ARTICLES BY ABBY PROCH
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![Oncolytic Virus immunology, immunotherapy, cancer vaccine-GettyImages-1445620397]( "Calidi's Study Aims To Have An Oncolytic Virus Outsmart The Immune System")
Calidi's Study Aims To Have An Oncolytic Virus Outsmart The Immune System10/2/2026Calidi’s Eric Poma, Ph.D., explains how CLD-401 could evade immune clearance — and how the biotech is designing Phase 1 to prove safety and efficacy fast.
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![CT scan heart]( "New Imaging Approach Could Improve IPF Trial Design")
New Imaging Approach Could Improve IPF Trial Design10/1/2026AI-powered quantitative CT could help sponsors detect treatment effects earlier, strengthen IPF trial endpoints, and make better go/no-go decisions.
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![Senior woman meeting with doctor-GettyImages-2205398466]( "Examining The Potential Of P-tau217 To Provide Earlier Diagnosis Of Alzheimer's")
Examining The Potential Of P-tau217 To Provide Earlier Diagnosis Of Alzheimer's9/25/2026P-tau217 blood tests could accelerate Alzheimer’s diagnosis. Lilly’s Nino Sireci, MD, MSc, explains the research, evidence thus far, potential clinical use, and next steps.
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![elderly care, rehabilitation, recovery-GettyImages-2274991410]( "How VNS-REHAB Aims To Improve Stroke Recovery After Patients Have Plateaued")
How VNS-REHAB Aims To Improve Stroke Recovery After Patients Have Plateaued9/22/2026Learn how a stroke trial standardized intensive therapy, sustained patient adherence, and exposed access barriers after FDA approval.
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![Mixing medications-GettyImages-907865696]( "Repurposing Three FDA-Approved Drugs For A New Stroke Recovery Strategy")
Repurposing Three FDA-Approved Drugs For A New Stroke Recovery Strategy9/17/2026When three drugs become one — the polypharmacology strategy, 505(b)(2) pathway, and objective endpoints Nuero-Innovators is relying on to bring new hope to stroke patients.
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![CMT main image-GettyImages-2210725149]( "Coalition Takes Guesswork Out Of Charcot-Marie-Tooth Disease Research With New Guidance")
Coalition Takes Guesswork Out Of Charcot-Marie-Tooth Disease Research With New Guidance9/16/2026A new Charcot-Marie-Tooth guidance introduces practical recommendations to help sponsors design clearer, more patient-centered, regulator-ready trials.
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![aprea-GettyImages 2151588975]( "Dose Escalation, Combination Strategy Keep Aprea Ahead In Its Oncology Trials")
Dose Escalation, Combination Strategy Keep Aprea Ahead In Its Oncology Trials9/2/2026Aprea’s Gene Kennedy explains how smart dose escalation, next-gen sequencing, and combination planning are helping the company advance its oncology trial for multiple solid tumor types.
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![MRI scanner-GettyImages-978265118]( "How A $96M Gift Is Transforming Pediatric Brain Cancer Clinical Trial Infrastructure")
How A $96M Gift Is Transforming Pediatric Brain Cancer Clinical Trial Infrastructure9/1/2026By pairing donor priorities with research needs at Children's National, Milken Institute SPARC is turning philanthropy into faster trials, stronger infrastructure, and long-term care goals.
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![World map, World globe-GettyImages-505575304]( "Planning A Global Clinical Trial With The Right Sites, Not The Most Sites")
Planning A Global Clinical Trial With The Right Sites, Not The Most Sites8/27/2026Less is more for Yi Larson and the team at Excursion Therapeutics, which opted to build right site network — not the largest one — for its Phase 2 trial.
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![Nitric oxide-GettyImages-1458025913]( "Turning A Historically Limited Modality Into A Respiratory Drug Opportunity")
Turning A Historically Limited Modality Into A Respiratory Drug Opportunity8/26/2026How can sponsors revive a promising modality with known safety limits? Vast Therapeutics CEO Nate Stasko, Ph.D., explains how ALX1 is reshaping nitric oxide delivery.
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![Oncolytic Virus immunotherapy and cancer vaccine Therapy-GettyImages-1440747009]( "Immune Priming, Oncolytic Viruses, And The Next Phase Of Solid Tumor Immunotherapy")
Immune Priming, Oncolytic Viruses, And The Next Phase Of Solid Tumor Immunotherapy8/25/2026Can priming with oncolytic viruses be a better path to reeducating the immune system to recognize and attack cancer? Oncolytics Biotech advisor Richard Vile, Ph.D., says yes.
