Feeds:
Posts
Comments

Posts Tagged ‘Canada’


struktura infliximabu

struktura infliximabu (Photo credit: Wikipedia)

Larry H Bernstein, MD, FCAP, Reporter

GI Disease, inflammation, elastase-inhibitor, membrane junctions and fatty acids

Sci Transl Med 2012; 4(158): 158ra144

Sci. Transl. Med. DOI: 10.1126/scitranslmed.3004212

RESEARCH ARTICLE
INFLAMMATORY BOWEL DISEASES
Food-Grade Bacteria Expressing Elafin Protect Against Inflammation and Restore Colon Homeostasis
Jean-Paul Motta1,2,3,*, Luis G. Bermúdez-Humarán4,*, Céline Deraison1,2,3, Laurence Martin1,2,3, Corinne Rolland1,2,3, Perrine Rousset1,2,3, Jérôme Boue1,2,3, Gilles Dietrich1,2,3, Kevin Chapman5, Pascale Kharrat4, Jean-Pierre Vinel3,6, Laurent Alric3,6, Emmanuel Mas1,2,3,7, Jean-Michel Sallenave8,9,10, Philippe Langella4,* and Nathalie Vergnolle1,2,3,5,†

1INSERM, U1043, Centre de Physiopathologie de Toulouse Purpan (CPTP), Toulouse F-31300, France.
2CNRS, U5282, Toulouse F-31300, France.
3CPTP, Université de Toulouse, Université Paul Sabatier (UPS), Toulouse F-31300, France.
4Institut National de la Recherche Agronomique (INRA), UMR 1319 Micalis, Commensal and Probiotics-Host Interactions Laboratory, Domaine de Vilvert, 78352 Jouy-en-Josas Cedex, France.
5Department of Physiology and Pharmacology, Faculty of Medicine, University of Calgary, Calgary, Alberta T2N 4N1, Canada.
6Pôle Digestif, CHU Purpan, Toulouse F-31059, France.
7Division of Gastroenterology, Hepatology and Nutrition, Children’s Hospital, Toulouse F-31059, France.
8Institut Pasteur, Unité de Défense Innée et Inflammation, Paris F-75015, France.
9INSERM U874, Paris F-75724, France.
10Universite Paris Diderot, Sorbonne Paris Cite, Cellule Pasteur F-75013, France.

ABSTRACT

Elafin, a natural protease inhibitor expressed in healthy intestinal mucosa, has pleiotropic anti-inflammatory properties in vitro and in animal models. We found that mucosal expression of Elafin is diminished in patients with inflammatory bowel disease (IBD). This defect is associated with increased elastolytic activity (elastase-like proteolysis) in colon tissue. We engineered two food-grade strains of lactic acid bacteria (LAB) to express and deliver Elafin to the site of inflammation in the colon to assess the potential therapeutic benefits of the Elafin-expressing LAB. In mouse models of acute and chronic colitis, oral administration of Elafin-expressing LAB decreased elastolytic activity and inflammation and restored intestinal homeostasis. Furthermore, when cultures of human intestinal epithelial cells were treated with LAB secreting Elafin, the inflamed epithelium was protected from increased intestinal permeability and from the release of cytokines and chemokines, both of which are characteristic of intestinal dysfunction associated with IBD. Together, these results suggest that oral delivery of LAB secreting Elafin may be useful for treating IBD in humans.

Copyright © 2012, American Association for the Advancement of Science
Citation: J.-P. Motta, L. G. Bermúdez-Humarán, C. Deraison, L. Martin, C. Rolland, P. Rousset, J. Boue, G. Dietrich, K. Chapman, P. Kharrat, J.-P. Vinel, L. Alric, E. Mas, J.-M. Sallenave, P. Langella, N. Vergnolle, Food-Grade Bacteria Expressing Elafin Protect Against Inflammation and Restore Colon Homeostasis. Sci. Transl. Med. 4, 158ra144 (2012).

Cytokines involved in IBD

Cytokines involved in IBD (Photo credit: Wikipedia)

Metabolism

Front. Physio., 10 October 2012 | doi: 10.3389/fphys.2012.00401
Outlook: membrane junctions enable the metabolic trapping of fatty acids by intracellular acyl-CoA synthetases
Joachim Füllekrug*, Robert Ehehalt and Margarete Poppelreuther
Molecular Cell Biology Laboratory, Internal Medicine IV, University of Heidelberg, Heidelberg, Germany
The mechanism of fatty acid uptake is of high interest for basic research and clinical interventions. Recently, we showed that mammalian long chain fatty acyl-CoA synthetases (ACS) are not only essential enzymes for lipid metabolism but are also involved in cellular fatty acid uptake. Overexpression, RNAi depletion or hormonal stimulation of ACS enzymes lead to corresponding changes of fatty acid uptake. Remarkably, ACS are not localized to the plasma membrane where fatty acids are entering the cell, but are found instead at the endoplasmic reticulum (ER) or other intracellular organelles like mitochondria and lipid droplets. This is in contrast to current models suggesting that ACS enzymes function in complex with transporters at the cell surface. Drawing on recent insights into non-vesicular lipid transport, we suggest a revised model for the cellular fatty acid uptake of mammalian cells which incorporates trafficking of fatty acids across membrane junctions. Intracellular ACS enzymes are then metabolically trapping fatty acids as acyl-CoA derivatives. These local decreases in fatty acid concentration will unbalance the equilibrium of fatty acids across the plasma membrane, and thus provide a driving force for fatty acid uptake.

