Cicada Spotlight: Dr Diego Correa

Diego Correa joined our Health Tech Hub, General Manager, Lilly Bojaski for a fireside chat in Westmead. Hear his journey and insights below. 

Tell us the journey you’ve taken in your career that has led you to your current role as Director of the IQVIA Cell and Gene Therapy Center of Excellence?

From a young age, I knew I wanted to be a surgeon, pushing me to work hard to enter medical school. After receiving my MD degree, I started practicing as an attending physician in the ER department. However, after a short time, I realised the limitations of that work in terms of my professional development, given the type of questions I had in my mind, related to the understanding of the intricacies of how musculoskeletal tissues heal after injuries and how to accelerate that process to finally improve patient care. As a result, it became clear to me that it would require a non-traditional training approach. So, I registered for a master’s degree (MSc) in mechanical engineering with a focus on biomedical engineering, specifically working on Orthopaedic tissue engineering research, and quickly fell in love with biomedical research. After completing that program, I returned to the clinic enrolling in a residency in Orthopaedic surgery to complement the basic research with clinical training, aiming at becoming a clinician scientist. Going through the residency, I received the great news that I had been accepted to a highly competitive PhD program to which I had applied earlier, involving a full scholarship. Notwithstanding the fact that in my mind the scenario of having formal training as a scientist was appealing, abandoning clinical training (and a clinical career) was certainly a difficult decision to make. 

The career shift brought me and my wife (recently married) to New Haven, CT – USA, where I started a PhD program in Cellular and Molecular Physiology at Yale University. We then moved to Boston, MA to finish the program at Harvard University, following the move of my thesis mentor. The next step brought us, now with 2 daughters, to Cleveland, OH, where we’d spend the next 6 years working hand-by-hand with Professor Arnold Caplan in the field of stem cell biology and their clinical applications. My journey in cell and gene therapies had begun!

After those years at Case Western Reserve University with Professor Caplan, I joined the University of Miami School of Medicine Faculty, advancing research studying the application of Mesenchymal Stem/Stromal Cells (MSC) in Orthopaedic conditions, type 1 Diabetes and other debilitating conditions, all involving basic, translational and clinical development work. Five years passed when, in the middle of the COVID-19 pandemic, I received a call from IQVIA, exploring whether I would be interested in taking a Medical Strategy Lead role within their Cell and Gene Therapy Center of Excellence. Throughout my life, I’ve always been willing to give new directions and challenges special consideration, trying to be open-minded about opportunities as they present themselves. This one was extremely interesting yet involved another key career shift, requiring me to leave academia. 

After accepting the challenge and moving to the industry, I stayed in the Medical Strategy Lead role with IQVIA until 2 years ago, when the former head of the Cell and Gene Centre of Excellence (and my mentor within the organisation) left. I was approached to take the head role, initially for an interim 6-month “trial” period. With the great support of my team and senior leadership, I succeeded through that 6-month period and was formally promoted into the role.

On leaving academia I can say a few things - first off is that the Industry is not as they typically present it: “joining the dark side”! The “Dark Side” doesn’t exist in my view. The industry moves at a different pace, and it is a different way of working, but it is a vital part of bringing new therapies to patients. Academia has always been pivotal in generating knowledge and as a foundation for scientific and medical discoveries and progress. However, sometimes advancing rapidly to create therapeutic solutions becomes a hard task. You could eventually say that academia plays the role of an incubator of ideas, whilst industry is more of an accelerator or executor, motivated by getting therapies to patients as fast as possible. That being said, such distinction is no longer that clear, as new drug development models and collaborations between the many stakeholders emerge.

