Outsourcing in Clinical Trials Southeast 2022

Biography:

Session Details: Insights from viral vector: Harnessing insights to achieve patient onboarding for a targeted patient population 29-03-2022, 2:30 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: PANEL DISCUSSION From pre-clinical to clinical: Getting started in clinical trials and exploring avenues of funding for early-stage clinical trials 29-03-2022, 4:15 pm View In Agenda

Biography:

Session Details: Unlocking the potential of remote monitoring activities in clinical trials to promote data quality collection 29-03-2022, 11:30 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: Accelerating team relationships and collaborations to elevate the overall success of the trial 29-03-2022, 3:45 pm View In Agenda

Biography: Dr. Rosenberg is a 30 plus year executive with proven experience in driving operational excellence at all levels within the pharmaceutical, biotechnology, eclinical and contract research organization sectors. With his diverse background which includes executive management, clinical and regulatory operations, business development, eclinical technology solutions and new product/licensing evaluations, he brings tremendous hands on insights to optimizing the drug development cycle, from the early start-up stage to global product registration across many key therapeutic areas including CNS and oncology. Dr. Rosenberg is Managing Partner of eP2Consulting, Inc. since 2001. He also currently serves as Head, Clinical Operations at Beat AML, LLC, a division of The Leukemia & Lymphoma Society. Dr. Rosenberg received his Ph.D., from the Kellogg Pharmaceutical Clinical Scientist Program, University of Minnesota, College of Pharmacy and his Bachelor of Science, Pharmacy, from the Philadelphia College of Pharmacy and Science. Contact Information: 4 Quail Court, Mount Laurel, NJ 08054 (c: 609-923-9443)

Session Details: Unleashing the power of advanced genomic technology when matching patients to the most promising treatment and exploring the reality of current technological trends disrupting the industry 29-03-2022, 9:30 am View In Agenda

Biography:

Session Details: PANEL DISCUSSION From pre-clinical to clinical: Getting started in clinical trials and exploring avenues of funding for early-stage clinical trials 29-03-2022, 4:15 pm View In Agenda

Biography:

Session Details: PANEL DISCUSSION From pre-clinical to clinical: Getting started in clinical trials and exploring avenues of funding for early-stage clinical trials 29-03-2022, 4:15 pm View In Agenda

Biography:

Session Details: PANEL DISCUSSION Moving forward: Using lessons learned from the impact of COVID 19 on the way we conduct future clinical trials 30-03-2022, 10:00 am View In Agenda

Biography: Bonnie Bain, PhD, is the Global Head and EVP of Healthcare Operations and Strategy. Bonnie has over 20 years’ experience in the healthcare sector and a proven track record of developing innovative solutions on both the client and agency sides of the business. Bonnie was GlobalData Healthcare’s first Western analyst, and under her leadership, the company launched a number of premium syndicated reports, analytical tools, and databases in the pharmaceuticals and medical devices space. Prior to GlobalData, Bonnie was Vice President and Global Research & Analysis Director for Informa’s Pharma Division, which includes Datamonitor Healthcare, Scrip Group, and Business Insight. Bonnie also worked for several years at Decision Resources as an Analyst and Project Manager. On the client side of the industry, Bonnie worked for several years as a Senior Manager in Marketing Strategy and Analytics at Boston Scientific, where her work contributed to the successful commercialization of the first ever Access and Visualization Platform at the company. Bonnie has a PhD in Biochemistry and Molecular Biology from Purdue University and completed a Post-Doctoral Fellowship in Molecular Pharmacology at the University Of Miami School Of Medicine. She also has a graduate certificate in Applied Management Principles from Purdue University Krannert School of Management.

Session Details: The pharmaceutical industry's digital transformation; The changing future of the workplace 30-03-2022, 9:00 am View In Agenda

Biography:

Session Details: PANEL DISCUSSION Moving forward: Using lessons learned from the impact of COVID 19 on the way we conduct future clinical trials 30-03-2022, 10:00 am The development in home health: getting creative in clinical trials 30-03-2022, 2:30 pm View In Agenda

Biography: Behtash Bahador is an Associate Director at the non-profit organization CISCRP, and holds a Master of Science in Health Communication from the Tufts University School of Medicine. Since 2014, 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.

