Halloran - For Your Development

People

Halloran is led by an experienced team of executives and consultants with a diverse and rich background in all stages of product development as well as clinical and regulatory operations. Our team is committed to helping our clients build and execute the most effective and efficient development programs to position their drug or device candidates for success.

Laurie Halloran

Chief Executive Officer and Managing Partner

Laurie HalloranLaurie founded Halloran Consulting Group in 1998. With over 20 years of experience in clinical affairs management with contract research organizations and biotechnology companies, Laurie is recognized as an industry expert in improving the organizational effectiveness of clinical research programs with a specialty in gap analysis and strategic planning. Laurie has executed over 25 clinical trials from Phase 1 to Phase 3 for both emerging and established companies and has managed operational budgets of up to $24 MM. Prior to founding Halloran Consulting Group, Laurie spent 10 years at PAREXEL International where she developed worldwide training capabilities with the clinical operations group. She has also established clinical operations at OXiGENE and Antigenics.

She is an adjunct professor at Boston University Medical School.

Laurie earned a B.S. in nursing from Russell Sage College and a M.S. in management from Leslie University.

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Greg Dombal

Managing Partner

Greg DombalGreg joined Halloran Consulting Group in 2007 as a Managing Partner. He leads Halloran's Regulatory Consulting practice area, which focuses on helping emerging companies navigate the challenges of early product development while establishing appropriate clinical and regulatory structure to drive efficient development. He brings over 15 years of experience in worldwide regulatory affairs, quality assurance and clinical operations. Prior to joining Halloran Consulting, Greg was responsible for the regulatory affairs and quality assurance groups at ArQule as well as directing clinical operations for the oncology portfolio and managing the Company's key strategic alliances in Japan with Kyowa Hakko Kogyo. Prior to joining ArQule, Greg worked in the regulatory affairs groups of PAREXEL International, Antigenics, Genzyme and DepoTech. He has successfully filed multiple clinical trial applications (IND or equivalent), successfully obtained Orphan Drug designation and/or Fast Track designation for six individual products and has had extensive involvement with NDA/MAA submissions resulting in multiple product approvals.

Greg earned a B.S. in biology from the University of North Carolina - Chapel Hill.

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Shaghig Palanjian

Managing Partner

Shaghig PalanjianShaghig joined Halloran Consulting Group in 2007 as a Managing Partner and leads the Organizational Consulting and Quality Management practice areas. She focuses on helping businesses implement the appropriate infrastructure to achieve their development objectives. Shaghig brings 25 years of experience in health information and operational management and has designed, developed and implemented hospital information systems, clinical trial management, data management, electronic data capture (EDC) and safety systems. Prior to joining Halloran Consulting, Shaghig was Vice President of World Wide Technology Implementation at PAREXEL International, where she was responsible for the strategic planning and implementation of products utilized in the conduct of clinical trials. During her 15 year tenure at PAREXEL, Shaghig managed and supported groups delivering services via web-based technologies, including process improvement initiatives for clinical operations and data management associated with EDC, interactive voice response systems, medical imaging, data integration and was also responsible for general organizational management, planning, development, implementation and maintenance of projects.

Shaghig earned a B.S. in health record administration from Northeastern University and a M.B.A. from Regis University. She also holds RHIA accreditation.

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Vicky Hines

Principal Consultant

Vicky joined Halloran Consulting Group in 2010 as Principal Consultant and is working with Halloran’s early-stage clients on strategic planning and program management. She works with project teams to establish objectives and execute individual projects in an efficient, timely manner that are consistent with the corporate objectives. Vicky brings over 20 years of broad experience in strategic planning, portfolio management, and project management for global biopharmaceutical and private equity firms. Her involvement with the development of biologics, small molecules and vaccines provides clients with solutions by viewing problems through a lens that spans basic research thru commercialization. Prior to joining Halloran Consulting, Vicky was Therapeutic Director at Celtic Pharma – a healthcare-focused private equity fund - where she had strategic and operational oversight of oncology and vaccines programs. Leading virtual global project teams, Vicky has a deep understanding of the opportunities and challenges of initiating and managing virtual development teams, making key sourcing decisions and selecting and managing external vendors. Her understanding of the capital funding environment also enables her to assist clients to prepare for due diligence and/or divestment. Vicky worked at Chiron Corporation for 15 years where she held positions in regulatory affairs, toxicology, program management, strategic planning as well as European commercial operations.

