Clinical Operations in Oncology Trials USA: Virtual Experience

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: Case Study: Beat AML Master Trial- The role of basket/umbrella/platform trials in oncology 17-11-2020, 12:00 pm View In Agenda

Biography: Jennifer has a comprehensive background in managing global clinical development programs spanning from phases I-IV across multiple therapeutic areas in Oncology, She has expertise in Transplantation, Urology, Infectious Disease, Cardiovascular, CNS, and personalized cellular immunotherapies and rare disease. Seasoned in managing external CROs and vendors. Sound regulatory experience. Excellent verbal & written communicator. Strong track record of building, leading and motivating clinical teams.

Session Details: Assessing the Benefits and Challenges of Integrating Technology in Oncology Trials; what does the future hold for your trials? 17-11-2020, 1:00 pm View In Agenda

Biography: Michael’s background spans contract and proposal development; contract negotiations in multiple languages; set up and management of vendor oversight and governance programs; and related change management. He has worked for CROs as well as small and large biotechnology companies. Over the course of his career, he has worked on clinical development of 23 compounds currently marketed in 1 or more therapeutic indications.

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Session Details: Exploring the use of technology as a tool for successful patient-centric oncology trials resulting in enhanced patient retention 17-11-2020, 2:00 pm View In Agenda

Biography: Susan Carino, MBA, MS, PMP, RAC is a Principal Consultant with Integrated Project Management Company, Inc., (IPM) headquartered in Chicago, IL with offices in Boston, Los Angeles, Minneapolis, New Jersey, Saint Louis, and San Francisco. She has 25 years of industry experience in R&D across multiple therapeutic areas and specializes in project/program/portfolio management and regulatory submissions. She is a founding member of IPM’s Center of Excellence for Quality and Regulatory Affairs. Her career includes roles leading diverse cross-functional program teams engaged in complex product development, clinical trial conduct, regulatory submissions, product launches, and post-approval regulatory commitments to ensure quality and regulatory compliance. Projects she has led include the development and launch of new pharmaceuticals, biologics, medical devices, and in vitro diagnostic tests. Susan is a certified Project Management Professional (PMP) with the Project Management Institute (PMI) and is also certified in Regulatory Affairs (RAC) currently serving as the San Francisco Bay Area Chair for the Regulatory Affairs Professionals Society (RAPS). Susan is a UC Berkeley Extension Advisory Board Member for the Clinical Research Conduct and Management Certificate Program. She is also a course developer and instructor. Susan holds a Bachelor of Arts (BA) in Chemistry from Oberlin College, a Master of Science (MS) from the University of Wisconsin at Madison,

Session Details: Innovation at FDA- Oncology Center of Excellence Leads the Way 17-11-2020, 1:00 pm View In Agenda

Biography: Aditi Khurana, is an Associate Director of Project Management with Jazz Pharmaceuticals, Palo Alto, CA. She is a Project Management Professional (PMP) and is certified in Global Regulatory affairs (RAC). She holds a Bachelors in Neuroscience from University of California Los Angeles, and a Master of Business Administration from University of Illinois Urbana-Champaign. She has 11 years of combined experience working initially in the biomarker identification, companion diagnostics & assay development space as an ASCP licensed Clinical Cytogenetics and Molecular Biologist, and later in project management roles leading planning for clinical development and regulatory submissions deliverables. Key areas of focus include study concept development, IND and BLA submission planning, decision frameworks and developing strategic roadmaps for global product success.

Session Details: Innovation at FDA- Oncology Center of Excellence Leads the Way 17-11-2020, 1:00 pm PANEL DISCUSSION: How has Covid-19 affected your oncology trial operations has and what impact has it had on your partnerships? and negotiations successfully to efficiently allocate resources 17-11-2020, 3:30 pm View In Agenda

Biography: Julie Martin, M.Sc., MBA, Director, Clinical Operations, Scimega Research has developed an expertise in managing a wide array of oncology clinical trials set in early and late clinical development stages including collaborative efforts with larger CROs. At Scimega she is responsible for the strategic planning, conduct and oversight of oncology clinical trials across Canada, and for the development of project proposals. In addition, Mrs Martin serves as Director, Business Development, and is a member of Scimega’s managing Board of Directors. She received her Master of Science in Biochemistry from the University of Montreal and holds a Masters of Business Administration from Concordia University. Mrs. Martin is a member of the American Society of Clinical Oncology (ASCO) and the Society of Clinical Research Associates (SoCRA).

Session Details: Why Scoring High on Critical Trial KPIs Matters Most 17-11-2020, 9:00 am View In Agenda

Biography: Michelle has been employed in the healthcare industry for over 20 years.  Her background includes sales and training for numerous World Renowned medical device and pharmaceutical companies. Michelle joined RxSolutions in 2017 as the Director of Business Development where her responsibilities include working with sponsors and CRO’s to provide unblinded clinical supplies through a pharmacy adjudicated model. This unique and innovative model significantly simplifies the clinical supply process by improving study flexibility while reducing costs and activities for the clinical supply and study team.

