Month: November 2021

Listening to Clients and Expanding Across the Clinical Supply Chain

As drugs become more complex and are developed for a wider range of indications, including for specialty and rare diseases for which no approved treatment options exist, the volume of clinical trials has increased. The clinical trials industry is on track to grow at a CAGR of 5.7% through 2028.1 This increase in demand has put pressure on contract research organizations (CROs) and sponsor companies who might find that the resources needed to successfully launch and execute a trial are lacking.

The increasingly global reach of clinical trials adds to this complexity, and the need to find the right partner to navigate local regulations and interface with governments is heightened. The urgency regarding clinical trials has also increased throughout the industry owing to the high stakes involved in bringing a drug to market, as well as logistic challenges, unfamiliarity with foreign markets, and myriad other potential roadblocks on the way to moving a product to commercial launch. When it comes to clinical trials, time is correlated with spend. The median cost of a clinical trial is $20 million, though this can be much higher, depending on the complexity of a molecule or the number of sites and participants involved.2

A Full-Service Clinical Trials Partner

CROS are central to enabling clinical trials, and these players must innovate to keep pace with demand and evolving client needs. As a single-source solution provider for comparator and reference drug sourcing, clinical trial materials, ancillary supplies, clinical packaging and labeling, storage and distribution of investigational medicinal products, placebos, pharmaceuticals, and more, Globyz Biopharma Services is well positioned to leverage our integrated offering to introduce Globyz Clinical Solutions, a new vertical for CRO solutions in support of clinical trials. After referring clients to other vendors in the past, we made the decision to expand and fulfill their requests by offering a broader range of services under one roof. This expansion has been made possible through our strategic partnerships with local vendors. Our clients benefit from the company’s existing industry relationships and, by only interfacing with us, are spared the aggravation of extending timelines, increasing costs, and dealing with other parties, which is common when sourcing trial supplies from multiple vendors.

As products move between vendors — especially internationally — risk increases. Relying on more than one third-party vendor is correlated with greater expenditures and increased timelines, which adds up over the course of a clinical trial. To avoid bearing the brunt of that cost, not to mention delaying time to market, we give sponsors full access to a range of services. When we deliver products, we deliver directly to the sites and interact with the investigators. Providing supportive CRO capabilities is a natural extension of our business, and we are equipped to succeed in this space because we will continue dealing with the same stakeholders.

Taking Advantage of Flexibility

As a nimble, mid-sized organization, we can accommodate a diverse range of client requests and deliver faster than larger, rigid CROs. We are also able to offer clients a reduced cost compared with larger CROs, since our overhead is low. Globyz Clinical Solutions is equipped to handle a variety of requests without consuming all resources. By aligning with small biotech and pharma companies, we have maintained our flexibility.

This flexibility is so central to our organization that we currently offer our clients customized packages, so they have the liberty to pick and choose the exact services needed. For instance, some clients rely on us exclusively as a depot service or for comparator sourcing, while others take advantage of our capacity across the entire CTS space, including sourcing comparator drugs, packaging, labeling, storage, and distribution, as well as identifying sites and assuming clinical trial operations and data management.

Having a physical presence in Canada, the United States, Europe, India, and Southeast Asia helped spur our transition into an end-to-end clinical trials partner, as we realized how attractive and beneficial our global reach and existing infrastructure have been for our existing customer base. Much of our expansion came about by connecting the dots of our different internal capabilities, including project management, data management, biostatistics, and regulatory support.

Meeting Customer Demand

Expanding and diversifying based on customer demand has been a reoccurring scenario for Globyz throughout our life span. When our clients begin inquiring about additional services, our immediate reaction is to find a way to adapt and extend those offerings directly to them. Once those capabilities are developed in-house, we start alerting other customers. We attribute our focus on accommodating clients with our ongoing growth — we’ve grown organically as well as operationally to meet their needs.

By enhancing our service offering, we have moved up the value chain and are generating business. We’re also evolved from the supply chain side of the industry to the “knowledge-based” side, adding value to customers as we grow. While we can’t predict what’s coming next in the clinical trials space, we’re remaining on top of the increased digitalization activity underway across the industry, including with artificial intelligence, the Internet of Things, and electronic patient monitoring. As opportunities and challenges alike arise, we prioritize technology, learning as we go, and building the capabilities required to stay competitive.

The Globyz Competitive Advantage

A competitive mindset is integrated into our organizational structure. One of our primary differentiators is how diffuse we are, as opposed to competitors that are markedly siloed. These organizations specialize in comparator sourcing only –– and there are only a handful of companies that can provide both comparator sourcing and clinical trial supply management. Even if they have this dual capacity, there are many other key CRO services they are unable to provide. While a company may have clinical trials supply management capacity and packaging and labeling, they’ll hire a courier company for transportation, meaning that they ultimately outsource key activities. At Globyz, customers can feel confident that all the diverse elements of their clinical trial are being handled by the same professionals who understand the broader needs beyond any one service.

By building strengths in packaging, labeling, distribution, transportation, project management, site management, identification of the site for feasibility, and everything else that goes into a clinical trial, Globyz has established a very unique position. Our relationships with sponsors, customers, and stakeholders and our history of dealing with this type of activity throughout our comparator sourcing foundation have given us the confidence needed to expand. Globyz’s ultimate goal is to provide a seamless experience for our clients so they can benefit from the outputs associated with relying on one partner rather than wrangling different solutions from multiple vendors.

Evolution from Basic Distribution to a Comprehensive Biopharma Services Company

Pharma’s Almanac Scientific Editor in Chief David Alvaro met with Salman Pathan, CEO of Globyz Biopharma Services, to discuss the company’s evolution from a distributor to a comprehensive biopharma services company offering comparator sourcing, packaging, labeling, storage, distribution, transportation, resource management, and clinical trial services management support and where the future will take Globyz.

