Outsourcing in Clinical Trials Southeast 2021 - Virtual Conference

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: The impact of corporate catabolism on clinical trials: Team dynamics, individual performance and bottom line 30-03-2021, 9:30 am Debate: Decentralized Trials; the future of medicine or a disaster waiting to happen? 30-03-2021, 3:00 pm View In Agenda

Biography: For 30 years, I have been a serial entrepreneur, starting multiple tech companies. Today, I am adviser to startup companies and venture capital funds, including startups originating at universities. I am a partner in Spectacular Health Ventures, a newly forming venture firm and fund in 2020 that applies advanced technology and modern trends to disruptive health ventures. I am active on the boards of startup companies. I am Chairman of Cloud Pharmaceuticals, a leader in Artificial Intelligence based drug development, located in Research Triangle Park. I am also a part-time adjunct professor/lecturer of Entrepreneurship, Product Management and Engineering. To that end, my goal is to motivate engineering students to find their passion and create breakthrough products and ventures. I advise a number ventures including Drug Logic, Parallel Profile, and PolarisQB, as well as some emerging new starts that are under wraps. My approach to venture work is unique. I work for long periods of time incubating new venture projects, but I only work on high quality, promising opportunities. With a technical background in Artificial Intelligence, Bioinformatics and Software, and a business background in Life Sciences, Healthcare and SaaS, I started 7 companies, funded 5 of them and exited 3. I have twice been named "Entrepreneur of the Year" by different organizations. I have advised 7 venture capital funds and over 20 early stage ventures. I am a frequent public speaker on entrepreneurship, innovation and new venture work, as well as on Artificial Intelligence in Healthcare. I have an interdisciplinary technical background acquired through grad school, teaching at universities and advising technical startups. It includes AI, IT, bioinformatics and genomics, HPC, parallel and distributed computing, quantum computing, IoT and drug discovery. The Covid-19 period has shifted my focus to telemedicine, more AI-based drug discovery, and new methods of capital raising. I hold a BSEE from Virginia Tech, two MS degrees from Johns Hopkins, an MBA from Duke University, and an 'online' law degree from Concord Law School at Perdue University. I completed a sabbatical year at MIT in Artificial Intelligence. This eclectic educational background along with my multi-industry experience is uniquely suited to the entrepreneurship, innovation, startup and venture capital worlds, as well as university and industry roles in managing design, innovation programs, and partnerships. I stay current by reading approximately 500 pages per day.

Session Details: A vision for the future Artificial Intelligence (AI) trial 30-03-2021, 1:00 pm View In Agenda

Biography: Greg Hottell is a Director in the Clinical Supply Chain 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, and implemented Network Capacity Planning processes, 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.

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Biography: Joy Carson is the VP of Clinical Development and Operations at Asklepios Biopharmaceutical (AskBio), where she leads the design and implementation of clinical protocols across indications, and oversees the AskFirst Patient Advocacy program.  With more than 30 years of experience in the design and implementation of clinical trials, she began her career in the Behavioral Neuroscience laboratory at MIT, and has split her experience among academia, sponsors, and CROs.  Currently focused on opportunities using viral vectors in the delivery of gene therapy and vaccines, she also has extensive experience in oncology drug development.  Her experience spans first-in-human through post-registration studies, with study sample sizes from 3 – 500,000.

Session Details: Building your study around the patient to promote overall success within trials 30-03-2021, 8:30 am View In Agenda

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 30-03-2021, 10:30 am View In Agenda

Biography: Nickie's experience includes the following: industry experience at contract research organizations (CRO) and biotech. Broad project management across matrix teams encompassing clinical development, alliance management, and business development. Study-level oversight and accountability for multiple functional departments to include project management, clinical operations, data management, pharmacovigilance, quality assurance, start-up and regulatory. Project and line management experience and strong organization skills. CRO business development activities including, client development, alliance relationship management, bid defense meetings, and project costing. Global clinical trial management experience including North America, Europe, Asia Pacific. In depth understanding of the drug development process, clinical trials conduct, GCP, ICH, FDA CFR and international regulations. Experience in Phase I - IV clinical trials, including multi-phase protocol design. Experience evaluating and performing due diligence of potential candidates. Experience in all steps of site start-up.

