Excellence and equity: From pilot to program, a Pfizer experience

In 2021, Pfizer global regulatory affairs colleagues piloted an advanced pharmacy practice experience program as part of a company-wide diversity, inclusion, and equity program in collaboration with Howard University College of Pharmacy (CoP), a US-based historically Black college/university (HBCU).¹ Following pilot success, the initiative was elevated to full program status and the prospective student pool was expanded to include all HBCU CoPs in the US, as well as one predominantly Black institution. Selected students were placed under the supervision of volunteer Pfizer colleagues at the director level and above, and across different therapeutic areas and categories. 
*Pfizer   †Florida A&M University
 
Keywords – equity, excellence, global regulatory affairs, historically Black college/university, predominantly Black institution, talent pipeline development, experiential education
 

Introduction

Excellence and equity are core values that define Pfizer’s company culture to develop breakthroughs that change patients' lives. Both values underpin the need to achieve transformative patient outcomes in teams in which every member is seen, heard, and cared for. These goals are actioned through the Pfizer enterprise-wide three-pillar diversity, equity, and inclusion (DEI) strategy (Figure 1).

Figure 1. Pfizer’s DEI strategy – Three strategic pillars



CoP, college of pharmacy; GRA, global regulatory affairs; HBCU, historically Black college/university; HUCOP, Howard University College of Pharmacy; PBI, predominantly Black institution.
Source: Pfizer
 
In alignment with the overall DEI strategy, particularly pillars 1 and 3, colleagues in Pfizer’s global regulatory affairs division (GRA) identified HBCUs and predominantly Black institution CoPs as potential partners to support the mission of encouraging careers in regulatory affairs among diverse and talented students.

[Related article Carter M, et al. Fostering diversity and talent: A Pfizer case study. Regulatory Focus. Published online September 2021. https://www.raps.org/RAPS/media/news-images/Feature%20PDF%20Files/21-9_Carter-et-al_rev-1.pdf ]

HBCUs are defined under Title III of the Higher Education Act of 1965 by the US Congress as schools of higher learning that were accredited and established before 1964 and whose principal mission is the education of African Americans.² Of the more than 100 HBCUs across the US, those with accredited CoPs educate a significant percentage of pharmacy students identifying as underrepresented people of color (UPOC) nationwide. Although HBCU CoPs represent only 3%-4% of the total number of pharmacy schools in the US, they have consistently enrolled a larger percentage of UPOC students compared with all pharmacy schools nationwide. From 2015-2019, this included enrollment of 22.8% of African American students, 6.6% of American Indian and Alaska Native students, and 2% of Native Hawaiian and other Pacific Islander students.³
 

Predominantly Black institutions (PBIs) are also classified and defined by the US Congress. Under the Higher Education Opportunity Act of 2008, the bill that reauthorized the Higher Education Act of 1965, the key goal of PBIs is to expand higher education opportunities for eligible Black American and first-generation college students.^2,4 At least 50% of the students who matriculate at these institutions are low-income (i.e., individuals from a family whose taxable income for the preceding year did not exceed 150% of an amount equal to the poverty level determined using the criteria of poverty established by the Bureau of the Census) or first-generation (i.e., individuals whose parents did not complete a baccalaureate degree).⁵ Of all students enrolled at a PBI, 40% or more are African American.⁵

 

Pfizer GRA-HUCOP Pilot Program

The Pfizer GRA-Advanced Pharmacy Practice Experience (APPE) Pilot Program was initiated in 2021 in collaboration with Howard University COP (HUCOP), a top-ranked HBCU. A number of unique elements were built into the pilot design and implementation strategy to enhance the overall value of the experience. Unlike any other program at Pfizer, the pilot was intentionally focused on graduate-level doctor of pharmacy (PharmD) candidates from diverse backgrounds and with a strong interest in clinical research and regulatory science as evidenced by their prior experiences. In addition, the pilot experience was completely remote and delivered in a virtual format to allow for students from across the nation to participate without the financial burden of short-term physical relocation near a Pfizer campus.
 
Selected fourth-year HUCOP students with previous industry and/or health authority (e.g., US Food and Drug Administration [FDA]) externship experience enrolled in the pilot program and attained academic credit toward completion of the PharmD curriculum. Following graduation, each student gained employment with a Fortune 500 multinational, biopharmaceutical company in regulatory strategy and medical affairs functional roles. One student was hired as a full-time Pfizer colleague and is currently working in the GRA-Internal Medicine group as an above-country, regional regulatory strategist.
 

Expansion from pilot to program

Following the successful pilot in 2021 with HUCOP, the Pfizer GRA leadership team endorsed expansion to a full program with the opportunity to include students from additional HBCU and PBI CoPs.
 
