Article
Interview: Evolving and expanding global consulting with local expertise
In these interviews, Tania Attanasio, Vice President of Marketing Strategy at Cencora, talks with industry experts Kirsten Jacobs, Chief Service Strategy Officer and Executive Vice President of Regulatory Affairs at PharmaLex, part of Cencora, and Herbert Altmann, Vice President of Market Access and Healthcare Consulting Europe at Cencora, about the complexities of global market expansion. They discuss the critical importance of integrating global insights with local expertise to successfully bring products to market.
Development journey
Tania Attanasio:
Welcome, Kirsten and Herbert. Thank you for being here today.
Nowadays, many companies seek global presence and are not limiting themselves to U.S. and European markets, which brings a lot of complications from both an infrastructure and regulatory perspective. So, Kirsten, what are some of the considerations, and how does local expertise play a role in that global product development journey?
Welcome, Kirsten and Herbert. Thank you for being here today.
Nowadays, many companies seek global presence and are not limiting themselves to U.S. and European markets, which brings a lot of complications from both an infrastructure and regulatory perspective. So, Kirsten, what are some of the considerations, and how does local expertise play a role in that global product development journey?
Kirsten Jacobs:
Having a presence in local markets is imperative for companies. They need to establish infrastructure and local presence to effectively communicate and incorporate regulatory requirements into global product development. It is crucial to ensure that all local regulatory intelligence is communicated to headquarters, as it is essential for having a centralized function that manages this information. Global product development and the maintenance of a product in the market must adhere to the requirements set by local and regional authorities.
To enter a market, you must ensure that your global product development and maintenance consider local requirements, including material development for all markets, clinical strategy, clinical data, and product data that needs to be generated in all markets. Additionally, having Good Practices (GXP) processes in place is necessary to comply with all local and regional regulations.
So essentially if you want to enter a market, you need to ensure that your global product development and maintenance consider the local requirements.
Having a presence in local markets is imperative for companies. They need to establish infrastructure and local presence to effectively communicate and incorporate regulatory requirements into global product development. It is crucial to ensure that all local regulatory intelligence is communicated to headquarters, as it is essential for having a centralized function that manages this information. Global product development and the maintenance of a product in the market must adhere to the requirements set by local and regional authorities.
To enter a market, you must ensure that your global product development and maintenance consider local requirements, including material development for all markets, clinical strategy, clinical data, and product data that needs to be generated in all markets. Additionally, having Good Practices (GXP) processes in place is necessary to comply with all local and regional regulations.
So essentially if you want to enter a market, you need to ensure that your global product development and maintenance consider the local requirements.
Regulatory landscape
Tania:
Herbert, what are some of the considerations when it comes to the regulatory landscape when bringing products to the global markets?
Herbert Altmann:
When discussing global markets, especially Europe, we need to consider the European Union's 27 member states, as well as Switzerland and the United Kingdom. All of these governments must manage patient needs while addressing affordability challenges within the healthcare infrastructure.
Herbert Altmann:
When discussing global markets, especially Europe, we need to consider the European Union's 27 member states, as well as Switzerland and the United Kingdom. All of these governments must manage patient needs while addressing affordability challenges within the healthcare infrastructure.
Focusing on the European Union, the European Commission decided in 2022 to implement a new Health Technology Assessment (HTA) regulation with three main objectives: first, to reduce bureaucracy and make the system more efficient; second, to speed up the entire process and third, to support equality, allowing more patients to access innovative medicines more quickly.
What this means for manufacturers is that they must now prepare their regulatory filings with the European Medicines Agency (EMA), including the Joint Clinical Assessment (JCA) dossier and the HTA dossier, which will be submitted centrally. The JCA report will be available thirty days after the EMA process. In the second phase, manufacturers will take this report and submit it to individual member states to receive a value assessment. For example, in Germany, this would involve the Federal Joint Committee (GBA) for an additional benefit assessment, and in France, the Health Authority (HAS) and SMR assessment. These are crucial steps as they lead into the pricing and reimbursement process, ensuring that the product is listed, priced, and made available to patients.
This regulatory landscape influences Research and Development (R&D) departments. It presents an opportunity, even though it may seem like an additional step in the process. As Europe speaks with one voice, this could encourage R&D departments to invest in producing a more robust evidence package to meet EU requirements. At Cencora, we partner with many pharmaceutical and biotech companies and have a fast and accelerated learning experience, which can help launch products not only in major EU countries but also in smaller and mid-sized countries.
