Industry Blog

This article will focus on the important role Regulatory Affairs has in the development of business strategy.

Regulatory Affairs professionals have many skills to offer their company – more than product registration and compliance. Regulatory Affairs people are central to everything that is happening and are therefore in the best position to have input into strategic discussions. These strategic discussions involve a comprehensive analysis of the business in relation to the industry, the competitors and the business environment in both the short and the long term. Regulatory people have: knowledge of the clinical data; established external relationships with key influencers eg TGA/FDA; knowledge of the competitive environment eg what is needed to get a product registered (eg clinical trial design); as well as an in-depth understanding of products in the same category and emerging products/therapeutic classes.

There are a number of business tools to review strategy and in this article we will consider Michael Porter’s five force model (“Competitive Strategy: Techniques for analysing industries and competitors” Michael Porter, Harvard University, 1980) and the role that Regulatory Affairs people will have in the strategic discussions.

Porter offers tools for investigating the five forces that determine the level of competition, and consequently, the level of profit in an industry.

Within the Strategic Framework Model, the five competitive forces within an industry are the:

1. Bargaining power of Suppliers
2. Bargaining power of Buyers
3. Threat of Substitutes
4. Threat of new Entrants
5. Intensity of rivalry among Competitors

1. Bargaining Power of Suppliers

 
The Suppliers to the pharmaceutical and medical industry include: providers of raw materials and intermediates; manufacturing and production plants; overseas head offices that supply finished product; local co-marketing partners; third party suppliers of all aspects of the supply chain; and suppliers of clinical trial data needed for submissions (investigators, patients, CROs).

The role of Regulatory Affairs in strategic discussions is to give insight into these Suppliers. In formulating the business strategy discussion centers around the degree of influence these Suppliers have on a particular business and determines action plans to work effectively with these Suppliers.

In strategic planning meetings the following questions are considered:

How much influence do our suppliers have?
How robust are our secondary suppliers? Will they always be able to supply?
Do we need another back-up supplier?
Should we buy the supplier (backward integration)? Will our competitors buy the supplier?
How much will it cost to switch suppliers?
Can our current supplier provide the volumes we require?
What factors will prevent our suppliers from delivering and do we have contingency plans?
Will they threaten to withhold supply and will this have serious consequences eg delayed regulatory submissions (if data is not available; manufacturing issues and delayed product launches)
How strong are our supplier relationships? Regardless of signed agreements, it is always people who do the work.

2. Bargaining Power of Buyers

 
The Buyers in the pharmaceutical industry are the TGA, PBAC, PBPA; Tender Boards, Hospital Boards; Drug committees; Chief Pharmacists; Patients and family members; and Head office/Partners buying regulatory submissions.

The contribution of Regulatory Affairs is to give insight into the needs and behaviour of these Buying groups.

In strategic planning meetings the following questions are considered:

What are the needs of the buyers?
Who are the decision makers?
How knowledgeable are the buyers and what demands are they making based on their knowledge?
How much influence do we have over the buyers and what do we need to do to increase our influence?
How price sensitive are the buyers?
Will they always be buying from us?
What volume do they buy from us versus our competitors?
How strong are our relationships with the buyers?
How can we add value to the buying process eg providing information services, bundling additional products, timely delivery, discounts, rebates.

These are all areas where Regulatory Affairs can make significant contributions to strategic discussions based on their knowledge of Buyers.

3. Pressure of Substitute Products

 
The third competitive force affecting a company is the real or potential pressure of substitute products. Substitute products can perform the same function as the product eg a substitute for an original product is a generic, and likewise some devices and interventions can substitute for pharmacology.

Regulatory Affairs professionals have an in-depth knowledge of existing and emerging substitutes and can offer strategic advice with regards: the development, timing and management of a generics strategy; and the potential uptake by the market of substitutes.

4. Threat of New Entrants

 
New entrants can impact business and how significant they are depends on the barriers to entry. These barriers can include: regulatory policy: patents, regulatory standards; capital requirements and financial resources – manufacturing, R&D costs, marketing, sales, distribution; access to distribution channels: preferred agreements/tenders; brand reputation of the product/company and established business relationships.

