Vice President Regulatory Affairs, Clinical and Quality Assurance

SEANE DILLARD JONES

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

Corvallis, OR 97333

817-***-**** email, *******@*****.***

Seasoned, experienced, progressive thinking Regulatory professional with 19+ years experience. Broad range experience in Regulatory, Clinical, Quality and CMC. Proven track record of achieving global approvals (9+ NDAs, 17 ANDAs, electronic filings). Numerous IND filings. 8+ years experience with direct oversight, review and approval of advertising and promotion materials for branded product line. Collaboration with Marketing and development teams to provide strategic marketing campaigns. Primary liaison to DDMAC for all promotion and advertising activities. Ability to develop and train inexperienced staff. Knowledgeable and experienced working with numerous governmental agencies; FDA, DDMAC, DMETS,BARDA, NIH, CDC, WHO, USAMRIID, EMEA, Canada, Japan, Israel, Australia, New Zealand, South Africa, Switzerland, ROW countries. Therapeutic areas experienced in include: Anti-Virals, Antimicrobials, Anti-Infectives, Ophthalmic, Dermatologicals, Allergy, Antifungals, Gastroenterology, Generics and OTCs. Experienced in numerous dosage forms: inhalation, nasal drug delivery, topical, parentals, solid oral dosage, liquid oral dosage, suppository, gels and ointments.

Professional Experience

SIGA Technologies, Inc. April 2008 – March 2009

Corvallis, Oregon

Vice President Regulatory Affairs, Clinical Affairs & Quality Assurance

Recruited by SIGA to establish a Regulatory, Clinical and Quality Assurance groups to assist in the development of their research candidate compounds (Smallpox and Dengue). The company had relied solely on contract organizations for all FDA communications, filings and advice. Establishment of this department has saved the company millions of dollars spent externally.

Regulatory

• Consolidated and organized all correspondence and filings;

• Established back up files electronically for all filings and communications;

• Established structure for electronic filings, researched publishing systems, purchased publishing system for electronic filings;

• Established version control for all critical documents;

• Provided advice to Chief Scientific Officer, CEO, CFO and Board of Directors;

• Wrote, reviewed and edited all public corporate communications;

• Negotiated clinical trial design with FDA so as to receive a waiver for QTc prolongation studies, saving the company in excess of $3M;

• Communicated with FDA, ran face to face meetings and teleconferences;

• Provided meeting briefing packages;

• Wrote and edited all Clinical, CMC and Toxicology communications to FDA and NIH;

• Submitted Annual Reports for INDs to FDA and Orphan Drug Office;

• Communicated with National Institutes of Health (NIH);

• Assisted in writing, editing and execution of all NIH budgets (including CMC, Clinical, Regulatory, Tox, Quality etc) and scope of work issuances;

• Wrote, crafted and submitted Annual Reports to NIH;

• Ran meetings with NIH, SIGA and numerous other government organizations;

• Resourced, hired and managed outside consultants and service providers as needed;

• Edited numerous Scientific Journal articles and grant proposals;

• Wrote and edited European Scientific Advice briefing package to EMEA;

• Conducted successful face to face Scientific Advice meeting with EMEA;

• Resourced, hired and managed outside consultation for Japan filing needs;

Clinical

• Wrote and edited: Informed Consents, Clinical Investigator Brochures, Protocols, Protocol Amendments, Compassionate Use Protocols, Emergency Use Protocols;

• Redesigned protocols to include criteria helpful for achieving global registrations, savings to the company in the millions;

• Wrote and edited all NIH documents for conducting trials under their domain;

• Resourced, hired and managed outside consultants and service providers for clinical trials, e.g. Central labs, Central IRBs

• Resourced, hired and negotiated payments with clinical trial sites;

• Resourced, hired and managed contract organizations for the execution of clinical trials;

• Participated in NIH Drug Safety Monitoring Boards (DSMB) safety reviews and helped establish ISM (Independent Safety Monitors) for each clinical site;

Quality

• Established and wrote policies governing the conduct of business for SIGA in alignment with current and relevant regulations;

• Wrote and established documented training procedures for company;

• Established training records for all internal SIGA personnel

• Wrote and trained personnel on Standard Operating Procedures;

• Trained and encourage other departments in establishing and writing critical SOPs for their areas;

• Conducted GxP audits for CMC facilities, clinical sites, testing facilities and toxicological labs;

• Established criteria and wrote SOPs for vendor qualification and verification;

• Conducted assessment visits for vendor qualification and verification;

