Q: What Do CROs/CDMOs Need to Do to Ensure That They Provide Effective Global Support but with Locally Oriented Services?

Local vs. Global Manufacturing

Ramesh Subramanian, Ph.D., VP, Strategic Marketing and
Global Head, Business Development, Piramal Discovery Solutions

A: Easy accessibility to the manufacturing site, F2F discussions with the CDMO team and tax or other benefits of outsourcing locally increases the ease of doing business. Maintaining an excellent track record with global regulatory agencies is also a requisite for CDMOs to easily facilitate launch of drug products across different regions globally.Access to facilities in Asia and in the West to provide economical solutions to the client is an added advantage. Overall, service providers must have a positive impact on the flexibility and efficiency of pharmaceutical firms. Piramal has created a global network of development and manufacturing facilities located in North America, Europe and Asia that offer a multitude of services covering the entire drug life cycle, from Drug Discovery & Development to Commercial Manufacturing of Active Pharmaceutical Ingredients and Finished Dosage Forms. Our development centers and manufacturing sites have accreditations from regulatory bodies in the U.S., Europe and Japan.

Stefan Peterli, Ph.D., Vice President of Strategic Business,
Development, Minafin S.P.R.L. 

A: Business is global, technology is local. While our clients are all over the globe, our manufacturing units for intermediates and APIs in France, Belgium, Germany and the U.S. are regulated locally from the labor and SHE point of view. cGMP regulations are national (local health authorities) and global (ICH Q7). In order to properly serve international clients, we rely on experienced project managers for client interactions on a technical level. These project managers are located at the manufacturing plants to ensure tracking of project details with the local team on a daily basis and interaction with the client on at least a weekly basis. Key account managers handle commercial aspects and do not necessarily have to be located at a plant, but instead are traveling frequently to visit clients and attend trade shows.

Justin Schroeder, Executive Director of Marketing, Business
Development & Design, PCI Pharma Services 

A: PCI Pharma Services provides services for products destined for over 100 countries around the world, which includes manufacturing services, clinical trial supplies and commercial packaging services. This creates a need for robust understanding of the local regulations, import/export requirements and other cultural concerns and considerations. Likewise, supplying such a multitude of locations also brings significant regulatory requirements and auditing from individual countries’ regulatory agencies. As a full-service CMO, we have to strike the right balance in ensuring our staff and facilities are very geographically accessible to the pharmaceutical and biotech clients we serve, as well as staying oriented to the geographies and end markets for which our products are destined. Furthermore, the global pharmaceutical supply chain continues to evolve as the global economy evolves, affecting both upstream and downstream supply.  Our best strategy is to constantly take inventory of market trends and stay continually engaged with our customers to stay ahead of the curve.

William J. Monteith, Chief Operating Officer, PCT

A: For a CRO or CDMO to do this effectively they would need to look at two scenarios
and then, based on the level of funding and resources available, choose one of the two scenarios. 

Scenario One

Look to establish CDMO-owned centers in the global areas of interest. The areas to be looked at would obviously be based on the area with the best reach to their customer base. This scenario gives the CDMO the best control of their own destiny but can be costlier upfront.

Scenario Two

Develop regional centers globally through partnerships or collaborations with existing CMO entities in the region. This may provide the ability to establish presence in the global market with lower infrastructure costs, but will require clearly negotiated agreement for items such as regulatory responsibility, governing quality system, etc.

Considerations for Either Scenario
  • Specific global areas to be targeted based on customer reach and need
  • Local regulatory and government requirements
  • Site-logistic access
  • Workforce stability
  • In the case of partnerships, the partner’s financial stability, covered through due diligence
  • Cost effectiveness — in terms of investment, cost of goods, infrastructure, local incentives
Mark Quick, Executive Vice President of Corporate, Development and
Jean-Francois Hilaire, Executive Vice President, Head of Strategy &
Global Integration, Recipharm

A: Establishing a global supply solution is one of the important topics of discussion in the industry, and certainly one that our customers (and in particular the larger pharma companies) are talking about.  Pharmaceutical companies face many potential roadblocks that cannot necessarily be addressed without involving multiple capabilities, which often means accessing skills and technologies in different geographic locations. The key is for CDMOs to offer a wide breadth of capabilities, while still delivering a locally oriented service.

