Envigo launches PATHWAY to enable FIH clinical trials11 Mar 2019
PATHWAY manages the complexity of the entire safety assessment process on behalf of the company’s pharmaceutical and biotechnology customers.
Envigo has launched PATHWAY – an integrated solution that optimizes non-clinical safety assessment programs to enable first-in-human clinical trials. PATHWAY manages the complexity of the entire safety assessment process on behalf of the company’s pharmaceutical and biotechnology customers by integrating safety assessment study types and bioanalytical support with scientific and regulatory consulting, program design and project management.
The decision to develop the PATHWAY solution was made to help customers navigate the increased scientific and regulatory complexity facing advanced therapies going through safety assessment. The intricacy of design and management of these critical non-clinical programs, and the level of interaction with regulatory bodies required, raises the risk of introducing delays and costs to development programs. PATHWAY has been designed to leverage Envigo’s capacity, capabilities and experience in the field to optimize safety assessment programs and deliver translational biology insights to prepare customers for first-in-human clinical trials.
“Our deep expertise in the complex fields of biologics and advanced therapies adds particular value to our customers with drug development programs in these growing categories. On our customers’ behalf, we frequently work with regulators to determine the most appropriate interpretation of regulatory guidance as it applies to a specific therapeutic,” commented Lee Coney, Envigo’s Chief Scientific Officer.
“PATHWAY makes full use of our beginning-to-end understanding of the safety assessment process, and optimizes the journey to first-in-human studies. Experience of designing and conducting studies in a wide range of therapeutic modalities, and in working with regulatory agencies around the world, means we are able to anticipate the needs of a program at design stage, plan studies accordingly, and manage an optimal timeline of study execution,” Lee Coney added.
Follicum files patent application for new topical formulation for hair loss
30 Apr 2019
Using easy-to-apply cream instead of direct scalp injection would extend patent protection by 8 years.Read more
Hovione Technology acquires global rights to new pulmonary inhaler device
15 Apr 2019
The Papillon DPI is a single-part, blister-based, reusable inhaler, suitable for both chronic and acute treatments.Read more
Isotype-specific secondary antibodies for improved signal detection
10 Apr 2019
Offers an alternative to cross-adsorbed secondary antibodies when absolute specificity is required.Read more
Sterling Pharma to acquire CiVentiChem in the US
9 Apr 2019
The acquisition will enhance the CDMO's chemistry development capabilities to support pre-clinical and early phase clinical supply.Read more
Catalent expands OptiMelt hot melt extrusion capabilities
4 Apr 2019
The investment includes the addition of equipment to enhance development capabilities for preclinical and early clinical phase development, as well as adding downstream processing technologies to support HME formulations.Read more
'Drugs from bugs' joint venture
4 Apr 2019
Lonza and Chr. Hansen create a strategic joint venture to become the partner of choice for developing and manufacturing live biotherapeutic products for pharma and biotech customers.Read more
Curcumin and pomegrantes - new hope for Alzheimer’s prevention?
3 Apr 2019
New research at University of Warwick will test how curcumin kick-starts the brain’s cleansing of damaging plaques and cells.Read more
MedPharm's appointment with Destiny
28 Mar 2019
Global contract provider to develop new XF-platform drug formulations for the treatment of a number of topically treated infections, including diabetic foot ulcers and ophthalmic infections.Read more
Third Sartorius Research Xchange Forum 2019 focuses on CAR-T cell therapy
13 Mar 2019
Event for experts from academia and industry, including talks, live demo sessions, and panel discussion.Read more
Biogen acquisition boosts its ophthalmology pipeline
4 Mar 2019
Nightstar Therapeutics has two potentially first-in-class mid- to late-stage clinical assets as well as preclinical programs.Read more
Are you a supplier
Here's what we can do for you
- Generate quality leads for your business
- Stay visible for 365 days of the year
- Receive product inquiries and respond to meeting requests directly
- Improve company online presence through Search Engine Optimisation