focus – regulatory management & leadership effective ... · pdf filewithin the...

5

www.topra.org Regulatory Rapporteur – Vol 8, No 11, November 2011

AuthorJonathan Trethowan, Managing Director, TRAC Services, Redruth, Cornwall, UK.

KeywordsTraining; Memletic learning; Learning styles; Skills; Career development.

AbstractThis article describes how the creation of effective performance and development plans for regulatory affairs professionals can reap real rewards for the industry and the businesses within it.

In many ways, being thrown in at the deep end of a regulatory project remains one of the most effective ways for anyone to gain experience and develop real skills. An individual can learn all the theory there is, but real development comes from practical experience. Training courses are useful, as is subject reading to build understanding, but there really is no substitute for sitting down and trying out a process yourself and doing it repeatedly to build experience and knowledge.

However, when it comes to effective people management and development in regulatory affairs, the key is to offer the appropriate support and guidance designed built around the individual within the business and their specific training needs and, increasingly importantly, their own learning style.

A multi-disciplinary approach to effective development and training plans for regulatory professionals can reap real and positive rewards for the individual, team and business alike.

Selling regulatory affairs – attracting the brightest talent to the industryThe TOPRA Professional Development Committee was created in January 2010 to raise the profile of the regulatory affairs profession and to become much more proactive to ensure that, as a discipline within the pharmaceutical industry, we can attract the brightest new talent coming into and developing a regulatory career.

Good people need the opportunity to keep doing what they enjoy from their life sciences degrees without thinking that working in the pharmaceutical industry always involves wearing a white coat and working in a laboratory.

We also need to be aware that undergraduates and graduates are far more career-minded today. They are now thinking about and looking at what they need to do and the experience they require to effectively work their way up a chosen career ladder.

From an industry perspective, it is vital to highlight that regulatory affairs plays a crucial role within a pharmaceutical company, allowing regulatory affairs professionals to use and develop skills and experience, build in-depth knowledge and understand how to

Effective performance development plans for regulatory affairs professionals

overcome regulatory hurdles and develop strategy while remaining at the heart of the industry.

In few other areas of the pharmaceutical industry will a professional have the opportunity to play such a pivotal role within multi-disciplinary teams. The team assembled to work throughout development could be completely different from the team working towards a product launch to market, and potentially different again from the team involved with post-approval activities. Key skills that will be needed include:l Adaptabilityl Flexibilityl People skillsl Strategic thinkingl Diplomacy.

There will always be changes to regulations, so there will always be a need for regulatory professionals to interpret how these will impact their organisation. The industry cannot stop developing and evolving, which provides both challenge and opportunity for individual development.

An example of change in the last few years is the move from paper-based to electronic regulatory submission processes under eCTD. Advances like these will have a continual knock-on effect in the way that people are developed within the industry and in the corresponding management processes and leadership qualities required.

The importance of trainingWhen it comes to training, it is important to acknowledge that effective training has a dual benefit in terms of an individual’s enhanced knowledge and career development and the commercial success of the organisation they are working for. Effective leadership is needed to address the recruitment, development and ongoing professional development of the right people which will enable the business to flourish.

The key benefits of training include: l Increased job satisfaction and morale among employeesl Increased employee motivationl Increased efficiencies in processesl Increased capacity to adopt new technologies and methodsl Increased innovation in strategies and productsl Reduced employee turnoverl Enhanced company imagel Risk management.

Managed and delivered well, continuous professional development can bring real and measurable benefits to any organisation.

In a report carried out by the University of Leicester on behalf of the Institute of the Motor Industry (IMI)1 published in July 2011, the IMI teamed up with leading organisations in the automotive industry to commission an independent piece of research assessing the impact of their skills accreditation programme, known as Automotive Technician Accreditation (ATA). The study revealed a return on training investment ranging from 98% to 187% with benefits across the board, including raised technical standards, professional status, productivity, profitability, and customer confidence.

Focus – Regulatory management & leadership

6

Regulatory Rapporteur – Vol 8, No 11, November 2011 www.topra.org


Effective performance development plansWith many employers in regulatory affairs looking for candidates with at least two years’ experience, the opportunities for new blood and fresh talent to start a regulatory affairs career is potentially being hindered, to the long-term detriment of the profession.

The creation of in-house training and development programmes is undoubtedly a key way to overcome this issue, with the added benefit of enabling a regulatory affairs department to shape and develop professionals who will bring real value and ongoing benefits to the business.

While the phrases ‘in-house training’ and ‘development’ may illicit a sharp intake of breath, the opportunity to create a training and development blueprint – which can evolve with new recruits and as the business develops – can deliver real and measurable rewards and ultimately reduce the reliance on external training and associated costs. However, external training and events should still be considered and integrated as part of the development plan; they often provide good networking opportunities to help develop soft skills or other such personal skills.

The goal with an in-house training programme is to enable new starters to get up to speed as quickly as possible, build knowledge and experience within a structured and monitored environment, while at the same time being able to expose the individuals to as wide a range of activities and practical experiences as possible.