English: Acyl-CoA from the cytosol to the mito...

English: Acyl-CoA from the cytosol to the mitochondrial matrix. Français : Transport de l’Acyl-CoA du Cytosol jusqu’à la matrice mitochondriale. (Photo credit: Wikipedia)

English: The mechanism for Long Chain Fatty Ac...

English: The mechanism for Long Chain Fatty Acyl-CoA Synthetase (Photo credit: Wikipedia)

Read Full Post »


Reporter: Aviva Lev-Ari, PhD, RN

“A Synergistic Approach towards Biowaivers & Biosimilars”. Biosimilars-2012 is scheduled on September 10-12, 2012 at Hilton San Antonio Airport, USA.

Biosimilars or Follow-on biologics
http://en.wikipedia.org/wiki/Biologic_medical_product are terms used to describe officially-approved subsequent versions of innovator biopharmaceutical http://en.wikipedia.org/wiki/Biopharmaceutical  products made by a different sponsor following patent and exclusivity expiry on the innovator product.[1] http://en.wikipedia.org/wiki/Biosimilar#cite_note-biosimilars2012-0 Biosimilars are also referred to as subsequent entry biologics (SEBs) in Canada.[2] http://en.wikipedia.org/wiki/Biosimilar#cite_note-1 Reference to the innovator product is an integral component of the approval.
 
A Biowaiver is a waiver (exemption) of clinical bioequivalence studies given to a drug product.
 

Biowaivers and Biosimilars.

The main theme of the conference is “A Synergistic Approach towards Biowaivers & Biosimilars”.

Biosimilars-2012 is scheduled on September 10-12, 2012 at Hilton San Antonio Airport, USA.

 Click here to view the downloadable Preliminary Program 

 http://sm1.mailserv.in/omicsonlinebiz/lt.php?id=eR4DBVEEUA9UUksGBlMKAU4=UQMNDAgNSllRVQgECyUNWAodUg5C

This three day conference will cover the latest trends and challenges in Biowaivers and Biosimilars.   Biosimilars-2012 highlights the following topics:   

  • Biosimilars Pathway  
  • Immunogenicity   
  • Skill Set for Biosimilars Development  
  • Biosimilar Therapeutics      
  • Biomedical informatics  
  • BCS and IVIVC based biowaivers  
  • Transgenic animals & plants  
  • In vitro & In vivo Correlations  
  • Bioequivalence Testing  
  • BCS and IVIVC based biowaivers    
  • Oral drug delivery     

Conference assets are William Velander (University of Nebraska, USA), Lisa J. Murray (Absorption Systems, PA, USA), Leandro Mieravilla (Biosimilar-Biotech Global Expert, Canada) and David Goodall (Paraytec Limited, UK) who will discuss their novel research on Biosimilars & Biowaivers.

This conference is perfect for researchers and experts, as well as those who require in-depth analysis of the latest trends, technologies, and techniques.

Confirmed Speakers Including

Tentative Scientific Program18:00-19:00Registrations Sep-09-2012

Day 1

Sep-10-2012

07:00-08:00 Registrations

08:00-08:30 Breakfast

Breakout 1

08:30-09:00 Opening Ceremony

Keynote Forum

09:00-09:05 Introduction

09:05-09:30 Lisa J. Murray, Absorption Systems, USA

09:30-09:55 Yet to be Confirmed

09:55-10:20 Yet to be Confirmed

10:20-10:45 Yet to be Confirmed

Coffee Break 10:45-11:00

Track 1: Biosimilars : Innovator Pharmaceutical Products

Track 2: Biosimilars: Regulatory Approach

Session Introduction

11:00-11:20

Title: The role of scientific justification in the nascent us biosimilars approval pathway

Ben Kaspar, MMS Holdings Inc., USA

11:20-11:40

Title: The what million dollar question: Patent litigation and strategy under the biologics

price Competition and Innovation act

Bryan J. Vogel, Robins, Kaplan, Miller & Ciresi L.L.P., USA

11:40-12:00

Title: The role of patents in biosimilars and biobetters

Brian Dorn, Barnes & Thornburg LLP, USA

12:00-12:20

Title: New patent reform litigation options for biosimilars

Paul A. Calvo, Sterne, Kessler, Goldstein & Fox P.L.L.C., USA

12:20-12:40 Title: Regulatory consideration of the assessment of biosimilar products

