ASP Annual Meeting workshops

Workshops

Clinical Pharmacognosy: Contribution of Pharmacognosy to the Quality of Clinical Trials of Botanicals & Dietary Supplements

Saturday, July 14, 8:15 a.m. - 5 p.m.

Program Committee:

Ray Cooper Ph.D.

Fredi Kronenberg Ph.D

Marilyn Barrett Ph.D.

Jim McChesnsey Ph.D.

Joerg Gruenwald Ph.D.

Purpose of the Workshop:

We are offering a very exciting and important one day science symposium and discussion forum to address critical and timely issues related to conducting clinical research on botanicals. This unique event brings together leading international scientific scientists and experts to present the latest findings on characterization of test materials, challenges in conducting a clinical trial, safety aspects, and guidelines for future studies.

The Target Audience:

Natural products researchers from industry and academia, medical and health professionals, food and nutraceutical industry scientists and executives.

Benefits of Attending:
Opportunity for collaboration between ASP members, health professionals, scientific experts from academia and the Dietary Supplements industry and their executives

Workshop Program

Characterization of Clinical Phyto-preparations:

Meeting the National Center for Complementary and Alternative Medicine (NCCAM) requirements for botanical substances to be tested in clinical studies, and assuring reproducible test products: lessons to be learned.
Bio-equivalency of herbal medicines: implications for proprietary products and dietary supplement structure/function statements; bio-equivalency requirements.
Current status of characterization of botanicals in clinical studies: recommendation for researchers and publication editors.

2. Clinical Studies on Botanicals:

Issues and challenges facing investigators of clinical trials.
High level planning and performance of a clinical trial.
Complications of studying a multi-ingredient product.
Examples and issues in ongoing clinical studies.

3. Safety and Quality Issues

Safety Concerns in clinical trials of botanicals: Criteria for evaluating safety of botanicals.
Determining safety information from clinical studies, post-marketing surveillance and case reports: How is causality assigned? How strong does the evidence have to be?
Examples of potential safety alerts: Kava, SJW, black cohosh.

Technical characteristics in designing clinical trials:

- Choice of a specific intervention (plant, brand, claim)
- Right plant part; dosage form; marker compounds
- Toxicology and clinical pharmacology
- Role of Accurate Methodology in Demonstrating Safety and Efficacy of a product
- Perspectives on Adverse Event (AE) reporting on herbs
- Impact of new AE reporting legislation
- Challenges in collecting, assessing, evaluating post-market surveillance AERS
- Adverse event databases: how best to collect information in the US?
- Post-marketing surveillance: how it is done in Europe?

4. Perspectives on Botanical Drugs, Medical Foods, Phytomedicines, Dietary Supplements

Discussion on the possibility of multiple routes evolving for botanicals to gain acceptance in the clinic - the current Dietary Supplement route versus the new Botanical Drug route and the role of Medical Foods: relative pros and cons?
Recognizing the importance of herbal and nutritional supplements to provide missing principal nutrients from today’s processed food and diets. Importance of preventive health, including agents that may help maintain health rather than treat disease or its symptoms after onset of sickness.
Importance/challenges of designing preventive versus treatment clinical trials.

Workshop cost: $ 120

For more information, contact Ray Cooper, RCooperPhD@aol.com

Modern NMR Methods for Organic Structure Elucidation

Saturday, July 14 [9 am – 4 pm], Holiday Inn By the Bay

This course will be given by Professor William Reynolds (University of Toronto) and Dr. Eugene Mazzola (USFDA and University of Maryland). It is designed for graduate students and post-doctoral fellows working in the field of natural product chemistry, but would also be suitable for final year undergraduates and scientists working for pharmaceutical and nutriceutical companies or in government labs. Participants should have a basic knowledge of NMR (at the level taught in senior undergraduate courses on spectroscopic methods for structure elucidation). The course will be practical in nature and will cover the key features of modern NMR spectrometers, the relative advantages and disadvantages of various 2D and selective 1D NMR methods, the choice of optimum acquisition parameters and post-acquisition processing methods, sample preparation and magnet shimming, as well as demonstrating the concerted use of 1 and 2D NMR methods for determining structure and stereochemistry. It will also discuss various potential problems in structure elucidation by NMR and how to avoid or overcome them. Attendees will be provided with an extensive set of printed notes (in the form of book) covering both course material and basic NMR theory. There will be a break from 12 pm to 1 pm for lunch.

Workshop cost: $ 50 ($ 25 for students)

For more information, contact Eugene Mazzola (emazzola@umd.edu) or William Reynolds (wreynold@chem.utoronto.ca)

Training Course: Optimization and In-house Validation of Analytical Methods for Dietary Supplements

Thursday and Friday, July 19 and 20 [8:30 am – 4 pm], Holiday Inn By the Bay

10 Student Travel Grants for Validation Workshop from ODS

COURSE DESCRIPTION

A 2-day (July 19-20, 2007) training course on the development, optimization, and in-house validation of analytical methods for dietary supplements in compliance with internationally recognized laboratory validation guidelines. This workshop is sponsored by the NIH Office of Dietary Supplements (http://dietary-supplements.info.nih.gov/) at a significant cost reduction to attendees. The cost of attendance is $50.

WHO SHOULD ATTEND

Graduate students and post-doctoral scientists concerned with developing analytical methods, especially for dietary supplements, and who seek a better understanding of guidelines for single laboratory validation of those methods. The course is specifically intended for students, and post docs; others interested in gaining a broader understanding of the method validation process will be admitted on a space available basis.

WHAT YOU WILL LEARN

Proper in-house validation of a protocol (potential method) ensures that its technical performance and fitness for purposes can be objectively evaluated. To that end, this course provides an in-depth and comprehensive review of internationally recognized guidelines and criteria for single laboratory (in-house) method validation, with a focus on dietary supplements. Participants will acquire the basic information and skills needed to optimize the probability that a given protocol can be validated in a single-laboratory setting to the technical and practical standards required to demonstrate that a particular method is scientifically valid.

After taking this course you will be able to:

*       Recognize and prioritize decisive (determinative) factors/parameters as a prelude to adapting or developing and refining analytical methods and related Standard Operating Procedures;

*       Systematically generate and objectively evaluate raw (performance) data pertaining to linearity, accuracy, precision, ruggedness, Limits of Detection., Limits of Quantitation, etc.;

*       Evaluate a candidate protocol's overall fitness for purpose, vis-à-vis test materials and matrices; and

*       Clearly and effectively describe methods and SOPs in a written format, using appropriate checklists of key criteria (requirements) for validation.

Workshop cost: $50

For more information, contact Joe Betz, BetzJ@od.nih.gov

The American Society of Pharmacognosy

Workshops