Clinical Trials Midwest 2019

Biography: I have been in the industry for 20 years.  13 with CROs in various roles including Project and Account Management.  The last 7 years have been spent with Pharma, where I have served as an Outsourcing and Vendor Manager supporting multiple service lines, vendor types, and therapeutic areas.

Session Details: PANEL DISCUSSION | Conducting trials on a global scale; key tips for success  30-10-2019, 2:30 pm View In Agenda

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Session Details: PANEL DISCUSSION | Conducting trials on a global scale; key tips for success  30-10-2019, 2:30 pm View In Agenda

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Session Details: Ask the Audience | Achieving Compliance with Regulations 30-10-2019, 2:00 pm View In Agenda

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Session Details: Rountable 4 | Encouraging teambuilding between in-house and partners’ teams to improve trust, create a transparent environment and maximize resources 30-10-2019, 9:00 am View In Agenda

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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

Session Details: Keynote | Are there counterfeits in your supply chain? 29-10-2019, 9:00 am View In Agenda

Biography: I have been in the industry for 20 years.  13 with CROs in various roles including Project and Account Management.  The last 7 years have been spent with Pharma, where I have served as an Outsourcing and Vendor Manager supporting multiple service lines, vendor types, and therapeutic areas.

Session Details: PANEL DISCUSSION | Conducting trials on a global scale; key tips for success  30-10-2019, 2:30 pm View In Agenda

Biography: Mr. Ken Olovich is the Chief Financial and Procurement Officer for Chorus. Ken has over 27 years of pharmaceutical research experience. As one of the original founding members of The Chorus Group in 2002, Ken can be credited with designing and implementing much of the Chorus approach to clinical vendor relations, contracting, finance and budgeting, quality, and general operations. Prior to Chorus, Mr. Olovich served as Team Leader for Clinical Trial Operations in the Neuroscience Therapeutic Area where he supervised clinical associates and support staff in the planning and implementation of phase I/II neurology and psychiatry clinical trials. Prior to that role, Mr. Olovich was the Clinical Sourcing Team Leader within the Lilly Procurement division. Ken earned his Masters of Business Administration from Indiana Wesleyan University and his Bachelor of Pharmacy from Purdue University.

Session Details: Clinical finance & strategic outsourcing; a practical guide 29-10-2019, 10:00 am PANEL DISCUSSION From vendor to partner; how you can create relationships that go above and beyond the norm 29-10-2019, 3:00 pm View In Agenda

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Session Details: Vendor oversight: ensuring you are monitoring your vendors and complying with regulatory expectations 29-10-2019, 11:30 am PANEL DISCUSSION | Presenting a hands-on approach to implementation and ongoing assessment of RBM  30-10-2019, 12:15 pm View In Agenda

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Session Details: INTERACTIVE Q&A Leveraging mobile health technologies to engage patients and reduce timelines 29-10-2019, 3:45 pm PANEL DISCUSSION | Improving the site-sponsor relationships; developing a true site-centric clinical supply 30-10-2019, 11:30 am View In Agenda

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Session Details: Rountable 1 | Harnessing the power of Big Data in clinical trials; what are the benefits of this technology? 30-10-2019, 9:00 am PANEL DISCUSSION | Improving the site-sponsor relationships; developing a true site-centric clinical supply 30-10-2019, 11:30 am View In Agenda

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Session Details: PANEL DISCUSSION Niche vendors or full-service providers? Which is the best in delivering quality and helping you stay on budget 29-10-2019, 3:45 pm Rountable 3 | Sponsor-vendor relationship management: Don’t let a communication breakdown negatively affect your trial 30-10-2019, 9:00 am View In Agenda

Biography: I have been in the industry for 20 years.  13 with CROs in various roles including Project and Account Management.  The last 7 years have been spent with Pharma, where I have served as an Outsourcing and Vendor Manager supporting multiple service lines, vendor types, and therapeutic areas.

Session Details: PANEL DISCUSSION | Conducting trials on a global scale; key tips for success  30-10-2019, 2:30 pm View In Agenda

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Session Details: Chair’s opening remarks 29-10-2019, 8:50 am Keynote | Outsourcing your outsourcing process; lessons for small-sized companies 29-10-2019, 9:00 am View In Agenda

Biography: Perri Zimmerman is the Director, Clinical Supply at Esperion Therapeutics.  Perri overseas all of the clinical supply activities at Esperion.  Perri has over 15 years of clinical supply experience in both large and small pharma.  Perri also has 10 years of finance and marketing experience working with Ford Motor Credit Company.  Perri earned a Bachelor’s of  Arts in Economics from State University of New York – Binghamton and a Masters of Business Administration from Carnegie Melon University.

