Industry Blog

In this blog I’ll highlight several key developments within the regulatory environment in Australia and New Zealand. The material was presented at the ARCS Regulatory conference (Canberra 15/16 September 2011).
 

HARMONIZATION

The conference plenary session was opened by Megan Morris, Department of Health and Ageing, who has been appointed Deputy Secretary in charge of trans-Tasman harmonization. This initiative first started in 2003 with a Treaty to establish a joint trans-Tasman regulator (aligned to the principles of the trans Tasman Mutual Recognition Agreement (1996) promoting closer economic ties). During the period 2003-2007 negotiations between Australia and New Zealand proceeded, and in 2007 the process stalled when New Zealand was unable to get the necessary legislation through their Parliament. The initiative has since been reinvigorated with the signing of a Statement of Intent by Australia and New Zealand on 20 June 2011 to establish the Australian and New Zealand Therapeutic Products Agency (ANZTPA).

A progressive implementation over a period of 5 years is planned. The 3 staged approach will comprise:

1. Enhanced business to business cooperation and resource sharing.
2. Agreeing a common framework and a single entry point for business.
3. Establishment of a single agency.

This staged approach will bring benefits early on and will increase shared learning resulting in better outcomes. The staged implementation will have regard to new regulatory developments since 2007, and the current TGA reform process. A Ministerial Council (comprising Australian and New Zealand Ministers) will oversee implementation and a Transition Agency will be established to drive implementation and inform the Council.

Dr Stewart Jessamine, Group Manager Corporate, Medsafe, then provided an overview from the New Zealand perspective. He outlined that since 2007 there have been structural and process reforms and quality and performance reviews of the New Zealand regulatory system. This has resulted in a highly effective and efficient system, an abbreviated evaluation process, changes to the orphan/niche medicine approval process, Good Clinical Practice Guidelines more closely aligned to ICH, new pharmacovigilance systems (whereby 90% of GPs can report into a national ADR database from patient records), the introduction of quality systems and the setting of performance targets.

Overall ANZTPA will provide:

A single regulatory authority
A single enforcement scheme
A single market for therapeutic products
Pre and post market centres of excellence
Risk appropriate regulatory frameworks
An inclusive, transparent and open regulatory scheme
A cost effective regulatory scheme.
 

REFORM

Professor Dennis Pearce, Chair TGA Transparency Review Panel, discussed the consultation process that led to 21 recommendations, centered around increased accountability and transparency.

He outlined 3 groups of recommendations:

A. Raise stakeholder involvement in the TGA
B. Post-market (monitoring and compliance)
C. Market Authorization Process

A. Raise Stakeholder Involvement in the TGA

1. Establishment of an Australian Therapeutic Goods Advisory Council.
2. Consultation principles to guide transparency and accountability.
3. Comprehensive communication strategy to inform and educate.
4. Work transparently with other key providers of information.
5. TGA website up to date and meets audience needs.
6. User-friendly information on risk-based framework.
7. Education about non-evaluation of listed medicines.
8. Clear, consistent statutory advisory committees.
9. Improve access and quality of information on advertising and complaints.
10. Key Performance Indicators (quantitative and qualitative) on operational effectiveness and efficiency.

B. Post Market (Monitoring and Compliance)

11. Policy on disclosure of commercially confidential information.
12. Explanation on regulatory processes and publish outcomes of application assessments.
13. On-line system for submission and tracking of applications.
14. Improve labelling and packaging to aid consumer and health practitioner decision making.

C. Market Authorization Process

15. Early post marketing risk communication scheme.
16. Actively promote safety information and timely alerts and recalls.
17. Maintain currency of CMI and PI.
18. Publish the outcomes of investigations and compliance actions.
19. Facilitate recognition and reporting of adverse events by health practitioners and consumers.
20. Adverse event database available and searchable to support quality of therapeutic goods.
21. Improve visible management of adverse event reporting.

These recommendations have been passed to Government and are under active consideration.

The overall aim of the reforms is to have an appropriate, consistent, effective, efficient and transparent regulatory system.

Medical Directors have a pivotal leadership role within pharmaceutical companies and in this article I’ll profile their typical day.

Essentially the role of a Medical Director is to oversee all activities within a company’s Medical Department and to contribute to company-wide business operations through involvement in the senior leadership team.

In Australia Medical Departments vary in size from 2 to 100 people, and the responsibilities of the Medical Director vary correspondingly. In a small department the Medical Director is very hands on and will be closely involved with all functions. In larger companies the Medical Directors immediate reports will include Associate Medical Directors, Medical Advisers, and Heads of Clinical Research, Regulatory Affairs, Medical Information and Health Economics.

