Linda Nardone Email and Phone Number
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Accomplished senior drug development and operations executive with documented success coordinating drug and biologics development, such as Omnipaque®, Omniscan®, Bexxar®, and Protonix® throughout all regulatory and clinical phases (from early stage investigation and proof of concept to completion of clinical trials, FDA approval, and post-marketing) for pharmaceutical, biotechnology and clinical CRO organizations. I bring an unusual combination of research experience with a practical Operations background and understanding that has enabled me to rapidly develop and introduce new products into the marketplace. Critical areas of expertise include oncology, diagnostic imaging, anti infectives, pain, gastroenterology, cardiology, respiratory, endocrinology, biodefense, and vaccines. Formulation experience includes small and large volume parenterals, orals, inhaled dose forms, creams and ointments.Specialties: • Technology development• Project coordination/management• CRO management• Client/Customer satisfaction• Establish and meet goals• High integrity/high energy• Development throughout life cycle• Monoclonal antibodies
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Chief Regulatory OfficerNanophagix 2015 - PresentNanoparticulate delivery of drugs to target cells
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Vp Chief Regulatory OfficerNanoscan Imaging Llc 2011 - Present
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ConsultantNardone Consulting Sep 2009 - PresentPrincipal• Senior contracted resource roles and projects for small biotechnology and drug entities• Projects have included regulatory and/or clinical strategy and implementation/operations in several therapeutic areas: imaging; cardiovascular; and dermatology
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Global Head Of Regulatory AffairsPierrel Research Aug 2011 - Aug 2014After two years of a senior clinical operations role at Pierrel (running Phase III and Phase I trials), I have stepped into the senior regulatory role at a CRO that is skilled at small to mid-size trials, US and Global. The company is building its regulatory capabilities that are in addition to the regulatory aspects of the conduct of clinical trials.
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Coo And Exec VpEncorium Group, Inc. Nov 2007 - Aug 2009Chief Operating Officer (COO) and Executive Vice President• Managed all deliverables (clinical, data, document, regulatory filings) for 50 clients representing contracts worth $35M in annual revenue.• Led integration activities in clinical operations, data and document management, and information technology
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General ManagerZila, Inc. Oct 2005 - May 2007Fort Collins, Co, UsArizona-based entity whose investigation and marketed products were in the oral cancer detection and treatment and nutriceuticals areas.• General Management of Biotechnology Division.• Regulatory oversight of the life cycle (labeling, marketing) for the Division’s oral cancer device, Vizulite®.• Managed large Phase III SPA trial for a drug for oral cancer detection and preparations for an NDA in CTD format. Activities included overseeing a $25M CRO contract. -
Vice President, Clinical And Regulatory Affairs And QualityElusys Therapeutics, Inc. May 1999 - Oct 2005Parsippany, New Jersey, UsNew Jersey-based technology start-up company whose technology involves monoclonal antibodies and immunoconjugates. Therapeutic focus has been biodefense, anti-infectives, and oncology agents.• First person hired into this start-up biotechnology Company (by Seed One Venture Capitalists).• Overall responsibility for regulatory, clinical, and quality strategy and implementation for the Company’s monoclonal antibody-based platform technology.• Coordinated product development, regulatory and clinical affairs to complete two Phase I clinical trials within three years of the establishment of the Company in its facility in NJ.• Integral participant in all Company financing and government initiatives (Venture Capital, DOD, HHS, NIH). -
Vice President, Scientific AffairsAltana Pharma 1998 - 1999UsLeader in creams and ointments in hospital and office products. Offered a large generic portfolio. Investigational proprietary drugs were in the gastrointestinal and respiratory area.Vice President, Scientific Affairs• Approximately 250 people reported to me in Regulatory Affairs, Clinical Affairs, Quality Assurance and R&D.• Responsible for NDA and ANDA agents and products (drove the development of four proprietary products and 30 generic products).• Built clinical team for managing U.S. clinical trials (Phase I – III).• Scientific representative for Altana in significant licensing deal with Wyeth to guide clinical development plan and marketing/labeling development (Protonix®).• Submitted all US filings for respiratory pipeline agents in phases I, II, and III trials. -
Vice President, Regulatory AffairsCoulter Pharmaceutical, Inc. 1995 - 1998Start-up biotechnology company whose first investigational agent was a monoclonal antibody for an oncology indication (non-Hodgkins lymphoma). The product, Bexxar®, won regulatory approval after the sale to GSK.• Member of initial Corporate Management Team (sixth person in the company reporting directly to CEO. Helped build company from inception (1995) to approximately seventy people at end of 1997.• Helped raise $95M in venture capital financing, initial public offering (IPO), and secondary offering • Created Regulatory Affairs, Quality Assurance, and Project Management functions. Headed Phase I through III regulatory initiative for novel radiolabeled monoclonal antibody.• Set and met regulatory milestones (clinical, manufacturing) underlying all financing.• Managed regulatory component of outsourced manufacturing operation.