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![samples under microscopes, analyze data-GettyImages-2191794159]( "What BriaCell's Trial Design Says About Real-World Cancer Research")
What BriaCell's Trial Design Says About Real-World Cancer Research8/24/2026BriaCell President and CEO William Williams, MD, shares how broader eligibility criteria and physician’s choice controls can better reflect real-world cancer care.
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![Senior consulting with doctor in exam room-GettyImages-2205398583]( "'How Do You Feel?': Designing A Cardiac Trial With A Patient-Reported Primary Endpoint")
'How Do You Feel?': Designing A Cardiac Trial With A Patient-Reported Primary Endpoint8/21/2026Imbria Pharmaceuticals' Albert Kim, MD, Ph.D., shares why PROs are the point of the company's FORTITUDE-HCM trial for patients with non-obstructive hypertrophic cardiomyopathy.
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![Norovirus, viral disease vaccine-GettyImages-960428222]( "Stock Options: Choosing The Right Viral Inoculum For An Early-Phase Norovirus Trial")
Stock Options: Choosing The Right Viral Inoculum For An Early-Phase Norovirus Trial8/20/2026Viral stock can make or break a norovirus challenge study. Cocrystal Pharma's Sam Lee explains why inoculum quality, infectivity, and availability matter.
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![crowd forming a talk bubble-GettyImages-1457560942]( "Rare Disease Study Gets A Boost From Crowdsourced Patient Reported Data")
Rare Disease Study Gets A Boost From Crowdsourced Patient Reported Data8/18/2026Jen A. Levitt, MD, explains how crowdsourced patient-reported data and AI tools can compress rare disease research timelines and surface new signals.
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![GettyImages-1362711093-growing-arrow-people-group]( "The Patient Advocacy Strategy Behind Skyhawk's Rapid Enrollment")
The Patient Advocacy Strategy Behind Skyhawk's Rapid Enrollment8/13/2026Skyhawk’s patient-first approach shows how advocacy partnerships, site engagement, and operational quality can accelerate enrollment without losing focus on patients.
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![psych getty 1297049765]( "What The FDA's Latest Move On Psychedelics Means For Non-Hallucinogenic Drug Sponsors")
What The FDA's Latest Move On Psychedelics Means For Non-Hallucinogenic Drug Sponsors8/13/2026Taking another angle to the FDA focus on psychedelic research, Enveric Biosciences CEO Joseph Tucker, Ph.D., explores what the FDA’s moves mean for non-hallucinogenic drug sponsors.
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![psych-Getty1297049765]( "What The FDA's Psychedelic Drug Focus Means For Classic Psychedelic Development")
What The FDA's Psychedelic Drug Focus Means For Classic Psychedelic Development8/13/2026Complementing an interview with Enveric Bioscience's Joseph Tucker, Ph.D., this Q&A explores Josh Hardman's thoughts on what FDA’s psychedelic focus could mean for classic psychedelic development.
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![Light beam shining in eye, eye exam-GettyImages-1398519163]( "How FDA Alignment Is Shaping Opus Genetics' OPGx-LCA5 Development Strategy")
How FDA Alignment Is Shaping Opus Genetics' OPGx-LCA5 Development Strategy8/12/2026Opus Genetics shares how FDA alignment yielded a clearer path for its ultra-rare LCA5 gene therapy, shaping trial design, evidence generation, and operations.
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![GettyImages-2233249181_bloodwork]( "What It Takes To Validate A Biomarker For Real-World, Post-Transplant Care")
What It Takes To Validate A Biomarker For Real-World, Post-Transplant Care8/7/2026Yelena Bushman, MBA, VP of cell therapy and transplant at CareDx, discusses the operational challenges of validating biomarkers for post-transplant care.
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![c suite changes]( "C-Suite Changes Help Biotech Narrow Focus But Maintain Drive To Treat Fatal Neonatal Brain Injury")
C-Suite Changes Help Biotech Narrow Focus But Maintain Drive To Treat Fatal Neonatal Brain Injury8/5/2026Newly-appointed leaders at ReAlta Life Sciences discuss their skill sets, their goals for advancing a therapy for hypoxic ischemic encephalopathy (HIE), and how they keep momentum as they strive to help bring this potentially lifesaving therapy to market.
