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Establishing Medical Safety Groups Within a Biotech Startup:

6 Questions for a Medical Safety, Quality and Compliance Expert


I spoke with Dr. Ed Tucker, Senior Vice President for Medical Safety, Quality and Compliance from Acerta to discuss issues facing biotech startups when they’re considering establishing a medical safety group.

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September 12, 2016 | by Andrew Juurinen, M.Sc.

In advance of his upcoming presentation on Thursday, September 15th, I spoke with Dr. Ed Tucker, Senior Vice President for Medical Safety, Quality and Compliance from Acerta (A member of the AstraZeneca Group). We discussed the issues facing biotech startups when they’re considering establishing a medical safety group.

Briefly, what barriers and challenges might a startup face, when establishing a medical safety team?

The major obstacles are, first, identifying the need for a safety organization and second, determining the level of risk acceptable for an early startup company. For startups, it’s a capital investment in the future while not knowing if that future is still promising. Is there confidence in the molecule becoming a medicine? If yes, that can generate a need for a safety department as you move from pre-clinical into clinical phase. After all, you need a safety department before you're actually proceeding into clinical trials and this shouldn’t be fully outsourced to a service provider [Further details follow below].

What types of resources should a medical safety group have available for success?

Your medical safety group requires the appropriate capabilities, at the right scale that is suitable for your existing and future demands. as your clinical program enlarges, so think about how you intend to scale up. You need an appropriate safety technology platform, the ability to develop process documents that can describe your safety responsibilities and activities, and being able to show to compliance with the international regulations of the countries you intend to operate in.

How might a fully established medical safety team in a large biopharma company handle day-to-day operations, and should a startup use a fully established team as a model?

Fully established medical safety teams in a medium to large biopharma company are very different from medical safety teams in a startup. A fully established team has an entire infrastructure that is designed for premarketing and post-marketing and that can be very different from a startup that is typically focused on pre-market or pre-approved clinical development safety.

There are different capabilities that you’ll require in your medical safety system. Startups should consider specific processes that are applicable to the pre-approval space and talent that is more focused on that pre-approval space. On the technology side of things, since a startup may be in the early phases of development, you may want to avoid early investment in post-approval infrastructure, as you have time to develop this as your clinical development program matures. That is something you could do later down the line. This way, you’re taking a risk-based approach; it would be pointless to build out your safety department for commercialization too far ahead of your first approval.

For medium to large biopharma companies, there are usually multiple products involved, so there is more specialization in the large medical safety department within a large company. Within the startup, you need talent who can be generalists, and to some degree, specialists in the area of therapy that you're focusing on.

How might the changing priorities of a startup influence a medical safety group? How can receiving fast track status change priorities, for example?

The priorities change quite readily in a startup. That can be related to a number of things. The success of early clinical trials for a single product can determine the overall success of the startup. If there is remarkable clinical data revealed, you'll see a dramatic acceleration of development programs and regulatory approvals, which can accelerate the entire growth of the company based on a single product; so that needs to be accommodated in planning. A single product company has a very high-risk associated with it, so if there is an unexpected negative result in one or more clinical trials, that can be very impactful on your entire clinical program. This may determine whether or not you survive and thrive or close the business. This is a very high-risk area and not all molecules are successfully developed into medicines. The probability of success is not positive, generally, so one has to be planning for that for you personally, for your team and the company.

When you receive fast-track status, you must accelerate departmental development in the anticipation that fast track status will yield an approved medicine and resultant needs for post approval safety. As a result, you should be supporting the clinical development program, begin focusing on globalization and commercialization, and supporting the market entry from a safety perspective. You should be ensuring that you are maintaining oversight for patient safety while being compliant with the additional regulations of a commercialized product.

For a small biotech company that is thinking about creating a safety department, why should or shouldn’t they consider letting the CRO handle that task?

Patient safety is one of the critical foundational elements to successful clinical development and consequentially to the success of a startup company. I would be very reluctant to fully outsource the safety and oversight of your patients to a CRO. Those are foundational and critical to the success of the company. When you lose oversight, you lose proximity to the data. Being able to see your safety in real time is enabling for decision making and allows timely mitigation of risk when appropriate.

You can do a mixed model, where I recommend CRO support in some instances, but would not fully outsource safety. You can have a CRO processing your cases, but still maintain a safety function within your organization. You need to understand the safety profile of your drug better than anybody else. We'll talk about that in my presentation. I've outlined 6 major components that you should take into account when considering outsourcing to a CRO the compliance and safety science are critical elements that I would not recommend to be outsourced

What should the audience expect to learn in your upcoming webinar?

There is a clear contrast between joining a large pharma company that has an established infrastructure versus the small startup company where you have a blank canvas. I'll detail this in my presentation, as well as, some of the recommendations and experiences (both enjoyable and some testing!) that I've had in both of those scenarios.

Make sure to join Ed Tucker for the upcoming webinar, Drug Safety in a Startup Biotech, for more insight on these issues, as well as a chance to ask him questions of your own, during the Q&A session.

Keywords: Medical Safety, Intralinks, Startup



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