Session Details: Best methods of maintaining a successful relationship with a CRO to ensure each milestone is seamlessly met 31-03-2021, 12:00 pm View In Agenda

Biography: Roger has 30 years of management and drug development expertise from his leading roles in preclinical and clinical drug development programs, regulatory strategy and interactions, funding, and outsourcing to specialist service providers.  With his experience in basic research, large and small pharma, and CRO settings he provides valuable insight into business and R&D operations for pharma/biotech companies.  His specific therapeutic areas of expertise are in diabetes, oncology, gene therapy, and cardiovascular indications.  He is currently President and Co-Founder at BioKier and was previously CEO at Plakous Therapeutics and Senior Scientist in Clinical Development at Cato Research.  Roger received a PhD in Pharmacology and Biochemistry from Melbourne University and completed Postdoctoral fellowships at the National Institute of Environmental Health Sciences and at Burroughs Wellcome.

Session Details: Q&A: Looking at the best methods for securing funding for early stage clinical trials 30-03-2021, 10:30 am View In Agenda

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

Session Details: Outsourcing from a Small Biopharma Perspective 31-03-2021, 11:00 am View In Agenda

Biography: Rodney Villanueva, M.D., received his medical degree from the Uniformed Services University of the Health Sciences in Bethesda, Maryland.  He completed a residency in psychiatry at Tripler Army Medical Center in Honolulu, Hawaii and a fellowship in forensic psychiatry at Walter Reed Army Medical Center in Washington, DC. He also holds a certification in LGBTQ Health from Drexel University.  He had an extensive career as a US Army psychiatrist, spending 16 years in the Army, which included a year-long deployment to Iraq. He is currently a psychiatrist with Atrium Health in Charlotte, NC where, he serves as the Psychiatry Clerkship Director, the Associate Program Director for the Psychiatry Residency Program, and the Co-Medical Director of the Behavioral Health Advanced Practice Provider Fellowship Program.  He is an advocate for diversity and inclusion in healthcare, with particular interest in LGBTQ mental health. He has spearheaded efforts to raise awareness in LGBTQ health such as establishing an annual LGBT healthcare symposium with the Charlotte Area Health Education Center. He has spoken nationally and internationally on LGBTQ mental health as well as on the topic of minorities in clinical trials. Dr. Villanueva is an Assistant Professor of Psychiatric at Carolinas Medical Center and an Adjunct Associate Professor of Psychiatry at the University of North Carolina School of Medicine.

Session Details: DAY TWO KEYNOTE - Ensuring trials are reaching diverse populations as a means of ensuring success by meeting enrolment quotas 31-03-2021, 8:30 am View In Agenda

Biography: Ryan Hovda, Senior Director, Strategic Sourcing at Novan, Inc., has ~13 years of Pharmaceutical Industry outsourcing, contracts management, and client/service provider relationship management experience.  Mr. Hovda has represented both service provider and sponsor organization negotiations, beginning his career at Parexel as a pricing analyst and culminating in a contracts departmental leadership position during his tenure there.  Making the switch to sponsor side representation, Mr. Hovda has held leadership roles within the clinical development contracts/vendor management teams at Biogen, Array Biopharma (acquired by Pfizer), and Bioverativ (acquired by Sanofi).  In his current role at Novan, he is responsible for both clinical development outsourcing (encompassing CRO/vendor outsourcing, clinical site contracting, and related financial/relationship management oversight), and also supports pre-clinical, CMC, and other business related contracts and outsourcing activities. Mr. Hovda holds an undergraduate degree in finance, and a MBA from National University.

