Clinical Trial Supply East Coast 2023

Our Annual Clinical Trial Supply East Coast will take place on the 11th and 12th October 2023 in King of Prussia.

11 - 12

October

2023
  • Sheraton Valley Forge, King of Prussia, PA, USA
  • Free
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Featured Speakers

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AIMEE HODGE​

VP/GM Of Technical Operations, PCI Pharma Services

Aimee Hodge is the VP/GM of Technical Operations at PCI Pharma Services located in Bedford, NH. In this role, Aimee oversees the technical transfer, project management, validation and manufacturing technical science (MTS) groups supporting PCIs North American business units related to the contract manufacturing of sterile drug products and medical devices. Aimee is a member of New England PDA and International Society for Pharmaceutical Engineering. She is an active member of the NH EPSCoR Research and Industry Council. She earned her B.S. in Biology from the University of New Hampshire and holds numerous patents for medical devices.

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    2023 Sponsors Included:

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    Company Information

    N-SIDE is a deeptech company that empowers organizations in the life sciences to make better decisions and optimize the use of critical resources. We’re doing so by combining deep industry expertise with applied mathematics and artificial intelligence into easy to use and cutting-edge software that transforms uncertainty and complexity into deterministic outcomes. We are an active player in clinical trial supply chain management for over 20 years and have the majority of the top 20 pharmaceutical companies as clients.

    With our software solution, the N-SIDE Suite, and expert services, we streamline the clinical supply of pharmaceutical and biotech companies by accelerating clinical plans, mitigating risks and curbing drug waste. We empower clinical leaders to make better, faster and safer decisions for patients waiting for life-changing medications.

    Company Website

    To learn more , please visit our website - https://lifesciences.n-side.com/

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    Company Information

    4G Clinical is a leader in randomization and trial supply management (RTSM) for the global life sciences industry, offering the only fully cloud-based, 100% configurable and flexible solution utilizing natural language processing (NLP) and integrated supply forecasting. 4G Clinical is headquartered in the Boston Biotech corridor of Wellesley, MA, with offices in Europe and Asia. For more information, please visit www.4gclinical.com

    Company Website:http://www.4gclinical.com/

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    Company Information

    Abacus Medicine Pharma Services is the new name for the healthcare and pharma services company previously known as Aposave. The company has three service lines: Clinical Trial Solutions (CTS), Commercial Partnerships and Unlicensed Medicines.

    The CTS service focuses on comparator sourcing solutions for clinical trials as well as bespoke batch-specific sourcing of pre-clinical samples. We specialize in partnering biosimilar manufacturers, biotechnology and innovative pharma companies

    Company Website

    To learn more , please visit our website - www.abacusmedicinepharmaservices.com

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    Company Information

    TrialCard Incorporated is a full-service life sciences commercialization partner that provides comprehensive solutions that span the entire biopharmaceutical value chain. In addition to a foundation of fully integrated, digitally enabled patient support services, its broader offerings include everything from late-stage clinical trial management to post-marketing HCP engagement services and proprietary data-as-a-service payer intelligence and insights. Founded in 2000, TrialCard provides commercialization needs for more than 160 life science customers and has connected over 35 million patients with more than $18 billion in branded drug savings to date. The company is headquartered in Morrisville, North Carolina.

    Company Website

    To learn more , please visit our website - http://corp.trialcard.com/

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    Company Information

    YPrime’s cloud-based technology streamlines clinical trial data collection and management. Electronic clinical outcome assessments (eCOA) and interactive response technology (IRT) platforms introduce greater speed, precision and data quality to clinical trials. Our consulting services help clients simplify downstream processes, while moving faster and more efficiently to their next development milestone. 

    We innovate through pragmatic, forward-looking change that considers the needs of stakeholders in each clinical research role. We’re doing more than streamlining your processes. We’re streamlining your research, helping you get to your next milestone faster. 

    Company Website

    To learn more , please visit our website - http://www.yprime.com/

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    Company Information

    Yourway is The Biopharma Services Company changing the landscape of clinical supply chain solutions with a unique, single source model. We are the only truly integrated provider premium courier and clinical packager, supported by a global network of GMP facilities. We have the resources, experience and commitment to make your packaging and shipments faster, and management of trials easier and more efficient. For over 20 years, Yourway has guaranteed speed of delivery with highly customized transport and storage solutions for biopharmaceutical companies, CDMOs and anyone needing to move high value and temperature-sensitive materials around the world. By integrating your clinical packaging seamlessly, we provide unified project management and total visibility.

    Company Website

    To learn more , please visit our website - www.yourway.com

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    Company Information

    Acnos Pharma is privately-owned, specialized pharmaceutical company operating globally in the clinical trial supply landscape. The headquarter is in Germany, Aachen. We offer flexible, cost efficient and quality sensitive customized solutions for individual trial requirements. We offer a broad range of clinical trial services supply chain management, clinical trial procurement and logistics.

    Th combination of passion and expertise leverages our global reach and maximizes customer satisfaction.

