BioSafe Technologies Founder Wins 3 Stevie® Awards

2017 Stevie® Awards For Women in Business

The 14th edition of the world’s top honors for female entrepreneurs, executives, employees and the organizations they run were presented on November 17, 2017 at the Marriott Marquis Hotel in New York City. More than 550 nominated women and their guests from around the world attended.
The Stevie Awards for Women in Business is an international competition that recognizes the achievements of women executives, entrepreneurs and the companies they run. Congratulations to Ms. James-Meyer for her achievements in business, and in creating pesticide free, clinically proven products that are providing relief worldwide.

BioSate Technologies’s Lynn James-Meyer Wins 3 Stevie® Awards

BioSafe Technologies founder, Lynn James-Meyer was awarded three of these prestigious 2017 Stevie Awards For Women in Business in the following categories:

2016 Global Exporter of the Year Award from the Global Chamber Dallas

About The Stevie® Awards

The Stevie® Awards are the world’s premier business awards. They were created in 2002 to honor and generate public recognition of the achievements and positive contributions of organizations and working professionals worldwide. In short order the Stevie has become one of the world’s most coveted prizes.

Stevie Award judges include many of the world’s most respected executives, entrepreneurs, innovators, and business educators. More than 1,000 professionals worldwide participate in the Stevie Award judging process each year. All Stevie Awards entrants have access to all judges’ comments about their nominations.

XIM Bank Case Study: Got Lice?

January 23, 2018 Elizabeth Thomas, Business Development Specialist, Office of Small Business

Well we hope not, but if so, BioSafe Technologies of Denison, Texas, has the shampoo for you.

Founded in 2000, BioSafe products are the result of a research project seeking non-toxic methods for controlling insects on plants. Lynn James-Meyer, BioSafe’s CEO, found that several of the formulations worked on blood sucking insects, particularly fleas, mites and lice, and a company was born.

Lice are a universal problem and BioSafe began exporting its shampoo to Europe. Like many small companies, BioSafe required funds to grow manufacturing operations to meet international demand. Fortunately, Ms. James-Meyer discovered EXIM Bank through United Risk Consultants, an EXIM registered insurance broker.

EXIM’s export credit insurance product provided two solutions for BioSafe. First, BioSafe received a line of credit from their commercial lender by covering the accounts receivables generated by international sales. The additional cash flow enabled BioSafe to purchase raw materials, outsource manufacturing and meet the timeframes required by international customers. Second, export credit insurance empowered BioSafe to offer open account credit terms and provided peace-of-mind by protecting the company from nonpayment by foreign buyers.

“EXIM allowed us to take on a large customer overseas. We never would have expanded our exports without the support offered by EXIM. We could take on multiple orders, pay our vendors on time and offer better terms to our customers without concern for receipt of payment.”
Lynn James-Meyer, Founder and CEO

In addition to helping people worldwide, Ms. James-Meyer was recently awarded three Stevie Awards:

• Gold: Female Entrepreneur of the Year—Consumer Products, 10 or fewer employees
• Gold: Female Maverick of the Year
• Silver: Lifetime Achievements

The Stevie Awards for Women in Business is an international competition that recognizes the achievements of women executives, entrepreneurs and the companies they run. Congratulations to Ms. James-Meyer for her achievements in business, and in creating pesticide free, clinically proven products that are providing relief worldwide.

Original Article Link

Texas Company Removing Lice from Children’s Hair Worldwide

March 16, 2020 Aisac Accad, Office of Communications, EXIM Bank

Every March, Women’s History Month recognizes the accomplishments and contributions of women to society, culture, and history. From space exploration to the performing arts, women have impacted every sector and field. EXIM is committed to supporting women-owned businesses, and this Women’s History Month, we recognize several extraordinary women-owned businesses. In March 2020 as EXIM Bank celebrated Women’s History Month with Female Entrepreneurs by featuring BioSafe Technologies’ CEO Lynn James-Meyer.

As the article stated, “Blood-sucking insects are difficult to control, but that did not stop BioSafe Technologies’ CEO Lynn James-Meyer. While researching non-toxic methods for controlling insects on plants, she found the formulas worked well as a shampoo against fleas, mites, and lice. BioSafe now exports its pesticide-free, clinically proven lice shampoo to Europe and uses EXIM’s export credit insurance to protect the company from nonpayment due to commercial and political risks. EXIM covers up to 95 percent of the company’s sales invoice.”

