WEBINAR: Expanding zip codes: A novel approach to reaching and engaging clinical trial participants across the United States – VIEW ON DEMAND
We are faced with the reality that a drug may not work in certain individuals because it does not mirror a real-world population. There are many hurdles in reaching a broader population of clinical trial participants, which can lead to insufficient data on a drug's efficacy and safety.
- Clinical trial operations
- Community leaders
- Medical device/biotech
- Pharmacists
- Pharmacy executives
What you will learn
- The existing hurdles in expanding clinical trial participation, including social factors such as mistrust of the medical system.
- Real-world initiatives within the pharmaceutical industry to expand reach across rural communities in the United States.
- A novel approach to engaging and maintaining clinical trial participants in rural as well as urban regions within the United States.
Speakers
Carissa Jones
Founder, Ventus, LLC
Carissa has supported the pharmaceutical research and in-vitro diagnostics sectors in the field of cardiometabolism. She built the US operations for a Swedish immunoassay company, Mercodia, and helped them expand their business through the addition of a bioanalytical laboratory service in the US. Today she is the founder of a consulting firm built upon her experience in the field of immunoassay and laboratory science with a focus on those entertaining entrance into the US market.
William (Bill) Annes
Senior Director, Clinical Laboratory Sciences, Eli Lilly
William (Bill) Annes leads global strategies for biomarker integration, lab operations, and clinical diagnostics across diverse therapeutic programs. With a career spanning translational science and patient-centered research, Bill has played a pivotal role in advancing laboratory capabilities in China and other emerging markets, ensuring scientific rigor and operational excellence in complex clinical environments. His recent work includes navigating regulatory and logistical challenges for investigational products and diagnostics, and supporting biomarker-driven studies that bridge global standards with local feasibility. Bill is passionate about aligning scientific innovation with practical patient care, and fostering collaboration across clinical, regulatory, and operational teams.
Gerald E Finken
CEO, RxE2
Gerald is a licensed pharmacist with over 40 years of experience in the biotechnology and pharmaceutical industries. In 1997, he founded CSM, a clinical supplies packaging and labeling company, where he invented On-Demand packaging and labeling, Clinical Trial Research Pharmacist (CTRP®) services, and pioneered Direct-to-Patient services. In 2013, he founded Center Point Clinical Services and subsequently created the innovative Siteless CRO model. In 2020, Gerald launched RxE2 where he now serves as CEO and is bringing the practice of pharmacy to clinical trials.
Moderator
Founder, Patient Centric Sampling Interest Group
Located in Hertford, UK, Neil is the Chair and co-founder of the PCSIG. He also runs a consultancy company where one of the main drivers is to help Clients understand the benefits of patient centric blood sampling, develop appropriate technologies and workflows and implement them for the benefit of human wellbeing. Neil’s interest in these technologies began in 2007 whilst leading efforts at GlaxoSmithKline to find blood sampling and analysis approaches suitable for the measurement of pharmaceutical concentrations in samples obtained from children.
Sponsor information
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Altasciences: Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.
Alturas Analytics: Alturas Analytics provides expert GLP & non-GLP LC-MS/MS and GC-MS/MS bioanalytical and PK/TK analysis services of small and large molecules in any matrix for discovery through Phase IV clinical trials.
Artyc: Artyc's battery-powered cold chain packaging is purpose-built for remote microsample collection, featuring precise temperature and location monitoring to safely enable a wider range of tests (e.g., refrigerated) in remote settings.
BD: One of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.
Bento Biology Platforms: A leading self-service biosampling company, transforming the decentralized clinical trial and biorepository landscape. Bento’s Biology Boxes deliver best-in-class biosampling and biosensing tools to each patient’s doorstep and guide them every step of the way with 24/7 live support, all backed by a hyper-kitting facility and sophisticated kitting logistics software. Created and vetted with participant input all along the design path, powered by game economies and participate-to-earn wallet technology, our digital symptom diaries (PROMs) and pharmacovigilance tools build trust across all medical communities while also radically reducing costs, accelerating time-to-market, and significantly lowering cost per-patient-visit.
Boehringer Ingelheim: Boehringer Ingelheim is a research-driven group of companies dedicated to the discovery, development, manufacture and marketing of innovative health care products. Every day our scientists are charting new territory and continuing our commitment to innovation that has created exceptional medicines that have changed the lives of millions of patients. We embrace the power of partnership and diversity of minds across the life-science communities to realize even more innovation and incubate new ideas.”
Capitainer: Dried blood spots (DBS) is now quantitative with volumetric control through our microfluidic qDBS technology solution. Precision, accuracy, sample protection and ease of use both at sampling and in the lab are key features for us in all product development.
Celerion: A world-class bioanalytical CRO dedicated to advancing drug development through cutting-edge science and patient-focused solutions. With decades of expertise, we are at the forefront of patient-centric sampling, pushing the boundaries of sensitivity to reduce sample size while maximizing the value of every precious drop of patient blood. Our mission is to ensure that each sample contributes meaningfully to the research and development of new therapies, enabling faster and more accurate insights into drug efficacy and safety. Through innovative approaches and a commitment to excellence, we are proud to support research that brings life-changing medicines to patients worldwide.
