Benjamin Sena-Weltin – MedImmune
Benjamin Sena-Weltin has worked in research and development in the bio-pharmaceutical industry for over 15 years. Through his career he has worked in laboratory research, contract manufacturing, project management, independent consulting, and is currently a Senior Manager of GXP-IT QA at MedImmune; responsible for oversight of computer system data compliance.
He graduated from Virginia PolyTech with a BS in Biology, and later obtained an MS in Biotechnology and an MBA from Johns Hopkins University. He is a Certified Quality Auditor.
Bob Albanese – CSM
Bob Albanese brings over 30 years of experience in diversified industries to the CSM team. As Vice President of Operations, Albanese implements processes and tools that allow continual growth while reducing costs through streamlined operations.
As leader of the business development, operations, and marketing teams, Albanese is the catalyst of innovation and growth by expanding CSM’s global footprint and implementing cutting-edge technologies throughout the entire company.
Last year Albanese introduced a Direct-to-Patient shipping strategy for a pediatric clinical trial, which recently won the Clinical Informatics News’ Best Practices Award in the category of Study Startup and Design. Currently, he is leading a multi-million dollar expansion effort that includes opening an second CSM facility on the East Coast early this year.
Prior to joining CSM, Albanese spent 20 years in cold chain logistics, managing the daily operations for a nationwide refrigerated trucking company. He also spent 12 years with a large-scale construction company, managing software design solutions including cost control, budget management and real-time data from field operations. Albanese joined CSM in 2011 as the Director of Operations.
Brian Keesee – PCI
Brian Keesee, Executive Director of PCI’s North American Clinical Services business, has spent his entire career in the Pharmaceutical industry.
In his current role, Brian leads all North American Clinical functions, including PCI’s state-of-the-art Clinical packaging and distribution facilities located in Rockford, IL.
Prior to his role at PCI, he held leadership positions in Compliance, Operations Management, and Project Management within the pharma industry.
Brian has managed large global clinical studies and offers extensive experience and expertise in Supply Chain Management, Logistics, Clinical Package and Label design, Project Management, and IXRS.
Brian brings a unique perspective based on his global project management knowledge from his prior position with Aptuit/Catalent Pharma Solutions, his Compliance and Operations roles at AmerisourceBergen Drug Corporation, and his involvement in a Lean Six Sigma Black Belt Program.
He holds a Bachelor of Science in Business Administration from Missouri Western State University.
Cédric Druck – Belenox SPRL
Cédric Druck graduated in 2005 from Université Catholique de Louvain, in Belgium, with a master’s degree in applied mathematics engineering. Cédric was then hired by N-SIDE where he immediately got involved in the development of the clinical trial supply simulation/forecasting/optimization software CT-FAST since its early stages. Over the 10 years he spent there, Cedric was in turn a Consultant, Consulting Manager, and Business Developer for the Pharmaceutical Practice at N-SIDE. Cédric has developed strong experience in the Clinical Trial Supply Chain and expertise in related analytics. Eager to expand his knowledge and expertise in this field, Cedric founded the start-up Belenox SPRL in 2014, and is since involved in multiple innovative, excellence-oriented projects with top pharmaceutical companies as well as providers of IRT, forecasting, supply chain planning solutions and services.
Christine Gregorio – Vertex Pharmaceuticals, Inc
Christine Gregorio is Associate Director, Supply Chain Management at Vertex Pharmaceuticals, Inc. Christine has 8 years of experience in pharmaceutical Supply Chain. She has been with Vertex Pharmaceuticals for the last 8 years. Prior to Vertex Christine spent 6 years at Perceptive Informatics working in IXRS. In her current role Christine is responsible managing forecasting, packaging and distribution of Investigational Medicinal Product for global clinical studies.
Christopher Orlando – ThermoFisher Scientific
Mr. Christopher P. Orlando is the Vice President, General Counsel for the BioPharma Services Division of Thermo Fisher Scientific Inc. He has primary responsibility for all legal matters relating to the businesses within the division globally, including Fisher Clinical Services and Clintrak. Prior to joining Thermo Fisher Scientific, Mr. Orlando was the Senior Vice President, General Counsel and Corporate Secretary of Comprehensive NeuroScience, Inc., a clinical site management organization and CRO with facilities located throughout the United States. He began his legal career in private practice at law firms in New York, focusing on litigation matters including pharmaceutical product liability cases.
