Outsourcing in Clinical Trials Southern California 2021

Biography: Over 15 years of experience in increasing regulatory affairs and quality compliance responsibilities within the GxP regulated environment pertaining to Medical Device, Digital Medicine and Combination Product areas. Regularly provides Allergan therapeutic franchise units regulatory counsel and strategy to all aspects within the quality management system arena and regulatory affairs regarding:

• CMC Global Dossiers and Global Device Regulatory Strategy Registrations
• EU MDR/IVDR – Person Responsible for Regulatory Compliance (PRRC)
• 21 CFR Part 3 and Part 4 - Combination Products
• CE Marking
• ISO 13485:2016/MDSAP
• Product Development – Design Controls
• Risk Management
• Human Factors Engineering
• Acquisitions/Divestitures
• Import/Export – U.S. Agent
• Production Controls
• Regulatory Inspection Management
• Materiovigilance
• Health-Care Related Laws and International Regulations

Session Details: CASE STUDY: Developing a digital playbook for designing combination products and digital medicine studies 27-10-2020, 11:30 am PANEL DISCUSSION Examining the decision to postpone the MDR application date for one year 27-10-2020, 12:30 pm View In Agenda

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Rupesh Kanchi Ravi is the Lab Head in the Pfizer Oncology Clinical Research Laboratory (POCRL), a clinical genomics GCLP lab overseeing Pfizer Oncology custom genomics clinical sample testing and new platform evaluations for genomics biomarker strategy and clinical utility working with CROs. Previously, Rupesh held the role of Biomarker Assay Specialist as clinical genomics and NGS expertise managing clinical NGS testing for Translational Oncology Phase 1 study programs and working with cross-functional teams that included GPD Oncology, ECD, and Computational Biology.

Prior to joining Pfizer Oncology, Rupesh held senior scientist positions at Genoptix, UCSD’s Genomics Center, TGen in which he developed, validated, and launched novel NGS assays (cfDNA, targeted DNA, targeted RNA, exosomal RNA, miRNA) for GCLP and CAP/CLIA lab environments, and developed novel NGS library generation techniques for numerous nucleic acid sample types. Rupesh earned his PhD in Biotechnology at Pondicherry University where he studied the anti-inflammatory and anti-cancer properties of marine natural products. He received his first postdoctoral training at the French National Center for Scientific Research (CNRS) in the Extreme Environments Microbiology Lab where he characterized the DNA replication/repair machinery of hyperthermophiles. He received his second postdoctoral training at University of Arizona where he identified novel alternate DNA repair pathway Base Excision Repair pathway inHSV-1 and developed a High Thorough put assay for identifying single strand DNA-protein inhibitors.

Session Details: Tech & Innovation Breakout Discussions 27-10-2020, 4:15 pm View In Agenda

Biography: Kenneth Kleinhenzhas held numerous executive-level quality assurance and regulatory affairs position at public and private biotechnology companies to include 15 years of service as the Vice President and Chief Operating Officer at Cytori Therapeutics, a device-based, adipose-focused stem cell company. Previously, Mr. Kleinhenz was the Vice President of Quality and Regulatory at Avelas Biosciences, Director of Regulatory Affairs at MacroPoreBiosurgery, Chief Microbiologist for Becton Dickinson, and theManager 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 NavalHospital, San Diego. Mr. Kleinhenzreceived 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: PANEL DISCUSSION Examining the decision to postpone the MDR application date for one year 27-10-2020, 12:30 pm FDA’s Emergency Use Authorization process: What could this mean for your product in a future crisis? 27-10-2020, 4:45 pm View In Agenda

Biography: PeterStiegler earned his PhD in Molecular Biology at the University of Vienna Biocenter and performed a post doc at Thomas Jefferson University in Philadelphia PA. He since held positions in various operational functions in the Clinical Research arena with a focus in oncology early drug development at companies including EMD, Novartis Oncology Translational Medicine and Novartis Molecular Diagnostics. After working at the Duke Clinical Research Institute focusing on biomarker development he worked as the Director of Clinical Operations at diagnostic development companies Prometheus Laboratories and Progenit

Session Details: RBM as a mature activity: Now that RBM has been involved in trials for a number of years what are the best ways for implementation and what have been the responses? 28-10-2020, 2:45 pm View In Agenda

