Consulting Opportunities for Veterinary Anatomic and Clinical Pathologists in Industry Finding Your Way Graham S. Smith, BVMS, MRCVS, MSc, Diplomate ACVP (Clinical Pathology) CanBioPharma Consulting Inc., Rockwood, Ontario, Canada gsmith@canbiopharma.com Consultancy practices related to the safety assessment of bio-pharmaceuticals, chemicals pesticides and/or medical devices have afforded career opportunities for veterinary clinical and anatomic pathologists (hereafter described as veterinary pathologists) over the last 2 decades or more. In recent years, there appears to have been an increase in the number of veterinary pathologists with industry experience that are interested in or have started a consultancy business. This present dissertation does not intend to make predictions regarding future opportunities and manpower requirements for veterinary pathology consultants servicing the industrial sector. In fact, it is not clear where a source of such information exists. The impact of company mergers over the last 15 or so years on pharmaceutical R&D when taken together with the present turbulent economic climate seem to only compound the difficulty in making predictions regarding future needs for veterinary pathology consultants. Rather, based on the 13 or so years of small business consulting experience of the present author, this summary and the presentation to be delivered at the 2011 ACVP workshop titled Small Business for Pathologists. Starting a Business, Growing it, Lessons Learned and Exit Strategies is intended to offer some considerations primarily for veterinary pathologists contemplating or beginning a consulting practice in industry; however, consultants who are already in industrial practice may also find topics of applicability. Consideration of a change in career path to become a consultant may stem from one or several elective reasons, or may be necessary due to an altered situation affecting present employment that is beyond the control of the individual. The alacrity with which plans need to be laid towards embarking on a career as a consultant may differ according to the situation. It is best if circumstances afford the opportunity to properly plan in advance and pave the way in a professional and ethical manner. In brief, this requires networking and researching the business enough to decide if consulting seems right for you; learning where potential opportunities could lie in terms of scientific business; identifying the preferred geographic location to establish your business center; and perhaps tentatively identifying some potential clients and projects that could be awarded at the outset of your consultancy. If the decision to embark on a career as a consultant is precipitated by the imminent ending of a present work position, then the same fundamentals of planning need to be considered as per the elective situation, although the developmental time frame may need to be accelerated. In either scenario, it is important to begin to understand the consulting business and think through whether or not joining the ranks of consultants is right for you. There are many aspects that need to be pragmatically assessed bearing in mind your current and projected life circumstances. These include assessment of short- and medium-term personal monthly financial needs as well as potential personality fit as a consultant taking into account circumstances such as the business peaks and troughs. Candid introspection, discussions with family and 1
confidants, possibly seeking professional career counseling, and weighing the pros and cons in confidential discussions with other consultants in the relevant field(s) are each important prior to deciding to embark on your consulting career. Really knowing yourself, what you have to offer and researching and understanding the needs of your perceived potential future client base are fundamental initial building blocks. Whether the way forward will be to start your own business or to explore potential opportunities to join colleagues/companies already consulting should be considered. Accepting a position in an existing consulting firm offers the potential advantages of an existing business and legal framework with already established clientele and the possibility that projects will be available for you to work on at the outset while finding your way. This also provides the opportunity for you to glean from the experience accrued by other consultants in the firm. If taking a position in an established consulting firm, you need to consider what your future role (e.g. future partner/principal/shareholder opportunity) and potential professional growth in the organization can become, and also be aware of contractual obligations should you leave such employment (e.g. designated period of non-competition). Starting your own new consulting business as a single proprietor can be invigorating. However, you should be aware that you will need to fulfill most if not all of the roles/tasks required in starting and operating a small business. These include: defining and establishing the legal structure and requirements and accounting practices; and establishing/managing insurance needs, office and equipment requirements, administrative needs and record keeping, marketing tools (logo, business cards, web site, other promotional material), and an invoicing system; as well as generating proposals/contracts. Standard Operating Procedures (SOPs) and related operating parameters will need to be established if you plan to operate in compliance with GLP guidelines. You will need to ensure that all of these aspects and more are taken care of in addition to performing the project services that bring income. You may decide to look after most administrative aspects of the business by yourself at the outset. Alternatively you may want to hire part-time or even full-time help. Trying to manage all tasks yourself may seem like cost-saving, but, in effect, the time that you spend on tasks other than marketing and performing your professional services may be more likely detrimental to your financial bottom line in the long run. You should understand where your first business consulting opportunities and where potential growth may be, and have a vision of what your business can become. For example, is your ambition to grow the business with partners/shareholders and employees with a view to building a sizeable corporation and perhaps owning or leasing a laboratory that might be attractive to potential future buyers; or, is your primary aim to build your new enterprise to support the lifestyle that you want and to continue this enterprise as long as you choose to enjoy (e.g. home based business)? Also, should a personal goal be to travel more, you will want to plan your services to be portable. In any event, it is important to formulate a written business plan that should be subject to periodic review and ratification, molding and/or change as your business and life evolve. Objectively defining your business strengths, weaknesses, opportunities, and threats (SWOT) can not 2
