Manager Training
Resume:
Malou Gemeniano, PhD
Regulatory Affairs, Manager
**** ***** **** ***, ******* Ca. 94002
**********@*******.***
Summary
Regulatory Affairs Professional with experience in small molecules and
biologics used in oncology clinical trials. Expertise and training in
review of Biologics. Eight years of Regulatory Affairs experience both in
the FDA (as a Product Reviewer) and in Industry (as Regulatory Affairs
Manager).
A highly-motivated and detailed-oriented regulatory professional who has
developed the following skills:
. Thorough comprehension of the scientific and regulatory requirements for
the successful development of drug products (both small molecules and
biologics).
. Demonstrated competency in the organization and composition of high-
quality regulatory dossiers.
. Proven ability to communicate complex technical topics to a broad range
of individuals, both in writing and verbally.
. Capacity to interpret and resolve regulatory compliance issues.
. Proficient at prioritizing and managing multiple projects simultaneously
while meeting established timelines.
. Adept at working both autonomously and as an integral component of a
team.
Employment
Abraxis BioScience, Los Angeles, CA. (2008-present), Manager, Global
Regulatory Affairs
. Primary regulatory lead for the development of Abraxis' Biologics and IVD
(In-Vitro Diagnostics) programs. Participated in new product development
teams and due diligence activities as designated regulatory
representative. Collaborates with industry thought leaders and other
consultants on the formation of regulatory strategies. Negotiated
obligations and timelines. Composes and maintains development documents
including strategy plans, target product profiles and white papers.
. Responsible for authoring, compositing and submitting CMC sections of
regulatory dossiers (PAS, CBE-30, Annual reports) to FDA and Global
Regulatory Agencies in support of on-going development activities of
commercial product, Abraxane (Small Molecule). Performed Global
Regulatory assessments of change controls.
. Represents regulatory interests in cross-functional project teams
meetings. Works jointly with third party manufacturers and contract
research organizations during formulation development and manufacture of
clinical trial material. Reviews and approves protocols and technical
documents.
. Executed Regulatory functions of on-going IND (IND information amendments
and Annual Reports) and NDA activities. Served as regulatory inter-
departmental projects meetings. Secured timelines and coordinate receipts
of deliverables for regulatory submission. Provided regulatory guidance.
Engaged in written and verbal communications with FDA, submitted meeting
requests, drafted information packages and recorded minutes.
The Food and Drug Administration (FDA), Center for Biologics Evaluation and
Research (CBER Research), Office of Cellular, Tissue and Gene Therapies,
Rockville, MD. (2002 to 2008). Product/CMC Reviewer and research
Regulatory:
. CBER Expert reviewer on lentiviral and retroviral vectors used in
oncology indications. Additional review experience includes peptides,
adenoviral, DNA plasmid vectors, stems cells and combination (device /
biologic) products.
. Primary reviewer responsible for review and management of over 65 INDs
(biologic), IDEs (device), Master Files and their Amendments - including
original submissions, adverse events and annual reports, manufacturing
protocol deviations, quality control/assurance, comparability/stability
protocols and product release testing parameters.
. Review Pre-IND, IND, Pre-BLA(Phase 1, Phase 2 and Phase 3), IDEs and
Master File submissions for cell and gene therapy clinical trials
ensuring product is manufactured and tested using scientifically
sound principles, in compliance with pertinent FDA laws, regulations
and agency policies as well as ICH guidelines.
. Lead and participated in various formal and face to face meetings
with the regulated industry to provide guidance on regulatory
compliance, risk management, manufacturing SOPPs and CMC issues.
Provided regulatory direction and strategy for various cell and gene
therapy products.
. Proven track record of writing comprehensive memos, recommending and
defending regulatory courses of action to upper management and
communicating regulatory decisions to sponsors.
. Developed a tiered, risk-based approach to lot release testing
requirements for products utilizing lentiviral vectors.
. Lead and coordinated Team Biologics Inspectional training material
regarding the regulatory policy for Gene Therapy products.
. Participated in various Working Groups (Xenotransplantation working group
and Office of Vaccines Inter-Office Adjuvant working group). Served as
FDA liaison to HHS Interagency working group on issues related to the use
of lentiviral vectors in neurological indications. Co-Authored Guidance
for Industry: For Submission of Early Phase Clinical Trials for Somatic
Cell and Gene Therapies.
Additional Regulatory training and/or activities:
Basic Food and Drug Law Course, CBER Biologics Law Course, FDA/CBER
Reviewer Training, Inspection Training for Product specialist, Regulatory
Site Visit Training, Device Reviewer Training.
The United States Patent and Trademark Office, Gene and Cell Therapy Art
Unit (Patent Examining).
