spacer
home > epc > spring 2012 > strategic alliances
PUBLICATIONS
European Pharmaceutical Contractor

Strategic Alliances

 

As the shift towards global clinical research continues, sourcing for clinical trial supplies is more important than ever. Assessing a potential partnerís capabilities is essential when outsourcing this part of the drug development process. Strategic Alliances. In the face of economic restraints and the ongoing aim of maximising efficiency and quality of service, many pharmaceutical and biotechnology organisations are relying heavily upon the expertise of specialised service providers to increase their global reach and expand their internal capability portfolio. It is no secret that clinical trials are increasing globally in exponential numbers. Therefore, strategic alliances with organisations who can compliment internal capabilities or take on varied responsibilities and competencies that the company has deemed non-core to their purpose is one of the first assessments now being completed by clinical trial teams.

Expansion into emerging markets such as Asia, Eastern Europe, and Latin America has contributed to at least 15 per cent of this pharmaceutical growth. It has been reported several times over that by 2020 the emerging market will equal that of the US and EU combined. Therefore, to adequately compete within the industry, companies are forced to expand globally, specifically in remote and emerging regions. To support this growth, the industry is seeing first hand how regulatory harmonisation efforts make the execution of global trials more manageable. Therefore, companies have to rethink how they can support this global expansion without impacting the budget while continuously expanding their portfolio.

Organisational restructures as well as several mergers and acquisitions have increased the number of alliances needing further development within the industry. This trend has amplified the complexity of managing the already labour-intensive clinical trial supply chain. Supply requirements, general market performance and the geographical spread of trials are but a few factors that can influence how these relationships are formed, structured and managed. After reviewing their internal capabilities and assessing the available external support against the minimum requirements, companies turn their focus to finding a partner that can deliver and emulate their corporate identity and strategy. Within the industry, companies report that the minimum requirement of a partner is one that can demonstrate reliability and repeatability as well as one that has a global reach and proven secure supply chain where the five Rs are a priority: getting the right material in the right amount to the right place at the right time in the right manner. So how do companies build strategic alliances to support clinical trial supply sourcing activities?

Clinical Trial Supply Sourcing

The key to sourcing clinical trial supplies is having reliable procurement avenues. Clinical trial supplies are secured through either the innovator company, an authorised wholesaler/ distributor, or a speciality pharmacy. Depending on the complexity of the clinical trial, many teams opt to source internally through on-site resources or through their trial sites. Some teams choose to outsource the procurement of the clinical trial supplies and associated activities. While other teams use a hybrid approach of using internal and external resources to execute the sourcing tasks. Even if the sourcing is done internally or outsourced, there are several types of providers, including authorised wholesalers/ distributors, contracted research and manufacturing organisations, packagers, and clinical trial supply sourcing specialists.

Figure 1 shows the lay considerations when assessing a partnerís initial abilities in regards to sourcing clinical trial supplies.

 

Choosing a Sourcing Provider

One positive aspect is that sourcing providers are plentiful in this global market and the expertise is within reach; however, only the sponsor can decide if the sourcing activities should be implemented internally or if this is a service that can be relinquished to a trusted partner, which would subsequently lean towards organising a strategic alliance. Thus, sponsor organisations have to undertake extensive research to find the partner that best matches the needs of the clinical trial portfolio.

When deciding who is going to source the clinical trial supples, the sponsor organisation should:

  • Determine in-house capabilities
  • Evaluate core business functions and see if the team is willing to take on the task of sourcing the clinical trial supplied and their associated activities
  • Enquire on accessibility to information to facilitate the sourcing of the clinical trial supplies
  • Consider how the project and time management of the clinical trial supplies and their associated activities will impact the overall clinical trial timeline

Many teams believe that sourcing through the trial site is the most opportune scenario for the sponsor organisation due to both risk and cost. When sourcing through trial sites, there are minimal to no licensing and importation issues; however, sponsors have limited control over the budget and less control over stock. If necessary, labelling or further manufacturing might have to be performed at each site. In any case, teams do need to vet the possibility of this option because, due to local regulations, sourcing might not be available through the sites for the clinical trial.