In Europe, markets are so fragmented that a supply chain model without at least a packaging step in Europe can prove to be very inflexible and, in most cases, unable to address needs from multiple commercial channels. Mandatory retesting of products manufactured outside of Europe, as well as serialization requirements, are adding additional layers of complexity that are not easy to handle remotely without reducing the chance of meeting customer expectations.

The U.S. market requires large-volume products that can be formulated in various geographic locations, providing that manufacturing sites have been inspected and approved by the FDA. Although a wide range of options are offered by CDMOs and much development work and commercial manufacturing is taking place in Europe, we observe that many customers are opting for U.S.-based solutions principally for clinical supply, but also for the packaging step of commercial demand.

As the Japanese and Korean markets require a particularly high level of quality that is not necessarily delivered by most manufacturing sites, many companies located in these markets are looking for at least a local packaging step to guarantee that requirements are met.

In terms of emerging markets, several countries now require that a good manufacturing practice (GMP) certificate is granted to pharmaceutical manufacturers by their own administrations before a marketing authorization request can be submitted for a new product. Such GMP certificates may take multiple years to obtain.

Likewise, other countries are restricting import licenses for products that can technically be manufactured locally. In some other markets, only locally made products have access to government tenders or can benefit from higher subsidized prices.

Finally, some countries are suffering from unstable currency or high import taxes that make localization a valuable option. As many markets are too small to support an investment in production by a single pharmaceutical company, CDMOs that can pool together a number of customer requirements into a single facility are a more viable option.

In order to help our customers achieve high-quality products in a cost-effective way, Recipharm is focused on offering solutions to address all of these constraints and has a global, experienced team that is committed to delivering locally oriented services. By combining a wide range of capabilities with scale and a global presence, we can minimize the risks associated with working with multiple partners in multiple locations.

Song Li, CEO, Frontage Labs

A: Over the last 10 years, globalizing clinical trials into emerging markets has seen a steady incline. Despite an increase in the number of trials in areas like Asia Pacific, Eastern Europe and Latin America, conducting these studies outside of a more established market can prove challenging.

China has become the second-largest pharmaceutical market in the world, home to 17% of the world’s population. It is an ideal region for study recruitment and accelerated trial start-up times. Top pharmaceutical companies are taking advantage of this by placing project management teams in China to oversee trials being conducted there. It is important that sponsors look for CRO partners that have global capability support while also demonstrating a strong localized presence in the targeted areas.

With multiple sites in the U.S. and China, Frontage has delivered optimal value to our clients by addressing the diverse challenges inherent in these studies. We are well-known in China as a bridge to assist our partners forwarding their products to the international and China markets. We possess dedicated resources in DMPK, CMC, bioanalytical and early-stage clinical services on both continents. We have adapted our processes to adhere to local regulatory and oversight requirements.

 

Ramesh Subramanian, Ph.D.

With over 19 years of industry experience, Dr. Ramesh Subramanian currently serves as the Vice President of Strategic Marketing at Piramal Pharma Solutions, and also has commercial responsibility for the discovery services business. Most recently Dr. Subramanian was a General Partner at XL Advisors, a life sciences consultancy firm. Engagements included advisory roles at SK Capital Partners, a private equity firm with $1.9B of assets under management, and its portfolio firms, and Jubilant, a $1B, contract services firm. Prior to XL Advisors, Dr. Subramanian was the Global Head of Business Development at Chemizon. As part of the management team at Chemizon, Dr. Subramanian helped raised capital, and played a key role in developing the firm’s strategy, positioning, and revenue streams, from its start up to acquisition, to become a publicly traded firm at the KOSDAQ. Earlier, Dr. Subramanian was responsible for the Commercial business for North America at Johnson Matthey, with a focus on catalyst sales towards the pharmaceutical market. Dr. Subramanian has a doctorate in Chemical Engineering from West Virginia University, and a MBA in Finance from The Wharton School, University of Pennsylvania.