Ranbaxy, Daiichi Sankyo to collaborate to expand business - The Hindu

Drug major Ranbaxy Laboratories and its Japanese parent Daiichi Sankyo on Wednesday announced synergies in Brazil to expand their business in the Latin American nation
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As part of the collaboration, Ranbaxy will support Daiichi Sankyo’s Brazilian subsidiary, Daiichi Sankyo Brasil Farmaceutica Ltda to enter the branded generics market, in addition to its established business of providing innovative products, Ranbaxy said in a statement.

 

“With the announced synergistic collaboration, the Daiichi Sankyo Group will expand its presence in Brazil through its hybrid business model promoting innovative, branded generic and generic pharmaceuticals,” it added.

Please see link for full article: Ranbaxy, Daiichi Sankyo to collaborate to expand business - The Hindu
 

 

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Collaboration — The hot topic at LARC 2013

Collaboration — The hot topic at LARC 2013







Global regulators, industry professionals and academia will gather at the Latin American Regulatory Conference (LARC) 2013, to be held in Colombia, May 15 to 16. The event, titled "Pharma-co-vergence," aims to assist drug regulatory authorities to work in a collaborative way to best utilize resources for promoting improved public health globally. Attendees will discuss the current regulatory landscape, future research and drug development in Latin America. Find out more.     

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Economic pressures and an increasing scarcity of expertise give rise to the Virtual Scientific Workplace

The Burrill Report

The Burrill Report - Sponsored Podcast - The Virtual Scientific Workplace (.MP3,9.43 Mb)

Economic pressures and an increasing scarcity of expertise is leading companies to embrace new virtual networks models to draw on skilled scientific workers from around the globe to collaborate and share knowledge. In this final part of a three-part series of podcasts by The Burrill Report, produced in conjunction with Kelly Services, Harvey Yau, prodcuct manager for Kelly Services Americas Scientific Product Group, discusses the emergence of virtual networks in the life sciences, the benefits they provide, and what companies will need to do to be successful with these new workplace models.

FDA To Play Role In Medical-Device Research Consortium.

 

The AP (12/4) reports that the Food and Drug Administration announced Monday that it will "collaborate with medical device manufacturers on a public-private partnership." The FDA "says it hopes to offer guidance" to the Medical Device Innovation Consortium (MDIC), which was "created by LifeScience Alley, a Minnesota-based industry group" to streamline the "design and testing of medical devices." The AP suggests that the agency's decision to play a role in the new consortium is a response to "criticism from industry and Capitol Hill" about its "overly burdensome review process."

        Reuters (12/4, Kelly) adds that the goal of the nonprofit MDIC is to improve the methods used during the medical-device development process so more products can reach the market faster. Industry members involved in the MDIC include representatives from Abiomed, Becton Dickinson, Boston Scientific, Cyberonics and Medtronic. Reuters quotes FDA Commissioner Dr. Margaret Hamburg as saying, during a press teleconference, that the MDIC "is going to represent a model that will be watched carefully, will be replicated. I know there will be real advances and new approaches that will emerge from it."

        The Minneapolis Star Tribune (12/4, Walsh) adds that Dr. Hamburg noted that many companies "don't have the research budgets to find more effective ways of testing their products." She said the MDIC would "pull information and ideas from industry, government and academia" to ensure "we're applying the best science to the task and bringing together the best minds." The consortium will be "governed by a national board of directors, including industry executives and government leaders."

        According to CQ (12/4, Adams, Subscription Publication), the "partnership will be funded largely by device companies, although the FDA and the Centers for Medicare and Medicaid Services may contribute funding later." Dr. Hamburg called the consortium the "first public-private partnership of its kind in the medical device area" and cited "interest from a wide variety of groups, including members of Congress, for the agency's ability to move forward with the initiative." The MDIC will "invest in projects" that could reduce the time and costs involved in medical-device development. The alliance has not yet decided on "specific projects" to fund but they could "include investments in research to improve computer models or other tools that can test the effects of potential devices." The MDIC is planning to hold its "initial meeting in the first quarter of 2013."

