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Evolving Your FSP Relationships to Achieve Maximum Return.pptx
- 1. Evolving Your FSPRelationships to Achieve Maximum Return © MMS Holdings 2021
- 2. 2 Our Presenters Donnelle LaDouceur Director,Functional Service Solutions Liz Valley-Burr Manager, Project & Account Management Alan Nicolle Senior Director, Europe & South Africa Operations © MMS Holdings 2021
- 3. Agenda • Introduction • Dynamicindustry & outsourcing models • FSP foundations for adaptability • Filling the skillset gap • Efficiencies in cross-functional FSP engagements • Case study: Evolution of an FSP relationship • IR35 challenges and FSP options • Key messages © MMS Holdings 2021
- 4. 4 Pharmaceutical Industry Mergers& Acquisitions © MMS Holdings 2021
- 5. 5 Impact of theRace to COVID Vaccines and Treatment • Resources (manpower and financial support) shift to COVID programs • Other TA programs delayed, cancelled, or put on-hold • Rapid scale-up in team size – How? Outsourcing Partners • Sponsors and their partners had to quickly shift and adapt © MMS Holdings 2021
- 6. 6 Impact of theRace to COVID Vaccines and Treatment © MMS Holdings 2021
- 7. 7 A Modern FSPRelationship that Ensures Performance • The attraction of the FSP model lies in the flexibility it offers to become a unique solution to each client – It is a scalable model, allowing clients to adequately resource their departments in line with increased or decreased support requirements in real time – No additional burden of HR processes, such as hiring and onboarding, associated with permanent headcount. – The ability to augment the talent of an internal team • Clear advantages to using the "a la carte" outsourcing model that offer access to functional specialists • Shared accountability - the partner relationship is a priority © MMS Holdings 2021
- 8. Advantages of anFSP Model 8 • Long-term commitment • Stronger relationships, better collaboration • Shared expertise and industry experience • Continuity in relationship management and responsiveness to requests • Integration and Innovation True Partnership • Service provider choice • Resources and skill sets • Pricing models • Governance • Geography Flexibility © MMS Holdings 2021
- 9. 9 Today’s Challenge –Innovation means Innovative Roles We are looking to innovate. To leverage new methodologies and this means adding talent with new or emerging skill sets in our industry. At times I feel like I am searching for a unicorn. - Large Pharma, Biometrics Leader (RWE, Data Analytics) We have created positions that combine elements of several different functions, and this talent is hard to find. Our goal is to operate under an FSP model, but we cannot have our internal teams training to fill a skills gap. This means we give up the FSP advantages. - Large Biotech, Procurement (Computational Sciences) © MMS Holdings 2021
- 10. 10 Evolving Job Descriptions DataScientist Clinical trial data Strong JavaScript and HTML Advanced tidyverse/ggplot2/plotly Scalable Vector Graphic (SVG) Advanced interactive R-Shiny plots Advanced D3.js for animation Document Object Model (DOM) Statistical analysis, GitHub Senior Statistician Trial Statistician Exploratory work (ML and R Shiny) Med Affairs/publication support HEOR experience © MMS Holdings 2021
- 11. FSP Build-to-Suit Full contributor Client Work &Train the Gaps Deploy to Client Assess & Hire the Talent Identify Desired Skills Investing short-term to meet our Sponsor’s long-term needs 2 - 12 months Build-to-Suit* * Time required dependent on background skills and training required © MMS Holdings 2021 11
- 12. 12 Key Wins • Sponsoracquires hard to find talent without the burden of hire, train, and mentoring • Sponsor opportunity to lead and develop versus taking from somewhere else • Top talent gets free training and hands-on experience to explore Life Sciences, potential career path – contributes to greater job satisfaction • FSP and Sponsor develop expertise in critical skills needed to lead ongoing industry innovation © MMS Holdings 2021
- 13. 13 Efficiencies in Cross-functionalFSP Engagements Most FSPs have expertise in multiple core competencies. Efficiencies can be realized when sponsors utilize an FSP partner across more than one function, particularly when those functions hand-off to each other. • MSA, NDA, relationships, and governance in-place • Established sponsor systems knowledge and access • Understanding of sponsor culture • FSP in-house expertise to guide training, onboarding – Trouble-shooting support Reduced cycle time is a significant but indirect cost saving enabling sponsors to get drugs to market sooner and in a more cost-efficient manner
