Do you know the right strategies in the pharmaceutical manufacturing sector?

Strategies, security and software for a better process:

A lot of news in the pharmaceutical manufacturing sector creates a dire scenario. With a lack of products in the pipeline and a continuing patent cliff staring companies in the face, they also face rising costs in development and production. They need strategies to streamline processes, find the most promising new products and accurately move them through a regulatory morass.

To read the entire article click here.

Learn more at our next conference for a  business transformation approach:  
International Conference PLM in Pharmaceutical & Biotechnical Development
http://bit.ly/MriGOv

Product Lifecycle Management in Life Sciences Industry - Evolving from detached to cross-functional management

By combining product and process data PLM provides visibility and traceablity as well as the link between the regulatory and manufacturing world.

In the experience of Deloitte, the traditional functional PLM organisation of a Life Sciences company suffers from virtual walls between the functional silos, product and process data being separated making it difficult for cross-functional information to flow quickly and securely.

Gain insight and download here the complete article:

http://bit.ly/KJpzBk

PLM in Sanofi: Safer Projects & Accelerated Timelines for Development

In this interview Philippe Lienard, Head of the Early Development Unit at Sanofi explains the approach they have taken in the anticipation method for chemical stability which has resulted in safer projects and accelerated the timeline for development.

Product lifecycle management is a holistic approach to emerging product and process knowledge that spans the stages of a product from conception through to commercialisation, thus improving the manufacturing process and quality of products.

Pharma IQ: Philippe, could you describe what’s happening in the industry currently around the whole latest product lifecycle management strategies and how this can be used to optimise product development processes? 

P Lienard: So to optimise the product development process we are particularly involved in some in-silico approach to assess the properties of the candidate to enter in development, and the benefit of this will be to anticipate any potential issues regarding, for example, chemical stability, solubility, crystalinity, whatever property will be very key for the drug development.
 

Pharma IQ: What strategies do you use at Sanofi to design and create safer products?

P Lienard: So the strategy is to test the compound on several animal models and for this we have to address a formulation for animals. Generally, those formulations are designed to anticipate the clinic formulation and so it allows us to determine the safe dose, the maximum tolerated dose, and it’s a good starting point for the first treatment.

Continue reading the  interview here.

Learn more at our next conference for a  business transformation approach:  
International Conference PLM in Pharmaceutical & Biotechnical Development
http://bit.ly/MriGOv

Rückblick Pharma Sales Force 2011

IQPC blickt auf ein erfolgreiches Jahresforum Pharma Sales Force 2011.

Über 130 Teilnehmer nahmen an der Pharma Sales Force 2011 teil, um sich über aktuelle Herausforderungen im Pharmavertrieb auszutauschen. Auch das Networking kam wiedermal nicht zu kurz: Der Kongress bot zahlreiche Gelegenheiten zum offenen Austausch an. Und auch im Anschluss konnten Themen und Gespräche in angenehmer Atmosphäre vertieft werden.

Mehr als 30 Fachvorträge, Round-Table-Diskussionen und Workshops zu den Themen Market Access, Marketing und Vertrieb boten die Möglichkeit zum Benchmarking der eigenen Konzepte und Strategien.

Sehen Sie hier die schönsten Eindrücke der diesjährigen Pharma Sales Force 2011 im Impressionen-Video:

Für ein gelungenes Jahresforum in 2011 dankt IQPC allen Teilnehmern, Sprechern, Sponsoren und Medienpartnern. Die Vorbereitungen für 2012 sind bereits in vollem Gange. Bis nächstes Jahr!

Learn more about the Drug Discovery Process

We've all been touched by the miracles of modern medicine. But few people understand how medicines are made, and the immense effort required to get them to market and into our hands.

Discovery Partnerships gives you the change to share costs, developments and challenges along the way.