The Medical Director’s daily activities can include emails and phone calls, going to internal and external meetings and travelling.
 

1. Emails:

These are some of the requests that would be coming to the Medical Director: Head Office questions requesting updates on clinical trials, regulatory or health economics submissions eg “How is patient recruitment going in x trial”? “What did x investigator think about the draft protocol for the new trial”? “How many patients will Australia be able to commit to the global clinical trial program for x compound? “Here are the results from x trial to discuss with your investigators”;  “Here are the responses to the questions the TGA are asking about the compound which is being reviewed for registration”; “Here is some additional data to include in the reimbursement submission”; Here is a report on the serious adverse events in x trial”.

Similarly the emails being sent out by the Medical Director would include clinical trial updates (patient recruitment, questions from investigators), requests for funding to support additional patient recruitment; updates from discussions with regulators, key opinion leaders, advisory boards, patient associations.

There will also be lots of internal emails focusing on the business operations (such as agendas for meetings, finance issues, training and people management, sales and marketing initiatives).

2. Phone calls:

Calls will be received from trial investigators (around Inclusion/ Exclusion criteria eg “My patient is also taking x drug can I enrol him”; or around the clinical protocol eg “If the patient had missed 2 visits can they continue in the trial?). Calls will also be coming in from CRAs who are on-site at hospitals doing monitoring visits (eg “The study nurse needs more drug and I need your help in getting head office to send it quickly”).

The press may phone asking for a response to an overseas article on one of the company’s drugs. As the medical leader within companies the Medical Director is frequently asked to publicly comment on a range of topics, and would have undergone media training.

There will also be phone calls from patient associations regarding sponsorship; from doctors requesting patient-specific medical advice; and from investigators asking to have their own trials supported.

3. Internal Meetings:

During a typical day the Medical Director will attend lots of meetings.

Firstly there are the Departmental meetings. In the Clinical Research meetings a whole range of issues will be discussed. Progress made in all the clinical trials will be regularly reviewed.  Topics of conversation will center around Ethics Committee approvals, strategies to increase patient recruitment; availability of trial materials, site issues and management; trial budgets and payments and adverse event reporting.

Within Clinical Research meetings new trial protocols will also be discussed. This will involve reviewing protocols sent from Head Office, discussing whether they are applicable to Australian medical practice and identifying potential investigators.

In the Regulatory meetings the registration of New Chemical Entities, new dosage forms and new indications will be discussed. There will be updates on timelines for regulatory submissions and discussion on bottlenecks and issues which may delay registration.

During the meetings correspondence from the TGA will be reviewed and appropriate responses drafted; and the wording of PIs and CMIs will be finalised.

During the Medical Information meetings company promotional literature will be analysed to ensure that it meets Code of Conduct guidelines, with approval being given by the Medical Director prior to printing and distribution.

The focus during the Health Economics meetings is on reimbursement and market access. The strategy for PBAC submissions will be decided upon; the clinical data supporting the pricing strategy will be analysed; and additional supporting trials or analyses will be considered. Input from consultants (eg on economic modelling) and direction from head office (eg on international pricing) will be used to determine the negotiation strategy with the PBAC.

At these meetings there will also be discussion on the design of future clinical trials to ensure that they collect the right information for submissions. The Medical Director’s input will also include suggesting disease relevant health status questionnaires and Quality of Life instruments to incorporate into the trial design, as well as suitable gold standard comparator treatments relevant to medical practice in Australia.

In addition to Departmental meetings the Medical Director is also involved with across-company meetings.

One of these will involve having strategic input into the marketing meetings. The Medical Director’s medical knowledge and understanding of how patients are treated is useful when annual marketing plans are devised. Topics during these meetings include: sales forecasts, market trends, competitor activity, promotional programs, disease management programs, patient characteristics, and prescriber behaviour.

The Medical Director will also speak at the company’s national sales conference and product launches where they will discuss clinical trial results and facilitate disease area training.

During senior management meetings (also attended by the Managing Director, Sales and Marketing Director, Operations Director, Human Resources Director and Finance Director) the Medical Director will contribute to across- business discussions where a wide range of topics will include: operational and strategic planning, resource management, learning and development plans, succession planning, manufacturing and supply chain issues, policy development, external and corporate affairs initiatives, crisis management, and the monitoring of the company’s trading and cash flow position.

