General Partner of *****! ***** Foundation (non-profit), San Francisco, CA 5/2011 - Present
A not-for-profit company that provides advisory services and financial support such as specialty financing, infrastructure capital, equity, PO financing, and long term debt instruments for small to mid cap companies developing therapies or support systems to promote general health, mitigate or cure disease in humans.

The Foundation supports medical therapies for diseases like Cystic Fibrosis and Cancer, and furthers our philanthropic efforts fostering development of drugs, devices, procedures and therapies for other diseases and conditions affecting children and families. In addition to medical therapies, we support the development of healthy families, through direct support of family centered activities and youth sports programs. *****!'s innovative concept - beyond fundraising we create revenue stream through corporate and business development services. Access to our specialty financing partner and global team of experts in the Biotech and Pharma Development arena creates additional revenue. The profits from these activities are donated to our supported causes. We offer specialty financing that supports financing of purchase orders, accounts receivable, infrastructure capital and SBLCs. Our unique model – combining dollars with development and business mentorship - efficiently moves products in development forward through clinical trials, and regulatory approval, licensing, and partnerships, and planned exits.

CEO and Managing Partner
The *****, LLC (Formerly The Whitten Group) Lafayette CA 2/2007 – Present
We are a virtual global consulting group and ***** providing expert advisory and corporate/business development services and staff to Pharma, Biotech, Device and Neutraceutical companies, with experts a*****ss the continents specializing in efficient, creative and compliant solutions to complex GxP problems.

Our experts in clinical / device development, business development, licensing/partnership opportunities, due diligence, clinical monitoring, project management, medical and regulatory affairs, medical writing, quality systems and auditing, inspection preparation, and global PVG, SAE and risk management will creatively and efficiently solve your GxP dilemma. Our IT and Validation experts can shorten time to “Go Live” for internal system development, or validation and deployment and staff education for safety systems like ARISg, and ARGUS. Our skilled team conducts internal, external partner audits, and performs vendor qualifications and as an unbiased 3rd party, audits your *****s. We partner with *****! ***** to perform due diligence and insure that R&D companies it invests in follow a rational and efficient clinical plan.

Senior Director, Global Drug Safety & Pharmacovigilance
Cerexa Pharmaceuticals (Subsidiary of Forest Laboratories) Oakland, CA 6/*****/2010

Managed safety for all products. Responsible for development programs supporting ceftaroline and other early development products including: two first in man trials, sixteen phase I, two phase II and four concurrent phase III antibiotic trials (cCCSI and CAP), utilizing global *****s and up to 9 regional *****s per trial. Accountability extended to management of product safety profile, CCSI development, management of ICSRs, identification of SUSARs and global reporting of SAEs, safety signal identification (including nonserious AEs and labs), study setup, investigator meeting support, contribute/review protocols, IC’s, CSRs, NDA and ISS, as well as partner safety agreements and USPR, DSUR and potential signal workups, ***** selection, evaluate new business opportunities, and hire and develop local staff. As senior management team member, participated in strategic planning, clinical trial management and manage expense/budget and forecasting. Corporate PV liaison for partners/auditors and FDA, EMEA, Forest CMO, Global business partner Astra Zeneca). Reported directly to Company president. Restructured local multi-***** based model and successfully migrated all SAEs into the Forest Safety System (ARISg). Expanded role of local safety medic to include spontaneous case processing for Forest products while remaining primary reviewer for Cerexa developmental products. Resulted in cost savings of $120K annually. Writer/Reviewer for ISS, CSRs for NDA filed on time in December 2009. Developed safety data and change management process for the CCDS with EU partner

The Whitten Group – Consultant - 2/2007 – 6/2007
Hana *****, South San Francisco, CA

Developed and implemented complete SAE reconciliation program and reconciled all historic SAE data in support of the NDA. Supported successful safety system (ARGUS) launch, validation and configuration.


Head, Global Pharmacovigilance 10/*****/2006
Senior Director, Global Pharmacovigilance
Novartis (Formerly Chiron Corporation) Emeryville, CA

Responsible for management of day to day operations and complete safety profile for all development and marketed oncologic and antibacterial products held by Chiron Corporation through global corporate offices in Italy, France, London, US and Germany, as well as creating a responsible safety network of worldwide distributors and partners. Developed and implemented global training and auditing program.

