Shabbir Anik is an experienced executive in the biotech, pharmaceutical and contract services industry, with expertise in drug development, drug delivery, pharmaceutical technology, operations management, and business leadership. He is currently Sr. VP, Technical Operations at Amgen. He has held several senior management positions including VP, Program Management at Syntex, President, Pharmaceutical Development Services at Patheon, and CEO, Althea Technologies.
Dr. Anik has been credited with 5 issued patents, several research articles, holds a bachelor of Pharmacy, and Ph.D. in Pharmaceutical Sciences from the University of Bombay’s Institute of Chemical Technology and University of Wisconsin. In addition, Dr. Anik holds an MBA from Santa Clara University.
Siva Samy is responsible for overall management of the company as well as guiding product strategy for ValGenesis. Previously, Dr. Samy held several technical and management positions at different Biotech, Pharmaceuticals and Medical Devices companies in the Validation and IT areas. Dr. Samy has been credited with over 15 research articles, holds a Master degree in Analytical Chemistry, PhD in Medical Devices and Post-Doctoral in the area of Process Automation from University of Madras and University of Toronto.
As Vice President of Sales for ValGenesis, Narayan Raj is responsible managing ValGenesis’s worldwide Sales, Partnerships, and Lead Generation. Mr. Raj drives the company’s sales strategies including new customer acquisition and expansion with existing customers. Mr. Raj has extensive sales experience with the software solutions for regulated life science companies. He has held several sales management positions including Sr. Director Industry Solution at Pilgrim Quality Solutions and Director of Pre sales at Infor.
As Vice President of Professional Services of ValGenesis, Robert Van Der Laan is responsible for managing ValGenesis’s Implementation and Professional Services across globally. Mr. Van Der Laan has over 15 years of experience identifying and solving customer information system needs, the last eight years in leadership positions in enterprise system software companies. Driving customer satisfaction with the successful implementation of on-premise and cloud-based systems that provide tangible benefits in terms of lower costs, improved usability and enhanced business intelligence. He has held several sales management positions including VP of Professional Services at Pilgrim Quality Solutions and Client Business Executive at Click Software.
As Director of Support and Product Management at ValGenesis, Emmanuel Cansino is responsible for overseeing the client support and product management processes. Mr. Cansino has over 13 years of experience in information technology and application development. Mr. Cansino has a proven track record of providing timely solutions to clients and translating business requirements to application enhancements. Over the past 10 years, Mr. Cansino has played a key leadership role at ValGenesis with significant involvement in the evolution of the ValGenesis system.
Ajaz Hussain, PhD – Former Deputy Director Office of Pharmaceutical Science, FDA
Dr. Hussain is a distinguished contributor and acknowledged leader in the advancement of pharmaceutical and regulatory science and drug development. During Dr. Hussain’s tenure at FDA as Deputy Director Office of Pharmaceutical Science, he has held a critical role for FDA’s Process Analytical Technology (PAT) Initiative and CGMP’s for the 21st Century. FDA lead for Quality ICH negotiations and for the establishment of ICH initiative on Pharmaceutical Quality for the 21st Century (ICH Q8, Q9 and Q10). He is currently a Founder and Principle at Insight, Advice & Solutions, LLC. He has held several senior management positions including CSO & President Biotechnology, Wockhardt, Chief Scientific Officer, Philip Morris International, VP & Global Head Biopharmaceutical Development, Sandoz and Associate Professor of Pharmaceutics, University of Cincinnati – College of Pharmacy.
As the Vice President of Quality, Pradeep is responsible for nurturing quality across all phases of ValGenesis Product development, implementation, support and continual improvement. Pradeep has worked in diverse areas of Product development, Quality systems, Computer System Validation, Process engineering, tool automation and Support functions both in IT and in the Manufacturing industries. He has a deep understanding of the Life Science domain and has supported the pharma clients in optimizing & validating their disparate systems, through process design and computerization.
His extensive knowledge in implementation of complex business processes, models with controls at an Enterprise level, results in continual improvement & effective risk governance. He has lead and supported many global life science clients to optimize their processes and to build stronger solutions using LEAN & Six Sigma methods to reduce their cost and improve compliance.
Prior to ValGenesis, Pradeep had been associated with Navitas Lifesciences and Cognizant Technologies providing solutions and support for the top pharma organizations like AstraZeneca, Abbott Laboratories, Pfizer, GSK, Cipla in the areas of safety, quality, security, CSV, operations, customer support, clinical and regulatory.
Ivan Soto is the Director Client Engagement and Product Strategy, he is responsible for managing the product life cycle, strategy and overall client experience. Ivan Soto has been in the industry for over 20 years, and held several technical and management positions at different Pharmaceuticals companies in the areas of Validation, IT Compliance, Quality Control and Quality Assurance. In his previous role under his leadership, his team successfully implemented a lean validation program. He is an active speaker at conferences related to validation cost reduction and efficiency improvements. He is also a contributing editor for the Journal of GxP Compliance and Validation Technology. He has a (B.S) in Chemistry from the Catholic University of Puerto Rico.
We knew that by starting with electronic validation for enterprise process-related software. We were tackling the tough part first in a phased implementaion said Larry Lindberg. Varian’s Manager of IT Validation, Planning, Procurement, Security and Data Privacy
We had evaluated various options to manage our validation process electronically and valgenesis was a clear choice for Shire based on the process and functions that are pre-built into the solution said