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An article from Kenneth Kaitin, PhD, Professor and Director at Tufts Center for the Study of Drug Development.
This article was originally published by Tufts CSDD Insider.
Kenneth Kaitin, PhD, Professor and Director at Tufts Center for the Study of Drug Development.
Earlier this week, I was interviewed by a National Public Radio affiliate for a segment to be aired in the coming days on whether high drug development costs justify the high prices of many new pharmaceutical products. As many of our readers are aware, Tufts CSDD is known internationally for its series of studies estimating the true cost of pharmaceutical R&D. Our latest study (DiMasi et al, J Health Econ 2016;47:20-33) determined that the fully-capitalized cost to bring a new drug to market, including the cost of failures, is $2.6 billion, a 145% increase in constant dollars over our previous report published in 2003.
At more and more public and professional forums these days, I find myself addressing a common misconception about the relationship between R&D costs and drug prices. Much of this misunderstanding, I believe, comes from confusing messaging by the pharmaceutical industry. For example, when asked to explain why drugs are so expensive, the response is often, because it costs so much to develop new drugs (“The Tufts Center says it costs $2.6 billion to develop a new drug!”). On the other hand, when asked to provide the actual cost data for a specific drug, the response is often, “The cost to develop a drug has no bearing on the price of that drug.” A sane individual might ask, “How can both of these responses be correct?” The bottom line is that they both ARE correct.
As I explain it, average R&D costs represent the cost to maintain R&D operations. In other words, across a company’s marketed drug portfolio, average prices must be high enough for the company to generate sufficient revenue to maintain its R&D operations and (hopefully) develop tomorrow’s breakthrough drug. An individual drug’s price, however, typically reflects that drug’s perceived therapeutic and economic value, the competitive landscape, and the ability to obtain reimbursement. In other words, drug pricing is not unlike pricing of any other product.
The public debate over drug prices and the cost of healthcare in general is certain to continue into the foreseeable future. Greater transparency on how companies determine drug prices and how that relates to R&D costs would go a long way toward improving public understanding and furthering the discussion.
This article excerpt was originally published on the PhRMA website.
On January 31st, 2019, the Pharmaceutical Research and Manufacturers of America (PhRMA) elected three new officers to its board of directors. Olivier Brandicourt, CEO, Sanofi, became chairman of the PhRMA board of directors. Giovanni Caforio, M.D., chairman of the Board and CEO, Bristol-Myers Squibb Company was named chairman-elect and David Ricks, chairman and CEO, Eli Lilly and Company assumed the role of board treasurer.
Brandicourt formerly held the position of chairman-elect of the board and succeeds Robert A. Bradway, chairman and CEO, Amgen Inc. as PhRMA board chairman.
Brandicourt has served as CEO, Sanofi, since April 2015. Brandicourt joined Sanofi from Bayer Healthcare AG where he served as CEO from 2013 until 2015. Prior to joining Bayer Healthcare, Brandicourt worked at Pfizer for 13 years, where he served as a member of the executive leadership team and as president and general manager of the emerging markets and established products business units. He is an honorary member of the Royal College of Physicians in London and a board member of the Children’s Aid Society in New York. Brandicourt studied medicine at the University of Paris V where he specialized in infectious diseases and tropical medicine and holds an advanced degree in cellular and immunological pathophysiology from the Paris Descartes University. Brandicourt also received a master’s degree in biology from the University of Paris XII.
Dr. Caforio has served as CEO of Bristol-Myers Squibb since May 2015 and became chairman of the board of directors in May 2017. Dr. Caforio received his medical degree from the University of Rome and joined Bristol-Myers Squibb in Italy in 2000. He advanced through a series of roles in Europe and the United States, becoming president of the U.S. commercial organization in 2011. He was named chief commercial officer in 2013 and became chief operating officer in 2014. Dr. Caforio is a member of the Board of Trustees of Hun School of Princeton and a member of the Business Roundtable and the CEO Roundtable on Cancer.