As a senior in-house counsel with over 20 years of legal experience, Mr. Orlando has drafted, negotiated and closed numerous commercial transactions, including confidentiality agreements, master services agreements, manufacturing and supply contracts, service level agreements, and quality agreements. Drawing on this experience, he led the legal negotiations for the innovative collaboration agreement completed in 2010 between Fisher Clinical Services and Eli Lilly and Company, which resulted in Fisher Clinical Services taking over responsibility for Eli Lilly’s in-house clinical trial materials manufacturing, packaging and labeling operations on-site at the Lilly Technology Center – North in Indianapolis.
Mr. Orlando earned a Bachelor of Science degree in Pharmacy from St. John’s University College of Pharmacy and Allied Health in 1989. While practicing as a Registered Pharmacist in hospital and retail settings, he earned his law degree from St. John’s University School of Law in 1993. Mr. Orlando is a member of the bar in New York, New Jersey and Connecticut, and holds an in-house counsel license in the Commonwealth of Pennsylvania. In addition, he is a member of the Association of Corporate Counsel (ACC) and the International Association for Contract & Commercial Management (IACCM).
Daniel Kropas – Regeneron Pharmaceuticals ,Inc
Daniel Kropas, RPh, MS practiced as a pharmacist in New York City for the first fifteen years of his career; in hospital at Mount Sinai Medical Center, retail pharmacy including homeopathic and natural medicines, and was a director of a high tech home infusion pharmacy. For the past 17 years Daniel has worked in various areas of the pharmaceutical industry; narcotics regulations, randomization, clinical supplies, product complaints, clinical pharmacy, clinical operations, and trial management. Daniel has worked in GMP, GLP, & GCP areas; mostly in oncology and biotechnology investigational trials. Daniel is currently a Senior Manager of Clinical Logistics and Drug Supply at Regeneron Pharmaceuticals, Inc
Dave Gundrum – Fisher Clinical Services
Dave is currently the Director of Client Services with previous roles of QA Technician, Packaging Manager,
Packaging Director, Area Manager Operations Support.
Dave is a subject matter expert in use of Fisher’s GPM paperless operation, has experience in primary blistering, pouching, bottling, along with experience in secondary carding and labelling operations.
Dave has over 21 years of Clinical Packaging , Quality Assurance, Client Services, and Packaging Management experience and is a Certified Local Trainer; qualified in PPI-Lean Leadership Skills, PPI-Process Champion Training, PPI-Process Manager Training, Lean Problem Solving and is a Sig Sigma Black Belt.
Dave graduated in 1982 from Delaware Valley College with a Bachelor of Science in Food Technology.
Douglas O’Dowd – Xcelience, LLC
Douglas O’Dowd is the CFO of Xcelience, LLC in Tampa, Florida. Doug has extensive experience working with small to medium sized companies in a variety of industries, both in the US and internationally. Prior to Xcelience, Doug was Vice President/Controller at Inuvo, Inc., Vice President of Finance at Brandau Marketing, Inc., and CFO at MedAvant Healthcare. Doug is also on the Board of Directors at the United Methodist Cooperative Ministries currently serving as Vice President. In 2014, Doug was nominated for CFO of the Year by The Tampa Bay Business Journal and was elected as the Finance Officer of the Executive Committee of the Global Clinical Supplies Group.
Doug received both his Bachelor’s and Master Degree in Accounting and Finance at the Fisher School of Accounting at the University of Florida.
Edward Groleau – Eli Lilly and Company
Ed Groleau has been involved in Clinical Trial Materials Management at Eli Lilly and Company for 12 years. In his current role he is responsible for all aspects of clinical supplies management for an early phase development team. This small, highly integrated team is responsible for overseeing CM&C development of compounds from initial discovery through a proof-of-concept stage.
Prior to joining CTMM, Ed spent 2 years at Merrell Dow and 13 years at Lilly as a chemist in several different laboratories. He started in the Pharmaceutical industry developing and validating purity and potency testing methods using various separation techniques. He then became Lilly’s primary X-ray powder diffraction expert and was a founding member of the company’s Physical Characterization group responsible for XRD, XRF, and thermometric techniques. This group also handled Lilly’s forensic requirements for internal and external investigations. Immediately prior to transitioning to a CT supplies career he was in the spectroscopy lab doing structural determination of IP degradation products using NMR.
Ed received his B.Sc. in Chemistry from Illinois State University.