    Company Website

    To learn more , please visit our website - http://acnospharma.de/

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    Company Information

    AWT Healthcare manufacturers clinical trial labels. We have expanded our product line to include Medical Device Labeling through AWT Labels & Packaging. AWT Healthcare is solely focused on providing the clinical pharmaceutical and custom labels & packaging industry with state-of-the-art solutions at a fair price and competitive timing.

     

    For more information please contact Graig Daley – Business Development Manager and Jackson Young – Business Development Associate at sales@citlabels.com.

    Company Website

    To learn more , please visit our website - http://citlabels.com/

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    Company Website

    To learn more , please visit our website - http://www.bionicalemas.com

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    Company Information

    BMclinical, your global clinical trial supply partner. We offer worldwide commercial medicine supply, from analytical samples to bulk comparators, through to the supply of co-meds and pre-meds.  We can pack and label your IMP/commercial medicines from our GMP facility, where we also offer storage and distribution services. BMclinical is uniquely positioned to offer solutions for overage and unused clinical trial stock.

    Company Website

    To learn more , please visit our website - https://www.bmclinical.com

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    Company Website

    To learn more , please visit our website - https://www.boostcode.eu

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    Company Information

    Brocacef operates throughout the entire pharmaceutical chain, lending us an unique position as a wholesaler in the Dutch pharmaceutical healthcare industry. With expertise in global logistics, sourcing and supply chain experience Brocacef is able to offer a variety of services for clinical trials.

    Company Website

    To learn more , please visit our website - www.brocacef.nl

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    Company Information

    CCL Label is the largest label company in the world and provides innovative and sustainable solutions to consumer markets worldwide. The company has developed Labels and Aleeves that wow consumers through premium appearance as well as ecological solutions that support recycling, reduction and reuse.

    Company Website

    To learn more , please visit our website - https://ccllabel.com/market/beverage/

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    Company Information

    Endpoint Clinical is an interactive response technology (IRT) solutions provider that supports the life sciences industry. Our innovative, high-quality randomization and clinical trial management technologies are backed by over a decade of award-winning experience and expertise. Endpoint is headquartered in Wakefield, MA, with offices across the US, EU, and Asia.

    Company Website

    To learn more , please visit our website - http://www.endpointclinical.com/

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    Company Information

    Euromed Pharma deliver strategic services tailored to support companies in their quest to better healthcare. We support each industry player from drug development through the post-marketing phases. We offer solutions in CTS services, Clinical GMP Packaging, Labeling and Distribution, IMP management, Early Access and Named Patient Programs, Pharma Order to cash solutions, and Supply Chain & Logistics. We are present around the world with offices in Italy, Spain, Ireland, Germany, Singapore and the USA. Being one of the Petrone Group companies, Euromed Pharma is positioned at the forefront of innovation in pharmaceutical distribution.

    Company Website

    To learn more , please visit our website - www.euromed-pharma.com

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    Company Website

    To learn more , please visit our website - www.expericservices.com

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    Company Information

    IMP Logistics offers warehousing and logistics services for clinical trials in Russia, Ukraine and Belarus, operating in state-of-the-art licensed facilities. Our integrated range of services includes import of clinical trial materials, storage in temperature controlled areas (ambient,  2-8°C, -15 -25°C, and -80°C), re-labeling , purchasing comparators, distribution to/from sites and arranging destruction of returned materials.

    Company Website

    To learn more , please visit our website - http://www.imp-log.com/

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    Company Information

    The Inceptua Group Group is a dynamic, enterprising, and future-oriented service provider operating within the clinical trial and unlicensed medicines supply chain at an international level.

    Our multinational team provide connections to an extensive global network, offering our clients customized solutions ranging from strategic planning and sourcing, clinical manufacturing and global depot solutions, right through to early access to unlicensed medicines.

    We are committed to safety, and reliably supporting our clients every step of the way, leaving them safe in the knowledge that every potential obstacle has been considered, and every eventuality planned for.

    Our worldwide presence enables us to fulfil these services for the duration of trials, and our expert team work closely with our customers to ensure they receive full support throughout the lifecycle of their project.

    Company Website

    To learn more , please visit our website - http://www.inceptua.com/

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    Company Website

    To learn more , please visit our website - http://www.innovativesupplysolutions.com/

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      Why attend?

      We are excited to be hosting the next edition of Clinical Trial Supply East Coast on the 11th and 12th of October 2023 in the Sheraton King of Prussia.

      The conference covers all things CTS from reducing timelines and streamlining processes to handling clinical supplies in a decentralized trial world. Our expert panel will deliver case studies, thought leadership pieces, interactive panels and roundtable discussions.

      Clinical Trial Supply East Coast offers opportunities for both learning and networking with peers from across the CTS sphere, via informal networking breaks and lunches, as well as a relaxed drinks reception at the end of Day 1.

      We have the best delivery for clinical trials East Coast 2023 for which we have been chosen by online casino players among other deliveries. Also at the conferences, everything related to CTS is covered, we also talk about bills vs patriots dfs picks. Speakers from Pfizer, Merck, Janssen, online casinos and others perform on our first day.

