Archives: Speakers

 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.  

Tomasz Adamusiak, MD PhD, serves as the Chief Scientist for Clinical Quality and Data Science at MITRE, where he leads initiatives to improve healthcare outcomes through AI and real-world evidence. Previously, as Head of Data Science at the Pfizer Innovation Research Lab, he led work on digital endpoints and decentralized clinical trials. He has held leadership positions within the American Medical Informatics Association and SNOMED International, and has published extensively in peer-reviewed journals.

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.

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.

David Sokoloff is the Director of Global Logistics & Materials Management for Novavax, Inc. He manages the storage and transportation of Novavax’s products through its global network. David founded For Granted, Inc. in 2006, a nonprofit supporting community driven programming in education, water and sanitation, micro-finance, and child health.

David has managed supply chains for emergency relief efforts across the Globe. He ran operations in the field for several years with Doctors Without Borders, prior to working in Washington, D.C., leading logistics operations for the U.S. Office of Foreign Disaster Assistance. At the onset of the COVID-19 outbreak, David joined Novavax, Inc. He supports their global supply chain to deliver products preventing a broad range of infectious diseases. Novavax produces vaccine candidates in response to both known and emerging disease threats, including the company’s CoVID-19 vaccine.