4. External Meetings:

The Medical Director may be responsible for assembling and managing Key Opinion Leader advisory groups for key products. The advisory group’s role is to review particular products (pre-launch or marketed), discuss where the product fits into the management of the patient’s disease, to suggest synergies with other company products and to discuss leading developments in the field. Information gained during these discussions is then summarized and made available to marketing and R&D functions.

It is also likely that the Medical Director will participate in Medicines Australia and other industry committees thus ensuring that their company has a high level of professional standing.

External meetings will also include co-visiting doctors with CRAs to discuss current and future clinical trials, and with sales reps to discuss the company’s marketed products.

5. Travel:

As the company’s senior medical person the Medical Director travels extensively and represents the company via presentations to groups of experts, societies, regulatory bodies and at international meetings.

Whilst visiting hospitals the Medical Director will meet with Key Opinion Leaders to discuss clinical trial progress and results; to ask them questions regarding the feasibility of future clinical trials; and to discuss their involvement on Advisory Boards.

In Canberra the Medical Director will meet with the TGA where they will discuss scientific and clinical data with the regulators and build on-going relationships with key people.

When attending overseas meetings with Medical Directors from other countries there will be discussions on global clinical development programs; regulatory timelines for key compounds and strategies to gather data in support of reimbursement and market access.

When visiting regional offices (eg Singapore) or global Head Office (US, UK or Europe) there will be meetings with internal colleagues to build relationships; to request resources and headcount for Australia and to provide updates on clinical trials and regulatory, reimbursement and other medical issues.

Summary:

The typical day of a Medical Director within an Australian pharmaceutical company is varied and complex. As the company’s senior medical person they are called upon to use their clinical knowledge and understanding of patient treatment protocols to advise their internal colleagues on clinical research, regulatory, medical information, reimbursement and sales and marketing issues. As a member of the senior leadership team they use their medical knowledge and commercial acumen to contribute to the overall success of the company.

Slides of this article can be found at http://www.slideshare.net/pmpconnect

I recently attended the ARCS Annual Scientific Congress (26-27 May) and found the first session on Personalized Medicine very interesting. Over the last couple of years we’ve been hearing more and more about “Personalized Medicine” and to have it presented as a key note session highlights the rapid development of this field.

Three speakers (Dr Penny Wilson, Technology Strategy Board UK; Associate Professor Grant McArthur, Peter MacCallum Cancer Centre, Melbourne and Professor Robyn Ward, Prince of Wales Hospital) discussed the emerging issues and trends in personalized medicine including point-of-care testing, the impact on clinical trial design and patient subgroups, genetic biomakers as predictors of disease and the implications of personalized medicine on the registration and reimbursement of pharmaceuticals.

In short, personalized medicine is all about finding a targeted drug to suit the individual. It involves giving the right patient, the right drug, at the right time and in the right dose.

Speakers noted that pharmaceutical medicine has previously centered around gaining data from large cohorts of patients. However these large global studies have not taken into account genetic variability of individuals within populations and that this may explain the lack of response of some patients to medicines. For example, we heard that: 90% of drugs work in only 30-50% of individuals; 10-30% of patients who take ACE inhibitors and 15-25% who take beta-blockers are non-responders; and that $350 billion is spent annually on ineffective medicines globally.

With advances in molecular profiling technologies (proteomic profiling; metabolomic analysis and genetic testing) more information is available on how a particular patient may respond to a particular treatment.

A case study was presented by A/Prof McArthur of a 65 year old woman with pulmonary metastases from metastatic anal melanoma. At the time of presentation there was no genetic information available and the patient did not respond to standard chemotherapy. However following testing, when genetic information became available, a mutation (KIT 820Y) was found and specific therapy aimed at this mutation was commenced, with the tumour shrinking after 4 months of treatment.

The majority of research has been conducted in oncology however there are also rapid advances within the fields of infectious diseases; degenerative diseases; and metabolic disorders. Within these areas it was discussed that many novel therapies are very effective, but only in a proportion of the target population. Many clinical trial programs are now incorporating the use of biomarkers into their protocols to identify the characteristics of those patients which respond favorably.

The objective of personalized medicine is to identify these populations and to commence appropriate treatment. Identifying subpopulations that respond will also provide better long term outcomes and increase the cost-effectiveness of the drug.

Personalized Medicine has also seen an increase in the development of companion diagnostics whereby molecular assays measure levels of proteins, genes or mutations. Based on these measurements specific therapy can then be provided for an individual’s condition.

Additionally the session highlighted that recent advances in genetics will make it possible to predict an individual’s predisposition and likelihood of developing a disease (eg Type II diabetes) and this knowledge can be used for preventative interventions.