By taking a structured approach to training and personal development, regularly looking at the ongoing development needs of the individual will enable a business to take someone with no experience and set them on a journey equipping them with the skills and growing experience across a range of disciplines, creating well-rounded, qualified regulatory professionals.

This can be achieved by giving people as much access to experience as possible, within a support structure that is robust and repeatable, so that as a team grows, new starters are able to benefit from the process, creating a consistent flow of professionals into the business who fully understand both the business and the industry.

A training and development plan needs to be a constantly evolving process, with a major focus placed on the first two years,

providing the platform to increase an individual’s knowledge and experience dramatically.

This first two years is about giving people the foundations – a thorough grounding in regulatory affairs, by exposing them to as many aspects of the regulatory affairs function as possible.

Understanding the individual and tailoring the approachWhen it comes to managing people within regulatory affairs it is important to understand the strengths and weaknesses of the particular individual, and what it is they want to achieve. Furthermore, understanding the development requirements of each individual and creating a pathway should help them reach their objectives. This can be achieved through regular appraisals and the creation of individual professional development plans.

Strong leadership and management is about identifying what individuals 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 help them fulfil their ambitions.

It is also essential to recognise that everyone’s learning style is different, and to match training and professional development to each person’s own individual ways of learning.

Learning processes such as ‘memletic learning’2 are useful tools to help understand the individual learning styles of each member of the team and therefore adapt their training needs to match their own memletic profile (see Figure 1).

Not following this theory or an equivalent route and instead taking a ‘one size fits all’ approach to training will result in a situation where the training will fail the individual, not the individual failing the training. If individuals are to develop they must be given the tools they need, delivered in the most effective way for them.

Under memletic learning, the content and quality of the training is the same but it is the way in which it is delivered that varies according to the individual.

So what is memletic learning?Different people learn differently in relation to the learning technique employed. Some people will learn better if physical and practical demonstrations are involved, while others will learn better when a lot of descriptive words are used.

Learning styles are classified in different ways to obtain different results, with seven different learning styles identified. In summary, these styles are:l Visual – preference for pictures, images and spatial understandingl Aural – preference for using sounds and musicl Verbal – preference for using words, both in speech and writingl Physical – preference for using body, hands and sense of touchl Logical – preference for using logic, reasoning and systemsl Social – preference for learning in groups or with other peoplel Solitary – preference for working alone and using self-study.

To determine an individual’s profile, a simple questionnaire is used and a score against each of the learning styles can be produced.

It has been established through research3 that it is possible for a person to improve the substance gained and the learning speed if the person understands his or her preferred technique of learning; this is referred to as learning style, and works on improving these abilities through adopting the best approach for an individual which can also address any weaknesses that the memletic test identifies, to help improve their personal performance.

Figure 1: Example of a memletic learning style graph

Style Scores Visual 12 Social 8 Physical 5 Aural 9 Verbal 10 Solitary 13 Logical 9

LegendYour Style

Visual

Social

Physical

AuralVerbal

Solitary

Logical

20

15

10

5

7



Developing people and keeping the progression process movingThroughout anyone’s career in regulatory affairs, years 1–5 will generally be different from years 5–10. In years 1–5 it is about creating the documentation and writing submissions, while beyond the five-year point the regulatory professional is likely to be immersed in project management and possibly also people management.

The goal for the manager developing professionals at the early stages of their careers will be to identify those individuals who have the ability to work on wider issues such as regulatory strategy, ie, defining what strategy will be required to ensure a desired outcome for the stakeholder and the business.

From a career progression perspective, if someone shows an interest in project leadership then he or she will need to be encouraged to increase their understanding of which projects have worked and why, and the manager should then identify their training requirements and the tools they will need to grow into that role.

The responsibility of managers is to give people the opportunity for development that will also have a business benefit for the company by enabling them to extend their experience and knowledge.

Managing the changing face of regulatory affairsWhile the approach of training graduates with little or no experience has shown real benefits for some regulatory affairs organisations, there are also opportunities to be gained from wider industry changes, with global companies such as Pfizer and AstraZeneca publicly announcing major reorganisations.

With smaller companies now playing a significant role in the delivery of regulatory affairs services, these announcements are likely to see increased numbers of laboratory-based professionals looking for opportunities within the field.

Although there will be an amount of retraining required to adapt skill sets, wider knowledge, understanding and experience can create real benefit for the regulatory affairs function, with opportunities to potentially fast-track individuals through a two-year training cycle.

The importance of succession planningSuccession planning is also critical to avoid situations where one individual within a team becomes the sole expert on a specific area of regulatory affairs. Instead, their knowledge and expertise should be tapped into and shared around the team so that, should they move jobs, an organisation is not facing a situation where their expertise and knowledge is lost to the company.

Shared training and learning among a team is therefore vital – effectively making the experienced individual the trainer of other members of the team.

