and presentations. Currently Scientific Lead, eCOA and Mobile Health at Medidata Solutions, a clinical software platform provider. I am responsible for developing the company’s scientific expertise for electronic clinical outcome assessments and mobile health in clinical trials, and support internal teams and Sponsors around the implementation of industry and regulatory best practices in studies using eCOA and wearables. I am actively involvement in industry consortia such a C-Path ePRO Consortium, the Clinical Trial Transformation Initiative (CTTI) and the DIA Wearables Working Group.

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Biography: Ms. Bruns is an experienced patient advocate, an influencer within the rare disease community and a former rare disease nonprofit leader. Using strategic and operational leadership, she provides synergy between Clinical Operations and Patient Advocacy with a focus on building the framework for pipeline assets. Her direct understanding of the unique needs of the rare community provide valuable insights to the innovation teams. Ms. Bruns’ dedication to supporting families and rare disease organizations ensure that patient perspective is included in all areas of drug development.

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Biography: Veer Mehta is the founder and CEO at Halo Health Systems, a digital platform that accelerates clinical trials for pharma. With over 15 years of medical industry experience, he has extensive experience in the development & launch of FDA approved medical devices and digital health solutions. Veer has led engineering teams that have worked closely with large medical device and pharma companies, developing innovative technologies in the areas of endocrinology, cardiology, and immunology therapeutics. His passion for improving patient centricity in healthcare has led to an accomplished career in medical technologies, improving the lives of patients, clinicians, and researchers.

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Biography: David Larwood is a founder, the CEO, and chief chemist for Valley Fever Solutions, running the manufacturing process for a novel antifungal headed for Phase 2a trials in summer 2020. In his role as BD lead, he is responsible for many aspects of the company’s planning and operations. Valley Fever Solutions is a small startup working first on a new and improved treatment for Valley Fever (coccidioidomycosis). Their NikZ will transform the standard of care. Mr. Larwood co-invented his first two commercial molecules before age 30. His PhD research at UC San Francisco established the foundation for PEGylated drugs widely used today, where he co-invented suitable PEGylated lipids to make the very first PEGylated liposomes. As a bench chemist, he was the first to make Iotrolan, a CT contrast agent, now generic. Moving to law, he advised well known companies on patent matters, later moving to Apple Computer. Later, he took a VP role at startup FormFactor, staying in an IP role, then became the first General Counsel for startup Verisity Design, taking them public in 2001, then ultimately through acquisition in 2005. Mr. Larwood is the third of his family to be involved in Valley Fever.  His father was a clinician who developed an interest in the disease decades ago when the family moved to Bakersfield, California, a focal area for the disease. His mother started a foundation in about 1998 and raised some $20M for research into vaccines against Valley Fever.

Session Details: CLOSING KEYNOTE: Establishing how best to position your study design to maintain an agile protocol in the current climate, plus exploring projections for 2021 10-12-2020, 1:45 pm View In Agenda