Innovation in Life Science & Healthcare Research and Product Development

InnovationWell Autumn Community of Practice Meeting
14-17 October 2008
Bryn Mawr College, Bryn Mawr, Philadelphia, USA

Conference Link

Themes: Critical Path Advances in Drug Development, Innovation &
Knowledge Management in R&D and Translational Medicine, Computational
Biology, Predictive ADME, Predictive Toxicology, Metabolomics,
Biomarkers, Systems Biology

Program Summary
Systems Biology, chaired by Keith Elliston (Genstruct)
Computational Biology, chaired by Debraj Guhathakurta (Merck)
Knowledge Management in Translational Medicine, David Bousfield (Ganesha
Associates)
Applications of Metabolomics to Drug Discovery & Development, chaired by
Bruce Kristal (Brigham and Women’s Hospital)
Predictive ADME, chaired by Anthony E. Klon (Pharmacopeia Drug Discovery)
Predictive Toxicology, chaired by Artem Cherkasov (University of British
Columbia)

Pre-Conference Workshop, 13 October
Knowledge Management in R&D
chaired by John Conway (Accelrys) and Frank Hollinger (FRESH Directions
Consulting)

Speakers
Keith Elliston (Genstruct), Debraj GuhaThakurta (Rosetta Inpharmatics,
Merck & Co.), Stephen W. Edwards (U.S. Environmental Protection
Agency), Paul McDonagh (Gene Network Sciences), Christopher M.L.S.
Bouton (Pfizer), James R. Brown (GlaxoSmithKline), John Wilbanks
(Creative Commons), Barry Bunin (Collaborative Drug Discovery), Michael
Liebman (Windber Research Institute), Jerry Wright (Johns Hopkins
Medical Institutions), Anastasia Christianson (AstraZeneca), James
Golden (Science Applications International Corporation), John Speakman
(National Cancer Institute), William Hayes (Biogen Idec), Andrew
McMurray (Harvard University), Eugene Clark (Partners Healthcare), Alvin
Berger (Metabolon), John Newman (USDA), Bruce Kristal (Brigham and
Women’s Hospital), Anton Hopfinger (University of New Mexico), Heidi
Einolf (Novartis), Yojiro Sakiyama (Pfizer), Olga Obrezanova (BioFocus
DPI, UK), Anthony E. Klon (Pharmacopeia), Artem Cherkasov (University of
British Columbia, Canada), Ann Richards (US EPA), Curt Breneman (RPI),
Alex Tropsha (UNC), Barry Hardy (Douglas Connect), Weida Tong (FDA)

CFP
We invite contributed papers from members of academic, government
research and commercial organizations on areas of new research and
innovation relevant to innovation and knowledge management in the life
sciences. The work presented should involve innovative new method
development or application in the areas of systems biology,
translational medicine, knowledge management, computational biology,
metabolomics, predictive ADME, predictive toxicology or bioinformatics.
Studies including experimental work in medicinal chemistry, screening,
experimental toxicology, pre-clinical evaluation, lead optimisation and
translational medicine are welcome.

Abstracts (300-500 words) should be submitted to innovationwell [at]
douglasconnect.com by 31 July 2008, and be accompanied by a short
biography of the presenting author (300-500 words). Abstracts approved
by the scientific organizing committee will be selected for scheduling
on the conference program and in meeting poster sessions. Authors will
be notified of acceptance as soon as a review of submitted materials
takes place and at the latest by 15 August 2008.

Bursary
Bursary Awards will be used to support the attendance of a selection of
academic young investigators at the meeting and workshops. Applicants
should be working in a relevant area of research related to life
science, healthcare, and drug product discovery and development at the
postdoctoral, graduate student and senior undergraduate levels.

To apply for the bursary please send an email with a) your abstract and
biography (300-500 words each), b) your CV of 1-2 pages, c) a short
description of your interests and career motivations related to
R&D (300-500 words) to innovationwell [at] douglasconnect.com by
31 July 2008. The recipients of the bursary awards will be selected
based on an evaluation of the quality and innovation of the described
research and the potential positive impact of attendance at the meeting
on their research and career progress. Authors will be notified of
acceptance by 15 August 2008.

Poster Session
All InterAction Meeting registrants are eligible to present a Conference
Poster. The Poster Sessions will take place in the evenings in Thomas
Great Hall on campus, where refreshments and dinner are also served.
Poster Abstracts (300-500 words) with Title, Institution, Authors and
Contact Information should be submitted to barry.hardy [at]
douglasconnect.com Abstracts will be considered based on date of
submission and quality, and will be reviewed and accepted as they are
received. To be considered for the formal program, they should be
submitted at the very latest by 31 August 2008.

Contact:
Program: Dr. Barry Hardy, InnovationWell Community of Practice, Douglas
Connect. Tel: +41 61 851 0170. barry.hardy [at] douglasconnect.com

Registration Enquiries: Nicki Douglas, Douglas Connect, Baermeggenweg
14, 4314 Zeiningen, Switzerland. Tel: +41 61 851 0461. InnovationWell
[at] douglasconnect.com

Synthesize a peptide nucleic acid antisense oligonucleotide for HIV’s env gene’s mRNA. The reason for using PNA is that it is substantially more resistant to enzyme degradation by nucleases and proteases. The reason for choosing the gag gene is that it’s proteins, p24, p17, p7, and p6, code for the basic physical infrastructure of HIV; w/o these key proteins, there is no HIV. Then, encapsulate the oligonucleotides in liposomes studded w/ anti-CD4 antibodies. This will ensure 1) toxicity is limited—cf Ambisome, the liposomal preperation of amphotericin B—2) the biologic goes only where it’s needed, which is the cytoplasm of CD4+ T-cells. Decorating the liposome w/ anti-CD4 antibodies will trigger endocytosis, in my limited knowledge, at least. I predict low toxicity and high efficacy in reducing the patient’s viral load to 0 copies/ml.

