Yay!!! Three more days and we're free!!! I mean, boo...three more days and we have presentation! Apparently we were told that most of the mentors who taught us are going to be the audience, plus our lecturers are also coming (maybe to also see whether they chose the right people for IPEP?), what else is worse than that?
Anyway, morning was intense, which we covered Global Clinical Trials Organization (GCTO). Clinical trials are projects at such a huge scale that there is a separate subsidiary in the company just to cater to this need. Normally a NCE is patented for about 20 years. With pre-clinical trials, clinical trials and registration amounting up to 15 years, many a time companies only get to sell products for a short 5 years before the patent expires and every other company can grab away your market shares by copying your innovator products. So now there is a challenge for future clinical researchers to shorten the clinical trials years and optimize the patent period.
As we have learned in medicinal chemistry, there are millions of compounds in the corporate library, and when a therapeutic target is identified, validated (showing that the target is linked to the disease), then over 10000 compounds are derived which are similar to the target. After some modifications and screening, only about 250 compounds reach the pre-clinical stage. These compounds are tested in-vitro (in beakers or test tubes), in-vivo (animal studies) on their pharmacokinetics, i.e. ADME.
After that, only about 5 compounds are deemed fit for in-vivo use, which then proceeds to Phase 1 of the clinical trials. Phase 1 involves a few healthy patients who volunteer themselves. This phase is very important as it is conducted in high-tech facilities meant to keep subjects for overnight monitoring. So it's like those movies whereby the subject is connected to a machine for real-time monitoring of the subjects over a few days. Phase 1 is normally conducted in modern countries such as U.S., UK and even Singapore, but Malaysia has yet to establish on that aspect. Even before Phase 1, sometimes there may be Phase 0 (microdosing), which involves even smaller number of patients on really small doses of the drug. This phase is normally for critical drug compounds to ensure that they are fit for human use.
If Phase 1 is proven successful, Phase 2 then proceeds, this time with a population of patients. Phase 3 is an even bigger population of patients from many different medical centres. In Malaysia, these clinical trials are conducted in accredited Ministry of Health trial sites such as USM hospital, UM hospital etc. This is to reduce bias from any pharma companies that are sponsoring the trials. In phase 3, the labeling of the drug compound can be done. Is it only suitable as a stand-alone drug in the treatment (monotherapy), is it suitable for combination with other drugs? Is it better to put it as 1st line of treatment, or second line?
I think we have mentioned before, that in Phase 3 and other pre-launch clinical trials, the data obtained can only show statistical significance, which is a good estimate of the outcomes that the drug will give. However, it can never be the same as clinical significance which only can be obtained from post-marketing clinical trials, whereby the patients are not subjected to standardized conditions of the trials. Much more rare side-effects can be picked up from post-launch studies as variability between subjects are not minimized as this stage. For example, patients may be taking grapefruit juice which triggers a rare side effect when taken with the drug. In pre-launch studies, patients will need to adhere to a protocol on their diet as well as many other things.
Sometimes, the economical aspect of the trials also significantly influences the development of a new drug compound. Say if a new drug has a totally new therapeutic profile that was never preceded by any other drugs, or is much safer and efficacious than competitior drug compounds, but if it's too expensive or too difficult to manufacture in large quantities, companies would most often opt for the next best choice.
We also learned a famous saying by a famous chemist Paracelsus, who said that "All things are poisons, and nothing is not poisons. Only the dose permits something to be poisonous or not poisonous". Even apples, rice, water....anything can be poisonous at a certain dose. True?
So if all the research lab are in America, why do we need a clinical trial unit here? Again, there is a "bidding" process, much like an open tender. Whenever there is a proposed clinical trial from HQ, the branch countries will give their "quotations" on things like whether they have the population of patient, whether there are qualified investigators (doctors who have been trained to be clinical trials investigators) fit for the trial, whether there are adequate resources to import the new drug etc.
Some countries like China, Japan, Taiwan and South Korea have certain requirements for registration of new drugs. In the Dossier files, the clinical trials need to include a certain number of local patients in the sample population of the trial. Like for Japan, a totally new trial comprising of Japanese patient population needs to be conducted to show that the drug also works for Japanese, then only it can be submitted for registration. Therefore, when planning a clinical trial, this aspect is very crucial as if you include these countries into your regional study, it can take quite a while to get ready these sites for the trial; whereas if you exclude these countries, your new drug may not be able to penetrate those key markets where healthcare industry thrives.