Responsibilities include: CCSI development, management of ICSRs, identification of SUSARs and global reporting of SAEs, safety signal identification (including nonserious AEs and labs), study setup, investigator meeting support, contribute/review protocols, IC’s, CSRs, NDA and ISS, as well as partner safety agreements and PSUR, USPR, DSUR and potential signal workups, ***** selection, SOP development/ management, evaluate new business opportunities, and hire and develop local staff. As management team member, participate in strategic planning, and manage expense/budget and forecasting. Corporate liaison with partners/auditors and parent company (FDA, EMEA, MHRA, Chiron and Novartis CMO, Global business partners and distributors). Reported directly to CMO for Chiron, and Novartis VP Global Drug Safety. Restructured local distributor network and created a trained safety liaison (local responsible person) within each distributor organization. Co-Chaired team with QA for highly successful UK development program regulatory inspection, several partner inspections and two FDA postmarketing inspections. Prepared business case and won approval for new safety system (ARISg) and validated and upgraded existing system (ARGUS), designed and oversaw development/validation of an external data retrieval tool for ARGUS until the new system could be implemented. Created and launched a career path for qualified case processors/safety scientists to move into project management. Created internal training and assessment group that identified targeted training opportunities from weekly case processing metrics.

Director, Drug Safety *****
Bausch & Lomb Pharmaceuticals, Tampa FL

Senior Manager, Drug Safety *****
Quintiles - BRI, Rosslyn, VA

Clinical Study Manager Department of Clinical Pharmacology 1993 – 1995
Employed by FDA at USUHS (Uniformed Services University of Health Sciences), Bethesda, MD

Transplant Nurse/Charge Nurse 1991 – 1995
Pediatric Heart and Lung Stepdown ICU
Fairfax Hospital, Fairfax, VA

Marymount University, Arlington VA (RN) and George Mason University, Fairfax VA (BSN)

Shelly is an unusual find in a sea of well-qualified individuals. She is an experienced corporate executive and entrepreneur with 20+ years direct experience in biotech, pharma, *****, direct patient care, and non-profit management who navigates your project from concept through boardroom consensus, builds investor relationships, identifies partnership/licensing opportunities and develops successful continuing client relationships.

Shelly’s ability to share with her team a wide range of experience managing global clinical trials, regulatory affairs, business development, strategy/life cycle planning, risk management, global drug safety, quality, systems development/validation, is key to her success – and yours. She has demonstrated a consistent record of developing and implementing strategies - validated by successful defense in FDA, MHRA, and global business partner audits/inspections.

Shelly’s ability to identify and develop key relationships/synergies between partners, and link global teams together as a unit with clearly identified roles to reduce inefficiency, has led projects to complete early and under budget. Where GxP solutions are needed, she has been instrumental in redesigning organizations, and creating well defined networks of global partners and distributors resulting in a consistent approach and significant cost savings to the organization. Her areas of clinical development expertise include Phase I-IV clinical development of drugs and devices in oncology, cardiology, autologous and other vaccines, respiratory, antibacterial, small molecules, general medicine, and vision care.

She is an expert in global regulations and current industry practices, clinical and safety systems development and validation (ARGUS, ARISg and internally developed systems), global risk management; regulatory inspection preparation/defense and compliance. Her ability to identify additional revenue streams within an organization has been instrumental in business opportunity evaluation and alliance management.

She has authored/reviewed many regulatory documents including: NDA, IND, CSR, ISS, ISE, PSUR, DSUR, and signal/issue investigations. Where gaps existed, Shelly has historically partnered within the organization and navigated the path to create efficient programs: as an example, she partnered with QA to create an auditing program for clinical sites and vendors, and developed *****ss-functional complaint handling systems and sample quality investigation processes.

As a marathon runner, chef, surfer, and landscape photographer, Shelly enjoys the California Bay Area as her home. For the right opportunities, she is available for short term travel/relocation outside the US.