Our Insights

Learn about the Life Science Industry

Our featured insights contain all of our latest articles, columns and think pieces about issues that matter most in the life science industry today.

Regulatory Affairs

How to ask the right questions at an authority meeting

One way or another, as a drug developer, you have to live with the answers and comments you get from authorities. Therefore, it is crucial that you get scientific advice meetings right.

Statistics

How statistical modeling is used to predict the future

During the Covid-19 pandemic, experts at primetime news shows and in healthcare often used the term "modeling" to discuss how the epidemic would develop in Sweden and the world. But what does "statistical modeling" really mean – if reality is what it is, why should it be "modeled"?

Regulatory Affairs

Regulatory affairs considerations for drug development

Why is it so important for Life Science companies to invest in regulatory affairs activities as part of the development program for their products? What are the challenges and the key aspects for regulatory and business success?

Real-World Evidence

What is Real World Evidence (RWE) and why do we need it?

It is has been long established that it is essential to conduct randomized controlled studies as part of the drug development process. However, these “high-level evidence” studies are not always sufficient to get approval from the regulatory bodies. Often, additional evidence from so-called “Real World Evidence” studies is required. Dr Robert Szulkin explains.

Event & webinars

In our webinars and events you will meet experts from SDS Life Science and SDS MedteQ (see website). Read more and register below. 👇

Learn more!

Publications

Modelling multiple time-scales with flexible parametric survival models.

Batyrbekova N, Bower H, Dickman PW, Ravn Landtblom A, Hultcrantz M, Szulkin R, Lambert PC, Andersson TM.

BMC Med Res Methodol. 2022 Nov 9;22(1):290.

Survival After Breast Conservation vs Mastectomy Adjusted for Comorbidity and Socioeconomic Status: A Swedish National 6-Year Follow-up of 48 986 Women.

de Boniface J, Szulkin R, Johansson ALV.

JAMA Surg. 2021 Jul 1;156(7):628-637.

Hepatitis C Virus Infection and the Temporal Trends in the Risk of Liver Cancer: A National Register-Based Cohort Study in Sweden

Nurgul Batyrbekova, Soo Aleman, Charlotte Lybeck, Scott Montgomery and Ann-Sofi Duberg

Cancer Epidemiol Biomarkers Prev January 1 2020 (29) (1) 63-70;

RUV retrieves unknown experimental designs.

Lönnstedt IM and Speed TP.

Scandinavian Journal of Statistics January 2023.

Stem cell plasticity, acetylation of H3K14, and de novo gene activation rely on KAT7.

Andrew J. Kueh, Maria I. Bergamasco, Anna Quaglieri, Belinda Phipson, Connie S.N. Li-Wai-Suen, Ingrid M. Lönnstedt, Yifang Hu, Zhi-Ping Feng, Chris Woodruff, Rose E. May, Stephen Wilcox, Alexandra L. Garnham, Michael P. Snyder, Gordon K. Smyth, Terence P. Speed, Tim Thomas and Anne K. Voss.

Cell Reports January 2023,

Light-Chain Amyloidosis in Sweden (2011-2019): Incidence, Disease Burden, and Clinical Outcomes in Real-World Patients.

Ulf-Henrik Mellqvist, Qian Cai, Laura L Hester, Michael Grövdal, Jakob Börsum, Iffat Rahman, Eric M. Ammann, Markus Hansson Blood

(2022) 140 (Supplement 1): 5230–5231.

Medical and surgical postoperative complications after breast conservation versus mastectomy in older women with breast cancer: Swedish population-based register study of 34 139 women.

de Boniface J, Szulkin R, Johansson ALV.

British Journal of Surgery. 2022

Modelling multiple time-scales with flexible parametric survival models.

Batyrbekova N, Bower H, Dickman PW, Ravn Landtblom A, Hultcrantz M, Szulkin R, Lambert PC, Andersson TM.

BMC Med Res Methodol. 2022 Nov 9;22(1):290.