Finally, perhaps the greatest impact that this career change has made in my professional development and perspective around Medicine stems from the fact that in the past I was focused on becoming a Subject Matter Expert in a specifically defined area. Now, working in a fast-paced CRO, I get exposed to cutting-edge programs that are changing the medical therapeutics paradigm, favouring my return as a “generalist”. In my role I can find myself working on projects focused on ophthalmology, cardiovascular, neurology, oncology and many other therapeutic areas, pivoting throughout the day from cell therapy to gene therapy to RNA therapeutics with all their intricacies and unique features. The ability to play a part in patients receiving such innovative therapies is very rewarding, and I enjoy my work being part of these endeavours. 

In your role at IQVIA, how do you engage with incubators, and where do you observe incubator spaces making the most impact in the translational journey of early-stage small biopharma and start-up companies?

Incubators are an essential component of our early engagement strategy, as they concentrate talent becoming an efficient source of multiple sponsors at early stages. This is where we typically have the most impact as a Global Contract Research Organisation (CRO). Early decisions do impact the late stages of development and market entry.

Incubators serve as a supportive ecosystem enhancing the likelihood of success for startups in the Complexities of Cell and Gene Therapy (CAGT), based on their impact on:  

Access to Funding:
Many incubators provide seed funding or connect startups with investors specialising in biotech, which is critical for research and development.

Shared Resources:
Creating efficiencies for their sponsors, for example, “centralising” resources needed for clinical development that can be used for multiple programs simultaneously within the Bespoke Gene Therapy Consortium (BGTC).  

•  Access to laboratory space, specialised equipment, and administrative support can significantly lower overhead costs and speed up development.

• Regulatory Support: Guidance on navigating complex regulatory requirements can help startups avoid potential pitfalls and ensure compliance. 

Networking Opportunities:
Startups can benefit from a community of peers, mentors, and industry experts, facilitating partnerships, training and collaboration.

• Mentorship and Guidance: Experienced advisors can provide crucial insights on regulatory pathways, clinical trial design, and commercialisation strategies.
•  Training and Educational Programs: Many incubators offer workshops and seminars focused on specific aspects of biotech development, including business planning, regulatory affairs, and technology development.
•  Market Access and Business Development: Incubators often have connections and programs designed to facilitate market entry and expand business opportunities.

What advice would you offer those entrepreneurial scientists embarking on commercialisation/start-up journeys with Cell and Gene Therapies?

To balance scientific innovation with sound business practices. It's not always the best scientific idea that is the right one to start an entrepreneurial activity. 

Timing has been described as the #1 determinant of success/failure in start-ups (ahead of funding, team, and idea).

Basic tactics to enhance success would include:

• Thorough Market Research: Understand the landscape of your target market, including competitors, customer needs, potential applications for your therapy, etc. Run a Target Product Profile (TPP) and Clinical Development Plan (CDP) for Drug Development).

• Focus on Regulatory Pathways: Familiarise yourself with the regulatory requirements for cell and gene therapies, eg, Loss To Follow-Up (LTFU). Early engagement with Regulatory bodies can help streamline the approval process.
• Develop a Clear Business Plan: Outline your vision, mission, value proposition, and strategic goals. Include financial projections and funding strategies.
• Seek Funding Wisely: Explore various funding sources, including grants, venture capital, angel investors, and incubators. Be clear about your funding needs and how you intend to use the capital.
• Focus on Clinical Relevance: Ensure that your research addresses a significant unmet clinical need, as this will enhance the appeal to investors and potential partners.

• Prepare for the Long Haul: Commercialising a cell or gene therapy can take time and resources. Be prepared for potential challenges and setbacks, and maintain perseverance.

• Stay Agile and Open to Feedback: The biotech landscape is dynamic. Be prepared to adapt your strategy based on market feedback, scientific advancements, and new opportunities.

• Build a Strong Team: complementary skills, including expertise in business development, regulatory affairs, and clinical research.
• Leverage Collaborations: Form partnerships with academic institutions, research organisations, and other biotech companies to gain access to expertise, resources, and networks.
• Prioritise Intellectual Property: Protect your technology through patents and other IP strategies to secure a competitive edge and attract investors.
  
  

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