Stephen is a Compliance Officer within the Division of North East Imports for the FDA. He started his career with the FDA in 2008 as a Consumer Safety Officer assigned to the former New England District Office in the Investigations Branch. He started off working within the foods group conducting routine inspections, and a short time later, switched to the import group. During his time in imports, he has been proficient at entry review and field activities playing a key role in identifying violative products. Stephen has also been praised for representing the FDA, for always participating in broker outreach and inter-government relations, as well as training his peers. In 2018 he was promoted to a Compliance Officer.

Anthony has worked for the FDA since April of 2010 as an investigator in the BIMO, Foods and now import program area’s.

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.

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.

Sydney Reynolds, PharmD, MS, is the First Year Global Clinical Supply Chain Fellow at Takeda. Sydney graduated in May of 2023 from The Ohio State University College of Pharmacy with her PharmD and MS in Translational Pharmacology specializing in Clinical Pharmacology and Clinical Trial Design. Before that, she received her BS in Chemistry and Biology from the University of Indianapolis. Throughout pharmacy school, she was a Clinical Pharmacy Intern at The OSU James Cancer Hospital, where she was also heavily involved in research. She held leadership positions in Student College of Clinical Pharmacy (SCCP) and was a PharmD Ambassador for the college. For Sydney, pharmaceutical research is where her two passions collide – science and healthcare. She is excited to jumpstart her career with her fellowship and begin improving the lives of patients in the biopharmaceutical industry.

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.

Jessica Vieira, PhD, leads the global value chain environmental sustainability strategy at Takeda Pharmaceutical Company. She has a decade of experience in environmental sustainability strategy across the chemical, consumer electronics and food technology industries and holds a PhD focused on life cycle assessment as well as a background in environmental engineering. In her role at Takeda, Jessica leads the Scope 3 greenhouse gas emissions reduction program aimed at achievement of the company’s goal to reach net-zero across the value chain before 2040.

Sarah Mandlebaum is a dedicated sustainability professional serving as the Lead for Global Environmental Sustainability & Life Cycle Assessment at Takeda in Lexington, Massachusetts. With a strong foundation in sustainability, she currently leads Takeda’s work around measuring the sustainability performance of Takeda’s products. Sarah holds a Master of Business Administration (MBA) from the Yale School of Management and a Master of Public Health (MPH) in Environmental Health from the University of Michigan.

Rakib Ouro-Djobo is an empowering servant and a dedicated supply chain management leader focused on providing global access to life-saving treatments and life-changing opportunities. He has over 12 years of experience supporting mission-driven organizations in the life science and biotech industries. Currently, he works as the Clinical Supply Chain Lead for the Bill & Melinda Gates Medical Research Institute.

Gilad Beck serves as the Natick, MA Site Head, Operations and Manufacturing Director at Orgenesis. He holds a BSc in Biotechnology and has over 10 years of experience working in the cell and gene therapy industry, in leading manufacturing, process development and project management roles. His background includes extensive knowledge of various cell and gene therapy processes, process development, tech transfer, closed and automated systems and GMP operations. Mr. Beck is also an expert in building cross-functional high performing teams. He utilizes his skills and experience to lead the Natick, MA site set up and operations as part of Orgenesis’ POCare Network that brings together patients, doctors, industry partners, research institutes and hospitals worldwide to achieve harmonized, regulated clinical development and production of life-saving therapies.

Jamie Myers is a skilled and experienced pharmacist with a strong background in clinical research and inpatient hospital pharmacy operations. With a Pharm.D. from Saint Louis College of Pharmacy and a PGY-1 Residency from Duke University Medical Center, Jamie has a solid foundation in pharmaceutical knowledge and patient care.