What this means for manufacturers is that they must now prepare their regulatory filings with the European Medicines Agency (EMA), including the Joint Clinical Assessment (JCA) dossier and the HTA dossier, which will be submitted centrally. The JCA report will be available thirty days after the EMA process. In the second phase, manufacturers will take this report and submit it to individual member states to receive a value assessment. For example, in Germany, this would involve the Federal Joint Committee (GBA) for an additional benefit assessment, and in France, the Health Authority (HAS) and SMR assessment. These are crucial steps as they lead into the pricing and reimbursement process, ensuring that the product is listed, priced, and made available to patients.
This regulatory landscape influences Research and Development (R&D) departments. It presents an opportunity, even though it may seem like an additional step in the process. As Europe speaks with one voice, this could encourage R&D departments to invest in producing a more robust evidence package to meet EU requirements. At Cencora, we partner with many pharmaceutical and biotech companies and have a fast and accelerated learning experience, which can help launch products not only in major EU countries but also in smaller and mid-sized countries.
Product lifecycle
Tania:
If we think about the product lifecycle and the investments that are required to go from early product development to product maturity, Kirsten, what are some of the important investments to consider?
Kristen:
When examining a product lifecycle, people often focus on the first six to ten years, which typically involves product development. There are numerous investments necessary during this time.
If we think about the product lifecycle and the investments that are required to go from early product development to product maturity, Kirsten, what are some of the important investments to consider?
Kristen:
When examining a product lifecycle, people often focus on the first six to ten years, which typically involves product development. There are numerous investments necessary during this time.
First, you must develop a regulatory and clinical development strategy. It is important to determine which markets you want to invest in and present your product, as you need to consider the regulatory requirements for clinical development in those markets. Companies typically focus on U.S., European, Japanese, Canadian, Australian, and even Chinese markets. Most of these markets require new clinical development.
Additionally, during those 6 to 10 years of drug development, you must monitor regulatory developments to see what changes are applied to regulations. For example, there is a new EU regulation under discussion that will significantly impact how data is generated for clinical trials and the expected outcomes. This process continues after reaching the market; once your products are launched, there is an entire lifecycle to consider. Global drugs can have a lifespan of 60 to 70 years.
Throughout this time, numerous regulations will change. In the United States and Europe, as well as in other major markets, regulations are currently evolving to require even greater compliance. Supply chain issues will also be counterbalanced by additional regulations. As a headquartered company, you must be aware of these changes to adapt your processes and maintain product availability in the market.
Of particular importance are changes to GXP requirements, which impact both early development and later product maintenance. Therefore, it is essential to keep an eye on all regulations, adapt to the data requirements, and generate the necessary data. You will receive many reports on data related to clinical safety and pharmacovigilance once the product is on the market. All of this necessitates clear processes to acquire, examine, and interpret the data, allowing you to effectively serve the global market and maintain product availability.
Tania:
Thank you both for sharing your insights and perspective with our audience.
Additionally, during those 6 to 10 years of drug development, you must monitor regulatory developments to see what changes are applied to regulations. For example, there is a new EU regulation under discussion that will significantly impact how data is generated for clinical trials and the expected outcomes. This process continues after reaching the market; once your products are launched, there is an entire lifecycle to consider. Global drugs can have a lifespan of 60 to 70 years.
Throughout this time, numerous regulations will change. In the United States and Europe, as well as in other major markets, regulations are currently evolving to require even greater compliance. Supply chain issues will also be counterbalanced by additional regulations. As a headquartered company, you must be aware of these changes to adapt your processes and maintain product availability in the market.
Of particular importance are changes to GXP requirements, which impact both early development and later product maintenance. Therefore, it is essential to keep an eye on all regulations, adapt to the data requirements, and generate the necessary data. You will receive many reports on data related to clinical safety and pharmacovigilance once the product is on the market. All of this necessitates clear processes to acquire, examine, and interpret the data, allowing you to effectively serve the global market and maintain product availability.
Tania:
Thank you both for sharing your insights and perspective with our audience.
Our experts:
Tania Attanasio
Vice President of Marketing Strategy, Cencora
Kirsten Jacobs
Chief Service Strategy Officer and Executive Vice President of Regulatory Affairs, PharmaLex
Herbert Altmann
Vice President of Market Access and Healthcare Consulting Europe, Cencora
This article is intended to communicate Cencora’s capabilities, however, Cencora strongly encourages readers to review the links provided herein and all available information related to the topics mentioned and to rely on their own experience and expertise in making decisions related thereto as the article may contain certain marketing statements and does not constitute legal advice.
