James J. Krupa, Pharm.D.,  Director, Clinical Supply Team Lead, Operations at Takeda in Lexington, MA. In this position, I am responsible for providing the leadership and strategic direction in terms of planning, budget, coordination, scheduling, resources and tracking of global clinical trial materials. I have over 42 years of industrial pharmaceutical experience in multiple dosage form drug development. Building upon experience as a bench pharmacist in clinical and non-clinical supplies, formulations, process development, and technical services, I  have contributed to the success of early and late stage development programs intended for regulatory approvals in women’s health, pain, oncology, CNS disorders, anti-inflammatory diseases, metabolic disorders, anti-infectives, cardiovascular, gastroenterology, gene therapy, and rare disease therapeutic areas.

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.

Dr. Isaac R. Rodriguez-Chavez is a biomedical and regulatory leader with expertise in decentralized clinical trials (DCTs) and Digital Medicine Tools applied to multiple therapeutic areas including Infectious Diseases, Viral Immunology, Viral Oncology, and Vaccinology. Currently, he is an independent consultant for Scientific-, Clinical-, Regulatory-affairs, and digital medicine for modern trials such as DCTs enabled by Digital Health Technologies (DHTs). Past positions in the last 20+ years include: Senior Vice President for Scientific, Clinical Affairs, leading the Strategy of the Global Center of Excellence for DCTs and Digital Medicine at PRA Health Sciences and ICON plc; FDA, CDER Senior Officer for Clinical Research Methodology, Regulatory Compliance and Policy Development modernizing clinical research through Real World Evidence and DCTs enabled by DHTs and electronic Clinical Outcome Assessments (eCOAs); CEO and Founder, 4Biosolutions Biomedical Consulting Firm; Vice President, Research, Texas Biomedical Research Institute; Director of HIV Clinical Research Programs at National Institute of Allergy and Infectious Diseases (NIAID) and National Institute of Dental and Craniofacial Research (NIDCR), National Institutes of Health (NIH); Senior Clinical Scientist, Schering Plough Corp. – Merck & Corp.; Scientist, Columbia University; Scientist, Polar Biotechnology Company and Venezuelan Institute for Scientific Research (IVIC). He has a PhD in Virology and Immunology; a MS in Microbiology; a MHS in Clinical Research and Health Sciences; and a B.S. in Biology. He also has 5 years of postdoctoral specialty experience in Clinical Research (phases 1 & 2 trials) linked to AIDS Malignancies, Immuno-Oncology and Viral Immunology (Infectious Diseases) done at the U.S. NIA and NCI, NIH. Dr. Rodriguez-Chavez is a Founding Board Member of the Digital Medical Society (DiME). He is also a co-chair of the DiME’s Research Committee, driving digital medicine globally. He is an Advisory Board Member of BlueCloud by HealthCarePoint; a regulatory Advisor and Vice-Chair of the Institute of Electrical and Electronics Engineers (IEEE) fostering industry standards on DCTs and DHTs. He is a former Leadership Council Board Member of the Decentralized Trials & Research Alliance (DTRA). He is a Board Member of the Hypertrophic Cardiomyopathy Association (HCMA) and a Health Equity Board Council Member for equity, diversity and inclusion in rare diseases at the Global Genes. He is a global content editor for regulatory science and an Editorial Board Member of the DIA Global Forum Magazine. He is also an active member of sixteen professional associations, including the Infectious Disease Society of America, American Federation for Medical Research, American Association of Immunologists, American Society for Virology, American Society of Microbiology, Society of Quality Assurance, Association of Clinical Research Professionals, New York Academy of Sciences, International AIDS Society, International Association for Dental Research, American Association for Dental Research, and Regulatory Affairs Professional Society.

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

Sean Smith is a Biological Threat Exclusion Coordinator (BTEC) for CBP in the Office of Field Operations/ Agriculture Programs and Trade Liaison/ Biological Threat Exclusion. As a BTEC, Mr. Smith is charged with supporting and developing U.S. Customs and Border Protection (CBP) operational capacity and capability in preventing tools of agro/bio-terrorism from entering the U.S.  Mr. Smith has more than 17 years of public service with CBP, and has worked in a variety of environments, including on the southern land border, maritime, air passenger, and cargo locations.  He has also been able to assist in several past domestic and international CBP disaster recovery operations.