In discussing the threat of new entrants and the barriers to be erected, regulatory professionals have the knowledge and contacts to ask:

What information do we have about new entrants?
What clinical trial data is being presented at conferences?
What products are being registered in overseas markets?
What strategy will the new entrants likely adopt?
What do we know about the potential products?
How good are the products versus our own?
Should we consider leaving the market?
What can we do to prevent new entrants from arriving?
Can we make the regulatory conditions tougher?
Can we block distribution channels?
 

5. Rivalry between Competitors

Rivalry occurs because one or more competitors either feels the pressure or sees the opportunity to improve position. Rivalry among firms takes the form of jockeying for position using tactics like: price competition, advertising battles or product introductions.

Regulatory Affairs professionals have a particular level of insight with regards rival companies. They understand the patent status of their portfolio and can offer advice on patent extensions (eg manufacturing and process patents) to prolong the product’s life cycle. They are involved in Code of Conduct challenges with rival companies and have an in-depth knowledge regarding the competitor’s supporting clinical data. And they can offer advice as to what rival companies are likely to do in the marketplace and are closely involved when companies go into battle using advertising wars or litigation.

During strategic planning sessions each of these competitive forces are analysed in detail. After the analysis of these forces, the business can then determine: its strengths and weaknesses with regards suppliers and buyers; where it stands against substitutes; its position relative to entry barriers; and its ability to cope with rivalry from competitors.

Businesses compete by understanding their sources of competitive advantage. Through using the Porter model Regulatory professionals can offer insight on how to compete more effectively within the industry.

 In the June 2010 issue of the Harvard Business Review authors Paul Leinwand and Cesare Mainardi discuss effective corporate strategy and cite Pfizer as an example of a company who excel at the “Coherence Premium”.

Companies that focus on what they do best deliver sustainable, superior returns. The authors propose that in developing their strategy companies should firstly determine what they are really good at and then develop these capabilities until they are ‘best-in-class and interlocking’.  Following this, strategic decision-making involves aligning the distinctive capabilities with the right marketplace opportunities. The result will be significant returns to the company, measured as the ‘coherence premium’.

These capabilities include everything that a company does well, that customers value and competitors can’t beat. Capabilities are an ‘interconnection of people, knowledge, IT, tools and processes that enable a company to outexecute rivals on some important measure.’

‘Coherent’ companies build deep, scalable capabilities in several areas, and align their strategy and day-to-day decision-making to take advantage of them.

In a case study of Pfizer the authors further examined this ‘coherence premium’. Following the acquisition of Warner-Lambert and Pharmacia in the early 2000s Pfizer set the goal of becoming the leader in global consumer healthcare. They first examined the market dynamics to determine how the company should compete and realized that demonstrable health benefits mattered more than category strength in driving sales.

Pfizer identified a core system of six interlocking capabilities:

1. Science-based innovation around formulations.
2. Ability to influence regulatory management and government policy.
3. New product development through the Rx-OTC switch as well as through licensing and acquisition.
4. Claims-based marketing featuring a demonstrable health benefit.
5. Channel management in both general trade stores and pharmacies (particularly product positioning, pricing and promotion).
6. Focused portfolio management of aggressive and moderate growth brands and geographies.

Each of these capabilities was important, but it was the way they worked together that was competitively differentiating.

For Pfizer to build an unbeatable franchise in claims-based marketing it needed science-based innovation, as well as robust Rx-OTC switching capabilities to ensure the supply of formulations about which to make those claims. It needed to get the claims approved by regulators and it needed to translate these claims into terms consumers could understand when they made their purchase decisions.

Having decided how it would compete and on what capabilities it would compete, Pfizer executives then identified those products that no longer fitted with the strategy and divested them. These divestitures enabled Pfizer to focus more attention and resources on growing its global healthcare brands at above-market rates and acquiring new brands that could be differentiated based on claims.

