Suresh Dalapathy, MS

• Provided global clinical program and project management leadership for complex ophthalmic development projects. • Collaborated with sponsors to address critical patient and physician needs in the ophthalmic field. • Ensured compliance with regulatory standards while driving project timelines and deliverables.

With a proven track record in clinical trial management—particularly in Ophthalmology and Hematology/Oncology—I bring the strategic oversight and operational precision needed to guide complex studies from concept to completion. I have successfully led cross-functional teams, navigated evolving regulatory landscapes, and delivered critical milestones that move both drug and device programs forward. Partnering with a company that specializes in Strategy and Business Consulting within the Clinical Research and Life Sciences space, I am passionate about enabling Pharma and Biotech organizations to accelerate development timelines, optimize trial performance, and ultimately bring meaningful therapies to patients faster. My experience, combined with the company’s deep expertise, allows us to deliver solutions that are not only compliant and efficient—but transformative. Together, we help clients achieve the one outcome that matters most: significant patient impact, delivered with speed, quality, and confidence.

In my role at ICON plc and at JNJ, I led the operational oversight of complex Hematology/Oncology clinical trials, ensuring adherence to regulatory standards and high-quality data delivery. Collaborating with various stakeholders, I championed process improvement initiatives and actively participated in diversity planning efforts. My contributions helped streamline project management and foster a culture of excellence within the team.

In my role at Novartis Pharmaceuticals, I led the implementation of global clinical trials, ensuring adherence to regulatory standards and corporate policies. By focusing on project management at various levels, I successfully met study timelines and deliverables while maintaining high-quality standards. My efforts contributed to improved site performance and patient recruitment efficiency and NDA approvals

January 2017- January 2022: Approvals for Beovu from global HA - FDA, EMEA, TGA, Swiss Medic, Japan, Health Canada Phase III Novartis: HAWK Study- A Two-Year, Randomized, Double-Masked, Multicenter, Three- Arm Study Comparing the Efficacy and Safety of RTH258 versus Aflibercept in Subjects with Neovascular Age-Related Macular Degeneration Phase IIIb Novartis: TALON Study- A 64 week, two-arm, randomized, double-masked, multi- center, phase IIIb study assessing the efficacy and safety of brolucizumab 6 mg compared to aflibercept 2 mg in a treat-to-control regimen in patients with Neovascular Age-Related Macular Degeneration Other Key Deliverables: DSMB, Investigator Meeting planning and presentations, planning events at congresses like AAO, ARVO 2020-2021 - Digital Therapeutics Studies NoPHIS Protocol: Feasibility of Visual Acuity assessments using Focal View at home and in the clinic, including comparison with e-ETDRS assessment in the clinic, in subjects with nAMD or DME NIS: A non-interventional study based on HAWK and HARRIER clinical trials to evaluate the accuracy of the Intelligent precision dosing application (IPDA) in assessing disease activity in patients with nAMD treated with Brolucizumab A 52-week randomized, single masked, multicenter proof of concept study of binocular video games versus patching for amblyopia in children 4-7 years of age with an open-label sub-study of binocular video games in children 8-12 years of age

Leading Global Site Management Monitoring Team Members in Managing the Execution of Human Clinical Studies (Phase I, II, III, IIIb, IV) in the Medical Specialty Areas of Refractive Surgery, Glaucoma, Retina, Ocular Allergy, New Technology Contact Lenses, Visual Performance, Novel Biologics for AMD & Uveitis Clinical Studies. • The Lead Clinical Site Manager is responsible for supporting the implementation and execution of Alcon’s clinical trials by performing specific project management tasks at country, regional and site level. • Ensures achievement of timelines and study deliverables with excellent quality and full compliance with international guidelines, local regulations and corporate policies and procedures. • The Lead Clinical Site Manager is primarily responsible for • Successful implementation and execution assigned trial in compliance with guidelines, regulations, and procedures • Follows study metrics using all available tools and information (e.g., CTMS, EDC, CDM reports) to ensure achievement of target study milestones and deliverables • Consistency of Alcon’s processes and procedures across studies • Coordination of study activities with assigned CSMs • Reinforcing compliance with protocol monitoring plan, relevant procedures, and applicable regulations • Actively participates on the Clinical Trial Team (CTT), building relationships and serving as liaison between trial personnel as appropriate (e.g., CSMs, CMs, RMs, CRO personnel); and • Proactively identify potential/actual issues and risks, escalate to management and CTT as appropriate, and contribute to mitigation.

