The Global Clinical Supplies Group 2015 US Conference: Speakers

Biography:

Adrian Peskett has just moved to the new role, Head of Operational Strategy within Pfizer’s Global Clinical Supply Chain. He has worked with Pfizer for over 15 years supporting various aspects of the supply chain. Adrian’s responsibilities have included master planning, inventory management, commercial sourcing, packaging, labeling, process improvement, external vendor management, business development, licensing management and distribution. Today he is responsible for a team that is developing clinical supply operation strategy for the entire Pfizer portfolio. He is currently located in the US but spent many years in the UK and has considerable experience in optimizing international clinical supply chain activities. Adrian obtained his first degree from University of Wales, College of Cardiff and his MBA from the University of Kent.

Biography:

Brian Keesee, Senior Vice President of PCI’s Clinical Trial Services Segment, has spent his entire career in the Pharmaceutical industry.

In his current role, Brian is responsible for Global Clinical Operations, Logistics, and Project Management for PCI’s Clinical Trial Services sites globally.

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, Cold Chain Technologies and IRT.

Brian brings a unique perspective based on his global project management knowledge from his prior positions within the Clinical Supplies Industry, 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.

Biography:

Karen McNamara is the Product Development lead at Infinity Pharmaceuticals, Inc. which includes clinical supplies responsibilities. Karen has worked in the biotech/pharma industry for 15 years. Before joining Infinity 10 years ago, Karen was with Biogen Idec in the Global Operations team focused on clinical and commercial logistics. Over the past 5 years, Infinity has been through a roller coaster of events slimming down from a 300+ person, phase 3 registrational, NDA writing company down to a 25 person, phase 1, US only company and most recently beginning to grow again starting two global phase 2 studies in 2019. As you can imagine, Karen has found herself in a unique situation with a new perspective on influencing and collaborating with other key functions (both internally and externally) including taking on product development and alliance management at Infinity.

Biography:

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.

Biography:

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).

Biography:

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.

Biography:

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.

Biography:

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.

Biography:

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.

Biography:

After graduating from Penn State University, Keith started his clinical supply career at National Packaging Systems, a venture funded startup for clinical supplies, in Quality Assurance. During his 12 years working on the vendor side of the industry he took on roles in Quality Assurance and Logistics Management. He then transitioned to the sponsor side of the supply chain by joining Schering-Plough in their Resource Management group. In 2005 Keith joined a newly formed clinical supply group at Celgene Corporation managing clinical packaging and logistics vendors. During his time at Celgene he’s had roles within clinical supply Operations Management as well as Strategic Program Management. He currently is the Sr. Director, Operations, in Celgene’s Investigational Material Supply Chain department.&.

Biography:

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.

Biography:

Greg is Executive Director at Jeiven Pharmaceutical Consulting, Inc. where he provides consulting services and training to pharmaceutical, biotech, and nutraceutical companies.

Prior to joining Jeiven, he founded Kushla Consulting, with the main focus of clinical trial material support, especially in developing appropriate cost-effective and timely solutions to clinical study challenges.

Greg established the clinical supply planning and operation function for Daiichi Sankyo (formerly Sankyo Pharma) in the US. 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. Studies ranged from single-country trials to global mega-trials.

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 numerous regulatory submissions. Greg was also responsible for the clinical supply function for studies conducted primarily in North America.

Greg received his degrees from Rutgers University.

Biography:

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.

Biography:

Paul Miller is a Microsoft Certified IT Professional with more than 25 years’ experience. He is an advocate of SharePoint. Paul is the Director of Information Technology at Xcelience, LLC in Tampa, Florida. He resides in Wesley Chapel, Florida.

Biography:

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.

Biography:

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.

Biography:

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 20 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 14 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 audits of sites involved in the supply chain globally. She routinely provides consultancy to clients on regulatory updates with particularly focus on the expectations of the regulators and how these impact you. More recently she has developed a strong interest in Data Integrity and is passionate with regards to how the requirements should be viewed as a positive impact on the industry.

Biography:

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.

