Octagon's Regulatory Experts
Nancy Smerkanich
Vice President, Regulatory Affairs
Nancy Smerkanich has over 24 years of Regulatory Affairs experience, including 9 years at Merck, 7 years as an independent consultant and 7 years at Octagon Research Solutions, Inc. Nancy specializes in assisting clients to develop successful regulatory submission strategies with a focus on electronic submissions. She is a member of DIA and co-chair of the eCTD subgroup under the DIA Electronic Regulatory Submissions SIAC. She received DIA's Outstanding Service Award in 2004 and was selected as one of the industry's most influential thought leaders in the PharmaVOICE 100 for 2005. She was also a finalist in the ‘Best Entrepreneur – Service Businesses’ category in The 3rd Annual Stevie Awards for Women in Business.
Katie Russo
Project Manager, Regulatory Affairs
Katie has been with Octagon for 8 years and in that time she has contributed to numerous initial NDA, IND and DMF submissions as well as lifecycle management of those applications in both regulatory operations and regulatory affairs roles. While Katie specializes in eCTD submissions, she has also worked on applications submitted as paper, eNDAs and eNDA/CTD hybrids. Katie also supports Octagon’s SPL team and internal training initiatives. In addition to her role as a regulatory affairs consultant, Katie has significant practical knowledge of document processes, submission management issues as well as supporting technologies.
Ken Westervelt
Senior Regulatory Project Manager, Regulatory Affairs
Ken has been with Octagon for nearly 4 years as a Regulatory Affairs professional. He has 8 years of pharmaceutical experience, 6 years with Wyeth and 2 years with Merck. Ken also has 4 years of experience in FDA related food industry. His specializes in CMC (Chemistry, Manufacturing and Controls) documentation including stability, facilities, equipment, and validation. Ken has participated in approximately 25 electronic regulatory submissions. He is a member of DIA and holds an M.S. in Regulatory Affairs/Quality Assurance from Temple University.
Patrick Thomas
Associate Director, Regulatory Affairs
Patrick has 12 years of pharmaceutical industry experience spanning Regulatory Affairs and Regulatory Operations. At Octagon, he specializes in electronic submissions with particular emphasis on eCTD and SPL initiatives. In addition to his work with electronic submissions, Patrick serves as a Regulatory Agent for clients. He has participated in numerous initial NDA, BLA and IND submissions (in paper, eNDA/eBLA and eCTD format) as well as lifecycle management of those applications. Patrick is a member of DIA, RAPS, and the HL7 SPL Working Group. Patrick holds an M.S. in Regulatory Affairs/Quality Assurance from Temple University.
Jann Kochel
Associate Director, Regulatory Affairs
Jann has been with Octagon for 7 years and began her career at Octagon as a Senior Regulatory Project Manager. Jann has 20 years of pharmaceutical industry experience, which includes 6 years at AstraZeneca LP, 5 years with Sanofi Winthrop, Inc., and 2 years with Ages Laboratories. Jann has been involved in numerous eCTD/paper regulatory applications, as well as provides U.S. Agent services for clients. She has been a member of DIA since 2004.
Mark Turner
Managing Director, European Operations
Mark Turner has over 14 years of Regulatory Affairs experience from compilation of MAA's for NCE's and generics, maintenance of Centralized MAA's and Mutual Recognition licensing to project management of manufacturing compliance and technical transfer processes in the EU. In addition, Mark has 4 years of experience dealing with Central Eastern Europe, S.E. Asia/Australia/Middle East Africa and S. America territories and regulatory/manufacturing QA requirements. Mark is a member of The Organisation for Professionals in Regulatory Affairs (TOPRA).
Jessica Pung
Associate, Regulatory Affairs
Jessica has been with Octagon for over 4 years. She is responsible for conducting regulatory document reviews, CRFs, CRTs, CMC and clinical/non-clinical study reports. While at Octagon, Jessica has participated in processing, coordinating and reviewing of submissions including: Amendments, INDs, NDAs, eBLAs, eCTDs, NDA/eCTD Hybrid and Canada eCTD NDS. She also maintains and updates Octagon's internal compliance checks as new regulations become effective and has provided submission regulatory support to various clients. She also has significant practical knowledge of FDA Electronic Submissions Gateway production system. Jessica holds a B.S. in Biochemistry and a Quality Assurance/Regulatory Affairs Drug Development Certificate from Temple University.