Vicky earned a BA in Biology from Carleton College and a Ph.D. in Biochemistry from the University of Chicago.

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Michelle Hylan

Principal Consultant

Michelle joined Halloran Consulting Group in 2007 as a Principal Consultant. She focuses on preparing domestic and international clinical programs for acquisition or alliance and facilitates the integration by effective negotiation, risk mitigation and alignment of operating procedures. In addition, she applies her 13years in the industry, with 9 years of management, to determine gaps in a company's clinical operations resources and develops and implements plans for programs, teams or individual development. Prior to joining Halloran Consulting, Michelle was Associate Director of Clinical Research at Genzyme, acting as the principal clinical and medical liaison between the US headquarters and Genzyme Japan offices, and worked within the changing regulatory environment of Japan on clinical trial design, eCTD regulatory submissions and strategic planning. Prior to working at Genzyme, Michelle was Project Director at Impact DC, a grant funded Emergency department research project of the Children's National Medical Center.

Michelle earned a B.A. from Connecticut College and completed the post baccalaureate premedical program at Wellesley College.

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Laura Araujo

Senior Consultant

Laura joined Halloran Consulting Group in 2008 as Senior Consultant. She focuses on assisting clients with their quality management system implementation, software development validation and training. Laura brings over 20 years of experience in quality assurance, technology management and software development with a focus on the biotechnology and pharmaceuticals industries. Prior to joining Halloran Consulting, Laura was Vice President of Quality at Perceptive Informatics, a subsidiary of PAREXEL International, where she managed quality assurance and computer systems validation as well as corporate quality systems including validation, supplier management, internal audit program, regulatory, patient confidentiality and training. Prior to joining Perceptive, Laura was the Vice President of Quality, Information Technology, Customer Support and Hosting Services at Clinsoft.

Laura earned a B.S. in computer engineering from Southeastern Massachusetts University and a M.Ed, from Cambridge College. She is certified as an auditor and trainer.

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Stephanie Haller

Senior Consultant

Stephanie joined Halloran Consulting Group in 2009 as a Senior Consultant. She brings over 10 years of experience in domestic and global clinical trial conduct and product development strategy. Stephanie has held positions in Basic Science, Quality Control and Clinical Research with responsibility for products in a wide range of therapeutic areas including: cardiology, orthopedics, pain management, hematology, oncology, infectious disease, and neurology. Prior to joining Halloran Consulting, Stephanie was an Associate Director at Genzyme Corporation where she provided senior oversight of clinical operations within the Biosurgery and General divisions, lending expertise not only in developing drugs but also in medical devices, Humanitarian Use Devices (HUDs), and combination products. She has overseen Phase I, safety, and post-marketing; however the majority of her experience is with Phase III, pivotal trials for inclusion in product approval applications (NDA or equivalent). Before joining Genzyme, Stephanie worked in the Cell Biochemistry research laboratory at the Lindsay Kimball Research Institute, New York Blood Center and has held positions at ICON Clinical Research and Muro Pharmaceutical.

Stephanie earned a B.A. from Denison University and completed course work toward B.S. in Experimental Psychology at Villanova University.