The clinical trial department in pharma companies also help to ready the trial sites. They will have to go around looking for appropriate clinics and hospitals and to ensure that the investigators are clear about the protocols of the trials (which can be 200 pages long). They also need to ensure that the environment is suitable for the trial, such as room temperature, which may affect drug stability and hence the validity of the trial data. They also need to ensure that the subjects are well-informed and consented before beginning the trial. If the patient is illiterate, a third-party witness needs to verify that the doctor has explained thoroughly about the protocols. Pharma company staffs and trial sponsors cannot deal directly with the subjects, therefore they need to work closely with these investigators.
The Clinical Research department associates (CRA) also ensures that everything has an audit trail. This means that every single discussion, shipment, data collection etc. needs to be documented as regulatory agencies may do a random "spot-check" audit on clinical trials that are ongoing and even those that has already been finished. So sometimes we may get news that a certain medicinal product is not as efficacious as previously proven if the clinical trials are found to be flawed and unreliable after retrospective audits are done.
CRAs also carry out source data verification (SDV) at the trial sites. This is the checking of medical data of patients and making sure that it tallies with the recorded data from nurses, doctors and prescribers. CRAs also ensures that blood extracted from subjects are kept properly and sent to the central lab in other countries which handles blood testing for that particular trial. Everything must be done according to the protocol, and if any events deviate from the protocol, it must be reported and rectified, otherwise the trial will be deemed statistically weak.
Sometimes for these double-blinded trials, things can go wrong. For instance, the patient's glucose level may be uncontrolled and the doctor needs to know is the patient taking the active drug or the placebo in order to choose the right treatment plan. In this case, "unblinding" is possible, but this will also affect the reliability of the study. So in general it is recommended that we do not do "unblinding" unless circumstances requires us to do so.
Some things may go wrong for a clinical trial outcome. If protocols were not strictly adhered to, the trial may give a false positive or false negative result. False positive meaning the trial showed that the new drug works better but is actually non-superior. When it is launched into the market, it seems to not enhance treatments of the patients. If it's a false negative, meaning the trial showed that the new drug has no potential but it actually does works, it may cause a loss of a new drug that could save the world. How tragic is that!
Another two terms we learned today. To ensure quality of the trial, there is Quality Control (QC) and Quality Assurance (QA). Both may seem very similar but are actually very distinct from one another. QC is the monitoring process and site visits, whereby you go to the actual place and make sure everything is as documented. On the other hand, QA is the auditing (spot check) of documents, whereby you ASSURE that quality control is being carried out.
Being in the Clinical Research department of any pharma company involves a lot of documentation. The pre-clinical studies in laboratories are mostly overseas, so if you're really interested in the experimental part, you might want to consider working overseas. Over here, although you don't get to put your name as author in the clinical papers, you still get to really understand and appreciate how a real scientific experiment should be documented and implemented...not just "cincai-cincai" copy data and trying to straighten the graph line. Cheers!
Tuesday, July 30, 2013
Monday, July 29, 2013
Day 16 - New Product Planning and Business Development
We had a long session in the afternoon on New Product Planning (NPP) and Business Development (BD). Morning was project time so we were almost done compiling and now left with the touchups on the Powerpoint presentation animations and slide decorations.
NPP is under the support team of the sales and marketing department. When a new product is launched by Merck HQ, plans are already underway for the registration and launch of those products in Malaysia. It takes almost 2-3 years prelaunch to start arranging the timelines before it can actually be marketed to the customers. This is where the NPP department comes in. The NPP takes the lead to implement all the groundwork for the product (registration, awareness, market plan etc.) before it is passed on to a new Product Manager (PM) which will then be responsible for the product all the way until it is launched.
However, not all the new products from the pipeline is launched. Those that show superiority to current treatments definitely have their selling points, and are of caused arranged for launching. There are some products that show inferiority to current products, and therefore are not approved for launching. Some previously potential products may also be retracted back from launching if there are new clinical evidence to state the inferiority of that product. There are also some products that are only made available as a life-saving product, not launched to the market for sale. These products are ordered on special request by certain doctors if all other products fail to treat the patient and they think that the said product from the company may be able to save the patient.
A few new terms we learned today. Branded generics (BGx) are generic products which have the identical active ingredient molecule as the innovator product (for example Zocor simvastatin from MSD and its branded generic such as simvastatin by Ranbaxy). Innovative generics (IGx) are products which consist of different combination of generics (such as losartan with simvastatin, both off-patent) which are improved versions of generic products.
We also learned that in Malaysia, all generic products must have evidence of bioequivalence compared to the innovator product before it is approved for registration. This means that for example, theoretically, all the copy-cat products of simvastatin should give the same therapeutic effect as the original simvastatin Zocor. However, there are other factors which influence patients to still buy Zocor over other generics and that is altogether a separate matter.
