Tim Axtelle Email and Phone Number
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Senior therapeutic development leader with extensive experience in clinical, regulatory and cross-functional management•Leadership of cross-functional therapeutic development programs for infectious disease, oncology, neurology, urology and autoimmune indications. •Led 4 biotech companies to submit their first IND/initiate first clinical trial•Led 11 successful IND/CTA efforts•Global lead to successfully license once daily tadalafil (Cialis™) worldwide •Executive experience in research, clinical operations, regulatory affairs, quality assurance•Experience in development of antibodies, small molecules, antibody-drug conjugates, engineered proteins, peptides, oligonucleotides and natural products•Experience in all phases of drug development from Pre-IND through post-marketing •Proactive approach to risk management, personnel management•Positive and motivational management style; optimistic outlook and "can do" approach
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Sr. Director, Regulatory Affairs, Clinical OperationsSystimmune Jan 2017 - PresentRedmond, Washington, Us
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Sr. Director, Head Of Preclinical DevelopmentZymeworks Inc. Dec 2014 - Jul 2016Vancouver, Bc, Ca -
Sr. Director - Program ManagementCocrystal Discovery, Inc. Mar 2012 - Dec 2014➢ Program management and leadership of preclinical, clinical and regulatory development for antiviral therapeutics➢ Management of government sponsored research➢ Management of interactions with prospective overseas investors
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Sr. Director, ClinicalAvi Biopharma Sep 2010 - Nov 2012➢ Leadership of clinical operations for 3 clinical stage antiviral programs (Hepatitis C, Influenza, Rhinovirus)➢ Led initiation/completion of 3 first-in-man clinical trials for antiviral treatments for Ebola virus, Marburg virus and influenza➢ Recruited and managed experienced clinical development and biometrics team ➢ Managed clinical budgets and reporting for federally funded antiviral programs
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Vice President - Product DevelopmentAllozyne, Inc. May 2009 - Jun 2010➢ Leadership of clinical stage product development; management of all clinical and regulatory functions ➢ Led initiation and completion of the company’s first 2 clinical trials for multiple sclerosis in US and Europe➢ Prepared and delivered product development presentations to company Board of Directors
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Vice President - Research And DevelopmentImplicit Bioscience Mar 2007 - May 2009Woolloongabba, Queensland, Au➢ Leadership of preclinical and clinical stage research and development activities in US, Europe and Australia➢ Led completion of the company’s first 3 clinical trials (Phase I, Phase II) for infectious disease (Hepatitis C, Burkholderia infection)➢ Principal Investigator of $18 million contract for medical countermeasure development from the US Department of Defense➢ Led effort to identify and evaluate Phase II clinical stage development program for in-license➢ Led one of the first Pre-IND meetings to negotiate plans for development and approval under FDA’s Animal Rule➢ Negotiated with FDA regarding standards for clinical efficacy in hepatitis C➢ Prepared and delivered technical presentations to private investors ➢ Invited speaker at multiple joint Industry/Department of Defense symposiums and workshops -
Director, Therapeutic DevelopmentIcos Corporation Aug 1992 - Jan 2007➢ Executive management of 4 different product development programs as Product Development Team Leader➢ Led multiple biologic, small molecule and natural product development teams from discovery, pre-IND, IND through clinical safety and efficacy trials➢ Led ICOS-Eli Lilly partnership to develop and license once daily Cialis worldwide➢ Invited speaker at multiple international infectious disease medical congresses➢ Represented development programs to executive management, Board of Directors, key opinion leaders, investors and analysts➢ Led initiation and completion of over 15 Phase I, II and III and IV clinical trials➢ Led effort to file multiple authorizations for investigational use to regulatory authorities in US, Europe, Australia and Africa.
Tim Axtelle Skills
Tim Axtelle Education Details
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University Of Iowa
Frequently Asked Questions about Tim Axtelle
What company does Tim Axtelle work for?
Tim Axtelle works for Systimmune
What is Tim Axtelle's role at the current company?
Tim Axtelle's current role is Cross functional clinical and preclinical therapeutic development.
What is Tim Axtelle's email address?
Tim Axtelle's email address is ti****@****lle.com
What schools did Tim Axtelle attend?
Tim Axtelle attended University Of Iowa.
What are some of Tim Axtelle's interests?
Tim Axtelle has interest in Luthiery, Guitar, Weightlifting, Triathlon, Audio Electronics Design, Php, Tennis, Html, European History And Languages.
What skills is Tim Axtelle known for?
Tim Axtelle has skills like Clinical Development, Biotechnology, Lifesciences, Technology Transfer, Cro, Pharmaceutical Industry, Clinical Trials, Drug Discovery, Monoclonal Antibodies, Clinical Research, Ctms, Immunology.
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