Adding External Resources to Global Teams

This article provides a perspective on the inclusion of regulatory consultants and contractors in global pharmaceutical product development and commercialization teams. For purposes of this article, external consultants are defined as individuals or firms with specialized knowledge or expertise in a particular field or region. Contractors are those that provide resources and/or regional knowledge. Consultants are able to fill knowledge and experience gaps in project teams at critical points in product development, and contractors can provide much-needed resources during busy periods, together with local knowledge of regulatory requirements.

Including external consultants or contractors on project teams can have significant benefits, but there are pitfalls and issues that need to be managed to make this collaboration a successful one.

The Why

"All are needed by each one.

Nothing is fair or good alone."

-Ralph Waldo Emerson

Whether a company wants to partner its technology platform, develop a product in-house, sell its intellectual property or add new indications to an already-registered product, consultants can provide valuable and timely advice. For example, when seeking to partner technology, a consultant who has the right type of expertise could help develop a well-thought out regulatory plan and an appraisal of the benefits and risks of a product. This will add value to partnering discussions and add professionalism to the company's information package. When adding new indications, or developing a new product in-house, they also could help develop a good regulatory plan that will articulate the development strategy and keep the team focused on end goals.

Additional resources or skills often are required during periods of intense activity on projects and at key points in the development program. External resources play an important part in meeting these requirements, without adding ongoing overhead costs to the business.

Perhaps the most valuable skill an external team member can bring to bear is Socratic questioning.¹ Using this method, the questioner plays devil's advocate and initiates a rigorous questioning process on the topic of discussion. This process forces the team to think through the project and exposes gaps or conflicts in understanding. Questions such as "Why?" and "What would the next step be?" test assumptions and open up the discussion. Socratic questioning is a powerful tool that can be used to assist in clarifying goals and options and to bring an "outsider's" perspective to a project, free from Groupthink.²

International consultants can be particularly valuable assets to project teams. For example, while many companies focus their product development and submission dossiers initially on the US or EU markets, early planning can enable them to include the specific requirements for markets in the rest of the world (ROW). The effective use of external international consultants and contractors with local knowledge helps expedite global registration applications through better planning and, hence, manage costs. Contractors in the ROW can provide their local perspective on development plans and raise issues early, when there is time and ability to tweak chemistry, manufacturing and controls (CMC) and nonclinical studies, rather than repeating them later. They also can provide insights into upcoming changes in regulations that may impact the development plan and provide the team with local competitive intelligence.

The complexities associated with interpreting local requirements and navigating local processes are augmented when major changes are implemented by regulatory authorities. A recent example is the establishment of the new joint regulatory agency (ANZTPA) that is projected to replace the Therapeutic Goods Administration (TGA) in Australia and Medsafe in New Zealand in 2016. In this case, the agencies' requirements are being progressively aligned and, eventually, there will be a harmonized set of regulations, with new forms and guidance documents, along with agency internal processes and timeframes. The devil will be in the detail, and small changes, for example, new terminology listings for drug substance names or minor changes to packaging requirements, will affect new registration applications.

Each region's different regulatory and administrative requirements directly impact regulatory strategy. For example, orphan drug designations are slightly different across regions. New Zealand currently does not have an orphan drug program, while Australia is able to "salami slice" indications so subgroups of patients can be used to gain orphan drug indication status. However, this typically is not the case in Europe and these factors may impact the ROW strategy.

Most countries require a local legal entity or sponsor for clinical trials and product registration applications. This role often is filled by external parties prior to the appointment of product distributors or the set up of a local sales office.

Some countries have specific presubmission requirements. In Australia, TGA has implemented a presubmission process that effectively requires a good draft (preferably a final draft) of Module 2 at least 2.25 months before dossier submission. Applications for overseas current Good Manufacturing Processes (CGMP) clearances must be made through a separate section of TGA before dossier presubmission, and all excipients, actives and proprietary ingredients must have Australian Approved Names (AANs). Nuances such as these have to be included in the regulatory planning process or considerable delays to product registration may result.

While the International Conference on Harmonisation (ICH) Common Technical Document (CTD) structure has meant a good deal of harmonization, the content and interpretation still differ across regions and Module 1, which is region-specific, can be opaque to the uninitiated.

The How

"Teamwork is the fuel that allows common people to attain uncommon results."

-Author Unknown

A project team is like a family. There are distinct personalities, mostly moving in the same direction but sometimes going off on tangents. There are extroverts, introverts, specialists and generalists. And, somehow, they all have to get along.

Several factors need to be investigated before choosing a local consultant. A good CV is one thing, but strong recommendations from other clients are much better to confirm the consultant's technical knowledge, work ethic and personal style. A company should check references very carefully and question whether the consultant's personality will work within its team. Ultimately, this is about relationship building and having a high level of trust.