 David Admas David is a top performing Clinical Supply Chain Manager with over 15 years of pharmaceutical experience, ranging from stability testing, clinical packaging & labeling, and global clinical supply chain management.  He is both a leader and contributing member to many process improvement workstreams at Takeda that include being the Head of the Label Focus Group, developing and implementing clinical label text translation phrase library, guidance on Compassionate Use clinical programs, decentralized trials, and is the packaging & labeling subject matter expert for the Clinical Supply team.  David has presented at CTS conferences before on the topic of Direct-to-Patient delivery of IP supplies, but today is here to speak about best practices for Comparator Sourcing and Labeling.

John Gregg, Pharmaceutical industry executive, John Gregg, has extensive experience in worldwide clinical development and commercialization of new anti-infective drugs. He has spent much of his career in senior roles directing the development and commercialization efforts for a large number of antibiotic, anti-protozoal, anti-fungal and anti-viral drugs. He is a veteran of new product development leadership positions at Pfizer, Novartis, J&J, BMS, and more recently his start-ups, Symbiomix Therapeutics, LifeQual Pharmaceuticals, and AkaRx. He is now the CEO of a BalinBac Therapeutics, Inc., a specialty infectious disease and microbiome modulation company. He was trained as a microbiologist and has led multi-disciplinary anti-infective drug development teams at the largest pharmaceutical companies, as well as small, private specialty firms directing the work of colleagues and contract laboratories

BS Chemistry from University of Minnesota in 2017

PharmD from University of Minnesota College of Pharmacy in 2022

Started as postdoctoral fellow in global clinical supply chain at Takeda in July 2022

Fred Moreau is the Director of Centralized Ancillary Supply Management at Takeda Pharmaceuticals.  His responsibilities include development & implementation of supply strategies to facilitate and support the delivery of ancillary supplies.

Fred has over 20 years of experience in the pharmaceutical and medical device industry.  In his career he has been responsible for clinical and commercial supply planning for multiple programs; product lifecycle management; strategic sourcing; and planning for new product launches.  

Paul is an experienced, motivated, and enthusiastic professional/pharmacist specializing in the area of Clinical Supplies/Investigational Product Management. He aspires to make an impact on patient lives by motivating, inspiring, guiding, and mentoring teams to see the value of the work that they do and the contribution it makes to the lives of the patients we serve globally. With over 15 years of training and experience in this area, he has served in a multitude of roles, including study supply management, asset management (DS/API/DP Management), management and oversight of a secondary packaging operations team, site and resource planning, and development of multiple custom systems and tools to enable staff to work more efficiently and distribute information more readily.

Tomasz Adamusiak MD Ph.D. is a Chief Scientist in the Clinical Insights & Innovation Cell at MITRE. He leads a multi-disciplinary group driving high-impact contributions to private and public sectors in the Real-World Evidence, Genomic Data Science, and Digital Health space.

Before MITRE, Tomasz was the Head of Data Science in the Pfizer Innovation Research (PfIRe) Lab. His team was responsible for developing novel digital endpoints, designing decentralized approaches for clinical trials, and applying AI/machine learning methods to generate novel insights from clinical data. He served in leadership and advisory roles in the American Medical Informatics Association, the SNOMED International, and the Epic Research Data Network. He published several highly-cited research papers in peer-reviewed journals and is a frequent speaker at life sciences conferences.

Tomasz's interests are in the use of digital technology to improve health and healthcare. He believes strongly in empowering individuals to better manage their health and is passionate about the power of technology to facilitate these efforts and more broadly transform healthcare.

Susan Marlin is the President and CEO of Clinical Trials Ontario (CTO), an organization established by the Province of Ontario in 2012 to make Ontario a preferred location for global clinical trials while maintaining the highest ethical standards. Prior to joining CTO served as the Associate Vice-Principal at Queen’s University. Susan worked with the Canadian Cancer Trials Group for many years coordinating cancer clinical trials and leading the development and implementation of the Ethics, Regulatory, and International Office.

