Jim is a performance driven Supply Chain leader with over 20 years of experience in the Biopharmaceutical industry. Materials Management expert who has led the implementation of a SAP ERP system in a commercial environment utilizing both in-house and external manufacturing. Experienced in supplier auditing and qualification processes, sourcing and management of CMOs, and the use of QRM and OpEx to manage the end to end supply chain. Well-developed leadership skills that include formulation and deployment of strategy, succession planning and talent development, operational budget responsibility and ensuring compliance with Corporate Standards and cGMP/ICH regulations. A compliance-minded individual with strong knowledge of cGMPs, global regulatory requirements, and an understating of how they impact the supply chain. Demonstrated capability in a primary engagement role representing supply chain and functional operations to external regulatory agencies.
Arul Joseph leads the Pharmaceutical Development and Clinical Supply Chain function at Avanir Pharmaceuticals. He has about 15 years of experience in the pharmaceutical industry and has held roles of increasing responsibility at Gilead Sciences, Merck, and Schering Plough. Before joining the pharmaceutical industry, he conducted postdoctoral research at the Scripps Research Institute in La Jolla, CA. Arul earned his PhD in Organic Chemistry from the University of Maryland in College Park, MD, and an MBA in Strategy and Finance from New York University's Stern School of Business in New York, NY.
A focused and results-driven supply chain executive with a proven track record of success with sales/operations planning, operational excellence, sourcing/procurement, distribution management, logistics, inventory optimization, ERP implementation and supply chain transformation. Proven ability to identify strategic opportunities and develop, implement, and sustain changes to deliver year-over-year improvements in quality and performance for multiple programs. An effective leader who focuses on team development, diversity and inclusion. A top-performing and highly skilled producer who uses experience and expertise to obtain measurable results with increased operational understanding, process improvements, and portfolio growth.
Jim is a performance driven Supply Chain leader with over 20 years of experience in the Biopharmaceutical industry. Materials Management expert who has led the implementation of a SAP ERP system in a commercial environment utilizing both in-house and external manufacturing. Experienced in supplier auditing and qualification processes, sourcing and management of CMOs, and the use of QRM and OpEx to manage the end to end supply chain. Well-developed leadership skills that include formulation and deployment of strategy, succession planning and talent development, operational budget responsibility and ensuring compliance with Corporate Standards and cGMP/ICH regulations. A compliance-minded individual with strong knowledge of cGMPs, global regulatory requirements, and an understating of how they impact the supply chain. Demonstrated capability in a primary engagement role representing supply chain and functional operations to external regulatory agencies.
Arul Joseph leads the Pharmaceutical Development and Clinical Supply Chain function at Avanir Pharmaceuticals. He has about 15 years of experience in the pharmaceutical industry and has held roles of increasing responsibility at Gilead Sciences, Merck, and Schering Plough. Before joining the pharmaceutical industry, he conducted postdoctoral research at the Scripps Research Institute in La Jolla, CA. Arul earned his PhD in Organic Chemistry from the University of Maryland in College Park, MD, and an MBA in Strategy and Finance from New York University's Stern School of Business in New York, NY.
A focused and results-driven supply chain executive with a proven track record of success with sales/operations planning, operational excellence, sourcing/procurement, distribution management, logistics, inventory optimization, ERP implementation and supply chain transformation. Proven ability to identify strategic opportunities and develop, implement, and sustain changes to deliver year-over-year improvements in quality and performance for multiple programs. An effective leader who focuses on team development, diversity and inclusion. A top-performing and highly skilled producer who uses experience and expertise to obtain measurable results with increased operational understanding, process improvements, and portfolio growth.
Yogesha K is Director of Indian Operation and Head of Supplier Relations in Bluefish Pharmaceuticals. Responsible for developing and implementing effective strategies to support the business. Having 21 years of work experience in complementary blend of Pharmaceutical end-to-end supply chain activities, Production, Product Management and Marketing fields. Up-skilling it’s organisational team, instilling a challenge mind set. Driving total extended SC end-to-end Cogs optimisation. Key roles in transforming organisation to deliver the short term and long-term results. Inspires executives on how to bring change and manage and profit from organisational complexity through best practice in supply chain planning.
Mirko started his career as a Business Analyst at EuroGroup consulting, where he advised several major Pharma companies on various Supply Chain matters and then joined Pfizer in 2007, holding several key roles in the EMEA Supply Chain organization that brought him to lead both strategic transformational initiatives and operational teams throughout a 12 years tenure. At Pfizer, he currently holds the role of Global Supply Chain Lead – European Distributor Markets, overseeing the Supply Chain operations in a cluster of 22 Markets spanning across Eastern Europe and Central Asia. Mirko holds a Master’s degree in Business Economics from Università degli Studi di Salerno (Italy), a MSc in Logistics & Supply Chain Management from the Cranfield University (UK) and an Executive MBA from the Smartly Institute (US), he is a certified Six Sigma Black Belt and he’s currently based in London, UK.
