The tedious process of vendor selection for Clinical Trials, Commercialization Planning and Launch in Regenerative Medicine can be daunting, let alone having to think about the Support necessary for success before you even know who to go to for what.
Identifying which services and support are needed, formulating a supplier short list to engage with for each, sorting through the overload of information, understanding who provides what and where there is overlap are just a few considerations – not to mention the Requirements, Budgeting and Contracting process.
Once the due diligence is done and contracts are in place, you hold your breath, have more than a few sleepless nights and wonder - did you and the team make the right decisions?
There is no cookie cutter method to ensure success every time. Each planning process will vary, as will the environment as Regenerative Medicine continues to innovate and blaze new trails. So what CAN you do to make the process easier, more successful (and sleep better at night)?
1. Seek Out Experience
Although Regenerative Medicine is “new”, there are expert Service Providers who have grown with the industry from the earliest clinical trials through Commercialization that can be an invaluable asset to your success. Don’t let egos get in the way, and no need to start at square one. You’re breaking new ground along with your peers and there is much knowledge and expertise available. Make a list of what areas you need help with, who might be able to answer questions for you, then – just ask. You never know unless you ask, right?
2. Realize You Don’t Know What You Don’t Know
Many research organizations and sponsors are currently planning their first programs in cell-based therapies, or have finally reached the huge milestone of approval and are planning for Commercialization. Realizing a small number of trials have successfully progressed to the later stages of development, and only a handful have achieved Commercialization, where do you go for guidance – Rely on your own team? Recruit from competitors? Utilize regulatory guidance? Go to industry meetings? Hire a consultant, or do your best and hope it works?
All of the above are resources available to you – use as many as you have access to. Experienced Service Providers have gone through the same processes and challenges you’re about to embark on numerous times first hand with different clients, and have a wealth of knowledge and expertise to ease some of the burden.
3. Chain of Compliance™ and Mitigating Risk
Development of cell therapies takes years from concept to clinical trials, and even longer to achieve Commercialization. The investment of time and funding is tremendous to put it mildly. Protecting your assets and maintaining integrity during transport as you reach important milestones should be the primary goal for biomaterials wherever you are in the process. The ability to provide Chain of Compliance™ and mitigate risk is crucial.
Sponsors and CMOs have voiced issues with drug development that may be attributable to logistics rather than assay or CMC development, as well as significant failure rates on critical reagents, clinical sample and finished drug product logistics.
A critical consideration lies with the equipment being used to transport these precious materials. You have no idea about equipment - how can you make an informed decision?
As mentioned earlier, leave it to those with the expertise. Look for quality standards and processes incorporated into every day operations around equipment and components such as documented validation, recertification after every shipment, calibration frequency, component inspection, tracking of serial numbers and historical data, ability to identify trends before there is a problem – rather than waiting for a catastrophic failure to occur.
4. Pay Attention to Those Who Provide More During Your Due Diligence
Think about when you’ve planned a large house project, a family function, or a trip where you talked with a variety of contractors, visited multiple locations, or spent hours researching websites. Most likely those you decided to move forward with educated you more along the way, exceeded expectations and seemed more interested and knowledgeable then others. Why chase after a Supplier who’s not interested enough to talk in detail or provide a Quote for your Phase I study because it’s “small”?
Those most interested in acquiring your business and trust will take the time regardless of the size of your program. Why? Because they realize getting in on the ground floor is best for you as a client to gain experience working with them now, and if they do a good job - in the long term. In addition, Service Providers who show interest in learning more about your program often results in discussing additional services that can further support your needs, and not just for the reasons you originally contacted them.
Ask yourself what type of Services are offered to further support your program, are these part of their core competencies and have they provided similar Services for other clients?
Including each of the above points in the due diligence process can greatly assist in the success of your Clinical Trials and Commercialization.
Beyond Logistics – Cryoport provides a full suite of Services & Consulting to support successful Clinical Trials, Commercialization Planning and Launch:
- Shipping Validation including a Final Report to include with regulatory submissions
- Lane Assessment utilizing 200,000+ performance data points to identify recommended flights, carriers, lanes, customs processes, etc.
- Secondary Packaging & Accessory Design to maintain the integrity of contents during transport if off-the-shelf packaging does not
- Creation of SOPs and Supporting Documentation
- Commercialization Planning
Written by: Sue Blecman, Senior Director, Business Development, Cryoport
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