The NPP department works hand in hand with the other support teams like Market Access, Medical Affairs, Regulatory, and Clinical Trials Organization, which all the information is gathered to be submitted to the directors for discussion and approvals. Because ultimately, when you're at the top, you don't need to do the compilation work but your decisions matter very much on these analysis, which will also decide the fate of the company.
Business Development (BD) is a very new concept introduced into the pharma industry (around 2010). It is aimed to increase sales growth through partnerships with other pharma companies. Recently we hear things like mergers & aquisitions, joint ventures, outsourcing sales to a third party company....these are all business deals which needs a whole new area of expertise to deal with. Some business deals like co-promotion are very small deals between companies which are relatively easy to implement. Co-promotion is partnering with another company to sell your product, under the same brand name.
Then there are more complicated deals such as co-marketing, which is partnering with another company to sell the same active molecule drug, but under different brand names. This is more complicated as it involves more regulatory approvals, more awareness effort among customers etc.
Then there are the most complicated deals such as acquisition and joint ventures. Acquisition is like MSD merging with Schering-Plough (sort of like englufing the other company), so everything needs to be changed into MSD. Joint ventures is partnership between two companies to sell the same brand name. This is very complicated as it involves the alignment of marketing plan, approvals on both sides on every single aspect.
Before every deal is made, there are appropriate processes to identify and select the best partner out of a few partners that were approached. It's kind of like a "audition" whereby partners are selected based on scores and criteria met. This takes up to years before any signature is signed on the agreement, which then only the deal can be implemented. Therefore, for deals to be significantly profitable, it has to generate tens of millions of USD, on top of the sales target of that product! That amount is impossible to generate from the Malaysia market alone. It is only possible in a regional context (South East Asia for example). Therefore, deals are normally done on a regional to global scale. MSD - Schering Plough, for example, is a global deal.
That is why it is very beneficial for one to work in a global company as it involves many of these huge-scale processes. In turn, you can learn alot compared to working in smaller companies.
NPP is under the support team of the sales and marketing department. When a new product is launched by Merck HQ, plans are already underway for the registration and launch of those products in Malaysia. It takes almost 2-3 years prelaunch to start arranging the timelines before it can actually be marketed to the customers. This is where the NPP department comes in. The NPP takes the lead to implement all the groundwork for the product (registration, awareness, market plan etc.) before it is passed on to a new Product Manager (PM) which will then be responsible for the product all the way until it is launched.
However, not all the new products from the pipeline is launched. Those that show superiority to current treatments definitely have their selling points, and are of caused arranged for launching. There are some products that show inferiority to current products, and therefore are not approved for launching. Some previously potential products may also be retracted back from launching if there are new clinical evidence to state the inferiority of that product. There are also some products that are only made available as a life-saving product, not launched to the market for sale. These products are ordered on special request by certain doctors if all other products fail to treat the patient and they think that the said product from the company may be able to save the patient.
A few new terms we learned today. Branded generics (BGx) are generic products which have the identical active ingredient molecule as the innovator product (for example Zocor simvastatin from MSD and its branded generic such as simvastatin by Ranbaxy). Innovative generics (IGx) are products which consist of different combination of generics (such as losartan with simvastatin, both off-patent) which are improved versions of generic products.
We also learned that in Malaysia, all generic products must have evidence of bioequivalence compared to the innovator product before it is approved for registration. This means that for example, theoretically, all the copy-cat products of simvastatin should give the same therapeutic effect as the original simvastatin Zocor. However, there are other factors which influence patients to still buy Zocor over other generics and that is altogether a separate matter.
The NPP department works hand in hand with the other support teams like Market Access, Medical Affairs, Regulatory, and Clinical Trials Organization, which all the information is gathered to be submitted to the directors for discussion and approvals. Because ultimately, when you're at the top, you don't need to do the compilation work but your decisions matter very much on these analysis, which will also decide the fate of the company.
Business Development (BD) is a very new concept introduced into the pharma industry (around 2010). It is aimed to increase sales growth through partnerships with other pharma companies. Recently we hear things like mergers & aquisitions, joint ventures, outsourcing sales to a third party company....these are all business deals which needs a whole new area of expertise to deal with. Some business deals like co-promotion are very small deals between companies which are relatively easy to implement. Co-promotion is partnering with another company to sell your product, under the same brand name.
Then there are more complicated deals such as co-marketing, which is partnering with another company to sell the same active molecule drug, but under different brand names. This is more complicated as it involves more regulatory approvals, more awareness effort among customers etc.
