Accellient Partners LLC is a fully integrated and dedicated team of drug development experts that design, implement and manage the strategic, tactical, and regulatory-driven product development needs for the biotechnology and pharmaceutical industry. To meet the diverse needs of our clients we provide the following services:

• Develop and manage programs from late discovery through IND submission, Phase 1 and Phase 2
• Support API and DP manufacturing requirements and nonclinical development through registration
• Develop regulatory solutions to complex issues in chemistry, toxicology and clinical programs
• Write and submit electronic IND’s and NDA’s
• Provide US FDA Agency representation
• Perform program gap analyses
• Perform due diligence evaluations
• Assist with fund-raising
• Advise on general start-up activities

Our expertise includes:
Integrated Drug Development
Chemistry, Manufacturing, and Controls
Nonclinical Development
Regulatory
Clinical
Start-up Support

INTEGRATED DRUG DEVELOPMENT

Fully integrated program service costs (including vendor selection, vendor cost and vendor management, from manufacturing, nonclinical and IND submission through Phase 1) average from $1.5M to $4.0M for most small molecule projects and are delivered in 9 to 18 months. Accellient can also manage protein therapeutic programs. For the lowest possible cost and shortest timeline, Accellient will guide your company to its next financeable milestone or exit. Our validated approach helps our clients establish parameters of value and measure those values against program goals.

CHEMISTRY, MANUFACTURING, AND CONTROLS

Development starts with the synthesis of the test article, making active pharmaceutical ingredient (API) production a critical element to any drug development program. Our comprehensive drug development expertise encompasses development and manufacturing services to support all phases of CMC for a product from discovery through commercialization for small molecules, antibodies, therapeutic proteins, oligos and cell based therapies.
Our management services include:

• Analytical
• Formulation
  
• Drug Substance
  
• Drug Product
  
• QA/QC oversight
  
• CMC Regulatory
  

NONCLINICAL DEVELOPMENT

Accellient recognizes the criticality of making the correct nonclinical decisions the first time; our staff has been doing this well for over 25 years. Avoiding errors at this early stage will minimize expensive delays in development and maximize ROI. We will develop and manage an approvable program in the most efficient and productive manner to enhance the opportunity for regulatory and clinical success.
Accellient’s nonclinical support services cover all areas of preclinical research and development and include:

• Candidate Selection
• Efficacy Pharmacology
  
• Safety Pharmacology
  
• Bioanalytical
  
• ADME/Pharmacokinetics
  
• General Toxicology
  
• Genetic Toxicology
  
• Reproductive Toxicology
  
• Regulatory
  

REGULATORY

Accellient’s Regulatory Affairs team provides strategic guidance and management based on our clients’ program goals while also keeping the potential concerns of the regulatory authorities top of mind to minimize risks to program approval. Our team works with all major divisions of the FDA and has experience managing:

• PreIND and other FDA meetings
• EMA Scientific Advice
  
• IND and CTA submissions
  
• Annual Reports
  
• Fast Track ANDA’s
  
• 505(b)2’s
  
• FDA-EMA Orphan Drug Applications

We also have significant experience in eCTD submissions through FDA approved portals with our alliance partners and are currently filing eIND’s on a quarterly basis.

CLINICAL

Accellient’s clinical development experts have substantial hands-on experience in the development of small and large molecule therapies and will build a clinical plan that will minimize risks and improve approval prospects to maximize your program’s value.  Our core competency is on clinical programs from Phase I through Phase II proof-of-concept.
Our clinical services include:

• Understanding and refining a program’s clinical objectives and labelling
• Developing a critical path clinical plan with key opinion leaders
  
• Creating approvable clinical development plans
  
• Preparing clinical protocols
  
• Managing the distribution of clinical trial drug supplies
  
• Executing the management of Phase 1 and Phase 2 clinical studies
  
• Analyzing early PK data to support real time dose escalation in Phase 1
  
• Managing data analysis and reporting with Clinical CRO’s
  

START-UP SUPPORT

Accellient Partners can also assist you with your fund-raising process and provide start-up financial management and accounting support for your company or drug development programs as needed.


 

 

 

©2015 Accellient Partners® LLC