Eric Lang

• Provide strategic guidance on clinical development strategy, regulatory interactions, and clinical operations for novel pain programs • Support capital raise

• Supporting a smaller biotech with strategic guidance on clinical development strategy, regulatory interactions, and clinical operations for several novel programs

Led clinical development, regulatory strategy, and pharmacovigilance for neuroscience-focused biotech. • Developed clinical strategy for 3 novel indications across different therapeutic areas and filed 2 patents for novel treatment concepts • Designed and executed a phase 2 program (3 trials) for a novel fixed-dose combination for the treatment of acute pain • Supported successful IPO including investor roadshow, presenting clinical data and strategy to bankers and analysts • Built clinical operations team from ground up, hiring employees and establishing consultant network to execute development program

(including subsidiaries Vyluma and Nevakar Injectables) | 2018-2023 VP & Head of Clinical Development (2018-2020) → CMO Nevakar (2020-2021) → CMO Nevakar Injectables (2021-2022) → CMO Vyluma (2022-2023) Biotech focused on drug repurposing. Responsible for clinical development, regulatory strategy, pharmacovigilance, and clinical operations across parent company and two subsidiaries. • Led team that filed 3 NDAs: low-dose atropine for pediatric myopia (NVK002) and two hospital/ICU products • Designed and executed Phase 3 CHAMP trial (1,200+ pediatric patients, 36 months) published in JAMA Ophthalmology 2023 • Established clinical operations infrastructure including CRO management, site selection, and pharmacovigilance systems for 3 simultaneous development programs • Presented to and supported interactions with investors and bankers

Early-stage biotech developing oral peptide delivery technology for parathyroid hormone (hypoparathyroidism and osteoporosis). • Responsible for clinical, regulatory, and CMC strategy; built preclinical-to-clinical development plan for orphan indication program and for program for osteoporosis • Supported successful IPO including investor roadshow, presenting clinical data and strategy to bankers, venture capitalists and analysts • Designed and completed a Phase 2 proof of concept in patients with hypoparathyroidism

Led international teams providing strategic drug development consulting across discovery through registration for biotech and pharmaceutical clients. • Managed consulting business unit generating $120-170M annually in awarded revenue with team of 15+ PhDs and MDs • Developed clinical and regulatory strategies for 50+ client programs annually spanning IND-enabling through Phase 2 proof-of-concept • Led teams in FDA, EMA and Asia (China, Japan) regulatory meeting preparation and strategy for multiple therapeutic areas • Supported business development activities in US and Asia (China, Korea, Japan) generating approximately $80M annually

Led US clinical development for German pharmaceutical company's pain portfolio. • Managed US clinical development team and coordinated with global R&D headquarters in Aachen, Germany • Participated in Tapentadol NDA filing and FDA interactions for pain management indication • Designed development programs and led a phase 2 program for 2 novel analgesic products • Filed patent for first-in-class intrathecal/epidural opioid designed to prevent systemic abuse (US Patent 8,895,623) • Developed novel chemical concept for oral opioid formulation preventing multi-pill overdose

Responsible for clinical development, operations, biostatistics, and preclinical programs for acute pain portfolio. • Led team that filed NDA for Dyloject (first injectable diclofenac in US) in December 2009, approved 2014 • Completed phase 3 programs for two additional analgesic assets • Directed all regulatory interactions, study report preparation, and risk management plans for NDA submission • Restructured clinical development teams to align with corporate strategy, improving operational efficiency