Medical Director or Sr. Director
Content
CURRICULUM VITAE Curriculum Vitae _SARAH __E. STANTON, M.D., MSEE_ West Coast Address: 2 Acorn, Irvine, CA 92604 East Coast Address: 19 Thomas Street, Rockville, MD 20850 (858) 663-5791 email: [email protected] PHARMACEUTICAL & BIOTECH EXPERIENCE MEDIMMUNE, Gaithersburg, MD a" Full Time Employment GLOBAL SAFETY OFFICER/MEDICAL DIRECTOR, December 2009 a" Present _ACTING THERAPEUTIC AREA HEAD: ONCOLOGY & IMMUNOLOGY (MULTIPLE ONCOLOGY BIOLOGICS)_ * Review and edit First Time in Humans (FTIH), Phase 1 through 3 clinical Protocols, Informed Consent Forms and Investigation Brochures with focus on safety. * Provide safety support regarding protocol design and changes/updates in clinical trial protocols using monoclonal antibodies and immunogenic compounds that target cellular pathways for the purpose of inhibiting/stopping the development of multiplication and metastasis of cancer cells. * Author the developmental Risk Management Plans (dRMPas) and other internal technical documents for all Oncology compounds. * Oversee the medical assessment of Individual Case Safety Reports (ICSRas) and training of staff on this task. * Respond to regulatory agency (FDA, PMDA, Irish Medical Board, EMEA) inquiries for all phases of clinical trials and postmarketing products. * Serve on teams that develop toxicology studies, determine clinical trial indications and design the associated preclinical protocols with focus on safety matters * Review and edit documents prepared for publication (abstracts, posters, journal articles, etc.) *
Review and edit IMPDs (clinical section regarding safety and risk management) * Author Integrative Product Development Plans, in particular, the sections on Drug Safety and Risk Management for each Oncology investigational compound * Developed a method that allows intelligent forecasting of safety signals in oncology biologics, as well as other investigational and postmarketed compounds * Serve as an active participating member on the clinical and preclinical trial design teams for new investigational products * Serve as an active contributing member on the teams that assess and plan how to manage dose limiting toxicities that occur in phase I through III clinical trials _THERAPEUTIC AREA: INFECTIOUS DISEASE & ALLERGY/IMMUNOLOGY (RSV PROPHYLAXIS)_ Responsibilities include serving as the Patient Safety Lead on the MedImmune team that went before the FDA Advisory Committee. This assignment included * Worked closely with the Clinical, Regulatory, Research, Product Development and Statistic team leaders in preparing for this meeting. * Assessed the safety profile of existing monoclonal antibodies, in particular Synagis, and compared them to Motavizumab, the product under consideration for FDA approval for prophylactic treatment of RSV in compromised infants and toddlers. * Prepared questions and answers related to Safety concerns that could be, and were actually asked by the FDA advisory committee. * Prepared Safety slides for the presentation, as well as backup slides to be used during the FDA Advisory Committee meeting as visual aids to answer Safety-related questions. * Trained with professional consultants, as a team, in preparation for responding to difficult questions/issues that could be addressed at the FDA meeting. Significant unique accomplishments consist of: *
Serving as the Patient Safety Lead on the MedImmune team that went before the FDA Advisory Committee within a few months of joining this company. * Development of a process for intelligent prediction of safety signals that could be caused by new compounds that are currently under consideration for FTIH clinical trials. * Characterized Hypersensitivity that occurs with the use of monoclonal antibodies * Oncology Expert for 7 Investigational Compounds at MedImmune in Patient Safety ALLERGAN, Irvine, CA a" Full Time Employment GLOBAL SAFETY OFFICER/MEDICAL DIRECTOR, March 2008 a" September 2009 _THERAPEUTIC AREA: NEUROLOGY & OPHTHALMOLOGY_ Responsibilities include participation in all aspects of pharmacovigilance and risk management activities for assigned products, both Postmarketed and in Early Development. This assignment includes * Overseeing all postmarketing safety issues as the Global Safety Officer for Allergan products including Botox and Botox Cosmetic which have more than 20 indications in 80 countries, and other urologic and ophthalmic products. * Oversee safety issues as the Global Safety Officer for Early Development of Botox for new indications (Migraines, Hyperhidrosis, Pain Disorders) and Gatifloxacin Ophthalmic (Neonates, High Dose) * Medical analysis and decision making regarding postmarketing safety matters in the development and maintenance of the Company Core (Safety) Data Sheet for each assigned product. * Performing ad hoc aggregate analysis and safety reports. * Responding to field alert reports. * Development and review of the Periodic Safety Update Reports (PSURas) * Participation in the editing and review of the Risk Management Plans (RMPas) and Risk Evaluation and Mitigation Strategy (REMS) reports.
