Growing Up Wisely ...



My former colleague has a grown up son, who finished his high school, decided to pursue an ACCA course. She wanted me to meet up with him and, if possible, to mentor him. Well, after a few failed attempts, I managed to meet the son a few days back. I remembered meeting him years ago when he was very young - a few young years then. At that time, his mother was my colleague. How time has flown!

He is now 19 and I am way past that age. I looked at his youth and told him that "I was like you once". I had not really appreciated my youth then as I took growing up for granted and, it was, part and parcel of growing up, I thought. So, with good intent and purpose, I told him to enjoy his youth and growing up.

With the consciousness of wanting to set him on the right path for the years ahead of him, I asked him why he took up ACCA. Without hesitation, he replied that "I save time as I can go straight to ACCA without having to spend more time preparing for the Uni. After 3 years, I can start to work". I had the feeling that he had no specific ambition as both his parents are professionals being a Pharmacist and an Engineer. He just wanted to be in the work force quickest and be financially independent, which he affirmed, when I posed this to him.

Nevertheless, I wanted to encourage him and said its "okay" to take up ACCA. However, after completion, do work. And, do finish up, with part time study, being a qualified registered Accountant like having a CPA. I told him everyone needs to have a big goal in life which he seemed to understand.

As he is still in his youth and with many promising and productive years ahead, I also told him to be a responsible youth. Walk the right path and do not turn to wrong disruptive, irresponsible company of friends. Parents' love and concerns are always genuine and true. Consider their advice before making his own decision when advice is given.

The next piece of advice I gave to him was that think before "you post or upload any comments or remarks" in any social media like FB as these may haunt you later" eg "if you vent your frustrations every time in the FB, you may miss an opportunity as the potential employer may check your background on your FB and he may pass you by"... well ... as this was the first meeting, I decided to end here and we went for lunch ...








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A Historical Day!



28th June 2013 was a historical day for the Pharmaceutical Industry albeit a very low profile signing ceremony held at the office of the Senior Director of the Pharmaceutical Services Division (PSD), Ministry of Health (MOH), Malaysia.
 
I must thank PSD for making this possible with the signing of the MOU between MOH and IMS on the cooperation in the field of pharmaceuticals data. Indeed the Country and the stakeholders in the Pharmaceutical Industry will greatly benefit.
 
Malaysia will now have a more accurate pharmaceutical data base and both the Industry and the Government will be able to access to a common data base to derive analytic figures for measurements.
 
With this collaboration, MOH had also achieved a historical milestone in that, if I am not wrong, the collaboration with IMS, is the first Public Private Partnership not only in Malaysia but also in the region, if not globally. Congratulations to both Parties. 
 
The journey, took 2 years and 3 months, it was worth it. It began when I and the then IMS General Manager for Malaysia initiated this Project in April 2011. We strongly believed that the Country needed to have a single credible internationally accepted and respectable data source for its pharmaceutical Industry especially when the Country is in the process of its Economic Transformation Program (ETP) for National Key Economic Areas (NKEA): Healthcare. Malaysia cannot stand in a world forum and speak without such credibility.
 
We approached the Director of PEMANDU for Healthcare and then followed by a few meetings/presentations to PEMANDU and key personnel of the MOH. I was glad that the Government finally recognised the importance and the capability of IMS in supporting the ETP in this collaborative partnership. Much effort and time, also frustrations, followed in pursuing the Project to its conclusion as there were disruptions like changes in key personnel in the MOH. As they say, the rest is now history.

Personally, I also have the satisfaction in celebrating this event as since the day I joined the Industry, some 35+years back, I dreamt of having a common pharmaceutical data base where all stakeholders, including the Government be able to quote the same figures, whether be product market size, therapeutic groups etc. Today, I am glad I live to see the day.
 
 
 
 
 


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Today's Basic Prerequisite: Connectivity



Today, the majority of people are intimately connected with one another be it emails or any electronic social media like twitter, facebook etc

To be connected has its advantages and disadvantages. We have read of statistics where many are being addicted to their smartphones or other electronic gadgets. Many become slaves to these modern devices and technology.

