Vaccines 2020 Virtual Conference

Biography: have over 30 years of experience in the global pharmaceutical and biological industry and in healthcare IT, both at the helm of operations (from business unit head to general manager and CEO) and in marketing and commercial positions (from product marketing at country level to global marketing strategy). Through these local and global positions, I have acquired direct experience with blockbuster products in diverse markets (primary care, specialty care, hospital, vaccines, and biotechnology), geographies (US, Europe, Japan, China, India, Emerging Markets) and organizations.

Session Details: Commercialising Your Vaccine – What Do You Need To Know 12-08-2020, 11:45 am View In Agenda

Biography: An accomplished start-up and small pharma entrepreneurial scientist with extensive knowledge, experience, and achievement in a wide range of drug discovery and development programs. A respected leader of multi-disciplinary research teams with a strong record of identifying and developing novel assets whether emerging therapeutic targets or novel compounds, ranging from small molecules to biologicals. Experienced in both sell-side and buy-side deal crafting with a strong understanding of the requirements for raising capital and how to manage programs on limited budgets and tight time lines, including the use of virtual resources to achieve corporate goals

Session Details: Outlining The Importance Of The Vaccine Adjuvant QS-21 In The Design Process 12-08-2020, 8:15 am View In Agenda

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Session Details: Reducing The Use Of Antimicrobials Through Innovative Universal Subunit Vaccine Platform Design 12-08-2020, 9:15 am View In Agenda

Biography: Over 20 years of R&D experience in Biotech and Big Pharma, with focus on the development of biotherapeutics and novel therapeutic platforms in oncology. Core expertise in oncology and immune-oncology research and development, spanning from target identification and validation, selection of therapeutic modalities and lead compounds, development of companion diagnostics, translational support for early clinical development and regulatory filings. As CSO and SVP of 3 T Biosciences, Hanspeter is overseeing platform- and therapeutic program development of novel classes of TCR based therapies to enable differentiated, innovative and transformational, cancer therapeutics that impact patients’ lives significantly.

Session Details: Identification Of Novel pHLA Targets For Solid Tumor Targeting 12-08-2020, 10:15 am View In Agenda

Biography: Leadership of the Global Analytical Harmonization and Modernization organization within Global Quality reponsible for driving robustness, harmonization and modernization strategies and programs across GSK Vaccines with the intent to improve quality and timely QC testing

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Biography: Peter Shapiro, PhD, is the Senior Director of Drugs and Business Fundamentals for the Pharma Intelligence Center. He also serves as the Editor-in-Chief of GlobalData PharmSource. Peter previously was involved in the leading the integration of BioPharm Insight, Lead Sheet and PharmSource into GlobalData. Prior to joining GlobalData, Peter was an Assistant Manager at Target Health, a Contract Research Organization (CRO) where he helped a diverse set of clients with the demands of bringing biologics, devices, and drugs to the market successfully. Peter also worked in small molecule drug development for Abbott Labs and on in vitro diagnostics at Ambergen, a diagnostic startup. Peter holds a PhD in Molecular and Cellular Biology from the Sackler Institute of New York University Langone Medical Center and is located in GlobalData’s office in New York City.

Session Details: COVID-19 Vaccines: How to Overcome Manufacturing Challenges? 12-08-2020, 1:25 pm View In Agenda

Biography: Dr. Diaz-Mitoma is a renowned medical scientist and professor who most recently served as a professor of the Northern Ontario School of Medicine (“NOSM”). While in this position, Dr. Diaz-Mitoma was Vice President of Research at Health Sciences North and founder of the Advanced Medical Research Institute of Canada (“AMRIC”) and served as its Chief Executive Officer and Chief Scientist. AMRIC is focused on translational medical and vaccine development research. Prior to joining the faculty at the NOSM, Dr. Diaz-Mitoma was a professor of Pediatrics, Pathology, Laboratory Medicine, and Microbiology at the University of Ottawa. While in this position, he founded the Vaccine and Infectious Disease Centre at the Children’s Hospital of Eastern Ontario (“CHEO”), a pediatric health and research center. Dr. Diaz-Mitoma received his medical degree from the University of Guadalajara, completed fellowship training in Infectious Diseases at the University of Manitoba, and earned a Ph.D. in Virology from the University of Alberta

Session Details: KEYNOTE: High Seroprotection Rate in Adults immunized with a Tri-antigenic hepatitis B. Results of a Phase 3 randomized controlled trial comparing SciBVac and EngerixB 12-08-2020, 12:10 pm View In Agenda

