Meet the Faculty

JOSE SIERRA

Associate Teaching Professor, Associate Director - Cybersecurity and Information Assurance Graduate Program

Education

PhD in Computer Science, Carlos III University of Madrid – Spain
MSc in Computer Science, Málaga University – Spain
MSc in Business Administration, Rey Juan Carlos University – Spain
Applied Cyber Security, MIT Professional Education – Massachusetts Institute of Technology

Bio

Jose Sierra is an Associate Teaching Professor and Associate Director of Information Assurance and Cybersecurity Program at the College of Computer and Information Science. He earned his PhD at Carlos III University in 2000. Jose’s research areas include Authentication and Access control protocols, mobile payments protection, lightweight cryptographic protocols and IoT security. He has a very active publication record, with an important number of conference proceedings and journal papers. During his academic career, he has had the opportunity to research and work at several universities, such as the British Bradford and Westminster, to well-established US ones like UC Berkeley and MIT.

What are the specifics of your educational background?

My education has been focused on Computer Science: in this field I achieved my MSc degree in 1997, joining after that as a Research Assistant the Pontificia de Comillas University in Madrid. Parallel to that, I began my PhD on Internet Security Protocols at the Carlos III University, until 2000 when I obtained my doctoral thesis with honors.

In 2003, in order to complement my technical background, I took a MSc in Business Administration at the Rey Juan Carlos University, culminating it in 2005.

More recently, for personal interests, I was granted two professional certifications in Cyber Security: Certified Information Systems Security Professional (CISSP) and Certified Information Security Manager (CISM)

Research interests

Attribute-based access control
IoT communications protection
Technology innovations in Cyber Threats and Cyber Defenses

Click here to read more about Jose Sierra.

j.sierra@northeastern.edu

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Stephen Amato

Faculty Director of Graduate Regulatory Affairs and Life Sciences, Teaching Professor

Education:

Doctor of Philosophy from Boston College (1997)
Master of Business Administration from Boston College
Bachelor of Arts in Biochemical Sciences from Harvard College

Bio:

Dr. Stephen F. Amato has over 25 years of experience in the pharmaceutical, biotechnology and medical device industries. Prior to his position as Faculty Director of Graduate Regulatory Affairs and Life Sciences at Northeastern University, Steve was the Founder and Managing Director of Life Sciences Advisors, LLC, and also a Managing Director for Cardinal Health Regulatory Sciences.  Additionally, as an Executive with GfK Health, Dr. Amato managed and worked on client global regulatory affairs and reimbursement projects in the areas of market access, pricing, and payer coverage, coding and payment strategy.  Prior to GfK Health, as an Executive Director at Anika Therapeutics, Steve managed all aspects of the company's product portfolio including regulatory, reimbursement, market segmentation, targeting, positioning, pricing and promotional strategies.  From 2000 to 2007, he was the Group Director of Knee Repair at Smith & Nephew Endoscopy where he managed a $140M orthopedic product portfolio. Earlier in his career, Steve worked for Visible Genetics, where he was responsible for developing and launching genomic molecular diagnostics products used for subtyping Human Papilloma Virus (HPV) and other infectious disease agents.  \He has also worked with Critical Therapeutics on the development and commercialization of treatments for gram-negative sepsis.

Steve holds an AB in Biochemical Sciences from Harvard University, a Ph.D. in Molecular and Cellular Biology from Boston College’s Graduate School of Arts and Sciences, and an MBA from the Carroll School of Graduate Management at Boston College.  He has also received the U.S. and EU Regulatory Affairs Certification designations and is a Consultant for the Regulatory Affairs Professional Society.

Professional Experience:

Established global regulatory affairs/market access/HEOR professional whose mission is to lead the development of an efficient and globally competitive U.S. healthcare system based on 20+ years’ of life sciences industry and public service experience; Have consistently demonstrated expert-level proficiency in leading teams in diverse global markets to solve complex regulatory affairs/market access/reimbursement/coding/pricing associated challenges in the medical device/specialty pharmaceutical/combination product/companion dx/rare diseases space; Teams managed have consistent success in direct FDA/CMS/Medicaid/private payer/global regulatory body/payer interactions and negotiations, in securing state Medicaid coverage and in leveraging Type A/B/C FDA meetings; Life sciences industry experience includes leading productive team interactions with EU notified bodies, EMA, and direct collaboration with the Brazilian ANVISA, Japanese Ministry of Health, Labor and Welfare (MHLW) and Chinese FDA, as well as geographically specific payer assessment bodies (NICE, G-BA, IQWiG, HAS, CEPS) resulting in maximal penetration of healthcare products and services into Ex-US markets; am skilled in building alliances with diverse healthcare market stakeholders, including NGO’s, VC's and angel investors to raise capital, and in leading the evaluation, development & execution of global biomedical product regulatory and market access strategies; Healthcare product and associated services launches I have managed or supported in orthopedics/rare diseases/biologics/women’s health/oncology/infectious disease/molecular dx/biomarker spaces have generated over $7.75B in global revenue in inpatient/outpatient/home healthcare environments.

Member of RAPS, ISPOR, UPCEA, ACHE, DIA, MassMedic, MassBio, Boston Chamber of Commerce, Airplane Owners & Pilots Association (AOPA)

Click here to read more about Stephen Amato.

s.amato@northeastern.edu

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Mary Ludden

Assistant Teaching Professor

Education:

PhD from Walden University (2016)
Masters of Business Administration from Husson University
Bachelors of Science in Accounting from the University of Southern Maine

Bio:

Mary Ludden is an assistant teaching professor in the Master of Science in Project Management Program. She previously served as adjunct faculty in the MBA program at Southern New Hampshire University.

Prior to joining Northeastern, Dr. Ludden served as Vice President and Chief Operating Officer of National Government Services, a wholly owned subsidiary of Anthem, Inc. Dr. Ludden was responsible for a portfolio of programs and projects in excess of $450 million of annual operating revenue generated from government contracts consisting of both health information technology programs and business process programs. Dr. Ludden brings a breadth of expertise to her students, including project management, performance measurement, data analytics, information technology, and strategic planning. She is a frequent invited speaker on these subjects.

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Click here to read more about Mary Ludden.

m.ludden@northeastern.edu

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