David Alvaro (DA): Can you tell me a little bit about the history of Globyz, the genesis of the company, and how your business has evolved?

Salman Pathan (SP): I’ve been in the pharmaceutical industry for more than 25 years working in various countries and in various capacities in manufacturing and distribution setup. I ultimately founded Globyz Pharma in 2007 for the importation and distribution of APIs and food ingredients into North America.

In 2011, we expanded into comparator sourcing and have been growing that business globally. We then added primary and secondary packaging, placebo manufacturing, labeling, kitting, storage, distribution, transportation, QP Release, Importer or the Record services, and resource management in response to requests from our customers for this type of support.

More recently, customers have been asking us for assistance with additional clinical trial services, such as blinding, randomization, interactive web response systems, data management, clinical operations and site management, and medical writing, and we are responding by adding those capabilities in-house or partnering with other vendors who specialize in these activities. With this transition, we changed our name to Globyz Biopharma Services to better reflect all of the activities we are involved in.

By supporting our customers with such a range of integrated services, we are helping them eliminate the need to qualify and manage multiple vendors and thus significantly reduce risk, time, and cost required for their crucial clinical trials.

DA: What can you tell me about the market for comparator sourcing and the challenges in procuring comparator drugs for clinical trials?

SP: When developing new medicines, drug companies always encounter challenges in procuring currently marketed products for research purposes, because most innovator companies don’t want any competition. Hurdles are put in place in an attempt to prevent research companies from accessing commercial products.

Dealing with these challenges is a distraction for drug developers, who want to focus on advancing their candidates. As a result, most outsource this activity to a company like Globyz Biopharma Services, because we understand the challenges of sourcing comparator drugs — they can be hard to find, they are often needed in large quantities, and, in some cases, they must be sourced from a single manufacturing batch.

Comparator sourcing is wholly a relationship-based activity, and Globyz has an extensive network and established relationships with innovator companies that allow us to make it easier for sponsor companies to obtain these products in a timely manner.

DA: How has Globyz weathered COVID-19? What changes did you observe for your customers and your own business, and did any new opportunities arise during the pandemic?

SP: The pandemic definitely impacted clinical trials, because hospitals are working at minimum capacity, and patients are not coming into investigator sites, because it’s a safety issue. Of course, many COVID-19–related trials are running, so that’s a good thing. Product development work is continuing as well — the contract development and manufacturing organizations (CDMOs) are very busy.

At Globyz, we continue to provide comparator sourcing, packaging, labelling, storage, distribution, transportation, importation, and depot services to provide end-to-end services, which is keeping us busy. At the same time, we have been navigating through the impacts of the pandemic on the work environment and the need to work in different ways.

Overall, I think COVID-19 will have long-lasting implications for the industry. One of them will be increased direct-to-home or direct-to-patient services within decentralized or virtual clinical trials. The use of the Internet and Internet-of-Things (IOT)-enabled devices for patient treatment and monitoring will thus also continue to grow.

Before the pandemic, we were not particularly focused on direct-to-patient trials, but it is clearly the need of the hour. With decentralized trials, patients can participate from the comfort of their homes, which increases the patient pool and recruitment and decreases sponsor site costs. Distribution becomes more important, of course, with drug products and samples going to many different patients in different regions, which is where Globyz comes in.

DA: For cell and gene therapies and other emerging modalities with cold-chain requirements, does the necessary infrastructure yet exist that will be needed to enable the explosion of new trials that are coming?

Salman Pathan: Presently, there isn’t enough capacity for the traditional cold chain, and, moreover, emerging cell and gene therapies demand additional capacities. A lot of investment is needed, because biopharma is becoming an increasingly temperature-sensitive industry. With cell and gene therapies, the issue isn’t just transport, but also the need for cryogenic storage capabilities.

Globyz is responding with ongoing investments to meet customer needs and expectations. We have been adding new depots and partnering with others to ensure that we can meet customer demand on a global basis.

DA: What can you tell me about Globyz’ global presence ?

SP: Our head office is in Philadelphia, and we also have facilities in Toronto (Canada), Dublin (Ireland), and Mumbai (India) and a strong partner depot network globally. All our facilities are GMP compliant and we are currently planning to set up a warehouse/depot in Singapore. Hence, Globyz provides end-to-end clinical supply services.

DA: What types of companies does Globyz typically work with?

SP: We work with mid-size to small pharma and biotech companies in all therapeutics spaces but mainly in the rare disease, oncology, and neurology spaces that lack resources and need the services and support we offer. In some cases, companies that have not been getting the service they deserve from big service providers come to Globyz for more customized support and find that we can provide really rapid turnaround times as well. For that reason, we also get many new clients through referrals by existing clients who understand our capabilities.

What we hear from our customers is that some of the other, bigger vendors they have worked with have processes and standard operating procedures that are too rigid for many small pharma and biotech companies. Globyz is an agile partner that is willing to customize solutions to meet the specific needs of each client.

DA: How do you see Globyz evolving over the next decade or so?

SP: There are three areas in which we plan to grow Globyz. One is distribution of cell and gene therapy products, which require cryogenic storage and shipping and the associated specialized equipment and expertise. We are developing those capabilities. We are also adding clinical trial management and CRO services, including data management, regulatory support, medical writing, clinical operations, and so on.

The third area is expanded-access programs for rare disease drugs that are not available to patients in countries where these products are not yet approved or registered. Because they are treatments for rare diseases, the patient populations are very small, and drug manufacturers don’t always file for approval in every country. Instead, they come to a company like Globyz that has global presence to manage the supply of these products.

Salman Pathan
President and CEO
Globyz Biopharma Services

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