        Modern Healthcare (12/4, Daly, Subscription Publication) adds that the FDA's "support for the initiative may extend to its staff collaborating on partnership-supported research." The FDA's Center for Devices and Radiological Health Director Dr. Jeffrey Shuren said, "By sharing and leveraging resources, MDIC may help industry to be better equipped to bring safe and effective medical devices to market more quickly and at a lower cost."

        The Minneapolis-St. Paul (MN) Business Journal (12/4, Grayson, Subscription Publication) reports that the MDIC "will be led on an interim basis" by Maura Donovan, who recently served as "vice president of therapy research and development" at Fridley, Minnesota-based Medtronic Inc.

        Medscape (12/4, Lowes) says that in addition to the FDA, the CMS and the medical device firms, the MDIC's founding members include LifeScience Alley, the Pew Charitable Trust and the National Organization for Rare Disorders. HealthDay (12/4, Preidt) also covers the new public-private partnership.

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IFPMA - Policies that Encourage Innovation in Middle-income Countries - report by Charles River Assoc

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) asked Charles River Associates (CRA) to investigate the conditions necessary to encourage innovation in middle-income countries. Ultimately, the purpose of this project is to evaluate the policies of host governments that encourage investment in innovative activities and the implications for future innovation policy.

The report focuses on eight case study countries (Brazil, China, Colombia, India, Malaysia, Russia, South Africa and South Korea). The case studies were chosen using a number of criteria. Firstly, we selected countries from different geographic regions, focusing on those that had been most successful in developing innovative activities to date in their region. Secondly, we chose countries that illustrate a range of different policy approaches. Thirdly, we chose a mix of countries with a long-standing objective of developing an innovative industry as well as countries that had only relatively recently embarked on this. Finally, we included South Korea as a basis of comparison, which was a middleincome country when it instigated its programme to encourage pharmaceutical innovation and provides a longer term perspective on what is achievable.

In addition, to reviewing the existing academic literature and government sources, we undertook 25 interviews with government officials, academics, industry trade associations and individual companies.

 

Bristol-Myers Squibb Forms the International Immuno-Oncology Network - from The Burrill Report

VINAY SINGH

The Burrill Report

“The public-private partnerships formed through the collaboration will leverage the intellectual capabilities of an extensive global network.”

Bristol-Myers Squibb has created a new International Immuno-Oncology Network, a collaboration between industry, universities, and research centers from around the world aimed at furthering the scientific understanding of immuno-oncology, or the human immune system’s potential to fight cancer.

In addition to Bristol-Myers Squibb, the collaboration consists of ten academic or cancer-research institutions from around the world including The Netherlands Cancer Institute, Dana-Farber Cancer Institute, The Royal Marsden NHS Foundation Trust, the Institute of Cancer Research, and Johns Hopkins Kimmel Cancer Center.

Collaborations between academia, private research institutions, and Big Pharma has become increasingly common as pharmaceutical companies continue to look outside their own walls to acquire promising new early-stage treatments and try to lessen both the risks and costs of developing such drugs.
http://www.burrillreport.com/article-bristol_myers_squibb_forms_the_international_immuno_oncology_network.html

Global Regulatory Track at DIA2012

Global Regulatory Track

Interact with global regulators to create a new, more efficient collaborative paradigm to share information, experiences, and develop strategies to improve medical product development. This track seeks to establish mechanisms to facilitate the exchange of information, share best practices, identify commonalities, and develop approaches to overcome regulatory barriers.

• CDER Town Hall: Parts 1 and 2
• CBER Town Hall
• European Town Hall: Parts 1 and 2
• Indian Town Hall
• International Regulatory Cooperation: A Canadian Perspective
• Latin American Town Hall
• Pediatric Drug Development Progress: 15 Years Later and Across the Globe
• Pharmaceuticals and Medical Devices Agency (PMDA) Town Hall
• SFDA Town Hall
• State of Electronic Submissions at CDER, CBER, and CDRH
• Update from the EMA-FDA Parallel Assessment Pilot
• Update on EMA, FDA, and PMDA International Activities

For more details, please visit Global Regulatory offerings at DIA 2012.