Session Details: Navigating RFP development to ensure strong contract negotiation to promote clear communication and milestones within your study 31-03-2021, 9:30 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 VP, Clinical Operations at Lexicon Pharmaceuticals a small biotechnology company located in The Woodlands, Tx.

Session Details: Matchmaking between CRO’s & trial sponsors to find the right fit for your study 30-03-2021, 11:30 am View In Agenda

Biography: Mr. Recinella has over 35 years of experience in medical devices and has taken numerous products from feasibility to commercialization.  His experience covers a wide array of devices ranging from Class I to Class III and has included the development of implants, combination products, hardware and consumables.  Most of his career has been spent in engineering (R&D and Operations) and project management, but he also has experience in product management, regulatory and clinical. Dan started his career at Sarns (a division of 3M) where he was part of the team developing one of the first LVAD’s as well as consumables for open heart surgery procedures.  From there he moved on to Mansfield Scientific, followed by AngioDynamics where he last served as interim Chief Technology Officer before leaving in 2012. Dan was at Veniti where he served as one of the executive level managers and led R&D, Operations, Clinical and Regulatory. He left Veniti after the company was successfully acquired by Boston Scientific in 2018.  More recently, Dan served as the EVP of Device Development for ImmunSYS, Inc, a start-up company focusing on immunotherapy treatment for adenocarcinomas.  Dan currently is the VP of Product Development for Amsel Medical Corporation.  Amsel is developing a novel method for the treatment of non-compressible vessel trauma. Dan is named on numerous patents and patent applications.  Dan holds a bachelor’s degree in Mechanical Engineering from the University of Michigan-Ann Arbor and an MBA from State University of New York-Albany.

Session Details: Effective techniques for reviving a study that has gone off track 31-03-2021, 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: GlobalData Opening Address 30-03-2021, 8:15 am Debate: Decentralized Trials; the future of medicine or a disaster waiting to happen? 30-03-2021, 3:00 pm Challenges and considerations for cell therapy trials 30-03-2021, 3:30 pm View In Agenda

Biography:

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: Asia Pacific: The solution for accelerating your clinical trial program 30-03-2021, 9:00 am View In Agenda

Biography: Dr. Treiber is a CRO industry veteran with 28 years of clinical development experience. Most recently, Dr. Treiber was Chief Operating Officer at Elligo Health Research. Before that, he was Executive Vice President, Biopharmaceutical Development and GM at Chiltern. Dr. Treiber began his career as a Clinical Research Assistant at a large CRO. Since that time, 23 of his 28 years in the industry have been at CROs. He has also worked at Hospira and Elligo Health Research gaining valuable pharma and site network experience, respectively.   Dr. Treiber has expertise in clinical operations, clinical development, medical affairs, data management/statistics, pharmacovigilance/safety and quality. He has broad therapeutic expertise in neuroscience, oncology, hematology, pain, cardiovascular, gastroenterology, respiratory and women’s health.   Scott has a BA in biology from the University of Iowa, a PhD in neuroscience from the University of California Santa Cruz and an MBA from New York Institute of Technology.

Session Details: Moving the needle on diversity, equity, & inclusion in clinical trials 30-03-2021, 10:00 am View In Agenda

Biography: Anastassia is holding master's degree in Biology and spent 5 years in cancer research laboratory to specialize thereafter in regulatory affairs, policy and patient engagement in the scope of clinical research. She was part of several IMI and EU funded projects, has been closely following the development and implementation of EU directives and regulations relevant to clinical research, including GDPR, but also others such as clinical trials regulation, in vitro medical device regulation, etc. After almost 20 years of work at headquarters of one of the largest European non-for-profit clinical research sponsor (EORTC), Anastassia joined MyData-Trust to bring her expertise at the service of a large circle of organizations active in life science.