* Medical assessment of Individual Case Safety Reports (ICSRas) and training of staff on this task. * Responding to regulatory agency inquiries. * Safety liaison to GSK Japan and China focusing on postmarketing safety including responses to regulatory agencies, as part of Allerganas commitment through a Safety Data Exchange Agreement (SDEA) for Botox. Significant unique accomplishments consist of: * Development of a new signal detection automated system using the PRR disproportionality signal detection method to monitor unusual adverse events for all Allergan products. * Designing and development of an improved standardized method for performing medical analyses on each product so that comparisons on safety issues from year-to-year can easily be done between products without compromising individual results. * Restructuring of the itinerary for running the Global Safety Officer biweekly morning reports in which safety concerns are discussed for each product. * Improvement of working relationships between R&D clinical teams and the postmarketing safety group. * Improvement of the format used in medically assessing each individual case safety report (ICSR) in order that this information can be transferred directly into the Periodic Safety Update Reports (PSURas) as needed. * During a transitional period of six months, functioned as the only full-time Global Safety Officer in the United States without missing any deadlines. * Received an Excellence Award for Botox Analysis that ruled out any relationship between the use of this product and the development of QT Prolongation. * Received an Excellence Award for development of a Signal Detection Program for the company. ABBOTT VASCULAR, Santa Clara, CA a" _Consulting Assignment_ MEDICAL CONSULTANT AND WRITER, November 2007 a" February 2008
_THERAPEUTIC AREA:_ _CARDIOLOGY_ Responsibilities include writing and editing reports and documents on Drug-eluting Stent research and clinical trials. * Primary author of Interventional Cardiology book chapter on cardiovascular stents (i) beginning with review of coronary artery disease (CAD), (ii) Signs/symptoms of CAD, history and development of cardiovascular stents, (iii) risks versus benefits of using CV stents, (iv) discussion on the different types of drug-eluding stents, (v) introduction on state-of-the-art CV stents including newer designs of Drug-eluting stents and Biodegradable stents * Provided a comprehensive outline of publicized Cardiovascular Stent Clinical Trials for review and inclusion in Interventional Cardiology Text THE SCRIPPS RESEARCH INSTITUTE, La Jolla, CA _Postdoctorate Fellow_, July 2002 a" February 2005 _THERAPEUTIC AREA:_ _ONCOLOGY and in Microbiology and Immunology, the identification of gene targets that could be blocked and prevent infection and harm to humans when exposed to Anthrax and other like aggressive bacteria._ BIOTECH EXECUTIVE NETWORK CONSULTANTS, Los Angeles CA a" _Consulting Assignment_ SENIOR PARTNER AND PRACTICE LEADER, November 2001 a" July 2002 _AREA OF EXPERTISE: BIOTECH BUSINESS DEVELOPMENT_ Primary responsibilities included business development in the establishment of new clients, especially in the Healthcare and High Technology Industries. - _Major accomplishments included assisting executives of small companies in developing ideas and protocols for new products, as well as recruit the right people to help them get the job done._ CLINICAL EXPERIENCE MOBILE PHYSICIAN SERVICES/HOME PHYSICIANS MEDICAL GROUP, San Diego, CA PRIMARY CARE PHYSICIAN, July 2006 a" Present (Part time during employment with Allergan in particular * Developing integrative health protocols for a number of disease processes. * Researched and authored disease management protocols for health care facilities.
