"For one of our Raw materials, SmartChem helped us identify data on Certificate of Suitability Holders in just one click, which was taking time to extract from other sources. This helped the organization to take quick and correct business decision."

- Sourcing Manager, one of the top Pharmaceutical companies, Europe

"ROW2's RouteDesign service has given us many Novel Route ideas for our target molecules. The diverse route ideas recommended in RouteDesign reports also act as excellent stimuli to our own thought process. I must add that ROW2 team is very responsive and follow strict security norms. We are using RouteDesign service satisfactorily for the past 3 years.”

- Director Technology, Process R & D Dept, One of the top 10 global pharmaceutical companies.

Welcome to CI2E Quarterly – Issue 2, June 2009!

CI2E Quarterly is celebrating its 5^th year of connecting with R&D, Sourcing and Business Development professionals from Life sciences and Chemical industry. Introduced as a Compendium of Information, Interaction and Entertainment, CI2E family has grown to over 5000 readers from over 900 companies spanning across 25 countries. As a part of celebration, we invite our readers to participate in exciting CI2E contests and avail special discount offers on My Forum and Sponsor adverts.

• ROW2 World: Updates on ROW2 and its offerings

• Article: How to approach a Substance Information Exchange Forum (SIEF) formed under REACH legislation?

• Picks of the Quarter: Links to various interesting articles

• My Forum: Emma Delserieys from UBM International Media talks about their upcoming event, CPhI South America.

• Entertainment: Interesting facts on Universe and more!

ROW2 World :

ROW2 News

ROW2 launches REACH Corner: ROW2 is all set to launch REACH Corner, a new section in SmartChem. This new enrichment in SmartChem is designed to help its users get quick access to REACH related information such as details on High Concern Chemicals, Pre-Registered Chemicals and Prioritized Substances.

SmartChem receives applauds and appreciation: SmartChem entered its seventh year of providing value-adding services to the Life Sciences and Chemical Industry. It is a matter of great pride that SmartChem has achieved a landmark of servicing over 700 users from around 20 countries across the globe. We thank all our customers for their encouraging feedback on the SmartChem's new design and all its recent enrichments.

Upcoming Events: ROW2 plans to participate in OPR&D in Lisbon, Portugal from September 8-11 and ChemOutsourcing from September 14-16 in New Jersey, USA.

ROW2's Cricket Frenzy: ROW2 joined the cricket frenzy and organized "SmartChem Twenty20 Contest" for its Indian SmartChem Subscribers in Jun'09. Participants thoroughly enjoyed the contest and won exciting prizes like MP3 Players and Digital Camera. We congratulate all the winners!

CI2E 5^th Year Celebrations: Within 2 days of the release of Issue 1 of CI2E Quarterly 2009, we received over 100 correct responses for the interesting Fun Trivia. The first 5 correct entries will receive their prizes shortly. Participate in the Fun trivia in this issue and win fabulous prizes.

SmartChem News

SmartChem Orientation Program: With an aim to ensure that the subscribers derive maximum benefits from SmartChem, we have launched a SmartChem Orientation Program. The new SmartChem subscribers will receive their Orientation Kits soon.
This program is designed to orient the new users to SmartChem, its various features, data searching and its value adding initiatives. This Kit also shares customer experiences on how they are deriving benefits from SmartChem.

In case you are interested to get SmartChem Orientation kit, contact us here.

Launch of New SmartChem Demo: The new SmartChem Demo is now online. We invite industry colleagues to explore various features of SmartChem, evaluate data and experience SmartChem benefits.

To view the new SmartChem Demo, click here.

Upcoming Enrichments: SmartChem users can now derive even more benefits from the knowledgebase. Following are the upcoming SmartChem enrichments:

• REACH Corner
• Details on REACH Pre-Registrations for SmartChem Chemicals
• Alerts on REACH Prioritized Substances

Write to us to know more about these enrichments.

RouteDesign News

ROW2 strides further on the success path: ROW2’s flagship brand, RouteDesign continues to bag more long-term contracts with Top Life Sciences companies from USA and Europe. Also, more and more Biotech companies are now using RouteDesign service mainly for increasing the Value of their projects by strengthening their Licensing packages and for evaluating in-licensing candidates.

Important Events: July’09 to September’09

July:
07-10 : Scale-Up of Chemical Processes: Vancouver, Columbia

August:
26-28 : CPhI South America: São Paulo, Brazil

September:
08-11 : OPR&D: Lisbon, Portugal
14-16 : ChemOutsourcing: NJ, USA
15-18 : Biologic Europe 2009: TBA
16-18 : BioPharm America: San Francisco, USA
23-24 : Chemspec Latin America: Mexico (postponed till Third            Quarter of 2010)

Featured Article

Rob Rutjes of Royal Haskoning writes about the issues faced by pre-registrants of Phase-in substances in formation of Substance Information Exchange Forum (SIEF) under REACH legislation. He further shares his thoughts on approaching the SIEFs.

How to approach SIEFs?

At this moment many companies go through their first SIEF experience. In some cases this process moves smoothly, but in many cases the process turns out to be quite different than anticipated. We hear many complaints about SIEFs that do not start at all or SIEFs where the activity is limited to the communication of the CEFIC standard inquiry letters.
As the exchange of information on substances and data is new for most companies, it is not a surprise that companies competing on the market have difficulties to start up the process of data sharing & joint submissions.

