Why Choose P3R Quality as Your Trusted Partner?
No matter the size, M&A of assets or companies presents complex challenges, particularly in aligning quality systems, regulatory compliance, the conduct of clinical trials, and continuity of manufacturing processes. A well-executed integration ensures uninterrupted operations, best chance of regulatory approval (and value creation), ensures retention of data, and protects product quality and patient safety.
In the following case studies we explore real-world examples of integration challenges that P3R Quality experienced first-hand and worked through. No two deals are the same!
We’ve seen the best (and the worst) of Integration Governance, internal communication, senior leader decision-making, risk-based approaches, cross-functional collaboration and shared problem-solving throughout a company acquisition. P3R Quality has been in the Acquirer position and the Acquiree position - we’ve walked the path in your shoes. Lean on P3R Quality to expedite and smooth out your Quality integration tasks.
P3R Quality ensures your integration success with proactive risk mitigation strategies, robust knowledge retention, and traceability. While your internal SMEs might be overwhelmed by yet another M&A or big project, we can mitigate the workload so your SMEs stay focused on their existing quality and business goals.
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Company Integration P
~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 and resulting cash flow issues in target company.
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 swaps/mix-ups impacting clinical data from Phase 4 study required for conditional approval.
Enterprise-level decision to integrate SAP system six 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 Quality/QMS integration.
The primary asset didn’t fit with acquiring company’s existing product portfolio from administration perspective- (hospital setting vs. clinic or at-home setting, acute care vs. chronic care).
About 2 years after acquisition, the primary asset was transferred to another business unit of the global parent company.
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Company Integration S
~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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Portfolio Acquisition F
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 difficult on this acquisition as the new business unit did not have trained personnel to understand internal ways of working.
The structure of the deal has the organization still relying on resources from the licensee to this date.
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Company Integration A
~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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Company Integration C
~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 a QMS platform, enabling inappropriate access to blinded clinical trial data leading to a compliance investigation.
Large number of protocol waivers granted for ongoing clinical trials 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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Company Integration W
~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.