Continuous professional developmentOnce a regulatory professional is trained, the development process really starts again. Matching an individual’s strengths and skills to the roles and opportunities within the business, which will help them grow while at the same time maximise their performance for the benefit of the business, is critical.

It is not only important to seek to offer the training and support for an individual’s preferred career plan (in line with the business), it is also necessary to demonstrate strong leadership where their skills and ambitions lie. Some people will not want to look for continual career progression – they will reach a point where they are happy with the role they are playing in the organisation. Others may express an interest in a specific role or career path for which their skills and abilities (even with training) are inappropriate. Again, strong management is required.

But there are also other considerations that can help as part of an individual’s development opportunities and experience-building. This can be achieved through offering a more proactive role within an organisation’s corporate and social responsibility programme, providing people with development opportunities through a number of initiatives, and the associated management and organisation of these will come within the remit of individuals within the team. This is about giving people wider opportunities that are not just focused on their day-to-day job. From a benefit to the business perspective, offering people the opportunity to buy into the company and its ethos by taking a leading role in wider activities can provide real benefits.

Be realisticEffective performance development is about enabling individuals within a business to fulfil their professional needs while at the same time benefiting the business. However, there will undoubtedly be occasions where a business simply cannot provide the development opportunities that people will want. In this instance, trying to keep hold of them could be damaging to the rest of the team or the company in the long term.

At some point, the best thing for the individual and the company is to let them go – as long as you have done everything you can to develop them.

Key tips for people developmentl Ensure you listen and understand the needs of the individuall Make sure you are developing not what you want but what the

individual wants, and identify how that will most effectively work within your business

l Review regularly – yes, have your formal review policy, but also put in much more frequent informal reviews, which enables you to identify and address any issues before they build up into problems. No matter how often a manager will say to people they are free to come

and talk at any point, there will always be some people who will never take up this opportunity. The beauty of the regular informal catch-up is that within that environment individuals may feel more able to raise any issues.

Be positiveIn developing people it also pays dividends to highlight when people have done something really well, as praise is an extremely good motivator and developer.

By creating a positive environment in which everyone feels that they are being listened to, are making a positive contribution to the business on all levels and are playing a leading role in the development of team incentive and value initiatives, businesses will be best placed to develop talented and motivated regulatory affairs professionals.

Ultimately, effective management and leadership within regulatory affairs is about managing and motivating people, and offering a progression path that enables them to develop to their full and preferred potential. If you can keep members of your team motivated, happy and give them a sense of continued development and experience-building, both linked to their day-to-day role and on wider issues within the business, then you will reap the rewards not only from a morale perspective but commercially, as a result of having a stable and motivated team.

References1 www.motor.org.uk/information/roi-ata.html2 http://www.ronniejohnson.info/files/Creative%20Teaching/

Memletics-Learning-Styles-Inventory.pdf3 S Cassidy. ‘Learning styles: An overview of theories, models and

measures’, Educational Psychology, 24 (4) , pp. 419-444, 2004.

8 Career development


Training designed with you in mindWorkshops

CRED CD12* hoursLifelong learning (LLL)

*For more information please visit www.topra.org/lifelonglearning

CRED Clinical Development: Early to Late Stage Clinical Development

For more information or to obtain a booking form, please contact ToprA via email: [email protected] or tel: +44 (0) 20 7510 2560 or go to the website: www.topra.org/credclinicaldev

All data correct at time of print.

AimThis 2-day workshop will provide an overview with practical advice from regulators and industry on the process of designing and conducting clinical trials from phase I through phases II, III and even clinical trials considerations beyond drug marketing approval. Case studies are used to support learnings from the formal presentations and to draw upon experiences of those attending. The aim of this practical workshop is to enable all those involved in medicines development to gain an appreciation of the points to consider when designing a clinical development programme to support a marketing application and also that clinical development extends beyond the marketing application.

speakersFrits Lekkerkerker, Chairman, Steering Committee for Orphan Medicines, The Netherlands

Basel Houdali, Lilly

Steve Pinder, Envestia Limited

Plus other invited speakers

Who should attend● The less experienced regulatory professional

who requires comprehensive information on this subject

● The experienced professional who is a newcomer to this subject

● Anyone who wishes to update their knowledge on this subject

● persons from regulatory, medical, clinical and safety functions involved in phase I, II, III and IV trials.

For more information please contact ToprA via email: [email protected] or tel: +44 (0) 20 7510 2560 or go to www.topra.org/credclinicaldev

BookNoW

ToPRA – The organisation for Professionals in Regulatory Affairs Reference: CRED-CD1

Two-day Course

Date:1–2 December 2011

Venue: Marriott paris, st Denis, paris, France

email: [email protected] tel: +44 (0) 20 7510 2560 fax: +44 (0) 20 7537 2003 web: www.topra.org/credclinicaldev

9Focus – Regulatory management & leadership


Leadership excellence through coaching: A case study in regulatory affairs using neurolinguistic programming

AuthorLisa Wake, Director, Awaken Consulting & Training Services Ltd, Yorkshire, UK.