The authors also studied other companies and concluded that coherence in capabilities correlates strongly with greater profitability.

Coherence creates value in four ways:

1. It strengthens a company’s competitive advantage. Companies that focus on their capabilities continually improve them; employees become more skilled and systems more robust.
2. Coherence focuses strategic investment. Coherent companies direct capital, time and talent to those activities, products and businesses that enhance their position.
3. Coherence produces efficiencies of scale in that the same capabilities are deployed across a larger array of products and services.
4. Coherence creates alignment between strategic intent and day-to-day decision making. Coherent companies execute better and faster because everyone understands what’s important.

Companies who pursue a capabilities-driven strategy achieve sustainable and superior results because they have an aligned strategy, capabilities system and product and service portfolio.

2010 Budget Review comment:

Contributed by Alex Gosman, Alex Gosman Consulting Pty Ltd

Health reform has been a dominant policy issue for the Government and the opposition in the run up to the 2010  Budget.  Whilst the Treasurer Wayne Swan delivered on 11 May a “beige” budget with relatively little in the way of spending initiatives “health” again featured prominiently both in terms of new initiatives and also in offering expenditure savings from the PBS.

 The Government announced further spending initiatives as a follow up to the Health and Hospital Reform Commission Report focussing on e-health, Medicare Local (after hours support for patients) and an extension of super clinics. The continuing spending initiatives on health reform has placed additional pressure on Minister Roxon to obtain savings to balance the books.

After an extensive period of negotiation the Government was able to announce a $2.5 billion reduction in PBS expenditure over the next 5 years.  The savings are achieved primarily from a near $2billion cut in re-imbursement to manufacturers but also from the flow on reductions in payments to pharmacists and wholesalers from lower priced drugs. 

Medicines Australia should be congratulated for negotiating a Memorandum of Understanding with Minister Roxon to provide a five year period of stability for the PBS although offering price reductions.  This compares dramatically to Europe where the pressures from the financial crisis hitting a number of countries has seen budgets slashed including funding for pharmaceuticals with for example a 21.5% price reduction in Greece.

Whilst the pharma industry has been able to achieve some predictability going forward in Australia the reductions in reimbursement will cause real pain across the industry particularly for those companies with major branded generic portfolios or for those companies primarily focussed on the generic market.  It will maintain pressure on margins and staffing levels in Australia likely to be compounded by any major changes in reimbursement in major overseas.

Alex Gosman Consulting Pty Ltd

Email: alexander.gosman@bigpond.com

The keynote speaker at the second day of the Marketing Excellence and Analytics conference (27th-28th April) was Ian Thompson, Managing Director, Amgen Australia. Ian spoke on “Specialty care sales and marketing excellence. What will the future bring in Australia?”.

Ian’s theme was “change or be changed”. He opened his presentation with the question: “We are standing at a crossroads. Where do we go from here, and what do we need to do now?”

He commented that existing business models will not produce excellent results for companies in the future. The current market is dynamic and there are many drivers forcing change on industry fundamentals. Transitioning to the future, companies will need to initiate new capabilities, particularly with regards Key Account management and Payer management.

Key to the marketing success of any product is the effectiveness of the launch. In today’s environment a great launch involves strong uptake, market share leadership and an excellent return on promotion investment.

For success in the future there needs to be more. Broad indications for products will become extinct. Instead companies will undertake more detailed and robust segmentation with deeper customer insight and will enter a market with a narrower indication which they will expand later. When designing clinical trials they will need to accept riskier research targets to demonstrate cost-effectiveness, and will need to continue to gather data to defend their prices.

For success, companies will need new business models and new ways of thinking. They will need to understand the power of the payer vs the power of the prescriber and consider what they are doing with regards placing their resources to engage with these groups. Successful companies will understand how funding flows in particular disease areas; will recognize the decision makers controlling funds; and will understand the motivation and decision criteria of these decision makers.

So what will the future healthcare arena look like in say 2020?