      Our day one includes speakers from Pfizer, Merck, Janssen and many more who will be covering the latest innovations in the clinical supply industry. The day will be split into two different streams, with a clinical supply operations category as well as a stream highlighting great innovation and technological updates.

      Our conference continues into day two with some exciting talks covering the latest in IRT systems, some exciting case studies and a talk from the FDA.

      Don’t miss out, join us in King of Prussia on the 11th and 12th of October 2023.

       

      BRINGING TOGETHER PHARMA AND BIOTECH EXPERTS TO DISCUSS NEW TRENDS AND OPPORTUNITIES

      The Clinical Trial Supply East Coast is the meeting place for the pharmaceutical and biotechnology community to discover how to excel in clinical supply strategy as well as form key connections for long-term success. It’s time to build relationships and take away valuable lessons to for clinical trial success moving forward so we look forward to seeing you there!

      300+

      Attendees

      		35+

      Exhibitors

      		20+

      Speakers
      300+

      Attendees

      		35+

      Exhibitors
      20+

      Speakers

      Testimonials

      See What It's All About

      Agenda

      • 19 Oct 2022
      • 20 Oct 2022
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      Streams

      Stream one

      Clinical Supply Technology and Innovation Stream

      12:45 PM

      Lunch and Networking

      7:45 AM

      Registration and refreshments

      8:25 AM

      Chairs opening remarks

      8:30 AM

      Improving the efficiency of shipments across borders in a post pandemic world; and not forgetting the war in Europe

      • Is the pandemic truly over in the shipping world?
      • What countries are still having major issues post pandemic.
      • Sharing our story on the major challenges we’ve faced.
      • How to best compete for storage spaces.
      • Tips and techniques for ensuring smooth deliveries of all shipments

      9 AM

      How to make clinical supply more sustainable in a world of finite resources?

      • Navigating KPIs and trends that will strongly impact the future of clinical supply chain
      • How sustainability, ethics, waste reduction and faster timelines enable each other
      • What changes can be conducted in biopharma organisations to anticipate these changes
      • Illustration through case studies

      9:30 AM

      Exploring the issues with your supply chain management in a modern decentralized trial: how to avoid the big mistakes

      • Overcoming the barriers in each step of a decentralized trial: where did we waste the most time?
      • Are decentralized trials worth the extra hassle?
      • Adjusting ongoing trials to be fitted for direct to patient, what works and what doesn’t.
      • Standardization of decentralized trials: how collaboration and regulation can work for everyone.

      10 AM

      Starting With the End in Mind: Driving Clinical Supply Forecasting Optimization Through Outputs

      There are many different variables that affect drug waste and/or stock-outs within a clinical trial, so when it comes to forecasting, how do we facilitate specificity and intention in our decision making to help garner more overall accuracy in end-to-end forecasting?

      • Discuss forecasting challenges from a clinical operations and clinical supply perspective
      • Understand the best practice of utilizing forecasting tool outputs to help optimize drug level management from the start
      • Explore how modern technology helps facilitate overall visibility of clinical supply data to help optimize forecasting from the beginning

      10:30 AM

      Morning refreshments and networking

      11:15 AM

      Deconstructing modern day labelling of investigational drugs

      • Innovation in labelling has changed the game but has it made things easier.
      • With the extra demand to go bigger with trials and pool supplies, can we keep up and does Just in Time labelling help.
      • How to effectively plan for a smooth international trial.
      • Should you leave label translation up to your CRO.

      11:15 AM

      Panel: Exploring metric management – What are you measuring and why

      • How are industry professionals managing waste management and preventing over stocking.
      • Working with a CRO to prevent excess waste.
      • Is it worth it to really trim the fat on every trial?
      • Highlighting the downsides to over management?

      11:45 AM

      Looking into global diversity, supply strategy diversity and vendor diversity

      Global Diversity – Our planet Earth is a vast and diverse place

       

      Understand different countries, cultures, healthcare systems and distribution processes have an impact on supply strategy selection

       

      Supply Strategy Diversity – You can’t do the same thing everywhere

       

      Understand the value of a supply partner who can provide supply strategy diversity

       

      Vendor Diversity – Clinical supplies are not the only thing a trial needs

       

      Understand the value of a supply partner who can provide services beyond supplies

      11:45 AM

      Flexibility and Success in Partnership: Trial Supply Management & IRT Systems

      • A conversation on the successes and lessons learned in implementing large-scale global studies with robust demands

      12:15 PM

      Investigating how decentralized trials can improve the way we recruit patients

      • What are the primary drivers pushing people out of the clinic?
      • Patient reactions to home treatment compared to hospital visits.
      • Does culture influence the way decentralized trials are viewed?
      • Defining the extra steps to promote recruitment in decentralized trials.
      • The need to include Minority populations in decentralized clinical trials and how to recruit them

      12:15 PM

      Manufacturing and drug supply for early phase oncology trials from a start up perspective

      • Looking into the milestones of manufacturing from preclinical to clinical
      • How to manage fund raising and financing a novel GMP product
      • Covering the biggest challenges you will face with a start-up

      12:45 PM

      Lunch and networking

      12:45 PM

      Lunch and networking

      2 PM

      Uncovering the ways that blockchain will make your supply chain run more efficiently

      • What is blockchain and what role will it play in the clinical trial world.
      • How will you need to adapt in the future to work with blockchain.
      • Why should someone adopt this complex technology when it will be a huge time investment.

