Mr. Jacobs is a successful senior business manager, consultant, leader and communicator. He has been heavily involved in innovation, global cultural dynamics, high performing teams, and clinical supply chain operations for pharmaceuticals, biotech products and medical devices. He has presented globally on creativity, leading global teams, emotional intelligence, clinical supplies logistics, project planning, and contract negotiations and is a recognized expert in the clinical supplies industry.

In the past he has been 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.

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 rotary wing 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.

Gretchen Randlett has 7 years of experience in the biotech industry and 7 years of experience in the pharmaceutical industry. Mid 2008, she was chosen to become a Lean Six Sigma Black Belt due to her leadership experience and demonstrated success with process improvements. She is currently working as Black Belt in the Product Research and Development division of Eli Lilly and Company. This is a two year assignment where she is responsible for managing projects that help drive business process improvements, increase productivity, speed innovation, improve customer relationships and grow sales. Prior to her Lean Six Sigma assignment, she worked fours years as a Clinical Trial Operations Associated in the Clinical Trial Dry Products Manufacturing Department at Eli Lilly and Company. In this position she was responsible for managing clinical trial drug demand; including packaging and stability support of clinical trial material worldwide. Her work supported First Human Dose through Phase IV clinical trials.

Before joining Lilly, Gretchen spent 3 years with Cognetix, Inc. At Cognetix, she was a Senior Research Associate who worked to develop therapeutics based on research of on conopeptides; peptides derived from the venom of Conus species of predatory sea snail.

Finally, she worked 7 years at Tandem Labs as a Senior Scientist. While there she was responsible for providing GLP compliant analytical services for pharmaceutical companies, both in the United States and Asia. This included project management and assay development. These companies where involved in Phase I through Phase IV clinical studies.

Gretchen earned a BS in biology and Chemistry from the University of West Alabama.

Christine Fattore has 12 years experience in the clinical trial/clinical supply arena, most recently at MedImmune as Director, Clinical Research Pharmacy Services. In this capacity, she is responsible for a department of 11 people supplying biologic-based clinical supplies for trials in all phases of development.

Before joining MedImmune, Christine worked at Shire Pharmaceutical Development during which time she was responsible for activities ranging from API manufacture and stability to over-encapsulation, label design, and global distribution of CTM for a virtual company. Prior to Shire, Christine worked as a Medical Liaison Coordinator at Zeneca Pharmaceutical after having established and developed the Clinical Supply group at Otsuka America Pharmaceutical. Christine has also worked as a Clinical Research Associate and a hospital pharmacist.

Christine received a BS in pharmacy from the University of Minnesota College of Pharmacy. Her professional affiliations include the American Society of Health-System Pharmacists (ASHP), the International Society of Pharmaceutical Engineers (ISPE) where she is a past member of the Clinical Materials Committee and the Midwest Clinical Supplies Group (MCSG) where she is a current member of the Board of Directors.

Joe Iacobucci is Vice President Sales at Clinical Systems in Garden City, NY where he has worked for nineteen years. He is responsible for the sales and marketing department at Clinical Systems which offers ClinBookTM multi-page clinical labels, contract clinical label generation services, clinical randomization services, software validation services, and clinical label stock. Joe is also responsible for demonstrations, training, and implementation of the ClinPro/LBLTM clinical label generation system at client sites worldwide. He has been involved with clinical supplies for twenty-five years.

Before joining Clinical Systems, Joe managed the clinical supplies area at Rorer Central Research, worked as a supervisor in commercial packaging operations at Rorer Pharmaceuticals, and managed the investigational materials department at Berlex Laboratories. Joe has also worked as a hospital pharmacist.

Joe received a BS degree from Rutgers College of Pharmacy, an MBA in Marketing from Temple University and is a Registered Pharmacist in New Jersey and Pennsylvania. His professional affiliations include the International Society of Pharmaceutical Engineers (ISPE), Canadian Clinical Supplies Association (CCSA), Equal Partners in Clinical Supplies (EPICS), and the Midwest Clinical Supplies Group (MCSG), where he is a current member of the Board of Directors.

Dick Winokur is the Associate Vice President, Clinical Investigational Products for sanofi-aventis in Malvern, PA. His department is responsible for the design, packaging, labeling and assembly of clinical supplies for international clinical studies. The department is also responsible for the distribution of worldwide supplies.

Dick has been involved in all aspects of manufacturing and packaging of pharmaceutical products. He has over 30 years of experience in the industry. Dick's areas of expertise include manufacturing, planning, packaging operations, productivity improvements, equipment purchases, plant start-up and shut down, and employee relations. He has worked at Pennex, Wyeth-Ayerst, Bristol Myers Squibb, and Searle Laboratories.

Dick holds a BS in Industrial Technology from Westmar College, a M.Ed. in Administration and Supervision from Loyola University, and a Ph.D. in International Business Administration from Kennedy-Western University.

Dick is a member of IOPP, ISPE, and MCSG.