Ricks has served as CEO of Lilly since January 1, 2017 and became chairman of the board of directors on June 1, 2017. A 20-year Lilly veteran, he previously served as president of Lilly Bio-Medicines and as president of Lilly USA, the company’s largest affiliate. Ricks also served as president and general manager of Lilly China, operating in one of the world’s fastest-growing emerging markets, and general manager of Lilly Canada after roles as director of pharmaceutical marketing and national sales director in that country. He is the president of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) and serves on the board of the Central Indiana Corporate Partnership, the Elanco Board of Directors and the Adobe Board of Directors.
Ricks is a graduate of Purdue University and earned his MBA from Indiana University.
A historical reminder on the importance of Regulatory Affairs in Medicines Development
As the IFAPP Academy is gearing up for students to start Module 5: Regulatory Affairs, Drug Safety, and Pharmacovigilance we are reminded of the importance of these regulatory bodies and the need for continued oversight in medicines development. The FDA emphasizes this with a short video about what can happen when medicines are not being properly regulated.
Want to learn more about medicines regulations within medicines’ development?
The International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP) Academy provides online Continuing Professional Development for Medical Affairs Professionals.
The IFAPP Academy is a non-profit organization whose mission is to promote, develop, and implement educational activities that support Pharmaceutical Medicine by enhancing the knowledge, expertise, and skills of pharmaceutical physicians and medicines development scientists worldwide. Partnered with King’s College London, the Academy offers Professional Certification for students successfully completing the course. Click here to learn more about the benefits of Professional Certification from the IFAPP Academy.
Insight into 5 key areas where CRO’s should consider ongoing process improvement.
An article from the May 2018 addition of the Clinical Researcher seems especially relevant as the students of the current 2018 cohort are wrapping up Module 4, Clinical Trials: from concept to clinical study report. The article “Improving Clinical Research Trials: Best Practice Do’s and Don’ts for Managing Business Operations” (Ted Finlan, 2018), Finlan provides insight into 5 key areas where CRO’s should consider ongoing process improvement.
1. Regulatory Compliance
Pitfall: Failure to understand and plan compliance timelines
Internal and external regulatory groups have varying deadlines, with timelines that often intersect and overlap. For instance, approval for a drug import license can vary from country to country by a matter of weeks or months. Without a clear understanding of approval processes and their impact on the critical path, a study is at high risk of schedule slippage.
Best practice: Clear project planning blueprint
CROs should ensure clarity and alignment between staff responsible for designing a regulatory blueprint (e.g., ethics committees, institutional review boards, etc.) and those responsible for building, managing, and communicating schedules. When approval processes are clearly mapped out to achieve the most efficient response, CROs can expedite the commencement of work.
2. Information Flow and Governance
Pitfall: Lack of communication between departments and across organizations
Every department maintains critical information that other departments can benefit from. For instance, the Quality unit may be the first to become aware of new clinical trial regulations that impact the study start-up processes. If this information is not shared across the organization, various issues may arise, such as compromised core processes and missed timelines, jeopardizing overall delivery of the study.
This risk can be especially acute when working with new partners or third parties. Misplaced assumptions about “who knows what” or misaligned processes can creep in and drive quality issues or delays if initial and ongoing communication between these entities is lacking.
Best practice: Purposeful communication and collaboration
Clarity is a best practice when it comes to communication, and standard operating procedures should address optimal information flow. This requires every team member and site to have a clear understanding of their own responsibilities, as well as the roles and responsibilities of those adjacent to them. Processes should lend to proactive knowledge sharing as departments recognize how information intersects and how teams can fully leverage intelligence.
Mutually agreed-upon terms of engagement between sponsors, CROs, and vendors can also circumvent downstream quality, compliance, or timeline issues. These communication plans should ensure collaboration across all facets of the project.
