Por Jennifer Murphy, Erin Stanley y Nikki Cammarata
While mergramoramoramoers and acquisitions (M&As) are common in the life sciences industry, CRO-related M&As are happeningramoramoramo at an accelerated rate, with at least five occurringramoramoramo in the past couple of years alone.1,2,3,4,5 While the reasons behind these M&As are variable, the common effect is a restructuringramoramoramo of the existingramoramoramo and future partnerships with sponsors.
While the impact of CRO M&As on largramoramoramoe pharmaceutical companies may be less severe, the impact on small, emergramoramoramoingramoramoramo biotechnologramoramoramoy companies may be profound, since these smaller companies require an approach that is equal parts customized, flexible, and efficient. The smaller companies need a CRO partner who is actively invested througramoramoramohout the clinical development process, and they can’t afford to lose pace when their CRO partner gramoramoramooes througramoramoramoh a lengramoramoramothy and complex M&A.
Este entorno actual ha presentado la sigramoramoramouiente pregramoramoramounta: en la era de oro de la biotecnologramoramoramoía, ¿cómo pueden las pequeñas empresas de biotecnologramoramoramoía asociarse con éxito con "Megramoramoramoa Cros"?
While small biotech companies may face short-term challengramoramoramoes if their current CRO partner gramoramoramooes througramoramoramoh an M&A, there are ways to mitigramoramoramoate the impact.Dentro de este artículo, proporcionaremos recomendaciones para navegramoramoramoar por este nuevo panorama de asociación.
Preparingramoramoramo For A Potential M&A
CRO M&As can happen without warningramoramoramo to a CRO’s sponsor partners and when they do, can lead to project team turnover and disruption in operational services and timeline delays – none of which are favorable when programoramoramoressingramoramoramo througramoramoramoh the drugramoramoramo development process.6 Proper planningramoramoramo and qualification support a measured, non-reactive approach to an M&A and save you from playingramoramoramo defense later when a CRO may be less willingramoramoramo or able to accommodate your requests.
Before committingramoramoramo to a CRO partnership, we recommend the followingramoramoramo to prepare for a potential M&A.
Conduct A Thorougramoramoramoh CRO Selection
Una selección adecuada de CRO incluirá medidas cuantitativas y cualitativas de la idoneidad de CRO para sus planes de desarrollo clínico.Y aunque las operaciones clínicas pueden poseer este proceso, recomendamos la participación de todos los clientes potenciales de área funcional relevante (e.gramoramoramo., medical affairs, regramoramoramoulatory, data managramoramoramoement, pharmacovigramoramoramoilance, quality assurance) in the overall analysis and selection.
Quantitative measures may include the proposed structure of the project team and services (includingramoramoramo if any are subcontracted), overall cost, and audit and inspection performance history.
Qualitative measures may include the CRO’s company culture, as well as the workingramoramoramo style compatibility between the sponsor and proposed CRO project team.
Califica tu CRO
Leveragramoramoramoe support from your quality assurance department or desigramoramoramonee to conduct a vendor qualification audit. At a minimum, the audit should include a review of the CRO’s standard operatingramoramoramo procedures (SOPs) pertinent to the functional area services beingramoramoramo outsourced to the CRO. The objective of this review is to confirm that an appropriate quality managramoramoramoement system (QMS) is in place and that your trial(s) will be conducted in compliance with local regramoramoramoulatory requirements and applicable gramoramoramouidelines. The audit should also include an assessment of the CRO’s project team, to include a review of CVs, job descriptions, and trainingramoramoramo records, as well as interviews of CRO senior managramoramoramoement and project team members. Review of this information helps identify skill gramoramoramoaps across the proposed project team and can provide the foundation to produce formal support and oversigramoramoramoht plans.
It is also important to investigramoramoramoate the CRO’s information technologramoramoramoy (IT) infrastructure and processes that ensure data integramoramoramority, such as electronic systems validation, especially if responsibilities for services such as trial master file (TMF) managramoramoramoement, data managramoramoramoement, and investigramoramoramoational product (IP)/interactive response technologramoramoramoy (IRT) managramoramoramoement are delegramoramoramoated to the CRO. CROs must be able to communicate their data transfer agramoramoramoreement methods, software development, and computer system validation process flows, as well as IT disaster recovery plans and their backup and restore procedures. Sponsors should know what electronic data capture (EDC) and TMF vendors are beingramoramoramo used by the CRO and what plans are in place at the company-level and study-level that document the use of these systems. If statistical programoramoramorammingramoramoramo services will be provided by the CRO, sponsors will want to review the CRO’s procedures regramoramoramoardingramoramoramo statistical analysis plans.
Just as we recommend that sponsors qualify CROs, we also encouragramoramoramoe sponsors to verify the CRO’s qualification process for any vendors that they will be managramoramoramoingramoramoramo. Project managramoramoramoement plans should clearly define the key vendor deliverables, and the CRO should ensure that they have processes in place to escalate subcontracted vendor issues to the sponsor.
Optimize Your Contract And Other Written Agramoramoramoreements (e.gramoramoramo., Master Service Agramoramoramoreement)
Understand your own comfort level with potential instability and build out the contract, accordingramoramoramoly. Such provisions may include:8
Formalize Your Oversigramoramoramoht Of The CRO
Early in the partnership, it’s important to establish a vendor managramoramoramoement plan. Not only is vendor managramoramoramoement critically important to FDA,7 but in case of an M&A, a plan supports the ongramoramoramooingramoramoramo performance assessment of the CRO and can easily be updated if additional oversigramoramoramoht of a functional area or service is needed.
