Effective performance development plans for regulatory affairs professionals

Transcription

1 Focus Reguatory management & eadership 5 Effective performance deveopment pans for reguatory affairs professionas Author Jonathan Trethowan, Managing Director, TRAC Services, Redruth, Cornwa, UK. Keywords Training; Memetic earning; Learning styes; Skis; Career deveopment. Abstract This artice describes how the creation of effective performance and deveopment pans for reguatory affairs professionas can reap rea rewards for the industry and the businesses within it. In many ways, being thrown in at the deep end of a reguatory project remains one of the most effective ways for anyone to gain experience and deveop rea skis. An individua can earn a the theory there is, but rea deveopment comes from practica experience. Training courses are usefu, as is subject reading to buid understanding, but there reay is no substitute for sitting down and trying out a process yoursef and doing it repeatedy to buid experience and knowedge. However, when it comes to effective peope management and deveopment in reguatory affairs, the key is to offer the appropriate support and guidance designed buit around the individua within the business and their specific training needs and, increasingy importanty, their own earning stye. A muti-discipinary approach to effective deveopment and training pans for reguatory professionas can reap rea and positive rewards for the individua, team and business aike. Seing reguatory affairs attracting the brightest taent to the industry The TOPRA Professiona Deveopment Committee was created in January 2010 to raise the profie of the reguatory affairs profession and to become much more proactive to ensure that, as a discipine within the pharmaceutica industry, we can attract the brightest new taent coming into and deveoping a reguatory career. Good peope need the opportunity to keep doing what they enjoy from their ife sciences degrees without thinking that working in the pharmaceutica industry aways invoves wearing a white coat and working in a aboratory. We aso need to be aware that undergraduates and graduates are far more career-minded today. They are now thinking about and ooking at what they need to do and the experience they require to effectivey work their way up a chosen career adder. From an industry perspective, it is vita to highight that reguatory affairs pays a crucia roe within a pharmaceutica company, aowing reguatory affairs professionas to use and deveop skis and experience, buid in-depth knowedge and understand how to overcome reguatory hurdes and deveop strategy whie remaining at the heart of the industry. In few other areas of the pharmaceutica industry wi a professiona have the opportunity to pay such a pivota roe within muti-discipinary teams. The team assembed to work throughout deveopment coud be competey different from the team working towards a product aunch to market, and potentiay different again from the team invoved with post-approva activities. Key skis that wi be needed incude: Adaptabiity Fexibiity Peope skis Strategic thinking Dipomacy. There wi aways be changes to reguations, so there wi aways be a need for reguatory professionas to interpret how these wi impact their organisation. The industry cannot stop deveoping and evoving, which provides both chaenge and opportunity for individua deveopment. An exampe of change in the ast few years is the move from paperbased to eectronic reguatory submission processes under ectd. Advances ike these wi have a continua knock-on effect in the way that peope are deveoped within the industry and in the corresponding management processes and eadership quaities required. The importance of training When it comes to training, it is important to acknowedge that effective training has a dua benefit in terms of an individua s enhanced knowedge and career deveopment and the commercia success of the organisation they are working for. Effective eadership is needed to address the recruitment, deveopment and ongoing professiona deveopment of the right peope which wi enabe the business to fourish. The key benefits of training incude: Increased job satisfaction and morae among empoyees Increased empoyee motivation Increased efficiencies in processes Increased capacity to adopt new technoogies and methods Increased innovation in strategies and products Reduced empoyee turnover Enhanced company image Risk management. Managed and deivered we, continuous professiona deveopment can bring rea and measurabe benefits to any organisation. In a report carried out by the University of Leicester on behaf of the Institute of the Motor Industry (IMI) 1 pubished in Juy 2011, the IMI teamed up with eading organisations in the automotive industry to commission an independent piece of research assessing the impact of their skis accreditation programme, known as Automotive Technician Accreditation (ATA). The study reveaed a return on training investment ranging from 98% to 187% with benefits across the board, incuding raised technica standards, professiona status, productivity, profitabiity, and customer confidence. Reguatory Rapporteur Vo 8, No 11, November 2011

2 6 Focus Reguatory management & eadership Figure 1: Exampe of a memetic earning stye graph Legend Your Stye Logica Soitary Verba Visua Aura Socia Physica Stye Scores Visua 12 Socia 8 Physica 5 Aura 9 Verba 10 Soitary 13 Logica 9 Effective performance deveopment pans With many empoyers in reguatory affairs ooking for candidates with at east two years experience, the opportunities for new bood and fresh taent to start a reguatory affairs career is potentiay being hindered, to the ong-term detriment of the profession. The creation of in-house training and deveopment programmes is undoubtedy a key way to overcome this issue, with the added benefit of enabing a reguatory affairs department to shape and deveop professionas who wi bring rea vaue and ongoing benefits to the business. Whie the phrases in-house training and deveopment may iicit a sharp intake of breath, the opportunity to create a training and deveopment bueprint which can evove with new recruits and as the business deveops can deiver rea and measurabe rewards and utimatey reduce the reiance on externa