Kristin Brooks, Contract Pharma10.28.19
Unimaginable innovation in drug development has led to more complex and increasingly targeted therapies for smaller patient populations, particularly in the rare and orphan disease space. In clinical research, this translates into challenges, such as logistics and patient recruitment, that require global operations, advanced analytics, data and communications capabilities and scientific expertise.
Contract Research Organizations (CROs) have grown into a global industry these past 20 years, offering services across the drug discovery and development continuum. From their clinical origins, CROs have since added lab services, regulatory consulting, data capture and analytics platforms, as well as scale, all with the goal of helping sponsors to advance their drug development programs, make go/no-go decisions faster, provide critical information and quality data in real-time.
Randy Marchbanks, Senior Vice President, global development operations at PPD, discusses how CRO operations have evolved to accommodate changing industry needs and what we can expect for the future of the industry and outsourcing. –KB
Contract Pharma: What were some of the major pharma/biopharma industry changes in the past 20 years that have significantly impacted contract service providers?
Randy Marchbanks: Broadly speaking, there have been two major changes in the pharma/biopharma industry over the past 20 years that have changed the landscape for contract service providers. The first has been the continued consolidation of established, traditional biopharma companies combined with an unprecedented expansion of biotech companies. With both, cost and time pressures to bring new products to the market has driven the need for biopharma companies to increase productivity via identifying core competencies to internalize while outsourcing other activities. Global service providers have responded by expanding the global scope, scale and expertise of their offerings, allowing biopharma companies to outsource increasingly complex scientific, medical, analytical and clinical services to these providers.
The second change has been the shift in the portfolio of products under development by biopharma industry from traditional, small molecules targeting common maladies to a complex array of biological assets with specific therapeutic targets or products intended to treat rare diseases. This shift has resulted in a massive expansion, and in some cases the transfer, of bioanalytical expertise and specialty clinical laboratory testing to service providers. Further, the shift to clinical trials with targeted therapies and for rare diseases has pressured service provider to significantly expand their geographic footprint and patient recruitment expertise to find trial-eligible subjects with specific genetic markers.
CP: What are some changes you anticipate for the future of the industry and outsourcing?
RM: Service providers have experienced some dramatic swings in outsourcing approaches for the biopharma industry over the past two decades from best-in-class outsourcing to multiple providers for specific services to seeking single, global service providers that can provide high quality end-to-end laboratory and clinical trial support. The outsourcing of either single services or broader support has also been contracted in diverse ways including single study contracts to larger scale outsourcing of an entire function (functional service provider or FSP), dedicated full-time employees for specialized laboratory services or full-service outsourcing (FSO) of a single trial or entire development program. While major changes across these diverse outsourcing options are not expected, contract service providers should be anticipating the upcoming needs from our biopharma customers.
CP: How have service offerings and operations for CROs evolved over the years?
RM: The CRO industry has experienced exponential growth over the past 20 years, evolving from small, often single-region organizations with limited service offerings to multinational business enterprises offering an ever-expanding menu of services. Almost unthinkable advances in science in technology over this time have enabled this evolution across all of our global services and functions. One example is our pharmacovigilance team’s development of a real-time communication system with sites globally to address protocol inquiries or patient eligibility questions and development of an advanced case processing system with associated metric generation utilizing artificial intelligence (AI) and machine learning (ML) to increase productivity and reduce cost. Across our global laboratory businesses, implementation of numerous technological enhancements has driven significant global expansion and the movement from repetitive quality control functions to high science in support of the development of new products.
On the clinical front, the importance of moving clinical trial sites from agreement to participate to fully activated and eligible to enroll subjects has led to development of a sophisticated global department of professionals with a variety of skill sets (regulatory, legal, financial, etc.), positively impacting overall study timelines. To identify the best sites for clinical trials, the expertise of a separate team focused on patient centricity, engagement with internal and external data sources and strategic site collaborations has also been formed. Finally, critical clinical trial services that have evolved over the past 20 years include our global clinical supplies team who deal with complex trade compliance and import/export laws and regulations and out global data management organization which handles, processes and cleans electronic trial data from multiple data sources.
CP: What global market changes have had the greatest impact on the industry and CRO services?
RM: As mentioned earlier, the need to identify increasingly difficult to find subjects for clinical trials influenced the biopharma industry and CROs to expand their geographic interest and footprint to new global markets over the past 20 years. Coincident with that, government agencies, regulatory bodies and ethics professionals around the world initiated the processes of harmonization, standardization and the governance of clinical trials globally. This harmonization allowed biopharma companies to design and execute global trials in support of marketing applications in several countries, negating the need for local trials to support marketing of new products.
