Venture capitalists have pumped $2.8 billion into biotechnology startups in the first two months of this year alone (1). This means two things if you’re a startup. First, expect fierce competition because a huge capital pool attracts the very best in the industry. Second, this kind of investor confidence requires that you hit the ground running.
One of the biotech industry’s biggest stumbling blocks is unavoidable. There’s simply no way around the long development cycles for firms working on cutting-edge medicines and therapies. But there are many opportunities for you to improve R&D efficiency and to be ready to go.
In the past 12 years, I’ve had a chance to see up close how some biotech companies cleared the common hurdles for new companies. Most of them turned to my organization to reduce costs and improve compliance.
I would like to share with you two pivotal elements you are going to need to beat the competition. They are particularly crucial if you’re seeking capital investment or planning to sell your company down the road.
In regulated environments, if it’s not documented, it didn’t happen. And, if it’s not documented properly, you’re jeopardizing compliance. A study focusing on pharmaceutical clinical research showed that document control problems constitute the second most commonly cited deficiency in inspections of clinical trial sites by the U.S. Food and Drug Administration (FDA). Source documentation problems ranked fifth among the top 10 findings in inspections of clinical investigator sites by the European Medicines Agency (EMA) (2).
In many FDA warning letters and audit observations, cases of inadequacy and inaccuracy of documentation stems from paper-based processes. If you are in the process of establishing a quality system or improving an existing system, put automated document control and management at the top of your priority list. It’s an important foundation for your quality system going forward.
Aside from document control, you should prioritize change control and risk management. Up to 90 percent of medicines and other medical products in development fail before they ever get tested on people, according to the National Institutes of Health. This failure-prone development period is known as the “valley of death” (3).
As a startup, you need to be able to surmount this obstacle. You must brace for multiple iterations during the long discovery and development phase. This makes change control and risk management crucial.
Equip your team with the right tools. Having a centralized repository, preferably automated, for all product documents will allow you to easily revisit each iteration throughout the development cycle and even after you launch your product.
The supply chain drives the operations of biotech startups because most of them have neither the manpower nor the facilities to do everything in-house.
A survey of over 1,000 biotech and pharma companies shows that 77 percent of the respondents rely on outsourcing, not just for materials and manufacturing, but also for development services and clinical research (4).
If you belong to this category, you need to turn your business relationships with suppliers, consultants and contractors into effective partnerships. Doing so will significantly accelerate your time to market and improve product quality and compliance.
Establish a system that’s easy for you and your suppliers to access and use. The system should provide robust tools for collaboration, review and approval of documents. It should have the capability to notify all stakeholders of any issues in real time.
Although you are ultimately responsible for complying with regulations and standards, your suppliers and contractors should provide support by being compliant themselves.
Take note that the Food and Drug Administration Safety and Innovation Act (FDASIA) strengthened the FDA’s authority over the drug supply chain for a good reason – to address the increased dependency of manufacturers on suppliers throughout the world.
By beefing up your supplier-management compliance, you are also speeding up your time to market by paving the way for a smooth approval process. Think of it as a win-win.
Addressing your regulatory needs and building successful supplier relationships are compelling reasons to automate your quality, compliance, and business processes.
In this day and age, there’s no excuse to not leverage the latest technology. Even a small budget, the biggest reason in the past for sacrificing technology, is no longer an excuse today. Life science solution providers have a variety of economic models for all types and sizes of companies. Conduct due diligence to find the most suitable solution for your organization.
When you have an effective system from the start, you will be “ready to go” in the sense of being prepared to compete globally. Such state of readiness will make your organization more attractive to potential investors. It will make all the difference between success and failure as a startup.
Matthew M. Lowe, MasterControl executive vice president, is a mechanical engineer with over 15 years of medical device experience in product development, product management and regulatory compliance. He has successfully launched more than a dozen medical devices and has five patents issued. His regulatory compliance experience includes writing a 510(k) that was cleared by the FDA and managing a multisite, multiyear postmarket clinical study for orthopedic devices.
He joined MasterControl in 2006 as a product manager, rising to senior vice president after a few years and then executive vice president. As a medical device expert, he has written many articles in industry publications. He is the author of an e-book, “Convergence of Compliance and Technology: How Technology Has Changed Regulatory Compliance in the Past Decade,” published in 2016. He holds a bachelor’s degree in mechanical engineering from the University of Utah and an MBA from Indiana University.
(1) “In Two Months, Biotech Startups Raised More Money Than in All of 2013,” Matthew Herper, Forbes, March 5, 2018.
(2) “Good Documentation Practice in Clinical Research” by Chitra Bargaje, Perspectives in Clinical Research, April-June 2011 edition.
(3) “Development of FDA-Regulated Medical Products: A Translational Approach” (Second Edition) by Elaine Whitmore, pages 6-7, ASQ Press, Milwaukee, Wis., 2012.
(4) “Outsourcing Operations in the Pharma Industry,” citing a 2016 survey by Nice Insight survey, The Record, Dec. 22, 2016.
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