Esther Sadler-Williams – Catalent Pharma Solutions
Esther is currently Global Director, Strategic Alliance Development and Innovation for Catalent Pharma Solutions
Catalent acquired Aptuit CTS in February 2012, a company which had previously acquired Almedica where Esther was Director of Client Development having been a founder member of the then 10 year old European facility. So Esther has worked for 3 different companies for over 20 years without moving offices!
As a pharmacist, Esther has had over 30 years experience in various pharmaceutical fields including 5 years with Sanofi Winthrop where she was Head of Research Services during which time she managed groups of CRA.’s, medical writers and information/adverse event surveillance specialists. Previous roles include Principal Pharmacist with the Regional Drug Information Service at St Mary’s Hospital in Manchester, and Pharmacy Manager with Boots the Chemist.
Esther is also a past Chair of ISPE’s EU Investigational Products COP and has been a lead author for the ISPE guidance document on NIMPs and Delivery of IMP’s Direct to Patients’ Homes.
Gregory P. Kushla, PhD – Jeiven Pharmaceutical Consulting, Inc.
Greg received his Bachelor’s Degree in Pharmacy from Rutgers College of Pharmacy in 1983, and is a licensed Pharmacist in the state of New Jersey. He pursued graduate education at Rutgers University, earning his PhD in Pharmaceutical Science in 1991.
A formulator by training, Greg has experience in developing a variety of dosage forms, several of which have been successfully commercialized. During his tenure at Abbott Laboratories (formerly Knoll Pharmaceutical Company), he led a team of scientists responsible for formulation development, scale-up, and transfer to manufacturing sites; led global technical development teams; and contributed to the CMC sections of several INDs, NDAs, ANDAs, and BLAs. In addition, Greg was responsible for the clinical supply function for studies conducted primarily in North America.
Greg joined Daiichi Sankyo (formerly Sankyo Pharma) and established the clinical supply planning and operation function in the US and was instrumental in the development of a global clinical supply function across US, Japan, UK, and Germany divisions. His group’s responsibilities included import/export, development of study-specific packaging-labeling designs and IXRS specifications, vendor selection and contracting, execution of packaging, labeling, distribution, and returns/destruction activities for all phases of clinical trials, across several therapeutic areas including cardiovascular, diabetes, and oncology. Studies ranged from single-country trials in the US, EU or India to global mega-trials in nearly 50 countries.
After leaving Daiichi Sankyo, he formed his own company and provided consulting services to the pharmaceutical industry. The major focus of Kushla Consulting was clinical trial material planning and management, especially in developing appropriate cost-effective and timely solutions to clinical study challenges. Greg also provided training in clinical supply and GMP topics. In addition, Greg provided formulation development expertise, particularly in oral solids, first-in-human dosage forms, and blinded comparators.
In 2013, Greg joined Jeiven Pharmaceutical Consulting, Inc., as Executive Director, where he continues to provide consulting services and training to pharmaceutical, biotech, and nutraceutical companies.
Helene Nagy – Genzyme a SANOFI COMPANY
Helene is the Label Development Manager at Genzyme, A Sanofi Company in Northborough Massachusetts. She has 26 years of Pharmaceutical experience with 18 of those years in Clinical Supplies. Helene began her career at Bristol-Myers Squibb, New Jersey in the Microbial QC Division responsible for microbiological testing of antibiotics and vitamins. She then joined the Technical Registration Resources/ Analytical Resources Division where she did preparative isolation of pharmaceutical products by HPLC. 18 years ago Helene moved into Clinical Supplies as a Project Management Specialist where she managed the label printing and inspection work center. Helene joined Sanofi-Aventis as a Clinical Trial Manager in serving as a liaison between Clinical and Clinical Supplies Operations to facilitate the most effective packaging design. Helene relocated to Massachusetts to join Genzyme as the Global Label Development Manager. Helene leads a Label Harmonization Team and supports global translations and manages the phrase library within the label system. She developed a process to work closely with Regulatory Affairs to obtain and manage ever changing Minimum Country Requirements. Throughout her tenure Helene has gained extensive knowledge of Clinical Supplies Labeling and the Supply Chain Industry as a whole.
Helene has degrees in Retail Management and Applied Science, Chemical Technology.
She currently resides in Clinton, MA with her husband and younger son.
Ingrid Annan – Regeneron Pharmaceuticals, Inc.