What are your thoughts? Should LNA instead of PNA be used? Cell-penetrating peptides vs. liposomes? Targeting the gag gene vs. targeting the pol gene? Are there any publications about this subject?

And, just for fun, what do you think the generic name would be for this biologic? Brand name?

Thanks!!!!

1. What role do environmental factors, which affect pharmacokinetic and pharmacodynamic data, have in pharmacogenetic research?

2. Do scientists currently have the resources to determine key factors that affect treatment outcome or does an imbalance still exist among the importance of genetic and environmental factors?

3. Can concentration variability be minimized by avoiding concurrent medications and herbal supplements known to produce metabolic interactions for CYP450 substrates?

4. Should a physician prescribe a patient with a chronic condition such as HIV infection a less toxic, twice-daily medication such as IsentressTM, or a potentially more toxic once-daily drug such as Sustiva®?

5. Should there be consistent regulation of the efficacy claims of herbal medicines and natural health products?

6. Are current regulations adequate to ensure public safety and prevent deaths associated with supplements containing ephedrine?

7. Should an expert panel develop and oversee a system that categorizes the severity of drug interactions to help clinicians make better decisions?

8. Is the application of population-level evidence from trials to individual-level decisions too cumbersome?

9. Considering the trend toward globalization within the pharmaceutical market throughout the past decade, how has the FDA been challenged in their pursuit to ensure the safety and quality of available drugs?

10. Should drug manufacturers consider suppliers and intermediaries in addition to labeling and certification when confirming a drug’s safety?

1. Techniques such as imaging, pathology, surgery, radiation oncology, and medical oncology have decreased breast cancer mortality rates.
What other preventative methods, treatment techniques, and alternative therapies exist that have not been fully explored?

2. Have previous studies using tamoxifen to prevent invasive breast cancer in high-risk patients effectively measured its effect on overall survival?

3. Should neoadjuvant endocrine therapy for patients with locally advanced breast cancer be reserved for clinical trial use?

4. Will a “personalized medicine” approach integrating gene profiles and other predictive tools shape future therapies for breast cancer?

1. What are the limitations of current osteoporosis treatments such as bisphosphonates, estrogens, selective estrogen receptor modulators, and vitamin D derivatives?

2. Considering how human and mouse skeletons differ in terms of estrogen response, is the mouse model adequate for determining bone loss?

3. Is the development of cathepsin K inhibitors crucial for future osteoporosis treatment?

1. Is emergency contraception as effective in preventing pregnancy as studies suggest?

2. What, if any, are the social implications of increased accessibility to levonorgestrel?

3. How does the inability to precisely calculate efficacy affect the overall acceptability of emergency contraception?

4. Does evidence exist supporting cost-saving claims associated with emergency contraception?

5. What other issues related to efficacy, accessibility, and social expectations are important to consider when discussing emergency contraception?

Although the therapeutic potential of marijuana has been established in scientific studies, controversy remains regarding whether these benefits outweigh the harm of smoking. In 1999, the Institute of Medicine released a report stating that “scientific data indicate the potential therapeutic value of cannabinoid drugs, primarily THC, for pain relief, control of nausea and vomiting, and appetite stimulation; smoked marijuana, however, is a crude THC delivery system that also delivers harmful substances.” Alternative delivery systems of THC could eliminate this objection to medical marijuana. A recent pilot study of marijuana vaporization, published in CPT, concluded that the “vaporization of cannabis is a safe and effective mode of delivery of THC.” Other smokeless modes of delivery include ingestion and the use of tinctures.

Read the article here.

-In addition to accepting registration in any of the 5 existing registries, the ICMJE will accept registration of clinical trials in any of the primary registers that participate in the WHO ICTRP. Registration in a partner register only is insufficient.

-The ICMJE will begin to implement the WHO definition of clinical trials for all trials that begin enrollment on or after 1 July 2008. This definition states that a clinical trial is “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.”

-The ICMJE will not consider results posted in the same clinical trials registry in which the primary registration resides to be previous publication if the results are presented in the form of a brief, structured (less than 500 words) abstract or table.

This article follows the original Sept 2004 ICMJE announcement on clinical trial registration and the subsequent updates in October 2004 and May 2005.

ICMJE’s 2004 announcement sparked much controversy, and debate has been ongoing since. While many researchers have argued that phase I clinical trial registration will stem progress by stifling competition, organizations such as the World Health Organization and the Council of Science Editors have favored ICMJE’s decision. ICMJE claims that phase I clinical trial registration is necessary to counter the bias in trial reporting, which has often favored positive trials over negative or ambiguous trials.

What do you think? Does public policy have a place in the treatment of obesity?

What are your thoughts? Is personalized medicine attainable?