A person looking for a plumber would ask friends and colleagues for recommendations, rather than do a Google search. This is also the best way to find good external consultants and contractors. If they are good, their reputation will precede them, and it will be easy to find out about their work and communication style. A company should not be fooled by the consulting company's reputation either. Not everyone working for a well-known and respected company will be top notch or have the right temperament or working style to fit in with the company's team. When asked, the author always refers individuals, not just the contracting company, because the personality is as important as the CV.

Alexandra Levit, in her article, "8 Signs You are About to Hire the Wrong Person,"³ talks about the "Airport Test." To paraphrase: If the team could not stand to be trapped in an airport lounge with someone for a whole day, that person should not be hired. The same is true of an external team member. Just because the person is available and has a resume that seems to fit the task, he or she may not be right for that role, in that team, at that time.

Team culture and communication are vital to a successful project and can be challenging when members are scattered across the globe. If a contractor or consultant is viewed as a transient force rather than an integral part of the team, it is unlikely that the company will realize his full value, or worse, he may prove to be a negative influence on team culture.

Working from Australia, the author has several clients whom she has never met face-to-face. However, the drawbacks of distance must be overcome and team integration must be achieved quickly in order to move forward efficiently.

By far the best way is to have at least one face-to-face meeting, ideally near the start of the project. This leads to a much better understanding of personalities (including sense of humor, or lack thereof). There is a better chance of understanding that a very short and to-the-point email is not necessarily rude, but may just be the result of a very busy day, and it probably will not be held against the sender.

Video conferencing still is not a popular communication tool. Although it is common for personal use, in business, video conferencing has lagged behind, partly due to cost and security concerns. However, when it is used, the picture can be jerky and lagging can be an issue. Movements may look unnatural and there can be speech distortions. It comes in a poor second to a face-to-face meeting.

Teleconferencing is a very poor third in the race. Body language is not visible and audio quality can be muddy when there are more than three people on the call. Without visual cues, it can be more difficult to communicate with people who are not as fluent in the chosen language and it is not unusual to have truly global teams that include participants from Asia, Europe, Africa and the Americas.

Working across multiple time zones also can be very challenging, so simplify communication channels as much as possible and include only those regions that really need to be on the call, based on the particular topics for discussion that day.

It is important to remember that external consultants and contractors, while they may be viewed as part of the project team, are not part of the company. Therefore, they will not understand the subtleties of internal politics, hierarchy or behind-the-scenes friendships. A single point of contact should be designated for the external team members so they are not receiving emails from the entire team. They also may be in remote locations and not privy to "corridor conversations". The team should make sure they are kept in the loop about potential changes to strategy or targets.

The When

"To achieve great things, two things are needed; a plan, and not quite enough time."

-Leonard Bernstein

Time is a constant pressure. Time is money. Therefore, timely advice can save or make money, and that is the bottom line.

If a company does not have all of the experience, specialist knowledge, talent or information it needs to execute its project, it needs to go out and find it.

In his book Seven Habits of Highly Effective People,⁴ Stephen Covey suggests that beginning with the end in mind is vital for an effective plan. Working backward from desired milestones allows for rational planning of resources, helps identify when resource crunches will occur and how soon decisions need to be made.

The earlier the company has the right input into strategy and planning, the quicker it will succeed or fail.⁵ External team members can play a vital role in bringing needed skills, different perspectives and a questioning approach. Whether the company succeeds or fails early, the bank balance will be healthier and shareholders will be happier for it.

References

1. Paul R, Elder L. The Art of Socratic Questioning. Dillon Beach, CA: Foundation for Critical Thinking; 2006.
2. Janis IL. Victims of Groupthink. New York, NY: Houghton Mifflin; 1972.
3. Levit A. 8 Signs You're About to Hire The Wrong Person. Open Forum website. https://www.openforum.com/articles/8-signs-youre-about-to-hire-the-wrong-person/. Posted 30 October 2013. Accessed 3 January 2014.
4. Covey S. Seven Habits of Highly Effective People. New York, NY: Free Press; 1989.
5. Basulto D., The new #Fail: Fail fast, fail early and fail often.WashingtonPost.30 May 2012. http://www.washingtonpost.com/blogs/innovations/post/the-new-fail-fail-fast-fail-early-and-fail-often/2012/05/30/gJQAKA891U_blog.html. Accessed 3 January 2014.

About the Author

Rosalie Cull, PhD, a Graduate of the Australian Institute of Company Directors (GAICD), has 30 years of experience in pharmaceutical development, 17 of those in regulatory. She has extensive experience working with global teams and is the managing director of TudorRose Consulting Pty Ltd., a Melbourne, Australia-based regulatory consulting company. She can be reached at [email protected].

Cite as: Cull R. "Adding External Resources to Global Teams." Regulatory Focus. March 2014. Regulatory Affairs Professionals Society.