KeywordsCoaching; Neurolinguistic programming

(NLP); Leadership; Development; Goal

setting; Motivation.

AbstractCoaching is increasingly 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, employment

and net income growth. The framework

for coaching described in this case study

utilises a combination of neurolinguistic

programming (NLP), the ‘GROW’ model (see

Table 1) and ‘solution-focused’ coaching.

The coaching framework is described

in five stages: identifying the outcome

and benchmarking current performance

against key results areas within a promotion

opportunity; gaining alternative perspectives

to influence; eliciting and utilising an

‘excellence strategy’; devising a project plan

and utilising alternative perspectives to

influence; and reviewing and integration of

goal achievement. Information is given on

the outcomes achieved, reflections by the

individuals who have been coached (the

‘coachees’) and observations by the coach.

Background to coachingOrganisations utilise coaching to support high

potential; manage careers; deal with difficult

situations; manage interpersonal conflicts;

develop leadership skills; manage and enhance

performance; find solutions; improve confidence

and provide support for personal issues.

Coaching has many definitions, including:

“A collaborative solution-focused results-

oriented and systematic process in which

the coach facilitates the enhancement of

work performance, life experience, self-

directed learning and personal growth of the

coachee.”1 The International Coach Federation

defines coaching as “partnering with clients

in a thought-provoking and creative process

that inspires them to maximise their personal

and professional potential.”2

Kotter and Heskett3 of the Harvard Business

School identified that companies who focus

on performance enhancement experience

improved revenue growth, employment

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 utilises a combination of NLP,5 the

GROW model6 and solution-focused coaching.7

NLP is an applied psychology that uses

outcome-focused questions to facilitate

coachees to utilise their own resources to

achieve results. NLP consists of a series of

tools and techniques specifically designed

to facilitate performance excellence. One of

the models within NLP is the goal-setting

process (see Table 2).

The GROW model detailed in Table 1 is

good for ‘non-directive’ coaching, ie, to help

coachees find the answer themselves. This

model demonstrates that we can all coach by

developing questioning and listening skills and

that subject knowledge is not essential. In fact,

coaches who are different from the coachee can

help explore a different perspective. With this

model, goal-setting can be fluid and ‘iterative’.

Solution-focused coaching (see Table

3) uses questioning techniques that direct

the coachee’s attention towards solutions.

The coach works with the client to explore

desired goals, exceptions which have led to

success in the past, or when the problem did

not occur, and existing resources that can be

brought into play, and solutions and changes

that will occur once the goal is reached.

Case studyThe case study detailed here provides

information on the background to the client,

the coaching process, the outcomes achieved

and reflections by the coachee and the coach.

The client. The client requested coaching

via her line manager. She was very focused

about her coaching requirements and had a

clear idea of her own development areas and

career pathway. She was extensively qualified

in her area of expertise and was employed in

an appropriate role for her skill 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

professional knowledge and skills, objectives,

personal traits in relation to the core values

of the business and leadership behaviours, all

of which were assessed as part of the annual

appraisal process by her company.

The coaching process. This began with

an exploration of the coachee’s current

awareness of her role 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 personal appraisal report was

used as a benchmarking tool. Her current

capabilities were mapped against the job

requirements for a senior role and a number

of development areas were identified:

l Developing strategies, coordinating and

preparing submissions of marketing

authorisation applications in EU/EEA markets

and mutual recognition and decentralised

procedure (MRP/DCP) applications

l Compiling and providing regulatory

dossiers to stakeholders

l Coordinating responses to regulatory

questions relating to products

l Departmental level prioritisation and

coordination of key tasks

l Mentoring of project team members.

The coachee was supported with some

behavioural skills and techniques to address her

10 Focus – Regulatory management & leadership


Table 3: The solution-focused approach

Problem-free talk – What are you interested in? What do you enjoy? What are you good at? How would your best friends describe you?

Best hopes – What are your best hopes for this session? How will you know that the coaching was useful today?

Preferred future – Imagine that after you have gone to bed tonight a miracle happens and the problem that you brought here today is resolved. What do you see yourself doing differently, what will others see you doing differently to let you know the miracle has happened?

Exceptions – When are the times that this problem doesn’t happen?

Scaling – Use a scale of 0-10. Where are you now with regard to this goal? What would increase the rating on the scale?

Locating resources – When you have faced this sort of problem in the past, how did you resolve it? What other tough situations have you handled? What did you learn about yourself from how you handled it?

Table 2: The goal-setting process

P – Positive (what do you want to achieve? Stated in the present tense, what will this goal get for you?)

A – Achievement (what will you see, hear and feel when you have achieved it? How will someone else 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 – Ecology (what will you gain if you achieve this? What will you lose if you achieve this? What might be the wider positive and negative consequences of achieving this? How does this goal impact on other goals?)

