LINDA D. RHEIN, PH.D.

Permanent Address: 300 Woods Run Road

Muncy, PA 17756
Local Address: Vale Road
Whippany, NJ
Home Phone- 570-546-3920
Work Phone- 973-487-2981
Cell- 570-337-3424
PROFESSIONAL OBJECTIVE: Industrial R&D Scientific Leadership Position
- Therapeutics for Rx or OTC in medical affairs, clinical development
and/or pharmacovigilance
EDUCATION:

B.S. 1970 Chemistry, University of Maryland, College Park, Maryland

M.S. 1972 Biochemistry & Neurobiology, University of Maryland, College
Park, Maryland
Ph.D. 1976 Biochemistry & Neurobiology, University of Maryland,
College Park, Maryland
Postdoctoral Neurobiology Research: Biochemical Mechanisms of
Olfaction, University of
Training Pennsylvania, Monell Chemical Senses Center,
1977-1980 Philadelphia, Pennsylvania
SUMMARY OF INDUSTRY EXPERIENCE:
25^+ years experience in R&D research functions in fields of topical
medications, antimicrobials /antifungals, nasal decongestants and
analgesics for both Rx and OTC indications with pharmaceutical,
cosmetic, personal care, and feminine care companies along with
experience in fundamental applied research in dermatology. Have
technical and managerial experience with clinical development, medical
affairs and in global pharmacovigilance functions. Have managed as
many as 16 staff in 3 departments ranging from Ph.D. chemists /
biochemists, MDs, pharmacologist, clinicians, product development
chemists /engineers, and administrative staff. Have had responsibility
for full efficacy and safety programs for securing FDA approval of new
sunscreens, including the preparation of clinical, pharmacokinetic and
toxicology sections of 4 NDAs for a new chemical entity (sunscreen)
now approved and marketed. Have led clinical development of the
successful Rx to OTC switch of a single dose vaginal candidiasis
topical medication, switch of an antidandruff shampoo, and a nasal
decongestant. Have led clinical Rx and OTC programs for antifungals
for cutaneous fungal infections including Athlete's foot, jock itch,
onychomycosis, antiviral clinical trials for cold sores, and
treatments for acne, antibacterials, dry skin, stretch marks, eczema,
psoriasis and topical and oral analgesics. Have led clinical
development function conducting sensory trials that substantiated
early relief of cold sores for a topical antiviral, results praised by
the FDA. Have led development of 7 marketed Oxy acne treatment
products on a superior mildness platform based on clinical and sensory
(perceived) mildness. Have global experience preparing CTD submissions
and in global drug safety pharmacovigilance including assessment of
cases, signal detection, and preparation of Annual Reports, PSRs,
PSURs, Addendum Reports and Summary Bridging Reports, 120 Safety
Update Reports, for EU Health Authorities and FDA and responding to
queries.
PROFESSIONAL ACHIEVEMENTS:
Have achieved global recognition of research contributions in
understanding first time, skin lipid and sebum biophysical structure
and role in barrier function/repair and for mechanisms of
surfactant/soap damage of skin, prevention and repair. Authored over
50 publications, edited 3 books and presented over 25 invited lectures
world wide. Received numerous awards, the most prestigious were
Society of Chemist's Literature Award and Merit Award, am past editor
of Journal of Cosmetic Science, Society of Cosmetic Chemists
Monographs and elected President of Society of Cosmetic Chemists in
2008, serving a 3 year term. Was 4 years an Adjunct Professor of
Biochemistry Fairleigh Dickinson University graduate school teaching
Biochemistry and Basic Metabolism.
DETAILS OF EXPERIENCE:
2007 Deputy Director, Drug Safety
to present Bayer HealthCare, P.O. Box 1000, Montville, NJ 07045-1000
Leading scientific assessments of drug safety and pharmacovigilance
information for Global Consumer Care OTC products - both Rx and OTC
dermatologics and analgesics.
* Responsible for safety of over 40 Rx dermatologics and 3 major OTC
analgesics for global pharmacovigilance
* Prepare drug safety submissions (Annual Reports, PSRs, PSURs,
Addendum Reports and Summary Bridging Reports) for Health
Authorities including the EU and FDA.
* Monitor and identify potential safety issues and implement the
appropriate actions, e.g. label change, reporting to health
authorities and respond to health authorities inquiries.
* Prepare company core data sheets and justifications for labeling
changes
2006 Associate Director, Clinical Research and Medical Affairs
to Novartis Consumer Health, 200 Kimball Dr, Parsippany, NJ 07054
2007
Leading US and international clinical research and claims support
programs for OTC, NDA, and CTD submissions for topical drugs and
cosmetic products.
 * Designed and implemented clinical efficacy and safety trials for
Lamisil antifungal for single dosing regimens and combination
products. Preparing ICH clinical protocols that would satisfy all
requirements of FDA and EU regulatory authorities.
* Have prepared clinical efficacy, safety and pharmacokinetics
sections of CTD for new indication for Lamisil submitted to
regulatory authorities in the EU. Prepared briefing books, PIs,
etc. in preparation for FDA meetings.
* Identifying strategic opportunities in topical, treatment
strategies for cutaneous diseases such as fungal infections,
vaginal candidiasis, wart freeze-off treatments, stretch marks and
aging and dry skin, both for cosmetic and pharmaceutical products.
* Developed claims support platforms for approval of claims
substantiation for OTC monograph and NDA drugs and companion
cosmetic treatment products; label copy review/sign off.
2002 to Adjunct Professor, Fairleigh Dickenson University, for MS in
Cosmetic