The clinical research landscape, which had been largely confined to the US and Western Europe, first expanded to Eastern Europe and Latin America and in the late 1990’s and then further expanded into Japan, China and other Asia-Pacific (APAC) countries thereafter. The true globalization of clinical trials facilitated the substantial expansion of CROs into these regions. In addition to expanding their global footprint, this expansion also afforded the CROs to opportunity to tap into a larger pool of highly qualified resources to support their clinical and laboratory businesses in those regions.
CP: What are some of the major regulatory changes that have impacted the industry in the past 20 years?
RM: In addition to the adoption of ICH E6 Good Clinical Practice (GCP) Guideline in 1996, implementation of Data Privacy standards around the collection, analysis, transfer and archiving of clinical trial data has had the biggest impact on the biopharma and CRO industry. More recently, the release of ICH E6 R2 has initiated a fundamental shift if the way biopharma companies and CROs actively manage clinical trials – moving from a mindset of retrospectively monitoring clinical trial activities to a more proactive risk identification and risk management approach. To address the requirement of the new guidance, the industry has developed and implemented sophisticated data analytics systems to monitor key quality indicators (KQIs) in real time to quickly identify and address issues.
Finally, the FDA and other regulatory agencies are increasingly collaborating with the industry to innovate both the clinical trials process as well as the submission of marketing applications. A good example of this is the FDA’s acceptance, and even encouragement, of novel trial designs such as adaptive trials, platform trials and basket trials as well as the utilization of real-world evidence (RWE) to improve the efficiency of the clinical trials process. Further, there has been a movement toward acceptance of scientifically validated surrogates of response (such as biomarkers) as safety and efficacy endpoints. Finally, regulatory bodies worldwide are also collaborating with each other to streamline the marketing application and review process. In fact, in September the FDA, in conjunction with the Australian TGA and Health Canada under an initiative called Project Orbis, announced its first joint approval for oncology drugs granting accelerated approval for novel products targeting an unmet medical need.
In summary, the biopharma and CRO industries have simultaneously evolved – in more ways than we could have predicted –over the past 20 years. If this progress is an indication of what’s to come, we need to collectively fasten our seat belts for the next 20 years!
Randy Marchbanks, Pharm.D., serves as senior vice president of development operations within PPD’s global clinical development team. In this role, he is responsible for leading the development operations efforts for PPD’s strategic partnership accounts. Leveraging his years of operations and commercial experience, his strong customer knowledge and his positive relationships with colleagues, Dr. Marchbanks provides oversight of all strategic partnership development operations leaders to ensure partnerships progress according to strategic development plans. Since joining PPD in 1993, Dr. Marchbanks has held several management positions in the company’s clinical operations and commercial teams, most recently serving as vice president of commercial development.
Contract Research Organizations (CROs) have grown into a global industry these past 20 years, offering services across the drug discovery and development continuum. From their clinical origins, CROs have since added lab services, regulatory consulting, data capture and analytics platforms, as well as scale, all with the goal of helping sponsors to advance their drug development programs, make go/no-go decisions faster, provide critical information and quality data in real-time.
Randy Marchbanks, Senior Vice President, global development operations at PPD, discusses how CRO operations have evolved to accommodate changing industry needs and what we can expect for the future of the industry and outsourcing. –KB
Contract Pharma: What were some of the major pharma/biopharma industry changes in the past 20 years that have significantly impacted contract service providers?
Randy Marchbanks: Broadly speaking, there have been two major changes in the pharma/biopharma industry over the past 20 years that have changed the landscape for contract service providers. The first has been the continued consolidation of established, traditional biopharma companies combined with an unprecedented expansion of biotech companies. With both, cost and time pressures to bring new products to the market has driven the need for biopharma companies to increase productivity via identifying core competencies to internalize while outsourcing other activities. Global service providers have responded by expanding the global scope, scale and expertise of their offerings, allowing biopharma companies to outsource increasingly complex scientific, medical, analytical and clinical services to these providers.
The second change has been the shift in the portfolio of products under development by biopharma industry from traditional, small molecules targeting common maladies to a complex array of biological assets with specific therapeutic targets or products intended to treat rare diseases. This shift has resulted in a massive expansion, and in some cases the transfer, of bioanalytical expertise and specialty clinical laboratory testing to service providers. Further, the shift to clinical trials with targeted therapies and for rare diseases has pressured service provider to significantly expand their geographic footprint and patient recruitment expertise to find trial-eligible subjects with specific genetic markers.
CP: What are some changes you anticipate for the future of the industry and outsourcing?