- The burden of chronic disease will continue to soar.
- Health policy makers and Payers will increasingly mandate what doctors can prescribe.
- There will an increased focus on Pay for Performance.
- The boundaries between different forms of healthcare will become even more blurred.
- There will be an increased focus on prevention.
- Regulators will become even more risk averse.

Moving towards 2020 there will be opportunities to expand markets. This is because there will be an increase in the diagnosis rate of some diseases; an increase in the speed of this diagnosis; changes in the standards of care; improved compliance; and increased loyalty from prescribers and patients. Companies will strive for deeper customer insights and with this knowledge they will try to remove barriers to patients receiving treatment.

There will also be an increased use of technology within the healthcare sector, especially with regards e-prescribing, the use of the Internet, and more comprehensive usage of electronic personal records. For future success companies will need to take technology seriously and seek out major advances in how they work with the developing tools.

To compete effectively within the changing environment companies will need to accept a more innovative way of working. What worked years ago won’t work in the future. “Traditional models of marketing have changed since the days when your bosses boss had success”. These bosses today need to embrace new ideas and accept changes. Senior leaders working with Human Resources need to develop and build top talent so that their organizations can compete to Best Practice standard in tomorrow’s market.

I recently attended the Marketing Excellence and Analytics conference (27-28th April) where Alex Gosman, Director, Alex Gosman Consulting and ex External Affairs Advisor, GSK, presented his thoughts on “The healthcare environment in Australia: Future changes and impacts on your business”.

His overall message was: “Act now or lose your place in Australian healthcare”.

Looking into the future more products will be coming off patent; and there will be increasing pressure from government wanting more generic substitution. The main issues will be those of access and price. Alex posed the question: “Are companies willing to take a larger price reduction to gain earlier access to the PBS rather than offering a smaller price reduction to have it rejected?” He went on to suggest that industry needs to adopt a new mindset. Rather than continuing with the current business models industry needs to involve government and the community more. In the next few years there will be a move away from the ‘Instant Blockbuster’ to a ‘Progressive Blockbuster’ where approval will be initially given for a narrower indication and then a broader indication will be given when new clinical data becomes available. This will ultimately result in less return for industry and the introduction of new challenges for marketers.

Alex stressed that the current Health Minister, Nicola Roxon, has a busy agenda (ie National Health and Hospital Reforms; Preventative Taskforces; Health Taskforce; Primary Healthcare; Mental Health; Dental Treatment; Pandemics; the Guild Agreement; PBS Reform; Aged treatment and Immunization). With so much taking her attention, it’s up to industry to work with her, not against her.

Looking into the future we will continue to see:

- The maintenance of a robust approach to evaluation.
- Increased data being required, particularly post evaluation
- More Therapeutic Group Premiums
- An increased focus on the Quality Use of Medicines.
- Increased funding pressure for high value, low volume drugs.
- An extension of risk sharing arrangements.
- An increased focus on generic savings
- More HTA Assessments
- More global consistency
- An increased influence of prevention/managed care.
- Further Guild Agreements
- Hospital reform.

In considering the above points the main issue is the need for industry to engage with the Payers ie companies need to work with Government, not against Government. In doing this companies need a coordinated approach in dealing with the PBAC; they need to ensure that overseas trials are relevant to local needs; and they need to demonstrate their value proposition (especially the value to the patient).

Alex stressed that “Government understands the pharmaceutical industry more than industry understands the Government’s perspective”, and that “there needs to be genuine commitment and direction at the top levels of companies to working with Government, on Government’s terms.” In the changing healthcare environment he recommended that companies improve their effectiveness by 1. increasing their cross-functional alignment and 2. increasing their External Affairs function to effectively engage with the future Payers.

Facebook’s popularity is increasing in the commercial sector, with active participation from the pharmaceutical and medical industry. Facebook isn’t just for chatty teenagers anymore. Thousands of companies use the site on a daily basis to drive business objectives. They are using Facebook to engage with their market, to build on-line communities, and to deliver coordinated, branded programmes to their consumers. The result of this is enhanced connectivity and stronger emotional bonds between companies and their followers – being the main objective of any social media and networking initiative.

