How to Accelerate Drug Development Through the Use of Pharmaceutical Consultants

10

The time required to bring a new drug to market is estimated to be 10-15 years at a cost of 1-2 billion dollars (1).
Only 10% of the drugs in clinical development go on to be approved for commercial sale. Multiple factors contribute to these grim statistics. Drugs often fail in clinical trials due to lack of efficacy, toxicity, and poor drug-like properties (2). Drug developers must press for ways to successfully bring drugs to market while decreasing the time and cost of development if they are to continue to deliver value to patients and investors. Small biotech companies are key players in the development of novel drugs (3).
These companies are entrepreneurial in nature and frequently lack the financial, technical and human resources of their big pharma counterparts.
For these small companies, consultants can be the key to accelerating drug development.

 

Consultants are professionals with specialized skills and experience in a particular aspect of drug development (e.g. regulatory affairs) or with a particular therapeutic modality (e.g. monoclonal antibodies). Consultants may work in large organizations that sell consulting services as a package, or consultants may work as sole proprietors.
Small drug companies can benefit from consultants in two distinct ways.
The first benefit is that consultants provide access to expertise that might not be available any other way. Bringing expertise in-house through permanent employment is not always possible because candidates with the necessary skill set may not exist. In some instances, consultants are the only way to access the necessary technical expertise. This is especially true when working with newer therapeutic modalities such as mRNA, oligonucleotides, and gene therapies. The second benefit consultants provide is the ability for drug companies to manage expenses.
Companies that rely solely on investor funding must carefully manage cash during development. Consultants, unlike permanent full-time employees, are utilized on an as needed basis. Accessing expertise only when it is needed allows companies to manage expenses and conserve financial resources.

 

Consultants can be hired to work on every aspect of drug development. However, there are a few key areas where the use of an experienced consultant can be particularly impactful.

 

1. Vendor selection – Small drug companies frequently outsource most development activities including preclinical studies, manufacturing, and clinical trials. Selection of the wrong vendors for these activities can be costly and may result in long delays in development. If a vendor’s performance is poor, the project may need to be transferred to another vendor resulting in increased costs and project delays. A consultant can help a drug sponsor navigate the vendor selection process to ensure a vendor with the appropriate capabilities is selected. Once a vendor is selected, a drug sponsor may wish to have a consultant manage the interface between the drug sponsor and the vendor.
2. Developing regulatory strategies – The 1997 United States Food and Drug Administration Modernization Act developed regulatory schemes to address unmet medical needs. These include priority reviews, breakthrough therapy designation, accelerated approvals, and fast-track designation. European and Asian regulators also have regulatory schemes to expedite access to new medicines. An experienced consultant can help a drug sponsor take advantage of these regulatory provisions to accelerate the drug development and approval process.
3. Study designs – Allowing consultants to prospectively evaluate study designs and vendor protocols can ensure studies are efficient and compliant with regulatory requirements.
   Working with a toxicology consultant experienced with the sponsor’s therapeutic modality may accelerate preclinical studies. If the active pharmaceutical ingredient is complex, a consultant with knowledge of the manufacturing process can work with the contract manufacturing organization to reduce process development time and minimize risk as manufacturing is scaled up. Similar advantages are gained by utilizing consultants to help with the development of complex drug product formulations and with clinical trial designs.
4. Technical expertise for novel therapeutics – Drug candidates have become increasingly complex. An oligonucleotide-antibody drug conjugate is an example of a technically challenging class of drugs currently in development. The technology required to manufacture an oligonucleotide is very different from the technology needed to manufacture antibodies. Rarely does one person have expertise in both areas. For these types of technically challenging programs, consultants may be used to augment the technical expertise of the internal project team.
5. Due diligence assessments – One way drug sponsors acquire new drug candidates is through acquisitions. The acquisition may consist of a single drug candidate, a proprietary drug platform, or of an entire company and its corresponding intellectual property. In any of these scenarios, a due diligence process takes place to allow the potential buyer to evaluate the assets before sale. A thorough due diligence evaluation is crucial when assessing the potential risks as well as the potential value of the assets under consideration. Consultants with specific knowledge related to the asset can provide an objective assessment to the potential buyer.Several methods exist for identifying and engaging consultants. Large consulting firms may offer an array of consulting services that span multiple pharmaceutical disciplines.
   These companies frequently offer broad packages of consulting services that include support from multiple consultants with different skill sets. This approach offers convenience because the consulting firm will identify the sub-contracting consultants for the drug sponsor. Using a large consulting firm offers the advantage of streamlined project management, billing, and reporting. Before engaging a consulting firm, make sure it is clear who will be working on the project and what the skill sets and experience levels are of the consultants. Make sure the consulting agreement with the firm clearly states how subcontracting is handled and how the firm deals with staffing changes that may arise over the course of the project.

