NEW YORK--()--Makovsky Health Practice leaders are demonstrating specialized health sector expertise that both informs and reaches beyond their charge as strategic communicators for clients across the healthcare spectrum. Kristie Kuhl, JD, senior vice president and deputy head of the Health Practice, served as Chairman of the 2nd Biosimilars Congregation in London in February, and will lead a workshop at the 12th Biosimilars Conference America in April. Arielle Bernstein, MPP, vice president, was published in the Journal of Clinical Oncology, the official journal of the American Society of Clinical Oncology (ASCO), along with University of Chicago health economics colleagues, in a first-of-its-kind study on the off-label use of anticancer therapies in the US.
“Everyone is enthusiastic about biosimilars as a path to improve access to innovative and cost-effective care”
“Helping clients navigate successfully complex regulatory, competitive, economic and policy environments is the hallmark of Makovsky Health – and depends on the diverse backgrounds and expert strategic thinking of our people,” said Gil Bashe, executive vice president and Health Practice director, Makovsky. “Kristie and Arielle exemplify the curiosity, rigor and commitment to advancing patient care that is shared by all of our Makovsky Health colleagues.”
Kuhl, a leading global expert on biosimilar communications since 2004, chaired Day One of the 2nd Biosimilars Congregation in London, organizing and facilitating sessions focused on key drivers for biosimilar development, including technology transfer and comparability strategies, next-generation clinical challenges, and impact on clinical practice. In April, she will lead a Day One workshop at the 12th Biosimilars Conference America, titled Launching a Biosimilar in an Innovator v Generic World.
“Everyone is enthusiastic about biosimilars as a path to improve access to innovative and cost-effective care,” said Kuhl. “But companies focused on price alone will not succeed. Firms must demonstrate a focus on creating clinical confidence, building relationships with KOLs and advocates, and considering pathway organization influence.”
Bernstein, who has held a health economics research position with the University of Chicago since 2010 alongside her role with Makovsky Health, co-authored a first-of-its-kind study in the Journal of Clinical Oncology, establishing a benchmark for so-called “off-label use” of common anticancer drugs in the US. Using objective national data, the study found that in 2010 about 30 percent of the ten most commonly prescribed, patent-protected, intravenous chemotherapies were used “off-label” – for indications that differed from the specific uses approved by the US Food and Drug Administration (FDA). However, the study also showed that nearly half of this off-label use was supported by national clinical guidelines.
“Understanding that ‘off-label use’ does not necessarily mean ‘inappropriate use’ in the clinical setting is critical for payers and policymakers alike,” said Bernstein. “Our research identifies for the first time an important pattern in the use of chemotherapy drugs – and shows that often, off-label use is actually supported by clinical evidence. Even in cases when use is prescribed without FDA or expert backing, this may be in response to a lack of available treatments – and there is surely some value in these drugs helping to preserve hope for patients and families.”
Practice Head Gil Bashe also demonstrated new sector leadership as an appointee to the Advisory Committee of The American Academy of Pain Medicine Foundation, which supports the AAPM mission to optimize the health of patients in pain and eliminate the major health problem of pain by advancing the practice and the specialty of Pain Medicine. The Foundation’s efforts focus on patient safety by providing resources to expand and enhance education and research, as well as advocating for improved training and credentialing to advance pain management. The AAPM Foundation is at the forefront of mobilizing the experts and stakeholders needed to educate healthcare providers, inform patients and seek grant funding to expand the reach of the academy in education and research.
Founded in 1979, Makovsky (www.makovsky.com) is one of the nation’s largest independent integrated communications firms. The firm attributes its success to its original vision: that the Power of Specialized Thinking™ is the best way to build reputation, sales and fair valuation for a client. Based in New York City, the firm has agency partners in more than 30 countries and in 40 U.S. cities through IPREX (IPREX.com), the second largest worldwide public relations agency partnership, of which Makovsky is a founder.