Boston, MA, September 22, 2014 --(PR.com
)-- Clinical Network Services (CNS) Pty Ltd, an integrated service consultancy focused on product development, headquartered in Australia with offices in New Zealand, the UK and the USA and Ventac Partners, a dedicated life science consulting firm with offices in Europe, USA and Asia, today announced that they have signed a cooperative partnership agreement where CNS, and in particular the BioDesk consultancy, will become the preclinical, clinical and regulatory experts that Ventac can draw upon in support of portfolio companies and clients. Correspondingly, the multi-skilled team of Ventac Partners will be available to provide advice to clients of CNS in the various stages of fundraising, company evolution and drug-development pathways.
The partnership pools the corporate expertise of Ventac Partners with the regulatory expertise of CNS and expands the geographical reach of both.
The Managing Director of CNS, Russell Neal, commented, “We are absolutely delighted to be joining up with a life sciences investor and corporate consultancy of the standing of Ventac Partners. This agreement gives us greater access in particular with the US and Asian markets and we also hope that the corporate expertise of Ventac will be of benefit to our own client portfolio.”
Mikael Ørum, Co-Founder & Partner of Ventac Partners added, “We see Australia as an important market, particularly with the favourable tax and regulatory environment for clinical trials. CNS and BioDesk bring to our team top level regulatory expertise and clinical trial management, which will be of critical importance to our maturing portfolio and client companies.”
About Ventac Partners
Ventac Partners is a dedicated life science consulting firm with offices in Europe, USA and Asia. With prior careers as start-up entrepreneurs and CEOs, executives from large pharma, executives in IP, business and product development, pre-clinical and clinical experts, and board members, the Ventac Partners team offers strategic and operational experience in all facets of creating, running and growing biotech and medtech businesses. With our team come more than 200 years of international practical experience in growing good technology into successful businesses, both as entrepreneurs in start-up companies and as management in large pharma enterprises and CROs. Since the beginning of Ventac Partners in 2002, the team has:
· assessed more than 1000 invention disclosures and business plans from life science researchers and entrepreneurs
· raised more than EUR 250 million in funding for start-up and growth stage companies
· incorporated and grown more than 15 spin-out companies with inventors/universities/large companies as co-owners
· negotiated large technology and drug licenses in USA, Europe, Japan and China
· provided board level strategic input to companies and governments
· delivered turn-around teams to companies in distress or in need of a sharper commercial profile and/or successful business development impact in the market place
The Ventac Partners team has a long-standing record of achievement; both from previous positions and as part of Ventac Partners, and all members bring extensive networks to academia, industry, and investors. Further information about Ventac Partners can be found at www.ventac-partners.com
About Clinical Network Services
Clinical Network Services (CNS) is an integrated service consultancy focused on product development, headquartered in Australia with offices in New Zealand, the UK and the USA. The Company provides a broad spectrum of services in the planning, implementation and delivery of product development programs and Phase 1 and 2 trials for small –medium sized biotechnology companies. CNS offers a unique service where it integrates BioDesk, an intelligent global product development (CMC, nonclinical and clinical aspects) and regulatory affairs consultancy, with our committed, highly experienced Australian/New Zealand clinical operations and biometrics team. CNS’ regional clinical advantage is driven by the extremely pragmatic regulatory environment in Australia and New Zealand that makes it possible for clients to enter the clinic quickly, without prior regulatory approval.
CNS offers a uniquely differentiated, customer-orientated, suite of services to our clients which enables us to guide their products efficiently through critical post-discovery development and into initial human trials. CNS takes a global regulatory strategic approach to ensure that value is added at every stage of the product development life cycle. Further information about CNS and its intelligent development services can be found at www.clinical.net.au
CNS’s BioDesk is an expert consulting team offering manufacturing, toxicology, clinical and regulatory affairs consulting services for readying products to enter clinical trials or marketing approval.
The BioDesk team consists of experienced chemists, toxicologists, medical writers, regulatory affairs specialists and experienced clinicians based in Australia, Europe and the USA. BioDesk works closely with clients to design and implement manufacturing operations and non-clinical plans, mindful of commercial timelines and budgets. BioDesk further adds value by ensuring that a global regulatory standard is inherent within client development programs. After submission of a marketing approval, BioDesk collaboratively works with the experienced Australian/New Zealand clinical operations and biometrics teams to realise client goals.
Examples of BioDesk core services include:
· Developing clinical development plans and drug development plans - starting with the end in mind.
· Getting client GMP-compliant clinical trial material ready for the clinic.
· Completing client GLP- compliant toxicology studies before human studies start.
· Assisting with pharmacology studies to show the drug works before the human trial is designed.
· Assembling slide decks and data on behalf of clients for their stakeholders.
· Arranging meetings with the regulators and helping clients ask optimal questions in order to elicit helpful responses.
· Writing up all applications for the regulators including big or small projects from orphan applications, paediatric investigational plans, to New Drug Applications and everything in between.
· Helping in the management of client programs – particularly for virtual and small companies requiring a few more hands.
· Providing medical writers to write up protocols, investigator brochures and all modules in the Common Technical Dossier required for a marketing application.
· Ensuring that work is ready for electronic submissions so that clients can drop in a folder ready for publishing and submission.
· Finding a solution when the client does not have one.
We are flexible and have supported clients in many different ways including everything from collecting active compounds from locally grown trees, to working with chemists to cut down the synthesis steps for a client’s drug and, in countries where the legal language isn’t one the client speaks, finding a solicitor to complete the out-licensing deal.