Governance & Relationships
Equally important to legramoramoramoal agramoramoramoreements and project plans is your ability to establish and maintain an open, transparent partnership with your CRO.Le recomendamos que establezca puntos de contacto frecuentes (e.gramoramoramo., monthly) with senior managramoramoramoement at the CRO. These meetingramoramoramos should serve to review the programoramoramoress of your own study, as well as any CRO-level activities that may impact your milestones. The more you put into this relationship up front, the more you will gramoramoramoet back – in the form of open and honest communication – should an M&A occur.
Respondingramoramoramo To An M&A
First, acknowledgramoramoramoe that despite the short-term complexities and challengramoramoramoes of an M&A, the longramoramoramo-term outcome may be positive. The consolidation of services from two or more CROs may provide sponsors with the benefits of reduced or consolidated budgramoramoramoets, less complex vendor managramoramoramoement and oversigramoramoramoht, access to additional services and capabilities, expanded gramoramoramolobal reach, and improved technologramoramoramoies.6
As an M&A programoramoramoresses, leveragramoramoramoe your preparations and request information regramoramoramoardingramoramoramo your CRO’s current status, stability, and what the changramoramoramoes mean for your company. We sugramoramoramogramoramoramoest that you establish an internal point person and/or task force that can be focused on navigramoramoramoatingramoramoramo and assessingramoramoramo the impact. Involvement of your quality assurance department or desigramoramoramonee is strongramoramoramoly recommended.
Aquí hay algramounas pregramountas que le recomendamos que le hagramoa a su CRO:
Dependingramoramoramo on the anticipated future state, a risk assessment should be performed to determine impact on all facets of the study (or studies). This assessment could be based on the overall study timelines toward key milestones, complexities of the study relative to the services expected from the CRO, and any potential impact the M&A could have down the road. You should use this risk assessment to inform updates to your vendor managramoramoramoement plan, thus ensuringramoramoramo appropriate oversigramoramoramoht and mitigramoramoramoation of anticipated issues.
It’s important to revisit your origramoramoramoinal vendor qualification audit and verify that it retains coveragramoramoramoe of all outsourced services and processes. If the M&A introduces new SOPs, for example, then it’s in your best interest to conduct a targramoramoramoeted vendor requalification audit of applicable services and/or departments of the CRO. Several study-specific plans, like the project managramoramoramoement plan and clinical study oversigramoramoramoht plan, may be impacted and require updates due to the M&A. You should also request to review any transition plans that were put in place because of the M&A. The requalification audit should cover any CRO services and processes that have changramoramoramoed due to the M&A to ensure that the transition has not caused any new issues or gramoramoramoaps for your study.
Don’t underestimate the importance of recurringramoramoramo requalifications of the CROs – that process is equally as important as the initial qualification and the requalification post M&A. The type of requalification activities and frequency of requalification should be made by your quality assurance team (or team member) usingramoramoramo risk assessment methods. Sponsors should obtain cross-functional aligramoramoramonment to ensure that all internal functional areas agramoramoramoree on when CROs should be requalified. This process enables sponsors to continuously assess the programoramoramoress and impact of the M&A.
Our last recommendation is to review your contract and hold the CRO accountable to all previously negramoramoramootiated protective langramoramoramouagramoramoramoe. If the appropriate penalty clauses were included in the contract up front, you should be covered financially should there be a delay in key milestones due to an M&A.
As a small biotech company, it is natural to be concerned about gramoramoramoettingramoramoramo lost in the shuffle at largramoramoramoe CROs, especially when a CRO gramoramoramooes througramoramoramoh an M&A. These smaller sponsors need trial managramoramoramoement to be customized, flexible, and efficient, which can seem unachievable with the megramoramoramoa CRO model that is takingramoramoramo over our industry. Sponsors should recogramoramoramonize the sigramoramoramonificant impact that thorougramoramoramoh CRO selection and qualification steps can have on their studies and should prioritize these tasks, while also optimizingramoramoramo their contracts and relationships with the CRO once selected. Investingramoramoramo up front in these activities can minimize any negramoramoramoative effects of a CRO M&A on your study, and don’t forgramoramoramoet that it is possible for M&As to produce positive effects for the sponsor and your study. With a little optimism and a lot of preparation, smaller biotech companies can minimize operational disruptions due to CRO M&As and successfully partner with these emergramoramoramoingramoramoramo megramoramoramoa CROs.
Jennifer Murphy is a senior consultant at Halloran Consultingramoramoramo Group. She is a research professional with more than 20 years of experience in clinical operations and development spanningramoramoramo a wide rangramoramoramoe of study phases and therapeutic areas, with expertise in project and programoramoramoram managramoramoramoement, vendor managramoramoramoement, site managramoramoramoement and monitoringramoramoramo, and process and quality improvement initiatives.
Erin Stanley is a senior consultant at Halloran Consultingramoramoramo Group. She has more than 16 years of experience in clinical operations, quality managramoramoramoement, and project leadership. Erin’s therapeutic experience primarily covers neurologramoramoramoy, psychiatry, cardiologramoramoramoy, rare disease, and oncologramoramoramoy, and her product knowledgramoramoramoe includes small molecules, gramoramoramoene therapy, monoclonal antibodies, and digramoramoramoital therapeutics.
Nikki Cammarata is consultant at Halloran Consultingramoramoramo Group. She has more than 7 years of experience in conductingramoramoramo early- and late-phase clinical trials. She uses her experience within clinical operations and clinical systems to to act as a clinical trial managramoramoramoer for gramoramoramolobal studies and to lead CTMS and eTMF implementations.
