Outsourcing in Clinical Trials Southern California 2019

Biography: Dr. Saponjic has more than 25 years of drug development experience in the areas of global operations, project management, clinical operations, clinical systems and CRO Management. Prior to Respivant, he was Vice President Global Development Operations at Greenwich Biosciences, responsible for development governance structures, clinical operations, portfolio pipeline process, and supporting the NDA submission and FDA approval for Epidiolex®.  Prior to Greenwich, Dr. Saponjic was Vice President, Clinical Operations at Patara Pharma where he was responsible for execution of multiple international Phase 2 studies in the areas of chronic cough, idiopathic pulmonary fibrosis, indolent systemic mastocytosis, and uremic pruritus.  Prior to Patara Pharma, he was Vice President of Global Project Management and/or Clinical Operations at Synteract and PRA Health Sciences. Previously, he held senior management positions at biotech, CRO, and Genomics companies including: AirPharma, Alkensa Pharmaceuticals, Monitorforhire.com, Clingenix, and Quintiles.  He earned a BA in Psychology at Texas Tech University, MS and PhD in Neuroscience at Texas Christian University, and a Master’s of Business Administration from Baker University.

Session Details: Panel Discussion: Discussing how you can best work with your service providers to drive forward innovation in clinical trials 24-09-2019, 11:30 am View In Agenda

Biography: Ms. Zbyszynski has been in the clinical research industry for over 25 years.  She began her career as a clinical research coordinator at an ophthalmic clinical site.  Since then, Ms. Zbyszynski has worked in the clinical monitoring, project management and business development sectors of the industry.  Ms. Zbyszynski was the Clinical Research Manager for a start-up medical device company where she was solely responsible for managing the clinical trials that received FDA approval of the first human collagen dermal filler product.  Ms. Zbyszynski worked for 17 years in a CRO setting.  She managed the growth of a start up CRO division from $0 revenues to a $20 million revenue stream within three years, was instrumental in the strategic partnerships with vendors and investigators, oversaw business development and client relations as well as proposal and budget preparation.  Currently, Ms. Zbyszynski is the Director of Clinical Contracts and Outsourcing at Intercept Pharmaceuticals responsible for vendor oversight, vendor contracts, budgets and payments.

Session Details: Developing best practices for vendor selection to find the best match for your study 24-09-2019, 11:30 am View In Agenda

Biography: Melody began her clinical career over 35 years ago at Abbott HPD in Illinois; she moved to California to work for Syntex (now Roche).  She has worked for several small biotech companies with experience in medical devices, pharmaceuticals, biologicals, drug/device combinations, and drug delivery systems.  In 2001 she relocated to AUSTRALIA to establish a subsidiary of Clinimetrics; she subsequently worked for St. Jude Medical--Australia.  Upon returning to San Diego in mid-2009 she was a clinical consultant for a few years before returning to industry in 2015. She is currently employed by Avelas Biosciences, a COI Pharmaceuticals company.

Session Details: Speaker Hosted Roundtables 25-09-2019, 3:00 pm View In Agenda

Biography: Kenneth Kleinhenz is currently the Chief Operating Officer at Lorem Cytori USA, a device-based, adipose-focused stem cell company. Mr. Kleinhenz was a principal member of the Lorem Cytori USA acquisition team that purchased Cytori Therapeutics in 2019. Previously, Mr. Kleinhenz was the Vice President of Quality and Regulatory at Avelas Biosciences, Vice President of Global Regulatory Affairs and Quality Assurance at Cytori Therapeutics, Director of Regulatory Affairs at MacroPore Biosurgery, Chief Microbiologist for Becton Dickinson, and the Manager of Quality Assurance and Regulatory Affairs at Pacific Pharmaceuticals. Mr. Kleinhenz is a veteran of the United States Navy where he served as a Clinical Microbiologist for 6 years at the Naval Hospital, San Diego. Mr. Kleinhenz received his BS in Microbiology at the University of California, San Diego (UCSD) and his MBA in Technology Management at the University of Phoenix.