training and associated costs. However, externa training and events shoud sti be considered and integrated as part of the deveopment pan; they often provide good networking opportunities to hep deveop soft skis or other such persona skis. The goa with an in-house training programme is to enabe new starters to get up to speed as quicky as possibe, buid knowedge and experience within a structured and monitored environment, whie at the same time being abe to expose the individuas to as wide a range of activities and practica experiences as possibe. By taking a structured approach to training and persona deveopment, reguary ooking at the ongoing deveopment needs of the individua wi enabe a business to take someone with no experience and set them on a journey equipping them with the skis and growing experience across a range of discipines, creating werounded, quaified reguatory professionas. This can be achieved by giving peope as much access to experience as possibe, within a support structure that is robust and repeatabe, so that as a team grows, new starters are abe to benefit from the process, creating a consistent fow of professionas into the business who fuy understand both the business and the industry. A training and deveopment pan needs to be a constanty evoving process, with a major focus paced on the first two years, providing the patform to increase an individua s knowedge and experience dramaticay. This first two years is about giving peope the foundations a thorough grounding in reguatory affairs, by exposing them to as many aspects of the reguatory affairs function as possibe. Understanding the individua and taioring the approach When it comes to managing peope within reguatory affairs it is important to understand the strengths and weaknesses of the particuar individua, and what it is they want to achieve. Furthermore, understanding the deveopment requirements of each individua and creating a pathway shoud hep them reach their objectives. This can be achieved through reguar appraisas and the creation of individua professiona deveopment pans. Strong eadership and management is about identifying what individuas want to achieve and how an organisation can get them to that preferred outcome by offering them the training and on-the-job experience to hep them fufi their ambitions. It is aso essentia to recognise that everyone s earning stye is different, and to match training and professiona deveopment to each person s own individua ways of earning. Learning processes such as memetic earning 2 are usefu toos to hep understand the individua earning styes of each member of the team and therefore adapt their training needs to match their own memetic profie (see Figure 1). Not foowing this theory or an equivaent route and instead taking a one size fits a approach to training wi resut in a situation where the training wi fai the individua, not the individua faiing the training. If individuas are to deveop they must be given the toos they need, deivered in the most effective way for them. Under memetic earning, the content and quaity of the training is the same but it is the way in which it is deivered that varies according to the individua. So what is memetic earning? Different peope earn differenty in reation to the earning technique empoyed. Some peope wi earn better if physica and practica demonstrations are invoved, whie others wi earn better when a ot of descriptive words are used. Learning styes are cassified in different ways to obtain different resuts, with seven different earning styes identified. In summary, these styes are: Visua preference for pictures, images and spatia understanding Aura preference for using sounds and music Verba preference for using words, both in speech and writing Physica preference for using body, hands and sense of touch Logica preference for using ogic, reasoning and systems Socia preference for earning in groups or with other peope Soitary preference for working aone and using sef-study. To determine an individua s profie, a simpe questionnaire is used and a score against each of the earning styes can be produced. It has been estabished through research 3 that it is possibe for a person to improve the substance gained and the earning speed if the person understands his or her preferred technique of earning; this is referred to as earning stye, and works on improving these abiities through adopting the best approach for an individua which can aso address any weaknesses that the memetic test identifies, to hep improve their persona performance. Reguatory Rapporteur Vo 8, No 11, November

3 Focus Reguatory management & eadership 7 Deveoping peope and keeping the progression process moving Throughout anyone s career in reguatory affairs, years 1 5 wi generay be different from years In years 1 5 it is about creating the documentation and writing submissions, whie beyond the fiveyear point the reguatory professiona is ikey to be immersed in project management and possiby aso peope management. The goa for the manager deveoping professionas at the eary stages of their careers wi be to identify those individuas who have the abiity to work on wider issues such as reguatory strategy, ie, defining what strategy wi be required to ensure a desired outcome for the stakehoder and the business. From a career progression perspective, if someone shows an interest in project eadership then he or she wi need to be encouraged to increase their understanding of which projects have worked and why, and the manager shoud then identify their training requirements and the toos they wi need to grow into that roe. The responsibiity of managers is to give peope the opportunity for deveopment that wi aso have a business benefit for the company by enabing them to extend their experience and knowedge. Managing the changing face of reguatory affairs Whie the approach of training graduates with itte or no experience has shown rea benefits for some reguatory affairs organisations, there are aso opportunities to be gained from wider industry changes, with goba companies such as Pfizer and AstraZeneca pubicy announcing major reorganisations. With smaer companies now paying a significant roe in the deivery of reguatory affairs services, these announcements are ikey to