We have therefore entered the age of molecular information. This molecular information will improve our health and our lives and with personalized medicine an earlier diagnosis and the commencement of earlier treatments and interventions will result in better long term outcomes for patients.

For industry, personalized medicine involves taking a highly targeted approach to drug development. This will result in faster time to market through faster regulatory and reimbursement processes (because better data is being collected); increased targeted prescribing and increased market share within specialized areas.

The pharmaceutical and medical industry is constantly evolving. To meet changing market needs business leaders seek new business models. Having just read the latest Harvard Business Review (Jan-Feb 2011) I recommend anyone involved in business planning and strategic management to read the articles in the Spotlight section (pages 79-114) “Business Model Innovation”.

The first article, “Reinvent Your Business Before It’s Too Late” (Nunes and Breene) highlights that successful companies do three things differently from less-successful companies. 1. They focus on edges – they pay attention to the edge of the company and the edge of the market, in order to avoid the myopia that long-running success engenders. 2. They shake up the top team – they change the makeup of the senior team earlier, and more radically, than their competitors do. 3. They maintain surplus talent – when other companies are cutting staff to cut costs, they go in the opposite direction: they cultivate serious talent with the capacity to grow new businesses.

The second article, “New Business Models in Emerging Markets” (Eyring, Johnson and Nair) comments that when multinationals look to emerging markets for future growth they simply transplant their domestic business models. In doing this they end up slashing margins or confining themselves to the higher-income tiers, which aren’t large enough to generate sufficient returns. The authors advise that to exploit this market companies must identify unsatisfied needs, devise fundamentally new business models that can meet these needs profitably and affordably, and carefully implement and evolve the models by continually testing assumptions and adjusting them.

The next article, “When Your Business Model Is In Trouble” (Gunther McGrath) outlines how to recognize and react to signs of an impending crisis. Clear signs that a business model is in trouble are when 1. Next-generation innovations offer smaller and smaller improvements, 2. You hear customers saying that new alternatives are increasingly acceptable to them, 3. The problem starts to show up in your financial numbers or other performance indicators. The author comments that there is always very early evidence that a business model is in trouble, but it usually gets ignored or dismissed – that’s because at most companies the people at the top got there because of their success with the current model, so they have very few incentives to question it’s durability. In reacting to an impending crisis successful companies already have processes in place that cause them to challenge the existing assumptions in their business model; they bring together diverse groups – people who know something about the technology, people who understand customer needs, people who have a longer view of where things might be evolving – and develop hypotheses about the areas where they should experiment, investing in several in order to get ahead of competitors.

The fourth article, “How To Design A Winning Business Model” (Casadesus-Masanell and Ricart) states that there are three characteristics of a good business model. 1. Alignment with company goals ie the choices made while designing a business model should deliver consequences that enable an organization to achieve its goals. This may seem obvious but there are many examples of companies which have business units with goals that are not aligned to the company’s goals. 2. Self-reinforcement. The choices that executives make while creating a business model should complement one another ie there must be internal consistency. When there’s a lack of reinforcement it is possible to refine the business model by abandoning some choices and making new ones. 3. Robustness. A good business model should be able to sustain its effectiveness over time by fending off four threats. They are imitation (can competitors replicate your business model?); holdup (can customers, suppliers or other players capture the value you create by flexing their bargaining power?); slack (organizational complacency); and substitution (can new products decrease the value customers perceive in your products or services?). The authors also note that smart companies design their business models to generate virtuous cycles that strengthen their competitive advantage. These virtuous cycles, or feedback loops, are self-reinforcing (eg low prices result in high sales volumes which result in greater bargaining power with suppliers, which in turn results in lower fixed costs and this translates to even lower prices; or another example would be lower prices result in lower expectations of quality and therefore lower variable costs and then even lower prices).

The fifth article in the series, “The CEOs Role In Business Model Reinvention” (Govindarajan and Trimble) the authors comment that a forward-looking CEO must do three things: manage the present (Preservation); selectively forget the past (Destruction); and create the future (Creation). For companies to endure, they must get the forces of preservation, destruction and creation in the right balance. Striking that balance is the CEO’s most important task, however most companies overwhelmingly favor preservation, over destruction or creation. To be sure, the work of preservation – the day-to-day execution of the existing business model – is vitally important. They must concentrate daily on performance excellence and continuous improvement. Most CEOs ignore destruction and creation before it is too late. They bow to a myriad of short-term pressures: intense demands for quarterly earnings, risk aversion, discomfort with uncertainty, resistance to change, and an unwillingness to cannibalize established businesses. As a result, many companies fail to transform themselves. To win both today and tomorrow, CEOs must operate in all three areas simultaneously. They must recognize that destruction and creation are not about what the business will be doing in 20 years; they are about the preparations it must make today.