Session Details: Dealing with political uncertainty; considering how to best plan for Brexit’s impact on your clinical trials 24-09-2019, 4:00 pm View In Agenda

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Session Details: Chair’s opening remarks 25-09-2019, 8:50 am Panel Discussion: Discussing how you can best work with your service providers to drive forward innovation in clinical trials 24-09-2019, 11:30 am Chair’s summation and close of conference 24-09-2019, 5:00 pm View In Agenda

Biography: Reggie Hooks has been active in clinical research since 2004. Being a native Oklahoman, he graduated with an MPH in Epidemiology from the University of Oklahoma Health Sciences Center and an MS in Forensic Science from the University of Central Oklahoma. In addition to his education, his perspectives on clinical research are further derived from his prior work experiences in the laboratory, at research sites, with a CRO, and with non-profit and for-profit sponsors. Reggie has managed the conduct of clinical trials across multiple therapeutic areas in over 15 countries and specializes in expedited site activation, and the development and implementation of creative study rescue activities. Reggie enjoys teaching at professional conferences and volunteering his time as a career development mentor for junior research professionals

Session Details: Developing best practices for communicating with internal teams to ensure you are working towards a common goal 25-09-2019, 9:30 am View In Agenda

Biography: Dr. Glassy graduated from the University of San Francisco in 1974 with a B.S. in Biology and Chemistry.  He then attended University of California, Riverside and received his Ph.D. in biochemistry in 1978.  He did his post-doctoral studies in molecular immunology at the Scripps Research Institute in La Jolla.  Dr. Glassy joined the faculty of the Department of Medicine and Cancer Center at UCSD in 1980 and is currently in the Translational Neuro-Oncology Laboratory at the UCSD Moores Cancer Center.  In addition to UCSD, Dr. Glassy has held several upper management positions in commercial biotechnology.  Currently, he is the Founder and Chairman of Nascent Biotech, Inc.  He has prepared and directed several FDA approved clinical trials involving human monoclonal antibodies to cancer.  Dr. Glassy has over 175 publications in the scientific and medical literature, is the inventor of several issued patents in the human antibody field, is the Editor-in-Chief of the journal, HUMAN ANTIBODIES, and the Program Chairman of the meeting series, "The International Conference on Human Antibodies and Hybridomas".  Glassy is the inventor of pritumumab, the first human antibody used to treat a cancer patient and is the recipient of the 2003 Arthur Furst Award (citation: “Outstanding research advancing science for the betterment of humanity”).  He is also the author of the books, "The Biology of Science Fiction Cinema", “Movie Monsters in Scale”, and "Biology Run Amok!".

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Biography: Ken has been in the industry for over 30 years, with just over 20 in the CRO world, at Quintiles, Statprobe, and Clinimetrics/Omnicare.  Ken joined Pfizer in 2010 in an outsourcing role, and has been leading outsourcing efforts for multiple development programs.  Experience prior to Pfizer includes hands-on and line management roles in Statistical Programming, Biostatistics, Data Management, and Project Management, as well as overall responsibility for a local CRO office in San Diego that employed more than 70 local employees.

Session Details: C-level Panel: Defining your outsourcing strategy to contain costs and accelerate drug development time-to-market 24-09-2019, 9:00 am Demystifying site budget and contracting processes to improve financial transparency between sites, sponsors and vendors 24-09-2019, 12:30 pm View In Agenda

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Session Details: C-level Panel: Defining your outsourcing strategy to contain costs and accelerate drug development time-to-market 24-09-2019, 9:00 am View In Agenda

Biography: Andy Spinks is a Pfizer Digital IT Director based in La Jolla on the US West Coast. He has extensive IT experience spanning his 20 years with the company. His current role is Global Business Technology Lead for the Pfizer Next Generation Clinical Trials (NGCT) program.  This 3 year program (which is now coming to a close) has dramatically enhanced the way Pfizer conducts Clinical Trials, simplifying what had become a complicated and unsustainable business model spanning many processes, partners and systems by bringing control back in house. The new model works with single processes and systems across the global clinical trial landscape Pfizer operates in and has been designed to smooth a quicker path to future growth and change. Previously Andy led La Jolla Informatics teams spanning Research, Development and Enterprise parts of the organization. He began his Pfizer career in Sandwich (UK) in May 1999 as an IT Project Manager.

Session Details: Case Study: Next Gen Clinical Trials program- Simplifying clinical trials management now for future growth 24-09-2019, 12:30 pm View In Agenda