Session Details: PANEL DISCUSSION Considering why forecasting remain such a challenge when running clinical trials and what can be done to solve this 29-10-2019, 3:00 pm View In Agenda

Biography: Alain is currently responsible for CT Supply Chain Design and Management at Chorus, a virtual early phase development division of Lilly, where he is responsible for the overall Chorus portfolio CT Materials strategy and operations with ultimate responsibility for study drug design, demand & supply planning, CT supplies production and inventory management across all compounds, studies and sites. He furthermore has oversight of all the third party organizations executing all of Chorus CT supplies related activities. A large portion of Chorus' portfolio consists of cold chain, parenteral biologics, some of which involving pharmacy-based sterile compounding. Prior to Chorus, Alain was a Senior Associate, CT Supplies Coordination, supporting Lilly's clinical trials programs in Belgium then in Indianapolis. In this role, his responsibilities encompassed CT Materials demand and supply planning, production oversight, distribution and inventory management. Most his projects involved cold chain drugs. He also gained CT Supplies related experience at Covance, in their IVRS division, and at Lilly's CT Manufacturing Operations, in his chemist capacity, providing analytical support for in-process and release activities as well as stability programs. Alain holds a BS in Industrial Chemistry, with a specialization in Biotechnologies, obtained at the Paul Lambin Institute in Belgium.

Session Details: Panel Discussion: Exploring ways clinical supplies and quality assurance teams can work together to ensure trials run on time 29-10-2019, 11:00 am PANEL DISCUSSION Considering why forecasting remain such a challenge when running clinical trials and what can be done to solve this 29-10-2019, 3:00 pm View In Agenda

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Session Details: Chair’s opening remarks 29-10-2019, 8:50 am Designing and implementing a quality management system to improve how your clinical supplies are administered 29-10-2019, 10:00 am View In Agenda

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Session Details: PANEL DISCUSSION Harnessing Real World Evidence (RWE) to maximize its usefulness in improving your study design, execution and site selection 29-10-2019, 1:45 pm View In Agenda

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Session Details: PANEL DISCUSSION Harnessing Real World Evidence (RWE) to maximize its usefulness in improving your study design, execution and site selection 29-10-2019, 1:45 pm View In Agenda

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Session Details: PANEL DISCUSSION Harnessing Real World Evidence (RWE) to maximize its usefulness in improving your study design, execution and site selection 29-10-2019, 1:45 pm View In Agenda

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Session Details: Effective patient recruitment and retention strategies in Latin America 29-10-2019, 1:15 pm PANEL DISCUSSION | Presenting a hands-on approach to implementation and ongoing assessment of RBM  30-10-2019, 12:15 pm View In Agenda

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Session Details: PANEL DISCUSSION Determining how to enable clinical trial readiness from a small-medium size pharma perspective 29-10-2019, 1:45 pm View In Agenda

Biography: Dr Nancy Sacco is currently the VP and Head of Clinical Development at AnaptysBio, Inc, with 20+ years of experience through all phases of Clinical Development. She has worked with numerous CROs, clinical vendors and clinical investigator sites around the globe and is focused on best practices and optimizing operations toward highest quality deliverables and data.  Prior to AnaptysBio, Dr Sacco led Clinical Operations globally at Revance, Avexis and Takeda, overseeing clinical trials across aesthetics, neuromuscular and psychiatric disorders, metabolic disease, women’s health, infectious diseases/immunology, oncology, and gene therapy/rare disease. She was Executive Director of Strategic Operations at Astellas Pharmaceutics Global Development with responsibilities across US, Europe and Japan.  While at P&G, Warner Lambert/Pfizer, she had operational and leadership roles with increasing responsibilities. Over her career she has contributed to the development of Zolgensma, Xtandi, Myrbetriq, Cresemba, Lyrica, Rozerem and Risedronate.  Beyond drug product development, Dr Sacco represented Astellas on both the Transcelerate and AVOCA consortia where she contributed to the development of Risk-based monitoring, GCP Global Recognition for clinical investigators and Clinical Quality Management initiatives.  https://www.linkedin.com/in/nancy-sacco-888738b/

Session Details: The Small Pharma / Biotech Development Operations dilemma – Current challenges with Clinical CRO business models 29-10-2019, 11:00 am PANEL DISCUSSION From vendor to partner; how you can create relationships that go above and beyond the norm 29-10-2019, 3:00 pm View In Agenda

Biography: Tom has worked in the life sciences industry for over 20 years, initially as a pharmaceutical representative and then as a pharmaceutical product manager. Over the past 10 years Tom has become an expert in providing sponsors and CRO’s with an innovative clinical supply process that is patient centric, saves clinical operations and supply management teams time and saves sponsors money.

Session Details: An innovative approach to simplify the Clinical Supply Process for unblinded medication and supplies  29-10-2019, 9:30 am View In Agenda

Biography: As the Sensitech Professional Services Senior Project Manager & Industrial Engineer, Mark is responsible for working with a cross-functional team of nine Project and Assistant Project Managers with backgrounds in industrial engineering, regulatory, packaging, validation, logistics, refrigeration systems, statistics, and technical writing.  Mark has been with Sensitech for 14 years.   The team focuses on defining and executing projects such as storage validations and transportation qualifications, along with thermal mappings, shipping studies, risk-controlled ambient temperature profiles, package qualifications, cold chain assessments, gap analysis, and continuous process improvement through ongoing monitoring. These cold chain visibility solutions enable Sensitech customers to make decisions that meet regulatory requirements, impact product quality and improve profitability.   Mark previously worked at United Parcel Service (UPS) for 16 years as an Industrial Engineering & Operations Manager. While at UPS, Mark completed numerous projects as a Project Manager, focused on supply chain and warehousing improvements.   Mark earned his Master’s in Industrial Engineering and his Bachelor’s in Architecture from the University at Buffalo.

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