2006 Science Program

Teaching required graduate course in Skin, Hair and Nail Biochemistry
and Metabolism for students pursuing a Masters in Cosmetic Science.
2002 to Director, Drug Approvals Group
2006 L'Oreal USA, 30 Terminal Ave., Clark, NJ 07066
Leading all medical and clinical aspects of OTC and NDA drug clinical
research for L'Oreal USA as head of drug clinical operations. Position
has 1 regulatory administrative assistant and 1 regulatory scientist
reporting in.
* Have written and lead the preparation and assimilation of all
clinical, toxicology and pharmacokinetics sections of 4 NDAs for
new sunscreen chemical entity submitted to FDA that led to their
approval in 2006/2007. Prepared INDs, annual reports, amendments,
and safety updates.
* Designed and implemented all clinical efficacy and safety trials
for a new sunscreen chemical entity. Prepared protocols, CRFs ,
ICs and ICH clinical reports that would satisfy all federal
regulations for a new broad spectrum UVA sunscreen drug.
* Established a clinical operations function with appropriate
operating procedures for drugs at L'Oreal; participated in label
copy review
* Participated in claims support and label copy development and
advertising that would pass FDA scrutiny.
1997 to Director, Dermatology Category,
2002 GlaxoSmithKline Consumer Healthcare, 1500 Littleton Rd.,
Parsippany, NJ, 07054 [employed until dermatology brands were
divested]
Promotion to new function - technically establishing US dermatology
and analgesic programs for GlaxoSmithKline Consumer Healthcare,
reporting to R & D in the United Kingdom. Position is strategic and
had 1 Ph.D. and 1 medical technologist reporting in. A second Ph.D.
candidate at Rutgers University also reported in a joint capacity.
* Established PPAR nuclear hormone receptor fundamental research to
identify activators of the PPAR receptor that have OTC potential
based on safety; formed joint team with Glaxo Rx PPAR drug
discovery function post merger.
* Recommended two license opportunities (PPAR activators)
successfully clinically/preclinically tested on 3 indications -
psoriasis, acne and photoaging.
* Identified novel mechanisms / strategies for treating psoriasis
based on regulation of intracellular calcium and identified
several OTC candidates for validation in proof of concept.
* Published first time research on sebum macromolecular structure,
identified leads to lower its phase transition temperature,
promoting resolution of acne; used it to establish claims
platforms for OTC acne medications; developed clinical protocols
for superior sebum removal and antibacterial claims for acne
products.
Director, Dermatology Category Liaison
GlaxoSmithKline Consumer, 1500 Littleton Rd., Parsippany, NJ, 07054
Technically and administratively managing the dermatology programs for
GlaxoSmithKline Consumer Healthcare, North America reporting to R & D
in the United Kingdom. Along with medical technologist, a Ph.D.
candidate at Rutgers University also reported in.
* Lead project team that developed and launched a New Improved Oxy
acne treatment series of 7 new products with synergistic system of
surfactants and slow release polymer technology to confer mildness
superior to market leaders.
* Developed understanding of how to resolve complex issues in
product development and manufacturing.

