Dawn

Viveash
2500 6th Ave #107, San Diego, CA 92103 Phone 805 558 3650
E-Mail: dawnviveash@icloud.com

Summary

Experience

Dr. Viveash has a distinguished career spanning three decades of global experience in
biologics and small molecule development, including the commercialization of numerous
products including anti-inflammatory, oncology, and metabolic disorders. Prior to joining
Balboa BioConsulting, Dr. Viveash held vice president positions at Orexigen, Amylin, Amgen,
Immunex and Pharmacia and Upjohn. Areas of responsibility included regulatory affairs,
clinical safety and quality assurance. Dr. Viveash contributed to the successful development
of a number of products including most recently Contrave, Bydureon, Byetta, Kepivance,
Vectibix, Aranesp, Neulasta and Enbrel. Dr. Viveash played a significant role as a company
representative in a number of FDA advisory committees relating to product approval and
product safety assessment. Dr. Viveash received her degree in Pharmacy from The School of
Pharmacy, London University, her medical degree from University College Medical School,
London University and qualified as a member of the Royal College of Physicians UK.

Balboa BioConsulting. Vice President, Drug Development
Current
This consulting company provides drug development and regulatory affairs expertise to the
bio-pharmaceutical industry.
Orexigen Therapeutics Inc. Senior Vice President, Regulatory Affairs,
Safety and Quality Assurance

2009 2015

Responsible for management of a team of up to 12 staff members and was a member of the
companys executive team.
Accomplishments included:

FDA approval of Contrave (naltrexone/bupropion) for weight management. This

involved participation in an advisory committee and subsequent discussions using
dispute resolution to reach agreement of a required cardiovascular outcome trial.
Europe Commission approval of Mysimba (naltrexone/bupropion). This centralized
application required numerous interactions with member states and rapporteurs.

Amylin Pharmaceuticals Inc. Vice President, Regulatory Affairs and Safety

2006 - 2009

Responsible for management of a team of 60 - 80 staff members. Accomplishments

included:

Support for commercialization of Byetta (exenatide) and Symlin (pramlintide) for

treatment of diabetes.
Approval of sNDA for new indication for Byetta.
Development and submission of NDA for Bydureon (once weekly exenatide for
treatment of diabetes).
Leadership role in assessment of pancreatitis, an emerging significant safety signal
for Byetta. Activities included post marketing assessment of adverse events,
implementation of an observational study and labeling negotiations.
Chairperson of the Research and Development committee and participant in the
Global Portfolio Strategy Committee.

Bionexxus Inc. President

2005 - 2006

A consulting company providing regulatory affairs and safety expertise to the bio-
pharmaceutical industry. Key achievements included:

Input into development of commercialization programs for a number of

pharmaceutical products.
Development and delivery of a training program for regulatory affairs and safety.
Guidance regarding technical and procedural aspects of product safety issues.

Amgen. Vice President, Regulatory Affairs and Safety

2002 - 2005

Management of a global team of 250 staff members responsible for preparing global
submissions for biologics and small molecules. Accomplishments included:

Global approvals for Sensipar/ Mimpara (cinacalcet) for treatment of secondary

hyperparathyroidism. The application was achieved through priority review in the
US.
FDA priority review and approval of Kepivance (palifermin) for treatment of
radiation induced mucositis.
Label expansion and supply chain support for Enbrel (etanercept):
Ankylosing spondylitis. This was a priority review and involved
participation in an FDA advisory committee.
Psoriasis.
New weekly dosing regimen and associated pre-filled syringe.
New facility approvals.
Label expansion for Aranesp (darbepoetin alpha) supporting new dosing regimens.
Label extension for Neulasta (pegfilgrastim) extending use to broader patient
population.
Preparation of BLA for Vectibix (panitumumab)
Participation in Oncologic Drug Advisory Committee and European
Pharmacovigilance Working Party discussions evaluating safety of erythropoeitins.
Topics included survival, tumor progression, thrombotic events and pure red cell
aplasia.
Participation in Arthritis Advisory Committee evaluating safety of TNF antagonists.
Topics included infections, lymphoma and heart failure.
PhRMA clinical representative for ICHQ5E (comparability) and related industry/
regulatory discussions regarding bio-similar biologic development.
Supported pipeline products through participation in governance discussions and
oversight of IND submissions. The pipeline included a variety of treatment
modalities in therapeutic areas including oncology, metabolic disorders,
inflammation, nephrology and bone disorders.