For the past 17 years Ingrid Annan, MS has worked in various areas of pharmaceutical industry; Quality Control, Quality Assurance and Clinical Supplies. Prior to joining Regeneron Ingrid worked at OSI Pharmaceuticals, Inc. in Clinical Trial Supplies. Ingrid is currently an Associate of Clinical Logistics and Drug Supply at Regeneron Pharmaceuticals, Inc.
James Dewis – Clinigen
James has worked in clinical supplies with Clinigen since 2006, and was responsible for establishing their US operations in 2009. During this time he has worked with a large number of sponsors on clinical supply projects involving all kinds of molecules, supply, and logistical challenges.
In his current role he manages the US operations of Clinigen CTS, overseeing a team of supplies professionals tasked with delivering innovative supply strategies and exceptional customer service to pharma companies, biotechs, CROs and academic establishments.
James Klingelhoefer – World Courier
James Klingelhoefer, a Business Development Manager for World Courier, works with customers in the pharmaceutical industry to leverage supply chain efficiencies. He has extensive knowledge and experience in Temperature Control Management and Drug Distribution. For over 8 years, James has helped sponsors, CMOs, and packaging companies to shorten timelines, reduce costs, and meet the demanding industry and regulatory requirements in the area of global distribution of temperature controlled clinical and commercial product.,
With experience as an international customer service supervisor, James relies on his operational background to strategize with customers concerning bulk product logistics. He works with clients on clinical and commercial projects providing guidance in the areas of; packaging, import/export regulations, route analysis, and distribution strategy. James has spoken at several industry conferences including Institute of Supply Chain Management, Biologistics Summit, and Clinical Supply East.
Jason James – Bristol-Myers Squibb
Jason James has been running the clinical trial label production and assembled operations at Bristol-Myers Squibb UK since 2001. Jason has also been involved in the project management of trials at the BMS Moreton site from initial demand to final dispatch. During his time at Bristol-Myers Squibb Jason has been a member of the team that have implemented SAP and Label creation software globally. Recently Jason has been an active member of the ISPE elabelling and Pictogram teams and is also a member of one of the TransCelerate elabelling teams. Prior to this Jason worked for Unival (later to become PCI then Cardinal and now Catalent) and was involved in the project management of clinical trials production for a number of large Pharma companies.
John Musaus – MWV Healthcare
John Musaus is the Global Head of Electronic Adherence Solutions for MWV Healthcare (a business unit of MeadWestvaco). Previously, he served in various marketing/commercial leadership roles for GlaxoSmithKline and at Procter & Gamble. He participates in a number of adherence and packaging committees and groups including the International Society of Pharmaceutical Engineers (ISPE) Packaging Community of Practice (past committee chair); the European Society of Patient Adherence, Compliance and Persistence (ESPACOMP); the Duke University Patient Adherence Think Tank and the National Consumer League’s Medication Adherence Campaign. He has a BS Biological Systems Engineering from Virginia Polytechnic Institute and an MBA from Cornell University.
Juan Mendoza – Sanofi
Juan Mendoza has worked in the Clinical Supplies Industry for 18 years, currently, a as Director of Trial Supplies Operations Management for Sanofi. He received his Bachelor’s degree in Management Science from Kean University and a Master’s Degree in Project Management form University of Wisconsin. In 2013 he received the “Breakdown Leadership” Certification from Harvard Business School. Juan is a leader and likes to work in the area of interface with different areas of Clinical Supplies in organizations that have a shared commitment to improving the lives of patients in different markets.
Kristen Fahmy – Bristol-Myers Squibb
Kristen Fahmy is currently an Associate Director in the Global Quality and Regulatory Compliance-GMP group, located in New Brunswick, NJ. Since joining the company in 2002, Kristen has held various positions within quality. In her current position, she is responsible for managing a quality assurance team which provides oversight for packaging and labeling, warehousing, and regional logistics activities. She also has responsibilities for investigations and field complaints, Quality Agreements, GMP training, inspection readiness, and providing support for regulatory agency inspections. Kristen is a trained Lean Sigma Kaizen Leader and has experience conducting internal and external audits.
Kristen received a BS in Public Health from Rutgers University, a MS in Quality Assurance from California State University, and is a Certified Quality Auditor with the American Society for Quality (ASQ).
Karen McNamara – Infinity Pharmaceuticals, Inc.