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Deepa Elizabeth Oommen

Senior Consultant

Deepa Elizabeth joined Halloran Consulting Group in 2006 as Associate Director. She provides program management for small- and mid-sized biotechnology and pharmaceutical companies leading team to the successful achievement of key milestones. Prior to joining Halloran Consulting, Deepa Elizabeth worked with AstraZeneca-India where she was part of the core team that established the company's Indian clinical research operations. Simultaneously, she was AZ's Asia-Pacific regional trainer for e-clinical systems. In 2005, Deepa Elizabeth was the recipient of AstraZeneca's highest achievement in her field of work. Her career has spanned academics, R&D, training and clinical research.

Deepa Elizabeth earned a B.S. in pharmacy from Bangalore University and a M.S. in pharmacy from Rajiv Ghandi University of Health Sciences.

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Elizabeth Bodi

Senior Consultant

Elizabeth joined Halloran Consulting Group in 2004 as Senior Consultant. Her work focuses on clinical project management and infrastructure development, including establishing standard operating procedures and quality systems, on-site management, monitoring and clinical auditing, data query management, as well as the development and delivery of training courses focused on clinical research management and good clinical practice. Prior to joining Halloran Consulting, Elizabeth worked in the clinical training and compliance group at Antigenics, where she was responsible for the development and implementation of clinical trial management systems, quality assurance and standard operating procedures. Elizabeth has also held roles as a Clinical Research Associate at PAREXEL International, MTRA/AAI and Covance.

Elizabeth is an instructor at Boston College School of Nursing.

She earned a B.S. in cardiopulmonary sciences and a M.S. in applied anatomy and physiology from Boston University.

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Tina Forrister

Senior Consultant

Tina joined Halloran Consulting Group in 2008 as a Senior Consultant. She focuses on the development and delivery of both public training programs and our in-house customized training programs. Tina has 12 years of experience in clinical research expertise ranging from training and development to clinical project management and monitoring. Prior to joining Halloran Consulting, Tina was Senior Trainer at Schering-Plough Corporation, where she developed, delivered and maintained training courses on clinical research and clinical operations with a focus on clinical project management, global clinical research standards and best practices. In addition, Tina served as the primary liaison to Japan on Schering-Plough's international clinical training program, which was designed to support those implementing clinical trials in Japan using global standards. Prior to Schering-Plough, Tina was Clinical Program Manager at Purdue Pharma, where she led and represented clinical operations as a member of the clinical project team for Purdue's top priority program.

Tina earned a B.A. in psychology from the University of Massachusetts at Amherst.

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Su-Bih Hwang

Senior Consultant

Su-Bih joined Halloran Consulting Group in 2009 as a Senior Consultant of Program Management and Clinical Operations. She brings over 30 years of experience in clinical operations, project and program management, medical writing, process development and improvement, quality assurance, and clinical operations. Prior to joining Halloran Consulting, Su-Bih was Director of Clinical Operations at Ipsen, where she had extensive involvement in the NDA and BLA submissions. Before Ipsen, Su-Bih directed the clinical operations, medical writing and clinical quality assurance groups at Muro and Astra USA. At Astra, she was actively involved in several NDA submissions that resulted in product approval by the FDA. Su-Bih also held positions at PAREXEL International, Pennwalt Pharmaceutical Corporation and Norwich-Eaton Pharmaceuticals. She is a registered Pharmacist in the US.

Su-Bih earned a B.S. in Pharmacy from National Taiwan University, a M.S. in Pharmacology from University of Georgia, and a Ph.D. in business administration from Kennedy Western University.

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Desiree Yagovane

Consultant

Desiree joined Halloran Consulting Group in 2008 as a Consultant. Her work focuses on clinical operations and development initiatives for Phase 1 to Phase 3 clinical trials. Prior to joining Halloran Consulting, Desiree was Clinical Project Manager at ArQule where she managed Phase 1 and Phase 3 clinical activities including protocol design, case report form and informed consent development, site selection and vendor management for the oncology program. She also helped develop and implement ArQule's first clinical standard operating procedure program.

Desiree earned a B.S. in biology form Stonehill College and a M.S. from MGH Institute of Health Professions.

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