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Dr.Lingling Rogers is a Director, Regulatory Affairs, CMC at Arena Pharmaceuticals, Inc. in San Diego, CA. She has more than 20 years of experience in the pharmaceutical industry, including 14 years in regulatory affairs CMC. Her expertise includes serving as the company liaison for interactions with global regulatory health authorities; providing regulatory oversight for drug development of small/large molecules and drug device combination products; and leading global regulatory submissions in support of clinical studies, marketing applications, as well as lifecycle management. She has also served on cross-functional due diligence teams conducting 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: Keynote address Uncovering how to breakdown internal silos between regulatory affairs and clinical operations and how these functions can work together in the face of a crisis 28-10-2020, 9:00 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!".

Session Details: PANEL DISCUSSION - Debating what it takes to form an innovative start-up, to develop a product and finally exit 27-10-2020, 3:15 pm Outsourcing unconventional immunotherapy with an unconventional target 28-10-2020, 11:45 am 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: Uncovering the best tips & tricks for improved site selection and faster study start-up 28-10-2020, 12:15 pm View In Agenda

Biography: Dr. Alexander is the senior director of clinical research at Exagen Inc. where she oversees the clinical research activities of the company, including company sponsored clinical studies, investigator- initiated studies, and collaborations with pharma companies. She works mainly on systemic lupus erythematosus and other rheumatic diseases in close collaboration with key opinion leaders and community rheumatologists. Before joining Exagen, Dr. Alexander worked in drug discovery in the pharmaceutical industry where she focused mainly on gastroenterology, endocrinology, and pain.

Session Details: FIRESIDE CHAT ‘Working with niche CROs allows our study to be a priority because it’s a bigger piece of their pie…’ is it this simple? 27-10-2020, 4:15 pm View In Agenda

Biography: Experienced Clinical Research Scientist with 20+ years of experience in pharmaceutical drug discovery and development in CRO and industry settings. Most recent clinical development experience in multiple sclerosis space leading to the successful marketing authorization of Zeposia (ozanimod) in the US and Europe. Therapeutic areas: Dermatology, Gastroenterology, Immunology/Inflammation, Neurology, and Oncology (Hematology and Solid Tumors).

Session Details: Chair’s opening remarks 27-10-2020, 8:50 am Keynote Panel: Debating how COVID-19 will impact the way we outsource and conduct clinical trials in the future: How long will we feel the ripples of this pandemic? 27-10-2020, 9:00 am PANEL DISCUSSION Examining the decision to postpone the MDR application date for one year 27-10-2020, 12:30 pm View In Agenda

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Biography: David brings over 35 years of diverse business and scientific expertise to Xeno Biosciences where he is Chief Scientific Officer. He joined Abbott Laboratories in drug discovery and development and then then transitioned to business development and new venture roles including working with startups for the Nutrition division.  David held academic appointments in GI/Nutrition at U of Chicago and then in Neonatology at Rush Medical Center following his microbiology degree. He has 100+ peer-reviewed publications with 2000+ citations and numerous successful government filings.

Session Details: Interactive roundtable discussions 28-10-2020, 3:45 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: Rescue Studies: Increasingly common but is this an option for your trial? 27-10-2020, 5:15 pm View In Agenda

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: CASE STUDY: Delving into lessons learned from an initiative investigating whether patient referral or social media campaigns deliver the biggest ROI for patient recruitment 27-10-2020, 3:15 pm View In Agenda

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Session Details: Exploring the multiple facets involved with patient on-boarding to enhance patient recruitment and engagement 27-10-2020, 11:30 am PANEL DISCUSSION - Debating what it takes to form an innovative start-up, to develop a product and finally exit 27-10-2020, 3:15 pm View In Agenda

Biography: Ms. Cindy Croissant is currently the Vice President, Clinical Operations at LumiThera, Inc.  Prior to LumiThera, Ms. Croissant was the Sr. Director, Clinical Operations at Vital Therapies, Sr. Director of Clinical Operations and Project Management at Aeolus Pharmaceuticals, Director of Clinical Operations at PhotoThera, and Clinical Proposal Manager and Manager, Clinical Operations at PAREXEL.  Ms. Croissant has 28 years of clinical research and industry experience including phase I-IV drug, device and biologics trials.  Therapeutic areas include ophthalmology, hepatology, radiation exposure, neurology, oncology, dermatology and dentistry.  Ms. Croissant has been responsible for all clinical department activities involving the strategic planning, budgeting and execution of all clinical trials worldwide, including hiring, training and managing internal clinical staff and all contracted services. Ms. Croissant earned a B.S. in business administration and B.S. in Psychology from Colorado State University and an M.B.A. from Regis University.