      2 PM

      Assessing Sourcing Models to Determine the Optimal Sourcing Strategy

      • Overview of different sourcing models
      • Assessing options to determine optimal strategies
      • Working in a wholly outsourcing model; maintaining a strong supplier base

      2:30 PM

      From First Vial to Final Mile

      Sterile filling/finish and Lyophilization remains one of the most critical processes in biopharmaceutical manufacturing. In this presentation Aimee will take you on the journey of the vial, addressing:

       

      • High technique driven processes
      • Sterility Assurance and processing steps
      • Why to Lyophilize
      • Considerations for high level controls and requirements for every one of its critical manufacturing milestones.

      2:30 PM

      Using IRT to reduce effort and optimize clinical supplies

      • Supply risks associated with recruitment & trial design
      • Trials which benefit the most from automating site resupply strategy
      • Considerations when designing automated resupply strategies

      3 PM

      Supply Chain Digital Twin; using discrete event simulation to assess the health of our supply chain

      • Why traditional planning tools are insufficient for decision making under uncertainty?
      • The power of digital twins in enabling a data driven approach to key strategic decisions
      • How companies need to adapt in the future to work with prescriptive analytics ?

      3 PM

      Q&A Discussion: Exploring the world of customs and how preparation is everything in the modern world

      • Helping make sure your goods pass through at border inspection.
      • Case studies of inspections: when it really goes wrong and how to tackle it.
      • Breaking down the issues with cold chain at customs, how to ensure it doesn’t spend time stuck at the border.
      • Highlighting the key takeaways for ensuring a smooth inspection as we look to the future.

      3:30 PM

      Afternoon refreshments and networking

      4 PM

      Speaker Hosted Roundtables

      Speaker Hosted Roundtables

       

      Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others. Each roundtable session lasts for 30 minutes, and delegates may attend up to 2 roundtables

       

      •  Exploring the struggles of decentralized trials in the supply chain and what success stories have we had.
      • IRT Data in clinical supply analytics –
      • • Discuss hosting IRT data versus reliance on IRT vendors for reporting.
      • • Review critical challenges for using IRT data.
      • Current Trends in Comparator Sourcing – what’s going wrong, what are the underlying causes and what innovations are emerging as a result?
      • Q&A Session with the US Border Force – Here to help with any questions you may have about how to get goods in and out of the country

      5 PM

      Chairs Summation and Drink Reception – Prize Draw

      8:15 AM

      Registration and refreshments

      8:50 AM

      Chairs opening remarks

      9 AM

      CORE Elements of a Clinical Supply Project Manager

      • Key areas to focus on to become a successful Clinical Supply Project Manager
      • Core competencies and skillsets of a Clinical Supply Project Manager
      • Understanding the supply chain from a Clinical Supply Project Managers point of view

      9 AM

      An Update from the FDA

      • Focusing on the Importation process in order to increase product importation efficiency
      • Relevance of affirmations of compliance in speeding up FDA entry review
      • Good documentation eases the stress for your broker and the FDA entry reviewer

      9:30 AM

      Drive Innovation Into Your Supply Chain with Complete End-to-End Visibility

      • Ensure all your time-sensitive shipments arrive on-time and ready for use, with privacy in mind
      • Empower your organization to create a robust, reliable and efficient supply chain with real-time monitoring
      • Gain complete visibility of your supply chain at any time, from anywhere in the world

      9:30 AM

      Role of Technology in RTSM

      • Cloud technology to support complex study design
      • Seamless upgrades and mid-study amendments
      • Benefit of a analytics platform for cross-study visualizations and reporting

      10 AM

      Psychedelics Surge in the Pipeline: Implications for Clinical Trials and Manufacturers

      • What promising psychedelic drugs are on the market and in clinical trials?
      • For which disease indications are psychedelic drugs showing promise?
      • What are the requirements for controlled substance manufacturing and the opportunities for manufacturers?
      • What are the complexities of the treatment regimen for psychedelic drugs in trials?

      10 AM

      Case Study: Building a CAR-T Clinical Supply Chain model and leveraging it for other Advanced Therapies

      • Looking into the details of a CAR-T supply chain
      • How a CAR-T supply chain can positively impact your other supply routes
      • What are the next steps in the future of CAR-T supply and what will make it a smoother process

      10:30 AM

      Morning refreshments and networking

      10:30 AM

      Morning refreshments and networking

      11 AM

      Highlighting the importance of Customs Valuation and how you need to incorporate this into your trial forecasting

      • What are the regulators doing and how will this affect your supply chain?
      • How best to prepare for a formal customs audit.
      • How do you value your investigational medicinal product against what a customs valuation is.
      • Why it’s best to really look up what your CRO’s do in customs movements.