 Depending on the material supply restrictions, sourcing through the innovator company can entail disclosure of trial information and supply provision negotiations. Still, sourcing through the innovator is most preferable, as it does give access to a steady supply of large quantities in single lots with long expiration dating. Another advantage is that pricing can be more stable and predictable, and this option gives the best access to global inventory and documentation.

Traditional wholesalers are necessary and are most often able to source the large quantities and have robust quality systems in place, but can be limited in their capabilities and unable to source globally. Clinical trial supply sourcing is not typically a wholesalerís main business focus and, as a result, they are not always able to provide supporting documentation, special lot distributions or material with expiry beyond eighteen months. Nevertheless, at the request of the innovator company, pharmaceuticals can often only be procured through authorised wholesalers or speciality pharmacies.

Sourcing specialist providers are experts at fact fi nding, data sharing and knowledge support. They help to support the clinical supply chain from the planning stages to material reconciliation. They are trusted by the manufacturers and authorised wholesalers/distributors as most often they serve a dual role with the specialist provider as a client and supplier. As such, sourcing specialists are able to source directly from the manufacturer due to these client/ supplier relationships. Sourcing clinical trial supplies is the main business focus and core competency of sourcing specialist providers. They have extensive procurement options through a global network via central or local supply, coupled with logistic abilities to deliver direct to study sites. Sourcing specialists provide assistance in determining the best supply options; assist with information gathering, sample provision and any possible sort of requests; and can offer logistics and distribution services. In order to provide supply options, specialised providers gather information regarding local variations, assess availability globally, confi rm availability of compliance documentation, evaluate price differences, and provide key advice on the reliability of the supply. Furthermore, ensuring trial supply specifi cations and requirements are met and fully sought after and received is their priority and as such, engaging in specifi c negotiations with suppliers is also a core competency. Due to this focus, these specialist providers can secure the clinical trial supplies in individual or multiple lot batch disbursements with long expiration dates accompanied with the required documentation. Figure 2 shows what a sponsor organisation can expect from a sourcing specialist provider.

If the sourcing is not being managed within the sponsoring organisation, control and disclosure of trial information will have to be handed over in order to take full advantage of utilising a partner. Another point to consider is that when partnering with any provider, constant communication is key, and the more access to information the provider has, the more detailed and accurate the deliverables will be. When the sourcing provider is fully integrated with the team, the return on investment can be rewarding. In all cases, the sourcing objective remains the same and that is to determine the safest, most effi cient, and most economical option for procuring the supplies.

The following questions should be considered when assessing the capabilities of a partner:

  • Is clinical trial supply management a core competency and business function?
  • Are they able to support your clinical trialís supply chain? Assist in developing your sourcing strategy? Secure supply of your material for procurement? Facilitate your materialís further manufacturing? Manage warehouse and inventory clinical trial supply material and/or manage depot services? Distribute material to clinical sites? Assist in material reconciliation?
  • Do they have an international presence and how is their global reach defined?
  • Is the provider appropriately licensed/ accredited?
  • Are appropriate procedures in place and executable?
  • Is their team qualified?
  • Was the site visit/audit favourable overall?
  • Are emergency response and disaster recovery plans developed, practiced and available?
  • Do they have case study examples?

 

It is recommended that sponsors audit and test a providerís supply chain and confirm if they are efficient and accurate. After confirming the complementing capabilities of the involved organisations, to best compliment the clinical trial teamís goals ensure that a potential partner can:

  • Offer information intelligence and present flexible options via a global network
  • Provide transparency
  • Mitigate and control costs
  • Offer services in terms of project management
  • Give unbiased clinical trial supply advisement

Other recommendations to consider when partnering with a provider include:

  • Having preferred providers as well as backup or alternate providers that can compliment each otherís capabilities Executing well-defined service level agreements
  • Conducting consistent vendor management assessments to verify the quality of products and services being provided