see increased numbers of aboratory-based professionas ooking for opportunities within the fied. Athough there wi be an amount of retraining required to adapt ski sets, wider knowedge, understanding and experience can create rea benefit for the reguatory affairs function, with opportunities to potentiay fast-track individuas through a two-year training cyce. The importance of succession panning Succession panning is aso critica to avoid situations where one individua within a team becomes the soe expert on a specific area of reguatory affairs. Instead, their knowedge and expertise shoud be tapped into and shared around the team so that, shoud they move jobs, an organisation is not facing a situation where their expertise and knowedge is ost to the company. Shared training and earning among a team is therefore vita effectivey making the experienced individua the trainer of other members of the team. Continuous professiona deveopment Once a reguatory professiona is trained, the deveopment process reay starts again. Matching an individua s strengths and skis to the roes and opportunities within the business, which wi hep them grow whie at the same time maximise their performance for the benefit of the business, is critica. It is not ony important to seek to offer the training and support for an individua s preferred career pan (in ine with the business), it is aso necessary to demonstrate strong eadership where their skis and ambitions ie. Some peope wi not want to ook for continua career progression they wi reach a point where they are happy with the roe they are paying in the organisation. Others may express an interest in a specific roe or career path for which their skis and abiities (even with training) are inappropriate. Again, strong management is required. But there are aso other considerations that can hep as part of an individua s deveopment opportunities and experiencebuiding. This can be achieved through offering a more proactive roe within an organisation s corporate and socia responsibiity programme, providing peope with deveopment opportunities through a number of initiatives, and the associated management and organisation of these wi come within the remit of individuas within the team. This is about giving peope wider opportunities that are not just focused on their day-to-day job. From a benefit to the business perspective, offering peope the opportunity to buy into the company and its ethos by taking a eading roe in wider activities can provide rea benefits. Be reaistic Effective performance deveopment is about enabing individuas within a business to fufi their professiona needs whie at the same time benefiting the business. However, there wi undoubtedy be occasions where a business simpy cannot provide the deveopment opportunities that peope wi want. In this instance, trying to keep hod of them coud be damaging to the rest of the team or the company in the ong term. At some point, the best thing for the individua and the company is to et them go as ong as you have done everything you can to deveop them. Key tips for peope deveopment Ensure you isten and understand the needs of the individua Make sure you are deveoping not what you want but what the individua wants, and identify how that wi most effectivey work within your business Review reguary yes, have your forma review poicy, but aso put in much more frequent informa reviews, which enabes you to identify and address any issues before they buid up into probems. No matter how often a manager wi say to peope they are free to come and tak at any point, there wi aways be some peope who wi never take up this opportunity. The beauty of the reguar informa catch-up is that within that environment individuas may fee more abe to raise any issues. Be positive In deveoping peope it aso pays dividends to highight when peope have done something reay we, as praise is an extremey good motivator and deveoper. By creating a positive environment in which everyone fees that they are being istened to, are making a positive contribution to the business on a eves and are paying a eading roe in the deveopment of team incentive and vaue initiatives, businesses wi be best paced to deveop taented and motivated reguatory affairs professionas. Utimatey, effective management and eadership within reguatory affairs is about managing and motivating peope, and offering a progression path that enabes them to deveop to their fu and preferred potentia. If you can keep members of your team motivated, happy and give them a sense of continued deveopment and experience-buiding, both inked to their day-to-day roe and on wider issues within the business, then you wi reap the rewards not ony from a morae perspective but commerciay, as a resut of having a stabe and motivated team. References Memetics-Learning-Styes-Inventory.pdf 3 S Cassidy. Learning styes: An overview of theories, modes and measures, Educationa Psychoogy, 24 (4), pp , Reguatory Rapporteur Vo 8, No 11, November 2011

4 8 Career deveopment Workshops Training designed with you in mind ToPRA The organisation for Professionas in Reguatory Affairs Reference: CRED-CD1 CRED Cinica Deveopment: Eary to Late Stage Cinica Deveopment Two-day Course Date: 1 2 December 2011 Aim This 2-day workshop wi provide an overview with practica advice from reguators and industry on the process of designing and conducting cinica trias from phase I through phases II, III and even cinica trias considerations beyond drug marketing approva. Case studies are used to support earnings from the forma presentations and to draw upon experiences of those attending. The aim of this practica workshop is to enabe a those invoved in medicines deveopment to gain an appreciation of the points to consider when designing a cinica deveopment programme to support a marketing appication and aso that cinica deveopment extends beyond the marketing appication. speakers Who shoud attend The ess experienced reguatory professiona who requires comprehensive information on this subject The experienced professiona who is a newcomer to this subject Anyone who wishes to update their knowedge on this subject persons from reguatory, medica, cinica and safety functions invoved in phase I, II, III and IV trias. For more information pease contact ToprA via emai: meetings@topra.org or te: +44 (0) or go to Venue: Marriott paris, st Denis, paris, France Frits Lekkerkerker, Chairman, Steering Committee for Orphan Medicines, The Netherands Base Houdai, Liy Steve Pinder, Envestia Limited Pus other invited speakers A data correct at time of print. Book NoW For more information or to obtain a booking form, pease contact ToprA via emai: meetings@topra.org or te: +44 (0) or go to the website: CRED CD 12* hours Lifeong earning (LLL) *For more information pease visit org/ifeongearning emai: meetings@topra.org te: +44 (0) fax: +44 (0) web: Reguatory Rapporteur Vo 8, No 11, November