The above collection of articles offers insights into business models and is worthwhile general reading for everyone interested in rethinking their company’s competitive positioning.

The Flexible Workforce

Contributor – Kathryn Taylor, Pharmaceutical & Medical Professionals

2011 will be a time of change. The economy has taken off and workforces are expanding. Companies will be addressing this expansion in non traditional ways. They will be seeking new ways of doing business and trying new business models. Successful companies will be agile, and to achieve this they will need flexible workforces.

During workforce planning companies will be considering their immediate business objectives: what they need to deliver, how they can deliver, who they can partner with, and who they can trust.

The changing economic environment and expectations of businesses is creating a dynamic of increase demands on less resources. Cost will continue to be important throughout 2011, especially when global headquarters drive and monitor projects. Efficiencies will be sought as these projects are rolled out but not at the risk of reducing quality. Companies are seeking flexibility in how they manage these projects.

Insourcing, outsourcing, contracting or third party engagement are all methods of sourcing additional services and support which offer flexibility to deal with immediate business requirements.

Common themes from companies are the need to reduce costs while delivering to a high ethical standard without losing the quality control aspects of the project. While outsourcing has increased as a whole, insourcing allows a closer control of project needs. Suppliers of these solutions need to deliver a full solution of human resources and project management support, regular review of objectives and metrics and compliance to all legislative requirements.

During 2011 companies will require individuals with the ability to remain agile through change and with the ability to create solutions from challenges whilst remaining abreast of core business issues. For this reason companies are utilizing short term resourcing solutions from external suppliers. Maintaining clarity of ownership and employer responsibilities will ensure objectives of the projects are met by these resources.

We have seen increases in supply of volume contract or insourced solutions for many functions across businesses including customer service, administration, sales and merchandising forces, clinical monitors and sales support.

Flexibility can present as a risk but managed in the right manner, it can produce a long term solution to evolving demands on businesses with minimal retraining, management and effort.

The guest speaker at the MTAA End of Year networking function (Dec 7th) was Ainslie Cahill, CEO Arthritis Australia. Also as the Deputy Chair of the Consumers Health Forum Ainslie works to support more meaningful engagement between consumers, consumer health organizations, government and industry.

Established 27 years ago Arthritis Australia manages educational, advocacy and research projects to improve the quality of healthcare for the 4 million Australians with arthritis.

Ainslie’s main message was that Arthritis Australia is a ‘remarkable resource that must be tapped’. Being in touch with thousands of consumers Arthritis Australia knows what these consumers want, what they need and what they fear.

Ainslie described various initiatives undertaken by Arthritis Australia. These included:

1. Working with a complementary medicines company to undertake market research which resulted in packaging and labelling changes, based on direct consumer feedback. They also worked with the same company’s advertising agencies to devise specific health messages which were applicable to the target market.

2. Through publishing a book: ‘Women’s insights into rheumatoid arthritis’ and showcasing discussions between patients and politicians (eg Julia Gillard, Penny Wong and Julie Bishop) Arthritis Australia was able to get their message across to parliamentarians in a very novel and effective way. This, combined with the formation of a Parliamentary Friends subgroup, has resulted in Arthritis Australia being consulted by the Department of Health and Ageing on a range of arthritis issues.

3. A ‘Community Chest model’ where 6 pharmaceutical companies, with an interest in arthritis, contribute equal sums of money to different annual initiatives, managed by Arthritis Australia. The current one, ‘Voice of Arthritis’ is a comprehensive survey focusing on the social effects of arthritis.

She recommended that industry companies identify relevant health consumer organizations which have a focus on education, advocacy and research and engage with them, thus gaining access to a wealth of insight and knowledge.

We attended the New Insights into Medical Education conference organized by the APMRG on Nov 30th.

There were four speakers, each giving a different perspective on the above topic, and this article summarizes the conference highlights.

Christine Owen from the Royal Australian College of General Practitioners was the first speaker and she presented on ‘RACGP Education – all you need to know for the new triennium 2011 – 2013′.

Her talk was tailored to providers of medical education services to GPs and she provided helpful advice to assist with the preparation of new educational packages.  The spirit of the Quality Improvement initiatives discussed were to ensure that increasingly higher levels of quality care were being delivered to patients and that medical education suppliers should focus on continuously improving their material and services.