3. Getting a Fast Start
Pitfall: Final protocol delays
Delayed availability of the final protocol is one of the most significant stumbling blocks to patient recruitment. The final protocol is a critical path deliverable that impacts trial supply, site activation, and, of course, recruitment.
In fact, quite often, important work will begin before the final protocol is available. Proceeding “at risk” can lead to rework that can increase the cost and duration of start-up, and, in some cases, could lead to losing access to desirable clinical investigators or institutions. All of which impacts the ability to recruit and can affect the pace of recruitment throughout the study.
Best practice: Transparency and communication
Visibility into the availability of the protocol and expected impacts can significantly mitigate the impacts of delays. By actively planning for the delays and communicating proactively with the sites, a CRO can maintain engagement and be far more agile in adapting to change. This requires proactive communication and strong collaboration between the sponsor and CRO to make the changes needed for strategies, systems, and plans to run as smoothly and quickly as possible.
4. Budgeting
Pitfall: Improper management of uncertainty
A key characteristic of research is uncertainty. Unfortunately, that reality can make the budgeting process a series of “best guesses.” As noted above, delays in protocol availability can delay studies for unpredictable periods of time, as can the availability of investigational product (IP) supplies.
These, and other unknowns can lead to rework, changing of staff, and other impacts that affect the overall budget, including direct CRO services, grants, and third-party costs. Without effectively forecasting communication and change order processes, studies can run into financial trouble, including an inability to compensate investigators or pay third-party costs.
Best practice: Effective change management
In an ideal world, any CRO would like to minimize risk by matching the level of uncertainty with the right amount of “insurance,” often referred to as a reserve. This is rarely possible, yet the most effective CROs move forward with a considered, deliberate approach for “out of scope” work and a smooth change order process.
Another approach is to financially ensure alignment and motivation through targeted use of bonus clauses, incenting CRO performance by aligning its financial benefit with the goals of the sponsor. For example, hitting aggressive recruitment and retention targets.
It is important to remember that these approaches are two-way streets. Change orders for unused/unrequired spending result in savings for the sponsor and should be communicated just as proactively. As this may be driven by faster recruiting or other “good news,” it may appear to some that the CRO is being punished for exceptional performance. This is another good reason to align incentives and bonuses to match the sponsor’s desired outcomes.
5. Staff Workflows
Pitfall: Finding projects short-staffed
Inefficiency is always a concern, and the ability to efficiently allocate staff is a critical factor for service companies. A lack of consistency across organizations, various conflicting or ambiguous definitions for terms and data, misaligned assumptions, and an absence of clarity across processes and organizations can leave projects short of key staff, driving delays, quality issues, and other delivery problems.
Best practice: Aligning key resources
A holistic view of processes and clear data definition across the enterprise is key. This is usually attacked by mapping and integrating core processes, and in the case of services staffing, this is often referred to as the “quote to cash” process. As it sounds, this process takes the proposal and bidding activities into consideration, where staff capacity transitions to the reservation of specific individuals.
Once the formal assignment is in place and resources are used, the process moves into the billing and receivables portion. By clearly illustrating the processes and agreeing to common data definitions and metrics, the CRO can gain greater visibility into its “factory” and more efficiently serve its customers.
To sum up, “Good Business Operations = Effective Trials.” Finlan, emphasizes that as the clinical research environment continues to grow and change it becomes ever important to ensure a high-quality design to overcome these common pitfalls and ensure success!
Want to learn more about how to be an effective and more productive CRO?
The International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP) Academy provides online Continuing Professional Development for Medical Affairs Professionals.
The IFAPP Academy is a non-profit organization whose mission is to promote, develop, and implement educational activities that support Pharmaceutical Medicine by enhancing the knowledge, expertise, and skills of pharmaceutical physicians and medicines development scientists worldwide. Partnered with King’s College London, the Academy offers Professional Certification for students successfully completing the course. Click here to learn more about the benefits of Professional Certification from the IFAPP Academy.
