A Conversation with Colin Orford, Chair of Scientific Advisory Board

Colin Orford is an experienced drug developer with 33 years of experience across GSK, Novartis, Quintiles, Eisai, and ICON. He combines scientific strategy with operational execution and is well-networked across biotech, pharma, and the pharmaceutical investment community. With 22 years of hands-on pharmaceutical development experience and 10 years leading ICON’s Drug Development team, Colin has spearheaded R&D project teams from preclinical through Phase IIIb, transitioning numerous molecules from candidate selection to late phase development. Colin brings strong knowledge of regulatory guidelines for US, EU, and Japan markets, and expertise in due diligence for asset acquisition and investment funding. He has successfully guided Phase III teams through NDA and MAA submissions and works with emerging modalities such as cell and gene therapy.

Renal drug development is a very crowded, competitive, and specialized space. It’s a high-risk investment of both time and money. You can optimize your development strategy by anticipating and addressing potential points of failure to put you in a leading position, whether in a primary care or a rare disease space. Emerald Clinical Trials’ Renal Clinical Development Advisory Board is designed to help map out the key development strategies and highlight your risk points from the very early stages of development to maximize your investment and help ensure you are on the right path for regulatory success and commercialization.

Experience with the regulatory environment combined with clinical practice can best position your therapy in this very competitive marketplace by helping you target the right population, right endpoints, and assist in finding the most likely effective dosage.  It’s about generating a data package which is most likely to get regulatory approval and – most importantly – patient access. It’s about alignment.

Emerald Clinical has a pedigree of successfully delivering studies in the renal space. It has strong relationships with some of the top KOLs in the world from Europe, Asia, and the US, and over 90 renal experts who understand not only the development phase, but also the clinical practice space. Why is this important? Because the clinical expertise helps ensure your therapy is going to meet an unmet medical need that creates value for your patient population and will augment the standard of care. The development expertise helps ensure that you will engage with regulators and payors and get your therapy to the patients who need it. Our Renal Advisory Board will align your renal drug development program with the broader objectives throughout the development lifecycle to be best positioned to drive global patient care.

Why is a global perspective important?

Nowadays it’s almost impossible to develop a drug on an individual country basis. A global perspective integrated into your development strategy speeds development, approval, and commercialization across a larger footprint and reaches more targeted patients. Emerald’s Renal Advisory Board will help you with a comprehensive, differentiated strategy that positions your therapy in the worldwide market and defines how it is going to augment the standard of care across a global footprint – especially against drugs which have already been approved. The regulatory environment, clinical marketplace, and government formularies evolve very differently in different parts of the world. Thinking with the end in mind requires an understanding of regulatory standards and reimbursement benchmarks in all regions.

Emerald Clinical’s Renal Advisory Board has representatives from many different geographies – the US, Europe, and APAC. They have boots-on-the-ground experience with global variations in the regulatory environment, clinical practice, unmet medical needs, and how drugs gain successful approval, commercialization, and patient access. We’ll help you navigate the global renal landscape to ensure success of your therapy to reach patients worldwide.

How does Emerald Clinical’s Operational Expertise Enhance Risk Reduction?

Emerald Clinical has been conducting renal clinical trials globally for more than two decades, and trials like CREDENCE, SONAR, and ASCEND have changed clinical practice. Our success in this arena is due to two important elements: Having renal KOL advisors experienced in clinical practice and the clinical trial environment, and renal-specific operational teams who have a strong track record of delivering exceptional results. You need both components to optimize your particular asset development.

With the Renal Advisory Board’s strategic forecasting, you’ll have a realistic understanding of how protocol design, country selection, patient population, and competitive landscape can impact your actual operational delivery, costs and timelines. Your trials will be assured to be scientifically aligned, patient-centric, and run smoothly and efficiently. An added bonus is that Emerald’s network of KOLs have wide industry exposure and quickly disseminate information and lessons learned from the clinical trial arena to practicing clinicians.

Renal medicine is a broad space – if you’re developing a drug for a rare renal disease, it’s a very different strategy to working in the more general areas of CKD or diabetic nephropathy. We have the appropriate people on our Renal Advisory Board with experience from rare diseases to those broader categories, and they have been involved in drug development for many years. They know what it takes – not only strategically – but operationally. Emerald Clinical brings proven expertise in operational strategies and efficiencies that get you through the development phases much faster, shorten recruitment timelines, and have very high retention rates.

With nephrology KOLs across the world, we have on-the-ground knowledge that ensures your study is conducted in the best geographical locations – that it is conducted with the appropriate cultural nuances, and that it will generate data for widespread regulatory approval and eventual commercialization. Experience really does matter. We’ll help you create a roadmap that meets unmet medical needs and delivers to your target product profile.

Our renal teams have deep relationships with sites and investigators, as well as knowledge of where the best patient populations are for specific indications. We have access to renal-specific teams in >70 countries who have successfully conducted clinical trials with a strong track record of achieving exceptional recruitment and retention numbers, meeting or exceeding timelines, and providing data that meets regulatory requirements.

With the Renal Advisory Board, we are leveraging our extensive network of renal KOLS with the institutional knowledge that Emerald Clinical has in delivering renal trials.

Will the Renal Advisory Board be available if your drug is already in clinical trials?

Yes. Our Renal Advisory Board’s expertise can be deployed at any stage of development. While the best-case scenario is to seek advice from the Renal Advisory Board at the very earliest stages of renal drug development, their counsel can be invaluable at any stage of your program. If you’re moving from one development phase to another, we can help ensure that you are optimally positioned for the next phase – for getting through those regulatory hurdles to engage with payors and ultimately get that patient access.

If you’re moving into the more confirmatory Phase III – a much more restrained and stringent regulatory environment – studies have a more rigid framework and become much more logistically complex. Having those boots on the ground – people who understand the operational delivery – is extremely valuable. Combine that with Emerald Clinical’s institutional knowledge, and you have a powerful component to help you decide the way forward.

In terms of evidence generation — are you hitting things that matter in the real world? Are you reducing healthcare utilization – really hitting points that are relevant for your patient population? We can look at how you can differentiate in the marketplace – where the best positioning for your drug is to address standards of care against competitors. With access to Emerald’s Renal Advisory Board, you will have experts who have been there and done that and know how to best address the unmet medical needs across a broad geographic area. They know the clinical needs as well as the commercial landscape and have the operational knowledge to deliver results.

We understand that your assets and your development programs are costly, and you want to maximize the value you get from them. The Renal Advisory Board can help you with strategies for successful growth to ensure that your drug embeds into the overall landscape and continues to respond to a changing environment.  It’s about lifecycle management – regardless of where you are in your current development – and about getting you there more quickly.

Let Emerald Clinical’s Renal Advisory Board help you bring a new medicine to the market that is really going to make an impact. Let’s make lives better together.