Biography:

Sebastien Coppe has a Master of Engineering in Applied Mathematics. He then obtained a PhD by designing a pre-diagnostic tool for patients suffering from dementia, after having created a mathematical modeling of the brain behaviour. He is working at N-SIDE where he is leading the Consulting Group, which provides services to pharmaceutical companies in order to optimise their clinical trial designs and supplies thanks to CT-FAST forecasting and optimization solution.

Biography:

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.

Biography:

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.

Biography:

Mr. Dallmann is currently the Principal of CMD Clinical Supply, a consulting group focused on pharma Supply Chain management.  He was previously the Director, Clinical Packaging and Labeling for Gilead Sciences and has more than 20 years’ experience in product and process development.  Prior to joining Gilead Sciences, Mike served as Director, Global Clinical Trial Supply for Cubist Pharmaceuticals and at Forest Laboratories subsidiary Cerexa as Associate Director – Global Pharmacy and Logistics Management. He has held similar roles at Peninsula Pharmaceuticals, Inc., a Johnson & Johnson company and at Elan Pharmaceuticals.  Early in his career he was a Research & Development Scientist for Oral-B Laboratories. He received a bachelor’s degree in biochemistry from the University of Guelph in Ontario, Canada. Mike is also on the board of directors for the Global Clinical Supply Group.

Biography:

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.

Biography:

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.

Biography:

Volker Niermann is an Associate Director of Product Development Manager, Device Operations at Bristol-Myers Squibb.

Biography:

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.

Biography:

Lorna is an Electrical Engineer with experience across the following industries:  Heavy equipment design & manufacturing, financial, and information technology.  She 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 as a consultant by Schering Plough to lead the optimization of the clinical supply chain. 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 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.

Biography:

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.

Biography:

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.

Biography:

Steve is a successful consultant, trainer, business leader, executive coach, mentor and speaker. For the past 25 years he’s been heavily involved in clinical supply chain operations, IMPs, cGMPs, cGCPs, cGDPs, clinical development and quality (ICH Q8, Q9 & Q10) for pharmaceuticals, and biotech products.

He sits on the Board of Directors of the largest professional clinical supply organization in the world, the Global Clinical Supplies Group. His expertise also includes success in leadership, innovation, global cultural dynamics, organizational development, and high performing teams.

In the past he has been a CEO and COO, as well as the president and Global Chief Operating Officer, of a multinational clinical supply chain contract organization that served companies like Novartis, Eisai, Lilly and others in the pharmaceutical and biotech sector. Before that he was head of US clinical supply operations for Johnson & Johnson.

Steve 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 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.

Steve has traveled all over the world (4 Continents, 25 Countries, 42 States) and enjoys spending time with his Fiancé, son, and good friends, whenever he gets the chance.

Biography:

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.

Biography:

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.

Biography:

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.

Biography:

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.

Biography:

Ed Groleau has over 30 years of experience in the Pharmaceutical industry. The first 15 years were spent in a variety of laboratories for small molecule drug development.  He started out developing and validating analytical testing methods at Merrell Dow Pharmaceuticals and Eli Lilly.  He became Lilly’s primary X-ray powder diffraction expert and was a founding member of the company’s Physical Characterization group that established the optimal salt form for compounds in development.  Being responsible for all XRD, XRF, and thermometric techniques, Ed was also part of Lilly’s internal forensics team conducting investigations for internal manufacturing issues and external litigations.  After 7 years of physical characterization Ed moved to the chemical characterization group where he helped determine the structures of degradation products using NMR.

Ed moved to Lilly’s Clinical Trial Supplies group in 2003 starting in the group responsible for packaging and labeling of IP.  His responsibilities increased as the department changed over the years to include all aspects of CT supplies from planning to distribution. In 2011 he became part of a small, highly integrated CM&C team responsible for overseeing the development of compounds from discovery through proof-of-concept stage.  On this team Ed developed the procedures and processes required to conduct all aspects of the supplies for clinical trials from manufacturing through reconciliation.

In 2016 Ed moved to Elanco, Lilly’s animal health division, where he established a global clinical trial supplies group for developing companion and food animal projects.  Ed’s career at Lilly/Elanco ended in 2017 when he took advantage of an early retirement program the company offered.  Not ready to actually retire, Ed has joined a growing supply chain group at PCI where he continues to provide his experience and expertise to other companies in need of the service.