R – Resources (what resources do you have that you could use? Who else do you know who has achieved this?)

Table 1: The ‘GROW’ model

G – Goal (this should be as specific as possible)

R – Reality of the situation (what has happened in the past?)

O – Options (what are the options available?)

W – What/Will? (what is your commitment out of 10; what will help make it happen?)

behavioural goals. She quickly integrated her

learning and was rapidly able to apply her skills

with immediate positive results. One of the

tools used was ‘perceptual positions’,8 which

enabled her to gain alternative perspectives

on her behaviour. She was able to view herself

from first position, ie, how she experienced

an interaction with a ‘challenging’ colleague;

second position, where she was able to view

herself from the ‘challenging’ colleague’s

perspective; and finally, third position, where

she was able to learn from the other two

perspectives and use this information to

adapt her behaviour. An understanding of

her ‘excellence strategy’ was also discussed.9

This involved examining her strategy for times

when she was able to make a clear decision

that had political ramifications. This was then

mapped into the times when she was unable

to do this, and as a result of this comparative

process she was able to identify the missing

component – feedback. She was then able to

introduce this to her work-based interactions

so that she could move towards being more

politically influential.

The coachee was able to quickly integrate

her learnings into effective behavioural

change and the coaching progressed

towards working with her to develop a

position paper on gaining her promotion.

She utilised the perceptual positions process

to identify what key messages needed to be

included for her direct line manager and her

department director. She rapidly gained her

promotion and her intrinsic self-belief and

motivational process resulted in her setting

the next goal. She quickly identified that her

area of expertise and passion was gravitating

her towards a specific clinical area. She

continued to use her previously acquired

skills and developed a project plan for how

she could achieve a move to this area as an

expert. The project plan consisted of:

l A summary of personal and professional

development interests

l Training and development requirements

l Progressive career plan

l Short- to medium-term plan for key result

areas in the specialist sector

l Summary of interactions required.

She submitted the project plan to her line

manager and director and within three months

was appointed to the identified position.

Outcomes. Outcomes can be set by

organisations or managers for employees,

yet evidence suggests that when outcomes

are driven by intrinsically held motivation

patterns, personal choice and autonomy,

and are supported by strong self-efficacy

beliefs, they are more likely to be powerfully

motivating and self-correcting.10

The client identified her outcomes as both

behavioural and career targets:

l Develop skills in managing and utilising

positive and negative feedback loops

l Become more politically aware, including

to increase personal tolerance levels in

politically charged situations

l Become more open to ideas from others

l Gain promotion to a senior role.

Coach reflections. The client demonstrated

a very high degree of personal responsibility

for change throughout the coaching process.

She remained in charge of her own destiny

and was able to clearly articulate her current

and desired positions from a number of

different perspectives including her own, her

line manager’s, her functional director’s and

other stakeholders. She prepared fully prior

to coaching sessions and always completed

between-session tasks. She was able to

demonstrate flexibility of behaviour both

within the session – which facilitated significant

growth and change during the coaching

process – and also outside the coaching

sessions, which led to the following comment

from at least one senior manager: “I watch X

11Focus – Regulatory management & leadership


Evidence suggests that when outcomes are driven by intrinsically held motivation patterns, personal choice and autonomy – supported by strong self-effi cacy beliefs – they are more likely to be powerfully motivating and self-correcting

and sometimes I am envious of the speed of

her growth and change, nothing seems to get

in the way of her progress and development.”

Coachee refl ections. The coachee off ered

the following comments: “Working with an

external coach has allowed my development

to be much more transparent and also

goal-focused, but with no preconceived

expectations, pressures or limitations. This

has allowed me to aim towards much broader

personal development rather than working

to the confi nes of available positions, or to

department and company constraints. I’m

constantly amazed by how little can be said

by a good coach but how much of a positive

impact this can have, not only within work,

but also just as a general perspective on life.

“As I have developed, so too have the

sessions and my aims for them. There are

some problems which can’t be solved by

the coaching, but at least I have the tools

to cope and adapt as a result of the tailored

sessions. Hopefully many of these skills and

approaches will be transferrable into future

line management responsibilities.”

References1 Anthony Grant, University of Sydney. Association

for Coaching (2011) Coaching Defi nitions. http://

www.associationforcoaching.com/about/

about03.htm (date accessed 26 July 2011).

2 International Coach Federation (2011)Overview

and FAQ. http://www.coachfederation.org/

about-icf/overview/ (date accessed 26 July 2011).

3 J P Kotter, J L Heskett. ‘Corporate culture and

performance’, New York:Free Press, 1992.

4 Manchester Coaching (2002) Impact of Executive

Coaching. www.extraordinaryliving.com/

services/leadershipcoaching/impactofcoaching.

html date accessed 26 July 2011.

5 L Wake. ‘NLP Principles in Practice’, Ecademy

Press, 2011.

6 J Whitmore. ‘Coaching for Performance.

GROWing Human Potential and Purpose.