However, on the flip side, from the view point of harnessing the power of technology intelligently, one can reap great and positive benefits without being slave to these devices.

Restricting our focus to commercial interests, it is important for business to establish network and connectivity. The most basic a company should have is to have an email address, PC and a smart mobile phone. With a smartphone, one can get connected immediately when he is on the move, when an email is being received. In the "earlier days", before the advent of smartphones, mails are only accessible on the table top PCs, and also only in a fixed location like the static office space.

It is important to ensure that emails are received and replied according to urgency. Do note that there is no rush or obligation to urgently reply to all the mails received.

I have personally sent emails to companies where the mails are being rejected due to lack of mail box size. It is thus unfortunate that the intended recipients were not aware of the "returned mails" which to my mind is "missed business opportunity". Thus, being connected is not enough. You have also to ensure that you do periodic "house cleaning" and have adequate mail box size and upgrade the size when there is an expected increase in mail volume.

Believe it or not, there are also business practitioners, who have not taken upon themselves to have mail boxes loaded into their smartphones to harness the technology available. They thus, do not understand the importance of "speed to response", "taking advantage of opportunities presented" and the business lesson of the importance to be efficient and productive in connectivity.

To conclude, connectivity is important, whether on a PC or mobile device, to receive and response to mails accordingly. There is time compression and there is no space for delay or procrastination in decision making. Business can be won or loss due to speed of response. The early bird catches the worm. Be smart, stay connected!





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Team Leadership and Performance



Great Team Leadership and Performance. What are the attributes? Good to learn and put into practise. It works!

Participative leadership: The boss is part of the Team. The team understands that each team member depends on one another. There is an interdependency. There is empowerment, freeing up, serving and caring for one another. When one failed, all failed!

Embracing the same Vision:  Believing in the common goals of its existence and functionality. Every member is in the same boat and needs to row together in order to reach the destination within the defined time frame.

Be Innovative and Creative: Think out of the box. Do not be trapped in the past. Push the envelopes. Use individual talents. There is no such thing as a "silly or stupid idea".

Shared responsibility: All members, managers and workers, understand and undertake
the shared accountability and responsibility for achieving the performance within the strategic business unit.

Accepting Change:  Do not whine. Nothing is stagnant. Everything in life and business are in a state of flux and dynamic state. Change is constant and inevitable. Without change, there is no opportunity.

Appropriate and speedy response: Identify and act on challenges. Do not procrastinate. With challenges, come opportunities.

Effective communication: Establishing an environment for transparent, honest, trust and timely communication.

Focussed: Do not be distracted. Focussed on the job and results. Be passionate. Go for it!







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Common Data Source



It is an expectation, without having to remind anyone, that when a game of football is being played, the football rule is to be applied. When you play a game of basketball, or whichever game maybe, the relevant rule is to be applied accordingly.

Nobody would understand  or accept a basketball rule to be applied for a game of football. Confusion and chaos will rule if there is no rule at all in any game. For that matter, any new game that is being created must be accompanied with a realistic, fair and practical rule.

Thus, when a Pharmaceutical Company is to present its performance in a national or global arena, any measurement of its market performance must be measured against a universally agreed set of data.

For the Pharmaceutical Industry, IMS data is the globally accepted source of data information. The big global MNC Pharma boys recognise and use IMS Pharma Audits for sales and marketing analysis and planning.

In Malaysia, the private sector uses the IMS data whilst the various Government agencies have different set of data generated or referenced to some other sources.

Thus, it is heartening to note that, in Malaysia, there is now an understanding and acceptance, by all stakeholders in the Country, including the Government, to have a common data base, in this case IMS's, to measure the success of the Industry and PEMANDU's in driving the NKEA for Healthcare, EPP3. All stakeholders are now on the same wavelengths. They are now communicating, playing the same game and on the same playground.

The Government and IMS will soon collaborate in "data gathering and sharing". I am glad that I was able to initiate and play a role to drive this IMS data platform.



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Website - to have or not to have?