Biography: Mary Jarosz joined Daré Bioscience in 2018 and serves as the company’s Global Head of Regulatory Affairs. Prior to Daré, Ms. Jarosz was an independent Regulatory Affairs Consultant working with life sciences companies on regulatory strategies supporting prescription drugs, medical devices and combination products for US and Global markets. From 2014-2016, She was the Senior Vice President of Regulatory Affairs and Quality Assurance for Evofem, Inc. During her tenure, she led the regulatory team to a successful NDA filing under a 505 (b)(2) pathway and facilitated numerous interactions with the FDA, EMA and other regulatory bodies. From 2011 to 2014, Ms. Jarosz served as Vice President of Regulatory Affairs and Quality Assurance for WomanCare Global and was the Director of Regulatory Affairs for WomanCare Global from 2010 to 2011. During her tenure at WomanCare Global, Ms. Jarosz had the opportunity to work with several NGOs including PSI, FHI 360, DKT and other global non-profit organizations including the World Health Organization (WHO), United States Agency for International Development (USAID) and The Population Council. From 1996 to 2010, Ms. Jarosz served as the President and Principle Consultant for Jarosz Regulatory Services specializing in regulatory planning, strategy and implementation for large and specialty pharmaceutical companies worldwide. Ms. Jarosz spent the early part of her career working in international regulatory affairs for Abbott Laboratories. Ms. Jarosz has published in several journals, including Regulatory Affairs Focus and ESRA Rapporteur, has presented at regulatory conferences and served as a guest lecturer for several universities. She was Head of Publications and Publicity for The Organization for Professionals in Regulatory Affairs (TOPRA), North America Leadership Team. Prior to her experience in the pharmaceutical industry, Ms. Jarosz was a Clinical Pharmacist at Michael Reese Hospital in Chicago, Illinois and a Pediatric Intensive Care Clinical Pharmacist at the University of Wisconsin Hospital. Ms. Jarosz holds a Baccalaureate of Science in Pharmacy, is an appointed Fellow of TOPRA (FTOPRA), is RAC certified, and is a Registered Pharmacist in the states of Illinois and Wisconsin.

Session Details: Considering whether a virtual business model is the way forward for pharmaceutical companies 24-09-2019, 3:00 pm View In Agenda

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Session Details: Striking the right balance when monitoring your CRO to ensure you are ICHE6 R2 compliant 24-09-2019, 10:00 am View In Agenda

Biography: Co-founder of White Space Energy after enjoying close to 20 years in Shell in roles ranging from Reservoir Engineer, Asset Manager and Project Manager. Day-2-day responsibilities as managing partner include business development, marketing and partnerships. But those labels are too simplistic: we do what is needed to pursue our aim of redefining complex decision-making in Oil & Gas using state-of-the-art Artificial Intelligence

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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.  

Session Details: Discussing a model for early stage companies to bring their innovations in therapeutics, medical device or consumer health from concept to fruition 24-09-2019, 2:00 pm View In Agenda

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Session Details: Developing best practices for the successful integration of regulatory affairs during study start-up of a global trial 25-09-2019, 1:30 pm View In Agenda

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Session Details: Through the QA Looking Glass: Outsourcing in Clinical Trials 25-09-2019, 2:00 pm View In Agenda

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Session Details: Considering the UK as a location for your clinical trial 24-09-2019, 4:30 pm View In Agenda

Biography: Brian has spent over 23 years in clinical research, including CROs, Biotech and Medical Device companies. He began his career as a CRA before advancing to monitoring management and then Study Management. He has Lived and worked in Europe, Canada and the US, which has given him a firsthand perspective on the global nature of clinical trial operations. He is a graduate of Brunel University, London, UK and currently holds the position of Clinical Affairs Director at Endologix in Irvine, CA. Where he is responsible for global operations for Abdominal Aortic Aneurysm clinical trial deliverables, including the implementation and operation of the  eTMF system.

Session Details: Establishing best practices for implementing eTMF systems to ensure a smooth transition from paper to digital 24-09-2019, 3:00 pm View In Agenda

Biography: Dr. Lingling Rogers is Director of Regulatory Affairs, CMC at Arena Pharmaceuticals in San Diego, CA. She has more than 19 years of experience in the pharmaceutical industry, including 14 years in global regulatory affairs CMC. Her expertise includes providing regulatory oversight for global drug development of small and large molecules, drug device combination products, preparation and submission of clinical and marketing applications, serving as the company liaison for interactions with regulatory agencies. She had also served on cross-functional due diligence teams performing critical reviews of third party regulatory dossiers for potential in-license opportunities. Dr. Rogers holds a M.S. degree in Organic Chemistry from University of San Francisco and a Ph.D. degree in Medicinal Chemistry and Pharmacognosy from Purdue University.

Session Details: Addressing how to breakdown internal silos between regulatory affairs and clinical operations to align timelines and goals 24-09-2019, 2:00 pm View In Agenda

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Session Details: Workshop: Developing best practices for working with your vendors to project, detect and manage risk in clinical trials 25-09-2019, 11:00 am View In Agenda

Biography: Qiu has over 10 years’ experience in Clinical Study development and execution. He started clinical research journal from Pfizer, which involved in the global clinical trial resulted the successful launch of Viagra (Sildenafil), followed by leading couple of clinical trials in Beijing Novartis Pharma Co., Ltd. Dr. Qiu then switched his gear to clinical validation of diagnostic platforms in academics and IVD industry, including Beckman Coulter and Leica Biosystems. Under his leadership, Leica Biosystems’ Digital Pathology system AT2 DX has been awarded FDA 510(k) clearance 90 days after submission.