Judy is an Associate Director in Global Drug Supply Management at Abbott Laboratories in Abbott Park, IL. In this role, she is responsible for forecasting and managing clinical supplies demand for multiple programs, as well as coordinating and supporting clinical supply chain activities.

Prior to joining Abbott, Judy spent over 13 years at Pfizer, Pharmacia and the former Upjohn Company. There she held a variety of positions in analytical testing laboratories, sterile product formulation and manufacturing, clinical supply packaging coordination and project management.

Judy received her B.S. in Chemistry (Business minor) from Hope College, and an M.B.A. from Western Michigan University.

Email Judy

George is a Packaging and Labeling Manager within Clinical Supplies for Bristol-Myers Squibb, located in New Brunswick NJ. In this capacity, George has 23 reports and is responsible for managing production operations with regards to the packaging and labeling of clinical supplies for Phase I through IV programs. George has been with Bristol-Myers Squibb since 1985, serving in various capacities (Bacteriologist, Supervisor of Microbiology, Clinical Supplies Supervisor, Clinical Supplies Outsourcing Project Coordinator and presently Clinical Supplies Packaging and Labeling Manager).

George is currently the MCSG Vendor Liaison Officer. Previously he served as member of the MCSG Advisory Board and was a past chairman of the MCSG Steering Committee. George served as the chairperson for the Midwest Clinical Supply Group's 17th Annual Meeting.

George received a Bachelor of Science Degree in Bacteriology and Public Health from Wagner College, NY in 1984.

Email George

Frank Lueddeke is currently the Chief of the Clinical Materials Management Section (CMMS) at the VA Cooperative Studies Program, Clinical Research Pharmacy Coordinating Center (CSPCRPCC) located in Albuquerque, New Mexico. The VA Cooperative Studies Program has employed Frank for the past 16 years holding several different positions during this period.

Frank spent the first six years with the IQMU (Integrated Quality Management Unit) as a Quality Manager. He was responsible for all drug product samples, stability and retains programs for the various trials and projects conducted by VA Cooperative Studies Program.

Franks current position as Chief of CMMS oversees the manufacturing, processing and distribution of all clinical materials and devices at CSPCRPCC. Frank has been involved in the Centers quality initiative since 1994 and has served as Quality New Mexico examiner as well as Baldridge category champion.

Frank has held several positions on the MCSG executive committee over the years and is currently the Logistics officer.

Email Frank

Mariam has been involved in clinical supplies since 1999. Mariam currently works for Sanofi-Aventis as Clinical Supply Chain Trial Manager (SCTM); prior assignments include Clinical Investigational Product Manager (CIP PM) at Sanofi-Synthelabo.

Prior to joining Sanofi, Mariam worked as a member of the Investigational Materials Department at the Otsuka Maryland Research Institute, as a clinical supplies' contractor at both Shire Pharmaceutical development, and at Patwell Pharmaceutical Solutions.

Mariam holds two Masters degrees (Business Administration from France and Computer information Systems from USA) and a BS degree is Business Administration.

Ida is a Project Manager in the Global Clinical Supplies Planning department within the Pharmaceutical Sciences business of Schering Plough. In this position, Ida is responsible for planning supply chain activities to support a number of programs, across multiple protocols from Phase I through Phase III clinical studies. In this role, Ida has also had the opportunity to lead global cross-functional task forces across Clinical Operations, Regulatory and Pharmaceutical Sciences designed to enhance internal supply chain productivity and ensure greater predictability of on-time clinical supply delivery.

Prior to her role with Global Clinical Supplies Planning, Ida worked with Pharmaceutical Sciences Quality and led a number of reengineering efforts. She also worked in Human Resources for both Pharmaceutical Sciences and Drug Discovery, and played a lead role in the design of the company's global performance management process. In joining Schering Plough, Ida brought over 10 years experience in developing processes to support leadership development, talent development and learning programs, competency model development and assessment, organizational change initiatives, and succession planning processes. She has worked as a management consultant on organizational change efforts supporting pharmaceutical sales and marketing businesses as well as a number of other diverse industry sectors.

Ida received a B.S. in Finance from the Stern School of Business at New York University and an M.A. in Industrial/Organizational Psychology, also from New York University.

Information coming soon!

Email Barbara

Joe has over 20 years experience as a clinical supplies' professional in many CTM & development capacities. Joe is currently an Associate Director in Clinical Supply Operations at Daiichi Sankyo. Prior employers include Bilcare, Kos Pharmaceuticals, Novartis, Sandoz and ER Squibb & Sons, with positions ranging from Account manager to Clinical Packaging supervisor to Director of Demand & Supply Planning. Before joining the pharma industry in the early 1980s, Joe worked as a retail pharmacist for several years.

Joe earned his BS in Pharmacy from Rutgers College of Pharmacy and his MBA from Farleigh Dickinson University, both in NJ. Joe sits on the steering committees of EPICS (Equal Partners in Clinical Supplies) and MCSG (Midwest Clinical Supplies Group), and is a member of the International Society of Pharmaceutical Engineers (ISPE), Clinical Supplies Support Group (CSSG) and the NJ Pharmacist's Association, as well as an ad-hoc member of the Investigational Materials Discussion Group (IMDG).

