Team

Manijeh Goldberg, PH.D., M.B.A., M.S.

CHIEF EXECUTIVE OFFICER

Manijeh is the Founder and CEO of Privo. She has over 20 years of experience in the biomedical industry, in large companies and five startups (one was acquired for $475M).  She has developed US Key Opinion Leader (KOL) relationships, successfully lobbied to get PRV111 into a large, NIH-funded clinical study, planned and executed training, and helped drive on-time trial enrollment. Additionally, Manijeh is driving the execution of a second-generation Privo’s products. Her current focus is to conduct clinical trials, get PRV111’s second-generation products through the FDA, and explore initiating a second US clinical trial. Additional responsibilities include business development, general management, and driving the overall success of Privo’s research and products. Manijeh holds a Ph.D. in Biomedical Engineering, an MS in Health Sciences and Technology from Harvard Medical School, an MBA from MIT Sloan School of Management, and an MS in Computer Science and Mathematics.


James Mackay, PH.D

Chief Advisor

Dr. Mackay is the founder, president, and CEO of Aristea Therapeutics, an immunology company focused on developing treatments for orphan diseases. Prior to founding Aristea Therapeutics, Dr. Mackay led the successful $1.2B acquisition and transition of Ardea Biosciences into AstraZeneca. He was President & CEO of Ardea Biosciences from 2013 to 2018. He set up an innovative model for Ardea that retained the biotech’s independence and accountability for the development of the gout franchise while developing a collaborative relationship with the parent company, AstraZeneca. Prior to Ardea Biosciences, Dr. Mackay was Global Product Vice President for Diabetes franchise at AstraZeneca where he played a critical role in the successful development of the AstraZeneca/Bristol-Myers Squibb diabetes alliance. He held a number of senior roles in AstraZeneca’s Clinical Development Function including portfolio management of all AstraZeneca Clinical resources and budget worldwide and management of AstraZeneca’s strategic partnerships with drug development CROs.


Cuthbert Thomas

CONSULTING CFO

Cuthbert (Cutty) is Sr. Manager in Withum’s Boston office and leads their OASyS practice (Outsourced Accounting Systems and Services). Cutty has extensive experience in areas of financial reporting, financial management, financial systems, and operating consulting. He works with C-Suite executives and he is an expert at assisting start-ups through various stages of growth. He is an active member of the Firm’s Life Sciences Services Team. In addition, Cutty provides business valuation, litigation support and consulting services for closely-held businesses. Cutty received his MBA with Finance concentration from Drake University and his B.A in Accounting from Grand View University. He is a licensed Certified Public Accountant, a member of the American Institute of Certified Public Accountants (AICPA) as well as member of Iowa Society of Certified Public Accountants (ISCPA) and Massachusetts Society of Public Accountants (MSCPA). Cutty is also Accredited in Business Valuation (ABV) by the AICPA.

 


Nishant Agrawal, MD

Chief Medical Advisor

Dr. Nishant Agrawal is the director of Head and Neck Surgical Oncology at the University of Chicago Medicine. Dr. Agrawal specializes in the management of patients with benign and malignant tumors of the head and neck. His work has achieved international recognition in the field of head and neck surgical oncology, and head and neck cancer genetics. Prior to joining the University of Chicago, Dr. Agrawal was an associate professor at Johns Hopkins University. Dr. Agrawal’s lab is devoted to the study of the genetics and molecular diagnostics of head and neck cancer. The group has described the genomic landscape of head & neck squamous cell carcinoma, esophageal cancer and medullary thyroid cancer, and has developed assays using tumor DNA as a biomarker in saliva and plasma. His lab’s research is focused on the application of cancer genetics to design diagnostic approaches to reduce morbidity and mortality from head and neck cancer.


Joanna Ward

GMP MANUFACTURING

Over 30 years of experience in CMC strategy and manufacturing oversight across all development phases of biological and pharmaceutical products, ranging from pre-IND to commercial approvals of novel oncology therapies. Joanna holds a BSc in Plant biology from the University of Hull in the UK.

