Outsourcing in Clinical Trials Southeast 2021

Biography: Currently leading Clinical Operations at Tenax Therapeutics, Kevin M. Crawford is a 23-year clinical research veteran, having held leadership posts under such leading brands as GlaxoSmithKline (GSK), Johnson & Johnson, and United Therapeutics. A certified executive coach, contributing writer and vlogger as well, Kevin’s insights on a personal and professional mission, organizational leadership and life balance have garnered a growing cult following and demand as an executive consultant and speaker. With a Master’s degree in Biotechnology from the University of Maryland, he has published in the Journals of the American Thoracic Society and American College of Chest Physicians. Kevin lives in Raleigh, NC with his wife and three children, and when he is not “ON,” he enjoys playing soccer, kayaking, volunteering and having bad coffee with good friends

Session Details: Chair’s Opening Remarks 30-03-2020, 8:50 am The impact of corporate catabolism on clinical trials: Team dynamics, individual performance and bottom line 30-03-2020, 12:00 pm Crisis Scenarios: Obstacles with integrating technology in Clinical Trials 30-03-2020, 4:00 pm Debate: Decentralized Trials; the future of medicine or a disaster waiting to happen? 30-03-2020, 4:45 pm Chairs closing remarks 30-03-2020, 5:15 pm Chair’s Opening Remarks 01-04-2020, 8:50 am Chairman’s summation and close of conference 01-04-2020, 4:30 pm View In Agenda

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Session Details: A vision for the future Artificial Intelligence (AI) trial 30-03-2020, 1:30 pm View In Agenda

Biography: Greg Hottell is a Director in the Clinical Interface team at GSK, where he is responsible for the cost-effective, patient-focused supply of investigational product for GSK’s pharmaceutical development portfolio. Since joining GSK in 2011, Greg implemented an end-to-end planning platform for clinical supplies, helped redesign GSK’s approach to clinical supply blinding and unblinding risk management, was a core team member for the Investigational Material Supply strategic planning initiative, all while consistently delivering top-tier performance with on-time supply of IP to patients. Greg is a member of the ISPE North American Investigational Product community of practice steering committee.  Additionally, he has been active with the Global Clinical Supplies Group since 2016 by facilitating workshops, presenting, and authoring white papers. Greg has been a Supply Chain professional since 1999, most recently holding positions of increasing responsibility at Eli Lilly & Company and Fisher Clinical Services prior to joining GSK.  He holds a bachelor’s degree in Operations Management, an MBA, and is a Certified Fellow in Production and Inventory Management (CFPIM) through APICS.

Session Details: Discussion: Best practices for cold chain management of clinical trial materials and investigational medicinal products to ensure sensitive materials are not compromised during transportation 01-04-2020, 1:30 pm View In Agenda

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Session Details: Building your study around the patient to promote overall success within trials 30-03-2020, 9:00 am View In Agenda

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Session Details: Best methods of maintaining a successful relationship with a CRO to ensure each milestone is seamlessly met 01-04-2020, 12:00 pm View In Agenda

Biography: A courageous Quality Leader with lots of broad experience and the ability to motivate people at the team and individual level. An Innovative, "out of the box" thinker with excellent communication skills.

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Session Details: Lessons learned: Creating a data review plan to ensure adequate data monitoring thresholds are established and followed in your trial 30-03-2020, 11:00 am View In Agenda

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Session Details: Case Study: Juggling a fully outsourced model with multiple vendor contracts as a small biopharma 01-04-2020, 3:30 pm View In Agenda

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Biography: Mike McLaughlin, MS, MSEd, RAC, has over 20 years of clinical research experience working in various roles at both small and large pharmaceutical companies and in a variety of CRO environments. Since 2017, he has served as Associate Director, Clinical Operations at Dermavant Sciences, a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in medical dermatology

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Biography: Dr. Cary's entire professional career has been in the pharmaceutical industry. He has extensive experience in injectable products research and development as well as Drug Development. An MBA degree has given him the background to be an effective leader in New Business Development. At Abbott he successfully championed the development of pre-mixed drugs, as well as the Add-Vantage Drug Delivery System. He also played a critical role in the identification and commercialization of PCA (patient controlled analgesia). He is a co-founder of a successful specialty pharmaceutical company, Cary Pharmaceuticals Inc. and is the sole inventor of US patent 6,197,827 titled, Nicotine Addiction Treatment.