So what is Facebook? It’s a free, easy-to-use, social networking site created in 2004 by Mark Zuckerberg. It started as a way for Harvard students to meet on-line and it quickly expanded to include other universities and then to anyone aged 13 and over. (For a really interesting account of the formation and growth of Facebook read “The Accidental Billionaires, by Ben Mezrich, 2009).

Users can create profiles with contact information, photos, lists of personal information and other relevant information, and they can create and join interest groups. Communicating with friends and other users is then done through messaging and chatting, by using the Wall, Photos and the Status functions of the site.

The use of Facebook dramatically changed for business when Pages were introduced in 2007. Pages are Facebook profiles for entities other than individual people, like brands, companies, organizations, music bands or community groups. Pages are similar to a user’s personal profile with some significant differences which are useful within the business context. They are designed especially for advertising; aren’t subject to member limits so that they can have an unlimited number of fans; and are more search-engine friendly than personal profiles.

A Facebook member surfs to a Page (through searching, browsing or following a link) and they then sign up as a fan of the Page. Once a fan, they join into the communities activities.

Companies are using Facebook for several reasons. Connecting with current, past and future employees is one of the reasons companies have been using Facebook.  There are a number of groups (both official and unofficial) on Facebook with members from various companies and interest groups. These groups of employees can then stay in touch and enhance their global networks. Official company Pages are used to attract new employees to the company through the promotion of benefits, testimonials, and YouTube videos. A number of companies including AstraZeneca, Boehringer Ingelheim, GSK, Novartis, Pfizer and sanofi aventis, have a Facebook presence with fan pages targeted to bringing different groups of employees together, or driving recruitment initiatives.

The area that is developing with regards pharma’s use of Facebook, and the area which is being closely scrutinized, is the promotion of disease awareness and treatment adherence.

Here’s a few examples:

• The Gardisal Facebook Page (http://www.facebook.com/takeastepagainstcervicalcancer) was the first pharma page, and now has over 100,000 fans. The Page includes Patient Product Information and Prescribing Information; steps to prevent cervical cancer; videos of patients; and facts about HPV and cervical cancer.

• Astra Zeneca has launched their Community Connections Facebook Page (http://www.facebook.com/AstraZenecaUSCommunityConnections) which highlights the donations they have made to those organisations focused on disease awareness and prevention, education and research eg sponsoring Start! the American Heart Association’s movement to get Americans up and moving; launching the US AGAINST ATHERO Campaign, a national education program to raise awareness of atherosclerosis; and opening Astra Zeneca Hope Lodge Centers to provide a home away from home for cancer patients and their families who travel for treatment.

• Novartis has a Fan Page for Zometa. The mission of the page is to “educate patients with bone complications from metastatic breast cancer about the risks and benefits of Zometa, using actress Marcia Strassman as a patient advocate. The site has 6,842 fans.

• Novartis’ Page On-the-Go Women focuses on osteoporosis and includes information on weight-bearing exercises, calcium rich recipes, real stories from patients and product information.

• Bayer’s Strong@Heart Page on Facebook has over 30,000 fans and uses the site to share the latest news and information about heart disease through media clips, podcasts and interviews with experts.

• GSK’s Nicorette Page includes a range of tips and techniques to cope with withdrawals, patient support stories, and health checks.

For additional examples there’s an excellent resource called the Pharma and Healthcare Social Media Wiki, which can be found at http://www.doseofdigital.com/healthcare-pharma-social-media-wiki/).

The increasing use of social media within the pharmaceutical and healthcare sector is being monitored in the US by the FDA, and in September 2009 they asked for comments on the: “Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools”.

According to the FDA, “The continually evolving nature of the Internet, including Web 2.0 and social media tools… have raised questions and concerns over how to  apply existing regulations to promotion in these newer media.”

Patients, caregivers and healthcare professionals are using the Internet and social media to receive information and to participate in online conversations about products. In order to provide balanced information companies want to participate in these conversations but need guidance from the regulators on how to participate.

