www.cognateconsultants.com
New Hope, PA 18938
P: (215) 693-1066
F: (215) 325-1677
* optimizing drug discovery & development
* efficiencies in project management of clinical research programs
* strategies for regulatory approvals (drugs, devices and biologics)
* business development, technology assessment and licensing
* integrating medical and marketing/ strategic brand planning
* strategic business plans and business models
The obstacles that delay research and development programs or prevent products from achieving their full market potential are constantly changing. Overtaxed resources or lack of experience in various functional areas within your organization can often contribute to these obstacles and prevent or delay the success of your programs and ultimately your company.
In todays market, these delays or failures cannot be tolerated and a clear vision of the discovery to market pathway is necessary to integrate and optimize the various phases of product development.
A detailed assessment and The identification and design of the most appropriate, timely, and cost-efficient preclinical development program provides you with reassurance of the relevance and applicability of the data to your intended clinical trial protocol or product registration.
Cognate Consultants LLC, has the scientific, regulatory and business experience to provide the proper guidance and keep your programs on track. A proven track record and years of experience in the discovery and development of new chemical entities, biological products, regenerative medicine and medical devices. Tailored services such as program assessments and action plans, ongoing consulting to help in-house optimally mange their programs, and identification of key outsourcing vendors to accelerate your programs are available.
Scientific & Preclinical
* Nonclinical program design for drugs, biologics, and combination products
* Nonclinical program review and refinement
* Review and interpretation of nonclinical studies
* Preparation of nonclinical data for publication
Clinical & Regulatory
* Clinical study design, protocol, Investigator brochures and CRF development
* CRO selection and qualification, monitoring plans
* Regulatory dossier preparation
Medical & Post-Marketing Support
* Promotional review and compliance
* Strategic medical and marketing business planning
* Sales and speaker training courses
* Business development in-licensing/out-licensing, due diligence
Michael J. Daley, PhD, Principal has accumulated over 25 years experience in small virtual biotechnology companies and Forrtune 500 pharmaceutical companies in all phases of drug discovery, development and promotion. He has a uniquely diverse background in management of product-oriented research/development programs in biopharmaceutical and contract research industries. He offers experience in: tissue engineering, immunology, vaccines, rheumatology, infectious disease, nutrition, oncology & molecular biology. He has experience as a coordinator for clinical trials (Phase I-IV); experienced contract research/project management, U.S. and EU regulatory affairs; quality control and assurance; strategic medical marketing; medical affairs/promotional review; strategic publication planning; speaker/sales training, medical education, and reimbursement. His diverse experience, commitment to excellence in execution, excellent management skills and dedication to achieving challenging goals can help you achieve and optimize your return on your product development programs.