EXPERTISE
- Eighteen
years experience in Regulatory Affairs for Vaccines, Biologics
and Drugs
- Regulatory
strategy, assessment and competitive analysis for drug development
and licensure
- Regulatory
Liaison for FDA and EMEA regulations, guidance and meetings
- Application
of pharmacogenomics and biomarkers for clinical and regulatory
decision making
- IND,
BLA, NDA, VGDS reviews and due diligence
- Management
of regulatory workshops, stakeholder communications and
alliances
|
EDUCATION:
| Ph.D. |
Zoology,
University of Maryland, College Park, MD. |
| M.S. |
Zoology,
University of Maryland, College Park MD |
| M.S. |
Biology,
Villanova University, Villanova, PA |
| B.A. |
Biology,
Saint Vincent College, Latrobe, PA |
EXPERIENCE:
CURRENT
POSITION Feb. 2008 to present: |
|
Senior
Consultant, Biologics
Consulting Group, Inc., Alexandria, Virginia.
- During 2008 and 2009 provided regulatory affairs support for small and large pharmaceutical companies developing vaccines, biologics, drugs or IVDs. Specific projects included:
- Vaccines: (DNA, Viral and Bacterial): pre-IND meeting strategy, preparation and liaison functions; IND CMC writing; eCTD CMC writing for International Dossier; project management and preparation of eCTD IND; WHO Prequalification Submission strategy and review of chapters
- Biologics (antibody, tumor inhibitors): regulatory strategy, guidance, review of type C meeting package
- Drugs (oncology, antiviral): Regulatory Liaison for clinical development; regulatory advisor for pharmacogenomics and voluntary exploratory data submission for biomarker
- Devices (In vitro diagnostic test): Regulatory advisor and Liaison for Molecular Diagnostic Company for Pharmacogenomic test; and Voluntary Exploratory Data Submission for PG biomarker
- Application of pharmacogenomics in regulatory and clinical decision making; Application of pharmacogenetic diagnostic testing and personalized medicine;
- Steering Committee Member of Pharmacogenomic regulatory workshop
|
| |
|
|
| July
2006 - Jan 2008 |
|
Senior
Director & Therapeutic Area Head, Global Regulatory
Affairs, Wyeth Research, Vaccines. Collegeville,
PA and Blue Hill, NY
- Directed
Vaccine Research Group of 4 to 6 regulatory strategists
(Sr. Manager to Director) for vaccine products in
discovery to early and late clinical development,
and for marketed vaccines
|
| |
|
|
| June
2001 - June 2006 |
|
Director
II, Global Regulatory Affairs, Wyeth Research, Collegeville,
PA
- Regulatory
Affairs strategist and manager for investigational
antiviral, cardiovascular and monoclonal antibody
products
- Regulatory
Liaison for Translational Medicine Group that explores
pharmacogenomics, pharmacogenetics in the clinic to
define biomarkers that are predictive of drug response
and new targets for discovery research - including
six therapeutic areas
- Regulatory
Liaison with FDA on developing regulatory workshops
and guidance for pharmacogenomics
- Prepared
and submitted three Voluntary Genomic Data Submissions
- Chair
of the Pharmacogenetics Working Group consisting of
21 international companies engaged in pharmacogenomic
research (www.pharmacogeneticsworkinggroup.org)
- Member
of the PhRMA Genomics Technical group
- Member
of Wyeth Translational Medicine Review Board, and
Wyeth Bioethics Committee
|
| |
|
|
| Feb.
1997 - June 2001 |
|
Director,
Biologics Licensing, Merck & Co., Inc., Manufacturing
Division, West Point, PA.
- Direct
preparation, submission, and filing strategy for Chemistry
and Manufacturing changes to marketed and developmental
vaccines
- Support
all vaccine registration activities worldwide, with
emphasis on CBER and European registration procedures
- Liaison
with review officials; Director for group of 9 to
31 staff
|
| |
|
|
| Jan.
1996 - Feb. 1997 |
|
Director,
Regulatory Liaison, Worldwide Biologics and Vaccines,
Merck & Co., Inc., Merck Research Laboratories,
West Point, PA.
- Directed
mutual recognition approval of a viral vaccine in
European countries after obtaining licensure in the
reference member state
- Directed
licensure of a bacterial vaccine in U.S.