Then there are the most complicated deals such as acquisition and joint ventures. Acquisition is like MSD merging with Schering-Plough (sort of like englufing the other company), so everything needs to be changed into MSD. Joint ventures is partnership between two companies to sell the same brand name. This is very complicated as it involves the alignment of marketing plan, approvals on both sides on every single aspect.
Before every deal is made, there are appropriate processes to identify and select the best partner out of a few partners that were approached. It's kind of like a "audition" whereby partners are selected based on scores and criteria met. This takes up to years before any signature is signed on the agreement, which then only the deal can be implemented. Therefore, for deals to be significantly profitable, it has to generate tens of millions of USD, on top of the sales target of that product! That amount is impossible to generate from the Malaysia market alone. It is only possible in a regional context (South East Asia for example). Therefore, deals are normally done on a regional to global scale. MSD - Schering Plough, for example, is a global deal.
That is why it is very beneficial for one to work in a global company as it involves many of these huge-scale processes. In turn, you can learn alot compared to working in smaller companies.
Got this image from Google...our office building
The supermarket at ground floor, where we can buy fruits after lunch....
Anybody live near digital mall, you just have to try this curry mee. It's not too spicy, but the curry is somehow sweet! Try it some time =D
Wednesday, July 24, 2013
Day 14 - Free
For the first time, we have free time today! In mandarin it's normally known as 自由活动, which is commonly "celebrated" when the teacher is sick and a strange teacher you never met before enters class and says teacher is on MC, you can do whatever you want!
In our case, they call it "Project Time", in which we have to rush to prepare our presentation at the end of the month! So it's seriously time management, organize our own discussions, even rehearsing what we are gonna say! And there's so much chances to procrastinate, but we will rather complete our task for the day than to bring work home. A good chance to practise the healthy culture of "work during working hours, rest during off-working hours".
Have you ever wondered why some of our lecturers type in notes under some slides in their Powerpoint lecture files? It actually has a purpose. Most of us will project our monitor to the audience, which then exposes what we're clicking before actually starting the slide show. But there's a way to be more "professional"! Check this out :
We picked this technique up when our mentors conduct their sessions here. So much better than showing a dead blue screen or showing people what you have in your thumbdrive!
Day 13 - Hepatitis Day
Today...is a day for Hepatitis! Especially Hepatitis B and C! This day was celebrated by Selayang Hospital in conjunction with the World Hepatitis Day on Sunday!
There will be an attempt to make a Guinness World Record of making a bigger version of this!
See no evil, hear no evil, speak no evil! This is to depict the phenomenon that our society ignores the threat of hepatitis and that more awareness needs to be raised to counter this disease.
Our day started off with the briefing at the registration counter by the staff members on what to do. There are two main areas that we can help, which is approaching people to fill up a survey on hepatitis, and also to register patients for the blood test. The blood test normally cost around RM10 - RM30 whether the test is only for Hepatitis B antigen or for both B and C. There are other stations which deals with the extraction of blood, explaining about the disease, giving educational talks....but we haven't graduated yet so yeah, stick to the simpler tasks.
The registration counters
The senior staff members writing away
These are the survey forms, in Malay, English, Mandarin and Tamil, which is designed by the MOH to gauge the understanding of the public on hepatitis B, and whether awareness has improved over the years. There are even some questions like is transmission of Hepatitis B affected by sexual behavior, which is hard to explain in mandarin. The official term is called 性行为 and then whenever the patient needs elaboration, then that's where the awkwardness comes in.
The survey really helps us understand better about Hepatitis B. As all the questions in the survey is actually true statements, we ourselves are now aware how Hep B can be transmitted. From obvious things like blood transfusions to little things like sharing nail clippers. We can remember them so clearly after asking the public over and over again these questions.
This auntie was very friendly. She gave me a good laugh when she said she is loyal to her husband and then started asking me how does 性行为 relate to Hepatitis B. Oh boy...
Yeap she was so detailed going through the mandarin-version of the survey. She asked me what is 疫苗 and I had to check with the English version to find out. Luckily V-shenn told me how to pronounce it haha...paiseh
Soon it was lunch time! Headed to cafeteria...
Hospital being hospital
Cafeteria entrance
Of course, MSD gave us a treat for our contributions! XD Arigato!
V-shenn brushing teeth after lunch. She makes a good dentist la if she could. I'm not sure whether the fact that brushing teeth straight after meals (within 30 minutes) can damage your enamel layers...anybody can clarify?
Was on one of the entrances. Satisfaction is a KPI in Selayang Hospital!