* Lead innovation function for skin care teaming up with

universities to support applied fundamental research into barrier
function and identification of new actives that treat diseases of
the skin barrier like eczema, psoriasis, acne and dry skin
* Worked on team for the Rx to OTC switch of a cold sore antiviral
treatment, being responsible for the pivotal trial demonstrating
early reduction in perceived signs and symptoms as a preventive
therapy. Created sensory diaries that convinced FDA of antiviral
efficacy of drug by day 2 of treatment.
1995 to World Wide Manager, Therapeutic Skin Care Product Development,
Johnson 1997 and Johnson Consumer Products, Grandview Rd, Skillman, NJ
08558
Managed development of topical antifungal, antiacne, antiaging drugs
for perscription, Rx to OTC Switches and new OTC's for the global
market. Staffing includes 2 Chem Engineers, 2 B.S. Chemists, and 3
technicians.
* Worked with Ortho Dermatologics and Janssen Research (Belgium) to
identify technology opportunities for the next generation topical
antifungals, antiacne, and antiaging that can deliver unique
positioning in the Rx market.
* Strategically managed product life cycles for the current Rx
franchises and identify strategies for Rx to OTC switching by
providing for exclusivity through new dosing regimens, addressing
safety concerns, and securing approval of new Rx indications to
replace switched drugs, e.g. Nizoral antifungal shampoo,
antifungal for onychomycosis, steroid/antifungal combination
product.
1991 to Manager, Human Evaluations and External Development, Skin 1994
CareDermatologics, Bristol Myers Squibb, Products Division, 1350
Liberty Ave., Hillside, NJ 07207 [employed until dermatology brands
were divested]

Managed a division in Skin Care /Topical Medications with 3

departments: Clinical Efficacy and Sensory/Consumer Testing,
Chemistry, and External Development. Staffing included: 2 Clinicians
(1 DVM), 2 Chemists, 1 Clinical Research Associate, and 1
Administrative Assistant.
* Managed design and implementation of all clinical trials for OTC
including programs for diaper rash and other superficial skin
infections, wound healing, acne, antiinflammatories,
antiperspirants, sunscreens and for the special category of
contraception and prevention of sexually transmitted diseases.
* Managed key Rx--OTC switch program for vaginal candidiasis
requiring therapeutic equivalency clinicals among 1200 patients
that secured approval for switch of Vagistat-1.
* Participated (from R&D perspective) in company wide review of
Rx--OTC switch options in skin care/dermatologics; providing
switch strategies for both FDA and consumer positioning.
1989 to Director, Medical Affairs, Fisons Pharmaceuticals, OTC