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Vp RegulatorySanofi 1990 - 1995
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Vice President, Regulatory AffairsSterling Winthrop, Inc., / Sanofi/Winthrop/Nycomed 1989 - 1995One of top 10 largest pharmaceutical companies in 1989 with marketed and investigational agents in wide variety of therapeutic areas (e.g., cardiovascular, diagnostic imaging, anti-infectives, respiratory, pain) and with proprietary and generic drugs.• Responsible for regulatory operations for investigational and marketed drugs (approximately $600M in U.S. sales). Supervised employees in Regulatory Affairs, Quality Assurance, and Medical Affairs.• Team obtained FDA approvals for two NDAs and submitted a third under my direction.• Reorganized and developed Regulatory Affairs departments Sterling Winthrop Inc. and Nycomed Inc.• Obtained 25-50 FDA supplement approvals per year during 1991, 1992, and 1993 at Sterling Winthrop Inc.• Regulatory interface for three manufacturing plants.• Regulatory Affairs support to in-licensing and new business development.
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Director, - Vice President, Regulatory AffairsImmunomedics 1986 - 1989Morris Plains, New Jersey, UsOne of the first monoclonal antibody-based companies.• Experience with radioactive agents, in vivo diagnostic and therapeutic biologics, and in vitro diagnostics.• Submitted the following initial FDA filings for the company: – Three INDs for in vivo injectables for cancer imaging and therapy. – Three 510(k) s for in vitro diagnostic devices for autoimmune diseases. – Eight orphan drug designations. -
Associate Manager, Clinical Research And Manager - Director, Regulatory AffairsPharmacia, Inc. 1983 - 1986PHARMACIA, INC., Piscataway, NJ 1983 - 1986Employed in Pharmacia Ophthalmics Division.• Initially responsible for clinical research; subsequently transferred to Corporate Regulatory Affairs with increasing responsibilities over time.• Responsible for an eye irrigation solution (investigational), Xalatan® glaucoma drug now approved by FDA, intraocular lenses (investigational) and Healon®, a marketed viscoelastic (Class III implantable).
Linda Nardone Skills
Linda Nardone Education Details
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Penn State UniversityPhysiology -
Penn State UniversityPhysiology
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Fairleigh Dickinson UniversityScience
Frequently Asked Questions about Linda Nardone
What company does Linda Nardone work for?
Linda Nardone works for Nanoscan Imaging Llc
What is Linda Nardone's role at the current company?
Linda Nardone's current role is VP Chief Regulatory Officer at Nanophagix LLC.
What is Linda Nardone's email address?
Linda Nardone's email address is na****@****cox.net
What is Linda Nardone's direct phone number?
Linda Nardone's direct phone number is +197380*****
What schools did Linda Nardone attend?
Linda Nardone attended Penn State University, Penn State University, Fairleigh Dickinson University.
What skills is Linda Nardone known for?
Linda Nardone has skills like Clinical Development, Clinical Trials, Biotechnology, Drug Development, Cro, Fda, Regulatory Affairs, Oncology, Clinical Research, Quality Assurance, Therapeutic Areas, Medical Devices.
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