Why Choose P3R Quality as Your Trusted Partner?
The following case studies explore real-world examples of integration challenges that P3R Quality experienced first-hand and worked through.
Every deal is different! Your Quality team benefits from someone who has experienced a broad spectrum of challenging integrations.
Most Quality, CMC, and Compliance issues are not identified until after the Deal is struck - P3R Quality facilitates problem-solving alongside your SMEs in compliance with your QMS.
Case studies are organized from most advanced development state (Commercial) to earliest development state (R&D). In each case, P3R Quality served as Cross-Functional Quality Integration Team Leader: a global role that coordinates Quality requirements & business continuity across all GxP Functions. The role works closely with other functions such as BD, IT, HR, Accounting, Tax, Finance, R&D, Operations, and translates Quality requirements into business language.
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1. Integration P - Commercial
~300-person US-based company developing therapeutic proteins in the hematology area.
The primary asset had achieved conditional marketing approval in the US and EU, but achieved poor sales volume.
Well-developed internal QMS with document management system, training system and about 80 SOPs.
A second commercial product was in the midst of market withdrawal at the time of acquisition.
No GCP or PV expertise in the company, leading to significant gaps in pharmacovigilance compliance and lack of CRO audits/clinical site audits - required significant remediation efforts.
Issues with reliability of laboratory data and sample mix-ups impacted clinical data from Phase 4 study required for conditional approval.
Enterprise-level decision to integrate SAP system 6 months post-close impacted GMP/GDP Quality, in which inventory control was tied to QA/QP release and adherence with Distribution licenses. SAP integration was delayed by 4 months to address.
About 2 years after acquisition, the primary asset was transferred to another business unit.
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2. Integration S - Clinical
~50-person US-based company developing therapeutic proteins in autoimmune diseases.
Inaccurate advice from contract consultant resulted in discarding GLP study data prematurely, requiring amendment to several GLP Toxicology Reports and notification to FDA of noncompliance with 21 CFR Part 58.
No internal QMS, acquired company was heavily outsource dependent on CROs/CMOs.
About 4 years post acquisition, development of primary asset was canceled by the new parent company, leading to lawsuit by acquired company’s investors related to canceled milestone payments.
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3. Integration A - Clinical
~50-person U.S.-based company developing small molecules in clinical phase 1 & 2 as companion (add-on) therapies to biologics.
Well-developed internal QMS with document management system, training system and about 50 SOPs.
Good historical coverage of vendor audits and clinical site audits.
Large number of protocol waivers granted for ongoing clinical trials caused issues with adherence to inclusion/exclusion criteria - required protocol amendment.
QMS Integration achieved and operating business as usual within 10 months.
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4. Integration C - Clinical
~50-person US-based company developing therapeutic proteins in the metabolics/hematology areas.
Acquisition occurred following 3 years of a partnership/co-development effort.
Target company’s employees had been working on personal laptops, creating IP security/data privacy concerns.
Executives from the acquired company were co-owners of an internal platform, enabling inappropriate access to blinded clinical trial data.
Large number of protocol waivers caused issues with adherence to inclusion/exclusion criteria - required protocol amendment to address.
Late reporting of serious breach to U.K.’s MHRA.
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5. Integration W - Clinical
~50-person EU-based company developing small molecules in the metabolics therapeutic area.
The primary target asset had been owned by a prior Sponsor, leaving a messy preclinical and clinical development history.
Sponsor faced Regulatory and bioanalytical challenges with primary PD marker to show laboratory proof of concept/efficacy - required effort to redevelop assay and reanalyze samples after acquisition.
Difficulty showing clinical benefits beyond the standard-of-care.
6 years later, the primary asset was out-licensed following phase 3 clinical studies - not a successful acquisition from a pipeline/product development perspective.
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6. Portfolio Acquisition - Early R&D
Genomics Medicine Portfolio with multiple preclinical assets, sites (including equipment) and ~ 30 personnel.
It was a challenge to get critical information pertaining to the assets due to deal structure.
A Genomics Medicine Unit was created based on this acquisition, which created silos in ways of working.
Personnel were enthusiastic about joining the new organization and excited to continue to develop their portfolio of products.
Integration of suppliers was challenging as the new business unit did not have existing expertise to oversee and audit gene therapy suppliers. Resources from the global parent company assisted.