Outsourcing in Clinical Trials Texas 2019

Biography: Dr. Giles has been President, CEO and Director of Vapogenix since July 2017. She joined Vapogenix in 2009 as Chief Scientific Officer and has provided scientific and drug development leadership, in addition to making significant contributions to overall company strategy and to successful fundraising. Dr. Giles has held international leadership positions in large and small pharmaceutical companies and has wide experience in drug discovery and development from target validation, through clinical studies to final regulatory submission. She recently led Vapogenix through the successful completion of a Phase II clinical trial in Australia.  

Session Details: CASE STUDY: Uncovering strategies for planning and executing a clinical trial in Australia, drawing on experience from a small company’s perspective 11-09-2019, 3:15 pm View In Agenda

Biography: Adina Pelusio brings more than 15 years of experience in drug development, most recently as the Vice President, Clinical Operations at SillaJen Biotherapeutics (formerly Jennerex, Inc), where she spent a decade advancing oncolytic viruses in clinical trials. In addition to overseeing the Clinical Operations department at SillaJen, she managed and pioneered the medical educator role to expand hospital personnel comfort and knowledge globally with working on these types of agents. Prior to Jennerex, Ms. Pelusio served as a SWAT Senior Clinical Research Associate at PPD, a large, global CRO, where she was tasked with study rescue and served on a technology committee assigned with developing training for CRAs and project teams on new technologies within the field.   As we discussed, a topic for the event is clinical trials are becoming increasingly complex and require an increase in the scope of site education. Strategies for engaging and ensuring protocol compliance amongst multiple stakeholders on site.  Cancer therapies are increasing utilizing complex biologics such as live replicating viruses or bacteria and radioactive materials, but clinical sites remain uneasy or ill-suited to with the preparation, administration, or handling of these products and/or the patients receiving them.  In these instances, designing and outsourcing education to clinical sites may a strategic plan between the Sponsor and the CRO, as well as specialized educators above and beyond the classic CRA model to increase patient enrollment and site interest in this and future studies -      Identifying stakeholders -      Designing a comprehensive education plan -      When and what activities can be outsourced, but which activities should remain in-house -      Benefits and budget impacts

Session Details: Strategies for engaging and ensuring protocol compliance amongst multiple stakeholders on site 12-09-2019, 12:00 pm View In Agenda

Biography: Dr. Watowich is inventor of Ridgeline Therapeutics' technology, upon which he founded the company. He serves as the company's interim CEO to help with the launch and capitalization of the company.Additionally, he is Associate Professor of Biochemistry & Molecular Biology at the University of Texas Medical Branch and recent director of the University of Texas (UT) System's state-wide entrepreneurship program developed in partnership with UT McCombs School of Business. He is an accomplished educator, researcher, serial inventor, entrepreneur, and developer of innovative world-class resources.

Session Details: Striking a balance between outsourcing and utilizing in-house resources to improve trial efficiency: Which model offers the most value to the sponsor? 12-09-2019, 9:30 am View In Agenda

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Biography: Jason Jones has over 25 years experience in clinical research operations. He specializes in medical device and drug development research with advanced knowledge of FDA approval criteria.  Jason is the Vice President of Clinical and Scientific Affairs at LivaNova, a medical device company.  He has a Master's Degree in Exercise Physiology and is dual certified in clinical and regulatory affairs and is an advocate for advanced clinical research education.

Session Details: Key considerations for executing rapid study start-up with multiple vendors 12-09-2019, 9:00 am View In Agenda

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Session Details: Evaluating recruitment and engagement strategies to develop a successful rare disease drug development model 11-09-2019, 9:00 am Striking a balance between outsourcing and utilizing in-house resources to improve trial efficiency: Which model offers the most value to the sponsor? 12-09-2019, 9:30 am View In Agenda

Biography: Jane Hart has worked in the Clinical Research Industry for over 22 years, with 5 of those years in the Medical Device Industry.  She joined KCI in 2017 leading the Clinical Operations, Data Management, Biostatistics and Global Safety departments. Her team is focused on generating evidence to support the safe and effective use of KCI products primarily through company sponsored and investigator sponsored research. Jane started her career in Australia working in breast cancer research and relocated to the US 17 years ago.  She is experienced with executing pre and post market studies globally for both drug and devices.  Highlights of studies she has managed include FDA approval of a nanocoated cardiac stent, hormonal therapy for breast cancer and chemotherapy for hematological malignancies.   Jane is currently a member of the Association of Clinical Research Professionals (ACRP) and is PMP certified with the Project Management Institute.  In addition, Jane is a graduate of Charles Sturt University, Australia.

