By Dr. Karen Ring, Big3Bio Events Correspondent

In its May event, “Path to Market,” the San Francisco Women in Bio (WIB) chapter discussed the steps necessary to successfully bring a product to market. The event, the third segment of a four-part entrepreneurial series by WIB, was hosted at the global health company Genomic Health and featured a panel of four prominent women in product development within the life sciences industry.

(l-r: Elaine Cheung, Maureen Cronin, Lissa Goldstein, Deborah Kilpatrick)

(l-r: Elaine Cheung, Maureen Cronin, Lissa Goldstein, Deborah Kilpatrick)

Elaine Cheung, the associate director of business and corporate development at Illumina, was the moderator, and the panel featured Maureen Cronin, executive director of strategic information management at Celgene Corporation, Lissa Goldstein, CEO and co-founder of Auxogyn, and Deborah Kilpatrick, chief commercial officer at CardioDx. Each panelist began by giving a short introduction to their company and the products they have developed and brought to market.

Celgene/Cronin: Before working at Celgene, which develops therapeutics to combat cancer and inflammatory disease, Cronin oversaw the development of clinical diagnostic tests for oncology at Foundation Medicine and Genomic Health. She mentioned that for a product to be successful, a company “needs to understand the clinical environment, where their test fits into the market, and the needs of patients, physicians, the healthcare system, and payers.” She emphasized that “oncology is not an emergency situation”, and typically cancer drug development focuses on late-stage patients. She noted, however, that the tides are changing, and companies are now transitioning to a distributed diagnostic environment that will identify cancer at earlier stages and allow for early interventions, personalized treatments, and better clinical outcomes.

Auxogyn/Goldstein: Auxogyn licensed its novel technology from Stanford University where scientists first discovered the link between embryo health and developmental outcome. The company develops the Eeva test, which is a non-invasive technology that provides quantitative information on the health and viability of developing embryos. By identifying and choosing the healthiest embryos, women have an improved chance of a successful in vitro fertilization outcome. Goldstein initially opted to market their technology as a medical device in Europe after evaluating the value of and demand for their product. She said that Auxogyn is also looking to enter the US market and has filed for FDA approval for Eeva. Goldstein commented that it is essential to assess the value of your product in order to successfully market it.

CardioDx/Kilpatrick: CardioDx is a genomic diagnostics company focusing on patients with cardiovascular symptoms or conditions. They provide a gene expression test that determines whether patients with chest discomfort have serious heart conditions such as coronary artery disease, and they also have had historical focus in cardiac arrhythmia and  heart failure. The company’s goal is to provide accurate and timely data to doctors so that they can personalize patient management or avoid unnecessary procedures. Deborah’s main message on taking products to market was “know your market!” She explained that when their product initially launched in 2009, CardioDx did not launch directly into primary care as the main customer. However as their product gained traction in the clinic, they found a booming market of 3 million patients with chest discomfort that needed diagnosis. She mentioned that working with primary care forced CardioDx to be more efficient in distributing their product and integrating it into the fast pace of primary care clinics today. Consequently, a major focus is now to simultaneously delivery “better quality and more efficient care” focusing on both economical and clinical values for their product.

The main questions the panelists felt were important to address with regards to successfully bringing products to market:

1) Will the product meet an unmet need?

2) Who is your market?

3) Who is your target population, who will benefit, and how do you reach them?

4) How will you provide important information about your product to your customer?

Their take home points:

1)     Focus on defining the product, proving analytical validity, clinical validity, clinical utility, and considering the financial, ethical, legal, and social implications.

2)     Know your market and the value of your product

3)     Show that your product works and is important to human health

4)     Show that there is a need for your product

5)     Evolve your product as the market opportunity and demand evolves