5 Focus Reguatory management & eadership 9 Leadership exceence through coaching: A case study in reguatory affairs using neuroinguistic programming Author Lisa Wake, Director, Awaken Consuting & Training Services Ltd, Yorkshire, UK. Keywords Coaching; Neuroinguistic programming (NLP); Leadership; Deveopment; Goa setting; Motivation. Abstract Coaching is increasingy being used by organisations to provide support for managers for a number of different reasons. Research into coaching suggests that companies who invest in this area benefit from improved revenue, empoyment and net income growth. The framework for coaching described in this case study utiises a combination of neuroinguistic programming (NLP), the GROW mode (see Tabe 1) and soution-focused coaching. The coaching framework is described in five stages: identifying the outcome and benchmarking current performance against key resuts areas within a promotion opportunity; gaining aternative perspectives to infuence; eiciting and utiising an exceence strategy ; devising a project pan and utiising aternative perspectives to infuence; and reviewing and integration of goa achievement. Information is given on the outcomes achieved, refections by the individuas who have been coached (the coachees ) and observations by the coach. Background to coaching Organisations utiise coaching to support high potentia; manage careers; dea with difficut situations; manage interpersona conficts; deveop eadership skis; manage and enhance performance; find soutions; improve confidence and provide support for persona issues. Coaching has many definitions, incuding: A coaborative soution-focused resutsoriented and systematic process in which the coach faciitates the enhancement of work performance, ife experience, sefdirected earning and persona growth of the coachee. 1 The Internationa Coach Federation defines coaching as partnering with cients in a thought-provoking and creative process that inspires them to maximise their persona and professiona potentia. 2 Kotter and Heskett 3 of the Harvard Business Schoo identified that companies who focus on performance enhancement experience improved revenue growth, empoyment growth and net income growth compared with companies that do not. Another study referenced by the Association for Coaching, the Manchester Study, recognises a 5.7 times return on investment in coaching. 4 The framework for coaching described in this case study utiises a combination of NLP, 5 the GROW mode 6 and soution-focused coaching. 7 NLP is an appied psychoogy that uses outcome-focused questions to faciitate coachees to utiise their own resources to achieve resuts. NLP consists of a series of toos and techniques specificay designed to faciitate performance exceence. One of the modes within NLP is the goa-setting process (see Tabe 2). The GROW mode detaied in Tabe 1 is good for non-directive coaching, ie, to hep coachees find the answer themseves. This mode demonstrates that we can a coach by deveoping questioning and istening skis and that subject knowedge is not essentia. In fact, coaches who are different from the coachee can hep expore a different perspective. With this mode, goa-setting can be fuid and iterative. Soution-focused coaching (see Tabe 3) uses questioning techniques that direct the coachee s attention towards soutions. The coach works with the cient to expore desired goas, exceptions which have ed to success in the past, or when the probem did not occur, and existing resources that can be brought into pay, and soutions and changes that wi occur once the goa is reached. Case study The case study detaied here provides information on the background to the cient, the coaching process, the outcomes achieved and refections by the coachee and the coach. The cient. The cient requested coaching via her ine manager. She was very focused about her coaching requirements and had a cear idea of her own deveopment areas and career pathway. She was extensivey quaified in her area of expertise and was empoyed in an appropriate roe for her ski base. She had identified a number of outcomes that she was working towards and had brought to her first session an extensive consideration of her professiona knowedge and skis, objectives, persona traits in reation to the core vaues of the business and eadership behaviours, a of which were assessed as part of the annua appraisa process by her company. The coaching process. This began with an exporation of the coachee s current awareness of her roe and behaviours. Her evidence for her desire to change her current behaviour was discussed, as was her evidence for knowing when this had occurred. The second coaching session focused on her desire to gain promotion, and her current persona appraisa report was used as a benchmarking too. Her current capabiities were mapped against the job requirements for a senior roe and a number of deveopment areas were identified: Deveoping strategies, coordinating and preparing submissions of marketing authorisation appications in EU/EEA markets and mutua recognition and decentraised procedure (MRP/DCP) appications Compiing and providing reguatory dossiers to stakehoders Coordinating responses to reguatory questions reating to products Departmenta eve prioritisation and coordination of key tasks Mentoring of project team members. The coachee was supported with some behavioura skis and techniques to address her Reguatory Rapporteur Vo 8, No 11, November 2011

