Clinical Trials Center of Middle Tennessee, LLC: Company Profile

Background

Overview

Established in 2019, Clinical Trials Center of Middle Tennessee, LLC (CTCMT) is a physician-led research organization specializing in the management and execution of clinical trials. The center was founded by Dr. Alex J. Slandzicki and Dr. Aaron Milstone, both with over 20 years of experience in clinical trials. Their vision was to create a research facility that upholds the highest standards of excellence, leadership, and investigator involvement.

Mission and Vision

CTCMT is dedicated to advancing medical research by conducting high-quality clinical trials that explore new treatment options across various disease states. While the center primarily focuses on pulmonary diseases, it is structured to manage studies in a variety of other medical areas.

Industry Significance

As a specialized clinical research center, CTCMT plays a crucial role in bridging the gap between pharmaceutical sponsors and patient populations, facilitating the development of new therapies and contributing to the advancement of medical knowledge.

Key Strategic Focus

Core Objectives

• To conduct high-quality clinical trials that adhere to the highest standards of ethics and patient safety.

• To collaborate effectively with pharmaceutical companies, academic institutions, and government organizations.

• To expand the scope of research beyond pulmonary diseases to include a variety of other medical areas.

Areas of Specialization

• Pulmonary diseases, including asthma, chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, and refractory chronic cough.

• Potential expansion into other therapeutic areas as the center grows.

Key Technologies Utilized

• Standardized clinical trial protocols to ensure consistency and reliability.

• Advanced data management systems for accurate and efficient data collection and analysis.

Primary Markets Targeted

• Pharmaceutical companies seeking reliable clinical trial sites.

• Patients with pulmonary diseases interested in participating in clinical research.

Financials and Funding

Funding History

Specific details regarding the total funds raised and recent funding rounds for CTCMT are not publicly disclosed. The center operates as a private entity, and financial information is not readily available.

Notable Investors

Information about individual investors or investment firms involved with CTCMT is not publicly disclosed.

Utilization of Capital

While specific utilization details are not available, it is typical for clinical research centers to allocate funds towards:

• Recruitment and retention of qualified research staff.

• Acquisition and maintenance of medical equipment and facilities.

• Implementation of data management and analysis systems.

• Compliance with regulatory requirements and quality assurance measures.

Pipeline Development

Key Pipeline Candidates

CTCMT is currently involved in several active clinical trials focusing on pulmonary diseases. Specific details about pipeline candidates are as follows:

• Chiesi Pillar for COPD: A study evaluating a new treatment for chronic obstructive pulmonary disease.

• AstraZeneca Tharros for COPD: A trial assessing the efficacy of a novel COPD therapy.

• Avalyn Mist 2 for Pulmonary Fibrosis: Research focused on a potential treatment for pulmonary fibrosis.

• BI 1462-0004 for Idiopathic Pulmonary Fibrosis (IPF): A study investigating a new drug for IPF.

• Interstitial Lung Disease (ILD): Ongoing trials exploring treatments for various interstitial lung diseases.

• Idiopathic Pulmonary Fibrosis (IPF): Research aimed at finding effective therapies for IPF.

• Asthma: Clinical studies evaluating new asthma treatments.

• COPD: Trials focused on advancing COPD therapies.

These trials are overseen by Dr. Aaron Milstone, a board-certified pulmonologist and Medical Director at CTCMT.

Stages of Clinical Trials

The center is engaged in various stages of clinical trials, including:

• Phase II and III Trials: Assessing the efficacy and safety of new treatments.

• Phase IV Trials: Post-marketing studies to monitor long-term effects and effectiveness.

Target Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

• Pulmonary Fibrosis

• Idiopathic Pulmonary Fibrosis (IPF)

• Interstitial Lung Diseases

• Asthma

Anticipated Milestones

Specific timelines for anticipated milestones are not publicly disclosed. However, typical milestones in clinical trials include:

• Completion of patient recruitment.

• Interim data analysis.

• Final data analysis and reporting.

• Submission of results to regulatory authorities.

Technological Platform and Innovation

Proprietary Technologies

CTCMT utilizes standardized clinical trial protocols and advanced data management systems to ensure the integrity and reliability of its research. Specific proprietary technologies are not publicly disclosed.

Significant Scientific Methods

• Clinical Trial Protocols: Standardized procedures to ensure consistency across studies.

• Data Management Systems: Advanced systems for efficient data collection, monitoring, and analysis.

AI-Driven Capabilities

There is no publicly available information indicating the use of AI-driven capabilities at CTCMT.

Leadership Team

Executive Profiles

• Dr. Alex J. Slandzicki, M.D.: Medical Director, CEO, and Co-founder. Dr. Slandzicki obtained his medical degree from The Ohio State University College of Medicine and completed his residency at Hamot Medical Center in Erie, PA. He is board-certified in family medicine and has over 10 years of research experience in areas including diabetes, infectious disease, Alzheimer’s, and pulmonology.

• Dr. Aaron Milstone, M.D., FCCP: Medical Director, President, and Co-founder. Dr. Milstone is board-certified in pulmonary disease, internal medicine, sleep medicine, and critical care medicine. He graduated from Wayne State University School of Medicine and completed his residency and fellowship at Vanderbilt University Medical Center. Dr. Milstone has over 15 years of clinical research experience and has served as Principal Investigator for several pulmonary trials.

• Erica Scaramuzza, CCRC: Clinical Research Director. Ms. Scaramuzza holds a Bachelor of Science from Vanderbilt and Northwestern University. She has extensive experience in medical research, having worked at Vanderbilt University Medical Center and ObjectiveHealth. She is certified as a Clinical Research Coordinator (CCRC) and has experience in therapeutic research areas including orthopedics, dermatology, cardiology, and pulmonary medicine.

• Casi Miller, FNP-C, MSN, RN: Sub-investigator. Ms. Miller earned her Master of Science in Nursing from Vanderbilt University and has nearly 15 years of experience in primary care as a Family Nurse Practitioner. Her interest in clinical trials was sparked by personal experience, leading to a career shift in clinical research.

Leadership Changes

There is no publicly available information regarding recent significant changes or appointments within CTCMT's leadership team.

Competitor Profile

Market Insights and Dynamics

The clinical research industry is characterized by a growing demand for specialized research centers that can efficiently conduct high-quality trials. Factors such as an aging population, increasing prevalence of chronic diseases, and advancements in medical treatments contribute to the expansion of this market.

Competitor Analysis

• Tennessee Clinical Research Center (TCRC): Established in 2002, TCRC specializes in dermatology and dermatologic surgery research. Located in Nashville, TN, TCRC conducts multiple FDA-regulated studies simultaneously and is regarded as one of the Southeast’s leading clinical trial sites.

• Access Clinical Trials, Inc.: Founded in 1999, Access is a hospital-based research center and trial management organization in Nashville, TN. It supports over 70 physicians and groups in conducting hundreds of pre-clinical Phase I-IV studies across multiple therapeutic areas.

Strategic Collaborations and Partnerships

Specific details about CTCMT's collaborations and partnerships are not publicly disclosed. However, it is common for clinical research centers to collaborate with pharmaceutical companies, academic institutions, and government organizations to facilitate clinical trial execution and expand research capabilities.