- Direct
Liaison with WHO, CBER, European Agencies on development
of guidelines for DNA vaccines and gene therapy
|
| |
|
|
| Jan.
1994 - Dec. 1995 |
|
Director,
Europe, Regulatory Liaison, Worldwide Biologics and
Vaccines, Merck & Co., Inc., Merck Research
Laboratories.Starnberg (Munich) Germany.
- Two
year assignment in Germany managing regulatory affairs
in Europe for all MRL vaccines in development (pre-clinical,
clinical and Chemistry Manufacture and Control)
- Directed
registration of Hepatitis A vaccine in the first country
in the world for Merck & Co. and the first approval
by the mutual recognition procedure in Europe.
- Provided
key regulatory support to our European Clinical group
and the Aventis Pasteur Merck Vaccine Joint Venture,
Lyon, France
- Developed
working relationships with national control agencies
|
| |
|
|
| Jan
1990 - Dec 1993 |
|
Associate
Director, Regulatory Liaison, Worldwide Biologics and
Vaccines, Merck & Co., Inc., Merck Research
Laboratories.
- Represented
MRL as an agent in matters of FDA registration and
licensure of biologics, vaccines, antibiotics and
antivirals.
- Directed
regulatory approval of one antibiotic and 30 antibiotic
supplements for efficacy , labeling or manufacturing
changes
- Submitted
over 15 IND's for bacterial vaccines, and a recombinant
protein.
|
| |
|
|
| Jan.
1981 - Dec. 1989 |
|
Senior
Project Biologist, Merck & Co., Inc., Merck
Manufacturing Division
- Provided
technical support to Biological Quality Control, Production,
Analytical Development, International Technology Transfer
projects including on site evaluations in Taiwan,
Korea and Egypt
|
| |
|
|
| June
1973- Dec 1980 |
|
Senior
Research Virologist, Merck Research Laboratories,
Merck & Co., Inc.
- Developed
vaccines for feline leukemia virus and Herpes simplex
types 1 and 2. Tested and published first sub-unit
vaccine for feline leukemia
|
| |
|
|
| 1969-
1973 |
|
Senior
Technician, Associate Scientist and Associate Investigator,
Microbiological Associates, Bethesda, MD |
|
PROFESSIONAL
SOCIETY MEMBERSHIPS/ACTIVITIES
- Regulatory
Affairs Professional Society
- Received
special recognition award in 1995 for organizing
the first international conference in Barcelona,
Spain
- Chaired
the biologics sessions in Vienna, in 2000
- Drug
Information Association
- Past
chair of the Pharmacogenetics Working Group
(PWG)
- Chaired
several DIA sessions on pharmacogenomics
- PhRMA
Genomics TG member
- Co-chaired
three major FDA/Industry workshops in Pharmacogenomics
and Drug Development.
|
| SELECTED
PRESENTATIONS |
| Dec
11, 2007 |
Fourth
Workshop on Pharmacogenomics in Drug Development
and Regulatory Decision Making, Bethesda,
MD. Pharmacogenomics: Five Years of Progress |
| June
21, 2006 |
DIA
Annual Meeting, Philadelphia, PA. Impact
of "regulatory" initiatives on use
of Pharmacogenomics |
| May
24, 2006 |
2006
Rozman Symposium, Drug Metabolism Discussion
Group, Langhorne, PA. Pharmacogenomic Initiatives
in Global Drug Development. |
| March
7, 2006 |
DIA
Euro Meeting, Paris, France. Impact of
PGx Regulatory Initiatives. |
| Nov
18, 2005 |
Medical
College of Wisconsin, Pharmacogenomics, Proteomics,
Pharmacology Toxicology Forum, Milwaukee,
WI. Pharmacogenomics for Drug Discovery
and Patient Management. |
| May,
24 2005 |
CHI
Biomarkers for Molecular Diagnostics Translation
from Discovery to the Clinic, Philadelphia,
PA. Genomic Biomarkers in Drug Development
and Regulatory Decision-Making. |
| Apr
11, 2005 |
Pharmacogenomics
in Drug Development and Regulatory Decision
Making - Workshop 3, Bethesda, MD. Overview
of FDA/Industry Pharmacogenomics Workshops. |
| Oct
5, 2004 |
R
& D Leaders Forum. Phacilitate, Geneva,
Switzerland. FDA Pharmacogenomics Guidance.