Session Details: KEYNOTE Patients as Partners, Patient Centricity and Patient Engagement 29-03-2022, 8:30 am PANEL DISCUSSION: Challenges related to Diversity, Equity and Inclusion for Clinical Research 30-03-2022, 10:30 am View In Agenda

Biography:

Dave is an entrepreneur and technology innovator. He is known for pioneering the fields of A.I.-based medical decision-support, Training Analytics, and Virtual Clinical Simulation (VPS).

When he was Founder and CEO of TheraSim, Dave launched the world’s first successful online VPS system for physicians and trained over 1,000,000 doctors in every country on Earth. He also built the world’s largest network of computer-based clinical simulation sites in Africa in support of the USAID and the CDC’s HIV-treatment effort.

Since then, he has focused his passion for technological innovation and learning systems in the field of clinical trials, helping sponsors make their studies more accurate and efficient through finding the right technology mix such as virtualization, performance management and applied behavioral sciences to produce the most effective, lasting, and engaging results for clinical trials.

Dave is passionate about building performance management systems that are fun to use, predictive, adaptive, and measurably effective, producing lasting changes in a quickly changing field. Dave has always valued the interconnectedness of our vastly changing world and has traveled to over 70 countries for global health work and with cultural development outreach through music.

Session Details: Remote SIV and study training is not a panacea, better training is. These approaches deliver measurable results and high impact ROI. 29-03-2022, 9:00 am PANEL DISCUSSION Moving forward: Using lessons learned from the impact of COVID 19 on the way we conduct future clinical trials 30-03-2022, 10:00 am View In Agenda

Biography:

Session Details: Confronting the issues of site engagement in the evolving clinical trial landscape 29-03-2022, 10:00 am View In Agenda

Biography:

Session Details: The Growing Constellation of Asset Development Partnerships 29-03-2022, 11:00 am 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: Innovative solutions for today’s clinical trial needs 29-03-2022, 12:00 pm View In Agenda

Biography: Sverre Bengtsson started in the clinical trials industry over 30 years ago. He started as a statistician/statistical programmer, later into data management and since over 20 years into business development. He has been working in both CRO’s as well as in clinical trials technology companies, including the global first ePRO company. 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. He’s on the board of both some industry organisations and in clinical technology companies.

Session Details: Decentralized Clinical Trials/Hybrid Trials: What you need to understand to run them successfully 29-03-2022, 2:00 pm View In Agenda

Biography: Dawn has over 20 years of experience in the pharmaceutical industry. She have worked within every level of clinical data management, from Data Coordinator to Senior Director where she participated in or had oversight for more than 250 clinical trials. During her time in the industry, she has provided consultation to organizations on clinical trial conduct, best practices in Data Management and data capture as well as developed standardized libraries and templates to support the adoption of CDISC standards. She is an active member of SCDM as a GCDMP SME, course designer and webinar presenter as well as former Co-Chair of the annual conference (2018-2021) and serves on the SCDM Board of Trustees. Dawn is involved as a member of the CDISC-CDASH core team, Diabetes sub-team, CDASH CFAST Expanded Leadership Team and former Co-Chair of the CRF Library project. Dawn currently holds the position of Senior Director, Data Strategies, where she supports business development as a Clinical Subject Matter Expert for both software and data services.

Session Details: Data-Driven Operations and Oversight with elluminate 29-03-2022, 3:00 pm View In Agenda

Biography: Derek Ansel, CCRA, has more than 8 years of experience in clinical laboratory research, monitoring, and project management in Phases I-IV. He has a wide breadth of therapeutic experience including non-malignant hematology, vaccines, infectious diseases, and nephrology. He is a 4-time US PharmaTimes Clinical Researcher of the Year finalist and is currently pursuing a master's degree in pharmacology and toxicology from Michigan State University. He is a writer for the Vaccine Education Center at the Children's Hospital of Philadelphia, an active consultant for several start-ups in the eClinical software space, and serves on the institutional review board (IRB) at Thomas Jefferson University in Philadelphia, PA. He is also a contributing member of Cochrane, a non-profit organization that promotes evidence-based decision making in healthcare

Session Details: A DCT Approach to Enrolling Rare Disease Patients in Complex Studies? 30-03-2022, 9:30 am View In Agenda

Biography:

Session Details: PANEL DISCUSSION Moving forward: Using lessons learned from the impact of COVID 19 on the way we conduct future clinical trials 30-03-2022, 10:00 am View In Agenda

Biography:

