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Therapeutic Areas

Please see below for details about the breadth of drug discovery and development experience we have in the following Therapeutic Areas:

Anti-infectives

TRN’s ID team brings pharmaceutical R&D ID expertise together with the broad-based skills of chemistry, toxicology, pharmacokinetics and formulation within TRN. Our team understands the specific needs of the anti-infectives drug R&D process including strategic development for specific patient populations, efficacy models, resistance generation and monitoring, screening strategies, clinical sample analysis and regulatory studies. In addition we have consultants with specific expertise in combination toxicology and formulation strategies common to new generation anti-infectives regimens.

With our network of CRO partners, we can design and deliver innovative studies to move your projects forward effectively and efficiently. Our team have worked closely with a range of global CROs and understand their capabilities and services. TRN’s unique resource of skilled pharmaceutical professionals and its CRO network provides significant value for their clients.

Pre-Clinical Drug Discovery
We can partner to deliver full data packages as part of a project team or offer consultancy services as needed.

  • Target Validation studies
  • Assay design and development
  • Screening cascade and triage consultancy and implementation
  • Hit-to-lead and candidate profiling
  • Generation of resistance
  • Clinical Isolate profiling
  • Impact of Human Serum binding studies
  • Generation of anti-infectives data packages for regulatory-mandated documentation
  • Design and delivery of in vivo toxicity studies
  • Drug formulation consultancy including drug combination

The Clinical Anti-infectives team supports candidate anti-infective drugs from candidate selection through regulatory approval and beyond:

  • Ensure pre-clinical anti-infectives packages are adequate for supporting first-in-human studies and develops this package in parallel with clinical studies to meet regulatory requirements.
  • Provide expert input for the regular updates to Investigator Brochures and INDs.
  • In collaboration with pre-clinical and clinical pharmacologists, provides advice on initial dose requirements for first-in-patient studies.
  • Advise and support the preparation of a clinical development plan and its presentation to regulatory authorities, including obtaining scientific advice from agencies.
  • Provide the anti-infectives/CRO interface for defining and implementing the infectious-disease focused element of clinical operations in studies with patients.
  • Provide expertise in problem solving during the course of clinical trials.
  • Ensure the appropriate clinical samples are analysed using appropriate, validated assays and collaborates with data managers to ensure all clinical microbiology data is deposited in the clinical database.
  • Provide a tailored anti-infectives analysis plan for implementation by statisticians and programmers.
  • Prepare reports and microbiological sections for regulatory submissions.
  • Provide or support representation to regulatory authorities as required, including Advisory Committees, meetings to seek scientific advice and other ad hoc meetings.
  • Provide microbiological representation to advisory boards seeking key opinion leader advice on development strategy.
Cardiovascular & Metabolic Diseases

TRN’s CV&MD Team possess a deep expertise in the cardiovascular and metabolic (diabetes/obesity/ hyperlipidaemia) disease sectors. The team’s experience spans small molecules (including oligonucleotides) and biologics (peptides, mabs and rProteins) across multiple phases (target identification, lead identification, lead optimisation, pre-clinical and clinical development).

The team’s goal is to increase the speed and efficiency for you in taking your idea, concept or asset to the market. We will partner with you to discuss your needs and develop and execute the best strategic plan to control risk, maintain disciplined investment, and provide you with the best chance success.

We provide you with a single point of contact to manage all your project work. Your company can access metabolic disease specific expertise of this team in medicinal chemistry, biochemistry, molecular biology, in vitro and in vivo pharmacology, physiology, small molecule, peptide and protein experience as well as expertise in ischaemic disease and diabetic complications; Through working with other members of TRN we can also provide expertise in formulations, toxicology, clinical development, and regulatory affairs, all managed through one person.

Our successes have included support at pre-launch of marketed drugs such as Avandia and Crestor and driving many of our own internal candidate drugs into clinical development. We established world leading capabilities to enable highly efficient drug discovery processes with dramatically reduced cycle- times and invested in disease area science such that our group became a “partner-of-choice” for many academic and commercial collaborators. Other successes have included direct liaison with the FDA to mitigate potential risks with preclinical projects and have participated in numerous in-licencing evaluations, due diligence and subsequent project leadership of successful deals. Together we have a wide network encompassing cardiometabolic drug discovery in academia, peer pharma and biotech and in the CRO business community.

Whether you are a large pharmaceutical company looking to outsource efficiently the advancement of your candidate drug to first time in man, or a University Technology Transfer Group looking at maximising the medical and financial benefit of discoveries from academic scientists, we can help you generate efficiently and effectively the right data for key decision points in ischaemic and metabolic disease.

TRN will act as your single point of contact to manage your integrated project needs from start to finish.

Dermatology

The TRN Dermatology team can assist you in moving your project from idea to the clinic and ultimately to approval. Our goal is to bring your compound or technology to the market and we have the experience and expertise to accomplish this. What we will do is partner with you to develop and execute the best strategic plan to control risk, maintain disciplined investment, and provide you with the best chance success.

We start by listening to you and your needs. We provide you with a single point of contact to manage all your project work. Your company can access dermatology specific expertise in pharmacology, formulations, toxicology, clinical development, and regulatory affairs managed through one person.

With in-house expertise and our network of collaborators, TRN can assist you in project strategy, planning, and execution. Whether it is management of the full project or selected services, or consultation about a specific challenge, s team brings deep dermatology expertise and broad experience in both topical and oral drug development. We offer a full range of services with access to contract research organizations and knowledge leaders best suited to the needs of your project.

Our team understands the unique needs of projects in medical and aesthetic dermatology as well as the different requirements for prescription and consumer dermatology products. Whether you are a dermatology company looking to manage costs or a biotech looking for a dermatology application for your compound, TRN will act as your single point of contact to manage your integrated project needs from start to finish.

