True North Synergy Inc.

West Vancouver, BC, Canada
Phone: (604) 922-1045
Fax: (604) 922-0282
Email: amancini@truenorthsynergy.com
Regulatory Experience

Over 30 years, Alexandra Mancini has led numerous regulatory meetings with the US Food and Drug Administration, the Canadian Therapeutic Products Directorate, and Regulatory Authorities across Europe. Meetings have encompassed all areas of Regulatory Affairs (preclinical, clinical, chemistry, manufacturing & controls).

Specific Regulatory Approval Applications:

NIPENT® (pentostatin) for Hairy Cell Leukemia, Parke-Davis Pharmaceutical Research Division, Warner-Lambert Co

Wrote major portions of the regulatory approval applications (US New Drug Application and European Marketing Authorisation Application), including individual clinical study reports, Integrated Summaries of Effectiveness and Safety, Benefit/Risk Assessments, Package Inserts, and Expert’s Reports.

PHOTOFRIN® (porfimer sodium) for Esophageal and Lung Cancers, QLT PhotoTherapeutics Inc

Led the clinical data evaluation, summarization, and defense of the PHOTOFRIN applications in the US, Canada, France, Germany, the UK, and Finland for esophageal and lung cancers.  In the US, the esophageal cancer filing was a drug-device combination-product submission, consisting of one New Drug Application for PHOTOFRIN and three Pre-Marketing Authorizations (2 lasers and 1 fiber optic). Led all activities in preparation for the US FDA Oncologic Drugs Advisory Committee meetings and personally presented and defended at those meetings.

VISUDYNE® (verteporfin) for Age-Related Macular Degeneration, QLT PhotoTherapeutics Inc

Overall regulatory lead and additionally led the clinical efficacy data summarization for the VISUDYNE global marketing applications for age-related macular degeneration. This was a drug-device combination product application with a new chemical entity and associated diode lasers.

Marqibo® (liposomal vincristine), INEX Pharmaceuticals Corporation

Led the clinical data evaluation and medical writing for the pivotal trial in non-Hodgkin’s lymphoma, which formed the basis of a US New Drug Application (NDA) and a Canadian New Drug Submission (NDS). Led all regulatory meetings (>40) with the US Food and Drug Administration, the Canadian Therapeutic Products Directorate, and Regulatory Authorities in the United Kingdom, France, Germany, Spain, Belgium, the Netherlands, Denmark, and Sweden. Led all activities in preparation for the US FDA Oncologic Drugs Advisory Committee meeting and personally presented and defended at that meeting.

Key Public Regulatory Defenses:

FDA Oncologic Drugs Advisory Committee defenses for PHOTOFRIN® (porfimer sodium) for Injection for use in photodynamic therapy

  1. Palliation of esophageal cancer, Rockville, Maryland, September 12, 1994.
    Recommended for approval.
  2. Curative treatment of superficial endobronchial cancer, Bethesda, Maryland, September 18, 1997.
    Recommended for approval.
  3. Palliation of endobronchial cancer, Bethesda, Maryland, September 2, 1998.
    Recommended for approval.

FDA Oncologic Drugs Advisory Committee Meeting defense for Marqibo® (vincristine sulfate liposomes injection)

  1. Treatment of patients with aggressive non-Hodgkins lymphoma previously treated with at least two combination chemotherapy regimens, Silver Spring, Maryland, December 1, 2004.
    Not recommended for accelerated approval.