A note on Hep C. There was a little section whereby patients have to tick whether they had share needles, have unprotected sexual intercourse with multiple partners, tattoo, family members with Hep C, and/or undergone blood transfusion before 1994. It was part of the procedure to double confirm with them even after they ticked the form before registering them for the blood test. So imagine double confirming "sex with multiple partners". We get so many funny responses like "eh takde la suami satu je" or "wo mei you luan luan lai la...".
In the afternoon, we handled the registration counters for a change. We have to categorize the patients whether to only go for the Hepatitis B surface antigen test or to also go for the Hepatitis C antibody test if they fall into any of the categories stated above. Everybody is susceptible to Hepatitis B, which currently has a cure (albeit costly). However, Hepatitis C has no cure, for now. But the good thing is, there are vaccines for both B and C, so that's why awareness is very important!
How about Hepatitis A? Well it's a self-limiting disease which is easily curable (lots of rehydration and rest), so it's not that big a threat compared with B and C, which are as "popular" as AIDS, TB and Malaria among others.
We also had to label blood vials with stickers, and also to record down their details as the blood test results will be sent to their mailing addresses a month later. Lots of writing to do.
Few ongoing sessions of talks
The campaign banner is the second one inside
We even have a mascot!
Blood test stations
Hati-hati dengan hati anda! So next time when you "sakit hati", check for hepatitis!
Fyi, sakit hati means sad in Malay. But the heart as an organ is termed "jantung" instead.
Registration counter manned by us
The empty vials
We were given goodie bags, containing leaflets, an apple and some Maggi chicken curry stuff
Keeping the extra forms after the entire event
Tired, but having a good sense of satisfaction by helping the public. That awesome feeling you get when working in a hospital!
Day 12 - Compliance Department and about KOLs
Just a quick overview of the compliance department. Compliance here is a specialized area of staffs which worked a few years in MSD and has a comprehensive experience of how the company operates. They are the ones who set the procedures on how to track the processes that each department are involved in, from little things like knowing whether a budget to sponsor doctors are actually overspent, to big things like breaching the grant of authority (GOA). GOA is the maximum amount of spendings that can be approved for a certain ranking staff, the amount of grant that you can authorize.
Compliance also enforces the company values by training new staffs on these values and even build case studies on them. If MSD outsources to a 3rd party company for any kind of service, their staffs also need to be made aware of these values, and that's where compliance come in to make sure these values are adhered to. This is because, should the 3rd party company break any law, MSD as the hiring company will take responsibility as well. Companies like Zuellig Pharma are one of the examples as an outsourced distributor.
Basically the compliance department do not deal with review of promotional materials as that will be scrutinized under the medical department. However, the Standard Operating Procedures (SOPs) in which these reviews are conducted, as well as how sales calls are conducted by the product specialists, are thoroughly enforced by the compliance team as well. The compliance department carries out risk assessment on every type of business risk to see whether is the risk very frequent, or how big is the impact, and hence puts priority on each kind of risk. Then, they plan for the year to tackle each issue to further strengthen the company's structure year after year.
After lunch, Michelle was our mentor for the session on KOLs. As MSD also deals with many important hospitals, with each hospital having up to around 80 doctors, a few key account managers are designated to these hospitals. Their job is to handle that very hospital that they are assigned to. However, many problem arises with hospitals as each have their own policy on prescribing and treatment, furthermore there is a "blue book" formulary which contains the list of drugs the hospital is authorized to prescribe. Some of the products are not in the blue book, hence lots of approvals are needed for new unregistered drugs to penetrate into the Malaysia hospital markets.
Sometimes, key account managers also have to engage with KOLs from their assigned hospitals. When inviting a KOL to help give a talk in CME events, it not only involves making appointment, booking the venue and sponsoring the doctors, but you also have to convince the doctor why the need to attend the event and what are the intended outcomes. Because many pharma companies sought after these KOLs every year, so it is an important job which needs much cooperation from the sales & marketing department as well as the medical affairs department.
Just to share with you, before a tender is raised to the government for lets say, HPV vaccine, a form called Lampiran Q needs to be filled, which states all the necessary details and T&C which needs to be adhered to before submission.
Compliance also enforces the company values by training new staffs on these values and even build case studies on them. If MSD outsources to a 3rd party company for any kind of service, their staffs also need to be made aware of these values, and that's where compliance come in to make sure these values are adhered to. This is because, should the 3rd party company break any law, MSD as the hiring company will take responsibility as well. Companies like Zuellig Pharma are one of the examples as an outsourced distributor.