RM: Service providers have experienced some dramatic swings in outsourcing approaches for the biopharma industry over the past two decades from best-in-class outsourcing to multiple providers for specific services to seeking single, global service providers that can provide high quality end-to-end laboratory and clinical trial support. The outsourcing of either single services or broader support has also been contracted in diverse ways including single study contracts to larger scale outsourcing of an entire function (functional service provider or FSP), dedicated full-time employees for specialized laboratory services or full-service outsourcing (FSO) of a single trial or entire development program. While major changes across these diverse outsourcing options are not expected, contract service providers should be anticipating the upcoming needs from our biopharma customers.
CP: How have service offerings and operations for CROs evolved over the years?
RM: The CRO industry has experienced exponential growth over the past 20 years, evolving from small, often single-region organizations with limited service offerings to multinational business enterprises offering an ever-expanding menu of services. Almost unthinkable advances in science in technology over this time have enabled this evolution across all of our global services and functions. One example is our pharmacovigilance team’s development of a real-time communication system with sites globally to address protocol inquiries or patient eligibility questions and development of an advanced case processing system with associated metric generation utilizing artificial intelligence (AI) and machine learning (ML) to increase productivity and reduce cost. Across our global laboratory businesses, implementation of numerous technological enhancements has driven significant global expansion and the movement from repetitive quality control functions to high science in support of the development of new products.
On the clinical front, the importance of moving clinical trial sites from agreement to participate to fully activated and eligible to enroll subjects has led to development of a sophisticated global department of professionals with a variety of skill sets (regulatory, legal, financial, etc.), positively impacting overall study timelines. To identify the best sites for clinical trials, the expertise of a separate team focused on patient centricity, engagement with internal and external data sources and strategic site collaborations has also been formed. Finally, critical clinical trial services that have evolved over the past 20 years include our global clinical supplies team who deal with complex trade compliance and import/export laws and regulations and out global data management organization which handles, processes and cleans electronic trial data from multiple data sources.
CP: What global market changes have had the greatest impact on the industry and CRO services?
RM: As mentioned earlier, the need to identify increasingly difficult to find subjects for clinical trials influenced the biopharma industry and CROs to expand their geographic interest and footprint to new global markets over the past 20 years. Coincident with that, government agencies, regulatory bodies and ethics professionals around the world initiated the processes of harmonization, standardization and the governance of clinical trials globally. This harmonization allowed biopharma companies to design and execute global trials in support of marketing applications in several countries, negating the need for local trials to support marketing of new products.
The clinical research landscape, which had been largely confined to the US and Western Europe, first expanded to Eastern Europe and Latin America and in the late 1990’s and then further expanded into Japan, China and other Asia-Pacific (APAC) countries thereafter. The true globalization of clinical trials facilitated the substantial expansion of CROs into these regions. In addition to expanding their global footprint, this expansion also afforded the CROs to opportunity to tap into a larger pool of highly qualified resources to support their clinical and laboratory businesses in those regions.
CP: What are some of the major regulatory changes that have impacted the industry in the past 20 years?
RM: In addition to the adoption of ICH E6 Good Clinical Practice (GCP) Guideline in 1996, implementation of Data Privacy standards around the collection, analysis, transfer and archiving of clinical trial data has had the biggest impact on the biopharma and CRO industry. More recently, the release of ICH E6 R2 has initiated a fundamental shift if the way biopharma companies and CROs actively manage clinical trials – moving from a mindset of retrospectively monitoring clinical trial activities to a more proactive risk identification and risk management approach. To address the requirement of the new guidance, the industry has developed and implemented sophisticated data analytics systems to monitor key quality indicators (KQIs) in real time to quickly identify and address issues.
Finally, the FDA and other regulatory agencies are increasingly collaborating with the industry to innovate both the clinical trials process as well as the submission of marketing applications. A good example of this is the FDA’s acceptance, and even encouragement, of novel trial designs such as adaptive trials, platform trials and basket trials as well as the utilization of real-world evidence (RWE) to improve the efficiency of the clinical trials process. Further, there has been a movement toward acceptance of scientifically validated surrogates of response (such as biomarkers) as safety and efficacy endpoints. Finally, regulatory bodies worldwide are also collaborating with each other to streamline the marketing application and review process. In fact, in September the FDA, in conjunction with the Australian TGA and Health Canada under an initiative called Project Orbis, announced its first joint approval for oncology drugs granting accelerated approval for novel products targeting an unmet medical need.
In summary, the biopharma and CRO industries have simultaneously evolved – in more ways than we could have predicted –over the past 20 years. If this progress is an indication of what’s to come, we need to collectively fasten our seat belts for the next 20 years!