An Equal Partnership

Sponsor organisations and partners are equally responsible for the success of the trial by ensuring the quality of the clinical trial supplies. All parties involved are held to the same good manufacturing procedures, standards and regulatory policies to guarantee no compromise of the supply chain. Everyone who touches clinical trial supplies plays some part in assuring that the material has been manufactured and handled in the most compliant manner in accordance with all regulations. Thus, confidentiality agreements and service level agreements are normally entered into when the partnerships are formed. While auditing Ďreceivedí material for quality release is a standard operation, auditing partners for quality execution of requirements should also be an expected task. Hence, to monitor on-going performance, periodic audits and assessments are conducted and sponsor organisations should strive to have a consistent and thorough system in place to audit providers that would include an evaluation of comparable assessment criteria. This assessment should occur as often as teams deem necessary. In general, assessments are conducted in a three-phase format. As such, a pre-assessment is initially conducted, which includes general overview and the interview of partners as well as a review of any warehousing, inventory, distribution, transportation and building strategies. This is followed by an assessment whereby there is a confirmation of pre-assessment details and a physical walk-through of the facility to be used, as well as a review of any observations. Tasks which can improve the process are assigned for any necessary adjustments. Finally, a post-assessment should be conducted to review the summary of findings and any necessary adjustments, along with the confirmation of an executable action plan.

If the provider chosen to execute the sourcing of the clinical trial supplies will also be responsible for the warehousing, storage, inventory management and distribution of clinical supplies, then the following steps should also be considered:

  • Approve standard operating procedures
  • Visit/audit facilities in terms of compliance with GMP regulations
  • Assess temperature and security monitoring systems
  • Confirm generator back-up capabilities
  • Review communication, emergency response, and disaster recovery plans
  • Check applicable electronic systems (inventory, monitoring, and so on) for accuracy
  • Implement a consistent and executable vendor management scorecard

Each clinical trial should have its own distribution network that has been tried and tested for delivery of the clinical supplies to destination points without incident, up to and including various clearance points in terms of imports and exports. Thus, when evaluating the supply chain of clinical trial supplies, ensure that reliable procurement policies, processes and procedures are in place and are being performed accordingly. Meticulous assessments of core business functionalities and business plans help to create strategic partnerships which ensure that all necessary capabilities required to manage clinical trial supplies are being fulfilled by the most qualified organisation.


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
Lekishia White is Vice President for the Multipharma Group and Managing Director for Multipharma, Inc, where she is responsible for the US, Canadian and South/Latin American operations. Lekishia obtained her BSc in Biology from Spelman College in Atlanta, GA and an MBA from Pepperdine University in Malibu, CA. For over 10 years, she held several key roles in various departments for Amgen, Inc. She is a subject matter expert in the areas of good manufacturing practices and operations, good distribution practices, warehouse logistics, quality and regulatory compliance, clinical and commercial supply chain management, procurement and strategic sourcing and personnel and project management.
spacer
Lekishia White
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

The need for a blueprint emergency plan to avoid a HPAPI crisis

SMi reports: Taro Pharmaceuticals, Purdue Pharma and Sakari Consultants to present at HPAPI USA taking place on October 21st Ė 22nd in Boston
More info >>

White Papers

Cleaning Validation: What do you need to consider to ensure a successful outcome?

RSSL

Cross contamination must be avoided in the Pharmaceutical industry at all costs and successful cleaning validation ensures that patients are not put at risk due to cross contamination. The process can be divided into a number of sections each of which must be fully understood and areas of concern addressed to ensure a successful outcome across the entire process. This spans both the manufacturing and subsequent analytical and microbological support. The data used to confirm a positive/successful cleaning validation is underpinned by the results of validated analytical methods. It is essential that these results are truly representative as patient safety is based upon the absence of equipment residues. So what are those areas of concern, what affects your ability to get a successful outcome and what do you need to consider when carrying out a Cleaning Validation exercise?
More info >>

 
Industry Events

CPhI & P-MEC India

26-28 November 2019, India Expo Centre, Greater Noida, Delhi NCR, India

As the pharma industry looks increasingly towards India for high quality, low cost pharma solutions, CPhI & P-MEC India is the ideal event for companies wanting to pick up on the latest trends and innovations the market has to offer. At CPhI & P-MEC India, you will meet the movers and shakers from India's pharma machinery, technology and ingredients industries, giving you a competitive advantage that will help grow your business.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement