dedicated research institute keeps wyeth-ayerst focused on women's health

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JOURNAL OF WOMEN'S HEALTH Volume 6, Number 1, 1997 Mary Ann Liebert, Inc. Point of View Dedicated Research Institute Keeps Wyeth-Ayerst Focused on Women's Health ROBERT I. LEVY, M.D. AS THE 21 ST CENTURY APPROACHES, Women's health research has never been more ex- citing. Recent scientific advances in biology, chemistry, and genomics are providing un- precedented insights into some of the key cel- lular processes that modulate diseases while also providing researchers with powerful new tools to target those processes. At the same time, an aging population and reductions in funding of health care and research pose seri- ous challenges to the future of women's health. It was both the opportunities and the chal- lenges that led Wyeth-Ayerst to establish the Women's Health Research Institute (WHRI) in Radnor, Pennsylvania, in 1993. The Institute was the first research facility established by a major U.S. pharmaceutical company devoted exclusively to the development of innovative products that improve women's health. Its opening marked the beginning of a significant new chapter in Wyeth-Ayerst's long history as a leader in women's health care—a history that dates back to the introduction of Premarin in the 1940s. With a staff currently numbering more than 100 scientists and other profession- als in discovery research, clinical research, and alliance management, the Institute represents a substantial increase in Wyeth-Ayerst's invest- ment in women's health and underscores the company's commitment to improve the qual- ity of life for women around the world through research and education. Why did Wyeth-Ayerst open a dedicated re- search facility for women's health when the company and its parent corporation, American Home Products, were already at the forefront of women's health care and when many other companies were reducing R&D spending? Al- though significant progress has been made in women's health care over the past 50 years, there are still a substantial number of needs that are not adequately met by available ther- apies. The WHRI gives Wyeth-Ayerst addi- tional resources and focus to specifically ad- dress the unmet health needs of women and explore a new generation of safer and more ef- fective treatments and preventive medicines that will help women lead longer and health- ier lives. The WHRI centralizes all of Wyeth-Ayerst's research activities for women's health, merging the activities of basic and clinical research. The Institute's research programs address the con- tinuum of women's health issues, including fer- tility, contraception, reproductive diseases (e.g., endometriosis), menopause, and osteoporosis. This consolidation allows Wyeth-Ayerst to fo- cus on a coordinated research strategy, creating greater momentum for scientific discovery and development. The result is increased research efficiency and an accelerated development process. In addition to strengthening the links between discovery and clinical research, the WHRI has tightened the coordination of mar- keting programs to meet women's health needs. These changes, together with an expanded pro- gram of alliances, give the company the re- sources and sophistication needed to address today's complex health issues. Although the WHRI is dedicated to women's Wyeth-Ayerst Research, St. David's, PA. 45

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Page 1: Dedicated Research Institute Keeps Wyeth-Ayerst Focused on Women's Health

JOURNAL OF WOMEN'S HEALTHVolume 6, Number 1, 1997Mary Ann Liebert, Inc.

Point of View

Dedicated Research Institute Keeps Wyeth-AyerstFocused on Women's Health

ROBERT I. LEVY, M.D.

AS THE 21 ST CENTURY APPROACHES, Women'shealth research has never been more ex-

citing. Recent scientific advances in biology,chemistry, and genomics are providing un-

precedented insights into some of the key cel-lular processes that modulate diseases whilealso providing researchers with powerful new

tools to target those processes. At the same

time, an aging population and reductions infunding of health care and research pose seri-ous challenges to the future of women's health.

It was both the opportunities and the chal-lenges that led Wyeth-Ayerst to establish theWomen's Health Research Institute (WHRI) inRadnor, Pennsylvania, in 1993. The Institutewas the first research facility established by a

major U.S. pharmaceutical company devotedexclusively to the development of innovativeproducts that improve women's health. Itsopening marked the beginning of a significantnew chapter in Wyeth-Ayerst's long history as

a leader in women's health care—a history thatdates back to the introduction of Premarin inthe 1940s. With a staff currently numberingmore than 100 scientists and other profession-als in discovery research, clinical research, andalliance management, the Institute represents a

substantial increase in Wyeth-Ayerst's invest-ment in women's health and underscores thecompany's commitment to improve the qual-ity of life for women around the world throughresearch and education.

