STRATEGIC NONCLINICAL DEVELOPMENT
At Coelus we build pharmaceutical portfolios and provide value in safety assessment, pharmacology, integrated program development, and hazard identification
Coelus conceptualizes and facilitates early to late phase development of pharmaceutical intellectual property and provides consulting services in integrated drug development strategies, toxicology, pharmacology, and hazard assessment. We understand program development and specialize in applying our expertise to pharmaceutics, due diligence, pharmaceutical-related government grants and contracts, inhaled drug development, inhalation and general toxicology, and human health hazard assessment.
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YOUR OBJECTIVE IS OUR OBJECTIVE
Pharmaceutical Intellectual Property Development, Due Diligence, Government Grants and Contracts
Growing and Building Assets
Do you need nonclinical or efficacy-pharmacology data to convince investors your molecule has clinical promise?
Does your firm need assistance with nonclinical due diligence?
Do you need an expert CV and the language needed to describe an efficacy-pharmacology/ nonclinical development plan for an SBIR-STTR, government or foundation contract or grant?
Does your General Counsel or Intellectual Property Office need assistance in developing a solid pharmaceutical patent or need an applied sciences liaison for your academic or basic science researcher?
We can help! We understand what you need to advance your IP!
Coelus' Staff have facilitated the development of hundreds of pharmaceutics from concept and IP generation through early development to advanced clinical trials to approval. We work together to assess your assets' potentials and risks, to develop nonclincal regulatory strategies, to advance partnerships, to strengthen IP, and to facilitate obtaining venture capitol, or grant/ SBIR/ STTR and other "nondiluted" funding. We work with you to get the best data and strategy in place to advance your discoveries!
Pharmacology-Efficacy and Nonclinical Development Strategies, Virtual Team Development
Work with Experts
Do you need assistance with a nonclinical plan to advance your IP from discovery into the clinic and beyond?
Do you need assistance building and integrating a team to advance your IP?
We have built and integrated pharmaceutical development programs and have designed and implemented nonclinical pharmacology and toxicology programs for over 20 years.
Ceolus' expertise includes:
Integrated drug development planning
Efficacy-pharmacology
ADME/PK
Nonclinical safety/ toxicology to support IND/NDA/BLA
Formulation and device feasability
Assay development
Nonclinical-clinical dose translation and safety factor assessments
Clinical partner assessments
CRO Selection and Interaction
Our Staff have worked with disease indications ranging from neurological disorders, traumatic brain injury, cancer, infectious diseases, fibrotic disorders, hemorrhage, ocular and otic disease, respiratory disease, and nontraditional "Animal Rule" CBRNE disease states.
We understand how to move your asset to the clinic and toward approval!
General Toxicology, Inhalation Toxicology, and Hazard Assessment
Ensure Safety
Do you need to generate or evaluate toxicology data?
Do you need assistance developing a strategy to mitigate human risk?
With 25 years of experience in assessing the impacts of drugs, toxicants, additives, agri-chemicals, and source pollutant mixtures on biological systems, Coelus is ready to help you with your IND/NDA, programs, chemical and agricultural human hazard assessments, and toxicology needs. We know how to objectively evaluate and generate data and we understand data gaps and what is needed to fill them. At Coelus we specialize in respiratory delivery and inhalation toxicology and have experience with near all other routes of delivery.
Strategic Planning and Program Development
Achieve Your Goals
At Coelus we understand what you need to achieve to your drug development and safety assessment program goals. We have years of experience seeing the Big Picture and finding the right partners to build a portfolio, generate funding, execute and integrate drug development plans and projects, and finding the advisers to ensure safety hazards and risks are mitigated. We understand:
Science and technology fundraising
Govt funding mechanisms and business development
Commercial business development
Integrated drug development processes
Project and program management processes
P & L
Inhaled Pharmaceutical Development
Understand the Nuances
At Coelus we have profound expertise devising and implementing strategies for inhaled pharmaceutical development. Whether you are re-purposing a systemic drug or developing new chemical entities, biologics, or oligonucleotides, we understand the nuances of inhaled formulations, pulmonary dosing, aerosol deposition, ADME/PK, pharmacology, safety assessment, regulatory pathways, dose translation, and clinical development. With over 18 years of experience in the field and hundreds of enabling programs to our credit, we will ensure that you understand the benchmarks needed for inhaled pharmaceutical success.
Meet Our Principal
Expert Guidance
Matthew D Reed, PhD, DABT, Fellow ATS
Dr. Reed is the Principal and CEO of Coelus LLC. He has over 25 years of experience in pharmacology, toxicology, and nonclinical development. His full CV is available upon request. Or visit his LinkedIn profile at
https://www.linkedin.com/in/matthew-reed-phd-dabt-fellow-ats-ab716b8/
CONTACT US!
Be in touch today — and we will address your needs together
505-459-2541