Jun Wang, Duke University School of Medicine, USA

Lunch Break 12:40-13:20

13:20-13:40

Title: What hath FDA wrought: The February 2012 guidance and their implications for

securing biosimilar approval

Michal Swit, Duane Morris LLP, USA

13:40-14:00

Title: The role of clinical trials in demonstrating similarity of biological medicinal

products in the European Union

Cecil Nick, PARAXEL Consulting, UK

14:00-14:20

Title: Biosimilars panel: Opportunities and challenges to be overcome in the near term

Jennifer Brice, Frost & Sullivan, UK

14:20-14:40

Title: Graphical representation of the assessment of inventive step for patents using the

Problem-Solution-Approach (PSA)

Joachim Stellmach, European Patent Office, Germany

14:40-15:00

Title: IP strategies for the biosimilar arena

Ulrich Storz, Michalski Huettermann Patent Attorneys, Germany

15:00-15:20

Title: Biosimilars in emerging countries: Argentina

Gustavo Helguera, University of Buenos Aires, Argentina

15:20-15:40

Title: Developing biosimilars: Considerations, opportunities and challenges

Ming Wang, Gan & Lee Pharmaceuticals, China

Panel Discussion 15:40-15:55

Coffee Break 15:55-16:10

Track 3: Skill Set for Biosimilars Development

Track 4: Clinical Studies for Biosimilars

Session Introduction

16:10-16:30

Title: Strategies for development and validation of immunogenicity assays to support

preclinical and clinical biosimilar programs

Kelly S. Colletti, Charles River Preclinical Services, USA

16:30-16:50

Title: Transgenic blood proteins: An abundant source for next generation therapies with

worldwide availability

William Velander, University of Nebraska, USA

16:50-17:10

Title: The Danish HNPCC-system – Biomedical support to individual health care in

hereditary colon cancer families

Inge Thomsen Bernstein, Hvidovre University Hospital, Denmark

17:10-17:30

Title: Use of human protein transgenic animal models for immunogenicity testing and

their value for comparative studies of biosimilars

Melody Sauerborn, TNO Triskelion BV, The Netherlands

17:30-17:50

Title: Application of nanotechnology in drug delivery

Rawia Khalil, National Research Centre, Egypt

Panel Discussion 17:50-18:05

18:05-19:05 Cocktails: Sponsored by Journal of Bioequivalence & Bioavailability

Day 2

Sep-11-2012

Breakout 1

Track 5: Biosimilars Therapeutics

Track 6: Commercialization or Globalization of Biosimilars

Session Introduction

09:30-09:50

Title: Development of antibody arrays for measuring biosimilar conformational

comparability at molecular level

Xing Wang, Array Bridge Inc., USA

09:50-10:20

Title: Biosimilar market overview, present and future

Leandro Mieravilla, Biosimilar-Biotech Global Expert, Canada

10:20-10:40

Title: Modified biosimilars: Potential role in the emerging global biosimilar market

Pascal Bailon, Bailon Consultants, USA

Coffee Break 10:40-10:55

10:55-11:15

Title: The application of releasable pegylation linkers to improve the pharmaceutical

properties of biosimilars and biobetters

Hong Zhao, Enzon Pharmaceuticals, USA

11:15-11:35

Title: The clinical development of monoclonal biosimilars

Cecil Nick, PARAXEL Consulting, UK

11:35-11:55

Title: Ghrelin antagonist: Advantages and side-effects

Maria Vlasova, University of Eastern Finland, Finland

11:55-12:15

Title: Biosimilar market growth trends in emerging markets

Syamala Ariyanchira, Independent Consultant, Malaysia

12:15-12:35

Title: Developing of long acting glycoprotein hormones using gene fusion and gene

transfer: From bench to clinics

Fuad Fares, University of Haifa, Israel

Lunch Break 12:35-13:15

13:15-13:35

Title: Th1 immune response induced by Ipr1-PPE68 DNA vaccine in BALB/C mice model