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Session Details: Q&A: Top 5 Risk Management Considerations For Post Marketing In Vaccines 12-08-2020, 12:25 pm View In Agenda

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Session Details: CASE STUDY: Top 5 Tips On How To Manage A Clinical Trial During A Pandemic? 12-08-2020, 1:10 pm View In Agenda

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Session Details: BREAKTHROUGH SESSION: M-001 universal flu vaccine candidate: Pivotal, Clinical Efficacy, Phase 3 12-08-2020, 2:10 pm View In Agenda

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Session Details: CASE STUDY: Development of UB-612: a Designer S1-RBD Fusion Protein Combined With Synthetic Th/CTL Peptides as a Vaccine Candidate For COVID-19 12-08-2020, 10:00 am View In Agenda

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Biography: Dr. Mishra (formerly with Genentech, Roche, NCI, NIH, DHHS, US Government) is the founding president and CEO of the American Association for Precision Medicine (AAPM) and chair of ACT: AAPM Coronavirus Taskforce, a global team that is leading research efforts focused on preventing and curing COVID-19, cancer, and other chronic diseases. He is a serial entrepreneur who founded his first company after graduating high school, and second company while receiving his PhD. Since then, he has accumulated a wealth of experienced by building, investing, and advising numerous companies

Session Details: AI Innovations and Strategies To Counteract COVID-19: The Story of AAPM ACT, the first Global Coronavirus Global Taskforce 12-08-2020, 10:30 am 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.

Session Details: Benefits and Advantages Of Using Blockchain To Conduct Decentralized Clinical Trials During and Then Beyond a Pandemic 12-08-2020, 3:25 pm View In Agenda

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Norbert has been with Axon since its establishment in 1999. He has played a key role in guiding discoveries and has helped transform Axon’s portfolio of products, which eventually led to his appointment as CSO in 2015.

He has co-authored the project Synaptic Dysfunction in Alzheimer’s Disease (Marie Curie Innovative Training Network). In addition, he serves as the national coordinator and Chairman of the Neuroscience session at the first Frontiers of Science Meeting

Session Details: OPENING KEYNOTE: The AXON Multi-Peptide Vaccine COVIDAX Against COVID-19 – The Proper Solution For Vulnerable Populations 12-08-2020, 8:00 am View In Agenda

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Session Details: Understanding The Global Regulatory Processes In The Vaccine Space During COVID-19 12-08-2020, 2:40 pm View In Agenda

Biography: Ben is the CEO of LedgerDomain, founded in 2016 to bring blockchain solutions to enterprise ecosystems, unlocking a world of communal computing and real-time performance. After doing undergraduate and graduate work at MIT, Ben spent a quarter of a century incubating and investing in early-stage technology companies. In partnership with the Clinical Supply Blockchain Working Group (CSBWG), the world's largest pharmaceutical blockchain consortium, LedgerDomain developed the world's first iOS blockchain app for the clinical supply chain. In 2019, LedgerDomain also partnered with UCLA on a pilot for the US Food & Drug Administration (FDA) on a last-mile application that helps deliver lifesaving medications to babies.

Session Details: Blockchain and Drug Supply Assurance in the Coronavirus Era 12-08-2020, 2:25 pm View In Agenda

Biography: Scientist with extensive experience in Cancer Immunology. Current focus on Individualized Neoantigen Specific Therapy. Interested in innovative technologies to provide novel immunotherapy for cancer patients

Session Details: Characterizing Neoantigens To Improve Prioritization For Neoantigen-Specific Cancer Vaccines 12-08-2020, 10:45 am View In Agenda

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Session Details: Preference For An Oral Tablet COVID-19 Vaccine 12-08-2020, 11:30 am View In Agenda

Biography: Jesse Sevcik is a public and government affairs executive with more than 20 years of private sector, political, and government experience. In his current role as Executive Advisor, Global Government Affairs at Elanco Animal Health (NYSE: ELAN), he leads a team of senior professionals who interact with governments and other stakeholders on a wide range of policy and political issues such as access to medicines, food safety, trade, and intellectual property protection. Jesse builds positive relationships with government, trade organizations, and key stakeholder advocates and is well known for proactive policy and strategy development, leading negotiations, and resolving complex issues for the business. In recognition of his focus on delivering results and his communicative, decisive and transparent approach, he enjoys strong relationships with senior business leaders.

