36 Lundbeck Magasinet2008 Magazine 2008 clinical studies Clinical studies are necessary to document that all new drugs are safe and efficacious. such documentation can only be obtained by investigating drugs in clinical studies in which patients are treated with the test drug in carefully controlled clinical trials. clinical trials are conducted in three phases. Phase i trials are conducted with healthy volunteers and involve a modest number of persons to establish if a drug is safe and how it is metabolized by the body. Phase ii trials are controlled studies in a few patients. the aim is to establish efficacy and determine the optimal dose. Phase iii trials are large-scale studies that typically include more than 1,000 patients. they chart the efficacy and safety of a drug in clinical use. in phase iii trials, a compound is often compared with a similar substance and with placebo. linical studies are conducted all over the world. With the international regulations for clinical studies as its starting point, lundbeck has established centres for clinical research in, among other places, europe and asia. clinical studies involve a patient voluntarily being treated with a drug for a specified period of time, in order to enable regulatory authorities to register the drug as being both efficacious and safe. the very comprehensive regulations for clinical trials are laid down in the World Medical associations Declaration of Helsinki and in Ethical Guidelines for Biomedical Research Involving Human Subjects. While a study is in progress, patients are continually and thoroughly monitored, and all data is registered and collected as part of the necessary documentation. lars nelleman, Md, is regional Medical director of lundbeck asia pacific. i worked for five years as a medical doctor and anaesthetist in copenhagen. i began my career in clinical research at novo nordisk. after working with clinical research for seven years in c denmark, i moved to singapore where i have lived and worked for the last 13 years. since i joined lundbeck approximately five years ago, i have built up lundbecks international clinical research (icr) organization in asia. today we have employees in 10 countries and a total of 70 staff members who are all specialists in clinical research. naturally, we combine all the results we get they are equally valid regardless of their origin. We find doctors with whom we can work and design protocols for them to follow during a study. the doctors then identify the patients and collect data. the big advantage for patients participating in a study is that they get excellent treatment. they are a kind of Vip patients who have direct access to the doctor and are examined extra carefully. should complications arise during our studies, we cover the costs. in our case, however, complications are extremely rare because the drugs we work with are very safe. Many patients improve considerably when they are part of a study. in cases where we can see that it could have negative consequences for a patient to discontinue the study, we often offer them the option of continuing in an extended study. ethical rules My task as head of the organization is to ensure that everything functions. it is vital that everything takes place in accordance with stringent ethical rules, as well as in accordance with lundbecks vision, mission and values. We must supply the clinical study data that lundbeck needs to obtain regulatory approval of our drugs in the us and europe, as well as in china, taiwan, korea and india all of which have their own regulations on clinical studies of their own citizens. Most countries accept the results of clinical studies made in the united states and europe, but some asian countries require studies that have been made among their own populations. meticulous care lundbeck asia pacific will account for approximately one-third of the patients in future clinical studies at lundbeck.
Destination neXt DeCaDe LUNDBECK MAGAZINE 2008
Contents LUNDBECK MAGAZINE 2008 120 million persons page 22 strategy in place for new drugs page 1
Lundbeck Magazine 2008 3 My brAin, My self page 6 Anxiety is nAturAl, PAnic is not page 14 untreAt
4 Lundbeck Magasinet 2008 creating the future now
Lundbeck Magazine 2008 5 t Lundbeck, the futures demand for new drugs is the pivot of our activiti
6 Lundbeck Magasinet 2008
Lundbeck Magazine 2008 7 My brain, my self n last years danish thriller Love on Film there is a ve
8 Lundbeck Magasinet2008 Magazine 2008 despite all that has happened during recent years, the prej
Lundbeck Magazine 2008 9 Modern research shows that mental disorders arise in exactly the same way