Collaborate to Innovate

Big Pharma Bands with Academia in $23-Million Deal

AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Janssen Pharmaceutica NV, Merck Serono, and Pfizer have pledged support of more than £14 million ($23 million) to a translational drug development project being run by the UK’s Medical Research Council and the University of Dundee. The university’s Division of Signal Transduction Therapy (DSTT) has been working to develop treatments for several diseases including cancer, rheumatoid arthritis, and Parkinson’s Disease.
more...



The University of Dundee and the Medical Research Council (MRC) are pleased to announce new funding of over £14million from a consortium of six pharmaceutical companies for continuing research on the development of new drug treatments for major global diseases.

The consortium, called the Division of Signal Transduction Therapy (DSTT), includes six of the world's leading pharmaceutical companies -- AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Janssen Pharmaceutica NV, Merck-Serono (the Pharmaceutical division of Merck KGaA) and Pfizer -- and will provide core support of £14.4 million to the DSTT over the four-year period from July 2012 - 2016.
Minister for Universities and Science, David Willetts, said, "Collaboration between the life sciences industry and academia is vital for the development of new treatments and leverages significant private funding into our research base. This investment will continue the excellent work taking place at the University of Dundee on major global diseases, helping to bring benefits for patients and the economy."
Thought to be the world's largest collaboration between the academic community and the pharmaceutical industry, the DSTT includes 15 research teams based at the University of Dundee. Thirteen of the teams are based within the MRC Protein Phosphorylation Unit and Scottish Institute for Cell Signalling (SCILLS) at the College of Life Sciences. Together, consortium scientists will continue early-stage research in multiple areas, including cancer, arthritis, lupus, hypertension and Parkinson's disease.

Professor Sir Philip Cohen, co-founder of the DSTT, said, "Collaborations between academic laboratories and the pharmaceutical industry typically last a few years. Therefore to maintain and expand support for the DSTT from 1998 until at least 2016 is unprecedented and remarkable. It shows how valuable the collaboration has been for the pharmaceutical industry."

http://www.dundee.ac.uk/pressreleases/2012/may12/drugdiscovery.htm

Collaborate to Innovate - #DIA2012 June 24-28 Philadelphia

4 Days. 22 Tracks. 270+ Educational Offerings. 500+ Exhibitors. 7,500+ Attendees. The DIA 2012 48th Annual Meeting offers the most comprehensive and robust learning and networking opportunities to help you find solutions to the challenges you face in the discovery, development, and life cycle management of biopharmaceuticals, biotechnology, medical devices, and related products. Top biopharmaceutical thought leaders will be at the DIA 2012 Annual Meeting to pass on their expertise directly to you. Life Science Entrepreneur Pavilion Network with Entrepreneurs in this year’s new Life Science Entrepreneur Pavilion and discuss how they are changing the future development of new medicines. Pfizer is pleased to support the Life Science Entrepreneur Pavilion at this year’s DIA 2012 Annual Meeting. Funding Funding Innovation and Creating Opportunities in the Device, Diagnostic, and Drug Interface Partnering Models-Public Private Partnerships Pre-competitive Public Private Partnerships: The Changing Model of Pharmaceutical R&D How Industry Can Partner with FDA in Defining a Risk-based Monitoring Program Multistakeholder Development Partnerships: Harnessing Differing Perspectives, Objectives, and Strengths for Success Vaccines Vaccines: FDA and Japan Perspectives Integrated Partnership: A Vaccine Case Study Biotech First-in-human Challenges of Biologics and Biosimilars Product Candidate to Proof-of-concept: An Integrated Approach to Accelerate Programs Regulatory Affairs for Biologics Biomarker Focused Strategies for Personalized Medicine Understanding Comparative Effectiveness Research (CER) in the Biopharmaceutical Industry Other Special Topics Analysis and Impact of PDUFA V: How the Changes Will Affect the Work of Regulatory Affairs Professionals Pediatric Development in the US: Implementation of 2007 PREA and BPCA Against a Backdrop of the EU Pediatric Legislation CBER Town Hall CDER Town Hall: Part 1 of 2 CDER Town Hall: Part 2 of 2 Regulatory Roundtable on Biosimilars Update on Biosimilar Developments in the US Emerging Development and Policy Trends in the Economics of the Biopharmaceutical Industry Risks to and Securing of Global Drug Supply Chains Partnering for Impact in Global Health Executive Program: Pioneering Partnerships Much more! Register Online | Program Overview Group Discounts Available! Register 10 individuals from your company and receive the 11th FREE! Contact your group discount representative for details!