Basically the compliance department do not deal with review of promotional materials as that will be scrutinized under the medical department. However, the Standard Operating Procedures (SOPs) in which these reviews are conducted, as well as how sales calls are conducted by the product specialists, are thoroughly enforced by the compliance team as well. The compliance department carries out risk assessment on every type of business risk to see whether is the risk very frequent, or how big is the impact, and hence puts priority on each kind of risk. Then, they plan for the year to tackle each issue to further strengthen the company's structure year after year.
After lunch, Michelle was our mentor for the session on KOLs. As MSD also deals with many important hospitals, with each hospital having up to around 80 doctors, a few key account managers are designated to these hospitals. Their job is to handle that very hospital that they are assigned to. However, many problem arises with hospitals as each have their own policy on prescribing and treatment, furthermore there is a "blue book" formulary which contains the list of drugs the hospital is authorized to prescribe. Some of the products are not in the blue book, hence lots of approvals are needed for new unregistered drugs to penetrate into the Malaysia hospital markets.
Sometimes, key account managers also have to engage with KOLs from their assigned hospitals. When inviting a KOL to help give a talk in CME events, it not only involves making appointment, booking the venue and sponsoring the doctors, but you also have to convince the doctor why the need to attend the event and what are the intended outcomes. Because many pharma companies sought after these KOLs every year, so it is an important job which needs much cooperation from the sales & marketing department as well as the medical affairs department.
Just to share with you, before a tender is raised to the government for lets say, HPV vaccine, a form called Lampiran Q needs to be filled, which states all the necessary details and T&C which needs to be adhered to before submission.
Monday, July 22, 2013
Day 11 - Communications & Marketing Plan
Another day at the office. Can't wait for wednesday's field work at Hospital Selayang cuz when there's field work, there's more pictures! But for today, we're stuck in jaya33...sad.
Anyway, Ms. Rathika discussed with us about the communications department and their roles. The communications and market access department work hand in hand to engage with issues regarding the public and MSD. The communications department is the first point of contact for outsiders to engage with MSD and then only the appropriate request is channelled to the proper department for further action. The department also help to build the company brand from publicising the name up to creating demand from various bodies towards MSD. And with the recent merging with Schering-Plough, it is utmost importance for the communications department to bridge the understanding between SP staff and the MSD team.
Communications department also deal with corporate collaterals, which are mainly creating merchandises such as company notebooks, company pens, company mugs etc. that only have the company name and not a specific franchise or product. This gives a similarity and consistency of identity between staffs from different department, like a sense of togetherness. Other roles such as media relations, training, corporate info and dissemination are also under communications department. Communications also deal with the design and making of promotional items such as company buntings, greeting cards and paper bag for the use when dealing with the press media or public forums.
As an ethical company, MSD also engaged in many reach-out programmes to the society. These activities are also spearheaded by the communications department. One of the famous events are the launch of a cookbook for diabetic patients and in the subsequent year, a desert recipe book for diabetic patients. Check out the link http://www.thestar.com.my/Lifestyle/Health/2012/12/05/Recipes-for-diabetics.aspx ! These books are distributed to diabetic patients in hospitals for free, and they even have to print a few extra batches due to high demand! Although it is purely a contribution for the society with no revenues in return, it is the MSD way to give back to the society.
Another known contribution by MSD is the lighting of KL tower to blue colour. Oh, so MSD even played with our iconic tower? Well with a meaning of course! The blue colour is in conjunction with the World Diabetes Day. I'm serious! Check out http://www.nst.com.my/streets/central/menara-kl-helps-combat-diabetes-1.172222 . MSD have to even write to a French company who manages the tower's lightings. Probably is the same company managing the lightings of the Eiffel Tower?
Lastly, MSD is also known to spread awareness on important issues such as HIV/AIDS via the campaign "It Begins With You". http://www.thestar.com.my/story.aspx?file=%2f2011%2f12%2f4%2fhealth%2f10023576&sec=health . This programme aims to reduce the stigma by medical students towards HIV/AIDS patients and to treat them indiscriminatingly when they graduate as future doctors. All these events require multiple partnerships and collaborations, which inevitably involves the communications department.
In the afternoon, we learned about how a market plan is devised and executed. A market plan consist of the market overview, the buying process, positioning statement and how to track and evaluate the marketing execution. It is really like planning for war. We really need to be detailed about who are the competitors and what are their pros and cons in the market plan. A simple thing we learned is that, if a product has no distinct difference than other competitor products, it becomes a commodity (like rubber, metal, produce) which only the price differs, and it becomes a price war. However, when you can have a significant benefit over another product, you will have a position for your product to sell better than the other products. That's all about positioning your product.