Christopher Gutowski
Regulatory Project Manager
Christopher has been with Octagon for nearly 4 years. He is responsible for conducting regulatory reviews for CRFs, CRTs and CMC documents, labeling and study reports. Christopher is also responsible for ensuring that submissions adhere to ICH and FDA guidelines. While at Octagon, he has obtained experience with NDA/eCTD hybrid submissions, eNDA and amendments, eBLA, and INDs. Christopher holds a B.A. in Biological Science from the University of Delaware.
Robert Widergren
Regulatory Project Manager
Robert has been with Octagon for over 4 years. While at Octagon, Robert was a consultant in Process Solutions before he moved into Regulatory Affairs. Robert has 6 years of pharmaceutical industry experience. His submission experience includes eCTD (both IND and NDA), eNDA/CTD hybrids and SPL initiatives. Robert has significant practical knowledge of document and submission processes, as well as supporting technologies. Robert is also a member of DIA and RAPS.
Mandy Martino
Regulatory Project Manager
Mandy, a member of DIA and RAPS, has over 8 years of pharmaceutical industry experience across Quality Assurance and Regulatory Affairs. Her submission experience includes preparing and compiling NDA, BLA and IND submissions in paper and eCTD format as well as lifecycle management of those applications. Mandy has significant practical knowledge of document processes, submission management issues as well as supporting technologies.
Rohit Malhotra
Director, European Regulatory Operations and Affairs
Rohit has been at Octagon for nearly 3 years and has been in the Pharmaceutical Industry for over 17 years. Spending over 7 years at the UK Regulatory Agency the then named MCA (now MHRA) and over 6 years at Johnson and Johnson Pharmaceutical Research and Development within the Global Regulatory Operations Group. Rohit has participated in numerous initial MAA submissions in Europe within the Centralised, Decentralised and Mutual Recognition Procedures as well as lifecycle management of these applications. He also has experience with submissions to South East Asia, Latin America, Australia and Switzerland. Rohit is a member of DIA and TOPRA and is on the Steering Group for the TOPRA Special Interest Group for e-Regulatory Affairs. Rohit holds an BSc. in Applied Chemistry from the University of Portsmouth and a MBA from the University of Westminster, London.
Jim has 17 years of pharmaceutical industry experience specializing in Neurology & Anti-infectives. He has participated in over 100 submissions and is a member of DIA and RAPS.
Jim has been the recipient of several awards, including:
- Ernst & Young (2002) - Nominated for Life Sciences Achievement & CEO under 40, Finalist for Start up Company of the Year
- Ernst & Young (2003) - Ernst & Young Entrepreneur of the Year Award in Emerging Company Category
- 2003 High Tech Pioneer Award (Hale and Dorr & KPMG)
- 2003 Deloitte and Touche Fast 50 Rising Star
- #10 on the Philly 100
- Finalist for CEO Under 40
- Finalist in American Business Award for Best Company
- Nominated for Enterprise Awards categories: CEO under 40, Life Sciences Achievement Award, Life Sciences Technology (nominated by customer)
- Accepted and attended CEO Academy run by Mayer Leadership Group
- 2004 Deloitte and Touche Fast 500 and Fast 50
- 2003 & 2004 Philadelphia 100
- 2004 nominated one of Philadelphia Business Journal's 40 under 40
- 2004 Entrepreneur Magazine Hot 100
- 2006 American Business Award, Winner - Most Innovative Company
- 2006 American Business Award, Finalist - Best Executive
- 2007 Deloitte and Touche Technology Fast 50 and Fast 500
- 2007 Philadelphia 100 Hall of Fame
- 2007 Inc. 5,000
- Finalist in the 2008 American Business Awards for Best Chairman
- 2008 Inc. 5000 List
- 2008 Deloitte Technology Fast 50 and 5000 List