Susan has actively engaged in research ethics for many years.  She served as President of the Canadian Association of Research Ethics Boards, as a member of the Canadian Institutes of Health Research (CIHR) Research Integrity Committee, the Ontario Cancer Research Ethics Board and the Tri-Agency Panel on the Responsible Conduct of Research. Susan is on the Board of Directors and Executive Committee of Life Sciences Ontario and the Management Team for the Ontario SPOR (Strategy for Patient-Oriented Research) Support Unit.  She is an Adjunct Lecturer at Queen’s University in Kingston, Ontario and is the nominated principal investigator on the CHEER Project, a Canadian Institutes of Health Research funded project to streamline research ethics review for child health research across Canada. 

Susan was born and raised in Halifax, Nova Scotia. She holds a BSc (Hons) from Dalhousie University and an MSc in Community Health and Epidemiology from Queen’s University. She was awarded the Queen’s Elizabeth II Diamond Jubilee medal in 2012 in recognition of her work in support of military and veteran health research.

As President and CEO, James lead the development team of Asymmetrex® LLC. Asymmetrex® is a for-profit limited liability company with a mission of developing innovative tissue stem cell biotechnologies for applications in cellular medicine and drug development.

Asymmetrex's lead tissue stem cell biotechnology is the first-in-kind method for specific and accurate counting of tissue stem cells. Asymmetrex's TORTOISE Test^TM kinetic stem cell (KSC) counting technology is freely available to the stem cell research, biomanufacturing, medical, and pharmaceutical communities. By providing early and easy access to the new technology (https://lnkd.in/dGru6Tc), Asymmetrex® is achieving its vision of accelerating progress in tissue stem cell science and medicine by enabling, for the first time in the 60+ year history of stem cell science and medicine, the routine determination of tissue stem cell number and treatment dosage.

Kaitlin is working on the NIBR CQA team to manage quality issues by supporting clinical operations teams with root cause analysis and CAPA management to ensure patient safety and data integrity. She is also, actively involved in cross-divisional quality improvement projects focused on informed consent, inspection readiness, and quality culture.

Angelo Termine is the Chief Executive Officer and President of Ki Health Partners LLC doing business  as New England Institute for Neurology and Headache,  New England Institute for Clinical Research, our clinical research center, as well as Ki Clinical Research, a site  management organization (SMO) providing business, development and regulatory expertise to medical practices wishing to engage in clinical research.

Angelo started his career in research at Yale University, School of Medicine, Department of Psychiatry in New Haven.  He then transitioned to Research Manager at a large neurology practice in Fairfield, where he participated in more than 100 studies, and successfully lead a team of clinical research coordinators for more than eight years before the launch of Ki Health Partners, LLC. In addition to holding master’s degrees in science management and business administration, Angelo is certified as a Clinical Research Associate, Clinical Research Coordinator,  and Clinical Research Contract Professional. He is a certified rater with extensive experience on the following scales: NIH Stroke Scale, ADAS-Cog, NPI, MMSE and multiple clinical psychiatric assessment certifications. He is a member of MAGI (Models Agreements and Guidelines International) as well as the Headache Cooperative of New England, has lectured extensively on clinical research throughout the country,  and has coauthored numerous scientific papers.

Hyun has been a part of AOBiome's clinical pipeline leadership since 2016. Hyun brings over 25 years of drug development experience in the pharma and biotech industry.  Prior to this, Hyun has led Clinical and R&D programs and departments at Pfizer, Anika Therapeutics, Transport Pharmaceuticals, and Olympus Biotech.  He started his career at Genetics Institute and Wyeth, advancing R&D programs into the clinic.  He attended Brown University where he studied Biomedical Engineering and completed a PhD in Medical Science.

