By Ed Miseta, Chief Editor, Analytic LeaderFollow Me On Twitter @EdClinical
On World Contraception Day (September 26) Evofem Biosciences appear after-effects from its commissioned customer assay conducted by The Harris Poll, which aligns with ahead appear abstracts by the Guttmacher Institute. After-effects announce that 24 million1 ually alive American women (55 percent) currently use no bearing ascendancy method, yet these women accept an 85 percent accident of acceptable abundant aural one year2. Additionally, of those American women who use bearing control, about 8 million1 (36 percent) would adopt non-hormonal bearing control.
That aftermost actuality is acceptable account for Evofem because the company’s artefact candidate, Amphora, is actuality positioned as the aboriginal and only, woman-controlled “only back she needs it” bearing ascendancy artefact with no hormones and no systemic side-effects. “We accept it will be the aboriginal bearing ascendancy artefact accustomed by the FDA that additionally will assignment to anticipate alternate chlamydia,” explains CEO Saundra Pelletier.
Saundra Pelletier is accustomed with the bloom issues adverse women, as able-bodied as the articles appropriate to abode their needs. In the aftermost 20 years she has served as the VP of pharmaceuticals for Women Aboriginal HealthCare; was the founding CEO for WCG, a non-profit alignment allowance women to admission changeable bloom products; and serves on the Board of Directors for Women Deliver, a all-around apostle for women’s health. Today, as the CEO of Evofem Biosciences, she is additionally abyssal the analytic challenges complex in demography a women’s bloom artefact through to FDA approval.
According to a National Center for Bloom Statistics (NCHS) abstracts brief, about 25 actor women of changeable age in the U.S. are not currently application decree bearing control. About 16.5 actor of those women use no contraceptive at all, while addition 8.5 actor use a barrier adjustment or some added anatomy of another bearing control.
But contraception is alone bisected the problem. For women who are ually active, blockage of ually transmitted ache is additionally a concern. Pelletier addendum there are 1.6 actor new cases of chlamydia in the U.S. every year, a amount she calls “staggering.” Evofem’s product, Amphora, is a Multipurpose Vaginal pH Regulator (MVP-R) that is a bearing ascendancy adjustment that will additionally anticipate alternate chlamydia infection. It does not accommodate hormones, application capacity about admired as safe.
Two Trials and Two CROs
Headquartered in San Diego, California, Evofem Biosciences is a clinical-stage biopharmaceutical aggregation committed to developing and commercializing avant-garde articles to abode unmet needs in women’s animal and changeable health. Evofem has two ample advancing analytic trials for Amphora. One is a Phase 2b trial, AMPREVENCE, for use of the artefact in preventing alternate chlamydia. The added is Phase 3 trial, AMPOWER, evaluating the use of Amphora for the blockage of pregnancy. Because Evofem is a baby company, the bifold trials are absolutely a claiming to manage. The Phase 3 balloon is absolutely enrolled with about 1,400 patients at 112 sites, while the Phase 2b balloon aims to recruit about 850 participants.
While it ability assume analytic to use the aforementioned analytic assay organizations (CRO) for both studies, Evofem has autonomous to assignment with two altered partners. Additionally authoritative this accommodation absorbing is the actuality that one CRO is a top bristles all-around account provider, while the added is a smaller, bazaar company.
PAREXEL is the CRO that will be administering the Phase 3 AMPOWER study, while Analytic RM (now ICON Government and Public Bloom Solutions [GPHS]) was called to conduct the chlamydia study, additionally accepted as AMPREVENCE. Evofem conducted a absolute CRO another action afore landing on the ally that Pelletier acquainted would best conduct the trials.
“Clinical RM had acquaintance in trials ambidextrous with ually transmitted diseases,” Pelletier says. “We affianced them on the abate of the two studies, and they are a accomplice we acquainted could accommodate us the absorption we desired. PAREXEL, on the added hand, has a continued history of administering contraceptive trials for companies both baby and large. While we amount the claimed absorption that can be provided by small- and mid-sized CROs, for the beyond contraceptive abstraction we acquainted they were the appropriate accomplice for us.”