If a drug sponsor needs highly specialized consulting services, the sponsor may wish to identify and engage individual consultants directly. Platforms such as LinkedIn make finding consultants with specialized expertise straightforward. Consultants can also be identified by reviewing the attendee lists of conferences focused on the technical area of interest. If a drug sponsor is working with a completely novel therapeutic modality, there may not be a consultant with the exact skill set desired. In this case, it may be best to seek consultants from related disciplines. For example, when drug sponsors began entering the gene editing field, it was not possible to find consultants with experience in CRISPR/Cas-9 systems because the field was new. Consultants with experience in the field of oligonucleotide chemistry were frequently leveraged since there is an overlap with certain elements of both therapeutic modalities.

 

A formal consulting agreement should be in place between the drug sponsor and the consultant or the consulting firm. The consulting agreement should address topics such as confidentiality and ownership of intellectual property that may be developed during the project. It should also clearly state the expected scope of activities and the expected time commitment on the part of the consultant.

Many drug sponsors set a cap on the number of hours that can be accrued in a given period of time without prior authorization. The agreement should also contain provisions for how travel and other expenses will be handled. Some drug sponsors want consultants to appear to vendors and external partners as an employee of the sponsor company. This usually means the consultant will have a sponsor company email address, a title within the company’s organizational chart, and access to the sponsor company’s IT resources. These arrangements should be discussed in advance, and the corresponding details should be included in the consulting agreement. Different consultants work in different ways.
Some consultants are willing to approve documents such as study protocols and technical development reports on behalf of their clients. Other consultants strictly maintain an advisory role and are not willing to assume the responsibility of approving documents on behalf of the drug sponsor. Before retaining a consultant, make sure the expectations on both sides are clear and mutually agreeable.

 

Project management is crucial when a drug sponsor uses multiple consultants across multiple disciplines. Effective use of consultants can accelerate drug development, but adding multiple consultants to a project team will not ensure project success. Managing a project team with consultants is analogous to baking a cake. It takes more than just placing ingredients into a bowl. The ingredients need to be brought together in the right proportions, at the right time, and under the right conditions by the baker. The drug sponsor will need an internal project manager that, like the baker, can bring together the consultants and internal team members in a way that facilitates successful project execution.

A drug sponsor may hire consultants to obtain their expertise, but the drug sponsor never gets to outsource its responsibility for the safety and quality of its drug. For this reason, it is important to carefully screen consultant qualifications and to ensure that the drug sponsor maintains suitable oversight over all development activities.

 

Drug development is arduous work that is fraught with challenges. These challenges can be especially daunting for small companies with limited resources upon which to draw. The use of consultants at strategic points throughout the development process can minimize project risk, accelerate development timelines, and increase the probability of success.

 

References and notes

1. DiMasi J, Grabowski H, Hansen R, Innovation in the pharmaceutical industry: New estimates of R&D costs, J of Health Economics, 2016;47:20-33.
2. Sun D, Gao W, Hu H, Zhou S. Why 90% of clinical drug development fails and how to improve it? Acta Pharm Sin B. 2022 Jul;12(7):3049-3062.
3. Kennedy K, Gomez K, Thovmasian N, Chang D Small biotechs versus large pharma: Who drives first-in-class innovation in oncology? Drug Discovery Today 2023;28(2):103456.