‘An Incredible Signal’: 4 Experts Weigh In On Positive FDA Panel Vote For GW Pharma (NASDAQ:GWPH)’s Epidiolex

Shares of GW Pharmaceuticals PLC- ADR (NASDAQ: GWPH) were halted Thursday, ahead of a Food and Drug Administration vote on the company’s cannabis-derived drug Epidiolex. Trading resumed after the FDA advisory panel voted unanimously in favor of approving the medicine for the treatment of two rare childhood-onset forms of epilepsy that are commonly treatment-resistant.

The vote is non-binding and a final decision is expected by June 27, but it is customary for the FDA to act on its advisors’ recommendations.

While the cannabis plant is used to produce Epidiolex, the medicine is derived from CBD, a non-psychoactive component found in marijuana that is legal in all 50 states and contains less than 0.1-percent THC — the psychoactive component in weed that makes users feel “high.”

GW Pharmaceuticals offered “substantial evidence” to back Epidiolex’s effectiveness, according to the FDA panel’s report. While the drug carries a risk of liver injury, the side effects can be managed fairly well, the report said. 

Related Link: Exclusive: MassRoots Files SEC Paperwork For Cannabis Industry-Focused Cryptocurrency

Shares of GW Pharmaceuticals did not surge much on the news, as the market had already anticipated a decision and traded on speculation, with the stock gaining more than 5.6 percent since Monday.

Experts: Panel Vote A Milestone Moment 

The committee’s recommendation of approval for Epidiolex for epilepsy treatment on Thursday is “another step closer to full FDA approval,” Debra Borchardt, CEO at cannabis-focused financial media outlet Green Market Report, told Benzinga.

“Once that happens, it makes it harder for Congress to continue to list cannabis as a Schedule I controlled substance. If the FDA makes it clear that a cannabis-based pharmaceutical drug has medicinal value, then Congress can no longer claim there is no medicinal quality for cannabis.”

The favorable comments serve as “fundamental evidence” of the cannabis plant’s medical efficacy — as well as the investment opportunity surrounding the research and development of similar pharmaceutical products, said Harrison Phillips, vice president at Viridian Capital Advisors. 

Vridian expects to see additional cannabis-cased drug candidates introduced by companies for a variety of indications, Phillips said. 

“Furthermore, the acknowledgement by the FDA of cannabis’ potential medical efficacy is likely to rekindle debates as to the proper classification of cannabis, and particularly cannabidiol (CBD), the main active ingredient in GW’s product, under the Controlled Substances Act.”

Aras Azadian, CEO at AviCanna, the first cannabinoid therapeutics company to be admitted into Johnson & Johnson (NYSE: JNJ) Innovation’s JLABS @ Toronto, also seemed to agree with fellow cannabis experts. 

“It’s an incredible signal and further validation of the future potential of cannabinoid based therapeutics,” Azadian said of the FDA panel vote.

“Having unanimous support [from] the FDA advisory board of evidence-based cannabidiol drugs further motivates and validates the models of companies such as AviCanna and its partners to pursue clinical development of [their] intellectual property,” Azadian said. 

Finally, Benzinga reached out to Matt Karnes, founder and managing partner at GreenWave Advisors.

“While the consensus view is that FDA approval will occur, the impact such a decision will have on current DEA scheduling remains in question,” Karnes said. “Regardless, an FDA approval coupled with other positive news flow — including word from the Trump administration that it will not interefere with state-regulated marijuana markets — reduces an element of risk associated with cannabis investing,” he said.

Picture by Javier Hasse.

Related Link: Why GW Pharma’s Epidiolex Results Could Shape The Future Of Cannabis-Based Therapeutics

© 2018 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

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FDA Publishes Q&A on GMPs for APIs

On April 19, 2018, FDA published a guidance document that answers questions about the implementation of the International Council for Harmonization (ICH) Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. ICH Q7 helps pharmaceutical companies ensure that APIs meet quality and purity characteristics. This Q&A document is in response to industry requests for clarification of some ICH Q7 sections.

Topics addressed in the Q&A document include quality management, personnel training, facilities, process equipment, documentation, materials management, production, storage, and validation. Specifically, the document clarifies requirements for releasing raw materials, sampling, product quality review, risk management, acceptance criteria, evaluation of material suppliers, and more.