6 10 Focus Reguatory management & eadership Tabe 1: The GROW mode G Goa (this shoud be as specific as possibe) R Reaity of the situation (what has happened in the past?) O Options (what are the options avaiabe?) W What/Wi? (what is your commitment out of 10; what wi hep make it happen?) Tabe 2: The goa-setting process P Positive (what do you want to achieve? Stated in the present tense, what wi this goa get for you?) A Achievement (what wi you see, hear and fee when you have achieved it? How wi someone ese know you have achieved it?) C Context (where, when and with whom do you want it? Where, when and with whom don t you want it?) E Ecoogy (what wi you gain if you achieve this? What wi you ose if you achieve this? What might be the wider positive and negative consequences of achieving this? How does this goa impact on other goas?) R Resources (what resources do you have that you coud use? Who ese do you know who has achieved this?) Tabe 3: The soution-focused approach Probem-free tak What are you interested in? What do you enjoy? What are you good at? How woud your best friends describe you? Best hopes What are your best hopes for this session? How wi you know that the coaching was usefu today? Preferred future Imagine that after you have gone to bed tonight a mirace happens and the probem that you brought here today is resoved. What do you see yoursef doing differenty, what wi others see you doing differenty to et you know the mirace has happened? Exceptions When are the times that this probem doesn t happen? Scaing Use a scae of Where are you now with regard to this goa? What woud increase the rating on the scae? Locating resources When you have faced this sort of probem in the past, how did you resove it? What other tough situations have you handed? What did you earn about yoursef from how you handed it? behavioura goas. She quicky integrated her earning and was rapidy abe to appy her skis with immediate positive resuts. One of the toos used was perceptua positions, 8 which enabed her to gain aternative perspectives on her behaviour. She was abe to view hersef from first position, ie, how she experienced an interaction with a chaenging coeague; second position, where she was abe to view hersef from the chaenging coeague s perspective; and finay, third position, where she was abe to earn from the other two perspectives and use this information to adapt her behaviour. An understanding of her exceence strategy was aso discussed. 9 This invoved examining her strategy for times when she was abe to make a cear decision that had poitica ramifications. This was then mapped into the times when she was unabe to do this, and as a resut of this comparative process she was abe to identify the missing component feedback. She was then abe to introduce this to her work-based interactions so that she coud move towards being more poiticay infuentia. The coachee was abe to quicky integrate her earnings into effective behavioura change and the coaching progressed towards working with her to deveop a position paper on gaining her promotion. She utiised the perceptua positions process to identify what key messages needed to be incuded for her direct ine manager and her department director. She rapidy gained her promotion and her intrinsic sef-beief and motivationa process resuted in her setting the next goa. She quicky identified that her area of expertise and passion was gravitating her towards a specific cinica area. She continued to use her previousy acquired skis and deveoped a project pan for how she coud achieve a move to this area as an expert. The project pan consisted of: A summary of persona and professiona deveopment interests Training and deveopment requirements Progressive career pan Short- to medium-term pan for key resut areas in the speciaist sector Summary of interactions required. She submitted the project pan to her ine manager and director and within three months was appointed to the identified position. Outcomes. Outcomes can be set by organisations or managers for empoyees, yet evidence suggests that when outcomes are driven by intrinsicay hed motivation patterns, persona choice and autonomy, and are supported by strong sef-efficacy beiefs, they are more ikey to be powerfuy motivating and sef-correcting. 10 The cient identified her outcomes as both behavioura and career targets: Deveop skis in managing and utiising positive and negative feedback oops Become more poiticay aware, incuding to increase persona toerance eves in poiticay charged situations Become more open to ideas from others Gain promotion to a senior roe. Coach refections. The cient demonstrated a very high degree of persona responsibiity for change throughout the coaching process. She remained in charge of her own destiny and was abe to ceary articuate her current and desired positions from a number of different perspectives incuding her own, her ine manager s, her functiona director s and other stakehoders. She prepared fuy prior to coaching sessions and aways competed between-session tasks. She was abe to demonstrate fexibiity of behaviour both within the session which faciitated significant growth and change during the coaching process and aso outside the coaching sessions, which ed to the foowing comment from at east one senior manager: I watch X Reguatory Rapporteur Vo 8, No 11, November

7 Focus Reguatory management & eadership 11 and sometimes I am envious of the speed of her growth and change, nothing seems to get in the way of her progress and deveopment. Coachee refections. The coachee offered the foowing comments: Working with an externa coach has aowed my deveopment to be much more transparent and aso goa-focused, but with no preconceived expectations, pressures or imitations. This has aowed me to aim towards much broader persona deveopment rather than working to the confines of avaiabe positions, or to department and company constraints. I m constanty amazed by how itte can be said by a good coach but how much of a positive impact this can have, not ony within work, but aso just as a genera perspective on ife. As I have deveoped, so too have the sessions and my aims for them. There are some probems which can t be soved by the coaching, but at east I have the toos to cope and adapt as a resut of the taiored sessions. Hopefuy many of these skis and approaches wi be transferrabe into future ine management responsibiities. Evidence suggests that when outcomes are driven by intrinsicay hed motivation patterns, persona choice and autonomy supported by strong sef-efficacy beiefs they are more ikey to be powerfuy motivating and sef-correcting References 1 Anthony Grant, University of Sydney. Association for Coaching (2011) Coaching Definitions. about03.htm (date accessed 26 Juy 2011). 