The Principles and Practice of Coaching and

Leadership’, Nicholas Brealey Publishing, (4th

edition),London, 2009.

7 C Iveson, E George, H Ratner. ‘Brief Coaching: A

Solution Focused Approach (Essential Coaching

Skills and Knowledge’, Routledge, London:2011.

8 J Grinder, J Delozier. ‘Turtles All the Way Down’,

Metamorphous Press, Portland, Oregon, 1987.

9 G Miller, E Galanter, K Pribram. ‘Plans and the

Structure of Behaviour’, Hold, Rinehart and

Wilson, New York, 1960.

10 R M Gray. ‘NLP and Levels of Motivation’,

Suppose, the Offi cial CANLP/ACPNL Bilingual

Newsletter, pp20-24, 2008.

12


AuthorsTony Grundy, Director of Cambridge Corporate Development MSc; Laura Brown, Director, LB Training and Development Ltd & Course Director of the TOPRA MSc in Regulatory Affairs.

KeywordsMaster of Business Administration (MBA); Leadership and influence; Stakeholder analysis; Commercial skills; Change management; Strategic thinking; Project management; Implementation.

AbstractRegulatory affairs professionals are becoming increasingly interested in developing their management skills beyond the basic level of delegation and objective-setting. Today, they are looking to enhance their capabilities in order to cope with new challenges and to give them greater career opportunities and security.

Aspects of MBA thinking can play a major role in developing the more stretching skills to survive and succeed in the new order the pharma finds itself in. This becomes more important as, increasingly, technical skills will be more of an assumed set of competencies, while distinctive skills will be the new order of management requirements.

IntroductionThe pharma industry faces major change and challenges, and these pressures appear to be accelerating. For example, the industry has been heavily influenced and affected by:l Continual mergersl Restructuringl Generic competitionl Pressure from governmental buyers of

drugs to reduce pricesl Increased health technology assessmentl Increased regulatory requirements, and the

costs and change ramifications of these

Pharma management skills – Adding value in the new order through MBA thinking

l Internal initiatives such as leaner management

l Fewer blockbuster drugsl Emerging markets, eg, China, India, Brazil,

Russia l Costs of risk mitigation and risk

management l Spiralling costs of taking a drug to market.The historically very high returns enjoyed within pharma, as compared with other industries which have lower barriers to market entry, more direct competition and more price-sensitive customers, are thus being eroded. In order to deliver high shareholder returns commensurate with the increased risks, top pharma management is putting more pressure on those in senior positions below them to deliver even more. To do this, and to be able to exert the required influence upwards, a new order of management skills is needed for a new order in the pharma industry.

This new order of management skills is more strategic and business focused, as exemplified in the following five key areas:l Strategic thinkingl Commercial skillsl Change managementl Leadership and influencingl 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 should be applied at all levels: to corporate strategy, business strategy, the strategy of your unit and of projects, and of course to thinking about choices in your own role – and prioritising them.

In pharma there are complex choices around portfolio management and product lifecycle management decisions and how and where to implement these; for example in managing clinical trials and regulatory strategy, besides those on how to market these products and to exploit these commercially once the products appear viable. This means that strategic options need to be fully explored and evaluated.

Commercial skills. These skills are about understanding value added to different stakeholders, for example to customers and suppliers, and being able to assess these in financial terms of benefits, costs and risks, and also to be able to understand how to negotiate a deal.

This means that regulatory professionals need to understand and be capable of quantifying the financial effects and returns and risks that investment will involve and thus have a comprehension of financial appraisal techniques.

Change management. This entails understanding how to create effective strategies for change and also how to manage its dynamics as a process. The industry is constantly having to address the need to obtain more out of less – or what is known in MBA terms as ‘lean management’, not to mention having to implement changes through shifting resources both in organic development and acquisitions and alliances, as well as frequent restructuring.

Leadership and influence. Leadership and influencing are additional key skills of paramount importance in pharma due to the waves of continual change sweeping through organisations. Also, many senior staff have been promoted not so much because of the softer and less tangible skills but because of technical competencies; there is therefore often a need have a more rounded perspective on organisational challenges 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 developing and communicating the ‘vision’ and in enabling staff who are already under pressure to do what they are currently doing.

Project management. While regulatory professionals are often familiar with the more technical aspects of project management, they may be less comfortable with areas such as formulating a strategy for the project, based on a more creative exploration of the implementation options that are available. Within MBA ‘project-focused’ teaching


13


there are many insights on how to assess implementation difficulty so that constraints are systematically 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 invaluable in enabling senior pharma staff to be more effective as well as efficient – as well as being able to manage the inevitable stresses in a calm and more focused manner.

To give readers an insight into the kinds of tools available within MBA programmes, this article will explore one of the strategic tools – the ‘strategic option grid’ (see Figure 1), relating to strategic thinking, and also the ‘stakeholder analysis’ (see Figure 2), relating to change management, leadership, influencing and also project management. The five criteria have thus been set as:l Strategic attractivenessl Financial attractivenessl Implementation difficultyl Uncertainty and riskl Stakeholder acceptability.

Typically, each criterion is scored as either ‘very attractive’, ‘moderately attractive’ or ‘low attractiveness’, as shown in Figure 1. Half scores are also useful to discriminate refinement of judgements. Scores can be weighted and sub criteria devised or checklist questions for each criterion devised to reduce subjectivity.

Experience of the strategic option grid highlights its effectiveness in a number of ways:l Visually; because the strategic option

grid has columns for four or more strategic options, and this in itself can generate greater creativity among senior managers.

l It encourages significantly more creative thinking as managers are encouraged via its structure to see if they can improve on and optimise their scores, for example by thinking about better ways to implement options.

l The definition of specific decision-making criteria allows managers to think about options in a more objective way.

l The specific choice of the five criteria – although originally set instinctively – appeared to very closely reflect the unconscious and informal decision-making heuristics which managers use, especially the criteria of ‘financial attractiveness’, ‘uncertainty and risk’ and ‘stakeholder acceptability’. The two

criteria of ‘implementation difficulty’ and ‘strategic attractiveness’ may be slightly lower down some managers’ prioritisation preferences (in a financially driven environment). Note that high ‘implementation difficulty’ and ‘uncertainty and risk’ are scored as one, rather than three.

l Each of the criteria can be checked out/or supported by other, more specific techniques (‘deep-dive’ techniques, such as value and cost drivers, and stakeholder analysis). By spelling out these criteria separately, they do not merge together as a single criterion of ‘attractiveness’.The technique seems to alleviate some of

the worst difficulties of politics, because of stakeholder positions and agendas.

Financial attractiveness can be arrived at either by analysing financial value into its key value or by cost drivers (see Figure 3). Here a ‘value driver’ is defined as a variable either inside or outside of the business that has either a direct or indirect impact on the present or future cash inflows of the business. Examples of value drivers are the sales growth rate, the sales price, the relative

advantages of one product over other to intermediary or end customers, and the level of operating margin and the duration of superior margins before becoming generic. A ‘cost driver’ is defined as a variable either inside or outside of the business that has either a direct or indirect impact on the present or future cash outflows of the business. Examples of cost drivers are the quality and focus of project management and the extent to which existing or new processes that are/will be in place and the location of the deployment of resource and the nature of its sourcing, and the factor price of its inputs.

Value and cost driver pictures have a number of key advantages over non-pictorial and conventional management methods, including:l The breadth of analysis: ‘completeness’

of thinking about how value is created by the strategy, and also on the total scope of its costs – direct and indirect, short and long term

l The depth of analysis: by drawing these as a hierarchical picture, we discover more about the specific causal factors at work in generating cost inflows, and also outflows

There are many aspects of MBA thinking that can be invaluable in enabling senior pharma staff to be more effective as well as efficient – as well as being able to manage the inevitable stresses in a calm and more focused manner


Figure 1: The strategic option grid

*Benefits less costs – net cash flows relative to investment.

Score: 3 = Very attractive; 2 = Medium attractiveness; 1 = Low attractiveness.

Option 1 Option 2 Option 3 Option 4

Strategicattractiveness

Financialattractiveness*

Implementationdifficulty

Uncertaintyand risk

Acceptability (tostakeholders)

CriteriaOption

14



l More realistic quantifi cation of value can be assessed: once we have drawn up these pictures we are now able to quantify the most important factors to collect data on and prioritise their investigation

l Through better and more complete risk analysis

l Through being more able to re-engineer the design of the project to trade off choices in a more economic way, and also through being able to thus revise the project strategy ,and to assess the overall diffi culty of achieving desired goals.Besides its obvious application to

commercial thinking, where value and cost drivers are used to trial the fi nancial attractiveness that we saw in the strategic option grid, it can therefore be applied to strategic thinking too. Further, they can be useful in strategic infl uencing.

Figure 3 illustrates some of the key value and cost drivers for undertaking a clinical trial. These images highlight the number of implementation choices that are likely to impact on the development of a strategy for a clinical trial, and the work that is needed in order to arrive at a business case. This work will be partly qualitative in exploring these value and cost drivers at an even more micro level, and also quantitative in assessing the likely magnitude and timing of sales, the likely operating margin and the quantities, costs and timings of the resources consumed, phase by phase.

Our other tool, stakeholder analysis, allows us to judge how for or against the stakeholders are likely to be – and give their degree of infl uence. This requires taking the stakeholders’ own perspective either by asking them directly, or second-best by estimating their positions by imagining we are them (often called the ‘out-of-body experience’).

Stakeholder analysis allows one to take a ‘helicopter picture’ of the key players internally –both as groups and as individuals – and their positions in terms of both infl uence and also positive, neutral or even negative attitudes (their ‘agendas’) on either the whole decision or a part of it in an easy and visual way. These positions are likely to change over time and this can be represented too, either by directional arrows or through diff erent pictures for diff erent phases over time, or even as dynamic curves to plot the changing infl uence and possible attitude.