Yang Chun, Chongqing Medical University, China

13:35-13:55

Title: Anticancer noscapinoids: Synthesis to nanomedicine

Ramesh Chandra, University of Delhi, India

Panel Discussion 13:55-14:10

Track 7: Plant Produ ced Biosimilar Products

Track 8: Aggregation and Immunogenicity of Biosimilars

Session Introduction

14:10-14:30

Title: Biosimilars: Lessons learned from development to commercial launch

Niranjan M. Kumar, ABS Inc. USA

14:30-14:50

Title: Plant-based production and preclinical analysis of biosimilar Trastuzumab

Michael D. McLean, PlantForm Corporation, Canada

Coffee Break 14:50-15:05

15:05-15:25

Title: Immunological aspects of formation of anti-drug antibodies against aggregated

protein drugs

Melody Sauerborn, TNO Triskelion BV, The Netherlands

15:25-15:45 Speech Opportunity Available

15:45-16:05 Speech Opportunity Available

Panel Discussion 16:05-16:20

Breakout 2

16:20-19:20

Editorial Board Meeting

Poster Presentations

Scientific Partnering

Cocktails: Sponsored by Pharmaceutica Analytica Acta

Day 3

Sep-12-2012

Breakout 1

Track 9: Biowaivers

Track 10: BCS & IVIVC Based Biowaivers

Track 11: Bioequivalence Assessment

Track 12: Analytical Strategies

Session Introduction

09:30-09:50

Title: Role of process controls in mitigating the risk associated with manufacturing of

biosimilars

Indu S. Javeri, CuriRx Inc., USA

09:50-10:20

Title: Current analytical techniques for analysis of carbohydrate containing biosimilars

Parastoo Azadi, University of Georgia, USA

10:20-10:40

Title: Improving outcomes: A decade of industry and regulatory experience with BCS

based biowaivers

Lisa J. Murray, Absorption Systems, USA

Coffee Break 10:40-10:55

10:55-11:15

Title: Approach for development of w-3 phospholipid dietary supplement to potential lipid

drug

Su Chen, Chainon Neurotrophin Biotechnology Inc., USA

11:15-11:35

Title: Bioanalytical challenges in development of biosimilars

Carmine Lanni, Bioanalytical Development Services, USA

11:35-11:55

Title: Some statistical issues on the evaluation of the similarity and interchangeability of

biologics

Laszlo Endrenyi, University of Toronto, Canada

11:55-12:15

Title: Rapid characterization of formulations: Protein size, aggregate levels and viscosity

David Goodall, Paraytec Limited, UK

12:15-12:35

Title: Taylor dispersion analysis, a rapid, nanolitre method to monitor protein aggregation

behavior

Wendy Louise Hulse, University of Bradford, UK

Lunch Break 12:35-13:15

13:15-13:35

Title: Effects of drying technology and polymers on integrity and biological activity of

proteins

Amal Ali Elkordy, University of Sunderland, UK

13:35-13:55

Title: A global perspective on the challenges of GLP/GCLP-bioanalysis for biosimilars

Aparna Kasinath, Clinigene International Limited, India

13:55-14:15 Speech Opportunity Available

14:15-14:35 Speech Opportunity Available

14:35-14:55 Speech Opportunity Available

14:55-15:15 Speech Opportunity Available

Panel Discussion 15:15-15:30

Editorial Board Meeting

For Biosimilars-2012 Organizing Committee 

OMICS Group Conferences
5716 Corsa Ave., Suite110
Westlake, Los Angeles
CA91362-7354, USA
Phone:+1-650-268-9744 <tel:%2B1-650-268-9744>
Fax:+1-650-618-1414 <tel:%2B1-650-618-1414>
Email: biosimilars2012@omicsgroup.com <mailto:biosimilars2012@omicsgroup.com>
     
         

Read Full Post »


Reporter: Aviva Lev-Ari, PhD, RN

The information below is posted on our Scientific Web Site in solidarity with all the Young Life Sciences Scientists in the US, Canada and around the Globe regarding the discrepancy in the marketplace between high supply of highly qualified young scientists and the low demand for their talent by Academia and by the Pharmaceutical and Biotech Industries as evidenced by few jobs for that valuable talent.

The matter has been address by the NIH and was reported in my post on June 27, 2012

Picturing US-Trained PhDs’ Paths and Pharmaceutical Industry’s Crisis of Productivity: Partnerships between Industry and Academia

https://pharmaceuticalintelligence.com/2012/06/27/picturing-us-trained-phds-paths-pharmaceutical-industrys-crisis-of-productivity-partnerships-between-industry-and-academia/

Related matters on that subject are addressed in the following Posts by Dr. Jonathan Thon

Dr. Thon holds joint appointments within the hematology division at Brigham and Women’s Hospital, and Harvard Medical School in Boston, and is an American Society of Hematology Scholar.