Email Joe

Eric Deschamps, Director of Sales Fisher Clinical Services North America. Eric joined Clintrak in 2001 to spearhead the Business Development group. He brought a wealth of business experience to the company, specifically in the areas of sales and marketing. Over the past 8-plus years, including 4 years cross-selling products and services for Clintrak's former sister company AccuLogix, Eric has gained considerable knowledge within clinical supplies, particularly in clinical label generation, packaging and distribution. Eric has also developed and maintained key relationships with major pharmaceutical companies including Pfizer, Bristol Myers Squibb, Merck, Novartis and Boehringer-Ingelheim.

Prior to AccuLogix and Clintrak, Eric owned and operated a sporting equipment manufacturing and supply business where he gained valuable customer relationship skills while managing 13 regional sales representatives.

Eric earned his Bachelor of Science degree in Business Administration at St. John's University in 1983.

Bob has over 10 years experience as a clinical supplies' professional. Bob is currently a Manager in Clinical Supply Operations (CSO) at Daiichi Sankyo (DS); he is responsible for all supply-side aspects of investigational supplies on designated projects.

Prior to joining DS, Bob was at Bristol Myers Squibb as a Clinical Supply Operations Outsourcing Specialist. In this role, Bob was responsible for standardizing CSO Master Service Agreement (MSA) templates for all key suppliers. While at BMS, Bob was the creator and developer of the first Midwest Clinical Supplies Group website. Before joining the pharmaceutical industry, Bob worked as the pharmacist in charge for Pathmark and Rite-Aid Pharmacies.

Bob earned his BS in Pharmacy from St. John's University and attended New York University School of Continuing and Professional Studies for computer programming. Bob is a member of the International Society of Pharmaceutical Engineers (ISPE) and the Midwest Clinical Supplies Group (MCSG) where he is a current member of the Executive Committee.

Email Bob

Mike is a Senior Project Manager in Clinical Supplies at Procter & Gamble Pharmaceuticals with responsibilities for packaging, labeling and distribution in Mike is a Senior Project Manager in Clinical Supplies at Procter & Gamble Pharmaceuticals with responsibilities for packaging, labeling and distribution in support of all phases of global drug development. In this position for 5 years, Mike has additional responsibility for some direct reports including systems managers, processes to manage clinical supply demand planning and project execution. Mike is also responsible for the development, delivery and facilitation of training programs; including designing, planning, organizing, implementing and evaluating program effectiveness as well as conducting needs assessments.

Prior to P & G, Mike was a supervising pharmacist at a national chain pharmacy with extensive involvement in community health care initiatives; in addition to previous practice in hospital, managed care, pharmacoeconomics outcomes research and other pharmacy settings.

Mike has a Bachelor of Science degree in biology, a Masters of Public Administration and a Doctor of Pharmacy degree. He is also an active member of the Pi Alpha Alpha Honor society. He is currently a steering committee member of the Midwest Clinical Supplies Group (MCSG) and also affiliated with the American Society of Health-System Pharmacists (ASHP) and American Pharmacists Association (APhA).

Email Mike

Ed Groleau has been in the Clinical Trial Materials Management (CTMM) division at Eli Lilly and Company for 6 years and is currently a Clinical Trial Project Manager. In this role he is the primary contact for all compounds for which he has responsibility. He coordinates with Medical project managers to develop supply chain strategies for the compounds and represents the clinical needs on the CM&C team. He also is responsible for ensuring that the individual Study Coordinators have supply plans in place that will meet all individual trial requirements.

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. Prior to transitioning to a CT supply career he was in the spectroscopy lab doing structural determination of degradation products using NMR.

Ed received his B.S. in Chemistry from Illinois State University.

Email Ed

Mirwais (Wais) Shinwari has over 17 years experience in the Pharmaceutical Industry, in the area of Clinical Supplies manufacturing, packaging, planning and project management. Wais Shinwari has worked as Development Project Manager (Clinical), Portfolio Team Manager and currently as Supply Chain Project Manager in Investigational Products at AstraZeneca.

Prior to joining AZ in 2001, Wais worked in various capacities including as Project Manager in Clinical, Supervisor, Clinical Supplies Manufacturing and Formulation Scientist in P&ARD Dupont/Dupont Merck Pharmaceuticals. He stared his career in Pharmaceutical Industry as an Analytical Chemist with Kansas City Analytical Services (KCAS).

Wais earned his Bachelor of Pharmacy degree from Department of Pharmacy, at the University Peshawar, N.W.F.P, Pakistan, and his Master of Science degree in Pharmaceutics from the School of Pharmacy at the University of Missouri Kansas City (UMKC). He is member of the steering committee with MCSG (Midwest Clinical Supplies Group) and is a member of the American Association of Pharmaceutical Scientist (AAPS).