To support this effort, Pfizer GRA colleagues worked closely with members of the Pfizer Global Black Community (GBC) Colleague Resource Group (CRG) and reviewed literature to identify all accredited HBCU and predominantly Black university PharmD programs that could incorporate biopharmaceutical experiential student opportunities into their curriculum. A total of seven institutions were identified, including all six HBCU CoPs (Florida Agricultural and Mechanical University, Hampton University, Howard University, Texas Southern University, University of Maryland Eastern Shore, and Xavier University) and one predominantly Black CoP (Chicago State University; Table 1). Each institution provides an educational learning environment that caters to the unique experience of minority students. They serve as premier incubators for the development of African American science, technology, engineering, mathematics (STEM) professionals across the nation.^6,7 They rank among the highest producers of Black professionals in medicine and pharmacy.

Pfizer GRA program administrators and members of the Pfizer Talent Acquisition, Recruiting and Onboarding Delivery Team hosted a collaborative, cross-institution, kick-off meeting with CoP experiential program administrators and school deans to gauge their interest in partnering with Pfizer GRA to support student participation in the program. In addition, this discussion led to understanding of the individual institution programming practices/operating procedures to create targeted and valuable industry experiences for the students. The following potential program hurdles were identified:

• Requirements for the cross-departmental review process and timelines aligned with the finalization of the education affiliation agreement,
• Preceptor requirements,
• Use of the core experiential-learning management system software to manage student evaluations, and
• Varying block schedule start/end dates across each institution.

 
Solutions agreeable to both Pfizer and each CoP were identified to overcome these concerns.
 
All seven identified CoPs expressed interest in partnering with Pfizer GRA, and the program’s prospective student pool was expanded to include applicants from each school (Figure 2).

Figure 2. Expansion of Pfizer GRA-HBCU-PBI Advanced Pharmacy Practice Experience Pilot Program
 


GRA, Global Regulatory Affairs; HBCU, historically Black college/university; PBI, predominantly Black institution.
Source: Pfizer
 
In addition, Pfizer GRA program administrators attended virtual preceptorship fairs to further understand the administrative processes and timelines for individual university experiential-learning opportunities. These fairs also served as platforms for interfacing with potential student applicants and providing details of the overall program objectives, selection criteria, and timelines. During the fairs, students were most interested in gaining further information about regulatory science as a profession, connecting with Pfizer presenters to gain a better understanding of a day in the life of a Pfizer regulatory colleague, and discussing the overall skills and experiences that would be instrumental in supporting their candidacy.
 
Efforts to recruit additional Pfizer GRA preceptors were also prioritized and deemed as important as collaboration with CoP administrators and interfacing with potential students. A small kick-off meeting was initially held with pilot preceptors to confirm participation for the expanded program. Each pilot program preceptor agreed to participate and was retained. Subsequently, pilot preceptors served as program ambassadors and led recruitment interactions with potential new preceptors (Figure 3). Further awareness about the program was provided via broad advertisement across different internal media platforms (e.g., Yammer, Microsoft Teams, email), commentary provided by senior level leaders during townhalls and podcasts, discussions led by Pfizer CRGs, presentation roadshows hosted within GRA category meetings, and postings included on the GRA volunteer matching portal.
 

Figure 3. Expansion of Pfizer GRA-HBCU-PBI Advanced Pharmacy Practice Experience Preceptorship Program


GRA, Global Regulatory Affairs; HBCU, historically Black college/university; PBI, predominantly Black institution.
Source: Pfizer

 

Expanded program execution

Many of the learnings from the pilot contributed positively to the design of the expanded program. One example of this included maintaining the remote/virtual format to support student access. In addition, the Pfizer-CoP education affiliation agreements/contracts finalization process, which was identified as the key challenge and a rate-limiting activity for pilot program initiation, was optimized. This included extending the overall duration of the contracts/agreements and discussing intricacies and efficiencies early on during the kick-off meeting with the CoPs and Pfizer Human Resources Talent Acquisition. As a result, the agreement duration was extended from 1 to 5 years. Given this, the process will no longer be an immediate barrier unless there are significant program modifications.
 
A new element of the program design was incorporation of an option for students to participate throughout their institution’s academic year rather than the May-to-June timeframe for the pilot. This was a welcomed efficiency from the perspective of CoP administrators, potential students, and Pfizer GRA student preceptors. It allowed for students across universities to participate, despite differing rotation block schedules.
 
The key challenge associated with the expanded program was internal Pfizer resources. Although the pilot was expanded to a full program with an increased number of CoPs, students, and preceptors, the size of the Pfizer GRA administration team was not increased. As a result, it was challenging to manage activities and track key strategic imperatives with a small team of volunteers with bandwidth constraints (Figure 4).