- 14. 14 Efficiencies in Cross-functionalFSP Engagements Cross- functional • Data Mgmt Programming Biostats Medical Writing • Programming Medical Writing QC Publishing Advantages • Ease of communication – Direct and more accessible – Time efficient – Error identification/resolution • Collaboration to achieve deadlines – Delays or more time needed by one functional line can be absorbed/negotiated seamlessly across functions • Tools/templates lend themselves to this model (MMS tech enabled Smart Templates for example) © MMS Holdings 2021
- 15. 15 Efficiencies in Cross-functionalFSP Engagements Example Medical Writing Publishing (Reg Ops) • Hand-offs, MW provides Reg Ops source docs on a rolling basis • Publish in advance, reducing timelines, enhancing quality & resource planning • Reg Ops interact with MW for questions rather than sponsor teams • Reg Ops access to MW documents, can answer their own questions without involving MW • MW can ask Reg Ops questions throughout the writing process (linking strategies and source docs to provide) eliminating issues with publishing. © MMS Holdings 2021
- 16. Case study: Evolutionof an FSP Relationship © MMS Holdings 2021
- 17. Growth and Adaptability ©MMS Holdings 2021
- 18. IR35: Implications andCompliance in 2021 © MMS Holdings 2021
- 19. 19 • More commonlyknown as IR35. – Important to note this is not new legislation, but a ‘tweak’ to existing legislation • Affects all UK-based contractors/freelancers • “Disguised Employment” is the key focus • Main scope of the 2020 revisions; – It is now the Organization’s responsibility to determine where the tax liability falls – Liability applies across the entire supply chain, so HMRC could hunt for the liability HMRC. Press Release 35 Countering Avoidance in the Provision of Personal Services, 1999 © MMS Holdings 2021
- 20. 20 What is this'Liability'? • If a Contractor is deemed to be working within the scope of IR35, then they will be liable to pay income tax and NIC as if they were an employee • The Employer will then also become liable for the equivalent NIC and tax contributions • These amounts form the ‘Liability’ that are the HMRC can ‘hunt’ for up and down the supply chain • Net result is that the cost of using a Contractor increases significantly Contractor Staffing Agency FSP Provider Sponsor Client HMRC $$$ © MMS Holdings 2021
- 21. 21 Ensuring Compliance withIR35 • Establish and document a firm business need for a Contractor • Review and modify Contractor working practices where necessary – Key areas to focus on include; • Supervision, Direction and Control • Substitution and Mutuality of Obligation • Onboarding, Training and Continuing Professional Development • Contractor engagement is still a commercially viable business model • Be aware of the Staffing Models available and select a FSP Partner that can satisfy the needs of your business © MMS Holdings 2021
- 22. 22 Key Webinar Take-Aways MaximizingFSP partnership advantages through: • Scalability to support evolving and rescue needs • Innovative solutions to meet technology changes and talent gaps • Cross-functional efficiencies resulting in reduced cycle time • Capitalizing on the established trust relationship to evolve together • IR35 solutions © MMS Holdings 2021
- 23.
Editor's Notes
- #5 There’s a saying that the only constant is change and this is certainly true in the Pharmaceutical and Biotech world. There are massive changes within the industry that effect entire organizations. Obvious examples of these macro-level changes are mergers and acquisitions. [3 animate clicks] But large, high-profile drug programs can also have organization-level impacts. We’ve certainly witnessed that this past year with the race to develop Covid treatments and vaccines. https://pharmanewsintel.com/news/astrazeneca-to-acquire-alexion-in-39b-pharma-deal https://pharmanewsintel.com/news/eli-lilly-signs-800m-deal-to-acquire-prevail-therapeutics Jazz Pharmaceuticals to Acquire GW Pharmaceuticals plc, Creating an Innovative, High-Growth, Global Biopharma Leader
- #6 Each of the COVID efforts impacted multiple other programs within each Sponsor organization. Resources – both people and budget were shifted to support the program resulting in other Therapeutic area programs being delayed, cancelled, or put on-hold. Oftentimes, more than just a shift of resources was needed, more manpower was required in very short-order to meet extremely expedited timelines How did they meet these needs? [animate click] Vendor partners (either existing or new) were tapped to quickly scale-up to meet the needs. [Click] These were large, coordinated, interdependent efforts to shift, scale, and adapt.
