Get on the inside track with Weatherden
Choosing the right indication and building a target product profile
We collaborated with a biopharmaceutical company that is developing a new chemical entity for the treatment of cardiovascular indications.
Our team performed a comprehensive analysis of the clinical indication list provided by the client to assess suitability from a clinical perspective for proof of concept studies. Based on a detailed review of the client’s preclinical and Phase I data, along with scientific literature and KOL discussions, we prepared a report considering:
- The scientific rationale and known mechanisms of action
- Key clinical features and clinical endpoints
- Potential study tractability
- Indication incidence and prevalence
- Unmet medical need
- Patient stratification strategies
We worked in conjunction with one of our partners to combine this with a perspective on the commercial positioning to form a robust target product profile. Following completion of the indication prioritisation, Weatherden was subsequently engaged to design the studies and conduct a full feasibility assessment, identifying clinical sites, PIs and CIs, and managing the trials.
– Arash Yavari, Senior Drug Development Clinician
Translating a complex mechanism to disease
Weatherden was recruited by a stealth-stage biotech to help investigate a therapy for the treatment of B cell disorders. The mechanism of action occurs early in the immune response, giving the drug a broad potential range of clinical indications in which to demonstrate efficacy.
Our team designed and implemented a multi-layered programme of preclinical work, bioinformatics, KOL interactions and literature review to understand the interaction between the underlying mechanism of action and the pathological drivers of the immunology conditions. This enabled the client to build a broad patent base for their compound and to identify optimal clinical indications to pursue in proof of concept studies.
– Aaron Deveney, VP of Clinical Development
Implementing a robust quality management system
We worked with a US based venture-backed biotech to assess trial feasibility for a number of first in human studies in Europe. We assisted with CRO selection and provided an experienced clinical operations team to oversee the CROs on behalf of the Sponsor.
Prior to entering the clinical phase, we developed a full suite of SOPs to enable full compliance with ICH-GCP and worked with their internal QA manager to ensure a robust Quality Management system was in place, relevant team members were trained on the SOPs, and ensure that appropriate practices and procedures were embedded in the organisation. The SOPs created covered clinical development, risk identification and management, pharmacovigilance and regulatory applications and reporting.
– Holly Garratt, Manager Clinical Operations
Novel protocol design for early insights into patient data
Weatherden was engaged to work closely with a multinational biopharmaceutical company developing a novel platform of oral biologics to treat a range of chronic inflammatory diseases, through regulation of the immune response via multiple T cell pathways.
Our team successfully developed two novel Phase 1a/b combined protocols for the company which have since been accepted by both the EMA and FDA. These included a mix of healthy volunteers and patients in two indications. In such a scenario, a limited dose range escalation can be conducted to establish safety and tolerability followed by the treatment of patients to gain clinical benefit data, driving a strong value inflection point for the Sponsor.
If appropriately designed, this type of study can be Phase 2b enabling and offers a rapid route to approval. The biomarker and clinical endpoints used are the regulatory endpoints for topical and systemic therapies. We have since been involved in the subsequent design of the Sponsor’s Phase 2b clinical trial and strategy to launch.
– Duncan Mchale, Co-Founder
Navigating regulatory requirements for rare diseases and securing priority review
Weatherden has worked with an rare disease company to produce a combined development and regulatory strategy that has led to a successful orphan designation in the EU (on indication-based claims) and a priority review voucher for an expanded indication.
Prior to our involvement, initial orphan designation rejection was received by the company following FDA review but, with Weatherden input, the clinical strategy was redefined and resubmitted.
Following the second review by the FDA, an expanded Mode of Action label with clinical development plan (modified to reflect a mode of action claim) was proposed and this resulted in the approval for priority review designation by the FDA. We are now working with the sponsor to deliver the new clinical strategy.
– Alison Gadd, Regulatory Expert
Capital efficient company creation opportunity
Weatherden has co-founded a therapeutics company with an academic clinician. We formed a concept around an observation which formed the basis of a repositioning hypothesis and worked with the founder to build the investment case, seek investment and appoint an independent CEO.
As the asset was at the clinical stage, Weatherden was able to supply the key team members, including clinical development, clinical operations and regulatory strategy to design and oversee the preclinical experiments, design the clinical studies and oversee and manage the clinical studies.
By using an entirely virtual model, the company was able to be run with a substantially smaller budget, reducing dilution for the initial investors and founders and obtaining human data for under £5m of investment.
– Emma Tinsley, CEO
We see Weatherden playing an increasingly important role in the global biotechnology sector. Our input is rapidly scaling across all segments and we are excited to see this translate into tangible improvements in patient outcomes and value realisation for our clients.
Our track record
An above average rate of repeat business and word-of-mouth driven new client relationships reflects the quality of our input and the outcomes we achieve.
With a portfolio of clinical trials in 16 cities and 11 countries, our thoughtful design and integrated approach can chart your fastest path to efficacy in patients.
Blending more than 500 years’ experience, we are uniquely positioned to de-risk your programs and maximise value across the drug development lifecycle.
We can manage single and multi-centre trials across the world – our current portfolio involves 15 cities across 12 countries, including Brazil, France, New Zealand, Spain, the UK and USA.
We have led multiple defence meetings with regulatory authorities, including the MHRA, EMA, FDA, and PEI.
Our expertise spans more than 15 therapeutic areas, which is augmented further by our network of KOLs.