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

Life Sciences, Clinical Trials, Patient Recruitment & Retention, Cell and Gene Therapy,
  • Wednesday, February 21, 2024

Discover an informative webinar exploring patient-centered approaches shaping ophthalmology trials, uniting stakeholders for better treatments and outcomes. Clinical trials in ophthalmology require special considerations at every stage, including trial design, recruitment strategies, patient outreach and engagement, assessments and data collection and management of investigational products or devices.

The key to success is putting the patients and their caregivers at the center when considering the overall approach to the trial. This panel session is fortunate to include the father of a child affected by Leber hereditary optic neuropathy (LHON) and will open with the perspective of a parent and active patient advocate.

The speakers will address advances in trial design specific to rare/genetic diseases of the eye, with a focus on cell and gene therapy, the need to work collaboratively in this space to match advanced therapeutic trial design to the unique needs of investigating ocular diseases and how new perspectives on patient centricity is leading to the evolution of these trials.

Join this webinar to gain insights into how sponsors, service providers, investigator sites, caregivers and patient advocacy groups can work together to accelerate the pace of bringing new treatments to these patients, for better outcomes and improved quality of life.


Chris Marsh, UBS

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.

Message Presenter
Darby Thomas, Fortrea

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.

Message Presenter
Marlene Brown, Fortrea

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.

Message Presenter
Hannah Simonds, Fortrea

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.

Message Presenter
Tanya Richardson, Fortrea

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!

Message Presenter

Who Should Attend?

This webinar will be useful for bio/pharmaceutical and medical device/biotechnology professionals working in the following areas:

  • Ophthalmology: Sponsors with a pipeline supporting vision science
  • Cell and gene therapy: industry contributors with an interest in cell, gene and advanced therapies
  • Trial optimization: anyone working on trial design and optimization for the latest models including patient-centric design
  • Investigator site relations: Investigators and all stakeholders responsible for identifying and working with sites
  • Patient recruitment: all clinical trial staff that focus on recruitment and relationships with patient advocacy groups (PAGs)

What You Will Learn

Attendees will gain insights into:

  • A personal perspective on patient and caregiver needs
  • The role of patient advocacy groups (PAGs) in supporting trials
  • Cell and gene therapy concepts in the context of ophthalmology trials
  • Insights about stakeholder support: patients, caregivers, investigator sites, sponsors and vendors

Xtalks Partner


Fortrea is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas. Our talented and diverse team of more than 19,000 people working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally.

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