The truly bleak job prospects for young scientists in the life sciences

Posted on July 30, 2012 by Jonathan Thon

The following is my response to a letter from Canada’s federal minister of health, Leona Aglukkaq, who was in turn responding to an earlier letter from me:

Honourable Leona Aglukkaq,

Thank you first and foremost for taking the time to respond to my letter on February 7, 2012, regarding the lack of opportunity for early-career scientists in Canada (see the health minister’s response here). While the Canadian Institutes of Health Research (CIHR) is taking positive steps to meet its stated goals of attracting and retaining the best researchers, the Canadian government is failing to acknowledge how truly bleak the job prospects for young scientists are in the life sciences. While resources will always be limiting, the government needs to appreciate that current federal investment in biomedical science is insufficient to maintain the present rate of scientific advancement and falls short of supporting a sustainable pipeline of talented new health researchers. What’s more, this country’s overabundance of PhDs has kept postdoctoral salaries at a rate of $38,000 per year, which is shockingly low when one considers that a four-year undergraduate degree and five-year graduate program are required to fill the role. Worse still, it has extended postdoctoral fellowships (considered neither “student” nor “faculty” positions in Canada) to between four and eight years, creating a temporary “holding pattern” from which most young scientists ultimately transition to other careers.

If Canada is not prepared to make the necessary investment in academic biomedical research, universities must not be permitted to continue to push PhD students and postdoctoral fellows through the present system blindly, with complete disregard to the lack of academic career opportunities that await them. By failing to adapt to current labour market trends, the Canadian people are investing a significant amount of time and money into training highly-educated life scientists to take up positions that simply do not exist, forcing them into under-employment in the private sector. Not only does this represent a terrible return on investment, but it is stunting economic growth. The number of graduate students being trained for academic science positions that 80 percent of them will never fill needs to decrease significantly and the focus needs to shift from academic professorships to alternative professions as support scientists and consultants in neighbouring industries including medicine, finance, teaching and law.

Recently, both the U.S. National Academies and the National Institutes of Health’s Biomedical Workforce issued reports exhorting universities to “improve the capacity of graduate programs to attract talented students by addressing issues such as attrition rates, time-to-degree, funding, and alignment with both student career opportunities and national interests.” To accomplish this, the U.S. National Academies recommend that institutions “restructure doctoral education to […] shorten time-to-degree and strengthen the preparation of graduates for careers both in and beyond the academy.” The NIH concurred, citing the need to “involve relevant employers in the public and private sector in designing and training paths for students.” Among the reforms called for are:

  • Information and guidance about career opportunities and training in skills relevant to non-academic jobs to be provided to all graduate students and post-doctoral fellows on fellowships or principal investigator grants as normal parts of their programs.
  • Limitations to the period any individual can spend as a graduate student of post-doctoral fellow, which must be covered in its entirety under “any combination of training grants, fellowships and research project grants.”
  • Increasing the proportion of graduate students and post-doctoral fellows that receive support through fellowships and training grants versus faculty research grants, to shift the focus from the principal investigators’ labour needs to young scientists’ professional development. The report emphasizes that the overall number of young scientists supported should not increase.
  • Institutional tracking over time of career outcomes for all their graduate students and post-doctoral fellows, which should be made publicly available.

The last two recommendations are perhaps the most important and I have separated them here for added emphasis.

  • To improve career opportunities and limit the overproduction of transient trainees, labs should replace many of their post-doctoral fellow slots with permanent staff scientist positions.
  • Post-doctoral pay and benefits must improve. The Biomedical Workforce proposes implementing a starting salary of $42,000 (which I still consider to be a discouraging return on the increasingly lengthening 5-year investment necessary to earn a PhD), with a “large jump between [post-doctoral] years 3 and 4” intended “to incentivize principal investigators to move fellows to permanent positions.” Given the current state of academic science, the Biomedical Workforce felt it necessary to add that “all NIH-supported postdoctoral researchers on any form of support (training grants, fellowships, or research project grants) [should] receive benefits that are comparable to other employees at the institution,” including paid vacation, parental leave, healthcare, and retirement plans.

The government of Canada has done little to acknowledge and less to address the current overabundance of highly-trained young PhD scientists in low-paying dead-end jobs whose expertise will ultimately (after a significant period of re-training) be better served in other industries. While the CIHR’s efforts to improve current funding practices are necessary, they will not prove sufficient to resolve this issue. The current approach to training scientists and moving them through the labour force is frighteningly inefficient. Training more research scientists than we have the funds to support is not the solution – it is the problem. Acknowledging that we are facing a crisis and implementing the aforementioned recommendations will dramatically improve working conditions for young scientists while curbing inefficiencies in our labour market that are serving to limit economic growth.

Post to Twitter

In a concerted effort to practice what I preach, I write often to the Office of the Prime Minister to highlight issues facing early-career scientists in Canada. To their credit, I always receive a response. Below is a transcript of the most recent letter I received from the Minister of Health, Leona Aglukkaq. Please see ‘Bring home the scientific troops’ to review previous transcripts.

Dear Dr. Thon:

The office of the Prime Minister has forwarded to me a copy of your correspondence of February 7, 2012, concerning opportunities for young scientists in Canada.