To date the approach by pharmaceutical companies has been cautious and controlled. Social media is a revolution with regards communication and engagement. Just how it will be managed in relation to the more traditional means is currently being determined. It remains to be seen as to whether or not Facebook will be fully adopted by the pharma sector or whether future growth will be in the more consumer oriented arena.

Every day millions of professionals are using Twitter to share ideas with others, gather real-time intelligence and build relationships.

This article summarizes my personal introduction to, and views of, Twitter. Throughout 2009 I’d been hearing a lot about Twitter but I didn’t understand it and couldn’t appreciate its value, so I started to investigate it more fully. After reading many books and spending countless hours on the Internet I could see where Twitter was going but still struggled with its value. I compared the process I was going through to that of learning a new language. I surmised that if millions of people were doing it, something must be making sense to them, so I persevered.

I set up my Twitter account and started following people. Then I discovered that major pharmaceutical and healthcare companies, medical education and communication companies, government bodies and patient associations were on Twitter and were publishing interesting information. That’s when I had an ‘A-ha’ moment and now fully appreciate the significance of the service and use it every day to stay up-to-date and connected. The experience I had in getting started with Twitter is very similar to that of most new Twitter users.

So what is Twitter? Twitter is a very powerful communications platform which is highly useful for both personal and business needs. It was developed in March 2006 within a small San Francisco podcasting company and has experienced rapid growth over a very short period of time.

Twitter works this way. Twitterers or tweeters send and receive short messages (140 characters) called ‘tweets’ on Twitter’s website or with mobile phones. When a user logs in, Twitter asks one simple question: What’s happening? Users then answer in 140 characters or fewer. Because of the 140 limit Tweets are easy to write and read. They’re like news headlines.

Twitter is a ‘recipient-driven information network’ – ie you decide what messages you want to receive. People choose to follow other people and receive a stream of their messages. Messages are distributed in real-time and can be sent and received from mobile phones, PCs or websites.

When Twitter first started it asked the question “What are you doing” and people responded with comments like “having a coffee, going to the beach, watching a TV show etc”. Many people still use Twitter for this purpose so that they can stay connected with their friends. However Twitter has evolved over the last year and people have been having more serious dialogues and have been commenting on significant events in real time. In November 2009 Twitter changed the question to “What’s happening?” and as a result the type of information being exchanged has improved.

Twitter has become a great way of sharing common experiences, be them emergencies, organized events, concerts or conferences. People within the moment are sharing their experiences and their messages are being relayed virally.

Twitter is also emerging as a key business communication channel, one where companies engage with their customers and stakeholders in a very direct and public way. Through Twitter businesses can monitor what people are saying about their products and services; they can respond to customer requests; provide information and links to additional services; and run customer-engagement programmes. In short, they can add value to the communities in which they operate.

Twitter is becoming increasingly popular with professionals, especially healthcare professionals. As Twitter has gained followers people are using it more and more to talk about what they’re reading or thinking about and often including links to good content. Through this Twitter is distributing ideas and comments from experts in their field. There’s still a lot of nonsense on Twitter however if you carefully choose the people you follow you will be rewarded with a valuable stream of news and current events.

Within healthcare there are a number of emerging uses for Twitter. These have been summarized in a recent article (Healthcare advances use of Twitter. 140 healthcare uses for Twitter at http://philbaumann.com/2009/01/16/140-health-care-uses-for-twitter/) and some include:

1. Tissue recruitment (for kidney and other organs, including blood)
2. Epidemiological surveys
3.Disaster alerting and response
4. Emergency response team management
5. Adverse event reporting in the clinical setting and other pharmacovigilance functions
6. Drug safety alerts from the FDA
7. Daily health tips from authoritative sources
8. Environmental alerts: pollen counts, pollution levels, heat waves, severe weather alerts
9. Publishing health-related news
10. Publishing disease-specific tips
11. Publishing the latest advances in pharmaceuticals and  biomedical devices
12. Live-tweeting from medical conferences
13. Clinical Trial awareness
14. Product safety alerts
15. Discussing public health care policy

Within the pharmaceutical and medical industry Twitter has developed solid traction, particularly in the US. Major companies such as Allergan, Amgen, AstraZeneca, Baxter, Bayer, BD, Boehringer Ingelheim, Bristol-Myers Squibb, Genzyme, Medtronic, Merck Serono, Novartis, Pfizer, Roche and sanofi aventis are all active on Twitter.  They report results of clinical trials, mergers and acquisitions, attendance at conferences and breaking news.