Let me ask you a question? What is the main motivational factor in having your own website?

The most likely answer would be "as a window or an information portal to the world to know who and what I am". However, if you are in business, you would also hope that the website would create interests and attract visitors, business partners and wealth to your business.

You are not wrong in your understanding and expectations. Thus, it is important that in designing your website you need to give your utmost attention to the format, contents and details to ensure the site will be innovative, attractive, friendly, robust and informative. It must be dynamic and regularly updated with the latest development of yourself and/or business. It must also be able to attract repeat visitors.

I was thus appalled when I visited the website of a friend the other day. The contents of the website, from the home to the rest of the other pages, betrayed the dynamism and the success of the leadership and the Company that I was proudly associated with.  It lacked the "oomph" with well thought formatting and information! In my mind, information on the resources, talents, skills, experiences, successes, markets and capabilities of the Company were lacking and, if any, were not explicit, professionally and factually presented.

As the website is on the internet, it is accessible to an international audience as well. Thus, any local content, must be adapted and written with the international audience in mind. And, if the main objective of the site is for international consumption and interest, the site should be" skewed as such" and balanced with appropriate local contents.

I believe the CEO or Senior Managers of the Company MUST take charge of the design and contents of the website. It must not be left to the juniors or any "IT" personnel to "do" a "cut and paste" site.

It cannot be over emphasized that the website represents the face, philosophy, success and values of the Organisation when a person surfs the net for the background information of the Company. The website "sells" the Company even before an individual meets up with any of the Company's representative. Any website that is ill-designed would thus ring a death knell to the Organisation even before it is being given an opportunity to know one another.

Thus, be serious of your website design and contents otherwise please do not have one! It could damage you!



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Commitment or Contribution?



Someone was asking me about "what is commitment" some time back. The question quickly brought me back to a very graphic illustration which I learnt from my Superior, many years back, when I first started my climb up the Corporate ladder.

Some of you may have heard of this illustration. Nevertheless, for the benefit of those who have yet to hear, I will repeat, though with a bit of twist of my version.

One bright sunny morning, a chicken and a pig were having an early morning stroll when they came across a boarding house in the British country side. Outside the house there stood a big sign-board which read "Bed & Breakfast. Only £35 ! Free - Ham and Eggs served for breakfast".

The chicken, on reading the advert, proudly said to the pig "See, I have to work very hard everyday in order that the Innkeeper could provide the free eggs to the Guests."

The pig, was aghast and in reply, said to the chicken " ... this is nothing, in order to have ham for breakfast, I have to give up my life!"

Indeed both the chicken and pig contributed to the morning breakfast. But, between the two, which one of them demonstrated commitment to the Innkeeper? The chicken or the pig?

The obvious answer is the pig. The pig has to give up its life whilst the chicken lives another day as it continues to lay eggs.

Thus, I hope you would be able to define and differentiate between commitment and contribution.








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A "Shoe Story"



Another marketing story.

If you have already heard of this, do bear with me - or take this as a reminder or "refresher" if you can. For many who have not heard of this, here goes:

A very successful shoe Company, many aeons ago, having established itself in its home market, decided to venture abroad. The first potential and lucrative market that came into the CEO's mind was the  people in the third world countries.

So the CEO decided to send one of its senior Managers into a Country in the Africa continent. The Manager, after having many hours of flight, finally landed at the country's airport. He stepped out of the airport and made his way to the hotel. Along the way, as he travelled in the taxi, passing through the villages, he saw many people along the way. As he was a "shoe salesman", his eyes were fixed at the many feet that passed by him.

To his dismay many were without shoes. They were barefooted! If any were not, they were in simple, "torn" and crude "shoe-wares" made from local natural materials. He was disappointed!

On reaching the Hotel, he unloaded his luggage, and immediately went to the telegraph office and sent a telex (those days fax, emails or mobile phones were unheard of) to his boss:  "Boss. Landed safely. Many people here. Disappointed. No market for shoes as many do not wear shoes!" The Boss responded: "Please come home".

