Concept 2 Clinic has a proven track record across a variety of projects and situations requiring our experts to come to the table, take part in execution and build a path forward.  The virtual model works! 

 

Case Studies:  

 The integrated R&D Executive to meet corporate goals and restructuring efforts 

 Imbedded R&D Executive and support team 

  Running the Virtual R&D Model

  Virtual organizations lacking process knowledge and infrastructure

 Supporting the Entrepreneurial Spirit  

 Filling the Gap  

 Advisory on a specific element of portfolio development and optimization

 Execution of specific project elements and meeting with regulators

  Clinical Development

  In Vitro Release Test Method Development

  Formulation Development

  QA Support

 

 

 


 The integrated R&D Executive to meet corporate goals and restructuring efforts.

Stem Cell Therapeutics has appointed members of the C2C team to represent their Chief Medical Officer and Vice President of Development (www.stemcellthera.com) to advance a current phase 2 clinical trial in Traumatic Brain Injury.  As well, C2C provides ongoing support to the organization as part of their reorganization to focus activities towards licensing and acquiring stem cell technologies from research institutions positioning themselves as a bridge to translate basic stem cell research into commercial products.  The official press release: 

Stem Cell Therapeutics Announces Reorganization and Management Changes

- New Commercial Focus on Licensing and Acquisition of Additional Stem Cell Technologies -

The caliber of talent we have attracted with our new team members demonstrates our mutual vision for the potential of stem cells and regenerative medicine to fundamentally change how medicine is practiced. With this restructuring, we have clearly positioned Stem Cell Therapeutics as Canada's preferred commercialization receptor company for stem cell technologies, said Mr. David Allan, Executive Chairman of Stem Cell Therapeutics. 

 

Top


 Imbedded R&D Executive and support team to develop and define translation of novel technology from bench to clinic.

A new company created through the collaboration of one of Toronto ís top universities, research institutes and industry leader with a goal to commercialize promising technology. DLVR Therapeutics Inc. (www.dlvrtherapeutics.ca) is a privately-held biotechnology company founded in 2011 and based in Toronto , Ontario . The company is focused on developing a novel high density lipoprotein (HDL)-mimicking nanoparticle delivery system suitable for a variety of different payloads: in particular small molecule lipophilic therapeutics and siRNA, initially for oncology indications. The company appointed Dr Bev Incledon as Vice President, Research and Development and supported by the C2C network is responsible for defining lead clinical candidate for Phase I/II development, clinical and regulatory strategy, establishment of IND enabling plan (timeline and budget) and including sourcing, optimization and scale up and all related pre-clinical and clinical activities.

Top


  Running the Virtual R&D Model... A company created to advance a novel cell therapy from the academic environment to GMP batch manufacture and first-time-in-man studies, and understand commercialization potential.  

C2C provided a Chief Scientific Officer and Chief Medical Officer, CMC, Clinical, Regulatory and Project Management and successfully prepared a pre-CTA data package which was presented to Health Canada in March 2011. C2C has maintained technical oversight for process development, optimization and stability studies of the proposed finished product, GMP training and documentation support (SOPs, methods).  C2C also continues in its role as an embedded executive reporting directly to Board management and maintaining responsibility for strategic development and clinical trial design. 

Top


  Virtual organizations lacking process knowledge and infrastructure seeking support for manufacturing/packaging, technical and Quality oversight and CMC.  

C2C was selected to provide consultation and technical support for site selection and due diligence of an organizations API manufacture and optimization as well as quality and technical support for formulation and delivery methodology for an intranasal/sublingual dosage form.  Auditing services required meeting regulatory requirements (US and Canada) along with appropriate risk assessment and remediation planning to ensure readiness for Phase I/II clinical studies.  

 

C2C represents the entire Commercial Operations division with specific functional responsibility as Executive Director, Project Management, Formulation/Process Development, Analytical, Quality and Regulatory.

Gap analysis of current CMO, process/packing validation and formulation were conducted, identification and technology transfer to an alternate site completed in 2012. Formulation and Process optimization and validation planning is currently in progress to ensure marketplace demands are met.

Top


 Supporting the Entrepreneurial Spirit  

Scientific theory put to the test in a repositioning of an existing molecule, addressing an unmet need, within a specific patient population and creation of a delivery platform.

C2C is providing executive, project management and clinical trial support for clinical development, technology transfer of a molecular asset and development of a delivery platform.

Considerable value created for the company by retaining C2C. The C2C team is fully accountable and accessible with responsibilities for multi-site activities and removes the financial burden of hiring a large number of fulltime employees to cover all required functional areas (technical, clinical, regulatory and project management).

C2C has successfully completed a process transfer, optimization and manufacture of clinical material, shipped schedule II material into the selected CRO and monitored the first Proof of Concept clinical study.  A second compound is now being added to the program and formulation and process development activities have been initiated, clinical study design and CRO selection for Phase I/II study is targeted for 2012. 