The Canadian Institutes of Health Research (CIHR) recognizes the role that new and early career investigators play in creating a sustainable foundation for Canadian health research. In its second strategic plan entitled Health Research Roadmap: Creating innovative research for better health and health care, the CIHR stated its intention to build capacity to attract and retain the best researchers by working with partners at all levels, including teaching hospitals, other federal funding agencies and federal departments. This will involve, among other things, ensuring that sufficient operational support is provided by rectifying the inconsistencies in postdoctoral funding and reviewing the level and form of financial assistance provided.

As part of the CIHR’s commitment to ensuring the long-term sustainability of its contribution to the Canadian health research enterprise, the CIHR has also initiated a process to design a new open suite of programs and peer review system. The new design responds to concerns such as yours from the health community that we need to be providing more support for new and early career investigators.

In the new open suite of programs, the CIHR is considering specific support to new and early career investigators with excellent training and early career productivity to ensure that these researchers have an opportunity to build promising programs of research and knowledge translation. In a new scheme that focuses on projects, the CIHR is considering giving priority in the first stage of review to the quality of the idea with limited information about the track record of the applicant. This would remove some of the biases or barriers (real or perceived) for new and early career investigators.

The CIHR’s direct training programs are not changing as part of this process and will continue to be a part of the CIHR’s strategy to support a sustainable pipeline of talented new health researchers into the health research enterprise.

It should also be noted that the CIHR’s Strategy for Patient Oriented Research also has a focus on developing the talent pool for clinical research in Canada. You can follow the development of this important strategy on their website athttp://www.cihr-irsc.gc.ca.

With regard to your concern about the low levels of successful applications in the CIHR’s Open Operating Grants Program, it should be noted that in February 2008, the CIHR pledged to create and maintain a stable Open Operating Grant Program. This included a commitment to fund at least 400 new grants per competition (800 per year). This commitment will be maintained with the new program structure.

The CIHR currently funds some 14,000 researchers and trainees. In designing the new funding program, the CIHR’s intent is to continue supporting a similar number of investigators and trainees. Furthermore, the CIHR is committed to ensuring that approximately 70 percent of the grants and awards budget continues to be allocated to support investigator-initiated research.

I appreciate having had this opportunity to respond to your concerns.

Sincerely

Leona Aglukkaq

c.c. Office of the Prime Minister

I will be responding to Ms. Aglukkaq’s letter in my following post – and I encourage you to do the same. You can contact the Honourable Leona Aglukkaq at:

House of Commons
458 Confederation Building
Ottawa, Ontario
K1A 0A6

Tel: (613) 992-2848
Fax: (613) 996-9764
Email: Leona.Aglukkaq@parl.gc.ca

The research bottleneck – flying blind

Posted on June 25, 2012 by Jonathan Thon

Post to Twitter

The Bridges to Independence report (NRC, 2005) reveals that the number of PhD-trained life scientists in the United States ages 35 and younger increased by 59 percent between 1993 and 2001 while the number of these scientists in tenure-track positions increased by only 7 percent. At research institutions this number decreased by 12 percent over the same period of time. Studies by Michael S. Teitelbaum (Research funding: structural disequilibria in biomedical research. Science 321, 644-645. 2008) and Cyranoski, D. et al. (The PhD factory: the world is producing more PhDs than ever before. Is it time to stop? Nature 472, 276-279. 2011) support these observations and show that the supply-demand gap continues to grow.

Studies from the National Association of Teachers in Further and Higher Education, the British university and college lecturer’s union, and the BETT Report, published in June 1999 by the Independent Review of Higher Education, Pay and Conditions, paint a similar picture for scientists in the United Kingdom and suggest a similar situation worldwide. With limited employment opportunities in academia as it is (Improving graduate education to support a branching career pipeline: Recommendations based on a survey of doctoral students in the basic biomedical sciences. 2011.), this statistic reflects a bad situation only getting worse.

To better assess the magnitude of this problem and compel academic institutions to address it, I suggest federal departments require universities to submit a detailed account of the placement histories of their recent graduates, which should be made available freely online. Another statistic worth tracking is the percentage of graduate students or research fellows training under principal investigators that now support independent research programs of their own. Comparing these figures to research investment practices that have traditionally focused on graduate and postdoctoral funding while avoiding the larger issue of subsequent employment should let us measure the effect these policies have on the knowledge market and provide the impetus to change them. At the very least, it would let prospective scientists know what they were getting into.

Because I am not the first to suggest that dissatisfaction later in their career has less cogency if students investing in a bioscience research career when they choose graduate training are made aware of the risks pursuant, a recent NRC Committee on Trends in the Early Career Patterns of Life Scientists recommended in 1998 “that accurate and up-to-date information on career prospects … and career outcome information … be made widely available to students and faculty. Every life science department receiving federal funding for research training should be required to provide its prospective graduate students specific information regarding all pre-doctoral students enrolled in the graduate program during the preceding 10 years.”