2 Internationa Coach Federation (2011)Overview and FAQ. about-icf/overview/ (date accessed 26 Juy 2011). 3 J P Kotter, J L Heskett. Corporate cuture and performance, New York:Free Press, Manchester Coaching (2002) Impact of Executive Coaching. services/eadershipcoaching/impactofcoaching. htm date accessed 26 Juy L Wake. NLP Principes in Practice, Ecademy Press, J Whitmore. Coaching for Performance. GROWing Human Potentia and Purpose. The Principes and Practice of Coaching and Leadership, Nichoas Breaey Pubishing, (4 th edition),london, C Iveson, E George, H Ratner. Brief Coaching: A Soution Focused Approach (Essentia Coaching Skis and Knowedge, Routedge, London: J Grinder, J Deozier. Turtes A the Way Down, Metamorphous Press, Portand, Oregon, G Mier, E Gaanter, K Pribram. Pans and the Structure of Behaviour, Hod, Rinehart and Wison, New York, R M Gray. NLP and Leves of Motivation, Suppose, the Officia CANLP/ACPNL Biingua Newsetter, pp20-24, Reguatory Rapporteur Vo 8, No 11, November 2011

8 12 Focus Reguatory management & eadership Pharma management skis Adding vaue in the new order through MBA thinking Authors Tony Grundy, Director of Cambridge Corporate Deveopment MSc; Laura Brown, Director, LB Training and Deveopment Ltd & Course Director of the TOPRA MSc in Reguatory Affairs. Keywords Master of Business Administration (MBA); Leadership and infuence; Stakehoder anaysis; Commercia skis; Change management; Strategic thinking; Project management; Impementation. Abstract Reguatory affairs professionas are becoming increasingy interested in deveoping their management skis beyond the basic eve of deegation and objectivesetting. Today, they are ooking to enhance their capabiities in order to cope with new chaenges and to give them greater career opportunities and security. Aspects of MBA thinking can pay a major roe in deveoping the more stretching skis to survive and succeed in the new order the pharma finds itsef in. This becomes more important as, increasingy, technica skis wi be more of an assumed set of competencies, whie distinctive skis wi be the new order of management requirements. Introduction The pharma industry faces major change and chaenges, and these pressures appear to be acceerating. For exampe, the industry has been heaviy infuenced and affected by: Continua mergers Restructuring Generic competition Pressure from governmenta buyers of drugs to reduce prices Increased heath technoogy assessment Increased reguatory requirements, and the costs and change ramifications of these Interna initiatives such as eaner management Fewer bockbuster drugs Emerging markets, eg, China, India, Brazi, Russia Costs of risk mitigation and risk management Spiraing costs of taking a drug to market. The historicay very high returns enjoyed within pharma, as compared with other industries which have ower barriers to market entry, more direct competition and more price-sensitive customers, are thus being eroded. In order to deiver high sharehoder returns commensurate with the increased risks, top pharma management is putting more pressure on those in senior positions beow them to deiver even more. To do this, and to be abe to exert the required infuence upwards, a new order of management skis is needed for a new order in the pharma industry. This new order of management skis is more strategic and business focused, as exempified in the foowing five key areas: Strategic thinking Commercia skis Change management Leadership and infuencing Project management. Strategic thinking. Strategic thinking is about understanding your current position, where you may want to go and the options for getting there in the future. Strategic thinking shoud be appied at a eves: to corporate strategy, business strategy, the strategy of your unit and of projects, and of course to thinking about choices in your own roe and prioritising them. In pharma there are compex choices around portfoio management and product ifecyce management decisions and how and where to impement these; for exampe in managing cinica trias and reguatory strategy, besides those on how to market these products and to expoit these commerciay once the products appear viabe. This means that strategic options need to be fuy expored and evauated. Commercia skis. These skis are about understanding vaue added to different stakehoders, for exampe to customers and suppiers, and being abe to assess these in financia terms of benefits, costs and risks, and aso to be abe to understand how to negotiate a dea. This means that reguatory professionas need to understand and be capabe of quantifying the financia effects and returns and risks that investment wi invove and thus have a comprehension of financia appraisa techniques. Change management. This entais understanding how to create effective strategies for change and aso how to manage its dynamics as a process. The industry is constanty having to address the need to obtain more out of ess or what is known in MBA terms as ean management, not to mention having to impement changes through shifting resources both in organic deveopment and acquisitions and aiances, as we as frequent restructuring. Leadership and infuence. Leadership and infuencing are additiona key skis of paramount importance in pharma due to the waves of continua change sweeping through organisations. Aso, many senior staff have been promoted not so much because of the softer and ess tangibe skis but because of technica competencies; there is therefore often a need have a more rounded perspective on organisationa chaenges rather than respond by attempting to push through and manage changes in more of an administrative way. This can mean insufficient time and thought is spent on deveoping and communicating the vision and in enabing staff who are aready under pressure to do what they are currenty doing. Project management. Whie reguatory professionas are often famiiar with the more technica aspects of project management, they may be ess comfortabe with areas such as formuating a strategy for the project, based on a more creative exporation of the impementation options that are avaiabe. Within MBA project-focused teaching Reguatory Rapporteur Vo 8, No 11, November