Christine highlighted that a random selection of 10% of all activities will be quality reviewed by the RACGP and that suppliers should be mindful of the areas which have previously been deficient: 1. Learning objectives not having a patient safety objective; 2. Inadequate needs assessments ie insufficient justification for the program; 3. Evaluation forms were inadequate; 4. GP Adverse Feedback forms were not available and 5. Materials were not being filed. She also highlighted that if attendance lists and activity reports were not lodged within four weeks of the event a Quality Review may be initiated.

The second speaker, Louis Reginato, Managing Director, aeffect, discussed ‘Education – are you delivering to the needs of GPs?’

He noted that the demographics of GPs were changing and in the future there will be an increasing feminisation of general practice (with work/family commitment considerations), more corporatized practices, more home care and a greater reliance on technology. GPs will have less time for on-going education and they will be accessing this education through a range of channels, particularly online and digital.

Quoting US data it was shown that 72% of doctors have a smartphone, that 95% are downloading medical information and apps and that 50% are using apps at the point-of-care. The take away message was that providers need to be embracing how technology is changing how medical education is being delivered. When operating in the online environment providers must then be exciting their audience and making it worthwhile for them.

Lee Hayes, National Education Consultant Amgen Australia, presented on ‘Nurse Practitioners – an untapped education opportunity?’.

She highlighted that targeting groups of Nurse Practitioners presented companies with an excellent opportunity to connect with highly qualified and highly specialized healthcare professionals.

There are currently 590 members of the Australian College of Nurse Practitioners (www.acnp.org.au) representing both nurse practitioners and interested parties. The main areas of focus for this national peak organization are: emergency medicine, mental health, nephrology, neurology, pain management, rural and remote, chronic disease management, palliative care, oncology and surgical.

Nurse practitioners provide improved access to health services, a reduction in waiting times, a decrease in the length of hospital stay, improved healing rates, improved quality of life indicators and better continuity and coordination of care.

By involving nurse practitioners in their medical education programs companies will be able to access their high level of clinical knowledge and practical understanding of complex environments.

The last speaker was Michelle Goodwin, Education and Programs Manager Amgen Australia. In her presentation ‘How do specialists prefer their education’  Michelle described how a group of nephrologists were asked how they would like to receive their medical education and 53% of them wanted face-to-face meetings (either small group interactive learning sessions or round table discussions) with other healthcare professionals.

When asked would they access a video online if they couldn’t attend the meeting 73% responded yes, and of these 80% said that they would access this online material via their computer, not using a smartphone, app or iPad. The takeaway message here was that the specialists were computer savvy but not quite ready to embrace some of the latest technologies.

Michelle elaborated on how companies can make education a key differentiator for their businesses.

When planning a medical education program she advised providers to: ensure that the programs added value; partner with key stakeholders; drive brand and corporate equity through a differentiated platform and to focus on compliance and governance, whilst always ensuring that  strategy is linked to tactical plans.

Michelle advised companies to develop unique medical education initiatives and to use expert advisory panels to shape the programs. These programs are strengthened by allowing customers to facilitate meetings and for the company refraining from dictating product messages. Differentiated education can provide a company with market leadership and position them as a trusted partner of choice.

I’ve just attended the ASMI Annual Conference (Bringing Self-Care to Life), Sydney, Nov 18.

The key theme of the opening presentation was how the Internet can be used to advance health literacy, support self-care and save health services millions of dollars.

It was highlighted that consumers are increasingly using the Internet to seek out healthcare information eg 75% of patients research their condition online before seeing a doctor; and 70% go online afterwards to learn more. Having found health information online 55% changed their lifestyle or health behavior; 52% made a self diagnosis and 49% started an over-the-counter treatment (Google research, Oct 2010)

Bob Gann, Head of Strategy and Engagement, NHS Choices, continued his presentation by discussing “The Use of Online Health Information and Call Centres in the UK”, using NHS Choices as a case study.
 
Established in 2007 and employing 180 staff, NHS Choices is part of the Department of Health.
NHS Choices is the online ‘front door’ to the NHS and is the England’s biggest health website.

Its strategic objectives are:
1. Sustained health improvement.
2. Challenging consumers to take responsibility for their own health.
3. Improving access to NHS and social care information.
4. Supporting developments in the choice agenda.
5. Enabling citizens to network and provide feedback.
6. Producing a change in the quality of public information.

To meet these strategic objectives NHS Choices have developed a comprehensive health portal (www.nhs.uk) that contains 80,000 pages of multimedia content and has 100 million website visits per year.

