Medical Device, Pharmaceutical and Biologics industries worldwide have grown tremendously over the past 30 years.  Key milestones such as the development and marketing of recombinant products such as genetically engineered human insulin and hepatitis vaccine in 1980’s, the mapping of the human genome in the 1990’s and the development and marketing of combination products in the 2000’s have contributed to this growth.

Combination Products are those products that are combinations of devices, biologics or drugs.  The Food and Drug Administration (FDA) has significant information in terms of guidance documents on development and testing of devices, drugs, and biological products, when they are addressed separately.  However, information for combination products to address the technical, scientific, regulatory and quality issues is limited.  Our presentation would focus on strategic aspects of combination product development to ensure successful product development and launch.  These aspects include key activities that need to take place in different product development domains: Innovation, Customer, Functional, Design, Process, and Post-Launch.  We will also focus on quality systems needed to support development of combination products.

For additional reference on Combination Product development and regulatory challenges, please refer to the following book and /or individuals:

 ·        “Combination Products: Regulatory Challenges and Successful Product Development”, ISBN:  9781420064469, CRC Press, 2008,  

Dr. Smita Gopalaswamy, President, Advanced Solutions Consultants, Inc

SPEAKERS:

Dr. Venky Gopalaswamy:

Dr. Venky Gopalaswamy is a Vice President and Business Improvement Services Group Leader at Johnson & Johnson World Headquarters in New Brunswick, NJ.  In his role, he supports Business Strategy, Innovation and Product Development efforts across Johnson & Johnson to enable successful and Innovative Business, product, service or process launch.    In addition, he provides leadership to the corporation on Business Improvement Methodologies such as Six Sigma, Design Excellence (DEx), Lean and Change Management.

     Prior to his current role, Dr. Gopalaswamy was with Cordis Corporation (a Johnson & Johnson company) leading their process technology group and with Ethicon Endo-Surgery Inc. (a Johnson & Johnson company), leading their R&D Quality Engineering, Advanced Quality Systems and Supplier Quality organizations.  Before joining Johnson & Johnson, Dr. Gopalaswamy served in automotive and high-tech industries in both technical and leadership roles to develop safety-critical products and associated manufacturing process technologies.

     Dr. Gopalaswamy is a J&J certified Six Sigma Black Belt and is currently pursuing Master Black Belt certification.  He earned his Ph.D. and MS degrees in Industrial and Systems Engineering from the University of Illinois and his undergraduate degree in Mechanical Engineering from India.  He is also an ASQ Certified CQM/OE, CRE and CQE and is a senior member of ASQ and PDMA.  He has published and presented many papers and has co-authored 3 books:  “Practical Design Control Implementation for Medical Devices”, “From Design Control to Six Sigma for Medical Devices” and “Combination Products: Regulatory Challenges and Successful Product Development”.

Alberto Velez:

Alberto Velez is currently a Director of Quality and Compliance Worldwide (Q&C WW) at Johnson & Johnson.  In this capacity, he works with the Office of Operational Readiness and the R&D community at various Johnson & Johnson operating companies to capitalize on the opportunities in technology convergence.  Alberto has a long track record of introducing disruptive and transformational technologies in Drug Device combination products, Endoscopic surgery, Esophageal Reflux Disease and Enteral Feeding.  He began in R&D pioneering the field of Enteral Feeding, and then moved to QA & Regulatory Affairs to help establish Enteral Feeding as a standard of care.  He later started his own medical device company to develop and market Esophageal Reflux diagnostics devices. In 1991, he joined Ethicon Endo Surgery Inc. (a Johnson & Johnson company) to lead several R&D teams in introducing endoscopic surgical instruments. He joined Q&C WW in 2000 to provide Quality and Compliance support to J&J operating companies across the globe.  In addition to providing compliance support, he also successfully designed and implemented quality systems to support the J&J technology convergence initiatives.

      Alberto Velez is an Industrial and Chemical Engineer by training. His expertise spans many areas including Drug Device Combination New Product Development(NPD) Systems, GXP – Device, Drug, Combinations, Clinical, Laboratory, FDA/HA Readiness Preparation, Design Control & NPD Systems, Risk Management and Risk Analysis, Human Factors Engineering, Mistake Proofing, Validations – Process, Design, Software, Product Characterization, Project Management, Tech Transfer and Quality Engineering.

 SPONSORSHIPS ARE AVAILABLE FOR THIS EVENT

At a cost of $300, sponsorship represents an excellent opportunity to be identified as an industry participant and supporter of New Jersey Chapter's Professional Programming, and is a particularly cost effective means of increasing your firm's visibility to the Chapter membership.

A Table Space for each sponsor to display their company sales literature will be provided in the main room and on display throughout the evening. Table-top and Pull-up displays are acceptable, and sponsors must provide their own easels, if large posters are being used. Your company logo will appear in the Sponsorship Section of all future emails advertising this dual track event. Sponsorship Cost Includes Event Admission for One Person. 

A Special Thank You to our Event Sponsors

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