For life sciences companies, launching your first product is a busy and critical time. In addition to sorting out launch plans, supply chain, field force etc., you must be aware of the number of laws, regulations and other compliance requirements that increase with commercialization. If you aren't also focused on compliance, you may quickly find yourself in trouble. While there are many moving parts to commercializing your first product, it can be simplified by keeping these six considerations in mind to help ensure you are mitigating compliance risks and meeting the goals your organization is striving for while keeping expansion in mind.
- Know your markets.
This is obvious for any sales or marketing person, but it equally applies to the compliance world. It is good practice to consider the compliance risks and requirements you are going to face in the first countries that you launch in. Being aware of your market requirements enables you to be better prepared for initial launch as well as expansion as time progresses.
- Identify your risk.
Analyzing key risks is essential to staying on top of compliance. Consider which people within your organization have the chance to execute something non-compliant. What might be a distraction to your key players which could cause non-compliance? This will be helpful in identifying where controls need to be set.
- Develop a good culture.
Compliance incidents can occur for various reasons such as internal pressure of goals that have been set, fear that if a person fails that they will lose their job, external pressures, etc. All of these can cause distractions which can lead to mistakes. At the point of commercialization, it is likely that your company will have already gone through accelerated growth. Expanding from that small group that took your product through its trials to now having an increasing number of employees, consultants and contractors can cause confusion within the company. Communication becomes more difficult. Mini fiefdoms can develop. Staying on top of the developing culture and emphasizing the culture you want by both word and action can help prevent a lot of issues.
- Keep it simple.
The task list will continue to get longer the closer you get to launch. You may find that your investors will be more interested in your progress and your interactions with regulators will increase. Implementing simple, straight-forward controls and clearly communicating messaging that your frontline understands and can apply is essential for success.
- Look forward.
Compliance needs to be more proactive than reactive. It is better to be prepared for what may come rather than just react to what has happened. Your controls and processes need to be scalable to take account of what your organization will become, not what it was. Finding a compliance partner with industry knowledge and expertise to help your organization stay on top of current regulations, assess industry trends and help guide you through expansion will ensure your systems are ready for new requirements like managing and tracking HCP spend so transfer of value reporting becomes simple.
- Examine your key opinion leaders (KOLs).
When moving forward with your KOLs, it is important to ask yourself if there is enough diversity in your KOLs or if are you very dependent on the same small number of individuals. Many companies find themselves falling out with their KOL who was the chairman of the steering committee for the pivotal phase 3, or they find that their KOL is caught up in a scandal and they are no longer seen as independent as you hoped. It is important to minimize the risk by diversifying your KOLs and make sure you are continuously monitoring how much money you are spending with each KOL and what you are paying them for.
With more regulations on the horizon, the compliance framework will only become more complex. Finding a compliance partner with the industry knowledge and expertise to help your organization stay on top of current regulations, assess industry trends and help guide you through expansion is essential for success. To learn more about how MediSpend can help build your compliance program to execute your plans effectively, contact us.