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![medications in shopping basket-GettyImages-2281371864]( "From Signal To Strategy: What Oncology Basket Trials Can Teach Clinical Development Teams")
From Signal To Strategy: What Oncology Basket Trials Can Teach Clinical Development Teams7/29/2026AbbVie's Svetlana Kobina discusses how basket trials can help clinical development teams move from early clinical signals to a more disciplined strategy.
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![pharmacist checks inventory, drug shelves-GettyImages-1941443650]( "ImvivaBio's Trial For Off-The-Shelf CAR-T Strategy For Aggressive Malignancies")
ImvivaBio's Trial For Off-The-Shelf CAR-T Strategy For Aggressive Malignancies7/28/2026ImvivaBio CMO Jan Davidson-Moncada, MD, Ph.D., discusses the company's Phase 1b/2 study for aggressive T-cell malignancies, explaining their unmet need, the rationale for an allogeneic approach, and how they plan to address immune rejection.
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![Cancer Outpatient During Chemotherapy IV Infusion-GettyImages-1263248921]( "Expanded Access And Rollover Design Help CytoDyn Reach High-Need Cancer Patients")
Expanded Access And Rollover Design Help CytoDyn Reach High-Need Cancer Patients7/24/2026CEO Jay Lalezari and CFO Robert E. Hoffman share how CytoDyn meet patient needs when they approach trial design for cancer trials.
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![Biological cancer cell disease-GettyImages-2161692091]( "Unlocking Gentler, Cost-Efficient TIL Therapy For Cold Tumors")
Unlocking Gentler, Cost-Efficient TIL Therapy For Cold Tumors7/20/2026CuraCell Head of Clinical Operations Torbjörn Ström discusses, in the context of CC-38 and CytoPLY-derived tumor-infiltrating lymphocytes (TILs), the utility of named-patient experience, dosing and preconditioning, and T-cell therapy capabilities in cold solid tumors.
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![Online testing, questionaire, voting-GettyImages-873499310]( "What Pistoia Alliance's AI Poll Reveals About Industry Readiness And Regulatory Confidence")
What Pistoia Alliance's AI Poll Reveals About Industry Readiness And Regulatory Confidence7/17/2026Pistoia Alliance President Becky Upton, Ph.D., reviews findings from a poll about AI use in clinical research conducted at Clinical Trials Technology Congress (CTTC) that revealed barriers to adoption, early ROI, emerging use cases, and the role of patient-generated data.
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![woman receiving cancer treatment-GettyImages-1346190289]( "The Promise Of Bispecifics In The Quest For Outpatient Immunotherapy")
The Promise Of Bispecifics In The Quest For Outpatient Immunotherapy7/15/2026START San Antonio's Drew Rasco, MD, reflects on the evolution of immunotherapy and highlights how novel therapies such as bispecifics are both challenging and intriguing for principal investigators (PIs).
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![MRI_forPR_final-(4)-(1)]( "Digital Twins Enhance Disease Progression Measurements In FSHD")
Digital Twins Enhance Disease Progression Measurements In FSHD7/14/2026Digital twins can transform trial design by making data more robust and alleviating patient burden. In this interview, Epicrispr CEO Amber Salzman, Ph.D., shares how the company's using it to reliably predict muscle volume change in their trial for a FSHD gene therapy.
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![female doctor shakes hands with her young female patient-GettyImages-2123113270]( "Navigating The New EU Pharmaceutical Legislation: Key Implications For Pediatric Drug Development")
Navigating The New EU Pharmaceutical Legislation: Key Implications For Pediatric Drug Development7/13/2026UCB’s Senior Development Strategy Lead Pediatrics Martine Dehlinger-Kremer, Ph.D., discusses updates to the new EU Pharma legislation and how they impact pediatric drug development, including earlier pediatric investigational plans .
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![Start to finish-GettyImages-1410756550]( "i-Cubed Used End-To-End AI In A Proof-Of-Concept Trial. Here's What They Learned")
i-Cubed Used End-To-End AI In A Proof-Of-Concept Trial. Here's What They Learned7/2/2026Discover how well AI fared in document generation, patient engagement, data integration, and more in an end-to-end proof-of-concept study run by i-Cubed.