* Leading team to transition a Native American Indian reservation hospital from a US Government operated facility to a privately operated hospital * Developed cost effective Medical Protocols for outpatient patient treatment programs affiliated with the hospital. * Designed an electronic cardiac device. _Major accomplishment included all the above responsibilities._ NONTECHNICAL BUSINESS EXPERIENCE AMABILESTRINGS.COM, San Diego, CA _FOUNDER OF THIS COMPANY February 2005 a" June 2006 (Full-time) AmabileStrings.com is a small business founded for the purpose of raising money to fund orphanages in third world countries that provide a home environment for children who would otherwise be on the streets without any parental guidance. The source of income is from music composed by me, and possibly other composers, which is then licensed to orchestras and film companies for performance or film scores. This has been a part-time business, except for February 2005 through June 2006. - _Major accomplishments included (i) setting up a small business, (ii) writing business plans, (iii) understanding and developing budgets and expense reports, and (iv) fundraising._ ENGINEERING & PHYSICS PROFESSIONAL EXPERIENCE PARSONS CORPORATION, Pasadena, CA _SENIOR TECHNICAL MANAGEMENT CONSULTANT_, August 1998 a" February 1999 Under U.S. Government sponsorship lead the team that assessed the safety and operation of a new Chemical Weapons Destruction Facility (CWDF) to be built in cooperation with the Russian Federation in Russia. Primary responsibilities included _(i) _serving as a systems coordinator for the CWDF for both engineering and management, _(ii) _developing the system description for this facility and performed Safety Analysis checks on plant design_, (iii) _participating in technical meetings with the lead Russian scientists in Moscow, Russia regarding business and engineering issues,_ (iv) _recommending design modifications to significantly improve the human and environmental safety_ _of the facility, and_ (v)_ educating executive management regarding system operations and health concerns involving the plant design. _Major accomplishments included system description for chemical weapons destruction facility in Russia and identifying major health and safety concerns in building and operating this facility and ways to reduce the safety concerns._ IBM CORPORATION, Burlington, VT _SENIOR MEMBER OF TECHNICAL STAFF/MANAGER_, April 1980 a" March 1988
Primary responsibilities included the assessment of IBMas ability to perform Semiconductor Failure Analysis (SCFA) on semiconductor computer chips after mass manufacturing of these devices. Researching new technologies to support the implementation of a SCFA program over five years. _Major accomplishments included (i) Developed a patent on a direct memory access controller that communicated with a network of microprocessors. (ii) Designed 32-bit semiconductor memory chips for large-frame computer systems. (iii) Authored a corporate report on the role of SCFA within the IBM Corporation. (iv) Developed an enterprise-wide study to determine IBMas ability to adequately perform SCFA at all IBM facilities once a product has been mass reproduced. (v) Designed and taught advanced applied semiconductor device physics courses to professional IBM engineers. (vi) Designed and taught courses on the assessment of computer semiconductor device mathematical models used in the CAD system to simulate the operation and function of semiconductor computer chips. (vi) Taught professional IBM engineers how to develop and improve current CAD modeling techniques and (vii) taught professional IBM engineers how to research and develop new ideas related to computer device design._ AT an In-house publication for Medical Students studying for Pathology section of Medical Boards, part II. * Stanton, S. (1986). Semiconductor Device Physics and Device Modeling Lecture Series at IBM. * Stanton, S. (1982). 8N Computer System Direct Memory Access Controller. United States Patent Disclosure. * Stanton, S. (1981). Evaluation of Semiconductor Failure Analysis Within the IBM Corporation; Management and Research. IBM Confidential Corporate Publication. * Stanton, S., (1978). High Speed Digital Oscillators For Fiber Optic Signal Transmission, Bell Telephone Laboratories Confidential Research Publication; Holmdel, New Jersey. * Lord, Stanton, S., et al. (1978). Second Order Dipole Phenomena of Liquid Crystals At Low Temperatures. Journal of Theoretical Physics. PRESENTATIONS * Shingles-Diagnosis and Treatment, Sunrise LaCosta Senior Living Center 2008 * Immunofluorescence of Epithelial Cancer Cells, The Scripps Research Institute 2004 * Cytohesine 4, A Gene Target to Ward Off Anthrax Infections?, The