. Examination, searching and prosecution of Gene and Cell Therapy related
patent applications.
. Analysis of patentability of biotechnology inventions according to US
statues 35 U.S.C. 101 (Patentable Subject matter), 102 (Prior Art), 112
(Enablement and Definitiveness) and 103 (Obviousness).
Scientific: (CBER/FDA Research)
. Managed and trained junior research staff (2).
. Assess the public health risk by understanding the entry mechanisms
of porcine endogenous retrovirus (PERV) on human cells. Elucidated
determinants on PERV surface protein (SU) important for human cell
infection by constructing chimera PERV surface protein envelopes.
. Developed and performed a flow-cytometry based assay to measure PERV SU
protein binding to human cells, site-directed mutagenesis to identify the
specific amino acid(s) in the SU that may confer binding or post-binding
steps on human cells and infectivity assays on PERV pseudotyped viruses
carrying mutations in SU.
Microbiology Graduate Program, University of California, Davis,
Department of Medicine, School of Veterinary Medicine, (1996-2002) Pre-
Doctoral candidate
. Elucidated the function of Feline Immunodeficiency Virus (FIV)
accessory protein, Orf-A, by constructing FIV viral-vectors
carrying mutations in orf-A and identifying domains that are
necessary for retroviral replication, transcription and
infectivity.
. Optimized protein expression of Orf-A in mammalian and
bacterial systems and created cell lines carrying viral
elements; performed fluorescence microscopy to demonstrate
nuclear localization properties of FIV Orf-A and site-
directed mutagenesis to identify a nuclear localization
signal.
. Protein purification of Orf-A using various chromatographic
and centrifugation techniques. Developed and optimized
quantitative assays to measure viral transcription, DNA
integration and infectivity
EDUCATION
Ph.D. Microbiology, University of California, Davis. October 2002
Dissertation: Functional Characterization of OrfA of Feline
Immunodeficiency Virus.
B.A. Molecular, Cellular and Developmental Biology, University of
California, Santa Cruz. Undergraduate Thesis: Isolation and
Identification of Vacuolar ATPase Mutants in Neurospora crassa.
B.A. Psychology, University of California, Santa Cruz.
Awards and Fellowships
2007 Award for excellent review of Lentiviral/retroviral IND
submissions within tight deadlines and heavy workload
2007 Recognition for the development and coordination of Team Biologics
training material on Gene Therapy
1997-2001 National Research Service Award (NRSA) Pre-Doctoral
Fellowship
2001 AIDS Vaccine Conference 2001 travel award
1995 National Institute of Diabetes and Digestive Kidney Disease (NIDDK)
Travel Award
1994 Minority Access to research Careers (MARC) scholarship
Publications
Gemeniano MC, Mpanju O, Salomon D, Eiden MV, Wilson CA. The infectivity and
host range of the ecotropic porcine endogenous retrovirus, PERV-C, is
modulated by residues in the C-terminal region of its surface envelope.
Virology (2006) Nov 22.
Gemeniano MC, Sawai ET, Sparger EE. Feline immunodeficiency virus Orf-A
localizes to the nucleus and induces cell cycle arrest. Virology. 2004 Aug
1;325(2):167-74.
Gemeniano MC, Sawai ET, Leutenegger CM, Sparger EE. Feline immunodeficiency
virus ORF-A is required for virus particle formation and virus infectivity.
J Virol. 2003 Aug;77(16):8819-30.
Presentations:
Chair for Plenary Workshop titled: "Challenges of Personalized
Medicine: Characterization and Control" at the Well Characterized Biologic
Product (WCBP) conference (CASSS) 2008, Washington DC
Gemeniano MC, Havert M., Vatson, R, Bi L Introduction to Gene Therapy
-regulatory perspective. Team Biologics Training update 2007 CBER/FDA.
Gemeniano MC, Mpanju O, Wilson CA. Analysis of binding and infectivity
properties of two receptor classes with PERV. 2004 Viral Entry Conference,
Frederick, MD.
Gemeniano MC, Mpanju O, Wilson CA. Development and Use of a binding Assay
to study entry of Porcine Endogenous retrovirus PERV-A and PERV-C. 2004 FDA
Science Forum, Washington D.C. and at the 2003 NIH Research Festival,
Bethesda, MD.
References
Kimberly Benton, Ph.D, Deputy Director of Office of Cell and Gene Therapy,
FDA/CBER,
Onemo Mpanju, Ph.D Associate Director of Regulatory Affairs, PPD.
Dan Takefman, Ph.D, Branch Chief of the Office of Gene Therapy, FDA/CBER
Ralph Yamamoto, Ph.D Associate Director of Product Development, Abraxis
BioScience
Martha Riddle, Director of Regulatory Affairs, Abraxis BioScience
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