Sponsors conducting trials in complex or rare disease areas often face challenges with protocol design, patient recruitment and data quality. These issues can be addressed through development partners that offer focused therapeutic knowledge, adaptable operational models and close collaborative support, all of which can contribute to more efficient and effective clinical trials.
This webinar explores how specialty CROs provide strategic value across the full development spectrum, from therapeutic expertise to operational agility and improved sponsor engagement. The session will demonstrate how their customised solutions and niche capabilities support better trial outcomes, especially in challenging indications such as CNS disorders and rare diseases.
Attendees will gain practical insights regarding how to:
- Apply domain-specific expertise to strengthen protocol design and patient recruitment
- Use flexible operational models to adapt quickly and keep timelines on track
- Improve data quality and patient retention through targeted trial practices
- Build strategic collaborations that improve trial design, regulatory readiness and commercialization strategies
Using real-world examples, the featured speakers will illustrate how sponsors can evaluate CRO fit based on trial complexity and organizational needs.
Register for this webinar to learn how focused expertise and flexible trial strategies can improve outcomes in CNS and rare disease trials.
Speakers
Gary Zammit, PhD, Founder, President, CEO, Clinilabs
Gary Zammit, PhD, is the Founder, President and CEO of Clinilabs. He established the company in 2000 to advance CNS drug and device development. A recognized expert in neuropsychiatric drug development and sleep medicine, he is also a Clinical Professor of Psychiatry at the Icahn School of Medicine at Mount Sinai. Dr. Zammit has authored over 250 publications and two books, with a third due in Fall 2025. His leadership continues to drive innovation and excellence in psychiatric and neurological therapeutics.
Message Presenter
Colin Orford, PhD, Therapeutic Lead, Psychiatry, Clinilabs
Colin Orford, PhD, is the Therapeutic Lead in Psychiatry at Clinilabs. He is a veteran drug development executive with 33+ years of experience at GSK, Novartis, Quintiles, Eisai and ICON. He has led R&D projects from preclinical through Phase IIIb, with deep expertise in neuroscience, including depression, anxiety, Alzheimer’s and sleep disorders. Colin also brings 10 years of biotech consulting experience, strong regulatory knowledge (US, EU and Japan) and a proven track record in due diligence, clinical strategy and adaptive trial design. He previously founded and led ICON’s drug development consulting team.
Message Presenter
Mehran Ahmed, Partner, InTandem Capital Partners
Mehran Ahmed is a Partner at InTandem Capital Partners. He has over 20 years of experience in private equity and finance, with a specialization in middle-market growth strategies. He brings deep healthcare expertise, having led and advised companies across pharmaceutical services, clinical trials, life sciences, behavioral health and more. Before InTandem, Mehran was a Managing Director at Webster Equity Partners and held roles at Gemini Investors, Arsenal Capital Partners and Morgan Stanley. He has a BA from Bowdoin College, where he was a Sarah and James Bowdoin scholar.
Message Presenter
Michael J. Detke, MD, PhD, Founder, Detke Biopharma Consulting LLC, Clinical Professor, Psychiatry, Indiana University
Michael J. Detke, MD, PhD, is a board-certified Psychiatrist and CNS drug development expert with over 25 years of experience in biotech and pharma. He has led clinical programs across all phases, including INDs and NDAs, and held CMO roles at Lighthouse, Cortexyme, Embera, CoMentis and MedAvante. At Eli Lilly, he oversaw global development for Cymbalta and Prozac.
Dr. Detke is the founder of Detke Biopharma Consulting LLC, which advises pharma, biotech and NIH on CNS strategy and regulatory affairs. He is a Clinical Professor of Psychiatry at Indiana University and has published over 70 peer-reviewed papers.
Message PresenterWho Should Attend?
This webinar will appeal to professionals with the following job titles and departments:
- Clinical Development Executives (CFOs, COOs and CMOs)
- Biotech and mid-sized pharma decision-makers
- Medical and Regulatory Affairs
- Clinical project and strategic planning teams
- CNS drug development
- Rare disease trials
- Complex therapeutic areas
What You Will Learn
Attendees will gain insight into:
- Using therapeutic expertise to strengthen protocol design and data interpretation
- Approaches for applying flexible, high-touch solutions to improve trial efficiency
- Practices that enhance data quality and support stronger patient retention
- Strategies for fostering strategic partnerships that advance trial design and commercialization
Xtalks Partner
Clinilabs
Clinilabs is a global, full-service clinical research organization (CRO) focused exclusively on central nervous system (CNS) drug, device, and technology development. Drawing on deep, indication-level expertise, a proven process, and the latest technology, we expertly manage Phase 1-3 trials to accelerate treatments for a range of psychiatric, neurological, and substance use disorders, as well as rare and ultra-rare CNS disorders. With 25+ years of global experience, over 800 CNS clinical trial awards completed, and over 30+ marketed products across more than 25 indications, we are the industry’s leading neurotherapeutic clinical trial experts.
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