Immunex Corporation. Vice President, Regulatory Affairs, Safety

and Professional Services.

2000 - 2002

Responsible for management of regulatory affairs, safety and professional services staff.
Accomplishments included:

Approval of Novantrone (mitoxantrone) for multiple sclerosis.

Label expansion for Enbrel:
o Prevention of radiographic joint damage in patient with Rheumatoid
Arthritis. This included participation in an FDA advisory committee.
o Psoriatic arthritis (priority review).
Participation in Arthritis Advisory Committee evaluating the safety of TNF
antagonists. Topics included infections, demyelination and lymphoma.
Leadership role in transition activities relating to the acquisition of Immunex.

Safety Net Solutions, Founder and President

1998 - 1999

Provided consultation to the pharmaceutical industry on matter relating to

pharmacovigilance and regulatory submission strategies. Accomplishments included:

Assessment and audit of drug safety surveillance processes.

Advice regarding clinical development strategies.
International training program for global pharmacovigilance.
Interim vice president level role for large pharmaceutical company.

Pharmacia and Upjohn, Vice President Global Pharmacovigilance

and Chief Safety Officer

1995 - 1998

Responsible for management of a global safety organization with approximately 150 staff
accountable for evaluating product safety for commercial and development products.

Planned and executed departmental transition through a complex merger resulting

in the integration of three disparate global safety groups.
Implemented work process redesign, new global procedures and global database
resulting in improved performance and compliance.
Played a lead role in managing critical emergent safety issues relating to
pharmaceutical and pharmacologic safety issues and product counterfeiting.

The Upjohn Company

1986 - 1995

Performed a variety of roles for the company including:

Director, Drug Safety Surveillance and Regulatory Operations
Managed a staff of 50 individuals across two departments. The safety surveillance group
was responsible for assessing and reporting adverse events for commercial and
development products. The regulatory operations function provided logistic aspects of
regulatory submissions including governance and management of global product labeling.
Accomplishments included:

Ongoing safety assessment for companys portfolio of products including anti-

infective, CNS, oncology and anti-inflammatory products.
Re-engineered safety and regulatory operations processes to improve efficiency.
Managed package insert revisions on a global basis to ensure consistent safety
labeling worldwide.
Managed advertising and promotional material review for US products.

Clinical Research Manager

Responsible for design, conduct and reporting of clinical studies for anti-inflammatory and
anti-diabetic products. Key achievements:
Implemented phase 2 and 3 studies for Amaryl (glimepiride) contributing to
product approval in US and Europe. This was part of a co-development program
with Hoechst Roussel Pharmaceuticals.
Implemented clinical development program for Promedrol (methylprednisolone
suleptanate) resulting in product approval in Europe. The program included
indications for prevention of renal transplant rejection and acute asthma.
Medical oversight of marketed anti-inflammatory products (steroidal and non-
steroidal products).

Medical Advisor, UK Division

Responsible for design, conduct and reporting of clinical studies for anti-inflammatory and
womens health product. Accomplishments included:

Conducted phase 3 and 4 studies for labor induction, acute respiratory distress
syndrome, rheumatoid arthritis and oncology indications.
Established a plan for a 20 bed phase 1 clinical pharmacology unit.
Medical Internship and Residency
Southampton Hospital, UK, Senior House Officer

1984 - 1986

Responsible for hospital and outpatient care in general medicine, respiratory medicine,
gastroenterology, cardiology and neurology.
University College Hospital, London, UK, House Officer

1984

Responsible for hospital and outpatient care in general medicine and gastroenterology.
Edgware Hospital, London, UK, House Officer
Responsible for hospital and outpatient care in general surgery and gastroenterology.

B. Pharmacy First Class, London School of Pharmacy, England

Education

Bachelor of Medicine, Bachelor of Surgery (M.B.B.S.), University College Hospital, London,

England
Member of the Royal College of Physicians, London, UK

1983