On my company’s news Twitter site (www.twitter.com/PMPConnect) we follow these companies and retweet significant events. We also comment on industry issues and update our followers with real-time, relevant information. Signing up is quick, free and easy. Simply go to www.twitter.com and click the Sign Up Now button. Once you’ve created an account go to our Twitter site and click Follow, on the top left. Then search Twitter and follow other accounts, and when you login again you will have a stream of up-to-date topics to read and respond to.

Twitter is a powerful means of conversation, idea-sharing and collaboration because it’s an easy-to-use combination of messaging and microblogging. It will continue to grow and evolve within the Social Media space and at some stage will be replaced by newer technology (remember Netscape before Internet Explorer; and AltaVista before Google). Regardless of how it develops Twitter is changing the landscape of social communication within healthcare.

There’s a useful article in October’s Harvard Business Review about undertaking overseas assignments (Three Keys to Getting an Overseas Assignment Right, by Mark Clouse and Michael Watkins, HBR Oct 2009, p.115; http://hbr.harvardbusiness.org/2009/10/three-keys-to-getting-an-overseas-assignment-right/ar/1). It’s centered around a senior manager who works for a pharmaceutical company and has just moved to China.

The article provides advice on how to make a successful transition from a leadership position in a familiar setting to a position of similar or greater responsibility overseas.

The first principle is: Establish the Family First. If disruption for the family is minimized there are increased odds that everyone will thrive in the new setting. A crucial factor in ensuring a smooth transition is to retain as much of the familiar as possible, and to set up support networks to combat feelings of isolation and dislocation.

Principle 2: Build Credibility and Openness from the Start: Don’t try to “fix” problems first, rather ask people lots of questions even if you are sure you know what the central issues are. Setting up your office can wait. Go to the front lines right away and really listen. Start reaching out on day one.

Principle 3: Get Serious About Compliance: It’s critical for transitioning international executives to consider, identify and manage compliance issues. Taking the unofficial role of chief compliance officer, executives need to systematically ask people in the front lines detailed questions about their actions. It’s important to be able to differentiate between serious compliance lapses and unfamiliar but acceptable ways of doing business.

International assignments are exciting and challenging and managers grow and develop through their experiences.

Readers are invited to share stories related to “Getting an Overseas Assignment Right”.

I’ve just read an interesting article in the Harvard Business Review on mergers (Mergers That Stick by Rosabeth Moss Kanter, HBR Oct 2009, p 121; http://hbr.harvardbusiness.org/2009/10/mergers-that-stick/ar/1).

The pharmaceutical and medical sector has certainly seen a number of mergers over the years. Many candidates we talk with have been through two or three mergers during their careers. We get to hear their various stories about merger successes as well as a number of stories where the outcome has been less than successful. That’s why I found the HBR article interesting.

It highlights the importance of getting it right by truly focusing on the people involved. Rather than having scenarios of winners and losers, successful mergers embrace their new talent and work towards quickly integrating and motivating their employees. The result is less disruption, increased market share and a culture of innovation and adaptation.

The research in the article involved 350 interviews in 20 countries with the goal of identifying the practices of industry leaders. It was found that in successful mergers there was heavy investment in “emotional integration” events which were designed to forge relationships and form social networks. Companies complemented these events with specific training in relationship building and networking.

By doing this, attention is drawn away from territoriality and conflict and towards collaboration. Real value is then created by attending not only to operational integration but to the integration of talent.

Many readers would have experienced or witnessed mergers within the pharmaceutical and medical industry and you are invited to share you stories and thoughts.