Stakeholder analysis has a number of major advantages over political ‘muddling through’:

Figure 2: Stakeholder analysis

Attitude

FOR

NEUTRAL

AGAINSTLOW

In� uence

HIGH

Distract or fragment

Take out of play

Leave alone

Coalition building

Win over/coalition building

MEDIUM

Figure 3: Value and cost drivers in clinical trials

VALUE DRIVERS

COST DRIVERS

Trials

Trials

Efficacy

Premium pricing Present value

Compliance

CRO

Our projectmanagement

Studydesign

Operational

Bidnegotiation

Systems

Inspections/audits

Systems

OurSupervision

Recruitment

People

Their systemspeople

Training

Leadership

Location

Drug needs

Patient fee

Shippinglogistics

Monitoring

Side-effectsTime tomarket

Safety

15



l It identifi es and prioritises the key players and also picks out those to target to infl uence; it also forces a more in-depth refl ection on current infl uencing strategies and tactics

l It can be used as a more open vehicle for discussing the diff erences in views and their reasons and challenges, whether these are valid or artifi cial

l A more realistic assessment of implementation diffi culty can be done, and this has more chance of being mitigated and minimised

l Decisions can be made faster and more easily to dissolve much of the organisational politics.Stakeholder analysis has been used to great

eff ect in pharma, for example in the organisation of clinical trials and in the formulation of regulatory strategy. It has proved particularly helpful, for example, through the ‘out-of-body’ experience of imagining the key stakeholder(s) from the potential stance of regulatory bodies.

In summary, MBA tools like the three examples explored above can prove to be extremely helpful on framing pharma challenges and dilemmas, and in diagnosing and resolving them.

Bringing it all togetherIn an ideal world one might well consider doing an MBA course to get up to speed with these skills. The benefi t of doing a full MBA is that one would be thoroughly immersed in the various disciplines in these and other areas too, including organisational theory, marketing and fi nance. Part-time programmes can typically be three years or more, also giving you exposure to managers from many other industries, as well as specifi c case studies.

The advantages of taking a full MBA are that one will get a major and sustained stretch in one’s thinking on the challenges that pharma faces, seeing the bigger picture and how the various aspects are interrelated. The disadvantages are that this is quite time-consuming and diffi cult to

do in a challenging regulatory role where longer hours are already the norm. The cost of an MBA is substantial, too. Having said that, there can still be a positive longer-term return, with one’s career sometimes signifi cantly advanced using this route. Carrying out a tailored value and cost driver analysis can be of help here.

An alternative is to focus on a smaller number of these areas, like the core fi ve that identifi ed here to be at the heart of the more strategic skills. Typically branded as ‘mini pharma MBA programmes’, these week-long courses can be particularly helpful as they are attended only by pharma professionals and can be used to get a taste of a fuller MBA without having to make a huge commitment.

What is certain is there are many routes forward to explore in exploiting new leadership and management skills and techniques as senior regulatory staff . Aspects of MBA thinking can play a major role in developing the more stretching skills to survive and succeed in the new pharmaceutical industry order.

basicsbasicsof Regulatory AffairsOne-day Foundation Course

5* hours*For more information please visit www.topra.org/lifelonglearning

Ireland

Date: 10 Nov 2011Place: Ireland

Italy

Date: 12 Dec 2011Place: Milan, Italy

The purpose of the dayThe purpose of this Basics course is to provide you with a clear and concise understanding of the role played by Regulatory Affairs in obtaining and maintaining Marketing Authorisations for pharmaceutical products.

The course tutorsAll of the tutors have many years of Regulatory Affairs experience and are currently working in the industry.

This course will give a basic grounding in a relaxed, enjoyable environment.

What previous delegates have had to say about this course…“ Speakers very clear, concise and informative” “ Excellent overview in such a short time!”“ Made things a lot clearer and gave me an understanding of how things link together.”

“ Well structured set of presentations and very informative.”

Our promise

We guarantee you will leave the course with a better understanding of the regulatory process and your role within it.

email: [email protected] tel: +44 (0) 20 7510 2560 fax: +44 (0) 20 7537 2003 web: www.topra.org

For more information, please visit: Ireland: www.topra.org/basicsireland2011 Italy: www.topra.org/basicsitaly2011

A one day course that identifies the function and role of Regulatory Affairs in industry, suitable for all new employees to pharmaceutical and medical device related areas, including medical manufacturing, marketing, sales and compliance

CorrectionOur September 2011 issue (Vol 8, No 9) carried an error in the article titled ‘The ABCs of PDUFA’. It stated (p19) that an FDAAA Risk Evaluation and Mitigation Strategy (REMS) provision became eff ective on 1 March 2008. In fact the relevant provision came into force on 25 March 2008.

focus – regulatory management & leadership effective ... · pdf filewithin the...

Documents