The portal includes:

1. An online symptom checker, which includes videos of clinicians, patients and celebrity spokespeople, as well as links to other sources of information; patient organizations and registries of clinical trials.

2. Medicines guides and databases of OTC and prescription medicines.

3. ‘Behind the Headlines’ section whereby NHS Choices have analyzed 2400 media stories, looking at the evidence behind popular stories. It aims to respond to stories the day they appear with an unbiased analysis of the science behind the media. 

4. A ‘Choosing Providers’ section whereby consumers can compare different NHS hospitals with regards infection, mortality and readmission rates. Patients can also rate and review their hospital, GP or pharmacy experience.

NHS Choices have also developed a number of useful healthcare Mobile Apps. Using these tools consumers can find their nearest GP, pharmacist or hospital; check real-time Accident and Emergency waiting information; receive appointment reminders; record and track their drinking and smoking activity; and monitor fitness levels.

Through the use of digital technology NHS Choices has been able to increase the availability of healthcare information, promote self-care and save the health services millions of dollars.

I recently attended the TGA Business Process Reform meeting at the ARCS AGM, Nov 3, where the topic was: “How to successfully participate in the new streamlined submission process”.

The central theme of the session was that faster approvals will give patients better access to medicines in Australia. Companies will also benefit commercially through earlier market access.

In this blog I’m going to give a general overview of the reforms particularly for non-regulatory readers as these changes will have an impact on wider business processes.   There’s also lots of additional information, guidelines and forms on the TGA website at www.tga.gov.au/pmeds/pmbpi-submissionprocess.htm

The spirit of the meeting was that “it’s a time of change with open and on-going dialogue between industry and the TGA” and that “the process is moving forward in an environment of continuous improvement”.

The Key Reform Initiatives center around:

1. Improved access to information
2. Increased regulatory process transparency
3. Accelerated application entry.

There was acknowledgement that the current process needed improvement because there was no predictability; no ability to anticipate and plan; inconsistent and unreliable approaches and multiple points of requests for further data. The total time from submission to registration was on average 500 calendar days and the overall impact was a delay in access to safe, effective and quality medicines.

Under the new process, which commenced on Nov 1, 2010, the total time from submission to registration will be less than 12 months and this will mean that medicines will be available to patients sooner.

The changes included in the new process involve industry and the TGA working together to clarify the submission requirements, planning the resources, preparing an evaluation plan with predictable timelines, and coordinating the entire process using a case management approach.

A pre-submission phase involves the mandatory lodgement of an electronic Pre-submission Planning Form (PPF) from 6 months to 2.5 months prior to the submission date.

At this stage there are also optional meetings where TGA will respond to specific questions raised by the submitting company. The advice given is recorded and can then be used for future reference. The advice from the TGA is to “articulate your questions and TGA will assemble the right people to answer them”.

The key point in the planning process is that the TGA needs sufficient information to understand the scope of the submission so that they can provide the necessary resources.

In the new process, Part 1 of the PPF includes the Sponsors details; the submission plan; product details and indications. Part 2 includes admin and prescribing information; summaries; quality; non-clinical studies and clinical studies and Part 3 is the Declaration where the Sponsor acknowledges that they understand the process and the mutual obligations and that the dossier will be consistent with the PPF.

The pre-submission phase ends when TGA accepts the PPF as complete. Following this the TGA delivers a planning letter which includes milestone dates and highlights specific expectations of the final submission.

The submission phase then starts when the sponsor delivers the full submission; the dossier is then evaluated and consolidated S31 questions are then sent to the Sponsor. The Sponsor responds to the questions in either 30 or 60 days, depending on what they have nominated in their PPF and the process continues through to the delegates overview, the expert advisory review and then the decision; ending with the publication of the PI and CMI and listing on the ARTG.

The reform process is being undertaken in the spirit of continuous improvement. Anticipated changes will involve using Smart Online Form Technology and this will provide better access to and re-use of information; better linkages to manufacturing databases; the use of streaming questions (ie questions not relevant to a particular situation will not be asked), and the use of content-sensitive help at the question level.

The reforms are intended to bring medicines to market sooner through a planned and streamlined approach. There is however current debate as to whether this will actually happen, or whether companies will just delay entering the first stage (the submission of the PPF) because they don’t have all the required information available. Whatever the outcome, the reforms will improve the pre-submission planning process.

What’s Twitter? What’s a Hashtag? And how is this information useful for people working in healthcare?

