When developing a new pharmaceutical product, it is important to assemble the right team with the right expertise to enable an effective development program with the highest probability of success. For startup companies who are focused on one or two assets, it frequently is not possible to hire all the individual specialties required to develop the product. A cost-effective and widely used approach is to use expert consultants, which allows the innovator to manage costs while at the same time ensuring they have access to expert guidance.
This model is well-established in the preclinical stage of the development lifecycle, and selecting the right preclinical consultant is a critical step in ensuring program success. In today’s blog, we explore the question “What should I look for in a preclinical consultant?” in some detail with two of the finest professionals in the industry: Dr. Mary Richardson, Ph.D., DABT (Co-Founder, President, Lumino Advisors) and Dr. Kathleen Krenzer, OD, Ph.D., DABT (Research Fellow). See their bios below at the end of the article.
Ben: Welcome, Mary and Kathleen! First question: What should a company look for in a preclinical consultant?
Mary: I would suggest that you look for a consultant that has direct experience with the product type that you are developing. Not even the most thorough reading of the relevant guidance documents or standards can replace the experiential learnings from developing a product type. Additionally, I would select a consultant that matches your company’s culture. Finally, some consultants focus on strategic deliverable vs executional activities, so it is important to ensure that your scope of work matches both what you need and the consultant’s skill set.
Kathleen: I agree with Mary’s point and just would add – because often people forget this important criterion – make sure that your potential consultant has the bandwidth to take on your project when you need it and can give it the time and attention that is needed. Getting an estimate of timeframe to completion of a project and availability is always important. If you are looking for a longer-term commitment – it helps to agree on the workflow together.
Ben: Great insight and guidance! Next question: When in the product lifecycle should a company look for a preclinical consultant?
Mary: It is recommended to identify your preclinical consultant as early in the development lifecycle as possible. Your preclinical consultant(s) can assist in developing appropriate screening studies to support lead selection and even material selection. Early involvement will ensure enough time to develop a robust preclinical strategy and aid in project planning. Certainly, having preclinical expertise on-board prior to any Regulatory meeting (i.e. pre-IND meeting) is important.
Kathleen: I agree. In my experience, a lot of companies want to jump as fast as possible to the human clinical stage but ensuring a robust preclinical strategy and appropriately paced studies will help de-risk the program and answer important questions before proceeding to the more costly human trials and can actually save time in the long run.
Ben: Great point about de-risking programs – it seems to me that it is important to think of a preclinical program for a pharmaceutical product as not just a regulatory requirement, but also a key enabler to product development and, ultimately, clinical success. Now – What are some typical activities a preclinical consultant might provide to a company or project team?
Kathleen: It depends on the engagement, but in my experience, activities can range from strategic in nature, such as drafting a preclinical plan and issue management, to operational activities such as literature search and assessment, vendor selection, and management of all aspects of study execution. Not necessarily all inclusive, but this should give you a flavor of the breadth and depth of services required of a preclinical consultant.
Mary: Another area that we support for our clients is regulatory document preparation. Preclinical consultants often author key sections of regulatory submission documents (including INDs, 510K submissions, and briefing packages for meetings), and they often join the Sponsor in preparing for and attending meetings with regulators. A preclinical consultant should meet the client wherever their needs are at the time and immerse in the project as if it were their own.
Ben: Perfect! Another question for the two of you – What are some important skills and talents that should be considered when selecting a preclinical consultant?
Mary: In my mind, it comes down to three things: Technical Competence, Relevant Experience, and Cultural Fit. A consultant needs to know the regulations, understand the regulatory landscape, and have a solid grasp of the science of toxicology. In terms of experience, it is not necessarily about the years but about the relevance of their experience to your particular need. And, finally – and perhaps most importantly – is cultural fit. The consultant may sit on the Project Team and be expected to interact with a number of different technical and business leaders. Team dynamics are important for a successful project, so doing your best to select a consulting partner who will fit well with the team is very important.