Exporter/Customer: BioSafe Technologies, Inc. | EXIM Bank Product: Export Credit Insurance

New products are sometimes discovered serendipitously. This story is one. In 1990 Lynn James-Meyer was working on a humanitarian project in Brazil when she was introduced to a small research team seeking non toxic methods for controlling insect on plants. Having a biology background and great interest in finding safer products for the environment, she began assisting the group by field testing various formula compositions derived from plant sources. Lynn found that several of the formulations worked well on blood sucking insects affecting humans and animals, particularly fleas, mites and lice.

These insects were a huge problem in the neighboring area on both humans and animals. She developed lice shampoos using the newly discovered active ingredient compounds tested during plant studies. The products showed amazing results. It wasn’t long before Lynn returned to the US to patent the technology both domestically and foreign and begin clinical trials.

EXPORT CHALLENGE
In the late 1990s Lynn started selling her product in the U.S. through her website and formed BioSafe Technologies, Inc. in 2000. A research specialist in the UK amazed at the results from his clinical work with the product, encouraged the company to export its head lice shampoo to a European distributor. Later other large European companies expressed interest in private-labeling her lice care product.

Cash flow reality quickly dampened this good news. Essentially, Lynn required funds to manufacture her products and she was also concerned about receiving payment after the product was delivered. Offering long lead times for receiving payment was not possible if the company was to meet supply timeframes and raw material purchases. Therefore market expansion opportunities were difficult to consider.

EXIM SOLUTION
Fortunately, Lynn attended an exporter forum in Dallas and discovered EXIM through a broker from United Risk Consultants. EXIM’s export credit insurance provided two solutions for BioSafe Technologies. First, they received a line of credit from their commercial lender by assigning its insure foreign accounts receivable. Second, export credit insurance empowered the company to offer open account credit terms.

RESULTS
The additional cash flow from its line of credit enabled BioSafe Technologies to purchase raw materials, fund manufacturing, and meet the time frames required by international customers. The ability to offer credit terms to international buyers made them more competitive in international markets and provided peace-of-mind by protecting the company from nonpayment by foreign buyers.

“EXIM allowed us to take on a large customer overseas. We never would have expanded our exports without the support offered by EXIM. We could take on multiple orders, pay our vendors on time and offer better terms to our customers without concern for receipt of payment.”
Lynn James-Meyer, Founder and CEO

Original Article Link

Review on Antimicrobial Resistance (AMR)

Wellcome Trust & UK Department of Health

The Review on Antimicrobial Resistance (AMR), was commissioned in July 2014 by the UK Prime Minister, who asked economist Jim O’Neill to analyse the global problem of rising drug resistance and propose concrete actions to tackle it internationally. The Review on AMR was jointly supported by the UK Government and Wellcome Trust, although operated with full independence from both. Established as a two-year, time-limited process, the Review engaged widely with international stakeholders to understand and propose solutions to the problem of drug-resistant infections from an economic and social perspective, and produced its final report and recommendations in the summer of 2016.

Lord Jim O’Neill, chairman of the independent Review on Antimicrobial Resistance, which has assisted in the development of the Declaration, said: “This Declaration from industry is a major step forward in establishing a properly global response to the challenges of drug resistance. I am really impressed that such a wide range of companies have been able to agree on a common set of principles and commitments across these important issues: this is a level of consensus that we have not previously seen from the industry on this topic.”
AMR is one of the most serious public health threats globally with infections cause by multidrug-resistant bacteria currently estimated to kill 25,000 people every year in Europe alone.

The Review on Antimicrobial Resistance has now completed its work. The content of this website is frozen as an archive of the Review’s work, and will not be updated further. The legacy of the Review will be maintained by its sponsor organisations, the Wellcome Trust and the UK Department of Health.

For queries about the legacy of the Review, or for media enquiries for the Review’s former chair, Jim O’Neill only, please contact info@amr-review.org.

AMR Website

Antimicrobial Resistance

20 August 2017 | WHO News Release | Geneva

Many of the medical breakthroughs of the last century could be lost through the spread of antimicrobial resistance. Previously curable infectious diseases may become untreatable and spread throughout the world. This has already started to happen.

