+32 10 46 10 10 info@arlenda.com
Arlenda Newsletter

ARLENDA RANKED 26TH AMONG THE 50 FASTEST GROWING COMPANIES IN BELGIUM

Thanks to a growth rate of 99% between 2011 and 2014, we succeeded in being ranked
26th among the 50 fastest-growing technology companies in Belgium.

Last year, Arlenda was ranked as the 25th fastest-growing technology
company in Belgium with a 142% growth rate between 2010 and 2013.

This growth is mainly accounted for by the rapid expansion of our consulting business, launched in 2010.
Our software business continues to grow steadily but the success of the consulting support for our clients brings this activity far ahead.

GET READY FOR BAYESIAN STATISTICS WITH ARLENDA’S COACHING PROGRAM

You cannot embrace the full power of Bayesian statistics overnight and alone! That is why, Arlenda is helping most biopharmaceutical companies in making the transition towards the Bayesian thinking and acting. Over the last five years we’ve developed and improved a training and coaching
program that has been recognized as outstanding and an “eye opener”. This coaching program is expanding rapidly and in 2015 alone,
more than 100 scientists benefited from it. Our program is fine-tuned to your needs and includes easy-to-grasp theory, practical and powerful examples in clinical/non-clinical fields, as well as coding solutions in SAS (9.4 or above), R, STAN and JAGS.

Embrace the power of Bayesian statistics now and request a proposal for a customized program tailored to meet your needs at bayesians@arlenda.com

LIFECYCLE PROCESS VALIDATION

Arlenda continues to be very actively engaged in the implementation of the lifecycle validation approach described
in the 2011 FDA Guidance on Process Validation and European Commission Annex 15, Qualification and Validation.
Throughout 2015, we were invited to present our expertise at numerous forums (listed below). Our “lifecycle validation”
clients leverage not only our statistical expertise, but also our business acumen. Together we are able to design
solutions that don’t focus solely on compliance; they result in real business benefit through a combination of cost
and risk reduction. We can design an entire roadmap, or assist with discrete problems such as the development of
acceptance criteria, DOE for design space, Bayesian statistics to reduce sampling requirements, a risk
based response plan to statistical signals in control charts, and much more. We provide training in all
statistical methods that can be leveraged to meet your business needs.


Lifecycle process validation should not be a maze of deliverables and tools.

Leverage statistics to find the optimal path.


Lifecycle Process Validation Topics presented in 2015

ISPE Statistics in Process Validation Forum:
“Bayesian Approach to PPQ Sampling Plan”,
committee member

ISPE/FDA/PQRI Quality Manufacturing Conference:
“Progress with the Implementation of the Lifecycle Validation Approach:
Summary of Stats in PV Forum“

ISPE Process Validation Conference:
“Considerations for Attribute Sampling and Testing Plans throughout
the PV Lifecycle“, “Designing the Business of CPV: Red is the New Black “

Process Validation Summit
“Designing the Business of Process Performance Qualification
and Continued Process Verification;Leveraging Statistics”

2015 Non Clinical Biostatistics Conference:
“Bayesian Statistics for the Lifecycle Approach to Process Validation”

IVT Annual Meeting:
Statistics in Validation 3 hour Workshop and “Validation
Sampling Plans and Acceptance Criteria”

ISPE Annual Meeting
“ISPE/PQRI Oct PV Conference Summary –
Progress and Remaining Issues“

ISPE Process Validation Training
“Practical Implementation of Process Validation Lifecycle Approach“

ISPE QbD Training “Turning QbD into a Practical Reality “

FDA HAS TO PROVIDE A GUIDANCE ON USE OF BAYESIAN STATISTICS ACCORDING TO US CONGRESS

“WASHINGTON, DC – The U.S. House of Representatives July 10th approved H.R. 6, the 21st Century Cures Act, by a vote of 344-77. The nonpartisan legislation will help to bring our health care system into the 21st Century, investing in science and medical innovation, incorporating the patient perspective, and modernizing clinical trials, to deliver better, faster cures to more patients and loved ones in need.”

More specifically the new Bill recommends proposals for use of innovative statistical methods, in particular Bayesian statistics. The FDA has to provide a guidance within 48 months on the use of Bayesian methods in the development and regulatory review and approval or licensure of drugs and biological products.

MEET ARLENDA SCIENTISTS

Chimiométrie 2016, January 17-20, Namur, Belgium

JMP Discovery Summit, March 14-17, Amsterdam

BAYES2016, May 17-20, Leuven, Belgium

NCS2016, October 7-9, Cambridge, UK

ARLENDA’S BIRTHDAY
SEE YOU IN 2017

Back in September, we celebrated 12 years of
successful business and it was a pleasure to
share it with you.
We would like to thank you all again for coming
and making these birthdays possible.

With a little bit over 90 participants, a really
enthusiastic atmosphere and some
good times visiting Leuven, you all agreed that
we should do it again soon!

So stay tuned, because we can’t wait to celebrate the next challenging and exciting years ahead of us.

CONTACT US

Arlenda SA
Chaussée verte, 93
4470 Saint-Georges
Belgium
+32 10 46 10 10
www.arlenda.com
info@arlenda.com

 

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