9 Focus Reguatory management & eadership 13 there are many insights on how to assess impementation difficuty so that constraints are systematicay addressed in an iterative project design rather than trying to force the project through on time and to budget. In short, there are many aspects of MBA thinking that can be invauabe in enabing senior pharma staff to be more effective as we as efficient as we as being abe to manage the inevitabe stresses in a cam and more focused manner. To give readers an insight into the kinds of toos avaiabe within MBA programmes, this artice wi expore one of the strategic toos the strategic option grid (see Figure 1), reating to strategic thinking, and aso the stakehoder anaysis (see Figure 2), reating to change management, eadership, infuencing and aso project management. The five criteria have thus been set as: Strategic attractiveness Financia attractiveness Impementation difficuty Uncertainty and risk Stakehoder acceptabiity. Typicay, each criterion is scored as either very attractive, moderatey attractive or ow attractiveness, as shown in Figure 1. Haf scores are aso usefu to discriminate refinement of judgements. Scores can be weighted and sub criteria devised or checkist questions for each criterion devised to reduce subjectivity. Experience of the strategic option grid highights its effectiveness in a number of ways: Visuay; because the strategic option grid has coumns for four or more strategic options, and this in itsef can generate greater creativity among senior managers. It encourages significanty more creative thinking as managers are encouraged via its structure to see if they can improve on and optimise their scores, for exampe by thinking about better ways to impement options. The definition of specific decision-making criteria aows managers to think about options in a more objective way. The specific choice of the five criteria athough originay set instinctivey appeared to very cosey refect the unconscious and informa decisionmaking heuristics which managers use, especiay the criteria of financia attractiveness, uncertainty and risk and stakehoder acceptabiity. The two There are many aspects of MBA thinking that can be invauabe in enabing senior pharma staff to be more effective as we as efficient as we as being abe to manage the inevitabe stresses in a cam and more focused manner criteria of impementation difficuty and strategic attractiveness may be sighty ower down some managers prioritisation preferences (in a financiay driven environment). Note that high impementation difficuty and uncertainty and risk are scored as one, rather than three. Each of the criteria can be checked out/ or supported by other, more specific techniques ( deep-dive techniques, such as vaue and cost drivers, and stakehoder anaysis). By speing out these criteria separatey, they do not merge together as a singe criterion of attractiveness. The technique seems to aeviate some of the worst difficuties of poitics, because of stakehoder positions and agendas. Financia attractiveness can be arrived at either by anaysing financia vaue into its key vaue or by cost drivers (see Figure 3). Here a vaue driver is defined as a variabe either inside or outside of the business that has either a direct or indirect impact on the present or future cash infows of the business. Exampes of vaue drivers are the saes growth rate, the saes price, the reative Figure 1: The strategic option grid Criteria Option Strategic attractiveness Financia attractiveness* Impementation difficuty Uncertainty and risk Acceptabiity (to stakehoders) *Benefits ess costs net cash fows reative to investment. advantages of one product over other to intermediary or end customers, and the eve of operating margin and the duration of superior margins before becoming generic. A cost driver is defined as a variabe either inside or outside of the business that has either a direct or indirect impact on the present or future cash outfows of the business. Exampes of cost drivers are the quaity and focus of project management and the extent to which existing or new processes that are/wi be in pace and the ocation of the depoyment of resource and the nature of its sourcing, and the factor price of its inputs. Vaue and cost driver pictures have a number of key advantages over non-pictoria and conventiona management methods, incuding: The breadth of anaysis: competeness of thinking about how vaue is created by the strategy, and aso on the tota scope of its costs direct and indirect, short and ong term The depth of anaysis: by drawing these as a hierarchica picture, we discover more about the specific causa factors at work in generating cost infows, and aso outfows Option 1 Option 2 Option 3 Option 4 Score: 3 = Very attractive; 2 = Medium attractiveness; 1 = Low attractiveness. Reguatory Rapporteur Vo 8, No 11, November 2011

10 14 Focus Reguatory management & eadership Figure 2: Stakehoder anaysis Attitude FOR NEUTRAL AGAINST LOW Leave aone Coaition buiding Take out of pay Distract or fragment MEDIUM Infuence Figure 3: Vaue and cost drivers in cinica trias Time to market Premium pricing Inspections/ audits Bid negotiation Our Supervision Their systems peope Efficacy Present vaue Systems Compiance CRO Systems Recruitment VALUE DRIVERS Trias COST DRIVERS Trias Our project management Peope Safety Training Patient fee Operationa Study design Leadership Win over/ coaition buiding HIGH Side-effects Monitoring Shipping ogistics Location Drug needs More reaistic quantification of vaue can be assessed: once we have drawn up these pictures we are now abe to quantify the most important factors to coect data on and prioritise their investigation Through better and more compete risk anaysis Through being more abe to re-engineer the design of the project to trade off choices in a more economic way, and aso through being abe to thus revise the project strategy,and to assess the overa difficuty of achieving desired goas. Besides its obvious