Why did Wyeth-Ayerst open a dedicated re-

search facility for women's health when thecompany and its parent corporation, American

Home Products, were already at the forefrontof women's health care and when many othercompanies were reducing R&D spending? Al-though significant progress has been made inwomen's health care over the past 50 years,there are still a substantial number of needsthat are not adequately met by available ther-apies. The WHRI gives Wyeth-Ayerst addi-tional resources and focus to specifically ad-dress the unmet health needs of women andexplore a new generation of safer and more ef-fective treatments and preventive medicinesthat will help women lead longer and health-ier lives.

The WHRI centralizes all of Wyeth-Ayerst'sresearch activities for women's health, mergingthe activities of basic and clinical research. TheInstitute's research programs address the con-tinuum of women's health issues, including fer-tility, contraception, reproductive diseases (e.g.,endometriosis), menopause, and osteoporosis.This consolidation allows Wyeth-Ayerst to fo-cus on a coordinated research strategy, creatinggreater momentum for scientific discovery anddevelopment. The result is increased researchefficiency and an accelerated developmentprocess. In addition to strengthening the linksbetween discovery and clinical research, theWHRI has tightened the coordination of mar-

keting programs to meet women's health needs.These changes, together with an expanded pro-gram of alliances, give the company the re-sources and sophistication needed to addresstoday's complex health issues.

Although the WHRI is dedicated to women's

Wyeth-Ayerst Research, St. David's, PA.

45

Page 2: Dedicated Research Institute Keeps Wyeth-Ayerst Focused on Women's Health

46 LEVY

health research, it is not separate from the com-

pany's overall research program. On the con-

trary, the Institute serves as a focal point forWyeth-Ayerst's research worldwide that affectswomen's health—removing the boundaries andintegrating women's health research with thecompany's other discovery efforts in such areasas heart disease, stroke, breast cancer, andAlzheimer's disease. By promoting flexible bor-ders in research, the WHRI is leveraging all ofthe company's resources to find solutions thatbenefit women's health.

Wyeth-Ayersfs optimism about the futuredevelopment of new products to address un-met needs in women's health is fueled by a widearray of research programs under way aroundthe world that hold the promise of significantadvances in treatment and prevention.

From a global viewpoint, contraception is a

major health issue for women. The pharmaceu-tical industry continues to explore new com-

pounds and delivery systems aimed at givingwomen a greater choice of products that are

easy to use, are highly reliable, and have fewside effects. Several new lower-dose oral con-

traceptives, which use different combinations ofcompounds and are currently in clinical trialsin the United States, and internationally, shouldincrease both effectiveness and safety. Manynew approaches to contraception are also beingexplored in the laboratory. One particularly in-teresting area of research concentrates on find-ing nonsteroid hormone-based contraceptivesusing small peptide molecules that target a re-

ceptor in the brain that seems to play a keyrole in controlling contraception. Such neuro-steroids would have the advantage of not al-tering the body's natural levels of hormones.This same receptor seems to play a role in fer-tility as well, so a variation of this compoundcould potentially aid conception. In addition,some studies indicate that neurosteroids mayregulate growth and cognition, offering addi-tional potential for this area of research.

Hormone replacement therapy (HRT) is ben-efiting from research on new lower-dose com-

bination products for treating osteoporosis,such as Wyeth-Ayersfs recently introducedPrempro and Premphase (conjugated estro-gens/medroxyprogesterone acetate), a mile-stone in HRT that allows postmenopausal

women using estrogen and progestin to takejust one tablet a day. HRT research is also crit-ical because of the growing body of evidencelinking reduced hormone levels with cardio-vascular disease in postmenopausal women. Tofurther this research on heart disease, the num-

ber 1 killer of women, Wyeth is sponsoring theHeart and Estrogen-Progestin ReplacementStudy (HERS) a 5-year, $40-million, multicen-ter, placebo-controlled, double-blinded trial ofthe impact of HRT on approximately 2700 post-menopausal women with heart disease. In thelonger term, more tissue-specific HRT ap-proaches are being developed that could deliverthe protective benefits of HRT with few side ef-fects. The recent discovery of a new estrogen re-

ceptor could open a whole new area of researchon products to modulate that receptor.