As months passed, the Boss was restless and decided to send another Manager for a second opinion. The second Manager landed and was very excited on arrival to the Country. He observed what the first Manager observed. Quickly, he sent a telex to his boss: "Boss. Arrived safely. Very excited. Big market for shoes here as many did not have shoes"! And , as they said, the rest is now history as the Company was able to make great success out of the Country concerned. The Company became a market leader for its brand of shoes in later years.

In conclusion: Same scenario BUT different perceptions and therefore different opportunities from 2 individuals from the same Company. Thus, we must learn to "see" opportunities under adverse or seemingly unfavourable market conditions. There is always a silver lining in every dark clouds! Never say "no" or come to a conclusion immediately! Opportunity awaits!





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Elephant same, Different Perspectives



I was reminded of an "Elephant Story" - how  a few blind men "see" the elephant.

5 blind men were taken to a zoo to "see" an elephant as they had no idea, how an elephant looked like. For the blind, the sense of touch is one of the important "senses" that they must sharpened in order for them to "see" and get connected to the world around them.

The 5 blind men were standing before the elephant. Each was "standing" away from one another.

One of the blind men was holding the elephant's tail and said "the elephant is like a whip as it is a long cord and has tufts of hair at the end". The other, holding the elephant's legs said "No, the elephant is like a tree trunk. Steady, strong and mighty". The third exclaimed "the elephant is neither a whip nor a tree trunk but it is like a banana leaf" as he was feeling the flapping ear of the elephant. The fourth expressed his surprise and said "No. The elephant is like a filled long water hose" as he held and moved his hands along the elephant's trunk. The fifth, with a loud voice raised his voice and said "you are all wrong. The elephant is like a great solid wall" as he moved his hands along the large expanse of the elephant's body.

The morale of the story? Do not come to a conclusion, and adamantly insist that you are right, when there are different observations or views of the "elephant". These are all different perspectives of the same "elephant". As for the 5 blind men, they all have "bits and pieces" of information or "views" of the elephant ... and they are not wrong in their respective "observations"! If all of them would coolly meet and discuss among themselves they would surely have the "full picture" and gain much as a Team.

Thus, be careful, and don't to rush for a quick decision particularly in a group discussion. Be wise, make a point to listen to others. Ask probing questions and be ready to listen. Do not prejudge. Be analytical. Be a Team. Make intelligent decision based on informed/shared knowledge. It is better to be right then to be wrong. Do not be blind to the opinions or views of others!

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Next phase of Growth - Generics in Malaysia



More and more governments around the world, Malaysia is no exception, are pushing for the increase use of generics in order to contain health care budgets. With the patent cliff, value globally at USD 150 billion in 2015, the launch of copy products upon patent expiry will wipe billions of dollars off the original drug-makers’ revenues. Generics is indeed a challenge to the research-based companies.

Capitalising on this, Malaysia, under the Economic Transformation Program (ETP) NKEA for Healthcare EPP3, I was able to witness the close collaboration between the Ministry of Health (MOH), Malaysian Organisation of Pharmaceutical Industry (MOPI) and Pharmaceutical Association of Malaysia (PhAMA) where the 3 Parties co-sponsored the mini-lab for Pharmaceuticals, under the auspices of PEMANDU, to map the way forward in ensuring the trajectory growth for the local generic manufacturers, to the next level, in generating GNI and employment in the Country.

MOPI is an Organisation which represents the interests of the local generic pharmaceutical manufacturers. There are 38 members. On the other hand, PhAMA represents the big Pharma boys like MSD, GSK, Pfizer and other "smaller' global companies. There are 41 members.

Thus the min-lab was a historical moment when, at the end of the 3-day brainstorming sessions, score cards and KPIs were set, as a result of the effort, contributions and collaborative spirits from all Parties.

The main thrusts of the lab were for the developments and export capabilities of the local manufacturers for Biologics/Vaccines, Generics and OTCs/Health Supplements.

It is with certainty, in the Malaysian way, where Government authorities, acting as facilitators and enablers, will indeed help to realise the road map for the local Industry beyond the Country's border.