AOBiome Therapeutics, Inc. is a Cambridge, MA-based life sciences company focused on transforming human health by developing microbiome-based therapies for local, nasal and systemic inflammatory conditions. Founded in 2012 by PatientsLikeMe founder Jamie Heywood and MIT-trained Chemical Engineer David Whitlock, AOBiome is advancing a pipeline of multiple, clinical-stage therapeutic candidates. The company's portfolio includes multiple clinical-stage programs in atopic dermatitis, rosacea, and acne, as well as additional programs targeting diverse inflammatory indications. 

Amanda Murphy is the Director of Product Management at GlobalData, a company that focuses on research, data analytics and consulting that provide actionable insight into the pharmaceutical and medical device sectors.  She has 10+ years of experience working in pharmaceutical data science and web platform development (including BioPharm Insight, Lead Sheet, and the Pharma Intelligence Center).  She has developed models and solutions to support Clinical Operations & Feasibility teams plan and optimize trials, including an e-feasibility questionnaire tool resulting in 4x faster response rates from sites.  Amanda also has many years of experience supporting business development at CROs through data-driven lead delivery and CRM integration solutions.

James L. Sherley, M.D., Ph.D. is the founder, President, and CEO of Massachusetts stem cell biotechnology company Asymmetrex, LLC. Asymmetrex develops and markets technologies for advancing stem cell medicine, including the first method achieving specific and accurate certification of the dosage of therapeutic tissue stem cells, called kinetic stem cell (KSC) counting. Asymmetrex’s kinetic stem cell counting platforms are also used to optimize manufacturing of therapeutic stem cells and for evaluations of drug effects on tissue stem cells. Dr. Sherley is a graduate of Harvard College, with a B.A. degree in biology, and the Johns Hopkins University School of Medicine, earning joint M.D. and Ph.D. degrees. Prior to founding Asymmetrex, he held academic research appointments at the Fox Chase Cancer Center, Massachusetts Institute of Technology, and Boston Biomedical Research Institute. Dr. Sherley’s professional awards include Pew Biomedical Research Scholar, Ellison Medical Foundation Senior Scholar in Aging Research, and NIH Director’s Pioneer Award.

Antoine Remiot is N-SIDE's Director of Solutions Engineering. Over the past years, Antoine has been sharing his enthusiasm about lean clinical supply chain management, waste reduction and sustainability with various pharma partners. Meeting new people from both large and small pharma, understanding their challenges and optimizing complex supply strategies are really what drives him.

Maxime is an optimist and is passionate about problem-solving. He is a Senior Consultant and has been working at N-SIDE for over 4 years. He supports pharma partners with the optimization of multiple trials and programs from different therapeutics areas. He also helps those partners to understand the value of risk-based optimization and drive changes within their organizations. He loves to exchange ideas and discuss with people from the industry. Maxime has a Master in Business Engineering with a focus on supply chain.

Tom Gottschalk has worked in the life sciences industry for over 25 years.  His first 10 years were spent as a Pharmaceutical Representative and Product Manager for Bertek Pharmaceuticals, Merck, and GSK.  He then joined RxSolutions as a commercial services account representative before transitioning into a focused clinical role after creating the RxStudy Card offering.  He joined TrialCard in 2019 via its acquisition of RxSolutions.  For over 12 years, Tom has been committed to changing the paradigm of the traditional clinical trial supply process through the RxStudy Card.

As Clinical Supply Chain Solutions Consultant, Henk has been assisting Suvoda with his knowledge in various areas of clinical trial supply management since October 2020. Prior to joining Suvoda, Henk co-founded the clinical supply chain department at Grünenthal GmbH (Aachen - Germany) and served as Associate Director of this department for 10 years. At Grünenthal, Henk developed operational processes and promoted risk management procedures to establish the company as a clear market leader in the area of the clinical trial supply chain.

Following his time at Grünenthal, Henk moved to BioNTech S.E. (Mainz - Germany) where he assumed the role of Senior Investigational Medicinal Product Manager. At BioNTech, he streamlined data processing in the clinical supply chain for personalized oncology therapies.

Henk is an innovative expert in IRT, temperature excursion management and direct-to-patient logistics and a member of the DtP sub-team of the GCSG Regulatory e-Team.