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SmartChem Case Study Launched!

One of the US based chemical companies faced the following issues with their key product (organic intermediate):

Increased  competition from  Chinese & Indian  manufacturers.

Decline in the  sales & market  share of this key  intermediate.

The company needed to re-evaluate the market potential for their key intermediate quickly & explore business expansion opportunities.

Current Status: The Company started using ROW2's knowledgebase SmartChem & successfully identified new business opportunities. The intermediate has shown significant growth. The company has been deriving benefits from SmartChem for over 3 years.

To get a copy of this case study, write to us here.

"We have evaluated ROW2's new service PathWays Plus and are extremely satisfied with the results. The methodology that demarcates commercially scalable routes from routes of academic interest is unparalleled. PathWays Plus helped us reduce development costs and better allocate our resources."

- Head of Chemistry from a major chemical company

"ROW2’s RouteDesign report gave us novel synthetic routes suitable for commercial scale that we had not considered before, and therefore, added to our team's knowledge. We would definitely use this service again."

- Head of Process Research at Altana Pharma AG.

Welcome to CI2E Quarterly, Outsourcing special! We are delighted to bring you the first issue of this Newsletter for the year 2007. Outsourcing as a concept and practice has become an integral part of our industry for a successful and sustained growth. Recognizing this need as prompted to us from time to time by our customers and Industry leaders, we have dedicated this newsletter to Outsourcing Solutions!

The CI2E has been appreciated as a true Compendium of Information, Interaction and Entertainment, by many of our readers. CI2E Quarterly continues to reach over 5000 "select" industry professionals in the Life Sciences and Chemical Industries and enjoys good readership!

In this issue:

• ROW2 World: Activity Calendar for 2007

• Featured Article: An interesting article on Outsourcing of Chemistry by Dr. Anand Shintre of IndusChemie U.K.

• Links: to various significant articles published on Outsourcing.

• MyForum: Dr. Andrew Warmington-Editor of Speciality Chemicals Magazine writes about their magazine.

• Entertainment: Filled with excitement, a chance to win prizes and a dash of humor!

ROW2 World - Quarter 1 highlights:

ROW2 News

• Event: ROW2 kicked off this year by exhibiting at Informex'07 held at San Francisco, USA. At this event, ROW2 officially launched its new service PathWays Plus, designed to provide a comprehensive literature review and analysis of synthetic routes to a target molecule, ROW2 also presented its offerings SmartChem, RouteDesign and Route2India at Informex.
  
  ROW2’s booth was filled with excitement and our visitors thoroughly enjoyed our "Scratch & Win Contest" where contestants could win iPods, Technology packs, Designer Pen sets, Polo shirts and lots more. The "Struggle to Juggle Contest" created a lot of buzz when participants showed off their juggling skills and won fabulous prizes.
  
  ROW2 also attended OPR&D 2007 in San Diego, USA on Jan 8-10, 2007.
  
  

• ROW2 Press Briefing at Informex’07: The CEO of ROW2, Srini Gopalan presented his thoughts on a new emerging model that goes beyond the current outsourcing models. This novel concept christened, Cerebral Process Partnering (CPP) was presented at the Informex press conference titled “CPP: An emerging trend in Intellectual Partnering”. We take this opportunity to thank the eminent members of the Press and Publications for attending this conference!! Ms. Michelle Bryner of Chemical Week won an iPod nano in the ROW2 Lucky Number Contest. For detailed information on CPP, please contact us here.
  
  

• Upcoming events: We will be attending Chemspec India to be held on April 18-19, 2007 in Mumbai, India. We will also be attending CPhI Japan, Tokyo to be held on April 18-20, 2007 and OPR&D, Jersey, Channel Islands to be held on May 14-17, 2007. If you wish to meet us at any of these events, please click here to fix up an appointment in advance.
  
  

• ROW2’s Press Kit available: Our media colleagues can now view the ROW2 Technologies updates in our online Press Kit specially created for them.
  
  

SmartChem News

SmartChem is proud to Celebrate 5 years of providing Value Added Services to the Life Sciences and Chemical Industries worldwide. We celebrate this occasion with our SmartChem 5-Year Jubilee Offer*.

We would like to thank all our customers and well wishers, for their continued support and their timely feedback which have made it possible to grow SmartChem significantly, over the last 5 years.

• SmartChem Enhancements: In response to the suggestions from our customers, we have planned the following key enhancements for 2007.
  
