Post-regulatory support to an EMA clinical submission

Support required to respond to EMA feedback on study results

  • Several concerns raised by EMA on the design of the pivotal study for the registration of a generic drug diffusion system (DDS)

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Setup an Atlassian product (Jira, confluence)

Client wants to implement a WIKI or a Bug Tracking Tool via an Atlassian Product

  • A client in need of custom wiki or of a bug tracking tool but lacking expert knowledge and resources to handle the technical part internally

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Dilution recipe for vaccine production

Required support to avoid batch rejection due to poor assay performance

  • A vaccine manufacturer produced a bulk drug Substance (DS)
  • Dilution with a formulation buffer is made to obtain a Drug Product ready to be filled in syringes
  • However, the titration of biologic material is subject to large uncertainty due to poor assay performance, leading to frequent and costly batch rejection

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Continuous Manufacturing: Development, Optimization and Validation

Client lacks strategy for Continuous Manufacturing within QbD principles

  • Client lacks experimental strategy to develop, optimize and validate a new continuous Manufacturing (CM) process in Quality by Design (QbD) framework

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Bayesian modelling and prediction of patient recruitment

Required support for recruitment of patients for clinical trials

  • In many clinical trials, the amount of time needed to recruit the targeted number of patients is underestimated
  • Failure to recruit enough patients in the planned time frame causes delays, additional costs, etc
  • Consequently, estimating the recruitment duration is of crucial importance for the proper conduct of the trial

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Automatic detection of disease events based on accelerometer data

Manual process for recording data was unreliable and expensive

  • The client installed accelerometers on mice to record disease events
  • The system detected c.100 false positives for each real event
  • Results needed to be reviewed and corrected manually by experts
  • Data accuracy critical as data set was aimed to be used in pre-clinical trials to compare different treatments

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Analytical Method Comparisons

Client needed to demonstrate interchangeability of technology

  • Client needed to change from a costly and low through-put analytical technology, to an easier, faster high through-put assay

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Acceptance criteria for Bioassay validation

Client was in urgent need for a more cost-effective solution for Bioassay validation

  • According to USP standards, parallelism between a pair of dose-response function needs to be tested prior to validating a potency bioassay

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Outsourcing clinical trial safety activities to PharmaLex

Outsourcing clinical trial safety activities to PharmaLex assures compliance and puts project on track for fast registration

  • A US company was dissatisfied with a large global CRO’s study and drug safety management for a programme of multinational clinical trials involving a complex drug device combination therapy. These ongoing studies were pivotal to the successful registration of the treatment in the EU and US. PharmaLexwas given responsibility for all the clinical trial safety activities.

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Portfolio Maintenance Outsourcing Local RA responsibility – EU

Client plans to outsource RA activities in EU countries for defined products

  • High workload in local affiliates for established product portfolio in the EU
  • New products registered in the countries lead to increasing workload
  • Full RA responsibility for an established product portfolio to be outsourced for 16 EU countries
  • Cover of all RA life cycle management tasks including labeling and interaction with local partners (incl. PV, medical)
  • HA interactions done directly by PharmaLex

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Pre-IND Meeting for an antibody-drug conjugate (ADC) for an advanced cancer indication

Client in need of expertise for IND development and FDA interaction for First-in-Human study

  • European SME beginning first discussions with the FDA regarding IND development and submission of an ADC product for an advanced cancer indication
  • Intent to gain agreement on completed nonclinical program to support first in-human (FIH) study

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Dendritic cell vaccine (oncology)

  • Small biotech US company developing a dendritic cell vaccine for the treatment of the Orphan indication glioblastoma in EU
  • Timeline: long-term (8 years)
  • Support in

-Preparation and conduct of the Scientific Advices (SA)

-Medical and technical Writing

-Clinical trial Phase III

-Adaptive pathway

-Early access medicines scheme (UK)

-Hospital exemption (DE)

-Pediatric Investigational Plan (PIP)

-Pharmacovigilance: DSUR and PSUR

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Regulatory CMC Compliance reduced risk

  • Identified deficiencies in Change Control procedures and GMP manufacturing documentation
  • Uncertainty in verifying the current registered information held with Health Authorities
  • Lack of Regulatory Information Management (RIM) systems and therefore lack of oversight of product information for key stakeholders

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Definition of batches internal release limits based on stability results

A client faces multiple batch rejection due to outdated Internal Release Limits (IRLs) but he has 100+ products (500+ attributes) to analyze and follow up on a regular basis

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Lifecycle management for drug products

Reluctance to compute tolerance intervals

  • Needed support with the preparation of Module 3 and corresponding Module 2.3 documents for drug substances and drug products:
    • To reflect the current status of manufacturing process and state of the scientific art analytical procedures
    • To close gaps and achieve GMP compliance of regulatory documentation.
  • Required on-going lifecycle management for all drug product licences needed.

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Multi-country Phase III clinical trial support

Market specific CTA applications for a multi-country EU Phase III clinical trial

  • Assistance required to review core documentation.
  • Authoring of local documentation for country specific submissions.
  • Assistance with competent authority and ethics committee communication.
  • Support with handling of substantial amendments to competent authorities and ethics committees, as required.

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US-UK Phase II clinical trial support

Support for timely approval of a Phase II clinical trial in the US and UK

  • Required assistance in IND authoring, eCTD publishing and FDA Agent activities for submission to FDA.
  • Alongside support in authoring of IMPD and local documentation required for submission to MHRA.

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