We are delighted to introduce Sally Tucker as the President of Lexitas Global Services, where she will be responsible for steering the continued development and expansion of our existing capabilities outside of the United States. We chatted with Sally about her role, her vision, and what practical advice she has for sponsors looking to run an ophthalmology study.

Sally, thank you for joining us in this Q&A session. To start, could you share a bit about your background and your journey leading up to this point?

Absolutely, and thank you for having me! My journey in the world of healthcare began early on. My personal connection to vision issues, stemming from my severe hyperopic eye condition as a child, led me to pursue optometry, culminating in a Ph.D. in Ophthalmology with a special interest in glaucoma. During this time, I had the opportunity to spend three months in the United States at UAB, Alabama, which broadened my horizons in the field.

Since then, I’ve dedicated my entire career to ophthalmology, holding various roles in marketing, training & education, and clinical for global pharmaceutical and medical device companies. My educational background includes a B.Sc. with honors in Optometry from Aston University, as well as Post-Graduate Diplomas in Management and Additional & Supplementary Supply Therapeutics.

Can you describe your role at Lexitas and what you plan to prioritise as you step into this position?

So, as President of Lexitas Global Services, my primary focus is on expanding our existing global capabilities to better meet the needs of our clients, sites, and the patients we serve. Lexitas has already conducted a number of global studies successfully. My priority is to help us broaden our scope, and to ensure that we deliver high-quality ophthalmic studies that enroll on time, meet their clinical endpoints, and remain on budget.

We take pride in our track record of recruiting a remarkable 86% of our clinical studies on time or even ahead of schedule. Moving forward, we aim to expand these capabilities to more countries and regions globally, identifying areas where research is a viable care option for patients and recruitment can be favourable. This will enable us to bring breakthrough technologies to market quicker, benefiting those who need them most.

In fact, a CEO we have had the opportunity to work with commented that the survival of many companies begins and ends with the outcome of the clinical study. Because of that, the Lexitas team sees itself as part of the sponsor team working toward a common goal. For example, why we strive to find areas that we can support and ease the nuances of clinical trials to aid recruitment, which is one of the most complex aspects of a trial. Rather than just being a CRO, we see ourselves as product development partners to our customers working collaboratively toward a common goal.

The other thing is that we recognise that clinical trials are crucial to making advancements in ophthalmology. As someone who has worked both at the site level and from the sponsor side, I’m acutely aware of the needs of all stakeholders. We value our relationships with ophthalmic sites and strive to support them as much as possible. In fact, our strong relationships with sites and investigators are where we really help bring value to sponsors.

Finally, I am a passionate patient advocate – we must never forget that we are all patients, whether it’s ourselves or our loved ones. Bringing new technologies to patients in a timely manner can make a significant difference in their lives, and that’s a responsibility I take to heart.

What is your vision for Lexitas, and where do you see the organization in the next three years or more?

I see us being a bigger, better version of where we are today but with the same core values and mission. Our ophthalmic focus means that the people have a strong understanding of the therapeutic area, the conditions they work in, the patient journey, and with the sites themselves. This allows us to build compassion and empathy and drives people to go further knowing that they can, in their way, be a part of bringing the next drug or device to market that will have a huge positive impact on our patients. Now that is exciting!

What prompted you to choose Lexitas specifically, and what unique capabilities do you believe Lexitas offers that benefit sponsors?

Lexitas stood out to me for several reasons. First and foremost, it’s the people. The team’s dedication to and focus on clients is fantastic. The size and stage of the company also appealed to me. I felt I could make meaningful contributions and support its growth.

Lexitas’ therapeutic focus is another key differentiator. We have so many experts in specific areas, such as Drs. Lanita Scott, Joe Tauber, and Andrew Pucker. And there are countless more in our clinical operations and delivery functions as well.