Source: FDA

 

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Consultation, validation, training, and support

As the pioneers of the Limulus amebocyte lysate (LAL) testing methodology, Associates of Cape Cod, Inc., (ACC), specialises in bacterial endotoxin and
(1→3)-ß-D-glucan detection, using Food and Drug Association-licensed chromogenic, turbidimetric and gel-clot reagent technologies.

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Global Healthcare Analytical Testing Services Market 2018-2023 by Method Validation, Environmental Monitoring, Bioanalytical Services, Stability, Raw Materials, & Microbial Testing

DUBLIN, April 17, 2018 /PRNewswire/ —

The “Healthcare Analytical Testing Services Market by Type (Method Validation, Environmental Monitoring, Bioanalytical Services, Stability, Raw Materials, & Microbial Testing), End User (Pharmaceutical, Medical Device Companies) – Global Forecast to 2023” report has been added to ResearchAndMarkets.com’s offering.

The global healthcare analytical testing services market is projected to reach USD 5.97 Billion by 2023 from USD 3.43 Billion in 2018, at a CAGR of 11.7%.

The shift of focus towards analytical testing of biologics and biosimilars, increasing outsourcing of analytical testing by pharmaceutical companies, increasing acceptance of the QbD approach in pharma research/manufacturing, and adoption of FTE contracts in R&D outsourcing are the major factors driving the growth of the healthcare analytical testing services market.

The report analyzes the global healthcare analytical testing services market by type, end user, and region. On the basis of type, the bioanalytical testing segment accounted for the largest share of the global healthcare analytical testing servicess market in 2017. The large share of this segment is due to increasing number of drugs in the biopharmaceutical pipeline and the growing biopharmaceutical industry.

The global healthcare analytical testing services market by end user is segmented into pharmaceutical and biopharmaceutical companies, medical device companies and contract research organizations. In 2017, the pharmaceutical and biopharmaceutical companies segment accounted for the largest share of the market. The large share of this segment can be attributed to the increasing outsourcing of analytical testing services by pharmaceutical and biopharmaceutical companies to boost profit margins, avoid high capital expenditure, and reduce the time required to validate the process and product.

The rising demand for specialized analytical testing services and growth opportunities in emerging APAC countries are expected to provide further growth opportunities for players operating in the healthcare analytical testing services market. However, pricing pressure faced by market players and shortage of skilled professionals in the healthcare analytical testing services industry are some of the factors limiting the growth of this market during the forecast period.

Eurofins Scientific (Luxembourg) held the leading position in the global healthcare analytical testing services market in 2017. Over the past three years, the company has established itself as one of the leading players in the healthcare analytical testing services market.

Key Topics Covered:

1 Introduction

2 Research Methodology

3 Executive Summary

4 Premium Insights
4.1 Healthcare Analytical Testing Services Market Overview
4.2 APAC: Healthcare Analytical Testing Services Market, By End User & Country
4.3 Healthcare Analytical Testing Services Market: Geographical Snapshot
4.4 Healthcare Analytical Testing Services Market: Geographical Mix

5 Market Overview
5.1 Introduction
5.2 Market Dynamics
5.2.1 Drivers
5.2.1.1 Focus on Analytical Testing of Biologics and Biosimilars
5.2.1.2 Increasing Preference for Outsourcing Analytical Testing
5.2.1.3 Rising Adoption of the Quality By Design Approach
5.2.1.4 Adoption of Fte Contracts in R&D Outsourcing
5.2.2 Restraints
5.2.2.1 Pricing Pressure Faced By Major Players
5.2.2.2 Shortage of Skilled Professionals
5.2.3 Opportunities
5.2.3.1 Rising Demand for Specialized Analytical Testing Services
5.2.3.2 Growth Opportunities in Emerging Asia Pacific Countries
5.2.4 Challenges
5.2.4.1 Innovative Formulations and Medical Devices Demanding A Unique Analytical Testing Approach
5.2.4.2 Development of Appropriate Dissolution Methods
5.2.4.3 Growing Need to Improve the Sensitivity of Analytical Methods

6 Industry Insights
6.1 Industry Trends
6.1.1 Growing Industry Consolidation
6.1.2 Long-Term Outsourcing and Preferred Vendor Partnerships
6.2 Regulatory Analysis