Efficient drug discovery is still the key for the pharmaceutical industry to survive. With pharmaceutical companies worrying strongly about how to fasten time-to-market, effective drug discovery and enhanced prognosis become more important than ever. Therefore, many pharmaceutical companies are looking for long-term alliances and innovative ways of partnering to speed up development time and share risks.

IQPC's annual congress "Discovery Partnerships" is back. The only European event covering Early Discovery and Pre-clinical Partnerships! Be prepared for 2012 and beyond. Join the 3rd International Congress DISCOVERY PARTNERSHIPS from the 13 - 14 December 2011 in Düsseldorf, Germany.

Dieser in Englisch abgehaltene Fachkongress wird für die Fach- und Führungskräfte von pharmazeutischen Unternehmen, CROs sowie Biotechs initiiert. – Wie können erfolgreiche Partnerschaften etabliert werden? Welche Balance zwischen Risikostreuung und Kostenteilung ist vor allem bei einer Partnerschaft von KMUs und CROs optimal? Welche Vorteile bringen "2.0 Kommunikationskanäle" mit sich? – Diese und weitere Fragestellungen bilden den Rahmen des "3rd International Congress Discovery Partnerships".

Contract research on the rise

The global economic crisis has got most businesses pinching pennies just to stay afloat, and the drug development industry is no exception. But at least one area of the biotechnology sector -- contract research organizations (CROs) -- is on the rise.

CROs first showed up in the biotech industry in the late 1970s and quickly took on a significant role in research and development (R&D), eventually expanding from drug discovery and preclinical work to clinical trials, drug manufacturing, and even marketing.

According to a 2005 Thomson CenterWatch survey, the $15 billion CRO industry was growing at a rate of 12% each year, but data from the past two years show a substantially higher annual growth rate of nearly 17%. In 2007, of the approximately $60 billion biotech and pharmaceutical companies spent on drug
development, $15 billion (25%) was outsourced. Last year, despite the economic recession, the CRO market grew to nearly $20 billion -- 29% of the $74 billion drug development budget.

Tip: 3rd International Congress Discovery Partnerships from 13 - 14 December 2011 im Radisson Blu Scandinavia in Düsseldorf, Germany

The number and depth of the connections between CROs and drug developers has grown so much, they now have their own match-making website. Last October, serial biotech entrepreneur Jae Chung started what he expected to be a simple drug development directory. Now, just three months after its late April launch, goBalto boasts more than 7000 companies and consultants, including 2,200 CROs, all of which can be searched and rated by one another. With a couple of hundred companies and consultants adding themselves each week,
"we're one of the fastest growing professional networking sites," Chung said. Finding partnerships, which used to take four to six weeks, can now take as little as two days, he claimed.

The types of partnerships that CROs make are also changing. While pharmaceutical companies used to  contract work on single projects, explained Quintiles Transnational Corp. Executive Vice President Ronald Wooten, they're now outsourcing entire programs. "The CRO really becomes a permanent supplier of certain functions." Indeed, concurred John Watson, the President of Strategic Partnering and Integrated Drug Development Group at Covance, "with all the [recent budgetary] pressure that the larger pharmaceutical companies are under, there's been a shift to more strategic outsourcing" where CROs are no longer mere service providers, but full service collaborators.

"In turbulent economic times, clients have a greater need particularly for advisory services," Josef von Rickenbach, Chairman and CEO of PAREXEL International, agreed in an email. Some CROs are even stepping in to help make starting new biotech and pharma projects a safer endeavor -- Quintiles, for example, now co-invests in some projects with their clients so as to reduce the financial risk of any single program.

More integrated partnerships can shorten the time it takes to develop new drugs, and at an average of $2 million in lost revenue per day, significantly lower costs as well. Covance, for example, claims that their services can cut the time for preclinical testing by more than half.