Charles River: Charles River Laboratories are a leading drug discovery and development contract research organization providing a broad spectrum of laboratory and data science support to the clinical development industry. This includes bioanalytical chemistry, immunology, biomarker services, immunoassay, genomics, vaccine development and ADME services. With over 1000 dedicated laboratory colleagues across a global footprint and expertise in traditional and advanced modalities, Charles River Laboratories are well placed to leverage scale and scope to support Clinical programs carried out anywhere in the world.
Genentech: Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit gene.com.
GSK:We are a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of 2030. Our bold ambitions for patients are reflected in commitments to growth and a step-change in performance. We are a company where outstanding people can thrive.
IQVIA Laboratories: IQVIA Laboratories is a leading drug discovery and development laboratory services organization providing innovative solutions that encompass broad central laboratory and specialty biomarker services, including genomics, immunoassays, flow cytometry, anatomic pathology, precision medicine assays, vaccine assays, ADME and bioanalytical along with extensive offerings in antibody drug discovery, biomarker discovery, and decentralized clinical trial lab solutions. Through the Decentralized Clinical Trials group, IQVIA Laboratories is at the forefront of patient-centric sampling, offering a variety of self-collection methodologies and is validating multiple assays using micro-samples that are self-collected by study participants.
LabConnect: LabConnect is the world’s most agile central laboratory solutions partner supporting clinical trials of all sizes and complexity. With modern operations and strategic alliances with world-leading laboratories, LabConnect is uniquely positioned to provide access to the latest innovation and automation. LabConnect is the trusted partner for biotechnology, pharmaceutical, and clinical research organizations.
LetsGetChecked: Healthcare that meets your people where they are. We enable partners to seamlessly utilize at-home healthcare programs to reduce barriers to access for those most in need.
Neoteryx: Neoteryx, a Trajan Scientific and Medical brand, offers remote microsampling devices designed for easy, reliable, cost-effective specimen collection in the clinic or field by healthcare professionals and end-users. Our innovative tools support decentralized research, remote monitoring, and personalized medicine, enabling streamlined sample collection and lab anaysis for pharmaceutical, clinical, and research sectors. Products like the Mitra® with gold-standard VAMS® technology for biological fluid sampling and the Harpera™ Microbiopsy Punch for skin sampling provide convenient, cost-effective solutions for advancing human health.
RDi: Leveraging our expertise in data processing, technology, and automation, we are revolutionising the healthcare supply chain. Through fulfilment and traceable kitting, we’re changing the way pharmaceutical and medical companies operate and deliver as part of the medical supply chain.
RedDrop Dx: Next generation blood sampling solutions.
Resolian: Global bioanalytical and analytical sciences partner supporting drug development and multi-regional clinical trials. Resolian is a leading global Contract Research Organization providing specialized services in GxP and non-regulated bioanalysis, drug metabolism/pharmacokinetic, and GMP CMC analytical and materials science. Comprised of the former Alliance Pharma, Inc., Drug Development Solutions Ltd, and Denali Medpharma labs and powered by a team of more than 500 experts across the US, UK, Australia, and China, Resolian supports pharma and biotech companies’ programs throughout the entire drug development continuum.
Roche: Doing now what patients need next.
SampleFacts: SampleFacts is a company that specializes in providing dried blood spot (DBS) sampling. We offer a solution that enables instant separation of blood cells and plasma from a single drop of blood. With these characteristics the product facilitates the opportunity to provide a reliable and efficient method for collecting and storing blood samples, addressing the growing demand for remote sampling and biobanking.
Streck: Established in 1971, Streck develops quality control and sample stabilization products that give clinical and research laboratories worldwide confidence in the validity of their results and help make the world safer, healthier and more productive. Streck products are manufactured in La Vista, Nebraska, and delivered to thousands of labs across the globe.
Takeda: We exist to create better health for people and a brighter future for the world. While the science and technology we advance are constantly evolving, our ambition remains. We move science forward, so we can transform more lives.
Tasso: Tasso is an emerging healthcare technology company that is transforming the traditional blood collection paradigm with a patient-centric approach. The company’s devices enable simple, convenient, and virtually painless blood collection for users. Tasso technology has the power to bring healthcare anywhere, any time.
Unilabs York Bioanalytical Solutions is a specialist provider of bioanalytical, metabolism and biomarker services to pharmaceutical and biotech companies, supporting development of small and large molecule therapeutics from discovery through to post-marketing.
Veloxity Labs: Veloxity Labs is a CRO focused on LC-MS bioanalysis. Our company is employee owned and operated, and offers start-up times and turn-around times in days by maintaining 80% capacity.
Waters Corporation: Waters Corporation, a global leader in analytical instruments, consumables, and software, has pioneered innovations in chromatography, mass spectrometry, and thermal analysis serving the life sciences market for more than 60 years. Waters Corporation aligns with PCSIG's mission, supporting collaboration among diverse stakeholders to advance pharmaceutical medicines development and elevating healthcare outcomes and decision-making through analytical innovation and precision.
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For more info on the PCSIG, please visit www.pcsig.org and follow on LinkedIn here.
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