The report “Antimicrobial resistance: global report on surveillance 2014” showed that antimicrobial resistance is everywhere and has the potential to affect anyone, of any age, in any country.

In April 2015, WHO published a “Worldwide country situation analysis: Response to antimicrobial resistance”. It revealed that while much activity is underway and many governments are committed to addressing the problem, there are major gaps in actions needed across all 6 WHO regions.

This fact file describes the threat of drug resistance, some of its main causes, and how WHO is helping to lead the global response.

Drug Resistance is a Global Problem

Over the past years, the use and misuse of antimicrobials has increased the number and types of resistant organisms. Consequently many infectious diseases may one day become uncontrollable. With the growth of global trade and travel, resistant microorganisms can spread promptly to any part of the world.

What Causes Drug Resistance?

Drug resistance is a natural evolutionary phenomenon. When microorganisms are exposed to an antimicrobial, the more susceptible organisms succumb, leaving behind those resistant to the antimicrobial. They can then pass on their resistance to their offspring.

The Pipeline for New Tools to Combat Drug Resistance is Almost Dry.

Existing antibiotics and anti-parasitic drugs, and, to a lesser extent, antiviral drugs, are losing their effect. At the same time there is insufficient investment in developing new antimicrobials. Similarly, there is insufficient new research into new diagnostics to detect resistant microorganisms; and new vaccines for preventing and controlling infections. If this trend continues, the arsenal of tools to combat resistant microorganism will soon be depleted.

What is Antimicrobial Resistance?

Antimicrobial resistance is the ability of a microorganism (like bacteria, viruses, and some parasites) to stop an antimicrobial (such as antibiotics, antivirals and antimalarials) from working against it. As a result, standard treatments become ineffective, infections persist and may spread to others.

Drug Resistance is a Global Problem

Over the past years, the use and misuse of antimicrobials has increased the number and types of resistant organisms. Consequently many infectious diseases may one day become uncontrollable. With the growth of global trade and travel, resistant microorganisms can spread promptly to any part of the world.

Inappropriate Use of Medicines Worsens Drug Resistance

Inappropriate use of antimicrobials drives the development of drug resistance. Both overuse, underuse and misuse of medicines contribute to the problem. Ensuring that patients are informed about the need to take the right dosage of the right antimicrobial requires action from prescribers, pharmacists and dispensers, pharmaceutical industry, the public and patients, as well as the policy makers.

Lack of Quality Medicines Contributes to Drug Resistance

Most drug quality assurance systems are weak. This can lead to poor quality medicines, exposing patients to sub-optimal concentrations of antimicrobials, thus creating the conditions for drug resistance to develop. In some countries poor access to antimicrobials forces patients to take incomplete courses of treatment or to seek alternatives that could include substandard medicines.

Animal Husbandry is a Source of Resistance to Antibiotics

Sub-therapeutic doses of antibiotics are used in animal-rearing for promoting growth or preventing diseases. This can result in resistant microorganisms, which can spread to humans.

Poor Infection Prevention and Control Amplifies Drug Resistance

Poor infection prevention and control can increase the spread of drug-resistant infections. Hospitalized patients are one of the main reservoirs of resistant microorganisms. Patients who are carriers of resistant microorganisms can act as a source of infection for others.

The Pipeline for New Tools to Combat Drug Resistance is Almost Dry

Existing antibiotics and anti-parasitic drugs, and, to a lesser extent, antiviral drugs, are losing their effect. At the same time there is insufficient investment in developing new antimicrobials. Similarly, there is insufficient new research into new diagnostics to detect resistant microorganisms; and new vaccines for preventing and controlling infections. If this trend continues, the arsenal of tools to combat resistant microorganism will soon be depleted.

WHO Calls on Stakeholders to Combat Drug Resistance

The threat from drug resistance is increasing. There is a need for urgent action; everyone must play a part. At the Sixty-eighth World Health Assembly in May 2015, Member States endorsed a global action plan to tackle antimicrobial resistance. The goal of the draft global action plan is to ensure, for as long as possible, continuity of successful treatment and prevention of infectious diseases with effective and safe medicines that are quality-assured, used in a responsible way, and accessible to all who need them. Countries have been encouraged to develop national action plans to help achieve the global action plan objectives. So far 79 countries have national action plans, and a further 49 countries are in the process of developing a plan.