Session Details: PANEL DISCUSSION Moving forward: Using lessons learned from the impact of COVID 19 on the way we conduct future clinical trials 30-03-2022, 10:00 am View In Agenda

Biography:

• Focusing on key role of participants in clinical studies with opportunities for healthcare access and contributions to diversity in clinical trials
• Current and former role as VP, Clinical Operations (SiteBridge Research, Takeda, Revance); VP Clinical Development (Meitheal/Xentria, AnaptysBio) and Head of Strategic Operations/Clinical Research Operations (Pfizer, Avexis, Astellas) leveraging early and late stage Drug Development and global clinical trials experience toward creating a high-performance teams and outsourcing plans for clinical trials
• Experience in Global Development, Clinical Operations, Scientific Strategy and Clinical Affairs over the last 20+ years from bench to commercial; mergers, licensing and acquisitions and organizational evolution
• Global experience including reports both within NA and outside US (including Canada, Eu, Jpn)
• Former Astella’s Board member on AVOCA, Operations Committee member with Transcelerate, scientific development liaison for IFPMA/WHO Clinical Fellowship program.
• Key driver -- business case as part of Takeda strategy for Asia development operations in Singapore
• Therapy areas of experience: Women’s Health, Musculo-skeletal Disorders, Oncology, Immunology/Inflammation, InfDiseases, Urology/Nephrology, CKD, Metabolic Diseases, CNS/Pain/Movement Disorders

• Contributions to development, regulatory submissions and/or approval of DaxibotulinumtoxinA, ZolgenSMA, Myrbetriq, Xtandi, Rozerem, Cresemba, ACTOS, Lipitor, Lyrica, Actonel; numerous INDs/ODAs including mabs for rare diseases, pivotal trials for dermatologic and respiratory diseases
• Developing global strategy for Astellas’ Global Operating Model/Global Project Team, including implementation in US, EU and Jpn ; this model remains in place for some 2000+ colleagues in Astellas Medical/Development.
• Globalizing Clinical Operations at Takeda, establishing ‘business units’ with Clinical Program Managers/Study Manager in alignment with key TAs for which Takeda was developing compounds and having high stds/global processes to run projects from Phase I – IV, including internal processes and those for overseeing outsourced study management activities.
• Recognized leader and mentor Pfizer, Takeda and Astellas as a leader and mentor.

Session Details: PANEL DISCUSSION: Challenges related to Diversity, Equity and Inclusion for Clinical Research 30-03-2022, 10:30 am View In Agenda

Biography:

Session Details: PANEL DISCUSSION: Challenges related to Diversity, Equity and Inclusion for Clinical Research 30-03-2022, 10:30 am View In Agenda

Biography:

Session Details: PANEL DISCUSSION: Challenges related to Diversity, Equity and Inclusion for Clinical Research 30-03-2022, 10:30 am View In Agenda

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Session Details: Q&A: Maintaining effective strategies for the development, implementation, and oversight for ongoing and planned clinical trials 30-03-2022, 2:00 pm View In Agenda

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Session Details: Q&A: Laying out the US clinical trial regulatory landscape 29-03-2022, 1:30 pm View In Agenda

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Session Details: Confronting the issues of site engagement in the evolving clinical trial landscape 29-03-2022, 10:00 am View In Agenda

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Session Details: Case study: Exploring GIST oncology tumour trials 30-03-2022, 11:30 am View In Agenda

Biography: As a scientist, researcher, and educator for more than 25 years, Ingrid looks at healthcare from a holistic perspective -- ensuring a patient-driven focus is combined with data-driven science. Using digital data to promote precision medicine, Ingrid focuses on increasing the pace of medical discoveries and ultimately bringing therapies to patients faster, as well as delivering solutions to people when they want them and where they want them. As Senior Vice-President of Research and Strategy for Medable Inc., Ingrid uses strong technical, analytic and genetics background to improve the clinical trial experience for patients. The focus is on modernizing clinical trials, the digital virtual healthcare space, and creating technology and tools to collect precision data so we can get solutions to patients in half the time.

Session Details: Deploying decentralised clinical trials platforms: What the data tells us 30-03-2022, 12:00 pm View In Agenda

Biography:

Session Details: Q&A: Maintaining effective strategies for the development, implementation, and oversight for ongoing and planned clinical trials 30-03-2022, 2:00 pm View In Agenda