Kathleen: In addition to what Mary said, I think an important trait for a preclinical consultant to have is intellectual curiosity. Even the most seasoned consultants will come up against situations they may not have ever encountered – but the client is expecting guidance and a path forward. Having the insight to know when you do not know something, and the drive to figure it out is critical to becoming a truly value-added team member. Also, a consultant with a strong network of technical experts in related fields can be very important to a team, especially when unexpected results are observed.
Ben: This makes sense, yet may be counterintuitive to some – technical skills, while important, are not the only factor to consider when selecting a preclinical consultant. A lot of people I have spoken with over the years ask: How important is specific therapeutic experience in selecting a preclinical consultant?
Kathleen: I think having specific therapeutic area expertise is helpful, but a technically sound consultant could move across different types of small molecule development although there will be some necessary learning to understand the therapeutic class when designing the program.
Mary: I don’t disagree, however there are times where having certain technical expertise or experience can be very important. For example, hiring a preclinical consultant who has worked primarily on small-molecule projects might encounter a challenge getting a handle on the emerging regulations of a large molecule, gene therapy product or an immune-oncology product where the patient’s own cells are modified in a very complex fashion to deliver the therapeutic effect. In these cases, it would be important to seek out a consultant with this specific experience.
Ben: Interesting. This conversation has definitely highlighted how important a preclinical consultant is to the success of a project team, as well as the many things to think about when selecting a partner. In conclusion, what would be your final piece of advice or wisdom for companies to consider when selecting a preclinical consultant:
Kathleen: Using consultants for part of your development can give you a lot of flexibility and help you build a team that has the exact experience that you are looking for. I think it is important for a client to define what they need up front and how they want to work with their consultants – based on that, having a detailed conversation with a potential consultant focusing on their experience, communication style, availability, and your needs will go a long way to set it up for an early success.
Mary: I echo Kathleen’s sentiments – Working with an external consultant for your preclinical needs should not mean that you compromise quality or timing and if done right, should result in a very positive outcome. To get that successful experience, it is important to consider both technical and cultural fit of your preclinical consultant and make your expectations very clear in terms of deliverables.
About the Authors
Dr. Mary Richardson is an experienced board-certified Toxicologist with broad-based technical skills in Pharmaceuticals, Over–the Counter (OTC) products, Medical Devices, Toxicology, and Pharmacokinetics. She maintains in-depth research and development experience covering the full range of product life cycle including discovery and due diligence for in-licensing, product development, and post market support such as life cycle management, geographic expansion, and manufacturing support. Additionally, Mary possesses an extensive knowledge of world-wide global regulations, guidelines, and standards for registration of Pharmaceutical and Medical Device products in the US, EU, and Japan. Her technical leadership and excellence in development has resulted in Regulatory approval and the success of numerous regulatory submissions.
Dr. Kathleen Krenzer is a clinician-scientist, with board certification in Toxicology (DABT), focused on the nonclinical toxicology aspects of medical device, pharmaceutical, and combined product development, including novel products. She is experienced in working on multidisciplinary teams for product realization, from early research through development, registration, life-cycle management, and issue mitigation. Additionally, Kathleen has technical proficiency in nonclinical strategy development to meet project goals (including budgeting and staging), and execution against strategies. Finally, Kathleen brings a strong understanding of the global regulatory requirements through preparation of regulatory filings and interactions with health authorities in the US, Canada, EU, Japan, China, and Australia and various Notified Bodies.
iuvo is headquartered in Rush, NY and maintains a 30,000-square-foot preclinical laboratory testing facility that offers an on-site AAALAC accredited vivarium and specialty testing services for the medical device and pharmaceutical industries. iuvo has a talented team whose breadth of testing and consulting expertise spans multiple disciplines including Analytical Chemistry, Microbiology, Toxicology, and Sterilization Validation. Our experience is particularly deep serving the ophthalmic industry, including OTCs, drugs, devices, and combination products.
iuvo offers sterilization validation services with extensive experience in ethylene oxide sterilization, as well as gamma and E-beam. Our scientific staff has years of involvement on the AAMI Standards Committees for reusable device cleaning, disinfection, and validation and is able to provide consultation as well as testing services.
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