Session Details: How can public policy evolve to enable vaccine innovation, investment, and One Health solutions? 12-08-2020, 3:10 pm View In Agenda

Biography: Divya Chadha Manek both establishs and maintains existing strategic relationships with global and UK life sciences companies. Facilitation is her forte: working collaboratively with companies she advises, guides and connects people so that study sponsors and CROs who deliver research, derive maximum benefit from the support provided by the NIHR - the most integrated health research system in the world. From her roots in commercial research delivery in NHS hospitals, Divya went on to manage a national portfolio of commercial mental health studies before progressing to her current role. With this wealth of experience under her belt she can provide expert advice on how to use the NIHR services to optimise successful delivery of clinical trials in the UK

Session Details: KEYNOTE: Coordinating COVID19 Vaccine Trials For Success 12-08-2020, 9:00 am View In Agenda

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As Founder & Chief Executive Officer of Axiom, Andrew Schachter provides the visionary leadership integral to the company’s more than 17 years of eClinical technology and managed services success.

Axiom’s Fusion eClinical Suite, the leading unified eClinical platform, has been used to run hundreds of studies across a wide range of therapeutic areas, from Phase I to global Phase III studies and registries.

Session Details: IRT Done Right In 60 Days 12-08-2020, 12:40 pm View In Agenda

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Biography: Nadeeka is a neuroscientist and digital health outcomes expert with in-depth experience consulting on pre- and post-approval clinical trials. At ERT, Dr. Dias provides scientific and technology guidance to global sponsors on electronic clinical outcome assessments (eCOA) across several therapeutic areas. In addition to leading the ERT Science team in thought leadership strategy, her expertise extends to eCOA regulatory guidance, instrument development and validation, and eCOA product/software design. She has presented numerous abstracts at global conferences and published several articles on the patient perspective in clinical trials. Prior to joining ERT, Dr. Dias conducted clinical research at Harvard Medical School.

Session Details: Using Technology To Support Vaccine Trials In The Era Of COVID-19 12-08-2020, 8:45 am View In Agenda

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Session Details: Faster Forward with Accelerated First in Human(FIH) to Proof Of Concept(POC) Early Phase Vaccine Trials 12-08-2020, 9:30 am View In Agenda

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Session Details: Pre-Recorded Q&A: 5 Tips In Improving Your Supply Chain Framework 12-08-2020, 2:55 pm View In Agenda

Biography: Yang Su, Ph.D., is currently the Manager of New Technology and Applications at Microfluidics International Corporation, IDEX Material Processing Group. He has many years of experience in products/processes/applications development and improvements across a variety of industries. He is also an expert in numerical simulations such as computational fluid dynamics (CFD) and finite element analysis (FEM). In his current role, he is responsible for the overall direction and development of new technology, new application development, and shares responsibility for business line strategy of new technologies. Dr. Su received his Ph.D. degree in Chemical and Environmental Engineering from the University of Toledo in Ohio, USA. He is a member of the American Association of Pharmaceutical Scientist and Controlled Release Society.

Session Details: A Scalable Solution for Large Scale Manufacturing of Vaccine Adjuvants and Delivery Systems 12-08-2020, 1:55 pm View In Agenda

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Session Details: The Australian Solution to Expediting Your GMO Clinical 12-08-2020, 9:45 am View In Agenda

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Leading PRA's Center for Vaccine Research, Ms Burton gained her knowledge of vaccine studies with 20+ years of experience in the clinical research industry, including 16 years in project management. Before joining PRA, Ms Burton managed vaccine studies for 3 of the top global vaccine companies. Her vaccine clinical trial experience includes managing Phase I-IV studies in Zika, hepatitis B virus (HBV), influenza, herpes zoster, Lyme disease, polio, chikungunya, and infant combinations vaccines including a hexavalent vaccine. She has managed vaccine studies in the commercial and government environments. Ms. Burton’s global trial experience includes North and South America, Asia Pacific, and Europe. She acquired firsthand knowledge of Europe’s clinical trial practices during a 3-year tenure conducting vaccine trials in the UK. In addition, Lynlee continues to serve as visiting faculty at the University of Siena, teaching the Vaccines Clinical Operations Module for their Masters in Vaccinology and Drug Development program.   

Since January 2020, Ms. Burton has been working closely with both clients with COVID-19 vaccines and treatments, ensuring trials are executed as quickly as possible in the race for both a COVID-19 cure and vaccine. 

With industry awards for excellence in clinical research and a depth of knowledge of adult and pediatric vaccine trials, Ms. Burton is a vital asset to PRA’s vaccine portfolio. 

Session Details: Executing Clinical Trials in the COVID-19 environment: Is this the new normal? 12-08-2020, 11:00 am View In Agenda