Drug development consultants worldwide promise many things. Traditionally, biotech and pharma companies hire consultants to help guide them through the regulatory process or to fill in where their own companies have a lack of knowledge or resources, but many consultants can do much more than regulatory. There are several key questions you should ask before hiring a drug development consultant:
- What expertise does the consulting company offer?
- Will the consultant work with you as a true partner?
- What type of consulting does the company offer?
- What does the consultant consider as “success” for your product?
Camargo has worked in full-service strategic drug development for fourteen years and has noted many types of drug development consultant capabilities. The services and capabilities of each differ greatly. Some consultants will only read through the submission package you have written and submit it for you. A single-specialty consultant handles specific areas of expertise but outsources most of the development to other consultants. A full-service consultant, like Camargo, takes on a full partnership role with your team and shares and supports your goals through approval to market launch.
Question 1: What expertise does the consulting company offer?
All consulting companies will claim to be experts at what they do. However, when it comes to your unique product and program, it is critical to know if their expertise lines up with your specific needs.
Scientific & Medical:
You will want to gauge a potential consulting company’s expertise and experience in your scientific and therapeutic area. They should have the scientific knowledge to understand the full potential of your program, and the medical knowledge to help select the right target population, unmet medical need, etc. For 505(b)(2) applications, they should be able to utilize and leverage existing products and published literature to maximize the benefits of the 505(b)(2) pathway for your program. Finally, they should be able to provide examples of implementing creative strategies for maximized exclusivity or eliminating generic competition.
Technical/Chemistry, Manufacturing, and Controls [CMC]:
The consulting company should have experience in the technical aspects of product development and be able to coordinate these activities with the other scientific, commercial, medical, and regulatory demands of the program. For example, the chosen formulation could have a range of consequences on the requirements of the development program, such as toxicology studies, to justify excipients. These studies should be avoided as they can put extras strain on the clinical studies timeline by expanding the required safety database.
Working with the FDA is as much of an art form as it is following procedure. While the FDA is typically collegial in their interactions with Sponsors, they will not prevent a Sponsor from doing more than the minimum if the Sponsor is proposing a development plan that is larger than necessary. Knowing how often the consulting company works with the FDA is key to understanding their ability to negotiate the best possible program for your company, above and beyond simply understanding the regulatory guidances and regulations. The relationship and understanding with the FDA could save your program millions of dollars and years in development time.
Global Considerations and Market Assessment:
Even if you plan to market your product solely in the US, the global market can influence your development program. The consulting company should align your product for success in the market from the start as they write the labeling. They need to have an understanding and plan for the global potential of your product. If your product was originally approved in another country, the consulting company should be able to determine if it is considered the standard of care in that country and/or how that translates to the US and globally. Understanding a product’s place in the global market, whether previously approved or not, can minimize development time in the US and facilitate potential future expansion.
Team Structure, Function, and Expertise:
You will need to understand the consulting company’s areas of expertise and whether a single person or a team is working on your product. Having a cross-disciplinary team working on your project can greatly streamline costs and time because multiple experts from different areas focusing on your project can help fill in gaps that a single person or small, specialized group might miss. Communication from one area of the project to another is also much simpler when all team members are working together rather than individuals piecing parts of the project together.
Question 2: Will the consultant work with you as a true partner?
Even if the contract is narrow and brief, your consulting company becomes part of your team. You want a consulting company that works well with your team, is invested in your product, and is willing to take on some of your risk.
You want a consultancy which strives to understand the key elements of your program and works with you to identify potential challenges and roadblocks that you might not have previously identified. While most consultants can help guide you through the basics, you want a partner that is not afraid to push back on potential weak areas of a program, or to ask tough questions, because the FDA will most likely ask the same questions during the approval process. You’ll also want a consulting company that is not afraid to tell you what you need to hear, even if it means less potential business for either party.
A true partner is also willing to take on some of the risk of your program, whether that is through partnering via equity or attaching their name to your product in front of the FDA. This demonstrates that they are as invested in the success of the project as you are.
Question 3: What type of consulting does the company offer? Regulatory, CRO, CMO, CDMO, combination?
Having a single consulting company that can manage multiple aspects of drug development can greatly benefit your program. Managing multiple consultants for a given project can be challenging, as communication or collaboration barriers between different groups can hinder a project and its timeline. A consultant that can offer services in a range of areas can help to keep costs down. Finally, keeping many consultants focused on the task, especially when they are only participating in a small part of the project, can be much more difficult than a single team dedicated to the complete development of your product.
Question 4: What does the consultant consider as “success” for your product?
Many consulting companies would answer that success is getting your drug approved. But the best consultancies are ones that look at the “big picture”- starting from the most efficient path to approval to commercial viability of the product 5-10 years down the road. A consulting company that specializes in only one area could potentially leave costly downstream gaps in other aspects of the program.
Camargo’s Unique Approach to Drug Development
Camargo is a strategic drug development company that takes a creative approach to address the unique needs of our clients. We don’t look at a project and simply ask how we can get it approved. We operate in full, multi-disciplinary teams of PhD scientists and specialists dedicated to each project, who approach each challenge as a fresh look on the most creative and efficient way to design for a product’s market success. We also don’t work on your project in isolation. Our team is part of your team, working together with frequent communication and clearly defined goals. Each project is fully customizable based on your project goals, from full development programs to hourly contracts to guide your established team. Finally, Camargo has proven experience and expertise to get your products approved with the FDA: several former FDA employees on our team, 3 – 8 Pre-IND meetings per month, and more than 1100 Agency meetings in total.
We look forward to learning more about your project and goals, and to determining ways we can help you to meet them. Contact us to learn more.
Author: Rachel Krasich, PhD, Research Scientist, Camargo Pharmaceutical Services