Currently serving as Senior Manager of Global Clinical Supply Chain at Takeda, Jamie oversees the coordination and management of investigational oncology medication for phase I/2 research studies. Prior to this role, Jamie worked as a Clinical Research Pharmacist Specialist at Brigham and Women’s/Dana Farber Inpatient Hospital. There, she worked for investigational drug services and dispensed research medications for therapeutic areas like critical care, emergency room, oncology, neurology, dermatology, and rheumatoid arthritis. Jamie gained first-hand experience with gene therapy, viral vectors, and COVID-19 vaccines, and was involved in the design and implementation of clinical research studies.

Before joining Mass General Brigham, Jamie served as a Clinical Coordinator for Drug Trials at Maine Medical Center, where she handled both clinical research and pharmacy responsibilities. Jamie was responsible for dispensing, accountability, and advising for phase II through IV studies, and worked closely with CRAs for site evaluations, audits, and closeouts.

Jamie's career also includes experience as a Pharmacy Operations Manager at Winchester Hospital and as a Medical Science Liaison (Clinical Science Manager) at Abbott. She has been involved in accelerated oncology programs, served as a preceptor for fellowship programs, and has been recognized as a subject matter expert in temperature excursions. Jamie has also contributed to various publications and research studies in the field of pharmacy.

With a strong commitment to patient care and research excellence, Jamie has demonstrated her ability to effectively manage clinical trials, collaborate with multidisciplinary teams, and ensure the highest standards of pharmaceutical care.

Seasoned R&D Industry professional with over 30 years of experience in large pharma, mid-sized, start-up and virtual settings. Career appointments span the full spectrum of product life-cycle management, across every phase of development and every research platform, including pharmaceuticals, biologics, devices, combination products, gene and stem cell therapeutics, Phases I-IV. Achievements include contribution to the US and International market approval of 6 biopharmaceutical products.

Baljeet Kaur is an Agriculture Operations Manager (AOM) for U.S. Customs and Border Protection (CBP) at the Boston Field Office (BFO) consisting of six New England States (MA, ME, VT, NH, CT, and RI).  As an AOM, Ms. Kaur is charged with providing guidance to personnel within the BFO on various agriculture matters including, but not limited to: regulated garbage compliance, regulation of biological material, and entry requirements for regulated agriculture commodities.  Ms. Kaur has more than 15 years of public service with CBP, and has worked in a variety of environments including, air passenger, air cargo, and maritime.

Irena Seredina’ background is medicine, economics and management. She holds an MD, honors diploma and a MSc in Health Economics. During her medical practice,  Irena  worked in clinical research as a researcher and an investigator. The results of her research have been published in a number of articles and she is a recognized speaker at several industry forums and international conferences.  Irena worked at Amgen, and then joined S-Clinica in 2004. Now, as  Executive Director Irena gives direction for the product strategy and customer relationships.

Jas started his career in the 90s, as a data manager within clinical trials when these were done predominantly on paper - and has over the years seen the industry change and evolve.

He has a degree in Applied Physics, and has worked over the last 25 years within eClinical technologies and solutions, with global responsibilities in project management, solutions consulting and sales. Jas's role within S-CLINICA is to bring new business, and build strategic relationships with customers.

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.

Yves Dethier, a distinguished figure in clinical supply chain management, serves as CEO of Boostcode, enhancing supply chain efficiency for biotech firms. With a rich background advising industry leaders like GSK and J&J, he's also the founder of ClinOps Academy, a platform nurturing talent and skills in clinical operations through mentoring and development programs.

Kristen DeVito is a dedicated leader in the Clinical Trials industry, with a strong commitment to optimizing global supply chains and prioritizing patient needs. As the Executive Director of Clinical Supply at Exelixis, she leads a team that supports the development of the company’s oncology pipeline. With over twenty-five years of experience, she has a proven track record in clinical supply chain solutions, clinical supplies management, operations improvement, and client engagement.

In her past roles, she served as the Vice President of North America Operations and Vice President of Customer Service Excellence and Project Management in Clinical Supplies at Catalent Pharma Solutions.