  - Latest Date of Validation: SmartChem will soon display   the Latest Date of Validation against molecules and   companies.
  - After Sales Service made easy: A User friendly User   Interface, will help you send After Sales Requests faster.
  - Data Enhancement: SmartChem will continue its regular   path to data updation and validation. We have planned for   a significant growth in suppliers and their offerings.
  - RapidFire tool: The upgraded RapidFire tool will now help   you reach suppliers and customers faster than before.
  - Customized SmartChem Landing Page: This unique   enhancement allows customers to display customized   landing pages to potential target customers.
  
  In addition, subscribers will continue to benefit from our initiatives like the Elite Club Program, Win-Win Referral Program and Smart Tracker.
  
  *To request details of SmartChem 5-Year Jubilee Offer, click   here.



• Webseminar: Register for “Speaker Position” on ROW2’s Webseminar scheduled in 2007 on topics related to Sourcing, Business Development and Process Research and display your strengths to the most focused audience. To view our previous webseminars, click here.



• ROW2 Ad World: Through this initiative we give you an opportunity to be visible to the most qualified target audiences from the Global Life Sciences and Chemical Industries.
  
  
• Contests and Celebrations: We bring fun and excitement into your hectic work schedule with our energizing Contests. We will also be celebrating Thanksgiving Day in November 2007.
  
  

RouteDesign News

RouteDesign achieved a landmark by providing routes to over 60 molecules till date. ROW2 is now working towards strategic partnerships with a number of its customers.

• RouteDesign Enhancements: We will continue with “RouteDesign Enhancement Program”. Enhancements like ranking of routes, raw material costing, rejected route ideas will continue to be offered on a case-to-case basis.



• ROW2 Webseminar: We have scheduled a webseminar in June 2007 on a topic related to Process Research. It will be presented by an industry leader. To know more about the webseminar, write to us here.



• ROW2 Ad World: This initiative gives you an opportunity to be visible to the most qualified target audience from the Global Life Sciences and Chemical Industries.



• Celebrations: ROW2 will celebrate its annual Process Research Chemists Day on November 10, 2007.



• Surveys: Through the Industry Mirror we will continue to conduct market surveys on topics of interest to customers.

Event Alerts: To view our online Event Watch Calendar for 2007, click here.

Important Events in April & May 2007:

April:

12-13: Synth Heterocyclic Chemistry, Spain
16-18: Logichem Europe 07, Duesseldorf
18-19: Chemspec India, Mumbai
18-20: CPhI Japan, Tokyo
24-26: LogiPharma Europe 07, Geneva

May:
6-9: Bio international Convention 2007, Boston, USA
14-17: OPR&D, Jersey, Channel Islands

Featured Article

Global challenges of human and plant health in terms of disease control, cost of treatment and innovation are met using outsourcing of various business processes in life sciences industry. Outsourcing industry in pharmaceuticals sector alone is estimated to exceed USD 50 billion of which discovery chemistry is believed to be USD 7 billion. Such growth prospects have set the pace of consolidation in this fragmented industry.

Earlier success in outsourcing of non-core functions like clinical or field trials, analysis and patent filing etc. have lately encouraged outsourcing of core functions like discovery chemistry and process research after global IPR agreements. Various specialised suppliers now offer creation of library of compounds, HTS, molecular design, combinatorial chemistry on exclusive basis, even providing patentable synthesis ideas.

To read the full article click here

ROW2 picks of the quarter

The Option To Outsource: Why Do It And What To Consider:
Published in: pharmaceuticalonline.com

Why should one outsource? What to look for when determining an outsourcing partner? How to choose a Contract Laboratory? Find answer to some of these critical questions in this article.

Strategies For Choosing An Outsourcing Provider:
Published in: pharmaceuticalonline.com in January 2007

The author indicates very simply the 4 steps for effective selection of an Outsourcing Partner.

Strategic Outsourcing: The Growing Trend In The Pharmaceutical Industry:
Published in: pharmaceuticalonline.com

A must read article on Strategic Outsourcing and the growing trend in the Pharmaceutical Industry.

Crisis Management in Pharmaceutical Outsourcing:
Published in: Contract Pharma

An interesting article on implementation of a crisis management program.

Featured Article Cont'd.

Price pressures on existing molecules and time pressures on the new product development have resulted in two major sectors in outsourcing viz. contract manufacture and contract research. Immense pressure from the industry to create IP, to strengthen the company position in a particular therapeutic segment and the need to create cost-effective therapies has given outsourcing a tremendous boost.

Considerations for Outsourcing:

1. Function/s to be outsourced: Determine the type of function/s     that you wish to outsource. Following are some areas, which     can be outsourced: Library design, development product,     Process technology, GMP/non-GMP, materials, advanced     intermediate/generic/API, New route demonstration batches,     Phase II / III GMP supplies.