      11 AM

      Panel Discussion: Investigating the difference in forecasting perspective from a small company to a large one

      • Comparing the use of IRT against a more homebrewed design.
      • What are the cost benefits of different systems and can a smaller firm really make use of them?
      • Forecasting global trials: what are the big differences when working for a smaller firm.

      11:30 AM

      Technologies of the future that drive efficiency powering drug developments and trials

      • Investigating the parts of the supply chain that can be improved with AI.
      • Will adopting different technology actually save us money and time in the long run?
      • Exploring examples of when Blockchain has been effectively implemented and the benefits it has had
      • Will the industry adapt in time with the changing of technology?

      11:30 AM

      Relationship Management within Organizations: Building a Successful Clinical Supply Chain

      • Interfacing with upstream manufacturing and CMC teams
      • Collaborating with Clinical Operations
      • Utilizing forecasting a tool not a weapon
      • Partnering with external providers

      12 PM

      Technologies of the future that drive efficiency powering drug developments and trials

      • Investigating the parts of the supply chain that can be improved with AI.
      • Will adopting different technology actually save us money and time in the long run?
      • Exploring examples of when Blockchain has been effectively implemented and the benefits it has had
      • Will the industry adapt in time with the changing of technology?

      12 PM

      Opportunities for savings by automating temperature monitoring in clinical trials

      • Automation of temperature data ingestion, data review and data exchange
      • Integration of temperature data with dispensation  (IRT/RTSM) and other eClinical systems
      • Examples of cost savings for small and large molecule trials
      • Traceability, inspection readiness, and patient safety

      12:30 PM

      Lunch and networking

      1:30 PM

      An interactive session for tips and tricks for communicating with ClinOps

      • An open and honest discussion about best practices for internal communications between Clinical Supply and ClinOps groups.
      • Small takeaways that you can feel confident that your workplace dynamic can change tomorrow.

      2 PM

      Expanded Access – The Who, the What, the When, and the How

      • What is expanded access and when do we use it?
      • How do we plan for expanded access?
      • Who needs to be involved with expanded access and what is the key to its success?
      • What are means to get the medicine to the patient?

      2:30 PM

      Afternoon refreshments and networking – Prize Draw

      3 PM

      How to coordinate with the Clinical Operations team to ensure your drug is delivered to time.

      • Forecasting, ensuring we have enough drugs at the right time for patient
      • Labelling and lead times to ensure the drugs get to where they need to and are not held up with paperwork
      • How to talk to sites in order to have the appropriate paperwork in place
      • When to pull the trigger, what info is needed from both sides regarding availability

      3:30 PM

      Planning and preparation of your audit so as to not fall behind on clinical trials

      • Perceiving inspections as a check point, rather than a stop point of your study
      • Ensuring your supply chain isn’t negatively affected
      • Steps to ensure a positive outcome from an audit

      4 PM

      End of Conference

      Speakers

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      Ian Hoban
      Business Development Director , Abacus Medicine Pharma Services

      Ian has over 30 years of pharmaceutical industry experience, predominantly within global organisations such as Pfizer and Eli Lilly.  He built his reputation in the commercialisation of numerous brands in a variety of disease areas, and at every stage of the product lifecycle.

      During his career, Ian has worked closely with supply chain, ensuring accurate forecasting, and getting medicines to patients through the implementation of novel approaches.

      Before joining Abacus Medicine Pharma Services Ian worked in senior roles at two leading global clinical solutions companies.  He provided many leading pharmaceutical and biotechnology companies with successful comparator sourcing solutions which helped successfully deliver their pivotal late phase clinical trials.

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      Tom Skiendzielewski
      Associate Director Business Process And Integration, Takeda Pharmaceuticals

      Tom is currently serving as the Associate Director of Business Process and Integration in Takeda’s Clinical Supply Chain  group within the Lexington, MA office.  Within this role, he is responsible for the optimization and utilization of the in-house Clinical Supply Management Database (SmartSupplies) currently deployed for all of Takeda’s clinical trials managed out of the Lexington, MA office.  In addition, Tom is also responsible for the Clinical Supply chain integration activities related to any mergers and / or acquisitions made by Takeda’s Lexington office.  Prior to joining Shire, Tom lead the Logistics and Supply Chain Operations teams at two large Contract Manufacturing Organizations.  Tom has been responsible for the implementation of multiple ERP systems / IRT solutions at a number of organizations throughout his career.  These software solutions include SAP, Oracle, as well as a number of software applications developed “in-house”.  Tom has over 15 combined years of Clinical Supply experience from both the CMO and Pharma sides of the industry.

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      Bobbie L Whiddon
      Supervisory Consumer Safety Officer, Division Of Northeast Imports, Office Of Regulatory Affairs (ORA), U.S. Food & Drug Administration

      Bobbie Whiddon is presently the supervisor over the FDA imports group in Philadelphia.   He has been with the FDA for almost nine years.  Bobbie has acquired over 20 years of public health and environmental health experience through various positions in both government and industry.

