ABOUT
PROBLEM
HERBAL MEDICINES
DISEASES
PHARMACUETICAL DRUGS
HISTORY
Natural products have been used for centuries to treat diseases, but they have never undergone clinical standardization. However, with the onset of the 20th century and the rise of the industrial age, the use of natural products as herbal medicines declined, as synthetic drugs that were more specific, fast-acting, and cost-effective came to the fore. In those early days, science could not compare the healing properties of natural herbs with the synthetic drugs manufactured by the pharmaceutical industry. Today there is a different story.
PRESENT SITUATION
The current pharmaceutical approach to drug development employs the use of a single-molecule to ‘target’ development pathways in disease proliferation. This is a very expensive and time-consuming process to drug development. Yet and still, after more than a century of application, numerous viruses still pose a significant threat to humanity, with no known cures or vaccines; and chronic health issues have become a norm in America. Additionally, drug resistance is diminishing the effectiveness of many drugs, including antibiotics and vaccines. Furthermore, due to the high cost of R&D, rare and orphan diseases are often neglected and need more funding support.
OPPORTUNITY
There are thousands of historically documented herbal formulations made from natural products that researchers can investigate for their potential medicinal uses. By utilizing modern science, these early herbal formulations can be standardized for large-scale clinical use.
Natural products often contain multiple bioactive molecules that may be more effective than single-molecule synthetic drugs. Additionally, by utilizing the prior human use history of natural products, the cost for R&D is significantly reduced, plus treatment options for rare and orphaned diseases can be made available.
OVERCOMING CHALLENGES
Research indicates that performing clinical studies of natural products presents numerous "challenges" that BioAccelerate addresses.
Assembling a global effort to uncover and standardize ancient herbal formulations of natural products for current medical use presents a hurdle BioAccelerate is uniquely poised to surmount. Through our world-wide collaborative network, subject matter experts in natural products aid in our global quest.
Gathering and presenting documentation of prior human use of early herbal formulations from natural products that adhere to clinical standards is another issue that BioAccelerate addresses through assembling a skillfully coordinated blend of evidence captured and structured to be clinically compelling to the US FDA.
Further, designing clinical studies for natural products require a multi-disciplinary approach. BioAccelerate has created a one of its kind think tank to fulfill this need.
Finally, BioAccelerate has organized a venture philanthropy to secure financial support for the execution of clinical trials specifically involving natural products to achieve major disease impact.
SOLUTIONS
THINK TANK
BIOACCELERATE ACADEMIC RESEARCH CENTERS (BARC)
"By integrating and applying best practices in natural products clinical research translation, at BioAccelerate we position herbal medicines for botanical drug success." - Stevie Council, Founder
BARC represents a one-of its kind think tank comprised of experts from academia and industry organized to address critical issues confronting natural products research translation. We convene thought leadership across a multi-disciplinary spectrum of subjects which collectively offer a comprehensive platform for delivering world-class natural products clinical research. BARC accelerates natural products clinical translation by coordinating resources and infrastructure to support researchers, biotech companies, and manufacturers.
The Center for Herbal Historical Evidence and Academic Research as Therapeutics (C-HEART) program plans to examine herbs/formulations used in African and other traditional medicines, Ayurvedic medicine, and Traditional Chinese Medicine (TCM) by reviewing ethnobotanical research and implementing community engagement efforts. C-HEART collaborates with experts in each conventional medicine system to document their use of medicinal plants, conduct studies to test efficacy and safety, and identify potential drug leads for clinical use. The center's programs promote integration with modern medicine, education and outreach, and conservation of medicinal plant species and traditional knowledge. The program develops culturally appropriate and effective new therapies and drugs, while advancing the understanding and preservation of traditional knowledge.
African & Other Herbs/Formulations
Ayuveda Medicine
Traditional Chinese Medicine (TCM)
The Center for Botanical Multiple BioActive Molecules Medicine explores the synergies among the multiple medicinal molecules contained within a plant mixture. We accomplish this through BioAccelerate’s partner network which employs state-of-the-art molecular biology laboratories equipped with instrumentation to identify and characterize the molecular constituents of plant sources, analytical chemistry laboratories to study the chemical and physical properties of the identified molecules, as well as class BSL3/4 biological testing laboratories to investigate the activities of the identified molecules. Through our partner network, the center engages data analysts to integrate data generated from the different laboratories to determine the synergistic actions of the molecules present in plant extracts. Furthermore, the center works with botanical gardens to identify and access local medicinal plant resources to collect and store plant material, and facilitate collaborations with other research institutions, universities, and industry partners. The center's goal is to provide insights into the synergistic activities of medicinal plants and identify potential new therapies for various diseases.
Structure Determination
Characterization
Mechanistic Activity
The Center for Clinical Trials Innovation focuses on designing high-quality, cost-effective clinical trials of natural products. The center will establish best practices for clinical trials which exceed standards of the U.S. Food and Drug Administration’s (FDA’s) recommendation on botanical drug development for industry, while incorporating innovative cost-containment strategies. Center goals also include the development of a database to enable transparency in pricing for clinical trial services. From an Information Technology perspective, the center works to advance clinical trials decentralization using blockchain technology to enhance the integrity and security of the data generated. The center aims to transform the use of patient health data from clinical trials using blockchain technology to ensure data security and sharing and enable smart contracts. The center's approach delivers high-quality and cost-effective clinical trials of natural products, advancing the development of safe and effective therapies for various diseases.
Natural Products Best Practices
Cost Containment & Transparency
Blockchain Implementation
The Center for Advanced Botanical Bio-Extractions specializes in the processing and extraction of plant materials, to obtain active compounds. The center has access to botanical garden for sustainable plant material collection, in addition to a team of Scientists and Formulation Experts to convert the compounds into dosage forms, such as capsules, tablets, and creams.
Biomass Bio-Refinery
Bioassay Guided Precision Extraction
R&D/MFG.
The Center for Natural Products Health Equity Academic Research explores the use of herbal remedies in underserved populations. The center prioritizes community engagement and employs rigorous study designs, with state-of-the-art data collection and analysis methods. In addition, the center will coordinate training and capacity-building opportunities for researchers and community members and establish partnerships to support its research and programmatic activities.
Health Outcomes
Disease Disparities
Equity and Impact
CLINICAL ACCELERATORS
We have two clinical accelerators dedicated to natural products. The Botanical Drug Clinical Accelerator expedites the conversion of natural products into botanical drugs approved for the U.S. healthcare market, while the COVID-19 Clinical Accelerator concentrates on creating FDA approved treatments capable of managing all stages and symptoms of COVID-19.
CONTRACT RESEARCH ORGANIZATION
Bringing together the best professionals, BioAccelerate delivers maximum value in delivering botanical drug development strategies.
BioAccelerate combines its expertise in natural products research translation best practices with site management and patient management solutions to provide quality, productivity, and timely delivery of sponsor research projects.
We are a Full Solution CRO focused exclusively on botanical drug delivery. From protocol design to data management, we offer a best of class platform for achieving sustained study performance.
Click Here to access the BioAccelerate clinical research platform.
VENTURE PHILANTHROPY
BIOACCELERATE IMPACT FUND
The BioAccelerate Impact Fund's primary focus is on funding natural products clinical trial research. Our clinical accelerators constantly attract a pipeline of medicinal herbal formulations. These products are prepared for clinical trial design, implantation and financing, capable of treating various medical conditions such as viruses, cancers, and age-related illnesses. In addition to our current pipeline of botanical drug candidates, the clinical accelerators actively engage research partnerships to deliver herbal formulations suitable for global clinical development.