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 evolvingover 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.