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Malaysia Regulatory Updates 3: BE



MALAYSIA - REGULATORY UPDATES 3:

BIOEQUIVALENCE (BE)

Implementation of requirement for BE studies for all generic “Immediate Release, Oral, Solid Dosage Form” products. Applicable to products containing Scheduled Poisons 

New Registration : 1st  January 2012 

Existing Products:  1st January 2014 upon submission for renewal

Accreditation of BE Providers/Centres

Inspections by NPCB auditors based on GCP and GLP Principals 

Local and Foreign Centres to be accredited by National Pharmaceutical Control Bureau (NPCB) 

Payment by Product Holder for foreign Centres inspection by NPCB: €5,000 Inspection Fee  + Actual travelling Expenses. Inspection report valid for 3 years after inspection 

Listing of approved BE Centres available on NPCB website .

Source: 7-9 May NRC 2013_National Pharmaceutical  Control Bureau
 



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Malaysia Regulatory Updates 2: Product Registration



MALAYSIA - REGULATORY UPDATES:

GOOD MANUFACTURING PRACTICE (GMP)

In order for imported Products to be registered with the National Pharmaceutical Control Bureau, the Product must be:

1) Manufactured in a PIC/S or ICH country or 2) Manufacturing facility must be inspected and  compliant to PIC/S GMP guidelines by a National Drug Regulatory Agency of a PIC/S or ICH Member Country or 3) ASEAN Member State listed in ASEAN Sectoral Mutual Recognition Arrangement for GMP
Exemption Clause:

  Unmet Medical Needs  –  Orphan Drugs 
      Life-Saving Products  –  Oncology/Anti-Retrovirus  
      National Emergency  –  Pandemic  
      Technology Transfer

Implementation date:

       1st  July 2012: new registration of pharmaceutical products
       1st  January 2014: product registration renewal

 
Source: 7-9 May NRC 2013_National Pharmaceutical  Control Bureau
 
 


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Malaysia Regulatory Updates 1: DE & API



MALAYSIA - REGULATORY UPDATES:

1) DATA EXCLUSIVITY (DE). Directive effective: 1st March 2011

New Chemical Entities (NCE):  Application within 18 months from date of first registration  Duration: 5 years granting of DE in country of origin

Second Indication of registered product: Application within 12 months from approval of second indication. Duration: 3 years

Exclusion: Compulsory Licensing, National Emergency etc. Not applicable to Biologics/Biotechnology Products.

2) ACTIVE PHARMACEUTICAL INGREDIENTS (API).
 
API requirements for new drug applications implemented in stages:

2.1) New Chemical Entities (NCE)
         April 2011 : Voluntary 
         January 2012 : Mandatory

2.2) Generics : In stages according to risk
          Injectables/Parenterals :  Tentative January 2014
          Others: To be decided

2.3) Other issues:
          Existing Products: To be decided 
          GMP Standards:  PIC/S, WHO

Source: 7-9 May NRC 2013_National Pharmaceutical  Control Bureau
 


 


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Show-stopper ?



There were much excitements and participations among the group members who were diverse in backgrounds, experiences, roles, functions and capabilities but nevertheless shared a common platform in desiring  to advance Biologics, which is in its embryonic stage, in Malaysia for the local and export markets.

The dynamic and interactive group was looking at catalysts and solutions, eliminating negative barriers and concepts in order to leverage on the positives and working with enablers in accelerating the implementation of the Project. The end point of the mini-lab was to have Score Card and KPIs to follow through.

There was an individual who stood up prominently with full of passion, repeatedly said, when there were obstructions that seemingly hinder the Project, said "if it is not a "show stopper", the project must go on".

To me the signal sent was filled with passion, conviction and commitment. The statement encouraged many and the group continued with their support in overcoming the challenges which were the "non show stoppers" with workable proposals. From statistics gathered over the years, many Projects failed due to poor execution and not due to poor planning where the executioners lack understanding, passion, conviction and commitment for the projects.