Session Details: Q&A: Looking at the best methods for securing funding for early stage clinical trials 30-03-2020, 10:00 am View In Agenda

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Session Details: Ensuring trials are reaching diverse populations as a means of ensuring success by meeting enrolment quotas 01-04-2020, 4:00 pm View In Agenda

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Session Details: Fireside chat: Navigating RFP development to ensure strong contract negotiation to promote clear communication and milestones within your study 30-03-2020, 11:30 am View In Agenda

Biography: Chris is an innovative, results-driven, detail-oriented leader with over 30 years of pharmaceutical industry experience in the clinical operations, clinical development, and project management space.  His past work history includes tenure at both large and small pharmaceutical companies, as well as the CRO industry.  Chris currently works as an Executive Director, Clinical Operations at Lexicon Pharmaceuticals a small biotechnology company located in The Woodlands, Tx.

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Session Details: Q&A: Effective techniques for reviving a study that has gone off track 01-04-2020, 11:30 am View In Agenda

Biography: Revati Tatake currently serves as a Global Director of Databases and Analytics at GlobalData, where her primary responsibilities are to lead the development and continuous enhancement of integrated databases and analytical tools for providing competitive and business intelligence for pharmaceutical and biotechnology sectors Revati has more than 20 years’ experience, both in academic research and the healthcare industry, during which time she focused on basic and clinical research, drug discovery and competitive intelligence projects across many therapeutic areas.  After academic career at Tata Cancer Research Institute and the University of Connecticut Health Center, she began her healthcare industry career at Boehringer Ingelheim Pharmaceuticals, where she led drug discovery projects involving small molecules, gene therapy and cell therapy for cardiovascular diseases, Rheumatoid arthritis and Diabetes.  In addition to leading drug discovery projects, Revati co-chaired novel target identification group, scouted novel technologies for enhancing drug discovery efforts, established collaborations with experts in academic institutions to complement internal projects and evaluated in-licensing opportunities for their scientific and technical merit.  She is a co-inventor on several issued US patents and applications related to the projects on cell and gene therapies. Before joining GlobalData, Revati worked at Citeline, where she was involved in competitive intelligence and analytics of clinical trials and pharmaceutical products. Revati holds a PhD in Tumor Immunology from Tata Cancer Research Institute. She was a post-doctoral fellow at the University of Connecticut Health Center.

Session Details: Debate: Decentralized Trials; the future of medicine or a disaster waiting to happen? 30-03-2020, 4:45 pm Challenges and considerations for cell therapy trials 01-04-2020, 2:30 pm View In Agenda

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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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Session Details: General Data Protection Regulation (GDPR) considerations for clinical trial execution: Sponsor and CRO/Vendor partner frameworks 01-04-2020, 11:00 am View In Agenda

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Session Details: Running Global Trials with Regional CRO Specialists 30-03-2020, 9:30 am View In Agenda

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Deb Kientop brings over 25 years of experience in oncology drug development. She started in the cancer research labs at the University of Wisconsin and then moved into business development, medical affairs and clinical development roles within pharma and CRO. Her career has included thought leader engagement, product lifecycle planning, strategy development and execution for proposals and bid defenses, as well as corporate strategy and alliance management. Through her work with oncology investigators and patient advocacy organizations, she has been able to incorporate insights into patient-centric development strategies. Kientop is also a published author and cancer patient advocate.

Prior to joining Synteract, Kientop was the Vice President of Life Sciences at Inteliquet, a healthcare technology company. Previously, she held senior director strategy positions at two large CROs, as well as numerous biopharmaceutical organizations including MedImmune, MGI Pharma and Eisai. Kientop holds a Bachelor of Science in Pharmacology and Toxicology and a Master of Business Administration from the University of Wisconsin

Session Details: The Progression of Targeted Therapies: Addressing & Surmounting the Complexities in Clinical Development 30-03-2020, 2:30 pm View In Agenda

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