Clinical Research Independent Consultant

Nancy Westergaard-Hernandez

***** *** ***** **** *******

Los Gatos, CA 95033 (San Jose)

805-***-****

email - **********@***.***

QUALIFICATIONS SUMMARY

Over thirty years experience in Clinical Research providing project management and team leadership to the pharmaceutical industry as a field and in-house CRA, as well as in-house project management and research coordinating for research centers.

PROFESSIONAL EXPERIENCE

Clinical Research Associate

FTE for Sponsors in-house as well as Independent Consultant for Pharma and Device

Therapeutic drug experience in:

• CNS (all psychiatric disorders, migraine headaches, epilepsy, Alzheimer’s Dis- ease, insomnia, smoking cessation)

• Oncology (Glioblastoma multiforme, Melanoma, Cervical, Lung, Breast, Kidney)

• Diabetes

• Vaccines

• Pain

• Sinusitis

• Device experience in:

• Sinus Balloons

• Coronary artery stents

• Incision dressings

• Radio frequency cosmetic delivery system

Pharma and Device Clients Include:

Eli Lilly 5/2001-7/2001 (Site qualifications)

therapeutic area: Major depression, Generalized Anxiety, Panic Disorder Bristol Myers Squibb 4/98-1/99 (field CRA)

therapeutic area: smoking cessation

SmithKline Beecham; Glaxo SmithKline 1/99-6/99 (field CRA) therapeutic area: major depression

Mannkind 1/2007-1/2008 (in house Trial Manager)

therapeutic area: Phase 1 -cardiac QT prolongation Chiron 9/2002-1/2003 (in house Trial Manager)

therapeutic area: Oncology

Ampio 1/2017-7/2017 (field CRA)

therapeutic area: osteoarthritis

Palo Alto Health Sciences 3/2018-6/2018 (remote CRA monitor) therapeutic area: device for Panic attacks

Abbott Labs 10/2012-4/2014 (in house Trial Manager) therapeutic area: cardiac resorbable stents

Sereno 4/2018-9/2018 (in house Trial Manager & field CRA) therapeutic area:

cosmetic ; facial radio frequency medical device

Bavarian Nordic 2/2014-11/2014 CRA (monitor clean up project) therapeutic area: chickenpox vaccine for employees Johnson & Johnson - Acclarent 6/2014-7/2015 (Clinical Trial Manager & field CRA)

therapeutic area: Sinuplasty medical device

Tusker 3/2017-6/2017 (field CRA)

therapeutic area: inner ear pain, Phase 1

Neodyne 7/2011-12/2011 (field CRA)

therapeutic area: specialized surgical dressings post abdominoplasty Exelixis 9/2018-3/2019 (in house Trial Manager)

therapeutic area:

oncology (kidney, lung, liver, ovarian)

CRO clients include:

World Wide Consultants 1/98-8/99

therapeutic area: major depression, smoking cessation International Consultants: 1/2000-11/2000

therapeutic area: Pain, melanoma, ovarian cancer

Omnicare 4/2001-6/2001

therapeutic area: Major Depression

Bright Pharmaceuticals 9/2010-2/2013

therapeutic area: insomnia

EMPLOYMENT:

Pharmacon Group Inc. 4/93-Present Contract Senior Clinical Research As- sociate

Consulting on various clinical research trials/projects, to include:

• Consult on Protocol design

• CRF Design

• Review protocol edits, generate queries

• Site proposals/qualifications

• Site budget contract negotiations

• Manage site payments

• Site liaison with IRB submissions/queries

• Assist sites with ICF generation

• Assist sites with regulatory document collection 7 completion, files

• Perform site initiations

• Perform site monitoring: physical visits and remote monitoring

• Communicate with the central lab

• Attend initial dosing visits at site

• Review CRA monitor reports

• Report site enrollment & other study particulars to Sponsor management

• Perform investigational drug accountability

• SOP development/training

• Consult on product formulation

CoCensys 9/93-11/97 Senior Clinical Research Associate (in house project management & field CRA)

Therapeutic Area:

Migraine Headaches

Epilepsy.

Responsibilities included:

· Protocol Development of Phase I and Phase II Trials

· Recruitment, Selection and Contract Negotiation with Research Sites

· Selection and Contract Negotiation with CROs and Central Labs

· imanagement of in house CRAs, as well as Contract CRAs

· Informed Consent Development

· Site Evaluations, Initiations, Routine Monitoring and Close Outs

· Serious Adverse Event Reporting and Summaries

· Case Report Form and Patient Diary Design

· Consulted on Study Drug Formulation and Packaging

· Assist Data Management in Development of Data Edit Checks

· Develop Training Materials for Site and CRO Personnel

· Review and Archive Regulatory Documents

· Assur adherence to Good Clinical Practices and ICH Guidelines

· Ensure Timely Project Enrollment and Submit Milestone Reports to Management

· Perform Preliminary Clinical Data Reviews and Audits

· Assist with Final Study Reports

· Clinical SOP Development and Training

Allos Therapeutics, 11/97-4/98

Senior Clinical Research Associate (in house project management & field CRA)

Therapeutic Area:

Oncology: Glioblastoma

Responsibilities included:

· Assisted with Protocol Development of Phase II Oncology Trials

· Negotiated Contracts with Research Sites

· Assisted Sites with Informed Consent Development

· Case Report Form Design

· Assisted with Development and Review of Data Edit Checks

· Assisted Sites with IRB issues

· Performed Site Initiations and Routine Monitoring Activities

· Collected Regulatory Documents and Performed Review and Archiving

· Trained Research Sites on GCP and ICH Guidelines

· Developed Project Reports to Senior Management

· Managed Investigator Payments

· Developed Clinical SOPs

Center for Behavioral Medicine 4/93-8/96

Clinical Site Manager and Research Coordinator

Therapeutic Area:

Depression, Anxiety, Schizophrenia, Panic Disorder, Social Phobia, Obsessive- Compulsive Disorder, Alzheimer’s Disease, Migraine Headaches and Chronic Pain.

Responsibilities included:

· Supervised the Conduct of up to 15 On-Going Trials and a Clinical Staff of 20 Developed site budgets

Developed subject Informed Consents

• Presented protocols to the IRB and remained primary contact

• Primary contact with central lab

• Performed initial reviews of patient laboratory reports

• Performed Patient Screening and Eligibility Determinations

• Evaluated Patient Health and Safety during Research Participation

• Supervised Site Interaction and Communication with Study Sponsors

• Assured Site Adherence to GCP and Maintained Regulatory Document Files

• Assisted with Planning, Development and Administration of Department bud- gets

• Assisted in Site Business Development Plans

• Acquired and Negotiated Pharmaceutical Sponsor Research Contracts

• Developed Patient Recruitment Plans including Advertising and Public Relations Campaign

Plastic Surgery Associates 8/84-3/85

Surgical technician

Assisted with surgical procedures and patient evaluations at a cosmetic surgery specialty practice.

Aspen Arbor Animal Hospital, 8/80-7/84

Veterinary Technician

Performed a variety of routine clinical and surgical duties at a veterinary practice. EDUCATION

Bachelor of Arts Degree, 1980

The University of Colorado, Boulder, Colorado

ABSTRACTS/PAPERS

Ganaxolone in the Acute Treatment of Migraine Headaches in Females - 1997 Piloting the Westergaard Assessment Scale for Panic Attacks - 1993

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