3 Reasons why medical affairs professionals need to be savvy with social media.
The worldwide reach of social media has changed how people communicate. Social media platforms are becoming the go-to source for communication. Patients are more likely to share their medication side effects, such as the itchy rash they got on their butt or the achy joints that prevented them from playing golf with friends, on social media than to their doctor. Social media channels not only have the potential to act as a way of reporting adverse events but also help companies understand the wants and needs of patients.
Therefore, with the ever-increasing importance of patient centricity and personalized medicines, more and more companies are relying on social media to provide them with answers. These are just some of the many ways that companies are leveraging social media.
1. Creating a truly patient-centric approach
“There has been a lot of talk in recent years of a need to increase patient-centricity within the pharmaceutical industry. Indeed, there have been many great steps towards a more patient-centric approach, and a greater recognition of the value of patient choice and the need for increased self-management across healthcare systems” (Rees, Sumira, & Morton, 2018). However, to put this into practice companies must provide patients with the necessary tools and education. Companies are now relying on data from social media sites to help them learn how to provide patient-friendly information. “Listening to social conversation can add layers of insights. Online conversations can uncover valuable insights about the audience, whether this be patients, healthcare professionals or key opinion leaders.” (Rees, Sumira, & Morton, 2018)
[caption id="attachment_2000" align="aligncenter" width="845"] Figure 1 Sciformix Corp. “The Impact and Use of Social Media in Pharmacovigilance”
2. Product Vigilance (PV)
In a whitepaper by Sciformix, “social media has the potential to become an added new-age tool to monitor data in real-time, making it an early indicator of potential safety issues for further investigation. Further, this would enable companies to generate more robust product safety profiles by leveraging the additional social media information” (Sciformix Corporation).
3. Clinical trial recruitment
According to Medrio.com, “Social media has the potential to be a powerful tool in the clinical trial recruitment process because of its low cost and ability to reach a diverse and broad audience. In 2014, Facebook boasted over 1.2 billion monthly active users, Twitter had 255 million, LinkedIn was at 187 million. These numbers outweigh the traditional recruiting numbers in every way. This capability is something that one-sided print/TV ads or even clinician/patient referrals cannot provide: access to diverse cultures, age groups, gender, and income levels” (Medrio, 2015).
Want to learn how to expand your skillset and continue your professional development in Medical Affairs?
The International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP) Academy provides online Continuing Professional Development for Medical Affairs Professionals.
The IFAPP Academy is a non-profit organization whose mission is to promote, develop, and implement educational activities that support Pharmaceutical Medicine by enhancing the knowledge, expertise, and skills of pharmaceutical physicians and medicines development scientists worldwide. Partnered with King’s College London, the Academy offers Professional Certification for students successfully completing the course. Click here to learn more about the benefits of Professional Certification from the IFAPP Academy.
References
Medrio. (2015, August 6). Using Social Media to Recruit Subjects in Phase I Clinical Trials. Retrieved from Medrio: https://medrio.com/blog/using-social-media-to-recruit-subjects-in-phase-i-clinical-trials/
Rees, N., Sumira, D., & Morton, A. (2018, June 13th). The Patient Journey. Retrieved June 19, 2018, from PM LiVE: http://www.pmlive.com/pharma_thought_leadership/the_patient_journey_1239641
Sciformix Corporation. (n.d.). The Impact and Use of Social Media in Pharmacovigilance. Retrieved June 19, 2018, from Sciformix: https://www.sciformix.com/wp-content/uploads/Social_Media_in_PV_Whitepaper.pdf
World Pharma News. (2017, October 9). Social Media in the Pharmaceutical Industry. (SMi Group) Retrieved June 6, 2018, from World Pharma News: http://www.worldpharmanews.com/events/4139-social-media-in-the-pharmaceutical-industry
What are the benefits of earning a professional certification?
Despite the career, employees from construction to IT to Pharmacy have found enormous advantages in obtaining a professional certification within their field. Here are 5 advantages of earning professional certification.