1. Twitter

At the beginning of the year I wrote a blog on the “Increasing Importance of Twitter in Healthcare” (see Industry Blog January 27, 2010 http://pmpconnect.com/social_media.htm ). As we move towards the end of the year it’s relevant to review what’s happened in the Twitterverse, and how Twitter can be a useful search tool.

In January 2010 Twitter was really just starting to take off. It had been going since 2006 but only really gained critical momentum in late 2009. As a powerful communications platform Twitter is being used to share ideas with others, gather real-time intelligence and build relationships.

So, how does Twitter work? In short, Twitterers send and receive messages (140 characters) called ‘tweets’ on Twitter’s website or with mobile devices. When a user logs in, Twitter asks one simple question: What’s happening? Users then answer in 140 characters or fewer.

Twitter has become a great way of sharing common experiences, be them breaking news, emergencies, organized events and conferences and has gained increasing popularity throughout 2010 because of the increasing usage of iPhones,  iPads and other mobile devices.

Major pharmaceutical and healthcare companies, medical education and communication companies, government bodies and patient associations are increasing their presence on Twitter and are publishing interesting information. In my company we’ve been using Twitter for nearly a year now (http://twitter.com/pmpconnect), have posted over 1600 tweets on industry relevant news and developments and have 318 followers.

Within the wider healthcare arena there are also many uses for Twitter. These have been summarized in an article at http://philbaumann.com/2009/01/16/140-health-care-uses-for-twitter/ : “Healthcare advances use of Twitter. 140 healthcare uses for Twitter” and some are included in my January 2010 Industry Blog.

There’s also a comprehensive ‘Pharma and Healthcare Social Media Wiki’ at http://www.doseofdigital.com/healthcare-pharma-social-media-wiki/ which lists a number of initiatives undertaken by industry and industry participants including many Twitter leaders. It’s updated regularly and is a great reference.

Twitter is therefore a rich source of instantly updated information and more and more people are increasingly using it. However all this activity has resulted in the need to categorise the tweets, and this is where hashtags are being used.

2. Hashtags

A hashtag is a # symbol placed before specific keywords or keyword phrases to make content easy to find on Twitter. As such, hashtags are used to group tweets about the same subject or event together.

For example, say you are looking for tweets on pharmaceuticals, go to www.search.twitter.com and in the dialogue box type in #pharmaceuticals and you will see all the relevant tweets

When twitterers write tweets they will add a hashtag to a word in the tweet which is relevant to the subject (eg #subject).

Anyone can create a new hashtag, however it’s useful to do some research first to see if the subject you are tweeting already has an established hashtag.

When you add a hashtag to your tweet anyone who does a search for that hashtag will find your tweet.

3. Healthcare Hashtags

As mentioned above, there are many uses for Twitter within the healthcare sector. Hashtags can be incorporated within tweets to tag content and make it available for people searching within the field.

There are already some established and highly relevant industry hashtags being used. For example:

#fdasm includes the latest news and tweets regarding the FDA and the use of the internet and social media by pharmaceutical and medical device companies.

#hcsm is a weekly twitter conversation about communications and marketing practices by healthcare organisations including the use of social media.

#hcmktg – includes discussions on challenges and tactics for healthcare marketing.

#hcsmeu – Health Care Social Media Europe is a weekly live tweet-driven event.

#socpharm – is a weekly chat about social media and marketing in the pharmaceutical and biotechnology industry

The more specific the Twitter hashtag the better. Some hashtags eg #healthcare have lots of tweets, many of which are centered around healthcare reform. However there’s also lots of irrelevant and uninformed noise.

Hashtags are also a great way to promote events. For example, if you wanted to make sure that your tweets about an upcoming conference were found you would create your own hashtag and use it in your tweets. For example, the ARCS Annual Conference 2011 could have the hashtag #ARCS11. Everyone commenting on the conference before, during and after would then use the hashtag #ARCS11. As an event promotion tool, the hashtag would be prominently displayed and people encouraged to use it. When searching for updates all comments on the conference would then be aggregated under #ARCS11. As a speaker, ensuring that your presentation has key points within a 140 character limit would enhance the retweetability of the message. The audience would pick up on these ideas and retweet them throughout the Twitterverse’s virtual community.

Summary

Twitter has come a long way in the last 12 months. It’s rapidly gaining traction within the wider healthcare arena and the pharmaceutical and medical device industry has commenced a number of initiatives centered around using Twitter as part of a wider Social Media program. Twitter is an incredibly fast-moving communications vehicle and the use of hashtags categorises tweets into specific topics and events so that specific conversations can be tracked.