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![Woman in depression-GettyImages-2175026346]( "Social Media Is Replete With Patient RWD, But How Can Researchers Best Use It?")
Social Media Is Replete With Patient RWD, But How Can Researchers Best Use It?7/1/2026Pistoia Alliance's Thierry Escudier and Aditya Tyagi discuss how social media listening is used in clinical research, how it supports established evidence-generation methods, and how it can become a credible, structured input for drug development.
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![consoling-GettyImages-2190851878]( "Helus Shares Experience Studying Adjunctive Psychedelic For Major Depressive Disorder")
Helus Shares Experience Studying Adjunctive Psychedelic For Major Depressive Disorder6/26/2026Helus Pharma CMO Amir Inamdar discusses the strategic rationale behind its Phase 3 trial for major depressive disorder, including its adjunctive-treatment approach, patient population selection, and endpoint strategy.
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![EMR, Electronic medical record-GettyImages-917611012]( "RWE Increasingly Supports Rare Disease Research As RCTs Alone Fall Short")
RWE Increasingly Supports Rare Disease Research As RCTs Alone Fall Short6/25/2026Chiesi's Rachele Berria, MD, Ph.D., discusses how RWE is reshaping rare disease drug development strategies, from leveraging registries and patient-reported outcomes to navigating evolving regulatory expectations.
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![Human Circulatory System Heart Anatomy-GettyImages-2202279387]( "Designing Trials For Disease Modification: Cereno Scientific's Approach To Pulmonary Arterial Hypertension")
Designing Trials For Disease Modification: Cereno Scientific's Approach To Pulmonary Arterial Hypertension6/10/2026Cereno Scientific’s Rahul Agrawal discusses the scientific and strategic rationale behind extending the company’s Phase 2b study duration and how the company incorporated regulator and patient input.
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![Disability, daily activities-GettyImages-2169336772]( "New Primary Endpoint For Tetraplegia Drug Gets Support From Patients And The FDA")
New Primary Endpoint For Tetraplegia Drug Gets Support From Patients And The FDA6/9/2026NervGen CEO Adam Rogers discussed why choosing a hand function endpoint for tetraplegia made sense for patients and how regulators helped guide and support the company's decision.
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![Tidioute Health Care Center-GettyImages-1273786594]( "Expanding Access To Cell Therapy Trials Beyond AMCs And Into The Community")
Expanding Access To Cell Therapy Trials Beyond AMCs And Into The Community6/1/2026CEO Paul J. Hastings discusses Nkarta's decision to bring outpatient dosing into the community setting, including how it communicated with the FDA on safety and how the changes will improve patient access.
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![ispor]( "What's The Role Of HEOR For A Clinical Researcher? A Perspective From ISPOR 2026")
What's The Role Of HEOR For A Clinical Researcher? A Perspective From ISPOR 20266/1/2026On the heels of ISPOR 2026, discover what relevancy HEOR has in the world of clinical operations.
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![Female doctor examining patient-GettyImages-2217109316]( "Safety Is The Mantra In Kivu Bioscience's ADC Trials For Solid Tumors")
Safety Is The Mantra In Kivu Bioscience's ADC Trials For Solid Tumors5/29/2026Kivu Bioscience CEO Mohit Trikha, Ph.D., contends that safer ADCs enable higher effective dosing and could elicit a better response in solid tumors. In this Q&A, he also discusses how parallel trial execution, global site strategy, and stakeholder collaboration support rapid, data-driven development.
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![Healthcare benefits enroll-GettyImages-882379348]( "Taking On Patient Recruitment From Another Angle — The Payer")
Taking On Patient Recruitment From Another Angle — The Payer5/28/2026Medzown CEO Jennifer Carter, MD, discusses the challenge of patient recruitment and how coalescing around clinical care data might be a better “in” for recruitment.
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![Human circulatory system, internal organs-GettyImages-2211665100]( "Biotech Ecosystem Helps Advance A New Approach To Inflammation Into Trials")
Biotech Ecosystem Helps Advance A New Approach To Inflammation Into Trials5/26/2026BioAegis Therapeutics CEO Susan Levinson, Ph.D., talks about the role of partner and regulatory support in bringing their investigational immunotherapy into the clinic.
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![CTD story - GettyImages-1253880092 and Canva]( "How Did You End Up In Clinical Research?")