While this is a clear step in the right direction, a recent survey of 10 leading biology departments (experimental group) and professional schools (control group) in the United States concerning the information available to students considering a career in the biosciences showed striking differences between the two groups (Careers and Rewards in Bio Sciences: the disconnect between scientific progress and career progression). As a rule, biology departments had information about time to degree and percentage of matriculating students who obtained their PhD, but not about job placement. No biology department had a job placement adviser, although career counseling offices at some universities did try to help students leaving academic science find non-academic jobs.

By contrast, all of the professional schools – law, business, medical – tracked the salary and position of their graduates through Student Affairs or Career Services Offices. More often than not this information was advertised on school websites. The inaccessibility of specific information regarding pre-doctoral biosciences students enrolled in graduate programs over the last 10 years means that federal funding agencies regulating scientific development and growth are unequivocally flying blind.

Introducing career streams into academic research

Posted on June 4, 2012 by Jonathan Thon

Post to Twitter

In the 1990s the typical PhD in biological sciences entered the job market in their mid 30s, after spending approximately 3.8 years as a postdoctoral fellow (National Academy of Science, Enhancing the Postdoctoral Experience for Scientists and Engineers). This is 3.6 years longer than it was in 1970 (National Research Council, Trends in the Early Careers of Life Scientists) and roughly 10 years shorter than what it is today.

It is not surprising then that so few PhDs continue into academic positions after receiving their graduate degree. A major failing of our graduate school system is that despite their program choices both Master’s and doctoral students are exclusively trained to become academic investigators. This is a problem when only 20 percent of doctoral students will ultimately become professors and the average age of independence in academic research is now in the mid-40s (A deeper look into the 80 percent of PhDs who do not become professors, and A new era of science funding – Part 4: Speaking up in support of federally funded research). Meanwhile, industries such as biotechnology, drug development, policy development, and scientific writing (amongst others) employ the remainder.

Indeed, a recent study by Fuhrmann et al. have found that at the University of California, San Francisco, nearly one-third of students midway through their graduate training intend to pursue a non-research career path (Improving graduate education to support a branching career pipeline: Recommendations based on a survey of doctoral students in the basic biomedical sciences. 2011. In other words, we are training our graduate students to excel at professions they will never hold. To support the growing number of research PhDs universities are graduating yearly for which faculty positions are not available, we have extended the duration of the postdoctoral research fellowship position. Originally intended to allow for furthering expertise in a specialist subject, acquiring new skills and methods, and developing one’s ability to run an independent research program by apprenticing under an established professor, this has become a repository of misallocated talent that delay a scientist’s entry into their first “real” jobs by more than five years (Careers for Postdoctoral Scientists: The Ever-Aging Postdoc).

For the majority of scientists that are forced to transition into other industries, the postdoctoral fellow stage represents a significant waste of time that does not adequately prepare them for the career they will ultimately elect – and yet, because of the enormous number of postdoctoral fellows feeding into these professions, it has become a prerequisite for most of these positions. As with any new profession, employment in an altogether different field carries with it its own learning curve, further delaying the career advancement of the scientist.

A significant departure from the current trend of expanding the supply of research scientists without evidence of imminent shortages in either the private or academic sectors is necessary (Supply Without Demand), and could be addressed by implementing career streams at the graduate and postdoctorate levels. While this is not a new idea (Elizabeth Marincola and Frank Solomon. The career structure in biomedical research: Implications for training and trainees, The American Society for Cell Biology on the State of the Profession. Molecular Biology of the Cell. 9:3003-3006. 1998), research institutions such as Harvard are increasingly deciding to go the other way, creating additional temporary, non-tenure-track Instructor and Research Associate positions that are in every way equivalent to a postdoctoral research fellow designation and meant to follow postdoctoral training.

In my next post I will tell you why this is a problem.

A call to arms

Posted on May 17, 2012 by Jonathan Thon

Post to Twitter

Scientific research is a marathon, and if we fall behind now, while we are leaders in health innovation, the cost of recovering our position, in light of emerging economies with which we compete, will become progressively more expensive. Sustained increases in National Institutes of Health and Canadian Institutes of Health Research funding are critical to maintain North America’s innovation engines at a crucial time for research and the economy, and most importantly to improve the health and well-being of our populations.

Now is the time for scientists to advocate most strongly for national investment in biomedical research. Members of Parliament, Members of Provincial Parliament and Members of the Legislative Assembly in Canada, as well as senators and congresspersons in the United States are the decision-makers you elect to represent you – write to them. You can go to http://www.canada.gc.ca/directories-repertoires/direct-eng.html and enter your postal code (in Canada), orhttp://www.house.gov and enter your zip code (in the United States) to access your representative.

