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What We Do

Early to Late-Stage Solutions (E2LS) builds and leverages dedicated teams with proven records from the pre-Investigational New Drug (IND) phase through Phases I, II, and III and to New Drug Application (NDA) and Marketing Authorization Application (MAA). While working closely with our clients, E2LS develops collaborative, responsive, and cost-efficient partnerships to rapidly development drug candidates with the appropriate expertise and interwoven regulatory plan.   

E2LS works with all types of clients including biotech companies, not-for-profit institutions, academic investigators, and government agencies.  Services include planning, execution/control management, and closure of core activities within chemistry manufacturing and controls (CMC), nonclinical, clinical, and regulatory for development programs. 

Core Team Values

A highly, functional team respectfully values each other’s strengths and supports each other in individual weaknesses.

Early Drug Development Team (Example)

Functional Lead Areas

CMC

Chemistry, manufacturing, and controls (CMC) involves…

Chemistry, manufacturing, and controls (CMC) involves defining manufacturing practices and product specifications that must be followed and met to ensure product safety and consistency between drug substance and drug product batches. CMC typically begins after a lead compound is identified through drug discovery and continues through all remaining stages of the drug development life cycle.

Nonclinical

Nonclinical studies are integral to drug development…

Nonclinical studies in the drug development process provide a stepwise characterization of a pharmaceutical to support different phases of clinical development. The nonclinical program is synchronized with the clinical development of drug candidates, ranging from providing a basis for selecting doses for first-in-human (FIH) trials to informing clinical monitoring of potential adverse effects. The nonclinical assessment of new drugs encompasses studies to evaluate pharmacology, pharmacokinetics, general toxicology, genetic toxicology, reproductive and developmental toxicology, carcinogenicity, and special toxicities if any. The nonclinical development phase primarily aims to identify which candidate therapy has the greatest probability of success, assess its safety, and build solid scientific foundations before transition to the clinical development phase.

Clinical

Clinical development is the process of…

Clinical development is the process of designing and conducting clinical trials to answer specific research questions related to a medical product. The clinical phases start with testing for drug safety in a few human subjects, then expand to many study participants to determine if the treatment is effective in patients. The vision is transformed into distinct implementation phases of clinical studies wherein each have well-defined milestones and deliverables.

Regulatory

Regulatory Affairs and Regulatory Operations…

Regulatory Affairs (RA) is a multifaceted discipline dedicated to ensuring that life sciences products, such as drugs and medical devices, meet regulatory requirements imposed by government agencies, such as the FDA in the United States and the EMA in the European Union. 

Regulatory Operations (RO) is the practical arm responsible for managing the processes involved in regulatory submissions and approvals. RO professionals handle the logistics of document preparation, submission, and tracking, ensuring that regulatory submissions are accurate, complete, and submitted on time.

Founder and VP of Operations

Elliott Pauli, MPH, BS, PMP

Elliott Pauli, a pharmaceutical program manager with over 20 years of experience, manages the conduct of chemistry, manufacturing, and controls (CMC); nonclinical; clinical; and regulatory activities for the development of small molecules and biologics.  He has worked on the development of several programs from the pre-Investigational New Drug (IND) phase through Phases I, II, and III and to New Drug Application (NDA) and Marketing Authorization Application (MAA).   Most notably, he supported the Global Alliance for TB Drug Development for ~16 years in the development of the bedaquiline, pretomanid, and linezolid (B-Pa-L) regimen for the treatment of extensively drug-resistant tuberculosis (XDR-TB) and intolerant/non-responsive multidrug-resistant (MDR) TB of which pretomanid was named the 2020 Prix Galien “Best Pharmaceutical Agent”.  Being an early team member in the B-Pa-L program gave Mr. Pauli a unique perspective in knowing how best to interweave regulatory strategies and project operations.  Mr. Pauli manages scientific teams, regulatory strategies, timelines, protocol and data reviews, subcontractors (CROs, CDMOs, etc), consultants, and study completion for most all development activities. Before starting E2LS, Mr. Pauli worked at RTI International as a program manager and as a microbiologist for Bristol Myers Squibb and Idexx Pharmaceuticals. He holds an MPH in infectious epidemiology, a BS in microbiology, and is a certified project management professional.

Publications

  1. Pauli, E., Ma, Z., Ying, S, et al.  (2023, March) “Development of an Immediate-Release Prototype Tablet Formulation of    HCQS with an Interwoven Taste-Masking System.” Journal of Pharmaceutical Science; https://doi.org/10.1016/j.xphs.2022.11.002
  2. Pauli, E., Joshi, H., Vasavada V., Brackett, J., & Towa, L. (2019, December 26). Evaluation of an immediate-release formulation of hydroxychloroquine sulfate with an interwoven pediatric taste-masking system. Journal of Pharmaceutical Science.; https://doi.org/10.1016/j.xphs.2019.12.014
  3. Winter, H., Egizi, E., Murray, S., Erondu, N., Ginsberg, A., Rouse, D. J., Pauli, E. R. (2015, February). Evaluation of the pharmacokinetic interaction between repeated doses of rifapentine or rifampin and a single dose of bedaquiline in healthy adult subjects. Antimicrobial Agents and Chemotherapy, 59(2), 1219–1224. https://doi.org/10.1128/AAC.04171-14
  4. Winter, H., Ginsberg, A., Egizi, E., Pauli, E., & Everitt, D. (2013, November). Effect of a high-calorie, high-fat meal on the bioavailability and pharmacokinetics of PA-824 in healthy adult subjects. Antimicrobial Agents and Chemotherapy, 57(11), 5516–5520. https://doi.org/10.1128/AAC.00798-13
  5. Winter, H., Egizi, E., Erondu, N., Ginsberg, A., Rouse, D. J., Pauli, E., & Everitt, D. (2013, August). Evaluation of pharmacokinetic interaction between PA-824 and midazolam in healthy adult subjects. Antimicrobial Agents and Chemotherapy, 57(8), 3699–3703. https://doi.org/10.1128/AAC.02632-12
  6. Pauli, E. R., Synovitz, L., et al. (2007, October). Predictors of Mexican colonia residents’ health perceptions and spirituality level: A pilot study. The International Electronic Journal of Health Education, 10, 186–202.
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