      FDA determines whether products are admissible into U.S. commerce and may refuse entry to any that violate or appear to violate any provisions of the Federal Food Drug and Cosmetic Act (FFD&C Act). Importers of products intended for introduction into U.S. interstate commerce are responsible for ensuring that the products are safe, sanitary, and labeled according to U.S. requirements.  Imported products are subject to FDA inspection when offered for import at U.S. ports of entry. FDA may detain shipments of products offered for import if the shipments are found not to be in compliance with U.S. requirements. Both imported and domestically-produced foods must meet the same legal requirements in the United States.

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      Amaury Jeandrain
      Head Of Pharma Solutions Adoption, Life Sciences, N-SIDE

      Amaury Jeandrain has a Master’s Degree in Business Engineering with a specialization in supply chain management. After working for a CRO, he joined N-SIDE where he supported the optimization of hundreds of trials from different indications and pharmaceutical companies, providing services ranging from risk-based optimization to clinical trial design and solving drug supply shortage problems. Amaury now leads a group of consultants, focusing on the extension of N-SIDE’s solutions.

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      Maxime Derep
      Clinical Supply Optimization Senior Solutions Engineer, N-SIDE

      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.

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      EVAN HAHN
      VP North America, TSS,

      Throughout my career, I have focused on driving innovation by applying sophisticated approaches to leveraging data to life sciences. My previous companies are recognized as industry leaders in their respective spaces; TSS clearly fits that mold in the area. At Medidata, the leading eClinical platform provider, I led the growth of the of their RTSM solution from product startup to an industry leader. Responsibilities included RTSM go-to-market strategy, solution roadmap development, subject matter expert consulting, strategic partnership development Had the opportunity to meet with 100’s of supply chain leaders globally, gaining broad insights into the challenges they face Received feedback from large pharma, startup biotech’s, CRO’s, and regulatory agencies such as the FDA, and the NCI on biopharma supply challenges. Served as a delegate to the FDA to promote innovation in clinical trial approaches At Cytel, a company that provides analytical software and knowledge intensive services, I promoted the industry adoption of adaptive clinical trial designs to streamline drug development Have been an invited speaker at various conferences discuss topics including adaptive clinical trials, drug supply forecasting, and supply management technologies.

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      Steve Siron
      Statistical Design & Trial Supplies Consultant, CALYX

      Session Details:

      Using IRT to reduce effort and optimize clinical supplies

      2022-10-19, 2:30 PM

      View In Agenda
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      AIMEE HODGE
      VP/GM Of Technical Operations, PCI Pharma Services

      Aimee Hodge is the VP/GM of Technical Operations at PCI Pharma Services located in Bedford, NH. In this role, Aimee oversees the technical transfer, project management, validation and manufacturing technical science (MTS) groups supporting PCIs North American business units related to the contract manufacturing of sterile drug products and medical devices. Aimee is a member of New England PDA and International Society for Pharmaceutical Engineering. She is an active member of the NH EPSCoR Research and Industry Council. She earned her B.S. in Biology from the University of New Hampshire and holds numerous patents for medical devices.

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      George Amerson
      Biological Threat Exclusion Coordinator, U.S. Customs And Border Protection

      George Amerson 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. Amerson 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. Amerson has more than 16 years of public service with CBP and has worked in a variety of environments, including air passenger, maritime, cargo and CBP Training Academy.

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      Gabriela Gottlieb
      Associate Director Clinical Quality Assurance, Fujirebio Diagnostics

      Gabriela Gottlieb is an Associate Director of Clinical Quality Assurance at Astellas Pharmaceuticals, where she drives Clinical QA activities related to management of risks, non-compliance and auditing across a therapeutic program to treat Prostate Cancer. In this capacity she interacts with executive level management, external vendors, collaboration partners, clinical study and cross-functional groups to ensure compliance with regulations, Astellas business practices and clinical research program objectives. Prior to Astellas, Gabriela served in a variety of roles in the Medical Device industry in areas of Interventional Oncology, Orthopedics and Interventional Cardiology. She has a track record of implementing quality systems in Clinical Research and Regulatory Affairs. She also has led several regulatory inspections with FDA, EMA and other global regulatory bodies. She bases her approach to program implementation through change management principles with a focus on data integrity, human subject protection and quality.

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      Shanna Jackson
      Senior Director, Vendor Management & Strategy, Taysha Gene Therapies

      Experienced Clinical Operations professional with a demonstrated history of working in the pharmaceutical industry across multiple functions (research, development, operations, and outreach). I have had the privilege of being intimately involved in the development of a global orphan Oncology program from IND to NDA/MAA, commercialization, and post-market life cycle management. I look forward to the next opportunity that will directly contribute to the improvement of patients lives.

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      HANEEN MAZAHREH-BOIVERT
      Sr. Director, Global Clinical Supply, Optinose

      Session Details:

      Changing in EU regulation and how it impacts on the clinical supply world.