Impact on Drug Development. |
| Sept
18, 2004 |
Japanese
Society of Clinical Pharmacology and Therapeutics,
Shizuoka, Japan. FDA Pharmacogenomics Guidance:
Impact on Drug Development |
| June
17, 2004 |
DIA
Annual Meeting, Washington, DC. Developing
the Regulatory Pathway for Pharmacogenomics:
FDA and Industry Open Dialogue. |
| Mar
11, 2004 |
DIA
Euro Annual, Prague, Czech Republic. Pharmacogenomic-Guided
Drug Development: Regulatory and Research
Policy Perspectives - Industry Perspective. |
| Feb
19, 2004 |
II
R Conference, London UK. Regulatory Developments
in Pharmacogenomic Data Submissions. |
| June
17, 2003 |
DIA
Annual Meeting, San Antonio, TX. PWG Response
to "Safe Harbor" Proposal and Examples
of Data Submissions |
| Feb
26, 2003 |
ICDD,
Barton Creek, Austin, TX, Pharmacogenetics
Working Group Comments on an FDA Proposal
of "Safe Harbor" for Pharmacogenomic
Data |
| April
17, 2002 |
PhRMA
Biologics and Biotechnology, Scottsdale, AZ, Regulatory Environment Facing Pharmacogenomics
in Drug Development |
|
|
|
SELECTED
PUBLICATIONS
-
FW Freuh, RA Salerno, LJ Lesko, RD Hockett. 4th US FDA-Drug Information Association Pharmacogenomics workshop, held 10-12 December, 2007. Pharmacogenomics (2009) 10 (1), 111-115
-
RA Salerno, LJ Lesko. Three years of Promise, Prosposals, and Progress on Optimizing the Benefit/Risk of Medicines: A Commentary on the 3rd FDA-DIA-PWG-PhRMA-BIO Pharmacogenomics Workshop. The Pharmacogenomics Journal (2006) 6, 78-81
-
RA Salerno. Improving Efficacy, Safety with Pharmacogenomics. Drug Discovery & Development 8 (12) 48, 2005
-
RA Salerno. Pharmacogenomics Advancing the Science. PharmaVoice, November, 2005.
-
RA Salerno. Pharmacogenomics in Drug Development. Genetic Engineering News 25 (12) 14, 2005
-
RA Salerno. Post-Guidance Pharmacogenomics.. Pharmacogenomics Reporter. April 21, 2005.
-
RA Salerno. FDA Pharmacogenomics Guidance: Impact on drug development. Clin Eval 32 (1) 2005 (published in Japanese in Japan)
-
RA Salerno. Developing the Regulatory Pathway for Pharmacogenomics. Regulatory Affairs Focus (2004) 9 (8) 12-15.
-
RA Salerno, LJ Lesko. Pharmacogenomic Data: FDA voluntary and required submission guidance. Pharmacogenomics (2004) 5(5), 503-505
-
RA Salerno, LJ Lesko. Pharmacogenomics in Drug Development and Regulatory Decision-Making: The Genomic Data Submission (GDS) Proposal. Pharmacogenomics (2004) 5(1), 25-30
-
LJ Lesko, RA Salerno, BB Spear, DC Anderson, T. Anderson, C Brazell, J Collins, A Dorner, D Essayan, B Gomez-Mancila, J Hackett, SM Huang, S Ide, J Killinger, E Mansfield, R Meyer, S. Ryan, V Schmidth, P Shaw, F Sistare, M Watson, A Worobec. Pharmacogenetic and Pharmacogenomics In Drug Development and Regulatory Decision Making: Report of the First FDA-PWG-PhRMA-DruSafe Workshop. J of Clinical Pharmacology (2003) 43 (4) 342-358
-
DC Anderson, B. Gomez-Mancilla, BB Spear, DM Barnes, K Cheesman, PM Shaw, J. Friedman, A McCarthy, C Brazell, SC Ray, D McHale, L Hashimoto, R Sandbrink, ML Watson, RA Salerno, N Cohen, CE Lister. Elements of informed consent for pharmacogenetic research; perspective of the pharmacogenetics working group. The Pharmacogenetics Journal (2002) 2, 284-292.