Session Details: GDPR applied to Clinical Research: how to minimize risks and avoid the fines in 9 steps? 30-03-2021, 12:00 pm View In Agenda

Biography: After receiving her PhD in developmental neurobiology, Julia started her career as a medical writer in the regulatory group at Hoechst Marion Roussel (later Sanofi) in 1997. Since then she has been president of the European Medical Writers Association (EMWA) twice (2001-2002, 2007-2009). In 2002, Julia co-founded Trilogy Writing & Consulting, a company specialized in providing regulatory medical writing. In addition to managing the company as President/Senior Partner, she writes a wide array of clinical documents including study protocols, study reports, and is specialized in the clinical parts of CTD submission dossiers.

Session Details: The value proposition of good medical writing for clinical study protocols 30-03-2021, 1:30 pm View In Agenda

Biography: Andi DeStefano is an ACRP (Association of Clinical Research Professionals) Certified Professional with 15 years of biotech and 20 years of healthcare management experience. She has a Bachelor of Science degree in Management Studies from Saint Joseph’s University in Philadelphia, PA, and a Post Baccalaureate Certificate from Drexel University School of Medicine for Clinical Research Organization Management. Andi is dedicated to Veracity Logic’s clients, helping them select the right IRT modules for their study to provide the most efficient, user-friendly system and making sure their deadlines are met.

Session Details: Robust Validation and UAT best practices for your IRT 31-03-2021, 9:00 am View In Agenda

Biography: Heather DiFruscia is the Associate Director RTSM / IWRS and is responsible for managing and overseeing the RTSM department operations, strategy, processes, and software product development.

Session Details: Preventing Failure: How to leverage people and technology to mitigate common FDA audit findings 30-03-2021, 2:30 pm View In Agenda

Biography: Brian Dempster has over 25 years of clinical development experience, gained across a variety of therapeutic areas and geographical regions. He began his career as a CRA before being accepted to Amgen’s Leadership and Management Program. During a decade at Amgen, Brian held program leadership positions in Oncology, Endocrinology and Bone Health in Europe, Canada and the US.   In 2014 Brian joined Vital Therapies (VTL) where he was instrumental in the creation and execution of clinical development strategy, overseeing the entire Phase II and Phase III programs of VTLs combined device and biotherapeutic system for the treatment of liver failure.   Utilizing Fusion eClinical Suite in partnership with Axiom: Before joining Axiom, Brian led the clinical development group at Endologix, which oversaw the global team involved in the pre-approval and post-market clinical development of Endologix’s products, serving patients with a need for abdominal aortic aneurysm sealing and repair.   Brian has a thorough understanding of the clinical development process and has used this to successfully bring products to market. This includes leading teams through several regulatory inspections in relation to submissions, to FDA, MHRA and PMDA. Brian has a particular interest and passion for trial documentation standards, having forged the path for introduction and transition of several eTMF programs.

Session Details: Preventing Failure: How to leverage people and technology to mitigate common FDA audit findings 30-03-2021, 2:30 pm View In Agenda

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Session Details: Digital Strategies to Power #NoGoingBack 31-03-2021, 10:00 am View In Agenda

Biography: Louisa Roberts is VP Corporate Development and Partnerships at PRA Health Sciences. Her role focusses on the identification of capabilities and go to market strategies partner organizations can provide, to accelerate PRA’s transformation from a CRO into a Healthcare Intelligence Organization. She works with product, scientific and operations leadership to develop partnerships that accelerate growth of both existing and new offerings. Throughout her career Louisa has enjoyed applying data and technology/ AI to adress biopharma’s most pressing drug discovery and development needs. She has a Masters in Chemistry from the University of Edinburgh and developed her business acumen through receiving her MBA from the Tuck School of Business at Dartmouth.  Louisa lives in New Jersey with her husband and spends her free time trying to keep up physically and intellectually with her two daughters.

Session Details: Implementing decentralized clinical trials and CRAACO strategies - enabled by emerging Digital Health Technologies 30-03-2021, 11:00 am View In Agenda