Six Tips for Leveraging Values, Ethics and Compliance in Successful Drug Development

CMOs play several valuable roles for emerging pharma companies: manufacturer, sounding board, safety net, among others. Battle-tested, with skills honed through years of working with large pharmaceutical companies and the FDA, CMOs uniquely know the lay of the land and can help guide emerging pharma companies along the right path. Values, ethics and compliance are integral to the CMO’s ability to maintain high professional standards and pass along good practices to their customer base. For emerging pharma companies, choosing a CMO with these qualities can make the difference between success and failure.

Based on my experiences working with both large and small pharmaceutical companies, I would like to offer some tips for both CMOs and emerging pharma companies to leverage values and ethics in successful drug development.

Dos and Don’ts

1. Do remember that establishing a new relationship is harder than it seems. Building a project-related partnership is more intense than building a longer-term relationship because of the compressed timeline and scope of the project. Be patient and communicate thoroughly and often, with the goal of building a successful partnership right from the start. That being said, do remember to treat long-term relationships with the same level of care, interest and excitement you devote to newer relationships.
2. Do take time to explore values and ethics on both sides. For emerging pharma companies, this means asking questions such as: What is the CMO’s track record of integrity – delivering on promises and deadlines? What happens when results are not what was expected? How does the CMO handle conflicts of interest? For CMOs, this means questions such as: How does the emerging pharma company get its work done? At the end of the day, which is more dear, saving a buck or good chemistry? We once worked with the CEO of a virtual firm who assured us in the scope of work discussion that his company had the analytics necessary to do the required chemistry. GMP manufacturing is expensive, and you need the right level of analytics to do it successfully. The CEO ended up spending twice his original budget because he misrepresented the quality of his company’s analytics just to save a dollar. The lesson learned here: Really understand where your customer is coming from and what is driving his decision-making.

1. Do note that the compliance game is changing and FDA criteria needs to be built in earlier and earlier in the process. In its quest to ensure safer drugs for Americans, the FDA is inserting itself earlier and earlier in the drug development process. Knowing the changing criteria and building in anticipated FDA guidelines from the get-go saves money and can increase compliance in the longer term. So questions for emerging pharma companies to ask include: How does the CMO anticipate the FDA requirements? What level of scrutiny is applied? Are there signs of deceptive practices or corner-cutting? If money needs to be shaved, what areas are earmarked for potential savings? CMOs also need to evaluate and understand the emerging pharma company’s knowledge of regulations and compliance as well. Questions gauging the company’s experience level and familiarity with the appropriate regulations and process will help the CMO determine the right level of handholding required throughout the project. Real-world examples and case studies are particularly helpful to share, so that the emerging pharma company knows what to expect and when.
2. Do focus on the people and the culture. Over the years, we have learned that good chemistry between partners makes for good chemistry in manufacturing. It is a guiding principle for PCI. As partners, we are in tune with each other and trust that each of us is acting in the best interests of the companies and the project. Our values and ethics are complimentary. When we function as an extension of our customers’ teams, it is a win-win situation, with the best possible outcomes. As an example, we have a long-standing relationship with a customer where we collaborate closely and have solid two-way communication throughout every stage of our projects. In a recent project both our technical team and the client’s mutually agreed to increase the amount of R&D activity to support their project. More than $150,000 of additional investment was made into their chemistry. We had been originally contracted to produce 2 x 20kg batches of API. However, the very first batch yielded nearly 38kg of high quality material thus completely negating the need of a second batch. This saved nearly $450,000 and in the process the asset had now been significantly advanced, well positioned for future clinical trials. By investing up front they were ultimately able to save a significant amount of time and money and ensure a highly successful outcome.
3. Don’t keep secrets. Transparency at every stage bodes well for a successful project, so ensure that both sides are talking openly as the project moves along. Regular project reviews, preferably led by an accomplished project manager, keep communications flowing, expectations met and professional standards high. Applications of good practice should be apparent at every stage.
4. Don’t forget to trust your instinct. Ethical behavior should carry throughout both the manufacturing and billing parts of the project, but sometimes that just is not the case. Here is an example: A potential new biotech customer with limited funds wanted to work with us. We knew the chemist on the team, but we were hesitant taking the company on due to the funding situation. Against our better judgement, we offered discounted rates to get the company onboard. Immediately we had a billing nightmare on our hands, with the company holding up payments to get more leverage from us. It tried to bully us into cutting corners and taking all the risks, until we decided to “fire” the company. It was a trifecta of hard lessons: always do the due diligence regardless of who you might know, sniff out and refuse to take on bully clients, and when your business gut says “no,” you’d better listen.

About the Author

Ed is the President and CEO of PCI Synthesis (PCI), he serves as a co-chair of the New England CRO/CMO Council and sits on the Industrial Advisory Board for the Department of Chemical Engineering at UMass, Amherst. Ed is also a long standing member of the American Chemical Society and advises the Bulk Pharmaceutical Task Force of the Society of Chemical Manufacturer’s and Affiliates (SOCMA).

Do you have questions? Talk to Ed.