Session Details: Deploying a Virtual Clinical Supply Inventory in Oncology Trials 17-11-2020, 10:00 am View In Agenda

Biography: Bryant has enjoyed nearly 25 years in clinical research domain, mostly comprised of industry leadership in clinical data management and clinical operations. Most notably, he developed and led a global team of clinical data managers in the successful delivery of high quality data in Oncology, Hemophilia and Ophthalmology submissions. Bryant has led workstreams in the identification of innovative and transformative process and tools for future clinical data environments. Immediately prior to joining Medidata, he supported departments in clinical data standards and HEOR research. Bryant is currently the Director, Data Science and Analytics Portfolio where he ensures seamless coordination and oversight between commercialization, marketing, strategy and corporate development operations for Data Science products and solutions.

Session Details: Making Precision Medicine a Reality in Clinical Development, Discovery and Beyond 17-11-2020, 11:30 am View In Agenda

Biography: Melissa Hill MPH is a clinical programmer at Ce3 Inc. In this role, she balances the requirements of multi-disciplinary teams to develop cross-functional tools for reviewing clinical trial data in real-time.  Prior to her role as a clinical programmer, Ms. Hill worked at the Yale University Center for Perinatal, Pediatric, and Environmental Epidemiology as a Research Associate.  Specifically, she provided programming support, performed biostatistical analyses, and coordinated research teams for NIH funded grants.  Ms. Hill has co-authored a book Data Management Essentials using SAS and JMP (2016) as well as multiple peer-reviewed publications of epidemiological analyses (2010-2015) and regularly shares her work at relevant industry conferences.  Melissa holds a Bachelor of Arts from Villanova University and a Master of Public Health from Yale University.

Session Details: Clinical Analytics for Safety Assessment 17-11-2020, 1:30 pm View In Agenda

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Session Details: Clinical Analytics for Safety Assessment 17-11-2020, 1:30 pm View In Agenda

Biography: Michael Causey is Editor-in-Chief at the Association of Clinical Research Professionals, where he oversees the peer-review journal, Clinical Researcher, and a weekly news publi-cation, CRbeat. He also hosts the “Spotlight On...” series on ACRPtv. Previously, he was a journalist and Editorial Director at FDAnews, where he ran the newsroom.

Session Details: It’s Time to Diversify the Clinical Trial Workforce 17-11-2020, 12:00 pm View In Agenda

Biography: Jim Kremidas is currently the Executive Director for ACRP, a not-for profit association the represents the clinical research enterprise. Prior to that he conducted consulting services for a variety of clients including support for investigator sites, academic institutions, sponsors and sup-pliers. He was the SVP of Patient Recruitment at two different large CROs for over 6 years where he and his team were responsible for de-veloping and implementing patient enrollment strategies for global clin-ical trials. Prior to that, he spent 24 years with Eli Lilly and Company. From 1999 to 2008 he led their clinical trial patient recruitment and re-tention efforts. In this role, he focused on predicting and accelerating the enrollment rates for all corporate studies. While in Strategic Sourc-ing he was responsible for the outsourcing of clinical development pro-jects to strategic suppliers including CRO’s, scientific staffing firms and Patient Recruitment Suppliers. Before his assignment in clinical devel-opment strategic sourcing, Mr. Kremidas led Lilly’s efforts to select and establish relationships with direct to consumer and professional adver-tising agencies, as well as, implement standardized processes for the de-velopment and implementation of marketing materials. He is on the advisory board of CISCRP (a non-profit organization fo-cused on enhancing patient participation in clinical trials) and is also a volunteer for the Clinical Trial Transformation Initiative (CTTI) with Duke and the FDA. He is a frequent presenter at Industry Conferences and his articles/papers have been published in a wide variety of trade journals

Session Details: It’s Time to Diversify the Clinical Trial Workforce 17-11-2020, 12:00 pm View In Agenda

Biography: Revati Tatake currently serves as a Global Director of Databases and Analytics at GlobalData, where her primary responsibilities are to lead the development and continuous enhancement of integrated databases and analytical tools for providing competitive and business intelligence for pharmaceutical and biotechnology sectors Revati has more than 20 years’ experience, both in academic research and the healthcare industry, during which time she focused on basic and clinical research, drug discovery and competitive intelligence projects across many therapeutic areas.  After academic career at Tata Cancer Research Institute and the University of Connecticut Health Center, she began her healthcare industry career at Boehringer Ingelheim Pharmaceuticals, where she led drug discovery projects involving small molecules, gene therapy and cell therapy for cardiovascular diseases, Rheumatoid arthritis and Diabetes.  In addition to leading drug discovery projects, Revati co-chaired novel target identification group, scouted novel technologies for enhancing drug discovery efforts, established collaborations with experts in academic institutions to complement internal projects and evaluated in-licensing opportunities for their scientific and technical merit.  She is a co-inventor on several issued US patents and applications related to the projects on cell and gene therapies. Before joining GlobalData, Revati worked at Citeline, where she was involved in competitive intelligence and analytics of clinical trials and pharmaceutical products. Revati holds a PhD in Tumor Immunology from Tata Cancer Research Institute. She was a post-doctoral fellow at the University of Connecticut Health Center.