Karen McNamara is an Associate Director on the Supply Operations team at Infinity Pharmaceuticals, Inc. She is responsible for managing a team of supply managers tasked with timely preparation and delivery of clinical trial materials for global clinical trials which include activities such as packaging, labeling, distribution, inventory management and comparator sourcing. Karen has worked in the biotech/pharma industry for more than 8 years. Before joining Infinity about four years ago, Karen was with Biogen Idec as a Clinical Logistics Manager overseeing a team responsible for distribution to over 30 clinical trials being conducted in over 30 countries worldwide. Karen started her biotech/pharma career at Biogen Idec as a Logistics Analyst responsible for developing and executing supply chain shipping qualifications, including ground and air transport at various temperature and time profiles as required by product needs.
Kent Hassett, RPh – Eli Lilly and Company
Kent Hassett is currently an advisor in the Clinical Trial Supply Planning division of Eli Lilly and Company and has 17 years of experience supporting clinical supplies. He has held various roles across the investigational product supply chain including demand/supply planning, manufacturing, packaging, logistics, and vendor management.
Kent is a registered pharmacist and holds a BS in Pharmacy from Butler University in Indianapolis, IN.
Kevin Shea – Clintrak Clinical Labeling LLC., a part of ThermoFisher Scientific
Kevin began his career at Clintrak in May 2004 in the Manufacturing Division and was directly involved with label production. He joined the Client Services Department where he worked closely with clients in order to insure the successful completion of their jobs from protocol interpretation to label production. Throughout his tenure, Kevin has gained broad knowledge of the clinical label production process and the clinical supply chain as a whole while developing innovative solutions for clinical labeling challenges. Over the past few years, Kevin has spearheaded the development of translation and regulatory review solutions for clinical trial labels as a Label Program Director.
Kevin provides customer service support including client and site visits, quarterly meetings, trade meetings, exhibitions, seminars, whitepapers and leads industry discussion groups. He works closely with Clintrak specialists to develop customized solutions to meet client’s unique needs.
Kevin received his Bachelor of Arts degree from Hobart College in the year 2000. He currently resides in Patchogue, NY with his wife and two children.
Kristy Shipulski – Vertex Pharmaceuticals, Inc.
Kristy Shipulski is Sr. Director, Supply Chain Management at Vertex Pharmaceuticals, Inc. Kristy has 15 years of experience in pharmaceutical Supply Chain. She has been with Vertex Pharmaceuticals for the last 9 years. Prior to Vertex Kristy spent 6 years at Millennium Pharmaceuticals. In her current role Kristy is responsible for the Clinical Supply Chain department which manages forecasting, packaging and distribution of Investigational Medicinal Product for global clinical studies. Kristy received her B.S. in Biology from Tufts University and an MBA from University of Massachusetts, Boston.
Lorna Briddick – Brizzey
Lorna joined the Pharmaceutical Industry as a consultant to Pfizer, where she was involved in a corporate wide initiative to globalize, and optimize 2000+ clinical supply chain procedures across 6 countries to 200+ global procedures. Lorna was then retained by Schering Plough to lead the optimization of the clinical supply chain, supporting 3 large workstreams that integrated processes across multiple business units. Following that assignment, she was hired by Schering Plough as the Global Clinical Supply Regional Lead for Latin America, serving as the key interface between the clinical supply team and the clinical operations team in Latin America. In this role, she continued her leadership of process integration and optimization in support of the mergers with Organon and Merck. She is now a Managing Partner at Brizzey, a small firm dedicated to helping companies navigate the complexities of bringing new medicines to the market through the reliable, optimized and cost effective delivery of clinical supplies.
Maggie House – CSM
I have over 25 years in the pharmaceutical industry, the last 10 years dedicated to Clinical Supply Chain. I have worked in several pharmaceutical companies over the years, e.g. Sterling Winthrop, RPR, GlaxoSmithkline. As a result, I have gained an excellent knowledge of processes for packaging, labeling, distribution and project management. I have successfully led a project team for a new start up company. I have been project lead for IRT and Inventory System validation as well as IRT/Inventory system integration. I provide excellent leadership skills and recently joined CSM as Sr. Manager for the Project Management Team, leading a team of 10 project managers to support CSM client base.