Gain a competitive edge. Because let’s face it, competition can be stiff when it comes to the job market. Whether you’re applying for a new job, wanting to be considered for a promotion, or crossing your fingers for an end-of-year raise a professional certification will help to distinguish you from the pack. When considering two individuals with similar backgrounds, a professional certification may get your resume that second look. Certifications can differentiate you from other professionals in your field or company, showing that you have a demonstrated commitment to understanding and excelling in your profession and a desire to learn more.[1]
2. Increased competency. The success of a team depends on the knowledge and experience of each of its members, which is why professional certifications have become increasingly important in the field of medicine.[2] After all, the primary criteria for employers is to have professionals on their team that are up-to-date with industry standards, norms, and best practices which are in a constant state of flux.[3] E-learning allows providers, such as the IFAPP Academy, to provide the most current and relevant information in an accessible, convenient, and cost-effective manner.
3. Professional credibility. Earning a certification provides immediate credibility with employers and colleagues. Who is going to question a Cisco Certified Internetwork Expert (CCIE), a Microsoft Certified Solutions Expert (MCSE) or a Red Hat Certified Architect (RHCA)? Earning a certification from an internationally recognized organization demonstrates your dedication and motivation to professional development. Many companies will actively support their employees in earning these certifications that may even lead to promotions and raises.[4]
Networking opportunities. Working hard to earn a certification allows you to join a unique group of certified and skilled professionals that share similar goals and ambitions. This can prove to be an invaluable peer resource group that can be a boon when looking for answers to a particularly tough problem or when moving from one company to another. The IFAPP Academy encourages students to network and learn from each other through the student forums and live interactive webinars, providing additional viewpoints from an international perspective.
5. Increased confidence, because confidence is KEY! In a study conducted by the University of Melbourne, Participants were asked to describe their level of confidence at primary school, high school, university, and present day. Those who self-reported higher levels of confidence earlier in school earned better wages and were promoted more quickly. Lead author Dr. Reza Hasmath, from the University’s School of Social and Political Sciences, said the research demonstrates a crucial ingredient of workplace advancement. “The implications are tremendous in terms of the personality employers should look for when it comes to hiring or promoting staff,” Dr. Hasmath said.”[5]
Want to learn how to earn a Professional Certification in Medicines Development in Medical Affairs?
The International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP) Academy provides online Continuing Professional Development for Medical Affairs Professionals, resulting in the Professional Certification, CMD (Certified Medicines Development).
The IFAPP Academy is a non-profit organization whose mission is to promote, develop, and implement educational activities that support Pharmaceutical Medicine by enhancing the knowledge, expertise, and skills of pharmaceutical physicians and medicines development scientists worldwide. Partnered with King’s College London, the Academy offers Professional Certification for students successfully completing the course. Click here to learn more about the benefits of Professional Certification from the IFAPP Academy.
Resources/References
[1] Laurinavicius, T. (2017, December 07). Why Online Certifications Are Key To Professional Success. Retrieved March 28, 2018, from https://www.huffingtonpost.com/tomas-laurinavicius/why-online-certifications_b_11081630.html
[2] Rewards of Certification. (n.d.). Retrieved March 28, 2018, from https://www.bpsweb.org/impact-of-bps-certification/rewards-of-certification/
[3] Laurinavicius, T. (2017, December 07). Why Online Certifications Are Key To Professional Success. Retrieved March 28, 2018, from https://www.huffingtonpost.com/tomas-laurinavicius/why-online-certifications_b_11081630.html
[4] 10 Benefits of IT Certification for You (and Your Employer). (n.d.). Retrieved March 28, 2018, from https://www.globalknowledge.com/us-en/content/articles/10-benefits-of-it-certification-for-you-and-your-employer/
[5] Hasmath, D. (2012, October 18). Self-confidence the secret to workplace advancement. Retrieved April 09, 2018, from http://newsroom.melbourne.edu/news/self-confidence-secret-workplace-advancement
3. Getting a Fast Start