How Did You End Up In Clinical Research?5/20/2026To commemorate Clinical Trials Day, we asked clinical researchers to share their story, answering, "How did you get into clinical research?"
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![ALS, MND, Lou Gehrig's disease, terminal neurodegenerative disorder-GettyImages-2243922832]( "ALS Researchers Use Stratification, Diverse Endpoints To Address Heterogeneity")
ALS Researchers Use Stratification, Diverse Endpoints To Address Heterogeneity4/30/2026Coya Therapeutics' Fred Grossman dives into innovative trial design elements and a novel biomarker that might better account for clinical and functional progression in Coya's ALS trial studying a dual immunomodulatory therapy.
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![Diabetic Mobile App-GettyImages-1465477626]( "Philanthropy Empowers And Accelerates Testing Of Drug Combinations In T1D")
Philanthropy Empowers And Accelerates Testing Of Drug Combinations In T1D4/23/2026City of Hope’s Alberto Pugliese, MD, discusses how philanthropic gifts helped launch a landmark multi-center trial to test a combination therapy using repurposed drugs for the treatment of Type 1 Diabetes.
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![life sciences future sw]( "What Sites, Sponsors, Vendors, And CROs Can All Agree On")
What Sites, Sponsors, Vendors, And CROs Can All Agree On4/17/2026Experts representing sponsors, sites, vendors, and CROS discussed at Life Sciences Future SW the pain points and the opportunities that lie ahead in clinical research.
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![modern medical research center, ct scan-GettyImages-2160715346]( "Is It Time To Replace RECIST — Or Just Add AI?")
Is It Time To Replace RECIST — Or Just Add AI?4/16/2026Immunocore Chief Regulatory and Quality Officer Mark Moyer explains why new tools, including AI-based approaches, may better capture cancer treatment response than existing measures, such as ir-RECIST.
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![Kidney issues, medical-GettyImages-1360864678]( "First-In-Human Porcine Kidney Transplant Trial Builds On Expanded Access Success")
First-In-Human Porcine Kidney Transplant Trial Builds On Expanded Access Success4/13/2026eGenesis CEO Mike Curtis discusses the first-in-human trial of EGEN-2784, which they're studying whether a porcine kidney can restore near-normal quality of life while awaiting a human transplant.
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![Glioblastoma in Left Frontal Lobe with Midline Shift-GettyImages-2226756753]( "Lessons Learned While Taking Glioblastoma Drug From Bench To Clinic")
Lessons Learned While Taking Glioblastoma Drug From Bench To Clinic4/9/2026MimiVax CEO Mike Ciesielski recounts the company's transition from academia to industry, hitting on topics like vendor partnerships, FDA conversations, and manufacturer selection.
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![taking initiative, approaches, opportunities, achievement-GettyImages-1453367933]( "With A Clear Focus And Promising Asset, Crystalys Is Skipping Phase 2 Trials For Gout")
With A Clear Focus And Promising Asset, Crystalys Is Skipping Phase 2 Trials For Gout4/3/2026Crystallis President and CEO James Mackay shares insights from the company’s clinical decision-making for dotinurad, including the inclusion of an open label extension.
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![lymphatic system, lymphoid system-GettyImages-1418110454]( "RWD Helps Researchers Include More Patients In Lymphoma Research")
RWD Helps Researchers Include More Patients In Lymphoma Research4/2/2026Andrew Evens, DO, MBA, explores how outcomes research and collaboration across academic networks, registries, and industry partners are advancing more inclusive, data-informed approaches to lymphoma research.
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![chart data, graphs-GettyImages-1411083834]( "Opus Genetics Shows Proper Planning Is Key To Adaptive Trial Design")
Opus Genetics Shows Proper Planning Is Key To Adaptive Trial Design3/31/2026Opus Genetics CEO George Magrath, MD, shares the team’s experience with an adaptive Phase 1/2 trial design for an ocular gene therapy.
Abby Proch
Abby Proch is the executive editor of guest expert articles for Clinical Leader. Since 2022, Abby has worked with hundreds of industry professionals to share their expertise with the Clinical Leader community, including sponsors, sites, CROs, and supporting companies. She encourages industry experts to write from experience and share with passion. Her high-touch, end-to-end approach — from brainstorming topics to providing constructive feedback to approving works for publication — has helped experts reach thousands of life sciences readers across the web and social media. Abby has over 15 years of experience in writing and editing.