Major surgical postoperative complications and survival in breast cancer: Swedish population-based register study in 57 152 women.

de Boniface J, Szulkin R, Johansson ALV.

British Journal of Surgery 2022 Aug 5.

EE276 Patient Characteristics and Healthcare Resource Utilization in Patients with Chronic Inflammatory Demyelinating Polyneuropathy: A Nationwide Population-Based Study in Sweden.

Q Cai, Q Zhang, J Börsum, A Batista, K Heerlein, L Di Scala.

Value in health VOLUME 25, ISSUE 7, SUPPLEMENT , S387-S388, JULY 01, 2022.

Healthcare Utilization, Employment and Sickness Absence Among Patients with Psoriasis and Psoriatic Arthritis in Sweden: Descriptive Analysis from a Nationwide Register-Based Study

Q Cai, RE Teneralli, S Peterson, I Rahman, C Contre, L Di Scala

Value in Health, VOLUME 25, ISSUE 7, SUPPLEMENT , S410, JULY 01, 2022

Travel vaccines are strongly associated to reduced mortality in prostate cancer patients - a real effect or residual confounding?

Möller A, Schwamborn K, Spillmann A, Hoogstraate J, Szulkin R, Akre O, Egevad L, Clements M, Aly M.

Vaccine. 2022 Jun 15;40(27):3797-3801.

Impact of the Alpha VOC on disease severity in SARS-CoV-2-positive adults in Sweden.

Kristoffer Strålin, Daniel Bruce, Erik Wahlström, Sten Walther, Moa Rehn, AnnaSara Carnahan, Emmi Andersson, Anna M Bennet Bark, Håkan Hanberger.

Journal of Infection. 2021.

Changes in treatment patterns and survival in renal cell carcinoma (RCC) patients in Norway: A nationwide registry study for 1995-2018.

Puco K., Notland C., Szulkin R., Jonasson C., Beisland C., Børge Johannesen T., Solli O., Oldenburg J., Heinrich D.

Annals of Oncology 2021 32 Supplement 5 (S698-)

Potential bias introduced by not including multiple time-scales in survival analysis: a simulation study.

Nurgul Batyrbekova, Hannah Bower, Paul Dickman, Robert Szulkin, Paul C. Lambert, Therese M-L. Andersson.

Communications in Statistics - Simulation and Computation 08 Mar 2022.

Real-world study of direct medical and indirect costs and time spent in healthcare in patients with chronic graft versus host disease.

Frida Schain, Nurgul Batyrbekova, Johan Liwing, Simona Baculea, Thomas Webb, Mats Remberger & Jonas Mattsson.

Eur J Health Econ 22, 169–180 (2021

Genetic insights into biological mechanisms governing human ovarian ageing

Katherine S Ruth, (…), Iffat Rahman, (…), John R B Perry

Nature. 2021 Aug;596(7872):393-397.

Trans-ancestry genome-wide association meta-analysis of prostate cancer identifies new susceptibility loci and informs genetic risk prediction.

Conti DV, (…), Szulkin R, (…), Haiman CA. Nat Genet.

2021 Jan;53(1):65-75

The Use of Subgroup Disproportionality Analyses to Explore the Sensitivity of a Global Database of Individual Case Safety Reports to Known Pharmacogenomic Risk Variants Common in Japan.

Rika Wakao, Ingrid M. Lönnstedt, Yasunori Aoki, Rebecca E. Chandler.

Drug Safety April 2021,

Survival After Breast Conservation vs Mastectomy Adjusted for Comorbidity and Socioeconomic Status: A Swedish National 6-Year Follow-up of 48 986 Women.

de Boniface J, Szulkin R, Johansson ALV.

JAMA Surg. 2021 Jul 1;156(7):628-637.

Elucidating causal effects of type 2 diabetes on ischemic heart disease from observational data on middle-aged Swedish women: a triangular analytical approach.

Sundquist K, Johansson SE, Memon AA, Calling S, Ohlsson H, Szulkin R, Jimenez E, Sundquist J..