Scripps Research Institute 2004 * Anthrax, The Medicine and Immunology Behind This Bacteria, The Scripps Research Institute 2004 * Hormone Imbalance in Women, Huntington Hospital, Pasadena, CA 1997 * Obesity and Weight Loss, Huntington Hospital, Pasadena, CA 1997 * Endocrinology for Women, Orange County, CA 1997 * Taught a four-course series on the physics of computers, beginning with the basic classical physics models through quantum physics and numerical analysis modeling of semiconductor devices and computer architecture design. IBM, Essex Junction, VT 1982 a" 1986 * Presentation on a process for intelligent prediction of safety signals that could be caused by new compounds that are currently under consideration for FTIH clinical trials. MedImmune, Gaithersburg, MD. ACADEMIC BACKGROUND Post Doctorate Onc/Immunology The Scripps Research Institute, San Diego, CA (2005) Residency LA County & USC Medical Center, Los Angeles, CA (1995) M.D. Penn State University-College of Medicine, Hershey, PA (1993) MSEE Cornell University, Ithaca, New York (1978) BS in Electrical Engr. & BS in Physics Drexel University, Philadelphia, PA (1977) 7
Review and edit IMPDs (clinical section regarding safety and risk management) * Author Integrative Product Development Plans, in particular, the sections on Drug Safety and Risk Management for each Oncology investigational compound * Developed a method that allows intelligent forecasting of safety signals in oncology biologics, as well as other investigational and postmarketed compounds * Serve as an active participating member on the clinical and preclinical trial design teams for new investigational products * Serve as an active contributing member on the teams that assess and plan how to manage dose limiting toxicities that occur in phase I through III clinical trials _THERAPEUTIC AREA: INFECTIOUS DISEASE & ALLERGY/IMMUNOLOGY (RSV PROPHYLAXIS)_ Responsibilities include serving as the Patient Safety Lead on the MedImmune team that went before the FDA Advisory Committee. This assignment included * Worked closely with the Clinical, Regulatory, Research, Product Development and Statistic team leaders in preparing for this meeting. * Assessed the safety profile of existing monoclonal antibodies, in particular Synagis, and compared them to Motavizumab, the product under consideration for FDA approval for prophylactic treatment of RSV in compromised infants and toddlers. * Prepared questions and answers related to Safety concerns that could be, and were actually asked by the FDA advisory committee. * Prepared Safety slides for the presentation, as well as backup slides to be used during the FDA Advisory Committee meeting as visual aids to answer Safety-related questions. * Trained with professional consultants, as a team, in preparation for responding to difficult questions/issues that could be addressed at the FDA meeting. Significant unique accomplishments consist of: *
Serving as the Patient Safety Lead on the MedImmune team that went before the FDA Advisory Committee within a few months of joining this company. * Development of a process for intelligent prediction of safety signals that could be caused by new compounds that are currently under consideration for FTIH clinical trials. * Characterized Hypersensitivity that occurs with the use of monoclonal antibodies * Oncology Expert for 7 Investigational Compounds at MedImmune in Patient Safety ALLERGAN, Irvine, CA a" Full Time Employment GLOBAL SAFETY OFFICER/MEDICAL DIRECTOR, March 2008 a" September 2009 _THERAPEUTIC AREA: NEUROLOGY & OPHTHALMOLOGY_ Responsibilities include participation in all aspects of pharmacovigilance and risk management activities for assigned products, both Postmarketed and in Early Development. This assignment includes * Overseeing all postmarketing safety issues as the Global Safety Officer for Allergan products including Botox and Botox Cosmetic which have more than 20 indications in 80 countries, and other urologic and ophthalmic products. * Oversee safety issues as the Global Safety Officer for Early Development of Botox for new indications (Migraines, Hyperhidrosis, Pain Disorders) and Gatifloxacin Ophthalmic (Neonates, High Dose) * Medical analysis and decision making regarding postmarketing safety matters in the development and maintenance of the Company Core (Safety) Data Sheet for each assigned product. * Performing ad hoc aggregate analysis and safety reports. * Responding to field alert reports. * Development and review of the Periodic Safety Update Reports (PSURas) * Participation in the editing and review of the Risk Management Plans (RMPas) and Risk Evaluation and Mitigation Strategy (REMS) reports.
