Outsourcing clinical trials new england

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In his previous role as a Watson Solution Architect at IBM, he was instrumental in implementing many different AI systems from idea to implementation with various clients. In his current role, he works with various stakeholders, vendors, business SMEs, Machine Learning developers, and Data Scientists to deliver innovation and drive adoption of AI. Biography: John Seman is a Pharmaceutical Executive with a consistent track record of building teams, solving problems, adapting to changing markets, and establishing long term growth strategies.

Seman began his career in global life science corporations working for E. During his tenure at Squibb, he was a team member responsible for the introduction a new cardiovascular drug that achieved highest first year sales in company history. He served as Vice President of Marketing at the central laboratory division of Corning Pharmaceutical Services where he was responsible for expansion of services into the European market, and for developing an innovative marketing strategy to increase profitability with a growing base of top tier pharma customers.

For the past 20 years, Mr. He is an active participant in industry associations, and continues to be sought after to present at national and regional life science conferences. Seman also volunteers as a coach and mentor to aspiring life science entrepreneurs from the University at Buffalo, McMaster University, and Syracuse University to support their efforts to build companies, win business plan competitions, and secure financing.

Biography: Matthew Fedowitz is a life sciences industry lawyer who focuses his practice on achieving the business goals of clients. Matthew brings his legal insight and business instincts to bear for clients.

He looks at issues from all perspectives to achieve the most effective and desired outcome for his clients. This includes patent portfolio development and strategic patent prosecution; counseling with regard to FDA regulatory issues and their intersection with intellectual property; litigation in federal district court; and inter partes proceedings before the Patent Trial and Appeal Board.

Rising Stars, ; and Washington, D. Super Lawyers in Biography: A strong proactive leader of groups within the Data Analysis and IT disciplines in the Healthcare industry sector. A managerial style based upon vast global experience, which incorporates a pragmatic approach to issue management together with a progressive attitude to create and successfully implement business driven strategic change initiatives within multicultural environments.

Recent key achievements 1 Led a team that developed and implemented a Strategic systems approach to capitalise on the Clinical Data assets own by the Roche Product Development Group 2 Optimising the global sourcing solutions within the group by taking advantage of CRO, Contractors and Offshoring solutions.

Biography: Amanda Hayden is an Executive Director of Clinical Operations at Eledon Pharmaceuticals, and has worked for over 20 years in the clinical operations field. She has extensive prior monitoring and project management experience, with more than 10 years focused on Oncology trials. More recently, Amanda has spent significant time dedicated to large scale trial start-up, including global trial submissions and study launches in approximately 20 countries, as well as in overseeing ICH E6 R2 implementation and Inspection Readiness initiatives.

He plans goals and strategies and manages organizational structure and operational standards and process. He leads experienced clinical development teams specialized in data management, biostatistics, and programming to provide high quality and timely services to global biopharmaceutical clients.

Liu has published over scientific papers. He has worked with numerous Data Monitoring Committees DMCs in various capacities, including serving as a voting statistician member and coordinating and presenting frequently to DMCs. Liu has led numerous clinical development programs in various therapeutic areas. As President and CEO, he continues to lead the strategic growth of a world-class digital services company to the medical industry.

In the s, Bill worked in sales and marketing positions at Wyeth and Abbott. He was Business Unit Manager for the Depakote brand at Abbott, and helped form the first telemarketing sales department at Abbott. Throughout his career, Bill has spoken at numerous healthcare industry events and bylined articles in pharmaceutical trade journals on topics ranging from medical education to research training and digital technology. Bill holds an M.

Biography: Executive intrapreneur turned digital health entrepreneur, my career includes nearly 20 years leading global drug development, clinical research, and decentralized clinical trials DCTs for life science organizations. Named one of the Top Influencers in Digital Health, I also provide expertise and execution experience in digital health, clinical research innovation, and DCTs.

Learn more about John at www. Biography: Jay is responsible for managing the creation and design of product features and new capabilities for Trial Interactive. Jay brings over 25 years of product management, consulting, and engineering experience across verticals such as life sciences, enterprise software, healthcare, government, entertainment, and manufacturing.

Biography: Mark is a research professional with 25 years in drug development, sales leadership, licensing, and program management. Having earned an honors degree in molecular and cellular from the University of Connecticut, an MBA from Rensselaer Polytechnic Institute, and multiple executive leadership certificates from the Harvard Business School, Mark has been involved in most aspects of drug development throughout his career and is a seasoned corporate leader.

There, he is involved in biomarker planning and implementation on early phase clinical programs and studies across a wide range of therapeutic areas. Specifically, he has been heavily involved in identifying and evaluating near patient sample collection and analysis technologies.

This includes engaging and collaborating with internal and external partners on progressing to the ultimate goal of applying these to future decentralized and patient-centric clinical studies.

Matt lives in Burlington, VT with his wife and daughter. Biography: Jess has 15 years of clinical research experience, with much of that time uniquely focused on rare and orphan diseases. While at Penn, Jess worked closely with biotech companies to implement strategic clinical development initiatives and with thought-leaders to foster collaboration within the rare disease community.

She oversaw vendor partnerships to create patient registries and natural history studies, and, most impactfully, she worked hand-in-hand with patient advocacy groups, providing rare disease patients and their families with data-driven guidance while accelerating the clinical research process.

Prior to Penn, Jess spent eleven years in the CRO industry with Syneos Health, formerly INC Research, where she held director level positions growing their therapeutic business units, with a specific focus in global rare disease and pediatric trials. Since , 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. Biography: Michelle has been employed in the healthcare industry for over 20 years. Her background includes sales and training for numerous World Renowned medical device and pharmaceutical companies.

The unique and innovative TrialCard model significantly simplifies the clinical supply process by improving study flexibility while reducing costs and activities for the clinical supply and study team. Biography: Oren Cohen, M. Oren has extensive clinical development experience, most recently from Viamet Pharmaceuticals where he was CMO.

He brings more than 30 years of healthcare experience to the role, including several senior medical and operational leadership positions at Quintiles, including Chief Medical and Scientific Officer and global head of Early Clinical Development.

Oren received his M. He completed his infectious diseases fellowship at the National Institute of Allergy and Infectious Diseases NIAID , and stayed on to become an investigator in the Laboratory of Immunoregulation where he conducted basic and translational research on the immunopathogenesis of HIV infection. Email: oren. Biography: Samit is an Experienced leader in specialty pharmacy, managed markets, provider network, KOL engagement, and formulary management with contracting expertise under pharmacy and medical benefits.

Johnson is a professor of regulatory strategy at Northeastern University and Senior Director of Regulatory Strategy at Roivant Sciences, where she leads IND-enabling strategy for a variety of novel biotech and medtech products. She has authored over 20 publications, including on GCP and clinical trial strategy for medical devices and complex biologic products. Biography: Greg is an expert at designing innovative data collection plans, managing quality control of collected data, and creating custom tools and databases for end users, leveraging expertise in clinical software applications including SAS, DataFax, OpenClinica, Excel, and Access.

Biography: Sverre Bengtsson started in the clinical trials industry over 30 years ago. Sverre is very interested in making clinical trials efficient, in both study design but also in the processes and technologies used. Sverre co-founded Viedoc Technologies 19 years ago and is responsible for some of the major accounts but also the vision around the company.

Key experiences are within the US, Indian and all European markets across all phases and multiple therapeutic areas. Wesner ergomedplc. This site uses cookies to personalize and customize your experience. When you visit any web site, it may store or retrieve information on your browser, mostly in the form of cookies.

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