Bringing Ophthalmology Trials into Focus: Reducing Patient Burden, Improving Efficiency and Incorporating Cell and Gene Therapy

Chris Marsh, Cofounder and Advocate, LHON Collective

Chris Marsh is a Managing Director at UBS Financial Services. In September of 2021, Chris and his wife Malinda learned that their youngest son was affected with Leber hereditary optic neuropathy (LHON). In just over 2 years, Chris has become a leader in the LHON community, building partnerships between patient advocacy, clinicians and academic researchers and biopharma companies.

In collaboration with RARE-X, Chris co-leads a Vision Consortium, believing that greater collaboration can advance disease understanding and meaningful therapies across many genetic disorders of vision loss. The Consortium is working to collect patient-reported data, identify and share existing datasets and develop a business model to create clear value for biotech and pharma companies to invest in a shared data access model.

Darby Thomas, PhD, Scientific Director, Gene Therapies, Rare Diseases, Advanced Therapies and Pediatrics Team (RAPT), Fortrea

Darby Thomas, PhD, is the Scientific Director of Gene Therapies, in the Rare Diseases, Advanced Therapies and Pediatrics Team (RAPT) at Fortrea with over 20 years of experience in virology, cell and molecular biology, gene and cell therapy and biotechnology. Her background includes broad experience with adeno-associated virus (AAV) gene therapy with roles in CMC, discovery, translational development and patient advocacy for several AAV-focused companies with a career emphasis on rare pediatric diseases and ophthalmology.

Marlene Brown, CPM, PMP, Director, Rare Diseases, Advanced Therapeutics and Pediatrics Team (RAPT), Fortrea

Marlene Brown has more than 30 years of drug development experience inclusive of academia, large pharma and CRO in roles of research scientist; quality assurance; regulatory operations; project management; rare disease, advanced therapies and pediatric strategy and planning.

With 20 years of experience in project/program management encompassing large pharma and CROs, she has been involved in Phases I-IV clinical, worldwide regulatory, molecule development and multiple therapeutic areas. Her program management end-to end drug development experience includes leadership and/or project management of drug development teams spanning all phases of development.

Hannah Simonds, Director, Patient Recruitment and Engagement, Fortrea

Hannah Simonds has 13 years of industry experience, working across commercial pharmaceutical marketing, healthcare communications, patient support programs, clinical trial advertising and creative recruitment and retention solutions. She is experienced across a range of therapeutic areas, including ophthalmology, having worked on patient education and support programs for various forms of macular degeneration and inherited retinal disorders. She is passionate about working with patients as partners to promote awareness of clinical trials to a more diverse patient population and incorporate novel patient-centric solutions into the study design, to better meet patient’s needs.

Tanya Richardson, Executive Director, Strategic Delivery & Growth, Ophthalmology, Fortrea

Tanya Richardson has over 26 years of experience with Fortrea (formerly Labcorp, Covance and Chiltern), including monitoring, global project management, delivery director oversight and strategic planning and growth. Her clinical research experience includes a broad range of therapeutic experience with the last 15 years specifically focused on ophthalmology. Tanya’s ocular experience covers front and back of the eye indications, inherited retinal and ocular rare diseases across phase I-IV and medical device studies as well as ocular cell and gene therapies.

Her extensive delivery background, coupled with her ocular experience supports both internal and external stakeholders in the strategic development of a reduced burden approach, as well as an efficient and successfully executed ocular trial.

Tanya is passionate about ensuring the priorities of a clinical trial are to 1) reduce the burden across all stakeholders 2) have a realistic, common-sense approach because at the end of the day, we all do what we do for the patients!