Blog 2017-10-03T21:39:39+00:00

The HealthyWomen Dinner: The Difference Between Men and Women in Clinical Research

Table at HealthWomen DinnerHealth Decisions was pleased to participate in the 2018 HealthyWomen dinner, held at the Italian Embassy in Washington June 13, where the theme was “‘Alla Nostra Salute! To Our Health’ – Celebrating innovation that advances women’s health research and advocacy for future generations.” HealthyWomen is an independent nonprofit organization addressing one of many underserved needs in women’s health – the need for accurate information about women’s health issues and treatment resources.

The keynote speaker at […]

June 19th, 2018|Categories: About Us, Industry Events, Women's Health|

CEO Takeaways from BIO 2018: Focus on Women’s Health

Health Decisions CEO Patrick Phillips at BIO 2018Health Decisions CEO, Patrick Phillips, BSc (Hons), D.Phil., attended BIO 2018 in Boston to meet with companies active in development of new therapeutic and diagnostic products to improve healthcare outcomes for women. After the conference, Dr. Phillips offered observations on a variety of trends in evidence at the conference and on Boston as a conference setting with significant current development activity in women’s health and a rich history as well. The primary […]

June 11th, 2018|Categories: About Us, Industry Commentary, Industry Events, Women's Health|

Key Issues in Choosing a Specialized Clinical Development Partner

Handshake symbolizing partnershipPartnerships drive biopharma development today more than ever, especially in clinical development. The scope of partnerships ranges from contracts to conduct individual studies to functional-service-provider arrangements or outsourcing agreements encompassing whole development programs and sometimes even the whole of a company’s clinical development activity. While clinical development partnerships are commonplace, they are seldom simple. Forming a clinical development partnership requires both parties to consider a host of issues, including but not limited to the following:

  • the capabilities […]
June 4th, 2018|Categories: About Us, Industry Commentary, Strategic Partnerships|

BIO 2018: Time to Focus on Women’s Significant Unmet Medical Needs

BIO 2018 in BostonThe BIO International Convention convenes June 4 in Boston, MA. The City-on-a-Hill is an excellent setting for BIO for reasons including its role as a hotbed of both academic and commercial development. As a women’s health specialty CRO, Health Decisions sees another reason to appreciate Boston as a venue for BIO: the city’s history of advocacy in women’s health. For example, it was in Boston that a group of women came together, authored and published “Our […]

May 31st, 2018|Categories: Industry Events, Recent Posts, Women's Health|

A Project Manager’s Observations on Women’s Health Clinical Trials

Health Decisions recognizes the importance of increasing the participation of women in clinical trials in order to identify differences in female response, provide female-specific prescribing information and reduce the number of adverse events experienced by women taking approved medications. Based on Health Decisions’ extensive experience as a women’s health specialty CRO, Project Manager Jessica Kappes, MBA, MT, CCRA offers some observations from women’s health clinical trials, many of which apply to trials enrolling female populations in other indications. Ms. Kappes has nine years of experience […]

An OB/GYN’s Thoughts for National Women’s Health Week

Health Decisions CMO Andrea Lukes

Health Decisions’
Chief Medical Officer
Andrea Lukes, MD, MHSc, FACOG

As Health Decisions celebrates National Women’s Health Week (NWHW), we decided to sit down with our Chief Medical Officer, Andrea S. Lukes, MD, MHSc, FACOG, a practicing OB/GYN and active Principal Investigator as well as a CMO, to ask her thoughts on NWHW, key health issues for women at different life stages and women’s participation in clinical trials.

Why is National Women’s Health Week important to you?

May 16th, 2018|Categories: Recent Posts, Women's Health|Tags: |

An Update on Women’s Unmet Medical Needs: National Women’s Health Week 2018

A post in this blog during National Women’s Health Week 2016 discussed six areas of significant unmet medical needs in women’s health. This post for National Women’s Health Week 2018 provides an update on the status of product development in addressing three of those areas of unmet need.

  • Increased availability of noninvasive diagnostics for health conditions like endometriosis
  • Improved therapeutics for osteoporosis
  • More effective therapeutics for female sexual dysfunction

In addition, this post will provide information on the clinical development of new treatments for heavy […]

ACOG 2018: A Fun Run, the Fourth Trimester, Uterine Fibroids and HMB

The Health Decisions team attending ACOG 2018 – the Annual Clinical and Scientific Meeting in Austin April 27-30 – had a busy, enjoyable and productive week with our colleagues in the OB/GYN community. In keeping with its mission as a women’s health specialty CRO, Health Decisions sponsored and participated in the 5K Run/Walk for Women. Thanks to all who participated, including those in the snapshot. In addition to the fun run, we enjoyed and learned from a rich informational program at ACOG, beginning with the […]

Strategies for Accelerated Start-Up in Women’s Health Clinical Trials

Health Decisions Women's HealthMeeting planned enrollment timelines is a challenge in many clinical trials. Studies of novel products for treatment and diagnosis of women’s health conditions are no exception. Based on years of experience in women’s health clinical trials, the Health Decisions Clinical Affairs group has developed a methodology that has successfully accelerated start-up in studies in a variety of women’s health indications. In brief, key elements of the methodology include:

  • Simultaneous activation of all or almost all investigational […]
April 6th, 2018|Categories: Uncategorized|

Clinical Development of Treatments for Endometriosis

Endometriosis March 2018March is Endometriosis Awareness Month, a reminder of the importance of ensuring that clinical development of novel endometriosis treatments progresses as rapidly as possible. This is an area of significant unmet medical need affecting approximately 10% of women of reproductive age worldwide –  approximately 176 million women.  While sometimes asymptomatic, endometriosis is often associated with infertility and pelvic pain. Up to 50% of women with endometriosis may also have to deal with infertility. Even more women with endometriosis […]

March 23rd, 2018|Categories: Clinical Trial Methodology, Endometriosis, Reproductive Health, Women's Health|