In the pharma line, it is always best to have the first-mover's-advantage, meaning to have the first product of its kind. For example, if the company has a new product in a totally new class of drug, which in MSD's case, the famous Januvia product, is the first DPP4-inhibitor drug to treat diabetes. Although there may be more work to do as the first-mover, such as explaining to customers about the new class of drug and building their trust towards this new class, it will be rewarding at the end as prescribers tend to habitually prescribe the same product once they're used to it. Therefore the first-of-its-kind product will be very stable in the market and can only be overtaken if the competitors' products in the same class of drug has a more highly favourable profile, which seldom happens.
Of course, once the patent expires for products like Januvia, generic companies will start producing cheaper versions of Januvia and hence snatch away a portion of the market share. But with products such as medicine which deals with lives, once you build the trust, people will be willing to spend more for quality medications. That is why marketing in pharma industry is very crucial.
Anyway, Ms. Rathika discussed with us about the communications department and their roles. The communications and market access department work hand in hand to engage with issues regarding the public and MSD. The communications department is the first point of contact for outsiders to engage with MSD and then only the appropriate request is channelled to the proper department for further action. The department also help to build the company brand from publicising the name up to creating demand from various bodies towards MSD. And with the recent merging with Schering-Plough, it is utmost importance for the communications department to bridge the understanding between SP staff and the MSD team.
Communications department also deal with corporate collaterals, which are mainly creating merchandises such as company notebooks, company pens, company mugs etc. that only have the company name and not a specific franchise or product. This gives a similarity and consistency of identity between staffs from different department, like a sense of togetherness. Other roles such as media relations, training, corporate info and dissemination are also under communications department. Communications also deal with the design and making of promotional items such as company buntings, greeting cards and paper bag for the use when dealing with the press media or public forums.
As an ethical company, MSD also engaged in many reach-out programmes to the society. These activities are also spearheaded by the communications department. One of the famous events are the launch of a cookbook for diabetic patients and in the subsequent year, a desert recipe book for diabetic patients. Check out the link http://www.thestar.com.my/Lifestyle/Health/2012/12/05/Recipes-for-diabetics.aspx ! These books are distributed to diabetic patients in hospitals for free, and they even have to print a few extra batches due to high demand! Although it is purely a contribution for the society with no revenues in return, it is the MSD way to give back to the society.
Another known contribution by MSD is the lighting of KL tower to blue colour. Oh, so MSD even played with our iconic tower? Well with a meaning of course! The blue colour is in conjunction with the World Diabetes Day. I'm serious! Check out http://www.nst.com.my/streets/central/menara-kl-helps-combat-diabetes-1.172222 . MSD have to even write to a French company who manages the tower's lightings. Probably is the same company managing the lightings of the Eiffel Tower?
Lastly, MSD is also known to spread awareness on important issues such as HIV/AIDS via the campaign "It Begins With You". http://www.thestar.com.my/story.aspx?file=%2f2011%2f12%2f4%2fhealth%2f10023576&sec=health . This programme aims to reduce the stigma by medical students towards HIV/AIDS patients and to treat them indiscriminatingly when they graduate as future doctors. All these events require multiple partnerships and collaborations, which inevitably involves the communications department.
In the afternoon, we learned about how a market plan is devised and executed. A market plan consist of the market overview, the buying process, positioning statement and how to track and evaluate the marketing execution. It is really like planning for war. We really need to be detailed about who are the competitors and what are their pros and cons in the market plan. A simple thing we learned is that, if a product has no distinct difference than other competitor products, it becomes a commodity (like rubber, metal, produce) which only the price differs, and it becomes a price war. However, when you can have a significant benefit over another product, you will have a position for your product to sell better than the other products. That's all about positioning your product.
In the pharma line, it is always best to have the first-mover's-advantage, meaning to have the first product of its kind. For example, if the company has a new product in a totally new class of drug, which in MSD's case, the famous Januvia product, is the first DPP4-inhibitor drug to treat diabetes. Although there may be more work to do as the first-mover, such as explaining to customers about the new class of drug and building their trust towards this new class, it will be rewarding at the end as prescribers tend to habitually prescribe the same product once they're used to it. Therefore the first-of-its-kind product will be very stable in the market and can only be overtaken if the competitors' products in the same class of drug has a more highly favourable profile, which seldom happens.
Of course, once the patent expires for products like Januvia, generic companies will start producing cheaper versions of Januvia and hence snatch away a portion of the market share. But with products such as medicine which deals with lives, once you build the trust, people will be willing to spend more for quality medications. That is why marketing in pharma industry is very crucial.
