Halloran Consulting Group, a national consultancy guiding life science companies to optimize development and performance, has announced the expansion of its regulatory and development team with the hiring of additional, highly specialized consultants, Iva Toudjarska, Ph.D., MBA, as principal consultant, Amanda Ceres, MS, as senior consultant and Keri Siggers, Ph.D., as consultant II. Earlier this year, Michelle Rose, Ph.D., was hired as principal consultant, to further enhance the company’s ability to deliver regulatory strategies and services.

“As Halloran Consulting Group continues to serve a broader group of clients who need diverse regulatory guidance as well as clinical development leadership, we have sought to enhance the breadth and depth of our team to better meet those demands,” said Laurie Halloran, founder, president and CEO of Halloran. “The combined expertise of these four talented women will immediately support our clients’ needs for the strategic guidance they require in this evolving development environment.”

Toudjarska brings more than 15 years of industry experience to her new role at Halloran. She will enhance the company’s ability to perform in-depth and timely due diligence to inform strategic decision making in portfolio and pipeline rationalization. During her tenure at Putnam Associates, she informed strategic insights and decisions pertaining to new product development, portfolio prioritization, clinical development, and commercial opportunity assessments for large pharma clients. Previously, she was a founding employee at Alnylam Pharmaceuticals, the leader in RNAi therapeutics, where during her nine-year tenure she advanced several programs to the clinic as part of a multi-disciplinary team. Toudjarska earned a doctorate of philosophy from Bulgarian Academy of Sciences in Molecular Genetics and an MBA from F.W. Olin Graduate School of Business at Babson College.

Michelle Rose joined the company in March, bringing more than 17 years of experience in regulatory affairs in the pharmaceutical and biotech industry across all phases of the drug development process from discovery through clinical research to licensing. Michelle has extensive experience with expedited programs for serious conditions including fast-track designation, accelerated approval, breakthrough therapy designations, priority review, as well as unique regulatory pathways including NDA approval under the Animal Efficacy Rule. Michelle previously served as vice president of regulatory affairs for Chimerix, where she built the regulatory affairs and operations functions and led the strategy for and interactions with global regulatory agencies across anti-viral and oncology therapeutic areas.

Her expanded team now includes Amanda Ceres and Keri Siggers, who were brought on board to bolster strategic regulatory services for many of Halloran’s biotechnology and pharmaceutical clients. Ceres and Siggers will work to serve regulatory needs across multiple therapeutic modalities for Halloran’s clients.

With more than 14 years of experience, Ceres has worked closely with the FDA to navigate complex submissions and knowledge of various therapeutic areas including rheumatology, neurology, gastroenterology, and renal. Prior to joining Halloran, Ceres was associate director of regulatory affairs at Celgene where she developed and implemented global regulatory strategy and contingencies for inflammation and immunology programs. She earned a B.S. in biology from Clarkson University and a M.S. in drug regulatory affairs and health policy from Massachusetts College of Pharmacy and Health Sciences.

Siggers’ five years of experience in regulatory affairs and ten years as a bench scientist have provided her with extensive knowledge of therapeutic classes, including gene therapy, RNAi, and small molecules. She has also worked on programs in numerous indications including Parkinson’s disease, multiple sclerosis, adrenoleukodystrophy, liver disease, and hemoglobinopathies. Prior to joining Halloran, Siggers worked in regulatory affairs at Sanofi Genzyme, Alnylam and Bluebird Bio. She earned a doctorate of philosophy in biochemistry from Columbia University and a B.S. in chemistry from the University of California, San Diego.