7 Healthcare Analytical Testing Services Market, By Type
7.1 Introduction
7.2 Bioanalytical Testing
7.2.1 Cell-Based Assays
7.2.2 Virology Testing
7.2.2.1 In Vitro Assays
7.2.2.2 In Vivo Assays
7.2.2.3 Species-Specific Viral Pcr Assays
7.2.3 Immunogenicity & Neutralizing Antibody Testing
7.2.4 Biomarker Testing
7.2.5 Pharmacokinetic Testing
7.3 Physical Characterization
7.3.1 Laser Particle Size Analysis
7.3.2 Thermal Analysis
7.3.3 Image Analysis
7.3.4 Surface Area Analysis
7.3.5 Other Physical Characterization Analysis Services
7.4 Method Development & Validation
7.4.1 Extractables & Leachables Method Development & Validation
7.4.2 Process Impurity Method Development & Validation
7.4.3 Stability Indicating Method Validation
7.4.4 Cleaning Validation Method Development
7.4.5 Analytical Standard Characterization
7.4.6 Technical Consulting
7.4.7 Other Method Validation Services
7.5 Raw Material Testing
7.5.1 Complete Compendial Testing
7.5.2 Heavy Metal Testing
7.5.3 Container Testing
7.5.4 Karl Fischer Analysis
7.5.5 Wet Chemistry Analysis
7.5.6 Other Raw Material Testing Services
7.6 Batch-Release Testing
7.6.1 Dissolution Testing
7.6.2 Elemental Impurity Testing
7.6.3 Disintegration Testing
7.6.4 Hardness Testing
7.6.5 Friability Testing
7.6.6 Other Batch-Release Testing Services
7.7 Stability Testing
7.7.1 Drug Substance Stability Testing
7.7.2 Formulation Evaluation Stability Testing
7.7.3 Accelerated Stability Testing
7.7.4 Photostability Testing
7.7.5 Comparative Stability Testing
7.7.6 Other Stability Testing Services
7.8 Microbial Testing
7.8.1 Microbial Limit Testing
7.8.2 Sterility Testing
7.8.3 Endotoxin Testing
7.8.4 Preservative Efficacy Testing
7.8.5 Water Testing
7.8.6 Other Microbial Testing Services
7.9 Environmental Monitoring
7.9.1 Air Testing
7.9.2 Wastewater/ETP Testing
7.9.3 Other Environmental Monitoring Services

8 Healthcare Analytical Testing Services Market, By End User
8.1 Introduction
8.2 Pharmaceutical & Biopharmaceutical Companies
8.3 Medical Device Companies
8.4 Contract Research Organizations

9 Healthcare Analytical Testing Services Market, By Region

10 Competitive Landscape
10.1 Overview
10.2 Market Share Analysis
10.3 Competitive Scenario
10.3.1 Acquisitions
10.3.2 Expansions
10.3.3 Partnerships, Agreements, and Collaborations
10.3.4 Services Launches

11 Company Profiles
11.1 Eurofins Scientific
11.2 Labcorp
11.3 SGS
11.4 Charles River
11.5 Wuxi Pharmatech
11.6 Pharmaceutical Product Development, LLC (PPD)
11.7 Exova
11.8 Pace Analytical
11.9 Envigo
11.10 Intertek
11.11 MPI Research
11.12 Merck KGaA
11.13 Source Bioscience

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Research and Markets
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Solving the Problem or Merely Addressing the Issue?

 

Photo Credit: CoreDESIGN/Shuttestock.comIncognito focuses on a big challenge in regulated analytical chemistry laboratories.

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To put the title another way—why suture the wound when you can stop the bleeding with a tourniquet?

Well that works fine until the tourniquet is removed!

I have so many conversations about separation issues that end up with the other person glazing over when I start to explore the actual cause of the problem, which is typically something to do with chemistry.

Frankly, so many of us are just interested in finding a fix for the problem we have right now, to get the results out of the door, and who cares if the method is flawed; I just need the results for this batch (and who cares about the poor sap who has to run this method the next time—because I’m going to avoid it like the plague).