In addition, such dynamic partnerships serve to keep fixed costs low and "relieve [biotech and pharmaceutical companies] of the burdens and overheads of process management so they can focus on the medical, scientific, and regulatory aspects of drug development," Wooten explained. "It's all about the pharma companies wanting to be more virtual and more variable," Wooten said. For smaller biotech companies, virtuality is nothing new, but the virtual business is certainly becoming more popular during these times of economic budget crunching. Zafgen Inc., for example, an early phase biotech company focused
on developing new therapies for obesity, recently switched to outsourcing 100% of their work, including not just the drug development projects, but human resources, legal, and communication functions as well. This shift involved a staff cut of more than 50%, as well as a move to cheaper office space with no laboratories and the selling of their lab equipment. "We should all be careful about every dime we spend in biotech," said Tom Hughes, the company's president and CEO.

Despite the economic motivation for this recent restructuring, Hughes believes in enlisting the help of CROs where possible even in more lucrative times. "It's a great way to get some extra brains on the problem," he said. "There's a wealth of expertise out there that you can tap into that you would never be able to develop yourself."

Tip: Download free articles, whitepapers and presentations on Discovery Partnerships

The current CRO boom is not limited to United States. In China, in particular, the market seems to be accelerating even more rapidly. "From the end of 2007 to now, [during] the recession period globally, we do see the growth in China is stronger," said Jenny Zhang, a North America-based business development director for the Chinese company Tigermed Consulting Ltd. In addition to the big, international pharmaceutical companies setting up R&D centers in Asia, China's domestic drug companies are growing as well.

In both cases, Zhang said, this growth stems primarily from a cost advantage to doing business in China, both in physician salaries and healthcare costs, as well as what she calls the "patient advantage." In the US, patients -- especially those with health insurance -- are reluctant to participate in clinical trials. "In China," she said, "we have 1.3 billion people, [most of whom] don't have good access to the health care system." Participating in a study is often their best chance for treatment.

Both domestically and internationally, the CRO market is rapidly expanding, and while the recent economic depression may have instigated this change, outsourcing in biopharma is increasingly becoming the new way of doing business. Even when the economy bounces back, Wooten doesn't predict a reversal of this trend. If anything, he said, "I see an acceleration of it."

Source: The Scientist - Posted by Jef Akst

Konsequenzen des AMNOG für den Bestandsmarkt und für Indikationserweiterungen

Mit dem Inkrafttreten des AMNOG zum 1. Januar 2011 hat eine neue Zeitrechnung begonnen. Der Pharma-Vertrieb steht vor neuen Herausforderungen.

• Wie sollte sich die Industrie auf Nutzenbewertungen im Bestandsmarkt vorbereiten?
• Welche Problemstellungen gibt es bei der Zulassung neuer Anwendungsgebiete?
• Welche konkreten Auswirkungen ergeben sich für die Vertriebsstrukturen?

Auf diese und weitere Fragen müssen Antworten gefunden werden.

Mehr zu diesem Thema erfahren Sie auf der Pharma Sales Force u.a. von Dr. Steffen Wahler, Vice President Clinical Outcome and Reimbursement bei der Iroko Cardio International Sàrl in Genf. In dieser Funktion leitet er auch den Außendienst seines Unternehmens in Deutschland, Österreich und Polen. Zuvor war er seit dem Jahr 2006 Geschäftsführer des Geschäftsbereichs „Gesundheitsökonomie” im vfa. Er studierte Humanmedizin in Hamburg, Volkswirtschaftslehre an der University of California, Santa Barbara und Gesundheitsökonomie an der University of York. Er verantwortete in leitender Funktion die Themen Gesundheits-, Vertrags- und Kostenmanagement bei mehreren gesetzlichen Krankenversicherungen und internationalen pharmazeutischen Unternehmen. Dr. med. Steffen Wahler war vier Jahre Mitglied des Kuratoriums des IQWiG.

Treffen Sie Dr. Steffen Wahler und viele andere Experten auf der Pharma Sales Force 2011 in Berlin. Mehr Informationen finden Sie hier.