• Resourced and hired outside consultants to provide internal review of SIGA for NIH purposes;

• Reviewed and edited all Quality Agreements between SIGA and various vendors;

Alcon Laboratories, Inc. July 2000 to April 2008

Fort Worth, Texas

Director Regulatory Affairs, ENT and Generics

Recruited by Alcon to start a new product line. The company had several opportunistic compounds that could be developed into otic and nasal applications. Filed 10 INDs, received 7 NDA approvals. Responsible for negotiating all products labeling with FDA meeting Alcon Marketing expectations and usually exceeding expectations. Filed applications (dossiers/MAA) all over the world supporting approvals in Europe (EU), South Africa, Switzerland, Australia, New Zealand, Canada and ROW countries. The newly established otic / nasal product line went from $0 in 2000 to earnings in late 2007 in excess of $360 million (US only). Approved NDAs include: Cipro HC Otic, Ciprodex Otic Suspension, Ciloxan Solution, Vigamox, Travatan Z, Navanac and Patanase Nasal Spray.

Responsibilities Include:

• Preparation and filing of all INDs, NDAs, ANDAs and associated amendments, supplements, and annual reports,

• Involved in developing a new therapeutic line of products for Alcon which has been exclusively an ophthalmic company;

• Responsible for all meetings and communications with FDA and other International Regulatory Agencies;

• Responsible for all EU and National filings of new products and product support of existing ENT product line abroad;

• Responsible for departmental planning, strategic goals, interim reviews, weekly, monthly and yearly reports;

• Responsible for managing and mentoring personnel (5 direct reports);

• Responsible for keeping abreast of the latest Regulatory developments with competitors;

• Responsible for keeping up to date with the latest Regulatory Guidance’s, Rules, Regulations including International Guidances and Regulations;

• Responsible for teaching, informing and communicating to Project Teams and Senior Management new Regulations and Regulatory strategic plans;

• Responsible for searching Summary Basis of Approvals of competitors;

• Work closely with Medical Information Group, MSDs and Marketing Product Managers in reviewing all journal articles, convention / academy posters, slide shows, forums, etc.;

• Responsible for devising and strategizing development plans for new products;

• Responsible for working with Legal, formulations and MSDs to develop patents, strategize long range patent protection and file appropriate patents;

• Work closely with Legal on contracts with investigators and problematic issues dealing with investigators, products, consumers, research institutions, vendors, etc.;

• Brief departments, teams and individuals on changes implications of federal, state and International regulations;

• Work with Regulatory Compliance Group to assure FDA, Vendor and contractor audits meet Regulatory Agency expectations;

• Review and approve all labeling for US and International submissions;

• Review and approve all Marketing and Promotional materials including press releases (DDMAC materials);

• Work with manufacturing (US and International) to optimize efficiency and cost saving procedures as well as trouble shoot problematic products;

PathoGenesis Corporation December 1998 to 2000

Seattle, Washington

Manager Regulatory Affairs

Filings included approval for first inhaled Anti-Infective for the treatment of Cystic Fibrosis (Tobi). Additional programs included compounds for Bronchitis, Ventilator Acquired Pneumonia and Cystic Fibrosis. Company also had several Biologics in development at the time it was sold to Chiron.

Steris Laboratories June 1998 to September 1998

Phoenix, Arizona

Senior NDA Submission Specialist III

Company went under an FDA Consent Decree shortly after being hired due to numerous 483 observations and repeated Warning Letters. Worked with Lachman Consultant Group on answering 483 observations and implementing corporate Quality Systems.

Geneva Pharmaceuticals, Inc. June 1993 to June 1998

Broomfield, Colorado

Senior Regulatory Associate II

Geneva was Novartis’ Global Generics group now known as Sandoz. Our group was instrumental in recognition of good Generic fits for our organization. Performing the necessary Bioequivalence and Bioavailability studies, formulation, patent evaluations and all CMC work. During my time with Geneva I filed 17+ ANDAs a few INDs and 1 NDA.

H N Norton Company February 1990 to June 1993

Shreveport, Louisiana

Regulatory Affairs Associate

Stability Manager

Small Generic company bought out by IVAX. We also did a few 510(k)s, OTCs as well as numerous generic (ANDA) cough, cold and pain products.

Education

Texas A&M University 1982-1984

College Station, Texas

Masters – Physiology

William Woods College 1978-1982

Fulton, Missouri

Bachelor of Science – Chemistry and Biology

Contact this candidate