Session Details: Tech & Innovation Breakout Discussions 27-10-2020, 4:15 pm PANEL DISCUSSION / FIRESIDE CHAT Solutions-focused approach: Overcoming hurdles presented with CRO oversight, governance and turnover 28-10-2020, 2:15 pm View In Agenda

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Session Details: CASE STUDY: Early Clinical Development for RNA Based Therapeutics 27-10-2020, 12:30 pm View In Agenda

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Session Details: Tech & Innovation Breakout Discussions 27-10-2020, 4:15 pm View In Agenda

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Session Details: Risk mitigation in the current climate: What has changed and what will stay with global clinical trial strategy and management? 27-10-2020, 10:00 am View In Agenda

Biography: Dr. Gal has over 30 years of medical device experience as a practicing veterinarian, academician at Tufts University School of Medicine and subsequently in industry. Dov held R&D, clinical marketing and clinical affairs positions with increasing responsibilities in private start-up, and medium to large public medical device companies. Most recently, Dov led the clinical organization for the Heart Valve Therapy business at Edwards Lifesciences, overseeing clinical trials of Class III implantable devices. Prior to Edwards Lifesciences, he led the clinical organization at Broncus Technologies, a start-up with an investigational, minimally invasive device-drug combination product for the treatment of patients with severe COPD. The system was evaluated in an international clinical trial under an IDE. Prior to Broncus, Dov was a director of clinical research at Medtronic Vascular responsible for the AAA stent graft product line

Session Details: PANEL DISCUSSION - Debating what it takes to form an innovative start-up, to develop a product and finally exit 27-10-2020, 3:15 pm View In Agenda

Biography: Raj is the founder of the Gastric Vest Technology System (GVS), which was acquired in 2017.  The GVS has several issued patents involving weight loss technologies, including - gastric restriction, intra-gastric technology, bio-electronics for type II diabetes, and spine surgery.

Session Details: PANEL DISCUSSION - Debating what it takes to form an innovative start-up, to develop a product and finally exit 27-10-2020, 3:15 pm View In Agenda

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: Keynote Panel: Debating how COVID-19 will impact the way we outsource and conduct clinical trials in the future: How long will we feel the ripples of this pandemic? 27-10-2020, 9:00 am Tech & Innovation Breakout Discussions 27-10-2020, 4:15 pm View In Agenda

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Session Details: Development Challenges when Treating a Rare Disease 28-10-2020, 1:45 pm View In Agenda

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Session Details: PANEL DISCUSSION - Debating what it takes to form an innovative start-up, to develop a product and finally exit 27-10-2020, 3:15 pm View In Agenda

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Session Details: Exploring site optimization pre- post Covid 27-10-2020, 2:15 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.

Session Details: Discussing a model for early stage companies to bring their innovations in therapeutics, medical device or consumer health from concept to fruition 27-10-2020, 2:15 pm View In Agenda

Biography: Anca has over 15 years of experience in the biopharmaceutical industry, working both on the CRO and the Sponsor side.  She is currently the Founder and CEO of Strategikon Pharma, developer of Clinical Maestro^TM, the industry’s only end-to-end cloud-based platform for clinical trial budgeting, sourcing and budget management including strategic alliance/partnership management. Previously she served as Head of Clinical Outsourcing and Analytics for BioMarin Pharmaceuticals, where she was responsible for vendor contractual, relationship and financial management. She also had several leadership positions with PharmaNet Development Group (now Syneos Health), ICON Clinical Research and eMetagen Corporation.

Session Details: Keynote Panel: Debating how COVID-19 will impact the way we outsource and conduct clinical trials in the future: How long will we feel the ripples of this pandemic? 27-10-2020, 9:00 am Chair’s opening remarks 28-10-2020, 8:50 am PANEL DISCUSSION / FIRESIDE CHAT Solutions-focused approach: Overcoming hurdles presented with CRO oversight, governance and turnover 28-10-2020, 2:15 pm View In Agenda