Pre-filled Syringes Americas

Clark Merchant, Ph.D.
Senior Optical Scientist, (R&D)
Brightwell Technologies Inc.
115 Terence Matthews Crescent, Ottawa ON. CANADA K2M 2B2
Tel: +1.613.591.7715 x523
Fax: +1.613.591.7716
Email: cmerchant@brightwelltech.com

Colleen Hittle, RAC
Managing Partner & Director of U.S. Regulatory and Quality Systems
(317) 569-9500
TF (866) 521-9500
chittle@ansongroup.com

Colleen Hittle spearheads Anson’s U.S. Regulatory and Quality Systems support services. In that capacity, she works with medical technology companies to develop and implement regulatory strategies at each stage of the product development time line and to anticipate and manage regulatory issues that arise.

Tel : +33 (0)4.78.61.47.97
Mob : +33 (0)6.70.82.38.07
Email : danielle.labreche@aguettant.fr

Danielle LABRECHE, graduated from Hautes Etudes Commerciales (HEC) Montréal, Canada Business School in 1987, has worked as Marketing Director over the last decade in the Generic Pharmaceutical Industry in Canada at PHARMASCIENCE in Montréal, and overseas at RANBAXY PHARMACIE, in Paris.

As the Business Development & Innovation Director at LABORATOIRE AGUETTANT (Lyon, France), a company dedicated to the development and marketing of injectable drugs for hospital care, she is in charge of the innovation process for new products developments and is heading the licensing activities of proprietary dossiers and Delivery Devices patented worldwide by AGUETTANT, regrouped under its “AGUETTANT SYSTEM” portfolio.

AGUETTANT focuses on Emergency drugs, Micro Parenteral Nutrition and Parkinsonian Treatment.

Douglas Marenzi, born in 1963, is managing director and main share holder of Pharma Consult, a medical device developing enterprise, located in Vienna, Austria. In the Year 2000, a main share of Pharma Consult was acquired by Marenzi and Biomedica, a medical distribution group owned by his family. Since then, Auto Injectors and Drug Delivery Devices are developed and patented. One of Marenzi’s main companions at Pharma Consult is Ewald Pickhard, founder of Pharma Consult and nowadays running R&D for the company. Main achievements of the team are world wide patents for the military Injector PC-2M, the PC-LYO, a one piece device for the reconstitution and injection of freeze dry agents and for PC-MXo, a prefilled safety syringe with needle barrier system.

After studies in Austria and the UK, Douglas Marenzi started his career 1988 banking for Raiffeisen Zentralbank in Vienna. He started with his first freelance company, Rocatronic, which is still managed by him, in 1990 and worked for Constantia Packaging at Teich Flexibles in Austria and GB for 3 years, before joining Pharma Consult.

Dr Daniel Wheeler is Lecturer in Anaesthesia at the University of Cambridge, and an honorary Consultant Anesthesiologist at Addenbrooke’s Hospital, Cambridge, UK. His research interests include studying different means of improving patient safety, focusing on drug administration. He uses high fidelity simulation to recreate emergency scenarios in which randomised studies can be undertaken examining doctors’ and nurses’ abilities to administer parenteral drugs correctly. Much of his research makes a strong case for more widespread use of pre-filled syringes, especially generic drugs. In recognition that the market for pre-filled syringes containing generic drugs is in its infancy, he has developed a novel medical device for drawing up drugs from ampoules and labelling syringes safely.

Phone +49- (0) 5223 / 164 401
Mobile +49- (0) 160 / 90 912 306
Fax +49- (0) 5223 / 164 316
Email a.fries@gerresheimer.com

Dr. Arno Fries is Director Product Management Tubular Glass with Gerresheimer. He joined the company in 2006 and is currently responsible for global product management of pre-filled syringes, vials, cartridges and ampoules in the Tubular Glass Division. He has twelve years of experience in leading sales and marketing positions in pharmaceutical companies and the related supplier industry and four years as scientist at international research institutes in Japan and England. He earned his PhD in chemistry from the University of Würzburg and his degree in business administration from the IDB Institute in Frankfurt, Germany. Dr. Fries has contributed numerous publications on technical and marketing aspects of pre-filled syringes. He is a member of the Parenteral Drug Association and the Alexander von Humboldt Foundation.

Dr. Shawn D. Kinney found HCM in 1999 in order to provide aseptic manufacturing and filling services to the pharmaceutical, biotech and medical device industries.

Dr. Kinney holds a Ph.D. in Chemistry from the University of Massachusetts at Amherst, a Masters in Medicinal Chemistry from Northeastern University, and a Bachelor of Science in Chemistry from the University of Massachusetts at North Dartmouth. Dr. Kinney has worked at Anika Therapeutics, Wyeth-Ayerst, and Millipore, and he has more than 20 years of experience in the pharmaceutical industry. He has extensive experience in the development of sterile formulation and filling processes including viscous and difficult-to-fill products. Prior to founding HCM, he was responsible for the sterile formulation and filling of hyaluronate into prefilled syringes in his role as Vice President of Operations at Anika Therapeutics.

Recently Dr. Kinney has pioneered a new technology in online vacuum filling and stoppering and has authored two provisional patents in that area. He continues to oversee HCM’s expansion and leadership in the aseptic contract manufacturing industry. Dr. Kinney has been a member of the PDA for over 8 years.