David is Co-Founder/CEO of Colby Pharmaceutical Company, San Rafael, California. Colby clinically develops anti-inflammatory small molecule pharmaceutical drugs, immunotherapeutic and preventative vaccines with companion diagnostics in elderly, adult, adolescent patients for acute/chronic inflammation in immuno-oncology/-virology, including product candidates for acute respiratory distress syndrome, allergy and infectious disease. David was trained in molecular-virology, -oncology, -immunology at Dartmouth College, Baylor College of Medicine and UWisconsin-Madison Medical School. At UC-Berkeley, UC-San Francisco, Stanford Research Institute and Pangene Corporation, David led cross-functional-teams which developed recombinase-mediated-isothermal-gene-amplification and gene-family-cloning. At SRI, David teamed in completing acquisition of Sarnoff Corporation as a profitable SRI-subsidiary, led therapeutics/companion diagnostics, and commercialized nucleic acid-/antigen-/antibody-/drug-multiplex-diagnostic systems using Sarnoff-infrared-activated-UpConvertingPhosphor-ultrasensitive-visually-detectable-reporters for laser-diode-UCP-signal amplification with hand-held-diagnostics. At Colby, David sold three oncology drugs in early-clinical/late-pre-clinical development, merged Colby with Othera Pharmaceuticals’ clinical anti-inflammatory-nitroxide drugs, developed intralymphatic-, intradermal- and orally-administered vaccines with companion diagnostics (i.e., HPV-induced-HNSCC) and is continuing development of infectious disease vaccines.
Kevin has over 28 years in the pharmaceutical and biopharmaceutical supply chain, distribution and transportation management world. His primary focus has been on operational and quality improvements while also maintaining or achieving additional cost savings through gained efficiencies. He has extensive experience setting up, qualifying, and overseeing the daily operations of in-house distribution centers & warehouses, as well as over 20 years of experience managing third party warehousing, transportation, cold-chain and contract manufacturing vendors and suppliers. He has managed distribution & logistics operations and vendors for both domestic and international customers & partners. Kevin has also qualified and implemented shipping lanes for all temperature ranges while using various active and passive solutions to meet all shipment size requirements from small parcel up to Sea Container.
For relaxation Kevin enjoys traveling, taking walks on the beach with is wife, and occasionally dusting off his art supplies to draw or paint something that catches his interest.
Kevin has worked for various manufacturers over the years and has lived in multiple regions of the country, most recently moving to the San Diego area to work with Gilead Biologics at their Oceanside, California site
Background in Chemical Engineering from University of Kentucky (USA). Subject Matter Expert for Cold Chain Technologies, Logistics and Distribution of Vaccines and GDP related topics – Licensing, Distribution Standards, Distribution Risk Assessment, Developing QMS, Technical standards, Audits/Assessment of LSP/Distributors/Wholesalers, Qualification/Validation for temperature controlled systems (Warehouse, Cold Storage, Road Freight, Air Freight and Sea-Freight), Thermo-stability strategy and implementation, Temperature Excursion management, GDP Training Package development, Involvement and provided training for various MoH/Health Authorities. Board Member of ECA GDP Association in Europe.
(Since 2011 - Current) Director, Cold Chain and Logistics within Vaccines Global Supply Chain located in UK and Belgium.
Previous roles and responsibilities within Pfizer-Wyeth (UK) Organization as Cold Chain Technology Lead based in the UK.
Previous QA Roles within Fresenius-Kabi handling Temperature Sensitive Parenteral Nutrition Products based in UK. Process Engineering Role with TycoHealthcare based in the USA.
Mr. Brynjulfsson is Co-founder and CTO of Controlant, a technology company that is pioneering the development of next-generation supply chain monitoring and traceability solutions for digitally connected pharmaceutical cold chains. He has driven the technology innovation and product strategy of the company for the last 10 years. Controlant’s fully validated cloud and IoT solutions provide real-time, end-to-end visibility and risk mitigation across all lanes—air, road, rail, and sea—and through the last-mile. Managed services, including 24/7 global monitoring and response, inventory management, and reverse IoT logistics help to automate supply chain logistics, reduce quality review time, and proactively prevent business and product waste. Intelligent data analytics provide enterprises with proactive insights to fuel impactful decision-making and collaboration throughout their entire business ecosystem.
Stefan studied technical physics in Munich. He wrote 2 books about Simulation Software and a lot of articles in journals about mathematical modeling.
He is the managing director of SmartCAE, a software company that works on the digital Virtual Cold Chain.
SmartCAE is working on the Virtual Cold Chain. This platform allows to make data-driven lanerisk assessments for temperature sensitive shipments. With SmartCAE the risk of temperature excursions on product level can be determined under total cost of ownership. The Virtual Cold Chain is a digitial twin of the real cold chain and helps to reduce the risk of temperature excursion.
Kane Edgeworth has over 20 years experience working in his specialist field of temperature compliance since 2001, when one of the first sets of guidelines was written by senior MHRA inspector, Mr John Taylor. The article was published in the Pharmaceutical Journal and stands as a critical platform that shaped the majority of the current guidelines we work with today.
Having initially worked for one of the world’s largest data logger manufacturers for over 8 years, Kane then co-founded Biomap Ltd with fellow Director Niccolo Moreno in July 2009. Biomap was launched to fulfil the growing need for specialist compliance services specifically to meet the increasing demands of cGxP guidelines. Biomap has quickly become a respected market leader in its field and continues to grow at a fast pace.
Kane is a regular speaker on the topic of temperature compliance and was also a member of the GDP working party for the ECA and PQG interpretation guidelines package (published in response to the release of the EU GDP guidance in 2013).
Chiara Venuti is currently holding the position of Global Head of Airline Partners at SkyCell, one of the leading pharma airfreight container providers.
She has a 15 years track record of successful experience in international logistics and healthcare supply chain industry. Chiara is an acknowledged specialist in implementing end-to-end supply chain solutions for global vaccines distribution.
