SEARCH ALLIANCE
executive search and management consulting
750 Menlo Avenue Ste 100, Menlo Park, CA 94025
Ph 650-328-6400
Fx 650-328-6460
DIRECTOR / Sr DIRECTOR, REGULATORY AFFAIRS
THE COMPANY
Zogenix, Inc. is a private, specialty pharmaceutical company whose core strategy is the development and
commercialization of differentiated CNS and pain therapeutics that can meet significant unmet medical
needs. Zogenix' initial focus is the global development and commercialization of Intraject® sumatriptan –
the market-leading triptan in a needle free, single use, disposable, subcutaneous delivery system. This
product will compete in the $2.5 billion triptan segment of the migraine market. Intraject sumatriptan is a
drug/device combination product. Beyond commercialization of the Company's initial product, Zogenix will
focus on the development and sales of additional CNS/pain therapeutics that utilize the Intraject®
technology.
This newly formed company raised $60 million in a Series A private financing in August 2006. The
financing was co-led by Clarus Ventures and Domain Associates, LLC. Additional investors included BA
Venture Partners, Thomas, McNerney & Partners, Life Science Angels and Windamere Venture Partners.
A portion of these proceeds funded the acquisition of the Intraject technology assets from Aradigm
Corporation. This included the Intraject technology platform and intellectual property, manufacturing
equipment and infrastructure, and Intraject sumatriptan. As a part of the transaction, key employees and
all of the contract manufacturing relationships transferred to Zogenix to maintain the necessary skills and
competencies to complete the development and commercialization of Intraject-based products.
The remainder of this financing will be applied to accelerating product development and completing the
commercial manufacturing automation for Intraject, including enhancing a solid manufacturing and supply
chain infrastructure. These funds will also support the global registration of Intraject sumatriptan.
Zogenix will build a focused specialty sales and marketing organization in the United States to propel the
launch of Intraject sumatriptan into the migraine therapy market. Its emphasis will also be to
commercialize future products and establish co-promotion partnerships as necessary to maximize each
product's potential in the U.S. In addition, the Company will seek to establish partnerships to
commercialize its products in other geographies.
The Company intends to establish partnerships and license agreements with biotech and pharmaceutical
companies for the development and commercialization of other Intraject based products. Intraject
technology offers a variety of benefits (needle-free injection, sterile, pre-filled, disposable), which make it
an attractive choice for both novel and established compounds. It provides a highly differentiated
opportunity as an enabling technology for lifecycle management. Needle-free delivery systems have the
potential to play a significant role in any therapy where invasive delivery limits therapeutic benefit, ease of
access or patient compliance. Intraject should be the first needle-free delivery system of its kind to reach
commercialization.
Zogenix currently operates out of facilities in both Emeryville and San Diego, CA. Manufacturing is
performed under contract with world-class contract manufacturing organizations located in the UK and in
Germany.
SEARCH ALLIANCE
executive search and management consulting
750 Menlo Avenue Ste 100, Menlo Park, CA 94025
Ph 650-328-6400
Fx 650-328-6460
THE TECHNOLOGY - Intraject® Needle-Free Delivery System
Intraject is a novel platform delivery system that offers an advanced, pre-filled, single-use device for
needle-free injection. It is designed to offer comfortable, precise administration of liquid formulations to
the subcutaneous space. The drug enters the systemic circulation similarly to needle-based injections.
The pen-sized device requires only three steps and approximately one minute for a patient to use. It is
comprised of two main parts: the glass capsule with a pre-filled volume of liquid and a compact nitrogen
gas power source. Formulations delivered via Intraject are usually identical to those delivered via
conventional subcutaneous injection, allowing for an abbreviated bioequivalence-based clinical and
regulatory pathway.
Intraject subcutaneous delivery can be used for both small molecule therapeutics and high molecular