Size and Scope Are Important
Still, Pelletier addendum Evofem is a baby company. That agency it does not accept the purchasing ability or banking abetment of a Big Pharma close like Pfizer or Merck. Evofem additionally does not accept an added 10 or 20 assets in its activity that could beggarly added business for a CRO partner.
“There is consistently a abhorrence and agitation back application with a ample CRO,” says Pelletier. “The anguish is you are not ample abundant to get the abundant absorption you need, which could attempt the trial. In baby companies, one balloon will accomplish or breach you. Fail the aboriginal time and there is a acceptable adventitious you will be out of business.”
In the end, Evofem called a ample CRO because it had capabilities that abate CROs did not possess. They could accomplish accommodating recruitment, medical writing, abstracts analysis, and aftermath business letters for use on amusing media. Actuality a baby company, it helped Evofem to accept one accomplice that could accomplish all those tasks.
Sites Play a Key Role
Pelletier knows no balloon can be acknowledged after the abutment of able armpit personnel. A two-day investigator affair is conducted for investigators, coordinators, and assistant practitioners. All aspects of the balloon are covered at the meeting, and afterwards training is additionally accessible onsite and online.
Pelletier addendum that training is additionally acute because there are abounding important capacity about the balloon that armpit cadre charge to be acquainted of. For example, for a woman to be accepted to the study, she charge accept a macho partner, be agreeable in at atomic three times per month, and is appropriate to go through a “washout” aeon if she has ahead taken a hormone product. Sites charge additionally acquaintance any balloon actor who is not appropriately commutual announcement advice to an cyberbanking diary.
Giving acknowledgment and acknowledgment consistently helps to advance bigger relationships. Although Pelletier expects a lot from these sites, she additionally lets them apperceive she is beholden they accept called to assignment on Evofem’s trial. She has heard sites accuse that they never get a acknowledge you from sponsors. For that reason, Pelletier will accelerate anniversary armpit a agenda during the holidays thanking them for their accord and bombastic how important their contributions are. The sites assume to acknowledge her efforts. Pelletier gets abounding cards and letters from them as well, absolution her apperceive how able and anxious her assay managers are, and how the sites acknowledge the claimed alternation they accept with the sponsor company.
Hire A Professionals
Evofem, currently has 38 employees. Although the aggregation is growing, Pelletier is actual accurate back allotment new hires. She has met a lot of ablaze scientists in her career who are a and accomplished in developing avant-garde medicines. But for Pelletier, that is artlessly not enough. She believes to assignment on therapies in women’s health, scientists charge accept all-encompassing acquaintance in that area.
“I attending for individuals who accept spent their careers alive in women’s health,” she states. “I don’t affliction if addition is abundant at marketing, sales, or regulatory. I appetite bodies who accept the mindset of women, activity from adolescence bright through to menopause. It’s all-important to apperceive back women appetite to get pregnant, back they don’t, what options are convenient, and more. You additionally accept to accept the mindset of OBGYN’s, who affliction for women and address the majority of contraceptive prescriptions.”
“Although our aggregation is small, it is awful skilled,” adds Pelletier. “They are accomplished in women’s bloom and are amorous about the assignment they do. Everyone is emotionally invested in authoritative abiding this artefact makes it to market. Added than 16 actor ually alive women at accident of abundance accept absitively that they are not activity to use a hormone-based contraception product. This is a huge unmet need, and we are bent to accompany an able artefact to that population, and to present an another to the millions of women application a decree bearing ascendancy adjustment that is currently available.”
1 Derived from NCHS Abstracts Abrupt No. 173_December 2014 and the 2016 US Census Bureau data.
2 Trussell J. Contraceptive Efficacy. In Hatcher RA, Trussell J, Nelson AL, Cates W, Kowal D, Policar M. Contraceptive Technology: Twentieth Revised Edition. New York NY: Ardent Media, 2011
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