-
RA Salerno, C ODELL, JMcCauley, R Manicinelli, W Morges, A Gray. Quantitative analysis of 23 –valent Pneumovax by automated rate Nephelomety. Journal of Biological Standardization (1984) 12, 447-450
-
RA Salerno, VM Larson, AH Phelps, MR Hilleman. Infection and Immunization of Cats with the Kawakami-Theilen Strain of Feline Leukemia Virus. Proc of the Society for Experimental Biology and Medicine (1979) 160, 18-23
-
RA Salerno, ED Lehman, VM Larson, MR Hilleman, Feline Leukemia Virus Envelop Glycoprotein Vaccine: Preparation and Evaluation of Immunizing Potency in Guinea Pig and Cat. J Natl. Cancer Inst (1978) 61(6), 1487-1493
-
RA Salerno, GM Ramm, CE Whitmire. Chemical Induction of Subcutaneous Tumors in BALB/c and Swiss Mice infected with Wild Type C-RNA Viruses Derived from BALB/C Tissues. Cancer Research (1973) 33 69-77
-
RA Salerno, CE Whitmire, IM Garcia, RJ Huebner. Chemical Carcinogenesis in Mice Inhibited by Interferon. Nature New Biology (1972) 239, 31-32
Conference
Organizing Committees: 2001 - 2006
| Date |
Meeting |
Location |
Role |
| June
21, 2006 |
DIA
Annual Meeting. Session. Pharmacogenetics: FDA/EMEA |
Philadelphia,
PA |
Session
Chairperson |
| Mar
7, 2006 |
DIA
Euro Annual Meeting. Session 4. Biomarkers:
Preclinical, Clinical, Exploratory and Confirmatory
use |
Paris,
France |
Session
Chairperson |
| Feb
13-16, 2006 |
ICCD:
Increasing the success rate of the Critical Path
To Drug Development. Session Theme: A new clinical
trial continuum- Efficacy Biomarkers and Clinical
Endpoints |
Barton
Creek
Austin, TX
|
Session
Moderator, and Conference Planning Committee |
| Oct
6-7, 2005 |
FDA,
DIA, PhRMA, BIO, NIH, PWG Application and Validation
of Genomic Biomarkers for Use in Drug Development
and Regulatory Submissions |
Bethesda.
MD |
Organizing
Committee |
| May
24, 2005 |
CHI Biomarker World Congress 2005.
Track 4 Regulatory Acceptance of Biomarkers
|
Philadelphia,
PA
|
Track
chair |
| Mar
7-9, 2005 |
DIA
Euro Annual: Session 8. Applications of Pharmacogenomics-
Challenges of Parallel Diagnostic and Drug Development |
Lisbon,
Portugal |
Session
Chairperson |
| Apr
11-13, 2005 |
FDA,
DIA, PWG, PhRMA, BIO: Pharmacogenomics in Drug
Development and Regulatory Decision Making - Workshop
3
Three years of promise, proposals and progress on
optimizing the benefit/risk of medicines
|
Bethesda,
MD |
Steering
Committee Co-chairperson |
| Feb
14 -17, 2005 |
ICDD:
Challenge and Innovation on the Critical Path to
Drug Development |
Barton
Creek, Austin, TX |
Conference
Planning Committee |
| Oct
4, 2004 |
Phacilitate:
R&D Leader's Forum:
How can your organization build an optimal relationship
with the regulators
|
Geneva,
Switzerland |
Plenary
Session Chair |
| July
29, 2004 |
FDA,
DIA, PhRMA: Co-Development of Drug, Biological,
and Device Products. |
Arlington,
VA |
Program
Co-Chairman |
| Feb
23-26, 2004 |
ICDD:
Innovation, Efficiency and Predictability of Drug
Development;
Session- FDA's Risk Minimization Initiatives
|
Barton
Creek, Austin, TX |
Conference
Planning Committee and Session Moderator |
| Nov
13-14, 2003 |
FDA,
PWG, PhRMA, BIO, DIA: Pharmacogenomics in Drug
Development and Regulatory Decision Making: The
Genomic Data Submission Proposal |
Rockville,
MD |
Steering
Committee Co-Chairperson |
| May
16-17, 2002 |
FDA,
PWG, PhRMA, DIA: Pharmacogenetics and Pharmacogenomics
in Drug Development and Regulatory Decision Making:
First FDA-PWG-PhRMA-DruSafe Workshop |
Rockville,
MD |
Steering
Committee Co-Chairperson |
Page
Updated:
December 24, 2009
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