Top


 Filling the Gap to enable an existing organization achieve a corporate strategy and develop in-house expertise without in-house overhead.  

Large generic manufacturer with expertise and capability for development and commercial production of a specific dosage form required additional and unique expertise, planning and execution of toxicology and bioequivalency studies, and a confirmed desire to remain focused on their core manufacturing capability.

C2C is providing executive oversight and project management to design a toxicology qualification strategy for commonly occurring impurities. Within those roles C2C maintains responsibility for vendor selection for impurity synthesis, toxicology and bioanalytical laboratories, and quality assessments of all facilities utilized, proposal requests and contract reviews. Use of our preferred vendors and their experience has resulted in cost savings and reduction of risk with known entities.  

C2C, with its proven track record is now a strategic partner enabling them to attain new corporate strategies and initiatives.

Start-up organization with novel device at pre-clinical stage required experts to fulfil gaps in their operations team and maintain critical timeline and milestones.

C2C supported site selection for API and device, budget/contract negotiations, formulation development, excipient selection and characterization and development of product specification strategy.

 

Top


   Advisory on a specific element of portfolio development and optimization. 

A trusted partner for a large pharma company who lacked the expertise on biomolecule formulations.  C2C is assessing and performing due diligence for in-license opportunities on particular biomolecule formulations. 

 

 

Top


 Execution of specific project elements and meeting with regulators to formulate best strategy for FTIM.  

A government funded research institute required a technical audit/risk assessment of the manufacturing facility identified for GMP production as well as preparation of a pre-CTA meeting package compliant with Health Canada regulations for a virus project. 

C2C completed a site audit, gap analysis and risk assessment and prepared recommendation and action plan for the facility.  As well C2C prepared a pre-CTA package and met with Health Canada to review a proposed clinical and regulatory strategy for first-time-in-man studies. 

Top


 Clinical Development  

C2C is providing project management and clinical trial executive management to develop a Natural Health Product based on natural bioactives. At the project's onset, the client possessed only a vague idea of the level of risk associated with the desired label claim. Furthermore, the client was also faced with a tremendous challenge when it came to patient recruitment for a planned clinical study.

C2C was able to provide executive oversight to design a systematic claim strategy. By developing several claim tiers, each with a varying risk level, C2C significantly increased the probability of receiving Health Canada Agency approval. C2C also found and selected an experienced Principal Investigator with expertise in the appropriate therapeutic area for the clinical study. In doing so, the recruitment procedure was improved and the entire project timeline was significantly reduced.

Currently, the clinical study's timeline and expenses are very well controlled. The clinical study will be completed in 2016. Afterwards, C2C will work with the client to help launch the product in Canada and overseas.

Top


 In Vitro Release Test Method Development  

A pharmaceutical company had an urgent need for a reliable in vitro release test (IVRT) method in order to expedite the formulation and process development of an innovative topical product.

By using expertise in release test and analytical method development, C2C successfully, and efficiently, developed a suitable in vitro release method. All of the test parameters (e.g. release apparatus, release medium, membrane, etc.) were scientifically selected based on the specific product's properties and the related regulatory requirements.

This well-developed method, which was proved as specific, precise, accurate and robust, provided excellent guidance for both the formulation and process development of the topical product.

In excess of 20 formulations were screened using the IVRT method. Based on the IVRT release rates, a multitude of topical formulations were optimized in less than 2 months.

Top


 Formulation Development  

A pharmaceutical company sought expertise on formulation selection and development for its topical products, which needed to have both a fast-onset and a long-lasting release profile of its active component in order to fulfill a diverse set of treatment demands.

C2C provided a professional formulation development service in order to satisfy this client's needs, while also ensuring that all of the developed formulations strictly obeyed the health agency regulations and guidelines by using an official recommended release test method.

In a timely manner, C2C successfully developed a fast acting spray formulation as well as a longer acting gel formulation to meet the diverse market needs.

Top


 QA Support  

Due to an absence of sufficient Quality Assurance expertise internally, a pharmaceutical company was in search of support to help aid in the product development of a late-phase drug candidate.

C2C adeptly and swiftly established a team of its own in-house QA specialists to assist in the initiation of a companywide Quality System for this client, while also being trusted with the oversight of all their day- to-day Quality Assurance operations.

By partnering with C2C, this client has received orderly, expedient and economical QA Support that has afforded them the added benefit of not requiring additional QA staff on site.

Through its efforts, C2C has both successfully and effectively instituted a pertinent Quality System to satisfy its client's requirements, while also playing an essential role in the fulfillment of all QA activities to support the late phase product development.

Top


 

 
 
Home
Overview
About Us
c Our Team
c Our Advisors
c Preferred Partners
c Services

 

 

 

 

 

Copyright © 2010 Concept 2 Clinic Inc.