Michael Cohen – Myoderm
Michael has been with Myoderm since 2001. Through his passion, leadership, and commitment to meeting each client’s unique needs, he has enabled the company to grow into a global leader in comparator and commercial drug sourcing for clinical trials. Prior to working for Myoderm, Michael held positions in the publishing, advertising, financial, and utility industries. He holds a B.S. degree in statistics from the University of Pittsburgh, and an M.B.A. degree from the university’s Katz Graduate School of Business.
Michael Dallmann – Cubist Pharmaceuticals
Mr. Dallmann is currently the Director of Global Clinical Trial Supply at Cubist Pharmaceuticals. He has over 20 years of experience in product and process development as well as Clinical and Commercial Supply Chain. Mike is also on the Board of Directors for the Global Clinical Supply Group. He is a frequent speaker on Comparator sourcing and clinical supply forecasting and has just recently relocated to the east coast after almost 20 years in California. He is also a classic car enthusiast and a 20 year SCUBA instructor with the Professional Association of Dive Instructors.
Michael Faughey – Ancillare, Inc.
Michael Faughey is a Strategic Accounts Manager for Ancillare, Inc – a global company specializing in the proactive management of ancillary supplies for clinical trials. As a pharmaceutical supply chain professional for 27 years, Mike has significant experience encompassing multiple levels within both the operational and R&D disciplines of several pharmaceutical industry leaders. Recently Mike has had the opportunity to focus on stream-lining and simplifying the complexities of global ancillary supply management within Johnson & Johnson and Ancillare.
Mike Yoon – ThermoFisher Scientific
Mike Yoon is an Account Executive for Thermo Fisher Scientific, the world leader in serving science. He has spent the past five years in multiple roles within the company, focusing on the provision of ancillary materials used in clinical trials. Currently Mike works in the Clinical Ancillary Management group of Fisher Clinical Services, helping pharmaceutical companies and CROs establish global supply chain solutions for the management of ancillaries.
Olive McCormick – Almac Clinical Services
Olive McCormick is the Head of Quality at Almac Clinical Services residing at the main headquarters in Craigavon, Northern Ireland. Olive is responsible for the QA, QC and the QP teams at this site.
Olive has been with Almac for over 15 years where she has gained extensive experience in the practices employed in the manufacture, packaging and labeling of IMPs and has been acting as a QP for over 10 years. Her role involves management and oversight of the Pharmaceutical Quality System at the site and extends to include the routine duties of the QP. Olive has extensive experience in performing on-site audits of manufacturing, testing, packaging and labeling sites and distribution centres globally.
Patricia Larrabee – Rochester Clinical Research, Inc.
Mrs. Larrabee is the CEO and founder of Rochester Clinical Research (RCR).
Mrs. Larrabee is an Adult Nurse Practitioner and received her Masters Degree from University of Rochester in 1977. Mrs. Larrabee is an Adult Nurse Practitioner and received her Masters Degree from the University of Rochester, School of Nursing in 1977. She currently serves as a sub-investigator on all the trials RCR conducts. Her chief responsibilities cover all technical, operational and managerial aspects of clinical site management.
Rochester Clinical Research conducts FDA-approved phase 1, 2 and 3 clinical research trials as part of the drug development process in the US. The company employs 26 professional medical, nursing and administrative support staff, and retains 3 on-site physicians who serve as Principal Investigators. Since 1994, RCR has recruited over 12,000 patient volunteers and completed over 600 clinical research trials across multiple areas of therapeutic focus. RCR has a strong commitment to quality assurance and adopts lean six sigma techniques for its staff training. RCR also supports the community with a free screening program for monitoring coronary risk factors and a 6 week Diabetes Self Management class that is open to the public. Ms. Larrabee is member of Association of Clinical Research Professionals and a partner in the Alliance for Multi-Specialty Research, LLC. national network of independent sites that share best industry practices.
Russell Brierley – Y-Prime
Senior Director, Product Strategy & Innovation, Clinical Supply Management
Clinical supply chain expert Russell Brierley has seen the drug development world take many twists and turns. His view of the industry is shaped by three decades of in-the-trenches experience with some of the industry’s most recognized names. The result is an evidence-based perspective that drives him to deliver smarter clinical research technology as Y-Prime’s Senior Director for Product Strategy & Innovation for Clinical Supply Management systems.
Russ spent 21 years steering clinical supply chain, clinical manufacturing and biologics process development initiatives at Teva and Cephalon. He designed and directed operations of a 23,000 ft2 cGMP facility for clinical manufacturing, packaging, labeling and distribution of clinical supplies which has serviced over 1,000 clinical studies.