      2022-10-20, 1:30 PM

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      Charlotte Moser
      Chief Medical Officer, Deka Biosciences

      Dr. Moser is an oncologist who has worked as a clinician and academic researcher for over 20 years and specialized in drug development for the past 10. She completed her PhD in Statistics working at the EORTC in Brussels and has led many multi-institutional trials and related cancer survivorship projects since. After completing her MBA at MIT Sloan School of Management (2017), she moved to the US and shifted focus from academic to commercial research. She has helped drive the clinical pipeline from early to late stage in larger (Elekta, Roche) and smaller (Augmenix, Kaiku, Artidis, Galera Therapeutics) companies and commercialization of several products including the post-marketing performance. Dr. Moser has obtained extensive clinical operational and regulatory experience dealing with different stakeholders (academic, industry, policymakers and patient advocates). Dr. Moser has helped direct the investment in private owned drug-development, as well as new cancer centers worldwide and was instrumental in launching Portugal’s National Cancer Institute. Dr. Moser previously served as the Vice President for Clinical Development for Galera Therapeutics, with who she went IPO in 2019 and SVP Clinical Strategy for ELEKTA Inc, a global radiation oncology device vendor (2017-2018). She founded Nanocan Therapeutics Corporation in 2020 and serves as the Chief Scientific Officer. Working with different academic groups she obtained over 5M of NIH-STTR awards to drive preclinical research and opening first in-human trials.

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      Pedro J Rodriguez-Cardona
      Clinical Supply Operations Manager, Janssen Research & Development, LLC

      Experienced Leader with a demonstrated history of working in the pharmaceuticals industry. Strong operations professional, skilled in U.S. Food and Drug Administration (FDA), Verification and Validation (V&V), Life Sciences, GMP, Supplier Management and Six Sigma.

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      ADAM BRADBURY
      Editor PharmSource, GlobalData
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      Jennifer L. Northcott
      Director, West Point Clinical Supply Operations, Merck

      An agile CPM certified project manager currently working within the clinical supply chain managing a team of project managers eager to optimize and strength the the supply chain and get medicine to patients more efficiently.

      Prior 13 years of pharmaceutical experience, 5 years' managing clinical trials and 8 years’ experience executing high level scientific engagement meetings for various therapeutic areas, orchestrating cross-functional presence at international and national congresses, and managing clinical and pre-clinical investigator initiated trials.

      Session Details:

      Panel: Getting the most out of the relationship with your CMO and what we can do for them

      2022-10-20, 2:00 PM

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      Frank Leu
      CEO, Novapeutics,

      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.

      Session Details:

      Technologies of the future that drive efficiency powering drug developments and trials

      2022-10-19, 12:00 PM

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      ELVIRA D’MELLO
      Director Data And Digital Transformation, Clinical Supply Chain Technology, Bristol Myers Squibb

      Summary: Leader in digitization excellence and technology transformation for Clinical Supply Chain in Bristol Meyers Squibb. Results driven problem solver with cross-functional business expertise and technical knowledge, delivering success in energizing operational and systematic transformation.

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      GORDON GREGORY
      Clinical Supply Integrator & Operations Lead, Janssen Research & Development (Tentative)

      Gordon Gregory III, CCRP began his career in the Document Management field of Clinical Research Operations in 2008. He moved quickly from a Document Management Associate, through various Clinical Trial Associate roles, into Global Trial Leadership as a Clinical Trial Manager and GCDO Trial Leader and is currently forming a group within Clinical Supply Chain to oversee all of the patient scheduling on Janssen's CAR-T trials. In his 12 years in the industry, he has excelled at every turn and was even selected to be a part of the initial cohort of the GCDO Clinical Operations Leaders of Tomorrow Program.

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      Anis Ghossain
      Enterprise Supply Chain Analytics, Bristol Myers Squibb

      Anis has an MBA from Rutgers University with a specialization in Supply Chain Management and Data Analytics . In my employment thus far, I've achieved a record of success in Electrical/Mechanical Engineering, Supply Chain Management, Business Analytics and Project Management.

      Anis’s key personal strengths include his ability to manage diverse teams, strategic thinking in optimizing processes and delivering results. Anis has extensive software knowledge, with proficiency in SAP, AWS, R, Python, Tableau, Spotfire and SQL; I'm also fluent in English, French, and Arabic.

      Specialties: Electrical/mechanical engineering, supply chain end to end visibility, distribution and transportation management, project management, data science, supply chain digitization & control tower.

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      FIONA BARRY
      PharmSource Editor, GlobalData
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      Sean Walsh
      Executive Director, Quality & Chief Compliance Officer, Adlai Nortye Biopharma

      Experienced Technical Operations Lead with a demonstrated history of advancing clinical development programs in the biotechnology industry. Strong operations professional skilled in Manufacturing, Development, Supply Chain and Quality Operations for both large pharma and small biotech.

