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In this section we will cover several project acceleration techniques that could be used on any project. We then look at several possibilities for a COVID-19 vaccine project.
General Project Acceleration Techniques
- Crashing involves adding additional resources to activities on the critical path in an attempt to improve schedule.
- Fast tracking is doing activities in parallel that normally would be done sequentially.
Vaccine Project Acceleration Techniques
The technique employed on a pharmaceutical company's project to develop a COVID-19 vaccine is fast-tracking, by doing activities in parallel that normally would be done sequentially, accepting the associated risks.
Recall the extract from the BARDA contract with Moderna that stated:
"The project shall be accomplished on an accelerated timeline, with parallel activity WBS, aggressive manufacturing scale-up, risk management, and taking advantage of any regulatory flexibilities."[1]
The reference to "parallel activity WBS" is a clear reference to the use of fast-tracking. We can look for potential activities that could be performed in parallel, albeit with risk.
Some possibilities for parallel activity could conclude:
- Combining Clinical Trials Phase 1 and 2
- Overlapping Clinical Trials Phase 2 and 3. Some portions of Phase 3 clinical trials could be overlapped with Phase 2 clinical trials.
- Overlapping Clinical Trial Phase 3 and Manufacturing ramp. The volume production manufacturing ramp-up could be started in parallel with Phase 3 clinical trials (Moderna Phase 3 was 8 weeks). Without an emergency situation, it would be extremely risky to ramp up production before knowing the full results of Phase 3 clinical trials. The full results could indicate that the production formulation needs to be scrapped, with major financial impact. The government is helping to de-risk the situation.
Additionally, one could make use of "Adaptive clinical trial design." For example, if the clinical trial testing data is excellent, adjustments in schedule are possible. These adjustments might include reducing the durations of trials. It might be possible to use fewer clinical trial participants.
Let's now return to the Figure shown earlier in this chapter from the General Accountability Office's analysis that is replicated here for convenience.[2] We can see extensive use of overlapping of Clinical Trial Phases. For example, in the case of the Moderna vaccine, we can see that Clinical Trial Phases 1, 2, and 3 are overlapping. Figure \(\PageIndex{1}\) is only addressing the specifics of clinical trails, so it is not showing any overlapping of clinical trials with manufacturing ramp up.
The following is a recap of the synopsis of the Clinical trial phase overlapping as employed by various pharmaceutical companies from a project management perspective:
- Moderna: Phase 2 started and completed during Phase 1 in the Unites States. Phase 3 in the United States started while Phase 1 and Phase 2 were in progress.
- Pfizer/BioNTech: Conducted Phase 1 and Phase 2 in Germany, and started Phase 1/Phase 2 in Japan toward the end of Phase 1/2 in Germany. It initiated Phase 2 in China shortly after initiating Phase 1/Phase 2 in Japan. It also initiated Phase 1/2/3 in the US and other countries at the same time as it started the Phase 1/2 in Germany.
- AstraZeneca: After initiating Phase 1/2 in the UK with Oxford, it initiated an overlapping Phase 1/2 in South Africa, also with Oxford. While the Phase 1/2 in South Africa was in progress, it initiated a Phase 1/2 in Japan and a Phase 2 in Azerbaijan. A Phase 2/3 in the UK overlapped with the Phase 1/2 in the UK, as did a Phase 3 in Brazil, followed by the initiation of a Phase 3 in the United States and other countries, including Russia.
- Sanofi/GSK: Conducted a Phase 1/2 in the United States.
- Janssen: Conducted a Phase 1/2 in the United States and Belgium, with an overlapping Phase 1 in Japan, and a Phase 2 in multiple non-US countries,
- Novavax: It initiated a Phase 1/2 in the United States and Australia, followed by an overlapping Phase 2 in South Africa, which in turn overlapped with a Phase 3 in the UK and later by a overlapping Phase 3 in the United States.
Please keep Figure \(\PageIndex{1}\) in mind when you are doing your CIS 79 vaccine schedule assignment.
Early volume manufacturing
“As part of Operation Warp Speed, doses of a vaccine will be manufactured before it proves to be safe and effective. The goal is to have 300 million doses ready to be administered to the American public, and the administration has entered agreements with at least three companies.”[3]
“It's a process that requires a significant financial investment but one that Fauci has praised time and time again. On August 5, he told Bloomberg's Balance of Power show that preparing sites for clinical trials and proactively producing the vaccine can shave off months of time if a vaccine candidate works out. And if the candidate isn't viable, "the only thing you've lost is money," he noted.”[3]
Bolding of text was added for emphasis.
This will be discussed further on the section on risk management.
References
- HHS-BARDA-Moderna-Contract-75A50120C00034-16April2020-Version8Feb2021. BARDA-Moderna Contract. April 16, 2020. (Less redacted version obtained via FOIA lawsuit on February 8, 2021).
- United States Government Accountability Office. GAO-21-319 Operation Warp Speed Accelerated COVID 19 Vaccine Development Status and Efforts to Address Manufacturing Challenges. Accessible Version. GAO-21-319 OWS. Accessed February 2, 2026.
- Jenni Fink, Newsweek, "Fauci alls naming of Trump administration's Operation Warp Speed unfortunate, says it implies reckless speed." August 14, 2020.
2.14.2: Project Acceleration Techniques is shared under a CC BY 4.0 license and was authored, remixed, and/or curated by LibreTexts.
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