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Partnering for Impact in Global Health, DIA2012

DIA 2012 Collaborate to Innovate

48th Annual Meeting
June 24-28, 2012
Philadelphia, PA
Pennsylvania Convention Center

Partnering for Impact in Global Health
Wednesday, June 27, 2012
10:00-11:30 AM ET

Join representatives from the Bill & Melinda Gates Foundation to discuss the Foundation’s “Decade of Vaccines” effort. Panelists will address a partnership for tuberculosis drug discovery, provide examples of product development partnerships, and a outline the project on postmarket drug and vaccine surveillance in low- and middle-income countries.

Moderator

Nicole Bates, DrPH
Senior Program Officer
Global Health Policy and Advocacy
Bill & Melinda Gates Foundation

Panelists

Vincent I. Ahonkhai, MD
Senior Regulatory Officer
Global Health Delivery
Bill & Melinda Gates Foundation

Ken Duncan, PhD
Deputy Director
Global Health Discovery
Bill & Melinda Gates Foundation

DIA 2012 Annual Meeting: Early-bird Hotel Rates Expire Friday, March 30!

Conferences & Meetings | Exhibits & Advertising | Training | Online Learning | Membership | Get Involved

Nothing Says "Innovation" Like Philadelphia! You probably already know that the Greater Philadelphia region is home to 400 life science companies, with 53,000 workers in the core life sciences industry and 310,200 workers in supporting industries. Large multinational pharmaceutical firms have major operations in the region, and many trace their regional roots back to the 19th century. That's because this region has a strong history in public health and innovation. What you may not know, is that Philadelphia is one of America's top visitor destinations. America's Favorite Cities. Philadelphia has once again been named among the top 30 of "America's Favorite Cities" based on votes of visitors and residents on a range of criteria, including culture, shopping, dining, and for the first time this year, hotels and local airports. What's the word about Philadelphia? Philadelphia's Mayor Michael Nutter can tell you! Lock into the Best Hotel Rates in Philadelphia! Take advantage of early-bird rates as low as $166, and amenities exclusive to DIA attendees. Offer expires Friday, March 30! Since you must be registered for DIA 2012 Annual Meeting to receive full access to all discounted hotels, we urge you to Register and Book Your Hotel Today! The DIA 2012 Annual Meeting includes: NEW! Preconference Program 20+ Preconference Tutorials 270+ Educational Opportunities including: European Town Hall Part 1 and Part 2 June 25 | 10:00 – 11:30AM and 1:30 – 3:00PM Discussion with Former Center for Devices and Radiological Health (CDRH) Management June 25 | 3:30 – 5:00PM Orphan Drug Development: Global Regulatory Challenges and Initiatives June 27 | 1:30 – 3:00PM Implementation of the Physician Payments Sunshine Act: Now What? June 27 | 3:30 – 5:00PM 500+ Exhibiting Companies 6 month FREE access to all Audio-synchronized Presentations Executive Program: Pioneering Partnerships And much more... View DIA 2012 Preliminary Program! Follow us on twitter at #DIA2012