10 Lundbeck Magasinet 2008 meTro sTATIon / Kongens nyTorv / copenhAgen / DenmArK / gps: 55° 40 45.4
Lundbeck Magazine 2008 11 strategy in place for new drugs Jan egebjerg, Divisional Director of mol
12 Lundbeck Magasinet2008 Magazine 2008 produced with the aid of chemical synthesis. as of yet, lu
Lundbeck Magazine 2008 13 We believe that in the future it will be possible to make far more preci
14 Lundbeck Magasinet2008 Magazine 2008 Anxiety is natural, panic is not Working as an anxiety the
Lundbeck Magazine 2008 15 anxiety and panic affect not only the quality of the patients life to a
16 Lundbeck JuAn B. JusTo Av. pALermo / Magasinet 2008 / corDoBA Av. / Buenos AIres / ArgenTInA / g
Lundbeck Magazine 2008 17 untreated depression is terrible eric Wainwright is a psychiatrist and h
18 Lundbeck Magasinet2008 Magazine 2008 i believe i will have helped achieve something if in ten y
19 reaching the target groups creating an online community is of course not enough. We have to let
20 Lundbeck Magasinet2008 Magazine 2008 cristinas story cristina lives in Buenos Aires in Argentin
21 i have even started dreaming of getting a house by the sea. pHoto: nicky Bonne
22 Lundbeck Magasinet 2008 aL aTTba / aL azhar sTreeT / caIro / egypT / gps: 30° 02 51.33 n / 31° 1
persons There are 120 million persons in the countries that make up the Lundbeck Middle east region:
24 Lundbeck Magasinet2008 Magazine 2008 A good example Mourad Mohamed aly is Managing Director of
Lundbeck Magazine 2008 25 Even in the media one can come across attitudes that are very prejudiced
26 Lundbeck Magasinet2008 Magazine 2008 Success Wahiba Tharwat Mohamed gebriel is sales Manager of
Lundbeck Magazine 2008 27 H. Lundbeck A/S has been represented in the Middle East for 20 years, al
28 Lundbeck Magasinet sTATIon / moscoW / russIA / gps: 55° 45 56.19 n / 37° 36 15.68 e pushKInsKAyA
29 My Mission: my vIsIon: I had to make sure that we have good staff members who can ensure our fu
30 Lundbeck Magasinet2008 Magazine 2008 as Managing director one is given targets every year for
Lundbeck Magazine 2008 31 pHoto: lars BecH made a great deal of effort to train specialists in di
32 Lundbeck Magasinet2008 Magazine 2008 the lundbeck foundation increases donations to research he
supplement each other. our success criterion is that our donations must make a difference. We prefer
34 Magazine 2008 Lundbeck Magasinet2008 safe and efficacious clinical studies are very important i
35 chInAToWn / sIngApore / sIngApore / gps: 1° 17 06.26 n / 103° 50 42.79 e My Mission: my vIsIon:
36 Lundbeck Magasinet2008 Magazine 2008 clinical studies Clinical studies are necessary to documen
37 pHoto: lars BecH We attach enormous importance to being meticulously careful with regard to eth
38 Lundbeck Magasinet 2008 copenhAgen AIrporT / TermInAL 1 / KAsTrup / copenhAgen / DenmArK / gps:
Lundbeck Magazine 2008 39 inges forest Following three years of intensive spadework, Lundbeck has
40 Lundbeck Magasinet2008 Magazine 2008 y job is to ensure that lundbeck always has the best possi
Lundbeck Magazine 2008 41 i find working abroad and seeing other ways of looking at the world very
42 Lundbeck Magasinet 2008 the sleep command centre our built-in biological clock controls our sl
Lundbeck Magazine 2008 43 he human biological clock is located above the crossing point of the opt
44 Lundbeck Magasinet2008 Magazine 2008 A good nights sleep normal sleep consists of a series of s
Lundbeck Magazine 2008 45 the older one becomes, the more frequently one wakes during the night, a
Lundbeck Magasinet 2008 ponT Au DouBLe / noTre-DAme / pArIs / FrAnce / gps: 48° 51 00.30 n / 2° 21 1
Lundbeck Magazine 2008 47 Prepared for the future human resources Director marie-claude Ballandra
48 Lundbeck Magasinet2008 Magazine 2008 in the future, it will be necessary for everyone to have c
Lundbeck Magazine 2008 49 pHoto: nicky Bonne
50 Lundbeck Magasinet2008 Magazine 2008 from idea to drug distribution of drugs lundbeck drugs ar
Lundbeck Magazine 2008 51 700 million in the world according to the World Health organization (WHo
52 Lundbeck Magasinet2008 Magazine 2008 lundbeck milestones 1930-1945 expansion in manufacturing
Lundbeck Magazine 2008 53 1975-1990 Lundbeck defines cns as its primary focus 2005-2020 one of
54 Lundbeck Magasinet2008 Magazine 2008 lundbeck at a glance h. Lundbeck A/s is an international p
Lundbeck Magazine 2008 55 Cipralex/LexaproŽ (escitalopram) for the treatment of depression and anx
The specialist in psychiatry and pioneer in neurology H. Lundbeck A/S Ottiliavej 9 2500 Valby Denma