Services and Support - Pathogenus

Clinical Trial Design

Poor trial design or planning is the leading cause of errors, failure and increased costs in clinical trials. No amount of statistical manipulation or reinterpretation can rescue a poor trial design or provide significance to inappropriate or underpowered endpoints. 

Clinical Trial Design Services

• Recommendation of appropriate trial design using adjusted level of complexity , including Conventional, group-sequential, adaptive, and biomarker-based and complex and innovative designs;
• Advice on selection of endpoints and objectives;
• Optimised interim decisions, including stopping rules, group-sequential designs, sample-size re-estimation and futility analysis.

Regulatory Strategy

Regulatory consulting services may be critical to the smooth progress of assets through the development cycle and may allow for accelerated programs to be accessed and implemented leading to substantially reduced time and costs associated with achieving market approval.

Regulatory Services

• Design of Integrated Regulatory Strategies for Global Product Development;
• Expertise in conducting Regulatory Agency meetings with, examples, the European Medicines Agency (EMA), Food and Drug Administration (FDA), Therapeutic      Goods Administration (TGA) and other European National Competent Authorities (NCA);
• Access to Orphan Drug Designations (ODD);
• Accelerated Development Designations (Fast Track /      Breakthrough Designation, PRIME designation; Innovative Licensing and Access Pathway (ILAP)).

Clinical Development

Expert oversight and informed advice when designing, placing and initiating studies can reduce subsequent requirements downstream to adapt protocols or perform statistical subanalyses to investigate outliers. Pathogenus can provide industry leading opinion and advice for all stages of your development program with an emphasis on clinical trial design and performance. 

Clinical Oversight services

• Expert design and implementation of clinical studies (Proof of Concept, Phases I-IV) in      compliance with ICH GCP standards;
• Clinical development planning and execution;
• Expertise in virology, with advanced knowledge and experience in respiratory infections, including emerging and pandemic viruses / threats;
• Anti-infective safety assessments, including molecular chemistry of candidates and primary assets.

Scientific and Medical Affairs

• Medical and clinical evaluation of assets;
• Publication strategy and execution;
• Thought-leader / KoL identification and management;
• Design and implementation of pre-clinical studies and appropriate analyses / testing programs.

Data Analysis and Interpretation

• Review and interpretation of clinical trial safety and efficacy data, especially those relating to infectious diseases;
• Pharmacovigilance  and safety monitoring;
• Epidemiological  study design and analysis.

 Life sciences project management services can assist your business navigate complex projects, ensure regulatory compliance, and optimise product development, from early-stage research to manufacturing and commercialisation. 

Why Life Sciences Projects Need Specialised Project Management:

• Complexity: Life sciences projects are often highly complex, involving multiple disciplines, stakeholders, and regulatory hurdles. 
• Uncertainty: Discovery and development processes are inherently uncertain, requiring flexibility and adaptability. 
• Regulatory Requirements: Strict regulations, such as those from the FDA, must be adhered to throughout the project lifecycle. 
• Time Sensitivity: Meeting market deadlines and bringing products to patients quickly are critical in this industry. 
• High Stakes: The success of a life sciences project can have a significant impact on projections for improved public health as well as the company's financial performance. 

Key Project Management Services for Life Sciences:

• Project Planning and Execution: Developing detailed project plans, timelines, and budgets, and ensuring projects are executed on time and within budget. 
• Risk Management: Identifying, assessing, and mitigating potential risks throughout the project lifecycle. 
• Resource Management: Effectively allocating and managing resources, including personnel, equipment, and facilities. 
• Supplier Management: Managing relationships with suppliers, contractors, and vendors. 
• Regulatory Compliance: Ensuring projects adhere to all relevant regulations and guidelines. 
• Change Management: Effectively managing changes to project scope, timelines, and budget. 
• Quality Assurance: Implementing quality control measures to ensure products and processes meet required standards. 
• Capital/Site Facility Build Projects: Managing the construction and development of research and manufacturing facilities. 
• Clinical Development: Managing clinical trials and other aspects of drug development. 
• Product Development: Managing the development of new drugs, therapies, and medical devices. 
• Manufacturing: Managing the manufacturing process and ensuring quality control. 
• Technology Transfer: Managing the transfer of technology from research to development and manufacturing. 
• Project Portfolio Management (PPM): Managing a portfolio of projects to align with strategic goals and optimise resource allocation. 

Identifying, hiring, placing or otherwise accessing the appropriate operational leadership teams can be pivotal to achieving the accelerated programs and associated reduced time and costs required to sustainably progress the long journey to regulatory approval. Without build-in economies and verified quality assurance systems in place, companies can become top-heavy or overly-lean leading to missed opportunities. 

Leadership: Pathogenus can help you build high-performance, multidisciplined, international leadership, divisional and project teams, including KOLs, scientists, Regulatory (ISO 17025, GLP, GCP, GxP), HR, legal, compliance, QA and operations associates. Establish measurable alignment between shareholders, functions and customer-facing teams by communicating strategy, leadership by example and direction of tactical implementation phases.

Business and Corporate Development: 

Manage commercial strategy and incentivisation, lead sales team and execute deals. Drive strategic alliances. Negotiations on contract, pricing and terms. Designed and executed M&A strategies across multiple buy-and-build and add-on transactions.

Operational efficiency: Optimize complex operations within strict service-level and highly regulated environments and ensure alignment with strategic business and shareholder goals. Measurement by, inter alia, Key Performance Indicators and dashboard concepts and establishment of aligned business models.  

Due to restrictions in team size or experience, start-ups (biotechs) may suffer from 'closed-circle' scientific thinking.  Similarly, large pharma companies may lack appropriate individuals that can combine  in-depth knowledge of pre-clinical sciences with medical experience in the field. Both scenarios may lead to challenging communications between siloed teams, each focussed on its own area of expertise. Scientific advisory boards may equally lack sufficient time or breadth of knowledge to fully analyse the available data in the light of relevant regulatory requirements. 

Translational Sciences

Pathogenus offers independent, external, expert advice in challenging regulatory environments  and has a proven track record in interpreting and translating (pre-)clinical datasets to outcomes.

MOA and MOE

Pathogenus has experience in defining the Mechanism(s) of Action and Efficacy for a variety of agents and in realigning the development plans to fully satisfying regulatory agency requirements and in drafting  replies to RA queries.

Assay Selection and Validation

CROs and independent pathology service suppliers frequently offer standard test packages with limited validation data or provenance. Also, poorly considered logistics for testing programs can make clinical trial supplies and sample shipments overly complex and/or expensive. Guidance in selecting relatively inexpensive, pre-clinical assay validation services may save significant percentages on the overall clinical trial spend. 

With the experience and learned proficiencies of Pathogenus Consulting spanning both pre-clinical and clinical trial services, the team have helped clients develop and implement leaner and cheaper program, still achieving optimal outcomes.