Highlighting Female-Led Launch and Strategy Teams in BioHealth

A year ago, at the beginning of the COVID-19 Pandemic, BioBuzz highlighted Novavax, a local BioHealth Capital Region (BHCR) company, for their all-female team working to create a vaccine in Maryland. 

Inspired by the story of Novavax’s team working on vaccine development and antibody discovery, BioBuzz planned to highlight the female-driven stories for Women’s History Month 2021 across our weekly “5 Questions With….” Series and original content articles like “BioHealth Capital Region Women Making Waves in Venture Capital.” 

We identified two companies in the region——, a new addition to the region that just opened up their U.S. Headquarters here in the past year, and the other, a company that recently celebrated their 200^th Anniversary.

BioBuzz is proud to feature the all-female teams at Aurinia Pharmaceuticals and U.S. Pharmacopeia (USP) for Women’s History Month 2021.

Aurinia Pharmaceuticals

In January of this year, Aurinia Pharmaceuticals announced the U.S. Food and Drug Administration’s approval of its treatment for adult patients with active lupus nephritis (LN). It was a big win for the company that joined the BHCR last year with a 30,000 square-foot commercialization facility. 

In preparation for the commercial launch of their first FDA-approved therapy, employees from across Aurinia were organized into several launch preparation teams focused on the critical and immediate support of physicians and patients at the time of launch. Women-led teams from the new Rockville U.S. location, Canadian Headquarters, and beyond played important roles in the efforts to prepare for the approval and introduction of the company’s first FDA-approved therapy, LUPKYNIS™ (voclosporin) for adult patients with active lupus nephritis.

Aurinia’s launch readiness team focused on building the capabilities, services, and insights needed across the organization to support physicians and patients in successfully delivering their new therapy. An extensive team of women, who represent 50% of the company’s workforce within Aurinia, lead and coordinated more than 70 Aurinians, spanning across all functions from clinical and commercial operations to finance, patient advocacy, legal, regulatory and human resources, as well as drug safety, supply chain and patient services. 

The team members also worked closely with Aurinia MLR (medical, legal, regulatory) team to ensure that all launch materials and activities were compliant and met regulatory compliance and medical standards before they were able to begin sharing the approval news with physicians and patients. In total, the team reviewed over 200 individual materials the week leading up to launch. 

These 17 women of Aurinia’s Launch Readiness Teams provided the leadership and experience needed to successfully release their new therapy and the foundation necessary for the continued support of patients in need.

Key Aurinia Launch Readiness Team Members

• Cara Felish, VP Commercial Operations
• Sunena Wadhwa, Director, Marketing Operations
• Jessica Farnsworth, Sr. Director, HCP Marketing
• Bianca Jay, Sr. Director, Marketing
• Diane Caso, Sr. Director, Commercial Training & Development
• Sue Evans, Vice President, Regulatory Affairs
• Jen Gathman, Senior Manager, Launch Readiness
• Rashieda Gluck, Senior Vice President, Global Clinical Operations
• Rebecca Hoffman, Senior Director, Human Resources
• Christina Kennedy, Vice President, Financial Planning & Analysis
• Laura Lisk, Head of Clinical Development
• Christine Lindsay, Vice President, Patient Advocacy
• Sue Rodgers, Vice President, Commercial Supply Chain & Patient Service
• Laura Veasey, Director, Clinical Development and Drug Safety
• Missy Michaels, Specialist, Marketing Ops
• Christine Smith, Director, Regulatory Affairs
• Tricia Dring, V.P. Associate General Counsel

Key Aurinia Launch Readiness Team Members

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U.S. Pharmacopeia (USP)

U.S. Pharmacopeia (USP) rang in its 200th year at the start of 2020. The celebration was short-lived as the organization pivoted to address the fast-growing threat of COVID to public health. As new vaccines and treatments were developed to fight the pandemic, USP rapidly developed insights and tools to help manufacturers, regulators, and healthcare practitioners maintain quality assurance. At the same time, USP kicked off a new 5-year strategic cycle focused on expanding the independent nonprofit’s work in defining and protecting trust in the medicines of today and the future. 

The USP Strategy Team:

• Amanda Cowley, SVP, Legal, Strategy & People
• Felicia Yom, VP, Strategy, Pricing & Analytics
• Eva Agrawal, Director, Business Planning
• Ashley Elasfari, Director, Analytics & Data Strategy
• Manan Liu, Director, Pricing & Revenue Strategy
• Kaitlyn Lucey, Director, Enterprise Strategy

The USP strategy team sets priorities, pricing, business planning, analytics, and other activities core to ensuring that USP’s work builds the public’s trust. They have set the organization’s impact agenda to deliver on their commitment to building trust in the supply of quality medicine. Here the impact is focused on closing critical gaps in the manufacturing and production of quality medicines to increase global supply chain resilience. 

In 2020, the team drove and managed the organization-wide planning effort to guide USP’s work with regulators and manufacturers in over 120 countries. The team integrated the organization’s response to the COVID-19 pandemic, focused on strengthening the supply of quality vaccines, treatments, and preventatives. As USP moves into its third century, the organization is expanding its on-the-ground presence and increasing collaboration in Russia, South Korea, Indonesia, Mexico, Argentina, Bangladesh, and Peru. USP’s growth strategy aims to increase its footprint to strengthen the global supply of medicines.

The strategy team redesigned USP’s global laboratory network to increase efficiencies and enhance its alignment with emerging pharmaceutical supply chains. The redesign’s overall goal is to optimize the impact of support to meet the global supply chain’s changing needs. Efforts undertaken include doubling the USP India laboratory’s capacity and enhancing capabilities, constructing and establishing a new Synthetic Laboratory in India, and evaluating laboratory processes across our global sites to standardize and harmonize best practices.

The USP strategy team is the steward of the organization’s sustainability and growth efforts. Revenue and pricing programs provide USP the funding to achieve its mission on a global scale. The team developed and rolled out best pricing practices, leveraged big data and competitive intelligence engines to support fact-based pricing decision-making, and created processes and tools to optimize pricing. Also, the team supports the USP Impact Program, which has helped regulators in 36 low to middle-income countries implement USP’s quality medicine standards and improve local medicine standards through donations and discounting programs of reference standards.

To promote global collaboration and harmonization around the quality of medicines, the USP strategy team mapped documentary standards across the world’s key pharmacopeias. The information was used to identify and develop priority documentary standards that supported COVID-19 response efforts worldwide and was published by the World Health Organization.

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As Women’s History Month 2021 wraps up, BioBuzz would like to recognize these female-led teams and the organizations that support women in BioHealth Industries, including Women In Bio (WIB). WIB is an organization of professionals committed to promoting careers, leadership, and entrepreneurship of all women in the life sciences. The WIB Capital Region Chapter has been a strong partner of BioBuzz for many years, and we are proud to support their mission.