1991 Division, Rochester, NY 14603 [employed until company was sold]

Spearheaded all medical and clinical strategies and programs for the
OTC and INDNDA dermatologic, analgesic and allergy product
portfolios. Provided all label copy review and safety assessments.
Staff consists of 1 Clinical Research Associate and 1 Administrative
Assistant.
* Creative design and successful implementation of all clinical
efficacy (and safety) trials for antifungal products for Athlete's
foot - anti-inflammatories (topical steroids) combination drug,
antimicrobials for diaper rash, anti-allergy, and topical
analgesics for muscle pain. Assured all GCPs in place for NDA
submissions
* Researched and proposed successful strategy for an OTC switch
 prospect for Nasalcrom decongestant nasal spray.
1980 to Managed Research for Several Divisions -
1989 Advanced Technology-Skin, Global Skin Clinical and Sensory
Investigations, and Soap Product Development, Colgate-Palmolive
Company, Piscataway, NJ, 08854
Manager of strategic technical programs simultaneously in four
divisions of Personal Care Products supervising a total of 15
technical staff, 1 administrative assistant and 1 full time temporary
assistant. During the 10 years, received 5 promotions. Descriptions of
responsibilities are as follows:
Global Skin Clinical Investigations - In 1988 I established this area
as a support group. Staffing included 3 Ph.D's (one in our Belgium
facility) and 2 B.S. professionals.
Responsibilities included design and implementation of human skin
irritation and efficacy trials for personal care and OTC product
categories; establishing skin bioengineering capabilities
(transepidermal water loss, skin color, FTIR, skin conductance, and
image analysis); and developing a global Professional Program in Skin
Care for Colgate by establishing research programs with Dermatologists
worldwide.
Advanced Technology- Skin - From 1983 to 1990, I staffed and ran this
division with 3 Ph.D's, 2 B.S. Chemists and 1 Technician.
Responsibilities included defining and implementing basic research to
discover leads for providing skin care benefits in new milder soaps,
cleansers and dish washing liquids by defining fundamental mechanisms
of surfactant action and active ingredients which alter their
biological or physical chemical action. Other efforts focused on
identifying additives that deliver superior moisturization by defining
role of stratum corneum lipids in maintaining the cutaneous barrier
and cosmetic ingredients, which modulate the lipid barrier. Led
establishment of antibacterial testing of cleansers in house.
Soap Product Development - In 1990, was given leadership
responsibility for global launch of superior skin care technology in
complexion bars. Support staff consisted of 1 Ph.D. and 3 B.S.
Chemists.

Program included working with business partners to design and

implement a global business strategy and designing new syndet bar and
combar products for large-scale consumer tests, global test market and
launch.
Sensory Consumer Research - In 1986 to 1990 was given responsibility
for this group of 3 Ph.D's and 1 B.S. in Experimental Psychology and 3
Technicians.
Responsibilities were to provide for all Colgate sensory research
needs along with design of a state of the art testing facility with
fragrance booths, climate control rooms, water hardness controls,
direct panelists data entry computer system, and sophisticated
statistical experimental design capabilities.
1977-1980 NIH Postdoctoral Fellow - Monell Chemical Senses Center
University of Pennsylvania, Philadelphia, AP 19104
Neurobiology research into mechanisms of chemoreception. Research
resulted in several publications, 1 book chapter and several invited
lectures.
1970-1977 Research Assistant - Chemistry Department
University of Maryland, College Park, MD 20742
Research on characterization and mechanisms of metachromatic
leukodystrophies using genetic altered mouse models. Research resulted
in several publications and podium presentations at scientific forums.
Teaching Assistantship - Chemistry Department
University of Maryland, College Park, MD 20742
SCHOLARSHIPS, AWARD, SERVICESS AND MEMBERSHIP IN PROFESSIONAL
SOCIETIES:

- Scholarship, Pennsylvania Medical Society for excellent achievement

on a Science Fair Project, 1966.
- Scholarship Aid, University of Maryland, N.D.E.A., 1970.
- NIH Postdoctoral Fellowship, 1978-79.
- Grant, National Science Foundation, Principal Investigator, 1980.
* Nominated Member of the Society of Cosmetic Chemists
Committee on Scientific Affairs (COSA), 1991-present.
- Society of Cosmetic Chemists' Annual Award for best all around paper
presented at the 1985 annual meeting.
- Special Stock Option Award in 1986; one of 30 awards within
worldwide Colgate for entrepreneurial spirit, achievement and
leadership.
- Women and Industry Award, 1987 for outstanding contributions;
nominated by Colgate-Palmolive in recognition and appreciation for
excellent service.
- IBC Conference, September, 1998 Symposium on