About

"Accomplished life sciences senior executive known as a catalyst for growth and transformation through innovation and collaboration. Proven track record of success within start-up, biotechnology, and publicly traded biopharmaceutical companies in the US and Europe, with operations globally.

Demonstrated commercial acumen combined with strong scientific base in molecular biology, immunology and infectious disease. Build and lead high performing, cross organizational teams to successfully deliver complex development projects.

Multiple leadership roles in transactions, including company formation, mergers, acquisitions, licensing and asset sales. Significant experience working with the public sector, including academic partners, technology transfer offices, not for profit institutions, Foundations, and NGOs. Exemplary communication and motivation skills, skilled at interacting at all levels within an organization. "

Experience

• INOVIO Pharmaceuticals, Inc.  ( 4 yrs 3 mos )

  • • Chief Executive Officer  /   May 2022 - Present · 1 yr 1 mo  /   Plymouth Meeting, Pennsylvania, United States

    • Chief Operating Officer  /   Mar 2019 - May 2022 · 3 yrs 3 mos  /   Plymouth Meeting, PA

• Shea Consulting

  • • Independent Consultant and Director  /   Jan 2019 - Feb 2019 · 2 mos  /   Washington D.C. Metro Area

• Aeras  ( total : 4 yrs 9 mos )

  • • CEO  /   Aug 2015 - Dec 2018 · 3 yrs 5 mos  /   Rockville Maryland

    • COO  /   Apr 2014 - Aug 2015 · 1 yr 5 mos  /   Rockville, MD

• Emergent BioSolutions

  • • VP Business Development, Europe  /   May 2013 - Mar 2014 · 11 mos  /   General Manager and VP

• Oxford-Emergent Tuberculosis Consortium

  • • General Manager and VP  /   Oct 2008 - May 2013 · 4 yrs 8 mos  /   Wokingham, UK

• Emergent BioSolutions

  • • Senior Director Business Development  /   Jun 2005 - Sep 2008 · 3 yrs 4 mos  /   Wokingham , UK

• Microscience Ltd

  • • Senior Manager Business Development/Associate Director Discovery  /   Jan 1998 - Jun 2005 · 7 yrs 6 mos  /   Wokingham, UK

• Imperial College London

  • • Senior Research Officer  /   Apr 1993 - Dec 1997 · 4 yrs 9 mos  /   London, UK

Education

• Saïd Business School, University of Oxford

  • 1. High Performance Leadership, Organizational Leadership  /  2011

• National Institute for Medical Research

  • 1. Doctor of Philosophy (PhD), Molecular analysis of S phase control and initiation of DNA synthesis in the yeast cell cycle  /   1988 - 1992

• University of Bath

  • 1. Bachelor of Science (BSc) Hons, Applied Biology  /   1984 - 1988

Shares of [Inovio Pharmaceuticals, Incorporated] are down more than 22% in premarket trading after the company announced a leadership change at the helm and the discontinuation of a Phase III COVID-19 vaccine study.

Pennsylvania-based Inovio announced Tuesday that Chief Executive Officer [Dr. Jong Joseph Kim (born 1969)] has resigned from his position, as well as from his role as president and a member of the company board of directors. [Jacqueline Elizabeth Shea, Ph.D. (born 1965)], who has served as the chief operating officer of [Inovio Pharmaceuticals, Incorporated] since 2019, will take over the company's reins in his stead. 

Before coming to Inovio, Shea served as COO and later as CEO of tuberculosis-focused  [AERAS Global TB Vaccine Foundation], a not-for-profit drug development organization. She also previously held leadership roles at Emergent BioSolutions.

Not only has the company made a change in the C-suite, but in its quarterly financial report on Tuesday, Inovio announced plans to discontinue its Phase III Innovate trial in order to prioritize its heterologous booster strategy for COVID-19. The late-stage study was assessing INO-4800, the company's DNA vaccine candidate for COVID-19. The vaccine candidate is an intradermally-injected DNA plasmid vaccine designed to control the virological spread of COVID-19. 

In its announcement, changes in infection rates across the globe indicate the company will need to increase the trial size and cost of the INNOVATE study. In contrast, the heterologous booster market offers greater opportunities due to the endemic phase of COVID-19. So, instead of assessing INO-4800 as a two-dose vaccine, Inovio and its developmental partner Advaccine will examine the drug candidate as a heterologous booster to an inactivated COVID-19 vaccine. 

Earlier clinical data from a study conducted by Advaccine showed positive T cell immune response. In that study, interim immunogenicity data showed that using INO-4800 as a booster after six months resulted in a 6.3-fold increase in T cell immune response. 

In a separate Advaccine study examining a third dose of a COVID-19 vaccine, the cellular response increased by 1.7-fold. The highest booster effect of INO-4800 was observed with a 2 mg dose of INO-4800 delivered 6 months after a primary series with an inactivated vaccine.

With this understanding, Inovio said INO-4800 has the potential to play an important role in reducing the incidence of severe COVID-19 cases, particularly of viral mutations. The company is discussing this option with regulatory agencies across the globe.

New CEO Shea said the company believes in the potential of its DNA medicines and vaccines. In order to achieve the goals of being able to combat infectious diseases and other indications, Inovio had to "strategically prioritize" its resources to "capitalize on its demonstrated ability to generate functional T-cell and antibody immune responses."

As Inovio moves forward, the company intends to expand its partnership with Advaccine beyond INO-4800 to include heterologous boosters and vaccine candidates covering future COVID-19 variants. The expanded partnership will allow both companies to share data, leverage Advaccine's multiple manufacturing sites in China, and access opportunities globally.

Additionally, Inovio announced a change in plans regarding its therapy for HPV-associated cervical high-grade squamous intraepithelial lesions, VGX-3100. Following input from the U.S. Food and Drug Administration, Inovio will shift its focus to a biomarker study after the regulatory agency said data from the Phase III REVEAL2 study will not be sufficient for approval. 

The FDA recommended that data from Reveal2 could be used as an exploratory study to evaluate a biomarker-selected population. Then, Inovio can conduct one or two additional trials in the biomarker-positive population in order to provide enough evidence to support the approval of a marketing application.

In response, Inovio will amend the Reveal2 trial to revise the primary analysis population from the all-comers population to the biomarker-positive population. The change in regulatory guidance, though means that Inovio no longer anticipates filing a Biologics License Application for VGX-3100 in 2023.