Powerful new scientific tools now availableto discovery and clinical researchers are help-ing to accelerate advances in many other areasof women's health. Improved screening tech-niques, important developments in chemicalsynthesis and molecular biology, and genetictechniques are revealing new information aboutdisease mechanisms. Over the next 5-10 years,this new knowledge should produce signifi-cantly better treatments or preventive measuresfor breast and uterine cancer, endometriosis, fi-broid tumors, and pelvic inflammatory disease.Genomic technology also holds the potential forthe development of bone growth stimulatorsthat could help women recover from the effectsof osteoporosis.

Although research into heart disease, cancer,atherosclerosis, stroke, Alzheimer's disease,and depression is not specific to women, an ag-ing population and women's longer life spansmean that women will be increasingly subjectto these conditions. Longer Ufe after menopausecreates additional risks of osteoporosis andheart disease for women.

To combat Alzheimer's disease, in particular,more work needs to be done to find effectivetreatments or preventive measures. Studiesshowing a possible connection between hor-mone levels and cognition underscore the im-portance of Alzheimer's research. To supportthis promising research, Wyeth-Ayerst recentlyfunded a $16-million ancillary study to theWomen's Health Initiative (WHI) to evaluate

Page 3: Dedicated Research Institute Keeps Wyeth-Ayerst Focused on Women's Health

WOMEN'S HEALTH RESEARCH INSTITUTE 47

the role of HRT in the prevention and treatmentof Alzheimer's disease. Wyeth-Ayerst is alsoproviding Premarin and Prempro to the 6-yearWHI Memory Study, involving 8000 post-menopausal women aged ^65—the largeststudy of its kind.

Both excitement and challenge spur thesearch for better products in every area ofwomen's health, yet another challenge loomsequally large: the pressing need for better edu-cation about women's health. That is why theother key role of the WHRI, in addition to re-

search, is the dissemination of informationabout women's health and the support of awide variety of educational programs aimed atboth patients and physicians. For example,there is considerable scientific evidence thatHRT offers protection against osteoporosis inwomen after menopause. Although there isconcern about side effects, there is generalagreement that the benefits far outweigh therisks for most women. Yet the vast majority ofwomen who begin HRT for relief ofmenopausal symptoms do not continue thetreatments once those symptoms have abated,thus exposing themselves to the devastating ef-fects of osteoporosis, even though it is almostcompletely preventable.

In consultation with the American MedicalWomen's Association (AWMA), Wyeth-Ayersthas produced a program specifically designedto teach women about the complex life stage ofmenopause. Understanding Menopause, whichconsists of a text, video, and slide presentation,is an educational tool distributed to health care

professionals to use as a means of replacingmyths with facts. The program encourageswomen to take an active role in preparing forand managing menopause.

The pharmaceutical industry, physicians,pharmacists, and the government need to domore to raise women's awareness about the

treatments available for osteoporosis, as well asabout the protective benefits of HRT for heartdisease. To accomplish this, the WHRI contin-ually supports the work of women's health ad-vocacy groups, academic institutions, and or-

ganizations, such as the American College ofObstetricians and Gynecologists and the Amer-ican Heart Association.

Each year, Wyeth-Ayerst sponsors hundredsof educational seminars and meetings forwomen. These meetings are held in both ruraland urban hospitals and other community fa-cilities and feature experts who discuss topicsrelated to women's health, including familyplanning, pregnancy, menopause, and mam-

mography, as well as osteoporosis, depression,and obesity. The company is a leader in thehealth education of women and publishes morethan 80 different patient education materials,from brochures to books and videos, that helpeducate women about their health at variousstages throughout their lives.

All of this effort and investment in women'shealth by Wyeth-Ayerst and the WHRI have acommon goal: to provide women with as manychoices and as much information as possibleabout the health issues that affect them, so theycan make informed health care decisions andimprove their quality of life. It is a goal to whichWyeth-Ayerst has been dedicated for more than50 years and a challenge that the company willcontinue to meet and invest in as a worldwideleader in women's health care into the 21st cen-

tury.

Address reprint requests to:Robert I. Levy, MD.

PresidentWyeth-Ayerst Research

555 E. Lancaster AvenueSt. David's, PA 19087