Things to remember when composing your letter:

  • Identify yourself as a constituent and a member of the scientific community
  • Ask that the legislator support sustainable funding priorities for your federal funding agency.
  • Briefly explain why these issues are important to you.
  • Acknowledge the efforts that are being made by their party
  • Give them your contact information and ask to be informed about the actions their office takes in response to your request.

Letters need to be kept simple and as personal as possible, with tangible examples of actions MPs, MPPs, and MLAs can take to change the landscape of how biomedical research is supported in Canada. These should be provided to the legislator in the form of a one-page cheat-sheet with your contact information included for reference. If dealing with your senator or congressperson in the United States you will need to ask to speak/meet with your representative’s health legislative assistant who handles health care issues in the district or state.

Giving opposition members speaking points against current government policies, emphasizing the economic relevance/importance of your position, and holding legislators accountable for providing examples of and justifying actions they have taken on their own promises are all good ways of having your opinions considered. After the meeting it is important to follow up with your representative within the week, whether or not the representative was supportive of your position. This is your chance to remind them of what you discussed and further emphasize the importance of their involvement on this issue.

Canada-specific:

  • Major research funding in Canada is done federally, but provinces are responsible for health spending and many provinces (e.g.: BC, Ontario, Quebec) have contributed to major infrastructure projects.

U.S.-specific:

  • States often put aside money for research into targeted areas (e.g. California’s support of stem cell research) and are generally more independent than Canadian provinces.
  • Many federal representatives will have specific assistants/aides for health related issues -ask to speak/meet with them

Example speaking points:

  • Low funding rates (NSERC PDFs, CIHR operating grants, etc.)
  • Low postdoctoral fellow salaries compared to other countries
  • Plus, 4 or 5 more good statistics that show why basic health research is a good investment or is currently underinvested.

While the argument for the government to prioritize an industry where the number of clinical advances, drug developments and cures is proportional to total research investment is not a difficult case to make – it needs to be made. I and others at The Black Hole continue to work at concentrating and contextualizing some of the more important issues facing early career scientists in Canada and abroad.

Take advantage of this resource and use hard numbers to emphasize your points. Addressing these concerns forces the issue to light, and commits politicians to publicly defensible positions for which they can subsequently be held accountable. Government agencies cannot lobby for themselves and policy makers do not share your unique perspective. Our health, economy, and the future of scientific progress are at stake, so step up and speak out.

Show me the money!

Posted on May 4, 2012 by Jonathan Thon

Post to Twitter

It falls to scientists to speak up in support of federally funding research and in this third installment of a four-part series, I explore the economic cost of doing research in a cash-strapped system and the burden this is placing on young investigators.

To bring yourself up to speed, installements 1 and 2 are referenced below:

  1. Biomedical Research and Broken Clocks: All the Parts, but No Instructions
  2. A Difficult Pill To Swallow: The Harsh Realities of a 15% Funding Rate

As has been discussed here on and off for quite some time, 80% of PhDs in the US will not become professors. For the majority of these scientific investigators, the inability to secure a faculty position has meant that they must languish in a series of post-doctoral positions supported by grant-funded professors who are increasingly finding themselves with limited resources. The average age of independence in research is now in the mid-40s, a testament to the bleak prospects facing young scientists (PDF).

Given this highly unstable state of academic funding, it is not surprising that many investigators have chosen to transition into more secure professions like teaching, medicine or law. For an in-depth review of the career prospects of a post-doctoral research scientist please see Careers and Rewards in the Bio Sciences: The Disconnect Between Scientific Progress and Career Progression(PDF). The loss hurts our competitiveness in biomedical research and forces industry abroad.

Given our current economy, it is imperative that efforts to improve the nation’s fiscal stability be grounded in the long-term competitiveness of industries we currently head, and that we leverage our expertise in medical science and capacity to do high-tech research. This does not need to come from increased government spending alone. Whereas academic medicine cannot build R&D into the pricing of its services, universities profit directly from tuition fees, patents and personal endowments.

Since these revenues are derived from faculty teaching loads, the scientific success of their investigators, and established reputation of their research program, faculty support must be factored into departmental operating budgets, freeing up tax dollars to directly support research innovation. Another idea would be to create tax breaks for private donations to federal funding agencies in an effort to reduce their dependence on public dollars and incentivize industry investment in national research programs. In the United States (the same nation that passed the Bayh-Dole Act to spur commercialization of university research), government funding of university research exceeds business funding by an order of magnitude, and business investment in university research is nearly half that of Canada (PDF).

Finally, limiting the number of federal awards issued per investigator, most of which are held by senior faculty (PDF), would open up more funding opportunities to help support young investigators and significantly lower the age of independence. While the debate of whether to preferentially support established labs with proven track records over younger faculty with new ideas is ongoing, without early career support junior researchers will not succeed.

If we are unwilling to prioritize young faculty and share what wealth there is, perhaps the better question is “Should we continue training so many of them?”

Read Full Post »