Expert in authoring CMC sections of IND, IMPD, PMDA, CFDA and BLA’s. Responsible for development of complex commercial and clinical supply chains with global logistics, including complex contract negotiations and execution.


Jeff Fellows

Regulatory Affairs

Jeff is a seasoned pharmaceutical industry professional with over 30 years of drug development experience leading regulatory development efforts ranging from pre-IND to post-approval. Experienced in strategic development across numerous product platforms and therapeutic areas covering both North America and Europe with extensive clinical trial application filings and health authority interactions. He has a B.S. in Microbiology from Oregon State University.


Scientific Advisors

Nishant Agrawal, M.D.

Dr. Nishant Agrawal, is the director of Head and Neck Surgical Oncology at the University of Chicago Medicine. Dr. Agrawal specializes in the management of patients with benign and malignant tumors of the head and neck. His work has achieved international recognition in the field of head and neck surgical oncology, and head and neck cancer genetics. Prior to joining the University of Chicago, Dr. Agrawal was an associate professor at Johns Hopkins University.


Board Members

Manijeh Goldberg, PH.D., M.B.A., M.S.

CHAIRMAN OF THE BOARD

Manijeh is the Founder and CEO of Privo. She has over 20 years of experience in the biomedical industry, in large companies and five startups (one was acquired for $475M).  She has developed US Key Opinion Leader (KOL) relationships, successfully lobbied to get PRV111 into a large, NIH-funded clinical study, planned and executed training, and helped drive on-time trial enrollment. Additionally, Manijeh is driving the execution of a second-generation Privo’s products. Her current focus is to conduct clinical trials, get PRV111’s second-generation products through the FDA, and explore initiating a second US clinical trial. Additional responsibilities include business development, general management, and driving the overall success of Privo’s research and products. Manijeh holds a Ph.D. in Biomedical Engineering, an MS in Health Sciences and Technology from Harvard Medical School, an MBA from MIT Sloan School of Management, and an MS in Computer Science and Mathematics.


James Mackay, PH.D

Independent Board Member

Dr. Mackay is the founder, president, and CEO of Aristea Therapeutics, an immunology company focused on developing treatments for orphan diseases. Prior to founding Aristea Therapeutics, Dr. Mackay led the successful $1.2B acquisition and transition of Ardea Biosciences into AstraZeneca. He was President & CEO of Ardea Biosciences from 2013 to 2018. He set up an innovative model for Ardea that retained the biotech’s independence and accountability for the development of the gout franchise while developing a collaborative relationship with the parent company, AstraZeneca. Prior to Ardea Biosciences, Dr. Mackay was Global Product Vice President for Diabetes franchise at AstraZeneca where he played a critical role in the successful development of the AstraZeneca/Bristol-Myers Squibb diabetes alliance. He held a number of senior roles in AstraZeneca’s Clinical Development Function including portfolio management of all AstraZeneca Clinical resources and budget worldwide and management of AstraZeneca’s strategic partnerships with drug development CROs.


Jane Hirsh

Ms. Hirsh was Founder, President, and CEO of Copley Pharmaceutical, Inc., a large, successful generic pharmaceutical company. During her tenure, the Company completed over 80 ANDAs and attained revenues of $160 million prior to its acquisition. In 1993, Hoechst Celanese Corporation, the chemical and drug concern, acquired 51 percent of Copley Pharmaceutical Inc. for $546 million. In 2000, Copley was sold to Teva Pharmaceuticals. Jane is a co-inventor on over 9 patent applications and has over 40 years of experience in the pharmaceutical and related healthcare industries. In 2003, Ms. Hirsh co-founded and served as Chairman of Collegium Pharmaceutical. As a specialty pharmaceutical company, Collegium focused on intellectual property development under jane’s leadership. Onset Therapeutics, a dermatological specialty company, was founded in 2007 as a subsidiary of Collegium and sold to Precision Dermatology in 2010. In addition, Jane has served on the Board of Trustees for Tufts University and the Museum of Science, Boston.  


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