Understanding the business environment, the business flow and trending, product technical know-how, human talent, government regulatory requirements, sources for technical expertise and cell lines, manufacturing pathways, distribution value chain, commercial demand and constraints etc were crucial and important. All these, as the discussions went on, the group realised could be acquired with optimal monetary funding.

Thus, what stood up as a "show stopper" was monetary funding.

For many entrepreneurs, many great ideas with hugh potential and attractive financial returns did not fly, not for lack of project feasibility and effort but inability to get funding from financial institutions, venture capitalists or governmental funding. These funding institutions lack understanding of the healthcare sector where there is an incubation period due to product R&Ds, product trials and registrations, manufacturing before commercialisation.

This incubation period, could stretch from 1-2 years or more, will need continuous cash flow and thus financial support. The first dollar would flow in after commercialisation, which could take another year. Let not money be a "show stopper" as great projects would not be able to see the day. Thus entrepreneurs and funders should structure loans that are friendly to the entrepreneurs for a win-win partnership.

The desire to create and enter into the Biologic space is real and the journey just got started. Stakeholders and enablers (including the Government and Financing Institutions) must come together in order to reach the end-point soonest possible.












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Dress for the Occasion



After a visit to the Commercial Bank yesterday, I decided to have an early simple lunch in a hawker food centre. The hawker, whom I frequented often, looked at me and expressed his surprise "Wah, you are really well dressed today". Hmm ... it did not cross my mind that I was well dressed. I was in my blue jeans, dark coloured collar T-shirt, a pair of suede leather shoes and hair well groomed. Then, I remembered ... I was not in my "casual home attire of short pants, round colour short sleeve T-shirt, slippers and dishevelled hair which he was familiar with.

Quickly, I responded saying "I just came from the Bank" ... The hawker friend, on hearing my response, smiled and thought that I was clever. Yes, we all need to dress for the right occasion.

Then I realised that I had dressed appropriately, in my opinion, for the visit to the Bank as I was meeting a Bank Officer to address some issues. I had subconsciously avoided my normal "home casual wear" as I had wanted to be taken seriously and professionally by the Officer.

Dressing well for an occasion will definitely enhance a person's image and personality, confidence and influence felt by the other party in whom you are engaging in a conversation, negotiation or interview. It is all about perception in personality, truth, credibility and reliability.

The determinant factor to dress appropriately is thus "what is the occasion? what subject matter would you be discussing, who will be attending? where is the function or meeting going to be? is the function casual, ceremonial or official? ... and a host of other questions ...

You may need someone to guide you along initially, get some tips from relevant books or learning through observing how others dress ... or go for coaching class on grooming, dressings and business etiquettes.

Thus, to dress well, not "under-dress" or "over-dress", for a right occasion is one of the key enablers in contributing towards image building and success. It leaves impressions, or in today's jargon, your footprints in the other party's mind. It is a "game-changer" for you!










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Malaysia: Pharmaceutical Market at a Glance



Some quick data for the Pharmaceutical Industry in Malaysia:
 
Pharmaceutical Market, 2011: RM 4.4 billion 
 
Government 51% 
Private Clinic 19% 
Private Hospital 17% 
Pharmacy 13% 

Government Purchases in 2011

RM 588 mil Patents
RM 862 mil Generics
 
 
Market Landscape:
 
Leverage patent expiry cliff by pursuing generic opportunities. Value globally at USD 150 billion in 2015
 
Malaysia:
 
- A member of the Pharmaceutical Inspection Co-operation Scheme (PICS) 
-  Off-take Procurement Agreement for New Locally Manufactured Pharmaceuticals for  3+2 years
- Fast-track registrations for new products under EPP3 in the NKEA programme
- Compulsory service for pharmacists reduced from three years to one. Pupillage allowed in the private sector/industry
- All generics are subjected to BE Studies and their labs are inspected for compliance
- Strengthening patent related issues on pharmaceuticals
- Improve the collection and management of pharmaceutical data with IMS
- Improve market access into foreign countries


(Acknowledgement with thanks: Sources - IMS, Ministry of Health, PEMANDU)

 

 

 

 

 

 

 

 
 
 
 
 
 
 

 



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