only be a valuable guide for you, but also a tool that can be shared should you be seeking financing or business partners. Sharing your business plan with other consultant allies or even potential clients under certain circumstances can be advantageous. Short- to medium-term financial planning is required as part of your business plan. For example, you need to know where the funds will come from to support the early stages of your business will this be from your personal savings, or in the form of a business loan? Early in your business planning, you will need an extended management team to advise you in specialized areas where you lack knowledge, ability or interest. Your key nonscientific business advisors are your accountant and lawyer and, depending on your situation, your banker. The business structure and legal aspects of setting up your enterprise will necessarily reflect your business plan model and vision. There are basically three forms of legal structure: proprietorship; partnership; and limited company. You should seek competent legal and accounting advice before deciding on your business structure, as there could be distinct advantages or disadvantages to each depending on your situation. Many consultants begin as a sole proprietor which is the simplest way to start a business. Incorporating a company and conducting the consulting practice through the company should add some protection in a lawsuit if the company lacks any assets. However, conducting a business through a corporation is not an automatic guarantee of personal protection. Marketing involves a spectrum of activities ultimately directed at convincing prospective clients that their needs can be met and their problems can be solved by your specific services. While all modern tools should be considered, personal networking, consistent high quality of service, and word of mouth referrals likely are the most valuable means. You should have a clear idea of the nature of the services offered to potential clients. You may have decided on just one particular focus of interest and specialty, or you may have several areas that you will promote either to the same client or to different categories of clients. Services provided by anatomic or clinical veterinary pathologists may include one or several of the following: performing necropsy, histopathology, and/or ultrastructural evaluations and interpretations; pathology peer review; clinical pathology results interpretation; microscopic examinations of bone marrow smears and sections; tox-path issue resolution; and nonclinical study report writing. Also, those veterinary pathologists with experience in development and safety evaluation of biologics, drugs, chemicals, pesticides and/or medical devices may offer services to clients in program and protocol design and implementation through helping place and monitor study conduct on behalf of clients. Experienced experimental pathologists can provide key input regarding animal models in drug discovery. Services might extend into technical/laboratory support areas such as tissue processing/histology and immunocytochemistry. While services considered traditional may be the mainstay for the majority of current veterinary toxicology/pathology consultancies, exploring where potential opportunities lie should be expansive including outside of the box possibilities not restricted by traditional or 3
geographic limitations. Clientele type may be diverse or quite focused depending on the nature and range of consulting services offered; e.g. small, medium or large biopharmaceutical companies; contract research organizations (CROs); drug, chemical or pesticide regulatory agencies; and other consultants. Opportunities for contributions from veterinary toxicologic pathologist consultants can extend into areas such as regulatory affairs (compilation of dossiers for submission, expert independent review of submissions), contributing to teaching courses at colleges/universities (e.g. regulatory affairs diploma courses); working for virtual companies and venture capitalists (e.g. due diligence assessments of in-licensing therapeutic candidates or technologies); or performing duties for a company that has need for work continuity while their staff is depleted for a variety of possible reasons. Alliances with other established service providers (e.g. consultants, CROs) can bring work, which can help kick-start your business. Approaching other service providers to let them know how your expertise can complement their armament can attract shared or subcontracted project opportunities. Also, networking and instituting consulting agreements with colleagues who have expertise in relevant areas and identifying such colleagues as associates to your company can be a bonus in gaining and completing projects. There are several potential operating business models. The one followed by the present author was based on the concept of operating an independent company with minimal administrative needs or overhead costs (home office) and performing work that could be enjoyed for as long as health and enthusiasm afforded. As the workload progressively increased during the 2000 s, other experienced colleagues (veterinary pathologists and toxicologists) joined the company as consultants. Each of us, as consultants, retains his/her own private company used to bill the one central operating company (the only company that clients interact with) for services rendered. This way, each of us is at liberty to organize our own company affairs as we wish (e.g. income splitting with family members, tax write-offs based on portion of home office costs, etc.). There are numerous extended benefits in operating your own company. Determining your exit strategy needs to be highly personalized, will depend on the operational structure of your business and the involvement of other colleagues, and can be phased or absolute, but should be well planned ahead of time. In a snapshot, the following are some lessons learned by the present consultant relevant to small business consulting: - know what it is that you have to offer professionally and focus your services accordingly; - avoid getting into areas outside of your expertise; instead, be generous in referring such opportunities to others; - that being said, be forward thinking about new or related scientific business areas/technologies that your company can grow into; - never lose sight of who your client is; - clients are colleagues and your interactions should reflect this; 4
- each and every scientific and administrative project you decide to take on deserves the same meticulous attention; - build a network of trusted professional colleagues that you enjoy working together with; - colleagues joining the practice need to share the same company ethic as you do and need to feel part of the business; - how well you select and effectively use your accountant s skills to your advantage will have a direct bearing on your business financial success; having the same accountant look after business and personal affairs is advantageous; - avoid risk due to business exposure to foreign exchange rate changes; - practice good time management; be realistic and give priority to the most important projects rather than those that you enjoy more; - recognize the need for an alternative strategy(ies) before business demands become overwhelming. Predicting future directions and opportunities for veterinary pathology consultants is not simple, particularly in the present economic climate. However, the sage consultant still does his/her best to expand their knowledge and expertise, look ahead, anticipate trends and possible opportunities, and seeks to be nimble. The moment you stand still you are falling behind. References 1. Mattina JL. The impact of mergers on pharmaceutical R&D. Nature Reviews Drug Discovery. 10:559-560;2011. 2. Gray D. Consulting Business. Self-Counsel Press. Bellingham, WA. Ninth Edition, 2010. 3. Mohr A. Financial Management. Get a Grip on Your Business Numbers. Self- Counsel Press. Bellingham, WA. Second Edition, 2008. 5