Session Details: Comparing international with local medical device trials to develop strategies for overcoming barriers 11-09-2019, 4:15 pm Speaker Hosted Roundtables 12-09-2019, 1:45 pm View In Agenda

Biography: Patrick T. Moran is the founding board member of the Texas Cannabis Industry Association. Beginning October of 2013, he started to apply his professional experience to the emerging cannabis industry. He maintains Texas State Bar licensure and invested time & energy into the last three Texas legislative sessions, to help advance cannabis law reform. Mr. Moran is also founder and CEO of Pebble Global Holdings (www.pebble.life) an emerging bio-pharmaceutical company committed to natural plant solutions that include CBD-based products. Coming from a family with three generations of medical professionals on his mother’s side and six generations of industrial-scale agriculture & entrepreneurship on his father’s, he has led the company’s R&D, guided overall strategy and successful fundraising. Post Texas Hemp legalization, he is now helping advise TCIA coming into the 2020 elections and using the results of Pebble’s in-house clinical trial to inform subsequent larger scale studies.

Session Details: CASE STUDY: Discovering the operational challenges and successes of our recent CBD clinical trial to identify lessons learned and explore the future of CBD clinical studies 11-09-2019, 4:45 pm View In Agenda

Biography: Alicia Kae Miller is the Director, Patient Engagement, at Aeglea BioTherapeutics, Inc. Alicia has been with Aeglea since January 2017. Her work in biotechnology includes eleven years at BioMarin Pharmaceutical Inc. in varying capacities with increasing responsibilities.   Alicia is an accomplished patient engagement professional and versatile organizational manager with extensive training and planning experience in community-based advocacy. She obtained her BA from Dominican University of California and is currently a graduate student at St. Edward’s University in Austin, TX, and expects to receive her MSc in Leadership and Change in May 2020.

Session Details: Patient Perspectives Panel Discussion: A Stakeholder Conversation 11-09-2019, 10:00 am View In Agenda

Biography: Tara Burt has more than 15 years of experience in clinical research including clinical study design, project management, new product development, and clinical evidence strategy in both the medical device and pharmaceutical sectors. She is currently responsible for overall clinical study operations and execution, and strategy for Procyrion. Tara holds a B.A. from the University of Rochester and has held certifications in both clinical research and regulatory affairs.

Session Details: A Data-Driven World: Unlocking how to properly utilize Real World Evidence/Data to improve study design and execution 11-09-2019, 2:45 pm View In Agenda

Biography: Anastasia Gutierrez is a Director, Clinical Program Management at Bellicum Pharmaceuticals, where she is managing the execution of Adaptive Cell Therapy programs including timelines, deliverables, scope, risks and budget. Anastasia has almost 20 years of clinical research experience, with a focus on early phase oncology studies. Prior to joining Bellicum, Anastasia spent a number of years on the CRO side of industry where she managed a number of global Phase I-IV studies across Americas, Europe, Middle East, Africa and Asia/Pacific Rim.  She is a native of Russia and has her medical degree from Smolensk State Medical Academy. She came to the US in 2003 and settled in the Houston area, where she currently lives with her family

Session Details: Revealing Strategies to Work With CRO Partners to Ensure the A-Team for Your Trial 11-09-2019, 12:15 pm View In Agenda

Biography: Dr. Sofia de Achaval Wied is an epidemiologist with over 10 years of experience in clinical research. She began her career in Houston in psychosocial research and transitioned into research administration roles at leading academic research institutions in the Texas Medical Center. This year she expanded her clinical research and drug development experience by joining Tvardi Therapeutics, where she serves as the Executive Director of Research and Development.

Session Details: Speaker Hosted Roundtables 12-09-2019, 1:45 pm View In Agenda

Biography: Whitnie is a graduate of the University of Texas with a degree in Public Relations. She lives in the beautiful Texas Hill Country with her husband, Steve. They have three children, Rhett (11), Reid (9) and Cora (7). Reid was diagnosed with CTD at 2 1⁄2 years old. Whitnie is a passionate advocate for CCDS. She has served as a panelist at the FDA Inborn Error of Metabolism public forum and is actively involved in fundraising, marketing, and other initiatives to bring heightened awareness to the CCDS community. Aside from her work with the Association for Creatine Deficiencies she also runs the graphic design company, Strauss Design Group, LLC.

Session Details: Patient Perspectives Panel Discussion: A Stakeholder Conversation 11-09-2019, 10:00 am View In Agenda

Biography: Catherine has over 20 years’ experience in clinical research with a focus on complex and early phase oncology trials, including oncolytic viruses.  Prior to joining the newly founded Turnstone Biologics, in 2016, Catherine acquired invaluable experience on the site side of clinical research, including program management and serving as a reviewer for an oncology based ethics board for 5 years.  In her new role as Clinical Site Education Manager at Turnstone Biologics, Catherine draws upon all of this experience to provide a unique level of support to sites.

Session Details: Strategies for engaging and ensuring protocol compliance amongst multiple stakeholders on site 12-09-2019, 12:00 pm View In Agenda

Biography: Gowri Sukumar is the Director, CMC and Regulatory Affairs for Iterion Therapeutics, Houston, TX. Unique to her experience is leading all the technical disciplines of CMC development as well as regulatory Affairs. She has broad responsibilities that include process development, Drug Substance and Drug Product manufacturing from the CMC side. From the Regulatory affairs perspective, she provides regulatory leadership and expertise for regulatory strategy, liaises with the regulatory agencies including FDA, Health Canada and other Health authorities. For her leadership approach, she brings a strong focus beyond the necessary technical disciplines and regulations, looking at the interplay of culture and teamwork for successfully advancing programs in an effective and efficient manner.  Gowri holds a master’s Degree in Biosciences as well as the prestigious Regulatory Affairs Certification (RAC) awarded by the Regulatory Affairs Professional Society.  She is the author or co-author of several peer-reviewed research publications as well as book chapters. Gowri has breath of experience spanning R&D, CMC and Regulatory affairs. She also serves as a reviewer for several international Bioscience Journals for providing Scientific and technical expertise.