Sunday, July 21, 2013
Day 9 - Cycle Meeting
One World Hotel, Bandar Utama. Well we thought we will be using the huge ballrooms, but its actually at the lower ground floor where the small functions room are. Anyway, when we arrived, food was waiting for us.
Mr Sunny, the Business Unit Director, introduced us to the sales department who attended the meeting from the whole Malaysia under the same franchise. Today is actually the last day of a 4-day cycle meeting to update the product specialists on recent findings and new company strategies.
So it started off with assessment of product knowledge for the product specialists. They need to sit for exams just like us! There are true/false section, short-answer questions, and if you fail you have to resit the same paper, which is slightly better than us. After that, the speaker list out the agenda for the day. This, although is abit boring, but is important for the product specialists to mentally prepare themselves should any enquiries arises.
Then, the data of the sales volume from different companies on the same market were presented, showing areas where the department needs to improve on. It gives a good overview of where the company's sales are at the moment. This then leads to the briefing on marketing strategies for the next quarter of the year. A rough action plan is listed for the participants to ponder on. There is a check and balance exercise whereby the participants try to incorporate the action plan into their daily roles. If there are no good enough ideas, probably the marketing department need to revise the action plan.
Basically, the action plan hovers over 3 main areas, one of them being brand defending. As the pharma industry is flooded with generics, it is important for leading brands to stand out from the rest, hence the product specialist have to defend their brand in the market. For example, Cozaar XQ, a newly-registered Angiotensin-II antagonist (AIIA) + Calcium Channel blocker (CCB), currently do not have any direct generics competitors, but as many other companies try to penetrate this market, that's where brand defending comes into place. Btw, XQ means extra (X) blood pressure lowering due to the combination of the two drugs AIIA + CCB (compared to the common monotherapy of AIIA only or CCB only) and Q is for quality of the MSD product.
There was also another assessment just before lunch, to let the participants revise on what they have learned in the morning. So sometimes you don't even have time to study! Paying attention is a must at these conferences.
Then, it is lunchtime. We were lucky today. It's Japanese lunch day! We ate at a Japanese restaurant called Kora Restaurant, also in the same hotel. Pretty good reward for a tiring morning!
Saba fish set! Oiishii!!!
Next, while everyone was all filled up from Saba fish and nice Ocha, its time to fill up the brains! Mei Wen from the Medical Affairs department, who also conducted an IPEP session with us last week, updated the participants on the recent changes in the hypertension treatment guidelines. These include areas like systolic blood pressure for different patient age groups, or patients with complications such as diabetes etc. The medical affairs associates use credible sources such as the European Society of Hypertension (ESH).
Then, another medical advisor, Dr. Wendy, gave a review on clinical papers relevant to the training. She also shared about the general tips when dissecting a clinical paper, using the abbreviation PICO. PICO stands for :-
- POPULATION - Population of patient involved in the study, where they come from, how old etc.
- INTERVENTION - What kind of conditions set for the subjects, general methodology of the study.
- COMPARATOR - Most studies deal with comparing the profiles of different drugs with a reference drug.
- OUTCOME - The interpretation of trial results, and what conclusion can you draw from them.
She also clarified the difference between retrospective and prospective clinical studies. Retrospective means the study is looking into previous recorded data from clinics, hospitals, pharmacies etc. It is carried out as it only involves the compilation and analysis of recorded data, and also can accommodate a higher number of subjects. However, it is generally more biased as the conditions for selecting the subjects are not totally standardized. Even if you filter out subjects based on certain criteria, there are still uncertainty on whether all of the subjects' backgrounds are similar at all.
Prospective studies, the ones we normally see, deals with the set up of a trial, with pre-planning, standardized conditions etc. This method is generally more reliable as the data collected are under uniform conditions throughout the study. It is an active form of collecting clinical data compared to the retrospective studies, which are passive in nature.
Tea break!
Later in the afternoon, there was a workshop as part of marketing training. As the pharmaceutical industry is bounded by many codes and ethics, it is hard to fully utilize creativity in advertising and marketing of products. In this workshop, the participants get to be more liberal to think out of the box. A fun way to end the day!
Briefing on the workshop
V-shenn's group in action
Sui Lun's group in action...except him XD
Ok he pays attention now!
Presentation time! V-Shenn's group promoting Capple apple!
Capple's promotional "song"! Use Barney's song to sing...
Another group trying to sell instant noodles...
Sui Lun selling probiotics drink!
V-Shenn's group photo
What a day!
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