2. When to Outsource: Following are the phases/timings in the Life     Cycle of a molecule, which are best suited for Outsourcing.
    Early design/modelling, unavailable kit in-house, time crunch,     short product life, Low margins, serving distant market.

3. Selection of Location: Ascertain the choice of geographical     location for outsourcing taking into consideration:
    Human competence, language, business cultures, stable     currency, low labour costs, infrastructure, level of corruption,     special export incentives

4. Detailing: Ensure utmost attention to details pertaining to the     following:
    Fee for service or full time employed (FTE), Track record,     change control and regulatory systems, validated plant and     utility set up, confidentiality and trust, responsiveness, robust     QHSE systems, continual improvement culture.

Once the outsourcing partner is selected, the next challenge is to achieve consistency of performance. Clear understanding of the expected performance, effective communications and lower human resource turnover are key elements for this consistency.

Expected Performance:
Expected performance can be determined with KPIs based on: quality (no. of deviations in Bx mfg records / in process test results), ability to trouble shoot process variations ,on time delivery ,no. of customer complaints, material balance, HSE and GMP compliances are the major ones.

Methods of Effective Communication
Key documents giving the data on quality, yields and campaign BOM (Bill of Materials) should be exchanged on pre agreed frequency, either monthly or quarterly. Reporting of any GMP or HSE incident has to be within hours. The review meetings are held at agreed yearly or half yearly basis depending on complexity and volume of work. Various standard SAP reports are exchanged due to uniformity of format and understanding.

Tips for a successful relationship with your outsourcing partners:

1.  Get senior management involved and develop the      mechanisms to handle any unforeseen situations
2.  Ensure clarity in the specification and the performance      measurement criteria.
3.  Develop multi-sourcing in initial phase to create options for      later stage.
4.  Select the service provider based on tested facts and      professional audits.
5.  Facilitate exchange of all the new relevant      chemistry /regulatory information in good time
6.  Pay the supplier a capacity reservation fee if your forecasts      cannot be accurate
7.  Hold periodic quality reviews with manufacturers to discuss      compliance with the registered process / GMP and any      inconsistent quality performance etc.
8.  Chemistry suppliers will need very frequent contact and      reporting.
9.  Solve any IPR issues in discovery due to innovations from      supplier and arrange the process development work on      promising chemistry in good time
10. Ensure capable and experienced project management


Conclusion

India and China have emerged as the preferred outsourcing hubs of the world. The suppliers for outsourced intermediates/API manufactured from these countries have created their own niche based on quality and value for money. The leadership in process chemistry and discovery chemistry has yet not been established in these burgeoning countries as yet. Russia, UK and Europe still seem to be the preferred partners in drug discovery for big US companies. With growing support for greener chemistry and new IT based tools surely the geographical boundaries will disappear.

Outsourcing was an outcome of necessity and has now created an efficient and effective collaboration model in the Life Science Industry, ensuring a win-win situation for everyone. Consumers get better products at lesser costs, science is supported by innovation and supply chain is cured of its complacency!

About Dr. Anand Shintre

Dr Anand Shintre holds M. Pharm, PhD (Tech) from Bombay University. During his corporate career he has worked in manufacturing of pharmaceuticals, antibiotic fermentation, agrochemicals and specialty chemicals. His company (Indus Chemie) offers novel intermediates for research developed by associate laboratories and custom manufacture of agrochemicals from China on exclusive basis.

Indus Chemie also offers miscellaneous technical and business development services for chemical companies.

Contacts: sales@induschemie.co.uk - www.induschemie.co.uk

To sponsor future newsletters, write to us here.

Dr. Andrew Warmington, Editor - Speciality Chemicals Magazine, DMG World Media gives insights to their magazine.

Speciality Chemicals Magazine is the world's only dedicated monthly magazine of the fine and speciality chemicals sectors.
The May edition of this magazine has a section on 'Outsourcing' and it will feature articles by renowned thought leaders.

In this issue, Fine chemicals consultant Peter Pollak looks at how the industry has developed in recent years and how firms can stay competitive in Mega-trends in the article "Fine chemicals industry: Mergers, acquisitions & Globalization". Roger Granville of SRG introduces an alternative contingent worker System in "Keeping outsourced work in-house".

Srini Gopalan, CEO of ROW2 Technologies, will also be contributing an article on "Cerebral Process Partnering" to the Outsourcing section.

To know more about Speciality Chemicals Magazine click here.

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