Session Details: Understanding Initial IND 11-09-2019, 11:15 am View In Agenda

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Session Details: TMC Innovation: Accelerating life science startups in Texas 12-09-2019, 11:15 am View In Agenda

Biography: With over 15 years’ experience in clinical research, following 15 years in academia, Dr. Jacob ‘s experience working within the corporate infrastructure as well as establishing successful sponsor/site relationships, has allowed her to successfully develop and launch both large and small clinical trials across the research spectrum – retrospective, post market and IDE  studies.  She has been a study coordinator, then a CRA, a manager, director and is now Vice President of Research and Clinical Affairs at several medical device companies.

Session Details: Chairman's Opening Remarks 11-09-2019, 8:50 am Comparing international with local medical device trials to develop strategies for overcoming barriers 11-09-2019, 4:15 pm Discussing challenges associated with patient screening and recruitment to reduce timeline delays in orthopedic medical device trials 11-09-2019, 5:15 pm Chairman's Closing Remarks & Close of Day One 11-09-2019, 5:45 pm Chairman's Opening Remarks 12-09-2019, 8:50 am Close of Day Two 12-09-2019, 2:50 pm View In Agenda

Biography: Yan Wang, PhD in Biophysical Chemistry, has been working at MD Anderson since 2010. Started in Molecular Epidemiology research, Yan has joined the clinical research field in the Department of Investigational Cancer Therapeutics (Phase I Program) in 2016 and later moved on to the Department of Leukemia, providing patient care through clinical trials.

Session Details: Clinical trials in MD Anderson – from a site’s point of view 11-09-2019, 1:45 pm View In Agenda

Biography: Kara is responsible for setting the strategic direction and overseeing all pipeline activities for sourcing, selection, screening, onboarding, optimizing and tracking the portfolio across JLABS globally. Kara joined the JLABS team in 2012, shortly after the flagship JLABS site opened at Janssen R&D in San Diego. In her previous role, Kara executed on external engagement, sourcing innovation, portfolio management, operational excellence, educational programming, and P&L for the JLABS in San Diego site. Kara also serves as an Instructor for the I-Corps at NIH program, a program aimed at commercializing biomedical technologies, where she serves as Domain Expert in Therapeutics for NIH SBIR recipient companies. Kara came to JLABS from Galapagos NV in Belgium, where she had various roles of increasing responsibility, including business development, marketing, investor relations and medical communications at a time when the company grew from 60 to more than 800 employees and completed its initial public offering on Euronext. Kara holds a BS in Chemistry from the University of North Carolina at Chapel Hill and a PhD in Biochemistry from the University of Texas at Austin.  

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Biography: Ike Ogbaa, MD is currently the US Medical Affairs Lead for New Products and Integrated Diabetes Care at Sanofi. His current role is to develop the US medical affairs strategy for Sanofi’s pipeline of New Diabetes Drugs, Devices and Digital health Solutions. He has extensive experience throughout the Pharmaceutical value chain in Clinical Pharmacology, Drug Development, Field-based Medical Affairs and Home-Office Medical affairs. He has worked for a CRO, small biotech and 2 large Pharma companies.

Session Details: Speaker Hosted Roundtables 12-09-2019, 1:45 pm View In Agenda

Biography: As Head of Johnson & Johnson Innovation, JLABS in Canada, Allan is responsible for external engagement, innovation sourcing, company onboarding, portfolio management, operational excellence, educational programming and P&L. He catalyzes and supports the translation of science and technology into valuable solutions for patients and consumers across the pharmaceutical, medical device, consumer and healthtech sectors. Allan joined the JLABS team from Janssen Canada, where he has spent the last 12 years in positions of increasing responsibility in business development, marketing and market access. His most recent role was Therapeutic Lead Immunology and Primary Care where he was responsible for market access strategy for a complex product portfolio exceeding $1 billion. Allan started his career at PARTEQ Innovations, the technology transfer arm of Queen's University at Kingston where he was responsible for technology assessment and new company start-up. He then moved to Paladin Labs, where he successfully completed numerous in-licensing transactions for specialty pharmaceutical products for the Canadian market. Allan subsequently worked in business development for two early stage biotechnology companies in Canada leading their business development and partnering initiatives prior to joining Janssen. Allan received his Ph.D. in Neuropharmacology from Queen's University at Kingston, Ontario and his MBA from McGill University in Finance and Strategy.

Session Details: Discussing a model for early stage companies to bring their innovations in therapeutics, medical device or consumer health from concept to fruition 12-09-2019, 10:00 am View In Agenda