My entire career has been in ophthalmology, and I’ve worked with many CROs from a sponsor perspective. I firmly believe that to optimise partnerships, both parties need a deep understanding of the therapeutic area, condition, and patient journey. Lexitas, with its ophthalmic subject matter experts, embodies this approach and provides superior service to its clients. I truly believe that a therapeutically focused product development organisation can provide superior service to the clients they partner with.

And we hear this from our investigator partners. James Masunaga, a clinical research director at one of our most important sites, recently said:

“Working with Lexitas over the years has been an amazing experience. The staff has always provided great support and prompt responses to any questions that may arise. Our success in the studies that we participate in is definitely a testament to the resources and experience that Lexitas brings to the table.”

It’s not very often that you hear this type of feedback, and I think it’s a testament to what sets us apart in the industry.

What are some key trends you see in clinical trials, and how do you expect the CRO industry to evolve in the coming years?

One notable trend, especially post-COVID, is the move toward virtual and decentralised trials, which I believe will continue to evolve. However, I see a significant opportunity in the application of Artificial Intelligence (AI) to transform traditional trial execution. AI can support superior predictability, precise feasibility assessments, and proactive patient identification, all of which could assist in breaking the typical 80/20 pattern where 20% of sites deliver 80% of patients. It could even assist in protocol planning. I expect that we’ll get to a future where sponsors can expect trials that are better designed, and sites that are better matched to the studies they can recruit well in. It would result in time reduction and cost efficiency in overall trial execution.

What are some of the key challenges you foresee in clinical trials, and how should they be addressed?

Clinical trials can become overly complex, placing a burden on sites and patients alike. I advocate for involving both sites and patients in the trial design process to avoid overly complicated protocols that can hinder recruitment and retention.

Furthermore, the increasing use of technology platforms in studies can be restrictive, particularly for elderly or visually impaired patients. Involving patients in study design is crucial to ensure technology is used in a way that maximises patient involvement, retention, and satisfaction whilst addressing cultural differences in technological adoption across countries.

Another challenge is matching the trial to the right site, ensuring that sites are set up for success and can recruit well. For many trials, a minority of sites recruit the majority of patients, which results in unnecessary efforts at the site level and unnecessary costs at the sponsor level. Finding ways, potentially through AI, to match trials to the right sites can increase efficiency for both sites and sponsors, although I think we are still a little way off from that.

Do you have any specific practical advice for sponsors when looking to work with a CRO?

First and foremost, you really need more than just a CRO. It needs to be your trusted product development partner. I think that’s the very first thing that sponsors should think about. Are you comfortable working with a large ‘one-size-fits-all’ CRO who box sponsors into the same cookie cutter approach regardless of whether the trial is for oncology, ophthalmology or immunosuppressants? Certainly, there may be economies of scale to be realised for large therapeutic areas. But for a highly specialised area like eye disease, I think it’s better to work with therapeutic subject matter experts.

And just as there is no such thing as a perfect life, there is no such thing as a perfect clinical trial – there are always challenges that we face but being open and addressing things proactively will result in an optimum partnership. That’s why it matters a lot how you collaborate with your product development partner. That’s why the three pieces of advice I would give are:

• Establish clear roles and responsibilities early on with a clear communication pathway – communication is key for any relationship.
• Provide and encourage 360 continuous feedback. There are always two sides to every story, and encouraging empathy and compassion will support in developing that collaborative partnership.
• Support the CRO with transparency and full disclosure, working together to proactively identify and mitigate any potential risk or challenge. There are always challenges and risks to any clinical trial, and being open to these from the outset assists in mitigating problems later.
  

Finally, on a more personal note, what are some of your interests, hobbies, or experiences that you’d like to share to help our readers get to know you better?

Personally, I am married to Paul and have three wonderful children, Ethan, Rosie, and James. We live just outside of London with our black lab, Baxter. I’m passionate about fitness and enjoy going to the gym, and whenever I can, I love to immerse myself in a good book.

I recently did a parachute jump to raise money for my children’s school despite being terrified of heights and once met our late queen, although I am not sure I would have featured on her list of accomplishments.

Thank you, Sally!

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