Dr. S. Sundström received his Ph.D. in 2009 at the Royal Institute of Technology in Stockholm. He has spent 10 years in the pharmaceutical manufacturing field at AstraZeneca, specializing in the areas of Contamination Control. He is currently working at AstraZeneca as a specialist and researcher within cleanroom technology and contamination control in Sweden. Dr. Sundström is a frequent industry speaker and has presented at key industry events for PDA, BFS IOA, IVT, R3 Nordic etc.

Tel. +41 71 274 1656
Fax. +41 71 274 1698
Email: horst.koller@schott.com

Mr. Koller started his professional career in 1994 to work for Abbott Diagnostics GmbH managing the Process Engineering Group.
In 2000 he joined Schott in the business segment Pharmaceutical Packaging. He has been a key player in building the manufacturing unit for the Schott TopPac polymer syringe within Schott forma vitrum ag. He held different positions including Quality Manager, Head of R&D and Manager Scientific Advisory. In his current position he is the Head of Regulatory Affairs for Schott Pharmaceutical Packaging worldwide.
He is an active member as expert of ISO/TC 76/WG2 working group.

He holds a degree as Dipl. Ing (FH) in Biotechnology.

Ian Thompson has been with Ypsomed AG since 1995 working with pharma and biotech partners to develop and bring to market innovative self-injection systems. He studied biochemistry and biotechnology and completed his MBA in the UK. He has always focussed on the selling and marketing of technical products, the last 20 of which have been spent in Switzerland in the field of medical devices.

Principal, Aseptic Barrier Systems LLC
Agent for SKAN AG for the Americas
Director of Sales: SKAN US,INC
Phone: 702-363 0086
Fax: 702-804 1325
Mobile: 702-376 6661

James Spolyar founded Aseptic Barrier Systems in November 2002. Aseptic Barrier is the exclusive agent for the Americas, for SKAN AG, a Swiss Corporation. He was deeply involved in the formation of SKAN US, INC and in the development of sales for both SKAN US and SKAN AG. He was Director of Sales for Carlisle/Walker Barrier Systems from June 1996 to November 2002. Prior to joining Carlisle Barrier Systems, Jim served as Chief Operating Officer of La Calhene, Inc. from 1988 until April of 1996, involved in manufacturing and sales of isolation products for the pharmaceutical industry. He has been deeply involved in the design, sales and applications of containment and aseptic isolators, with all of the above companies. He received a JD degree from the University of Michigan Law School in 1964 and received his B.A. from the University of Michigan College of Literature, Service & Arts in June 1961

LEAH R. KENDALL* is an Associate in the Health Care and Life Sciences Practice in the firm's Washington, DC office. Ms. Kendall counsels a variety of medical device, pharmaceutical, and biotechnology clients on a wide range of issues implicating the requirements of the U.S. Food & Drug Administration and the Centers for Medicare & Medicaid Services.

Phone: +49/791/9495-2649
Fax: +49/791/9495-2619
E-mail: Matthias.Poslovski@optima-pharma.com

Mr. Poslovski, a graduate mechanical engineer, has been with the Optima Group since 1998. He began his career with Optima as the sales manager of the former division Inova pharma systems GmbH. From 2000 until 2002 he managed the Optima division of Kugler whose expertise was in non sterile filling and packaging technology. Today, Mr. Poslovski holds the title of Director Technical Sales of the OPTIMA GROUP pharma GmbH with the brands Inova (sterile filling), Klee (freeze drying) and Kugler (non sterile filling). His responsibilities encompass the overall United States and South American markets.

Mr. Mattias Haag received his BSc degree in engineering 1998. He has spent 12 years as a mechanical engineer, and the past 10 years in the pharmaceutical manufacturing field specializing in the areas of HVAC systems, clean room technology -, and pharmaceutical utilities. He is currently working at EnergoRetea in Sweden as a validation manager and also as a project manager within HVAC, safety ventilation and Cleanroom technology. Mattias currently holds a position as a director for the validation and pharmaceutical division at EnergoRetea.

Mike has a bachelor of science in chemical engineering from the University of Maryland and a MBA from Boston College. Mike has 15 years in the pharmaceutical machinery business, most of it in fill-finish. Mike has been with Bosch Packaging for 10+ years in the areas of fill finish, automation and secondary packaging. Prior to this, Mike was involved in custom machinery for manufacturing including project management, business unit management and design engineering.

Holder of a HND in Biology and a Master’s degree in Health Engineering & Biotechnologies, Pierre joined STELMI Paris head offices during the last quarter of 2008. Within the Technical Management, his mission aims at conferring efficient support and relay to Sales, Marketing, Technical, Quality and R&D departments of STELMI, customers and development partners in order to continuously improved the industrial excellence of each side.

Coming from the Pharmaceutical Industry, Pierre worked previously within the Global Medical Devices organization of the Sanofi-aventis group. Then he acquired a huge background in terms of pre filled syringes and advanced medical devices industrial development (Prospective, Projects & improvements, industrialization, troubleshooting, market survey…).

For Pierre the success key of the industrial excellence approach lies in a permanent and strong networking, a high level of knowledge of the market trends leaning on pragmatic and proactive strategies.

Renaud Janssen graduated as a chemical engineer from Leuven University, Belgium. After finishing his doctoral study in Applied Sciences he joined Janssen Pharmaceutica in Belgium, where he worked in the Department of Chemical Development and Production. In 1988 he joined Helvoet Pharma in Belgium where he has been holding various positions in R&D, Quality and Technical Support.
Currently Renaud is Global Director of Scientific Affairs for Helvoet Pharma.