Figure 4. Development and activities timeline of Pfizer GRA-HBCU-PBI CoP Advanced Pharmacy Practice Experience Preceptorship Program



GRA, global regulatory affairs; HUCOP, Howard University College of Pharmacy; CoP, college of pharmacy; HBCU, historically Black college/university; LT, leadership team; PBI, predominantly Black institution; IM, internal medicine
Source: Pfizer
 
 Student applicants were selected based on the following criteria:

• Good academic standing;
• Demonstrated interest in the biopharmaceutical industry, particularly regulatory science;
• Leadership skills and experiences (e.g., FDA/industry, but not required);
• Strong communication and interpersonal skills; and
• Successful interview with Pfizer GRA program administrators.

 
For students who were not selected, constructive feedback was provided to the experiential-education program administrators about the students’ submission materials and/or interview.
 

Extensive drug development and regulatory science training

Selected students were mentored by Pfizer colleagues at the director level and above, across four therapeutic areas (immunology and inflammation, internal medicine, oncology, and rare diseases) as well as global regulatory policy and intelligence and the Pfizer Quality and Compliance Center of Excellence. Like the pilot, the program was offered remotely/virtually and consisted of the following:
 

• Curated drug development training provided through the Pfizer training portal (e.g., FDA Code of Federal Regulation (CFR) related to protection of human subjects (21 CFR 50); institutional review boards (21 CFR 56), investigational new drugs (21 CFR 312); requirements for adequate and well-controlled clinical studies (21 CFR 314.126); regulations for biological products (21 CFR 600).

 

• Regulatory Affairs 101 Training Academy materials to give students an understanding of “a day in the life of a regulatory professional,” with vertical and horizontal matrix working models including other line functional colleagues. This content is delivered live, in a didactic format (recordings made available on-demand), by Pfizer cross-functional colleagues representing regulatory strategy; regulatory advertising and promotion; regulatory operations and labeling; regulatory chemistry, manufacturing, and controls; clinical development; safety; toxicology; commercial; marketing; medical affairs; and health evidence and outcomes research.

 

• Pfizer GRA Learning Academy materials, delivered through a digital training portal and including modules on core elements of regulatory affairs, an understanding of the importance of health authorities globally, insight into regulatory law, guidelines, and positions from an international and national perspective, key considerations for development of different types of products (e.g., small molecules, biosimilars/genetics), and corresponding clinical trial applications (e.g., new drug application, abbreviated new drug application).

 

• Hands-on experience in regulatory strategy, regulatory policy and intelligence, and regulatory quality and compliance through an assigned project with clear program deliverables (Table 2), which included:

• Integration into Pfizer line-function‒specific and broader global cross-functional asset teamss,
• GRA category or therapeutic area team meetings, and
• Project presentation to broad GRA community at the annual GRA Student Research Day.

 

• Structured networking and professional development opportunities with fellow undergraduate and graduate students, cross-functional colleagues, and Pfizer CRGs (e.g., Global Black Community, Latino Colleague Research Group, Global Asian Alliance).

 
 
Pfizer colleague feedback
Qualitative Pfizer GRA colleague feedback outlined in Table 3 suggests that student mentorship provided individual contributors the opportunity to showcase leadership capabilities, the space to contribute to transforming society through DEI partnerships, and the chance to make significant impact toward building an inclusive and diverse talent pipeline.
 
 

CoP administration feedback
Qualitative CoP administrator feedback outlined in Table 4 suggests the Pfizer GRA collaboration was positive and provided a unique opportunity for talented students.
 
 

Student feedback
Student feedback was captured through a voluntary, anonymous, digital Microsoft Forms Survey upon completion of the program. The survey was composed of single-answer, multiple-choice questions (i.e., respondents have to select one answer from a predetermined list of options) and an open-ended question to gain individualized feedback.
 
Overall, students rated the program and the level of support provided by their Pfizer preceptors as “excellent,” when given the following options: Excellent, Very good, Good, Fair, Poor. They noted that the program experience helped them improve their understanding of/experience in regulatory affairs and professional development. All students reported that they are “extremely interested” in pursuing full time-employment at Pfizer within GRA when given the following: Extremely interested, Somewhat interested, Neutral, Not very interested, Not interested at all. Table 5 provides some of the open-ended feedback from students.
 
 

Conclusion
Pfizer GRA has established meaningful metrics that support the overall goal of growing and maintaining a diverse regulatory science talent pipeline, including:

• Expansion of the Pfizer GRA program to include students from all HBCU and PBI CoPs across the US,
• Global expansion of the program to include recent PharmD graduates based in countries other than the US (i.e., Kenya, Nigeria, Hong Kong), and
• Hiring a Pfizer GRA- HUCOP pilot program student after graduation as a full-time employee within Pfizer GRA as a regional regulatory strategist.

 
Converting the Pfizer GRA preceptorship pilot experience into an established program has provided the opportunity for a considerable number of exceptionally talented, yet underrepresented, HBCU and PBI future pharmacists to gain invaluable experience toward pursuing careers in pharmaceutical regulatory science.