Original Article Link

A Critical Assessment of Incentive Strategies for Development of Novel Antibiotics

31 October 2014

LSE Health, London School of Economics and Political Science

Matthew Renwick, David Brogan, & Elias Mossialos1

In recent years, a concern has emerged in the public health arena regarding the deadly combination of increasing antimicrobial resistance and stunted antibiotic development. Antimicrobial resistance is an evolutionary adaptation that will not cease, but can be mitigated with careful stewardship of existing antibiotics. The decline in investment in antibiotic development is a complex, multifactorial market failure arising from the nature of antibiotic prescribing, current pricing, existing patent structures, and societal expectations.

While combating antimicrobial resistance is the realm of scientists, addressing public health crises due to market failures is the realm of policy makers. This report seeks to provide a basic armamentarium from which to begin that discussion. This project undertook a rapid review of the antibiotic incentive literature using guidelines from the Centre for Reviews and Dissemination. A total of forty-four antibiotic incentive strategies were identified and classified in traditional categories of push, pull, and hybrid mechanisms.

Push methods reduce the cost of researching and developing new drugs. Push incentives are useful because they lower the barriers to entry that preclude small and medium sized pharmaceutical enterprises. In addition, research and development incentives delivered upfront are dramatically more valuable than similar sized future payments, which must be discounted to present value. However, push strategies are troublesome because they can result in conflicting priorities of development trajectory and they expose a funder to the financial risk of project failure.

In contrast, pull mechanisms, which can be categorized as either outcome-based or lego-regulatory, reward successful development of a drug by increasing or ensuring future revenue. These pull methods are beneficial because they only reward successful research, encourage efficient and rapid development, and align the priorities of the developer with those of the funder or regulator. These strategies tend to be problematic because they rely on the payer remaining dedicated to their future payment commitment despite potential changes in funding priorities. It is also a challenge to define the optimal set of drug characteristics linked to the reward so that they are not perversely specific nor too loose resulting in a mismatching of goals.

Finally, a combination of complimentary push and pull strategies can be formulated into a hybrid approach that balances the merits and drawbacks of the individual incentives. A detailed review of the individual advantages and disadvantages of each incentive is provided.

Given the large number of incentives, a framework was developed to assist with the selection of incentives to address two major concerns – market failures and public health goals. Specific objectives within these areas have been identified as:

Objectives to address market failures:
1. Improve the overall net present value for new antibiotic projects
2. Enable greater participation of small and medium sized enterprises
3. Encourage participation by large pharmaceutical companies
4. Facilitate cooperation and synergy across the antibiotic market

Objectives to address public health priorities:
1. Promoting antibiotic stewardship
2. Improving patient access to new antibiotics

To make the selection process manageable, we suggest first selecting a set of incentives that address all four market objectives with the goal of creating an attractive and supportive market for investment in antibiotic research and development. To aid in this task, the incentives are classified into six different types based on their ability to meet these objectives. These incentive types include: broad-spectrum incentives, participation-focused incentives, cooperation and synergy-focused incentives, SME-focused incentives, Big Pharma-focused incentives, and weak market incentives. The broad-spectrum incentives are able to satisfy all market criteria while in other cases a 4 combination of multiple incentives from different categories could be used. Once this market-centric package has been created, it can be supplemented and reformed to additionally tackle the two major public health objectives: stewardship and access.

There are a number of crucial implementation issues that must be considered prior to finalizing an incentive package. These issues will reflect political priorities, operational realities, and industry demands concerning:
1. The size of the incentives
2. The timing of incentive delivery
3. Governance of the incentive package
4. International coordination
5. Intellectual property laws

The ultimate array of possible incentives to use will be constrained by the outcome of this feasibility analysis. Thus, an effective incentive package will be one that repairs the market failures that have resulted in a dry development pipeline, facilitates public health priorities that reflect the growing need for a sustainable solution to antimicrobial resistance, and function within implementation constraints. Much can be done, but a significant effort will be required to address the impending crisis.

Read Full Article (37 pages; PDF)