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      Bharat Dixit
      Chief Technology Officer, Adiso Therapeutics
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      Francesco Santo
      Associate Director Clinical Supply Chain , Huyabio International
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      Sean Smith
      Biological Threat Exclusion Coordinator, US Customs And Border Protection

      Sean Smith is a Biological Threat Exclusion Coordinator (BTEC) for CBP in the Office of Field Operations/ Agriculture Programs and Trade Liaison/ Agro/Bio-Terrorism Countermeasures. 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 joined CBP in 2005 as an Agriculture Specialist (CBPAS) and was promoted to Supervisory CBPAS in 2008. He has served CBP in the following ports of entry: San Diego, San Ysidro, Otay Mesa and Boston Logan Airport. From 2011- 2018, Mr. Smith served as the primary Public Affairs Liaison and Border Community Liaison, respectively, for CBP in New England. He has also volunteered to assist in past domestic and international CBP disaster recovery operations, including: Hurricane Ike (2008), 'Operation Safe Return' (Haitian Relief Effort- 2010), and Hurricane Harvey, DHS Surge Capacity Force (2017).

      Prior to CBP, Mr. Smith contributed to wildlife conservation for nearly a decade, completing field work on rare endemic Hawaiian birds on the Big Island of Hawaii, and raising rare and endangered birds (in some cases, extinct in the wild) at the San Diego Zoo's Avian Propagation Center. Also, Mr. Smith is a former reserve firefighter and EMT for the City of Borrego Springs in California. He holds a Bachelor of Science degree in Ecology and Systematic Biology from Cal Poly San Luis Obispo, California.

      Mr. Smith, his wife, two children, one dog, and one chicken live in an old farmhouse in Massachusetts.

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      Joshua Anderson
      Manager, Logistics Strategy Clinical Supply Chain, Janssen Research & Development

      Senior logistics and supply chain professional with extensive experience leading across pharmaceutical and healthcare firms. Unique educational background in biology/chemistry combined with a MBA in Supply Chain Management. Expertise in managing research, clinical and commercial activities with regards to strategic planning, forecasting and design of high quality and cost-effective production through distribution of finished goods.

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      Diego Montemeyor
      Sr Manager Global Trade Compliance, CSL Behring
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      Nick Spring
      CEO, FluoroMe

      Experienced, results-oriented executive with a strong track record of team building, strategic planning and tactical execution in high-paced organizations in med-devices, pharma, biotech, digital transformation - human and animal health. Utilizes keen analysis and insights and a collaborative team approach to drive commercialization, project planning, organizational improvements and implementation of best practices. Superior interpersonal skills, capable of resolving multiple and complex issues and motivating staff to peak performance. A leader with proven skills in:

      • Management & Leadership
      • Business Operations & Strategy
      • Effective Communication & Delegation
      • Adaptability & Determination
      • Forward Thinking & Calculated Risk Management
      • Working with investors & stakeholders
      • FDA compliant development & launch
      • Passion for healthcare devices, digital transformation, biotech, pharmaceuticals, consumer and professional products/brands

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      Kim Buchanan
      Associate Director Development Quality, Merck

      Experienced quality professional with strong leadership and exceptional background in packaging operations, technology, clinical supplies, commercial products, laboratory, and FDA & EU regulatory agency compliance and inspections. Cross functional roles include 2 interim clinical supply assignments, direct line supervision of Global Quality, Sterile & Biological Operations/Technology and Pharm Laboratory personnel.  Key in the development of Expanded Access Program at her company.

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      Ginelle Andrews
      Director Commercial Product Sourcing Strategy, Pfizer
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      Casey Ferrier

      Sr. Manager, Business Development for 4C Supply 4G Clinical

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      Ram Raju
      Former CEO NYC Health & Hosptials Corporation
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      Brian Sell
      Associate Director Merck
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      Megan Millager
      Portfolio Director, IRT YPrime

      Session Details:

      Lessons Learned in Partnership: Trial Supply Management & IRT Systems

      2022-10-19, 11:45 PM

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      Kelsey Peloza
      Associate Director, Trial Supply Management Bristol Myers Squibb

      Session Details:

      Lessons Learned in Partnership: Trial Supply Management & IRT Systems

      2022-10-19, 11:45 PM

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      Michelle Donelson
      Senior Manager, IRT Bristol Myers Squibb

      Session Details:

      Lessons Learned in Partnership: Trial Supply Management & IRT Systems

      2022-10-19, 11:45 PM

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      Krenar Komoni
      CEO Tive
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      Kelsey Kern
      Clinical Trial Supply Study Manager CSL Behring
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      Jeff Clement
      Executive Director, CDMO Business Development North America, PCI Pharma Services

      Jeff joined PCI in 2014 and he manages the North American Business Development Team for PCI’s Manufacturing and Development services.  Jeff has over twenty-five years in the biotech and pharmaceutical industries and his career includes experience in the pharmaceutical discovery sciences, high throughput automation, clinical formulation development, and cGMP analytical and manufacturing contract services.  All his business development experience is in the aseptic manufacturing and analytical fields. Prior to his current role, Jeff was previously the Director of Global Business Development at AMRI (Drug Product). Jeff received a B.S. in Biology from Keene State College and a M.S. in Quality Systems from The New England College of Business.

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