weight proteins. It is also useful in the delivery of monoclonal antibodies, a market that has grown 6-fold
since the first introduction in 1998 and continues to drive much of biologic launch growth. Intraject has the
ability to conveniently deliver viscous formulations, and therefore may be considered enabling for high
concentration formulations that are extremely problematic to deliver via conventional needle injection.
The technology has been extensively evaluated in clinical trials demonstrating bioequivalence and patient
preference delivering both large and small molecules. To date over 100,000 Intraject devices have been
manufactured including completion of the manufacturing of pivotal and clinical batches of Intraject
sumatriptan product.
THE PRODUCT - Intraject Sumatriptan
Intraject sumatriptan, a delivery/drug combination for migraine pain, is a late stage product with extensive
studies and data already completed. As mentioned, with the acquisition of Intraject sumatriptan, the
company gained the associated support systems. Multiple suppliers (mostly EU) produce components of
the highly engineered device component and an established supplier provides the drug product. There
are two primary CMO’s that complete the assembly and aseptic fill processes.
Sumatriptan is the leading triptan sold worldwide with over 50% share of 125 million doses sold annually.
Although pharmacokinetic studies have shown that the injectable form has a significantly faster onset of
migraine relief verses oral and nasal forms, unit sales of the current injectable sumatriptan are less than
5% of the total. Fear of needles and the complexity of the current injectable product are cited as primary
reasons for low acceptance by patients and clinicians. Intraject sumatriptan directly addresses these
issues. Market research shows strong acceptance of Intraject sumatriptan by neurologists, pain
specialists, and high prescribing primary care physicians.
The FDA has agreed that Intraject sumatriptan is to be filed under 505b2, leveraging the preclinical data
of the current marketed injectable sumatriptan, with only one pivotal study required. This study, a twoweek pivotal trial in 60 healthy volunteers will assess bioequivalence of Intraject sumatriptan to the
currently marketed injectable product. This study will be completed in early 2007. Clinical materials and
NDA stability batches and have already been manufactured with over 6 month’s stability to date. NDA
submission will follow immediately after the availability of the clinical report and 12 month stability data.
THE MANAGEMENT
Roger L. Hawley, Chief Executive Officer
Stephen J. Farr, Ph.D., President and Chief Operating Officer
Bret E. Megargel, Vice President, Finance and Corporate Development
Jonathan Rigby, Vice President, Business Development
John J. Turanin, Vice President, Operations
SEARCH ALLIANCE
executive search and management consulting
750 Menlo Avenue Ste 100, Menlo Park, CA 94025
Ph 650-328-6400
Fx 650-328-6460
THE POSITION
Reporting to the President and COO, this position will head the regulatory function for the company. The
Director/ Sr Director of Regulatory Affairs is responsible for the development and oversight of the global
regulatory strategy in an out-sourced pharmaceutical development and manufacturing environment. S/He
will be responsible for ensuring appropriate licensing, marketing and legal compliance of Zogenix’
pharmaceutical products and will be the primary liaison with worldwide regulatory authorities.
Initial opportunities/challenges include a near-term NDA submission and subsequent launch for the
company’s lead product sumatriptan Intraject, a “first of its type” pharmaceutical product. The Director/ Sr
Director will also plan for and support potential additional pharmaceutical products in the Zogenix
pipeline. S/He will work proactively with regulatory authorities, primarily FDA and EMEA, toward
successful filings which meet regulatory requirements.
S/He will significantly influence the overall drug development process and will work closely with other
functions to provide advice, counsel and oversight to align processes with regulatory strategies. He/She
will develop the Regulatory function within the company and will provide leadership on all regulatory
operational activities. The Director/ Sr Director of Regulatory Affairs’ responsibilities will encompass the
preclinical, clinical, and chemistry, manufacturing & controls disciplines.
OBJECTIVES

