In many facets of life, if you want to do something right, you feel inclined to do it yourself. This age old adage is no different for the biopharma industry, especially when it comes to developing home grown clinical software solutions. But now many biopharma companies actually employ an extensive software development team, not to mention enough IT resources and infrastructure to host and maintain the system? And with tighter resources available, is this really where a company’s talent and energy should be focused?
Archive for July, 2012
Put Some SaaS in Your Clinical Trial!
Monday, July 30th, 2012Commercial Launch – An Opportunity for IT Transformation
Monday, July 16th, 2012Commercial launch of a biopharma company’s first drug product is a transformative event. A first product launch includes not only preparing the organization for the transition from development to commercial, but also transforming the IT applications and support model for the company. IT organizations that have been trying to differentiate themselves or increase business presence have a unique opportunity to:
1. Modify IT’s current practices
2. Pre-plan for commercial needs
3. Support other departments, e.g. G&A, prepare for corporate transition
IT Transformation
IT organizations in small companies tend to focus on security, data centers, core applications and supporting people within the “four walls”. Commercialization and adding remote field personnel significantly challenge these current ways of doing business. IT organizations must also work to improve IT policies, enhance remote access, support new mobility devices, improving helpdesk operations and supported proposals for off-site datacenters and SaaS solutions. Organizational changes include roles and job requirements to enable IT to become partner focused.
Planning for Commercial IT
When commercial teams are hired they have already have experience launching products and typically come from more mature organizations. The new organization does not have processes, technology or people in place to support them at the rate they expect. Often, IT must develop plans and budgets prior to the commercial staff joining including the initial plans, resources and timelines for the product launch and the IT requirements necessary to support commercial efforts. As the commercial team comes on board, IT leaders should identify priorities, consult with outside experts, identify potential vendors and solutions and move quickly to execute. This approach saves time, money and keeps IT aligned with its new business partners.
Supporting Other Departments
Experience shows that cross functional support is an often forgotten aspect of commercialization. Everyone is so focused on the submission, launch and hiring a sales force etc. that little time is spent verifying if existing processes and systems are ready for the transition. New requirements and capabilities must be investigated and supported, such as:
• Aggregate Spend,
• Travel and Expense Modifications,
• Engaging with Legal to prepare for the onslaught of contracts,
• Working with Finance to change existing ERP processes and
• Supporting HR by modifying onboarding and offboarding processes.
Commercialization is a very chaotic time for a biopharma organization but IT can use it as an opportunity to change how it works and enhance its effectiveness as a business partner. This requires significant introspective assessment and engaging in a cross-functional way with the organization. However, if IT does change its business practices and focus, has initial plans and budgets ready to support new commercial management and enables other departments to actively support the changes, they can go from being just a provider of services to an active partner in commercial launch success.
Commercial launch of a biopharma company’s first drug product is a transformative event. A first product launch includes not only preparing the organization for the transition from development to commercial, but also transforming the IT applications and support model for the company. IT organizations that have been trying to differentiate themselves or increase business presence have a unique opportunity to:
1. Modify current IT practices
2. Pre-plan for commercial needs
3. Support other departments, e.g. G&A, prepare for corporate transition
Managing CMOs from a Customer’s Perspective – A Focus of the ISPE Supply Networks Conference
Monday, July 9th, 2012On June 7, 2012, I presented at the International Society for Pharmaceutical Engineering (ISPE) Supply Networks Conference (link to conference website) held in Baltimore, Maryland.
Attendees were mostly ISPE members with backgrounds in technical services, quality, and manufacturing in the pharmaceutical (“pharma”) and biotechnology (“biotech”) industry. 50% of the audience was big pharma members. Also in attendance were suppliers to pharma and biotech, including API manufacturers. The conference typically targeted discussion of supply chain issues from an educational point of view that most members were not familiar with. Members received educational credits by attending.
I spoke as part of the Designing and Establishing Supply Networks track in a session titled “Quality Expectations and Challenges in the Global Supply Network”. My topic was Managing CMOs from a Customer’s Perspective (link to presentation). This included the issues involved in successfully selecting and managing a CMO (“Contract Manufacturing Organization”), taking the viewpoint of a virtual pharma company, not a big pharma company. Significant technical and supply chain resources are needed to manage a large CMO network; therefore, a virtual pharma has to rely more on the CMOs technical capability because of their limited staff to support a CMO network.
Following the presentation, I received some interesting questions including, one asked by someone at a large pharma company where they routinely negotiate cost savings into their CMO contracts at the beginning of the relationship: Why does virtual pharma focus more on the CMO technical capability and less on cost? My response was that a larger pharmaceutical company appears to have more leverage in negotiating financial terms than a virtual smaller pharma, which is primarily focused on the quality, capacity, and technical capability of the CMO. Cost is important but not the most important issue.
Another question was: Why is it so important to build a relationship with the CMO versus a supplier? My response was that this is due to the set of requirements of a small virtual pharma, needing a CMO that has the right technical, quality and capacity capabilities and because the virtual pharma does not have the leverage that big pharma has in dealing with CMOs.It is much more important to build a strong relationship between the two companies and make sure that negotiated agreement represents a “win-win” for both parties.
Overall this conference provided an excellent forum for industry professionals to discuss and learn about biopharma supply chain issues. Please see my presentation (link to presentation) for more information and let me know if you have any questions or comments on this topic.
Bill Connell (link to bio), Vice President & Supply Chain (link to SC service page) Practice Leader
On June 7, 2012, I presented at the International Society for Pharmaceutical Engineering (ISPE) Supply Networks Conference held in Baltimore, Maryland.
Attendees were mostly ISPE members with backgrounds in technical services, quality, and manufacturing in the pharmaceutical and biotechnology industry. 50% of the audience was big pharma members. Also in attendance were suppliers to pharma and biotech, including API manufacturers. The conference typically targeted discussion of supply chain issues from an educational point of view that most members were not familiar with. Members received educational credits by attending.