Ophthalmic Pharmaceutical Product, Medical Device Development Phase I/II Glaucoma: Several PoC Studies Phase I-IIIb Clinical Studies: Travatan/Timolol combination DuoTrav™ NDA filing & approval Phase III Glaucoma Clinical Pharmacology / PK Study: PK study component of an NDA filing of SIMBRINZA® Ophthalmic Suspension Phase III Glaucoma: Pivotal US Study for a combination glaucoma drug NDA filing & approval leading to TRAVATAN-Z® Ophthalmic Solution Phase III Glaucoma: Travatan Dosing Aid Study (TDA) Study - Filing & approval Phase III Anti-infective: Vigamox® Phase IV: BETAXON™, TRAVATAN®-Z,Azopt/Timolol Combination, Brinzolamide/Timolol & Travatan/Brinzolamide studies Phase IV Allergy/ Dry Eye: Clinical Evaluation of SYSTANE® BALANCE in Subjects with Lipid-Deficient DE Phase I/II PoC NIBR/ Alcon/Esbatech Retina: ARMD: PoC study of topically delivered LHA 510 (small molecule TK Inhibitor) as a maintenance therapy in patients with wet ARMD. Phase I/II PoC NIBR/Alcon Retina: ARMD: Open label, single ascending dose and randomized double masked, ranibizumab controlled, safety, tolerability, and efficacy study of intravitreal LMG 324 (dual targeting molecule in which an anti-VEGF Fab is fused to a 95 amino acid HA- binding peptide) in subjects with neovascular ARMD Phase I/II PoC Alcon/Esbatech Retina: Global Retina Study with 52 sites assessing a novel biotherapeutic - RTH molecule for Age-Related Macular Degeneration Phase I/II NIBR/Alcon Uveitis: Acute Anterior Uveitis Clinical PoC: New Single Chain Antibody Fragment LME 636 Phase I/II PoC NIBR/Alcon Glaucoma: First in Human MGV 354 of Glaucoma medication Phase III: Alcon Refractive Surgery: Allegreto WAVELIGHT® Refractive Surgery Platform – Successful PMA Submission for PRK label approved by the US FDA in December 2016 Phase II: Vision Care: New Alcon Vision Testing System (AVTS): PoC/Phase I/II Phase II: Vision Care: New Generation & Concept of Contact Line of Sight Lens: PoC/Phase I/II: Novel Contact Lens

Maintained a stably transfected CHO engineered cell line which over expressed Human Myocilin Purified Myocilin using Size Exclusion Chromatography The purified protein was contracted out to generate monoclonal antibodies & perform X-Ray Crystallography for protein structure elucidation Contributed to presentation of Glaucoma basic research results within Alcon R&D at peer levels

Cloned, in a bacterial system, optimized, quantified, & purified human recombinant therapeutic cytokines (Gamma interferon, GMCSF) & a growth factor (Epidermal Growth Factor) Assisted the Clinical Research Group with the Clinical Product Launch materials for Syscan Eye Drops, Fluconazole Ophthalmic Solution 0.3%

Developed Nested PCR-based Nucleic Acid diagnostic assay for studies to detect viruses causing ocular inflammation (collaboration with Yokohama School of Medicine, Japan as a part of the world wide epidemiology of infectious conjunctivitis detection). Presented work in Ophthalmic Grand rounds at the Institute, National (IERG) and International Scientific Meetings (ARVO)

http://www.jic.ac.uk/corporate/index.htm