Sci Rep. 2021 Jun 15;11(1):12579.

Validation of data quality in the National Swedish Kidney Cancer Register.

Anna Landberg, Daniel Bruce, Per Lindblad, Börje Ljungberg , Sven Lundstam , Andreas Thorstenson & Pernilla Sundqvist.

Scandinavian Journal of Urology,

Risk of extrahepatic cancer in a nationwide cohort of hepatitis C virus infected persons treated with direct-acting antivirals.

Charlotte Lybeck, Daniel Bruce, Scott M. Montgomery, Soo Aleman, Ann-Sofi Duberg.

GastroHep. 2021. Volume 3, Issue 3, Pages: 117-208

Impact of the Alpha VOC on disease severity in SARS-CoV-2-positive adults in Sweden

Kristoffer Strålin, Daniel Bruce, Erik Wahlström, Sten Walther, Moa Rehn, AnnaSara Carnahan, Emmi Andersson, Anna M Bennet Bark, Håkan Hanberger

Journal of Infection. 2021.

Hepatitis C Virus Infection and the Temporal Trends in the Risk of Liver Cancer: A National Register-Based Cohort Study in Sweden

Nurgul Batyrbekova, Soo Aleman, Charlotte Lybeck, Scott Montgomery and Ann-Sofi Duberg

Cancer Epidemiol Biomarkers Prev January 1 2020 (29) (1) 63-70;

Clinical outcomes and economic burden for bladder cancer patients: An analysis from a Swedish cancer registry.

Joaquim Bellmunt, Thomas Powles, Roger Henriksson, Gary D. Steinberg, Nurgul Batyrbekova, Frida Schain, Sarah Fleming, Waleed Shalaby, and Arlene O. Siefker-Radtke

Journal of Clinical Oncology 2020 38:15_suppl, 5026-5026;

P204 Patient characterization and survival outcomes in pediatric chronic graft versus host disease patients: a population-based study in Sweden.

Schain, F., Batyrbekova, N., Dominicus, A., Baculea, S., Remberger, M., Mattsson, J., & Toporski, J.,

European Society for Bone Marrow Transplantation , Madrid, March 2020;

Signs of Intracranial Hypertension, Hypermobility, and Craniocervical Obstructions in Patients With Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Bragée B, Michos A, Drum B, Fahlgren M, Szulkin R, Bertilson BC.

Front Neurol. 2020 Aug 28;11:828.

CD4+ T cell proliferative responses to PPD and CFP-10 associate with recent M. tuberculosis infection.

Borgström EW, Fröberg G, Correia-Neves M, Atterfelt FB, Bellbrant J, Szulkin R, Chryssanthou E, Ängeby K, Tecleab T, Ruhwald M, Andersen P, Källenius G, Bruchfeld J.

Tuberculosis (Edinb). 2020 Jul.

Fernholm R, Holzmann MJ, Wachtler C, Szulkin R, Carlsson AC, Pukk Härenstam K.

BMC Fam Pract. 2020 Jan 29;21(1):20.

Real-word data on autologous stem cell transplantation in older patients with multiple myeloma.

Schain F, Dominicus A, Borgsten F, Mozart M, Björkholm M.

Ann Hematol. 2020 Feb;99(2):375-376

Disease-Modifying Effects of a Novel Cathepsin K Inhibitor in Osteoarthritis - A Randomized, Placebo-Controlled Study.

Conaghan P. G., Bowes M. A., Kingsbury S. R., Brett A., Guillard G., Rizoska B., Sjögren N., Graham P., Jansson Å, Wadell C. Bethell R., Öhd J.

Annals of Internal Medicine, 2020 Jan; 172(2): 86-95.

Real-world study of healthcare utilization and long-term productivity loss in chronic graft versus host disease in Sweden.

F. Schain, N. Batyrbekova, J. Liwing, T. Webb, M. Remberger, J. Mattsson.

Value in Health. 2019.