Beyond her professional commitments, Kristen actively contributes to the industry. She is a committee member of the Biotech Supply Management Alliance (BSMA) and has previously held positions as a committee member and chair of the ISPE Investigational Products CoP Steering Committee.  She has also shared her expertise as an instructor for the Center for Professional Advancement course on Clinical Trial Materials.

Antoine Remiot is N-SIDE's Director of BD and Partnerships. Over the past years, Antoine has been sharing his enthusiasm for lean clinical supply chain management, waste reduction, and sustainability with various pharma partners he supported in their change management journey toward digitalization.
Antoine is passionate about leveraging data and AI to improve clinical supply efficiency. He gained expertise in forecasting, planning, IRT configuration, and end-to-end clinical supply chain optimization through his work on hundreds of trials on multiple indications.

Jake Levine is a Solutions Engineer at N-SIDE. His experience in clinical supply expanded quickly by solving day-to-day supply challenges of biopharma companies. He is passionate about utilizing artificial intelligence and machine learning to improve the clinical supply industry and, ultimately, improve patients’ health. Jake received his Master’s Degree in Healthcare Systems Engineering from Lehigh University where he developed a strong interest in healthcare and biopharmaceutical market disruption, with a patient-centric approach.

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 parters with the optimization of multiple trials and programs from different therapeutics area. 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.

Digital Supply Chain Enthusiast. Built a career in Digital Supply Chain while working through ERP and other implementations in various healthcare organizations. Led Digital transformation programs for large Biotech's and other global Supply Chain Planning initiatives. Experienced in systems integrations through M&A's. Very excited with what the future holds from a Digital Supply Chain standpoint.

Andrea earned her B.S. in Biotechnology and M.S. in Biology and then began her career in the lab working on process development and validation before transitioning to a quality role.  Andrea has spent time in Quality Systems, Compliance, and Operations positions but now specializes in leading a QA Operations team supporting the CMC functions of early phase clinical programs through commercialization.

Tom has worked in the life sciences industry for over 26 years, with the first 10 as a pharmaceutical representative and marketing product manager for Bertek, Merck and GSK.

Tom joined Mercalis 16 years ago, created the RxStudy Card offering in 2009 and for the past 14 years has been focused on changing the paradigm of the traditional clinical trial supply process to one of greater efficiency through the RxStudy Card.

Bill is a 20 year life sciences veteran with a specialization in eClinical Solutions.  He has held roles with global pharma, CRO and technology providers with responsibilities spanning service delivery leadership, partnerships, strategy, innovation, and business development.  He has been active and influential in key consortiums including CDISC, SCDM and TransCelerate (notably the co-architect of the Digital Data Flow workstream).  Bill has a passion for applying innovative technology towards enhancing the ability to deliver new therapies to the world faster.

As the chief business officer, Peter is responsible for establishing and executing Frontier’s business development strategy which includes identifying target customers and managing the execution of the company’s sales strategy.  Peter is also responsible for identifying opportunities for business growth and creating business partnerships, along with overseeing the activities and performance of the business development team.

Prior to joining Frontier, Peter started the Contract Manufacturing business for Pharmascience in Montreal. He built their US division for over 6 years and is credited for growing that new business vertical to over $200M. Pharmascience is a full service CMO specializing in development and manufacturing of complex oncology injectables.

Peter has over 15 years of experience in the Pharmaceutical industry. His experience spans from preclinical development, to API sales, to Generic injectable manufacturing. He began his career in preclinical safety pharmacology where he lead the business development unit for Huntington Life Sciences in Princeton NJ. Gradually, he worked his way into the Clinical Trial sector and took up a Director of Business Development role for AIT Biosciences in Indianapolis. He later spent 5 years in the API industry and began MSN Pharma’s first US office in Edison NJ.

He received his undergraduate degree from The University of California Irvine in Biology and a Masters Degree in Biotechnology from The University of Pennsylvania (UPENN).