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Biography: Currently the Director, Outsourcing and Supplier Governance at Halozyme Therapeutics in San Diego.   Dan has over 20 years of outsourcing and supplier governance experience in the bio-pharmaceutical industry including large pharma and bio-tech.

Session Details: Moving beyond the traditional RFP to give service providers the opportunity to stand out in a crowded market 25-09-2019, 9:00 am View In Agenda

Biography: I have spent the last 17 years of my career in the Life Science, Regulatory and Clinical Industries working for medium to large companies in strategic roles within the Sourcing & Procurement and the Clinical Operations function.  I have had the opportunity to manage both the indirect and direct sourcing & clinical research channels for materials, trials and services. Specializing in clinical operations, supplier development and sourcing, I possess an in-depth knowledge of global operations. I have led cross-functional teams and provided oversight for key partnerships. I have developed standards and process improvements that achieve maximum efficiency and budget/contract savings. Former employers: ThermoFisher Scientific (formerly Life Technologies), Merck KGaA, Nuvasive

Session Details: Speaker Hosted Roundtables 25-09-2019, 3:00 pm View In Agenda

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Session Details: C-level Panel: Defining your outsourcing strategy to contain costs and accelerate drug development time-to-market 24-09-2019, 9:00 am Accelerating Clinical Trials in Asia-Pacific 24-09-2019, 9:30 am View In Agenda

Biography: Winitsky has more than 11 years of former FDA experience as a Medical Officer, team leader, and Acting Branch Chief in the Office of Tissues and Advanced Therapies (OTAT) in the Center for Biologics Evaluation and Research (CBER). He has extensive experience with review and supervision of cell and gene therapy files  ̶  INTERACTs (previously known in OTAT/OCTGT as pre-preINDs), INDs, and BLAs. Steve has also been a clinical reviewer for approximately 90% of the cardiovascular files regulated by OTAT/OCTGT, along with oversight of numerous files covering over 50 clinical indications. He has also reviewed or supervised the review of numerous Fast Track, Regenerative Medicine Advanced Therapy (RMAT), and Breakthrough Designation request applications.

Session Details: Clinical and Regulatory Considerations for Cell and Gene Therapy Development Programs 24-09-2019, 10:30 am Panel Discussion: Discussing how you can best work with your service providers to drive forward innovation in clinical trials 24-09-2019, 11:30 am View In Agenda

Biography: As Chief Medical Officer, Dr. Hoffman leads the global medical staff and provides medical oversight and expertise to support early clinical research studies. Dr. Hoffman has over 28 years of knowledge and experience as a physician in the pharmaceutical, device, and CRO industries to this role. He has extensive experience in global drug development, medical affairs, pharmacovigilance and regulatory affairs, and has a proven track record in building, managing and globalizing medical teams. Prior to this role, Dr. Hoffman served as Chief Medical Officer at Patient iP, providing clinical leadership around Patient iP’s innovative platform, customer programs and related medical affairs activities. Dr. Hoffman has also held the roles of Chief Medical Officer and Senior Vice President and General Manager over the Biopharmaceutical Business Unit at Theorem Clinical Research, leading the development of drugs and biologics. Previously in his career, he held positions of increasing responsibility in Medical and Scientific Affairs at Baxter, Hospira and Covance, providing senior-level strategic direction for Phase II-IV programs.

Session Details: Reducing white space: the importance of provider selection 24-09-2019, 12:00 pm View In Agenda

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Session Details: Engagement and Analytics – the Simple Path to Value for your Data; or, how ‘Advanced’ do Analytics Really Need to Be? 25-09-2019, 10:00 am View In Agenda

Biography: Mr. Berger joined the UBC team in 2003 and has since served in a range of diverse roles leveraging global capabilities in the execution of peri and post marketing product development programs and Real World Evidence generation.  In this role, Mr. Berger supports the development of RWD / RWE architectures and solutions to drive greater insight into the safety profile and value proposition of medicines. Mr. Berger received his Bachelor’s degree from the University of Kansas, holds the Project Management Professional credential and Six Sigma Green Belt certificate.

Session Details: Introducing innovative technologies and solutions into study designs that enrich data and optimize evidence generation 25-09-2019, 12:00 pm View In Agenda