Session Details: Ensuring Clinical Feasibility Planning for Gene Therapy Trials to Achieve Enrolment Target 17-11-2020, 8:30 am View In Agenda

Biography: Harry Barnett Harry is the co-founder and Executive Chairman of Lubris BioPharma, a clinical-stage biotech company developing a proprietary version of the novel, ubiquitous human protein, PRG4, for use in multiple indications.  Novartis owns rights to Lubris’ technology for ophthalmology. Harry’s two-decade life science career includes: (i) co-founding and executive management roles at three life science companies and two CROs; (ii) incubating, partnering and licensing successfully a wide array of pharmaceutical products and technologies including Pepcid Complete®, the OTC hearburn remedy sold by J&J, and; (iii) innovating multi-center, clinical trial processes using techniques that have been adopted as industry standard.  Prior to his transition to life science and biotech, Harry was a transactional business lawyer in private practice at DLA Piper in San Diego, and later at Faneuil Advisors, Inc., an investment advisory firm based in Boston where he served as General Counsel and Executive Vice President.

Session Details: Finding and Selecting the Right CRO in an Increasingly Competitive Market 17-11-2020, 9:30 am PANEL DISCUSSION: How has Covid-19 affected your oncology trial operations has and what impact has it had on your partnerships? and negotiations successfully to efficiently allocate resources 17-11-2020, 3:30 pm View In Agenda

Biography: Heather DiFruscia is the Associate Director RTSM / IWRS and is responsible for managing and overseeing the RTSM department operations, strategy, processes, and software product development.

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Kaitlyn Townsley is the Associate Director of Product Innovation at Axiom Real-Time Metrics Inc., where she continually innovates Fusion eClinical Suite and related technologies to support the evolving technological needs of Clinical Trials as Studies increase in complexity, maintaining the balance between an easy and intuitive platform, and providing Sponsors with the complex tools they require to run their Clinical Programs.

Session Details: Simplifying the Complex Data and Operational Awareness Needs of Oncology Studies Using Unified eClinical Tech 17-11-2020, 12:30 pm View In Agenda

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Dr Florence Mowlem is a Scientific Advisor at Signant Health, where she provides advice and guidance to internal and external stakeholders on eCOA solution design and project complexities to ensure adherence with requirements of the study protocol, and that industry best practice and regulatory guidance is followed. At Signant Health, Flo works across therapeutic areas and is also the eCOA Science Oncology lead; her most recent scientific work includes understanding how the unique needs of oncology patients (i.e., due to symptoms of the disease and side-effects of treatment) can impact their use of electronic devices in oncology trials, and harnessing this knowledge to optimize ePRO solutions. Flo has presented her work at international conferences, published numerous peer-reviewed papers, and actively participates in consortium working groups.

Twitter: @FloMowlem

LinkedIn: https://www.linkedin.com/in/florencemowlem/

Session Details: The Benefits of ePRO in Oncology Trials and Considerations for Optimizing Data Capture 17-11-2020, 11:30 am View In Agenda

Biography: Dr. Dumais is a neuroscientist with 7 years of experience in the design and management of neuroscience research. She has expertise in neuropharmacology, gender differences research, and performing behavioral assessments on stress, anxiety, and social dysfunction. She has significant experience working with PRO development and validation studies, questionnaire design, and developing site rater and subject training. She has co-authored book chapters and over a dozen manuscripts and has presented her work at national and international meetings

Session Details: From Surviving to Thriving: Incorporating the Patient Voice and Enhancing Outcome Measures in Oncology Clinical Trials 17-11-2020, 11:00 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 the University of California, Riverside and received his Ph.D. in biochemistry in 1978.  He did his post-doctoral studies as a Research Fellow 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 the University of California, San Diego in 1980 and is currently Professor 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 (OTCQB:NBIO) as well as a member of the Advisory Board of the University of California, Riverside, School of Medicine.  He has prepared and directed several FDA approved clinical trials involving human monoclonal antibodies to cancer.  Dr. Glassy has over 180 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: Pritumumab. Unconventional immunotherapy with an unconventional target 17-11-2020, 10:30 am View In Agenda

Biography:

Asad heads up the life science business globally for Volt International. He specialises in helping companies with their staffing needs across the globe on a permanent and contract basis.

Asad has over 105 recommendations on LinkedIn from various VP’s, Head’s & Directors of Clinical at Biotech, Clinical Stage, Pharmaceutical & CRO companies across the globe.

Vertical Expertise:

Clinical Operations, Clinical Research, Clinical Affairs & Clinical Development.

Client’s Expertise:

Pharmaceutical Companies, Biotechnology Companies, Medical Device Companies, Clinical Research Organisations, Clinical Stage Biopharma Companies & Start Up Patient Recruitment Companies.

Session Details: Doing Oncology Clinical Trials Inhouse vs Outsourcing to CROs Global Staffing Solutions (Permanent & Contract Hiring) Small-Medium Size CROs Competing against the Big CROs 17-11-2020, 3:00 pm View In Agenda

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