* Medical assessment of Individual Case Safety Reports (ICSRas) and training of staff on this task. * Responding to regulatory agency inquiries. * Safety liaison to GSK Japan and China focusing on postmarketing safety including responses to regulatory agencies, as part of Allerganas commitment through a Safety Data Exchange Agreement (SDEA) for Botox. Significant unique accomplishments consist of: * Development of a new signal detection automated system using the PRR disproportionality signal detection method to monitor unusual adverse events for all Allergan products. * Designing and development of an improved standardized method for performing medical analyses on each product so that comparisons on safety issues from year-to-year can easily be done between products without compromising individual results. * Restructuring of the itinerary for running the Global Safety Officer biweekly morning reports in which safety concerns are discussed for each product. * Improvement of working relationships between R&D clinical teams and the postmarketing safety group. * Improvement of the format used in medically assessing each individual case safety report (ICSR) in order that this information can be transferred directly into the Periodic Safety Update Reports (PSURas) as needed. * During a transitional period of six months, functioned as the only full-time Global Safety Officer in the United States without missing any deadlines. * Received an Excellence Award for Botox Analysis that ruled out any relationship between the use of this product and the development of QT Prolongation. * Received an Excellence Award for development of a Signal Detection Program for the company. ABBOTT VASCULAR, Santa Clara, CA a" _Consulting Assignment_ MEDICAL CONSULTANT AND WRITER, November 2007 a" February 2008
_THERAPEUTIC AREA:_ _CARDIOLOGY_ Responsibilities include writing and editing reports and documents on Drug-eluting Stent research and clinical trials. * Primary author of Interventional Cardiology book chapter on cardiovascular stents (i) beginning with review of coronary artery disease (CAD), (ii) Signs/symptoms of CAD, history and development of cardiovascular stents, (iii) risks versus benefits of using CV stents, (iv) discussion on the different types of drug-eluding stents, (v) introduction on state-of-the-art CV stents including newer designs of Drug-eluting stents and Biodegradable stents * Provided a comprehensive outline of publicized Cardiovascular Stent Clinical Trials for review and inclusion in Interventional Cardiology Text THE SCRIPPS RESEARCH INSTITUTE, La Jolla, CA _Postdoctorate Fellow_, July 2002 a" February 2005 _THERAPEUTIC AREA:_ _ONCOLOGY and in Microbiology and Immunology, the identification of gene targets that could be blocked and prevent infection and harm to humans when exposed to Anthrax and other like aggressive bacteria._ BIOTECH EXECUTIVE NETWORK CONSULTANTS, Los Angeles CA a" _Consulting Assignment_ SENIOR PARTNER AND PRACTICE LEADER, November 2001 a" July 2002 _AREA OF EXPERTISE: BIOTECH BUSINESS DEVELOPMENT_ Primary responsibilities included business development in the establishment of new clients, especially in the Healthcare and High Technology Industries. - _Major accomplishments included assisting executives of small companies in developing ideas and protocols for new products, as well as recruit the right people to help them get the job done._ CLINICAL EXPERIENCE MOBILE PHYSICIAN SERVICES/HOME PHYSICIANS MEDICAL GROUP, San Diego, CA PRIMARY CARE PHYSICIAN, July 2006 a" Present (Part time during employment with Allergan in particular * Developing integrative health protocols for a number of disease processes. * Researched and authored disease management protocols for health care facilities.