Russ launched his career at The UpJohn Company and as a process development scientist at Salk Institute Biotechnology Industrial Associates. His accomplishments include numerous pharmaceutical industry patents and publications. He holds a Bachelor’s of Science degree in Biology from University of Massachusetts Lowell and a Master of Science degree in Biotechnology from Worcester Polytechnic Institute.
Steven A. Jacobs – Global BioPharm Solutions – GCSG Board Member
Mr. Jacobs is a successful trainer, business leader, consultant, executive coach and speaker. He’s been heavily involved in clinical supply chain operations, IMP cGMPs, cGCPs, clinical development and quality for pharmaceuticals, and biotech products. His expertise also includes success in innovation, global cultural dynamics, organizational development, and high performing teams. He has presented globally on leadership, management, forecasting, planning, creativity, making global teams successful, emotional intelligence, generational differences, human error prevention, clinical supplies logistics, project management, problem solving and contract negotiations.
In the past he has been the CEO and COO of a start up company as well as the president and Global Chief Operating Officer of a multinational contract organization that served companies like Novartis, Eisai, Lilly and others in the pharmaceutical and biotech sector.
His ability to lead, drive outcomes, and bring teams together to deliver products and services on time and on budget was honed and developed as the head of US clinical supply operations for Johnson & Johnson. This was part of his 20 years of experience in clinical supplies, clinical development and global team leadership.
Mr. Jacobs was also a logistics and aviation officer, in the U.S. Army, where he rose to the rank of Major and was a maintenance test pilot, and pilot in command, for both helicopters and fixed wing Army aircraft.
His undergraduate degree is in Pharmacy from the University of the Sciences in Philadelphia and his MBA is from the University of Phoenix with a specialization in global management.
Sébastien Coppe – N-SIDE
Sébastien Coppe has a Master of Engineering in Applied Mathematics. He obtained his PhD in 2012 in Belgium, designing a pre-diagnostic tool for patients suffering from dementia by modeling the brain behavior.
He is working at N-SIDE where he is leading the Consulting Group, which provides services to worldwide pharmaceutical companies in order to optimize their clinical trial designs and supplies.
Vijaya Musunuru – Bristol Myers Squibb
Vijaya Musunuru is currently a Manager at Bristol Myers Squibb and has over 14 years of experience in Pharmaceutical/Biopharmaceutical cGMPs in R&D and/or commercial (OTC) manufacturing companies. In June 2006 she joined as a QA Associate at Bristol Myers Squibb (BMS), a global BioPharma company that develops medicines for serious unmet medical needs. Since then she held positions of increasing responsibility. At BMS she identified several continuous improvement projects, enhanced batch review and release cycle efficiency, created SharePoint site for collaboration, authored Risk Registers for Quality Agreements and Releases. She was also involved in integration and transition of products acquired by BMS, provided pre approval inspection(PAI) readiness support etc. Her areas of interest are Investigational Medicinal Products, Quality System Regulations, Regulatory Affairs and Continuous Process Improvements. Vijaya received her Master’s in Regulatory Affairs from Johns Hopkins University.
Vincent Ioele – Mesoblast
For the last two years I have been employed with Mesoblast as Director, Clinical Supplies. Mesoblast is a regenerative medicine developing biotherapeutics based on its proprietary cell-based and protein technologies. Prior to Mesoblast I was employed at Fisher Clinical Services (Allentown, PA) as Team Leader, Project Management overseeing a group of project managers. Before my time at Fisher, I spent four years at Teva Pharmaceuticals (Horsham, PA) as the Clinical Supplies Manager for their Respiratory Division. I was also employed at Johnson & Johnson (Titusville, NJ) as a Global Clinical Supplies Manager, at Altana Inc. and Altana Pharma (Melville, NY and Florham Park, NJ respectively) in Quality Assurance and then Clinical Supplies.
Wyndi Phillips – PRA
Wyndi Phillips, PharmD, is a Director of Clinical Vendor Management at PRA Health Sciences. She oversees PRA’s drug services and manages the relationship with the drug supply vendors. Prior to PRA, Wyndi worked at Almac Clinical Services and as a clinical pharmacist in hospital and outpatient clinics. Wyndi received a PharmD from Campbell University and completed her residency at Mercer University and Piedmont Hospital in Atlanta, GA.