To read the full article click here.

Interesting Links

Chemical Earnings Continue To Slide
Published in C&E News: April’09 issue

This article sheds light on how the deteriorating consumer and industrial demand is impacting earnings in the chemical industry.

Bio Companies Low on Venture Capital Cash
Published in PharmExec.com: May’09 issue

Read the informative report by Ernst & Young detailing changes in the biotech industry in the past 12 months.

Containing Swine Flu
Published in C&E News: May’09 issue

US FDA has responded to the Swine Flu threat by authorizing the emergency use of certain antiviral drugs. Read more about the USFDA’s response to Swine Flu challenge.

Featured Article Cont'd.

In some cases, however, SIEFs do function and the REACH registration process has been started. This is mainly the case where a consortium is in place, when companies have well established working relations, e.g. in a CEFIC-sector group, or where the SIEF facilitator has a clear interest in an efficient registration process. In other SIEFs we see a slow start due to the absence of a SIEF Formation Facilitator (SFF), lack of interest in taking the lead by any of the pre-registrants or the presence of a small company or consultant as SFF. In the last scenario neither the consultant nor the company has an interest in an efficient process and perhaps not even a direct interest in the registration of the substance. An additional problem, in our experience, is a lack of knowledge on REACH by the SFF.

When the SIEF functions appropriately, substance sameness discussions and data sharing have been started as the first stages of the registration process. In problematic SIEFs nothing happens and this is frustrating many companies. This mainly concerns companies that are not willing to take the lead, but have a clear interest in a smooth registration process. These willing companies are looking for possibilities to open the discussions without taking the lead (a possibility would be hiring an independent party to organize a one day face to face meeting of SIEF members to kick-off the process).

When your company is in a situation as described above and is involved in an inactive SIEF, you can take action starting from your own data. We recommend a number of steps to be taken. These steps are not different from those that need to be taken to work together in a well functioning SIEF.

Phase I

• Make sure you have all information on your substance (purity/impurity profile) and use the guidance for substance identification to establish the identity;
• Gather test data which you own or have the right to use (legimate possession or right to refer);
• Consider to initiate/join a form of cooperation, e.g. a consortium or sector group;
• Consider which endpoints you need to cover for your registration dossier depending on your tonnage band;
• Identify your data gaps and consider whether you need test data to fill the data gap or whether you can waive tests based on the possibilities as outlined in Column 2 of Annex VII-X or those as described in Annex XI;

Phase II

• Try to get your SIEF to move by pressure on the SFF or try to initiate an initial meeting;
• Request missing vertebrate test data from other SIEF participants (this can be done on an individual basis if necessary). All pre-registrants in the SIEF are legally obliged to respond and to share their data on a fair and transparent basis;
• Gather at minimum the data for Annex VII and VIII (when your tonnage band is 1-10 tonnes, Annex VII data is of course sufficient);
• Prioritize the work to gather the needed data and put highest priority to the 28-day and reprotox study data (necessary for Annex VIII)
• Try to waive data;
• Prepare your registration dossier (this is not a joint dossier, but vertebrate test data are shared with other SIEF members);
• This procedure is not an opt-out from the SIEF.

It is clear that the procedure described in phase II is not the ideal situation. Preparing an individual registration is much more expensive than a joint registration. However, by entering the first two steps of phase II, you might succeed to get some people in the SIEF starting to move and join you in your effort. The main risk of taking this approach is that you might end-up as lead-registrant. But on the other hand, what are your alternatives if you face the 2010 registration?

About the author – Rob Rutjes:

Ing. R.H.J. (Rob) Rutjes MSc is a Senior Manager Business Development at Chemicals Management, a department of the Environmental Division of Royal Haskoning, The Netherlands. In this consultancy, they take care of the life cycle of chemical products and dangerous substances from production, use to waste. With a team of over 50 consultants who have expertise in the field of chemicals, they help companies to make key decisions in regulatory compliance, product stewardship, chemicals management and REACH legislation.
r.rutjes@royalhaskoning.com
www.be-reachable.com

To sponsor future newsletters, write to us here.

Emma Delserieys from UBM International Media talks about their upcoming event, CPhI South America.

CPhI South America, the region’s largest pharmaceutical exhibition will take place in Sao Paulo, Brazil, from 26 to 28 August 2009.

- Enter a rapidly growing market

- Network and meet with new suppliers

- Discover the latest trends and innovations in the market

- Stay ahead of competition

Do not miss your chance to ensure your free ticket, register now by clicking here!

Interesting facts about Universe:

- The Pistol Star is the most luminous star known - 10 million times the power of the Sun and as big as the size of Earth's entire orbit around the Sun.

- Earth is the only planet not named after a Roman or Greek god.

- Although it is closest to the Sun, Mercury has ice in its craters.

- Pluto is no longer considered a planet. It is now known as a "Dwarf Planet".

- The full moon always rises at sunset and sets at sunrise.

Fun Trivia:

What is similarity in the two words given below?

ALUMINOSILICATES
PARASITOLOGICAL

First 3 correct answers will win a Prize! So hurry, rush your entries now.