* Leading team to transition a Native American Indian reservation hospital from a US Government operated facility to a privately operated hospital * Developed cost effective Medical Protocols for outpatient patient treatment programs affiliated with the hospital. * Designed an electronic cardiac device. _Major accomplishment included all the above responsibilities._ NONTECHNICAL BUSINESS EXPERIENCE AMABILESTRINGS.COM, San Diego, CA _FOUNDER OF THIS COMPANY February 2005 a" June 2006 (Full-time) AmabileStrings.com is a small business founded for the purpose of raising money to fund orphanages in third world countries that provide a home environment for children who would otherwise be on the streets without any parental guidance. The source of income is from music composed by me, and possibly other composers, which is then licensed to orchestras and film companies for performance or film scores. This has been a part-time business, except for February 2005 through June 2006. - _Major accomplishments included (i) setting up a small business, (ii) writing business plans, (iii) understanding and developing budgets and expense reports, and (iv) fundraising._ ENGINEERING & PHYSICS PROFESSIONAL EXPERIENCE PARSONS CORPORATION, Pasadena, CA _SENIOR TECHNICAL MANAGEMENT CONSULTANT_, August 1998 a" February 1999 Under U.S. Government sponsorship lead the team that assessed the safety and operation of a new Chemical Weapons Destruction Facility (CWDF) to be built in cooperation with the Russian Federation in Russia. Primary responsibilities included _(i) _serving as a systems coordinator for the CWDF for both engineering and management, _(ii) _developing the system description for this facility and performed Safety Analysis checks on plant design_, (iii) _participating in technical meetings with the lead Russian scientists in Moscow, Russia regarding business and engineering issues,_ (iv) _recommending design modifications to significantly improve the human and environmental safety_ _of the facility, and_ (v)_ educating executive management regarding system operations and health concerns involving the plant design. _Major accomplishments included system description for chemical weapons destruction facility in Russia and identifying major health and safety concerns in building and operating this facility and ways to reduce the safety concerns._ IBM CORPORATION, Burlington, VT _SENIOR MEMBER OF TECHNICAL STAFF/MANAGER_, April 1980 a" March 1988
Primary responsibilities included the assessment of IBMas ability to perform Semiconductor Failure Analysis (SCFA) on semiconductor computer chips after mass manufacturing of these devices. Researching new technologies to support the implementation of a SCFA program over five years. _Major accomplishments included (i) Developed a patent on a direct memory access controller that communicated with a network of microprocessors. (ii) Designed 32-bit semiconductor memory chips for large-frame computer systems. (iii) Authored a corporate report on the role of SCFA within the IBM Corporation. (iv) Developed an enterprise-wide study to determine IBMas ability to adequately perform SCFA at all IBM facilities once a product has been mass reproduced. (v) Designed and taught advanced applied semiconductor device physics courses to professional IBM engineers. (vi) Designed and taught courses on the assessment of computer semiconductor device mathematical models used in the CAD system to simulate the operation and function of semiconductor computer chips. (vi) Taught professional IBM engineers how to develop and improve current CAD modeling techniques and (vii) taught professional IBM engineers how to research and develop new ideas related to computer device design._ AT an In-house publication for Medical Students studying for Pathology section of Medical Boards, part II. * Stanton, S. (1986). Semiconductor Device Physics and Device Modeling Lecture Series at IBM. * Stanton, S. (1982). 8N Computer System Direct Memory Access Controller. United States Patent Disclosure. * Stanton, S. (1981). Evaluation of Semiconductor Failure Analysis Within the IBM Corporation; Management and Research. IBM Confidential Corporate Publication. * Stanton, S., (1978). High Speed Digital Oscillators For Fiber Optic Signal Transmission, Bell Telephone Laboratories Confidential Research Publication; Holmdel, New Jersey. * Lord, Stanton, S., et al. (1978). Second Order Dipole Phenomena of Liquid Crystals At Low Temperatures. Journal of Theoretical Physics. PRESENTATIONS * Shingles-Diagnosis and Treatment, Sunrise LaCosta Senior Living Center 2008 * Immunofluorescence of Epithelial Cancer Cells, The Scripps Research Institute 2004 * Cytohesine 4, A Gene Target to Ward Off Anthrax Infections?, The
Scripps Research Institute 2004 * Anthrax, The Medicine and Immunology Behind This Bacteria, The Scripps Research Institute 2004 * Hormone Imbalance in Women, Huntington Hospital, Pasadena, CA 1997 * Obesity and Weight Loss, Huntington Hospital, Pasadena, CA 1997 * Endocrinology for Women, Orange County, CA 1997 * Taught a four-course series on the physics of computers, beginning with the basic classical physics models through quantum physics and numerical analysis modeling of semiconductor devices and computer architecture design. IBM, Essex Junction, VT 1982 a" 1986 * Presentation on a process for intelligent prediction of safety signals that could be caused by new compounds that are currently under consideration for FTIH clinical trials. MedImmune, Gaithersburg, MD. ACADEMIC BACKGROUND Post Doctorate Onc/Immunology The Scripps Research Institute, San Diego, CA (2005) Residency LA County & USC Medical Center, Los Angeles, CA (1995) M.D. Penn State University-College of Medicine, Hershey, PA (1993) MSEE Cornell University, Ithaca, New York (1978) BS in Electrical Engr. & BS in Physics Drexel University, Philadelphia, PA (1977) 7