Gain an understanding of Zogenix’ products, their components and key attributes.
-
Become familiar with current project plans and timetables. Understand milestones and associated
deadlines.

Learn about the current regulatory strategy and understand activities to date in order to determine
refinements and future modifications.

Initially, will assume primary responsibility for the IND cleared by FDA in November 2006 for
sumatriptan Intraject and determine appropriate next steps.
-
Develop and implement the regulatory strategy related to a pre-NDA meeting, NDA submission
and support of PAI activities.
Educate and influence regulatory authorities on specifications and approval processes for
technologies used in Zogenix drug products.

Define and implement an overall regulatory strategy aligned with corporate goals. Strive for the
earliest approval for upcoming and future IND/NDA submissions.

Work closely with colleagues in preclinical, clinical, manufacturing, compliance, marketing and senior
management to create product development/regulatory strategies.
-
-
Ensure that research and product development programs are designed to meet FDA
requirements.
Ensure that projects in the pipeline are supported with fully integrated plans in which the
regulatory strategy is incorporated, documented, implemented and communicated to those
individuals responsible for successful execution.
Work in a collaborative manner with internal scientists and engineers and externally to oversee
technical, clinical and regulatory consultants to achieve these objectives.
Interface with Marketing and Manufacturing to ensure regulatory requirements are met for
manufacturing, packaging, labeling and advertising of Zogenix drug products.
SEARCH ALLIANCE
executive search and management consulting

750 Menlo Avenue Ste 100, Menlo Park, CA 94025
Ph 650-328-6400
Fx 650-328-6460
Oversee regulatory submissions to the FDA and EMEA.
-
Provide focused, strong oversight to colleagues involved in submission preparation
Ensure that individuals from functional areas receive appropriate advice and support in order to
ensure execution of reports and sound documentation.
Review these submissions and help to refine and improve their quality and approvability.

Develop regulatory processes and construct SOPs, templates and checklists for utilization by clinical,
R&D groups and manufacturing groups. These SOPs will address the full range of issues pertaining
to all aspects of regulatory submissions.

Serve as the regulatory expert for the company.
-

Advise colleagues and provide guidance in conducting studies that comply with FDA requirements
Clearly communicate critical regulatory information to team members in all phases of the
development cycle ( eg. IND,clinical, CMC, etc.)
Interpret the laws and regulations for other members of the company's executive, R&D,
manufacturing, compliance and commercial staff. Keep abreast of changing regulations.
Be proactive and provide staff with updated information in relation to these evolving FDA
requirements.
Advise the company regarding potential risks related to regulatory issues.
Work directly with appropriate regulatory agencies to represent the Company, solve problems and
develop sound solutions.
-
Maintain correspondence and other records of interactions with regulatory authorities.

Establish and manage relationships with regulatory authorities and consultants. Utilize personal
professional networks to achieve goals.

Support regulatory inspections at CMOs.
THE PERSON
Ideal Experience

A minimum of 10 years of experience in Regulatory Affairs in the pharmaceutical, biologics or drug
delivery industry. Drug/Device combination product experience a plus.

An individual with a track record of forming effective working partnerships with colleagues,
subordinates and counterparts from other companies and at regulatory agencies.

Possesses solid instincts concerning quality of regulatory submissions and sound scientific and
business judgment.

Has participated in setting regulatory strategy and can assume initiative in leading operations.

Has in depth knowledge and understanding of both the drug and device approval a process.
SEARCH ALLIANCE
executive search and management consulting
750 Menlo Avenue Ste 100, Menlo Park, CA 94025
Ph 650-328-6400
Fx 650-328-6460

Has a thorough, global understanding of the complex set of regulations with primary focus on US
FDA and EMEA. Has personal experience and a good track record of effective interactions with
these organizations.

Knowledgeable in cGMP’s, cGCP’s, QSR’s
Ideal Personal Profile

A BS/MS or equivalent in a scientific discipline with a PhD / PharmD preferred.

A bias for action and a sense of urgency.

Embraces science- and issue-based approaches to regulatory strategy.

Believes in the value of sharing regulatory information and of developing a strong and knowledgeable
workforce in the Company

A generalist, comfortable working with people from a range of disciplines; competent in asking
questions and defining answers.

Exceptional communication skills. Ability to negotiate issues with regulatory authorities and prepare
effective documentation.

Possess strong skills in leadership, problem solving and project management.

A leader who addresses potential issues head-on and solves them before they become major
problems.

Comfortable in an interactive, collaborative, team-oriented environment.

A regulatory affairs professional who is flexible, non-bureaucratic, open to new ideas and also fully
accountable for meeting individual and company goals.