With problematic chromatographic methods such as these, just releasing the batches where the quality controls (QCs) manage to squeeze through the acceptance criteria and repeating system suitability tests until they fall within the specification is not the answer. I’m aware that companies are tightening up on repeated system suitability testing and initiating investigations where out of specification (OOS) results are caused by poor repeatability (agreement) of QC samples, but show me a laboratory where methods don’t have to be “tuned” or “equilibrated” or “system flushes” inserted to get them to work, and I’ll show you a rare laboratory indeed. Further, “investigations”, “root cause analysis”, and “CAPA (corrective and preventative action)” analysis are fine—if you actually know something of the root causes, the fundamentals, and the first principles on which the techniques operate.

So many laboratory staff are chromatography users rather than chromatographers these days (1) and I wonder how many are able to identify the root cause of the problem in the chemistry of the separation, the susceptibility of the column chemistry, the poor design of the eluent system, the bad injection solvent, and the nonrobust nature of the eluent pH selected? How many of your recent investigations actually identified the root cause and implemented a truly preventative measure? I would suggest that where problems with the separation are concerned, if no chemistry is involved in the investigation, then the root cause probably hasn’t been addressed.

When I ask the glazed correspondent what the chemistry of the analyte is, the majority state that they have no idea. Therefore, they probably have little chance of really solving many of the issues we are having. How dispiriting! Perhaps ignorance leaves them blind to the futility of this situation.

The look of disappointment when I can’t suggest a “quick fix” involving a slight tweak to the operating conditions, a clever way to equilibrate or flush the column, or an “allowable adjustment” to help system suitability criteria to be met frightens me. Some analytical methods are old, some are poorly designed, and some should never have been properly validated. These methods need to be redesigned in order for them to work to the requirements of a modern regulated laboratory environment (and I’m not just talking about pharmaceutical laboratories by the way). I can’t give you a tourniquet and frankly you don’t know how to suture, and even if you did it appears they are too expensive.

So, your method is validated and registered, but this really doesn’t mean it’s any good. I can cite you many methods (particularly legacy methods using old column technology, ion pairing reagents, sacrificial bases) that made it to manufacturing process control or QC and are absolutely horrible. There are also methods using older technology (columns as well as instrumentation) that would be much more “fit for purpose” if they were updated to use new column technology, new instrumentation, and new detector technology with advanced settings.

I’ve heard a thousand times about the “totally prohibitive costs” to redevelop, revalidate, and reregister methods, which is a massive barrier to making a bad method better. Why are we in this position? Why should we live with poor methods because it costs so much to change them in highly regulated environments? Surely, we have just priced ourselves out of quality improvement? We need to address this issue, and it needn’t herald the loss of control and method “fiddling” that so concerns quality assurance (QA) departments and regulators—we need to start this debate and we need to start it now.

I also hear often that “Bob” (the chromatography expert who used to work in the laboratory but left, or got laid off, or transferred) did some work on this method “back in the day”, but no one can remember what it was that he did, or can remember what the problem was, but the issue seems to have appeared again. So, Bob is gone, you don’t know what he did to solve the problem, and the laboratory manager is pushing for results, and even they are of an age now that they may not have the depth of knowledge or experience in chromatographic science that would allow them to help. Your investigational analysis team has been outsourced to China or India and you need to get some release testing (raw material analysis, cleaning validation, stability analysis) done and there is literally no one that can help. I can see you reaching for the tourniquet as we speak. It’s not your fault. It’s a product of the situation in which we find ourselves: of increasing instrument complexity and inaccessibility, increasing regulatory burden, decreasing focus on analytical science in higher education, and an industry attitude that chromatography is a support service where button pushers produce data that allows us to release product. What a sorry state.

In summary, the issues with solving an ongoing analytical problem in a regulated laboratory environment include:

• A huge amount of pressure to get the results out of the door;
• A poor understanding of analyte and separation chemistry and the fundamental principles of chromatography, which is hampering any root cause analysis using first principles;
• A prohibitively large cost barrier to redeveloping and reregistering methods and therefore little chance of properly addressing issues in the short term
• The chromatography expert left and the investigational analysis team has been offshored because chromatography is now an ancillary service, which is almost fully industrialized, and therefore expensive experts are not required locally to support this function.

We are running out of tourniquets, no one knows how to suture, and to be honest, even the sticking plasters are a little thin on the ground.

What are we going to do about it?

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References

1. Incognito, The Column 12(21), 11–13 (2018).

Contact author: Incognito
E-mail: [email protected]

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