Neuroscience

The TRN Neuroscience team have extensive expertise in the discovery and development of novel drugs to treat neurodegenerative diseases and pain. Each team member has in-depth knowledge of the pharmaceutical industry, with experience of working with large companies, biotechs and independent drug discovery consortia. Details team of the TRN Neuroscience team can be found here.

Through partnership with our team, the performance and productivity to your drug discovery projects will be enhanced. We can offer optimisation of project planning, outsourcing of experimental work and data analysis, advice on effective investment and management of project progression through to successful delivery.

Our multi-disciplinary team is well placed to maximise the performance of your neuroscience programmes allowing us to flexibly fill gaps in your capability or to fully manage your project.

How we work
A TRN team member will be selected as your primary partner throughout the project and act your key point of contact. This TRN team member will orchestrate the work of our neuroscience specialists, giving you access to the experience and expertise of over 80 pharmaceutical professional based in Europe, America and Asia. They are all experienced leaders of drug projects from target selection through to Phase II clinical development for both small molecule and biologic drug candidates. The TRN neuroscience team has specialist biologists, medicinal chemists, pre-clinical in vitro/in vivo pharmacologists, translational scientists, and experts in drug metabolism/pharmacokinetics experts and safety assessment. For details of our teams capabilities please click here.

Additionally, our extensive business and scientific expertise allow us to provide authoritative technology transfer advice, evaluate the intellectual property landscape and offer guidance on how to make your technology an attractive investment. TRN has a proven track record of delivering integrated grant proposals and due diligence packages.

Whether you are a large pharmaceutical company looking to efficiently outsource the advancement of your candidate drug to first time in man, or a university technology transfer group looking to maximise the medical and financial benefit of discoveries from academic scientists, we can help you generate efficiently and effectively the right data for key decision points in neuroscience.

Oncology

To discover successful drugs in Oncology it is vital to have a clear view of the patient population that will benefit from the treatment from the very outset of the programme. The TRN Oncology team is staffed by a number of ex-AstraZeneca personnel who were responsible for the Discovery and Development of some of the first personalised Oncology products, targeted to patients with tumours carrying a specific molecular phenotype (Iressa and Vandetanib) as well as anti-hormonal drugs such as Anastrozole.

Our Oncology team can help you with picking appropriate targets and then developing a clear target profile that will be aligned to a potential patient group, thus increasing the chances of success. We can help you with designing the key biology experiments, both in vitro and in vivo, that will be needed to decide which compounds have the profile needed for clinical activity. We have expertise in both Medicinal and Computational Chemistry that will help you to tailor your chemistry to optimise the properties needed for achieving the target profile.

Finally, through our experience with compounds such as Iressa, we can aid you with both the clinical and pre-clinical translational package that will enable focussed Proof of Concept trials to be devised and run. Though links to other parts of The Research Network, we have the toxicology, pharmaceutical and regulatory expertise to ensure that your programme has all the necessary elements to progress smoothly to these pivotal clinical studies.

We can offer you the following oncology specific help based on our extensive experience:

  • Critique and advice on the strategy to prosecute for a given hypothesis, in either discovery or early clinical phases, to tailor approach to specific patient group
  • Critical review of data and plans to ensure project will meet goals
  • Critique of projects aimed at identifying new drug targets
  • Advice on medicinal chemistry strategy, including issues that need to be addressed with chemical leads
  • Guidance on experimental design (biochemical, cell culture, in vivo, ex vivo, pre-clinical or clinical PK/PD) to ensure agents have best chance to achieve clinical activity
  • Ongoing leadership of the biology, chemistry or DMPK on a project
  • Ongoing project or portfolio management including risk management both within and across projects
Respiratory & Inflammation

The TRN respiratory and inflammation team has a wealth of experience of inflammatory disease with a particular focus on respiratory diseases such as COPD and asthma. We have wide-ranging expertise in drug discovery and development including target identification and validation, compound optimization, translational sciences and clinical development to the end of phase II. Our experience spans oral and inhaled small molecules as well as biologics. The team can also provide expertise in IP landscape evaluation and co-ordination.

Our mutli-disciplinary team is uniquely placed to help you maximise the potential of your R & I programmes in Drug Discovery and Development. Our biologists apply their depth of pharmacological and histo-pathological understanding of human disease and animal models to identify potential new targets for R & I indications, devise target validation strategies and formulate appropriate screening cascades including in vitro and in vivo assays and disease models. In Medicinal Chemistry we apply state of the art methods and criteria to identify and optimise compounds for both inhaled and oral delivery and will design and co-ordinate intellectual property strategies through the complete project life cycle.

Our translational science experience covers identification of appropriate patient populations and biomarker strategies for therapeutic targets. Our safety assessment experts apply an investigative problem solving approach to toxicology to enable safety reviews of target biology, compound-related safety issues and development of early development toxicology (GLP) plans. In addition to their scientific expertise, our team members are experienced in leadership of projects from target selection to phase II clinical development and in delivering integrated due diligence analyses to allow evidence-based decision making.

As part of TRN, the respiratory and inflammation team also accesses a network of over 40 R&D experts in Europe and the United States with experience gained from careers in pharmaceutical and biotech companies. Our extensive business and scientific expertise allows us to provide authoritative technology transfer advice on how to make your project an attractive investment opportunity for major pharmaceutical companies. Since its formation in 2011 TRN has established a track record for developing and implementing program strategies as well as delivering integrated grant proposals and due diligence packages.

We will act as your single point of contact either to address gaps in your capability or to manage your integrated project needs from start to finish.

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