appication to commercia thinking, where vaue and cost drivers are used to tria the financia attractiveness that we saw in the strategic option grid, it can therefore be appied to strategic thinking too. Further, they can be usefu in strategic infuencing. Figure 3 iustrates some of the key vaue and cost drivers for undertaking a cinica tria. These images highight the number of impementation choices that are ikey to impact on the deveopment of a strategy for a cinica tria, and the work that is needed in order to arrive at a business case. This work wi be party quaitative in exporing these vaue and cost drivers at an even more micro eve, and aso quantitative in assessing the ikey magnitude and timing of saes, the ikey operating margin and the quantities, costs and timings of the resources consumed, phase by phase. Our other too, stakehoder anaysis, aows us to judge how for or against the stakehoders are ikey to be and give their degree of infuence. This requires taking the stakehoders own perspective either by asking them directy, or second-best by estimating their positions by imagining we are them (often caed the out-ofbody experience ). Stakehoder anaysis aows one to take a heicopter picture of the key payers internay both as groups and as individuas and their positions in terms of both infuence and aso positive, neutra or even negative attitudes (their agendas ) on either the whoe decision or a part of it in an easy and visua way. These positions are ikey to change over time and this can be represented too, either by directiona arrows or through different pictures for different phases over time, or even as dynamic curves to pot the changing infuence and possibe attitude. Stakehoder anaysis has a number of major advantages over poitica mudding through : Reguatory Rapporteur Vo 8, No 11, November

11 Focus Reguatory management & eadership 15 It identifies and prioritises the key payers and aso picks out those to target to infuence; it aso forces a more indepth refection on current infuencing strategies and tactics It can be used as a more open vehice for discussing the differences in views and their reasons and chaenges, whether these are vaid or artificia A more reaistic assessment of impementation difficuty can be done, and this has more chance of being mitigated and minimised Decisions can be made faster and more easiy to dissove much of the organisationa poitics. Stakehoder anaysis has been used to great effect in pharma, for exampe in the organisation of cinica trias and in the formuation of reguatory strategy. It has proved particuary hepfu, for exampe, through the out-of-body experience of imagining the key stakehoder(s) from the potentia stance of reguatory bodies. In summary, MBA toos ike the three exampes expored above can prove to be extremey hepfu on framing pharma chaenges and diemmas, and in diagnosing and resoving them. Bringing it a together In an idea word one might we consider doing an MBA course to get up to speed with these skis. The benefit of doing a fu MBA is that one woud be thoroughy immersed in the various discipines in these and other areas too, incuding organisationa theory, marketing and finance. Part-time programmes can typicay be three years or more, aso giving you exposure to managers from many other industries, as we as specific case studies. The advantages of taking a fu MBA are that one wi get a major and sustained stretch in one s thinking on the chaenges that pharma faces, seeing the bigger picture and how the various aspects are interreated. The disadvantages are that this is quite time-consuming and difficut to do in a chaenging reguatory roe where onger hours are aready the norm. The cost of an MBA is substantia, too. Having said that, there can sti be a positive onger-term return, with one s career sometimes significanty advanced using this route. Carrying out a taiored vaue and cost driver anaysis can be of hep here. An aternative is to focus on a smaer number of these areas, ike the core five that identified here to be at the heart of the more strategic skis. Typicay branded as mini pharma MBA programmes, these week-ong courses can be particuary hepfu as they are attended ony by pharma professionas and can be used to get a taste of a fuer MBA without having to make a huge commitment. What is certain is there are many routes forward to expore in expoiting new eadership and management skis and techniques as senior reguatory staff. Aspects of MBA thinking can pay a major roe in deveoping the more stretching skis to survive and succeed in the new pharmaceutica industry order. Correction Our September 2011 issue (Vo 8, No 9) carried an error in the artice tited The ABCs of PDUFA. It stated (p19) that an FDAAA Risk Evauation and Mitigation Strategy (REMS) provision became effective on 1 March In fact the reevant provision came into force on 25 March basics of Reguatory Affairs A one day course that identifies the function and roe of Reguatory Affairs in industry, suitabe for a new empoyees to pharmaceutica and medica device reated areas, incuding medica manufacturing, marketing, saes and compiance One-day Foundation Course The purpose of the day The purpose of this Basics course is to provide you with a cear and concise understanding of the roe payed by Reguatory Affairs in obtaining and maintaining Marketing Authorisations for pharmaceutica products. The course tutors A of the tutors have many years of Reguatory Affairs experience and are currenty working in the industry. This course wi give a basic grounding in a reaxed, enjoyabe environment. For more information, pease visit: Ireand: What previous deegates have had to say about this course Speakers very cear, concise and informative Exceent overview in such a short time! Made things a ot cearer and gave me an understanding of how things ink together. We structured set of presentations and very informative. Our promise We guarantee you wi eave the course with a better understanding of the reguatory process and your roe within it. Itay: Ireand Date: 10 Nov 2011 Pace: Ireand Itay Date: 12 Dec 2011 Pace: Mian, Itay 5* hours *For more information pease visit org/ifeongearning emai: meetings@topra.org te: +44 (0) fax: +44 (0) web: Reguatory Rapporteur Vo 8, No 11, November 2011