- #7 Whether the COVID campaigns were successful [2 clicks] or dropped for not meeting safety or efficacy targets [1 click] - all had further ripple effects throughout the companies themselves and their vendor partners. Continued increased levels of resourcing may be required to support further development as well as re-engage other TA programs that were delayed or put on-hold to focus on the COVID programs. For those programs that were abandoned, internal headcount is usually retained first, and the burden of any excess becomes a reduction in team size for the vendor partners.
- #8 But this is where the FSP relationship shines. These are exactly the scenarios they are meant to be able to address. - Scalable model: An excellent example of the ability to scale and adapt over time will be demonstrated in the case study that Liz will be sharing with us shortly. HR processes: The recruiting, qualifying, and hiring process, as we know, can be a challenge, this time and effort falls to the FSP. “a la carte” approach: This second bullet references the consistent findings from multiple industry surveys that quality and retention are increased when using an FSP model versus a full-service outsourced model And finally, FSP governance and executive-level commitment to the partnership results in shared accountability.
- #9 This slide just summarizes some of the advantages of the FSP model specifically in the categories of Flexibility and providing a True Partnership. In addition to the scaling – FSPs also offer flexibility in these areas. The true partnership component brings many advantages. We’ve already touched on the commitment to do whatever it takes to scale, the remainder of topics in this webinar also reflect the benefits of an FSP partnership.
- #10 As technology and data sources continue to evolve, so do the requests for talent. Shown here are a few quotes from industry executives. The new technologies combined with the new data sources and desires and needs for more and more real time and visual analytics - including animation and interactive dashboards - make it nearly impossible to find talent that checks all the boxes on the new “job description wish lists”. Everyone is struggling to fill these roles, both Sponsor organizations and CROs.
- #11 These are some examples of what we’ve seen in industry job descriptions. I’ll start with the Stats job description, which usually requires 5 – 10 yrs of experience. They say 5 but really mean 10 as those candidates with 5 years will generally get rejected. [Click through list]. Trial statistician … okay But…. We also like…. And…. Health economics and outcomes research experience. That’s usually 2 – 3 individuals Data Scientist requirements as you can imagine, are much more varied and extensive. [Click through list] …. And…. Clinical trial data. As the RWE and Data Analytics Leader was quoted as saying in the previous slide - Sometimes it feels like you’re looking for [Click] the proverbial Unicorn. So how to meet these talent gaps? Some of the larger sponsors have committed time and resources to creating innovative programs to develop this talent internally. But what if you’re a smaller company without the budget to do so, or if the internal program at your organization is too broad and isn’t specific enough to meet your talent-gap needs?
- #12 At MMS we’re working to develop talent and fill these gaps in partnership with our sponsors and also universities in a variety of different models; I’m showing one example here. This example could potentially be a candidate from another industry who already possesses some or all of the higher level skills required but lacks pharma industry or clinical data experience. A university grad or intern path would look different. To embark on something like this, it’s beneficial to have a level of trust as both parties need to have skin in the game to make this successful which is why an FSP relationship is valuable for this type of shared venture. Desired Skills List From Sponsor discussions and Industry knowledge Per Sponsor specifications MMS identifies candidates, accesses skills, and hires them The next step shown here is to start working immediately for the sponsor team but this is situation dependent and may or may not be possible right away. The level of the candidate and requirements of the work will determine whether or not there are contributions the candidate can make immediately. If there are, they can start project work right away while concurrent training happens. If not, there can be a period of initial training until the candidate can start supporting sponsor project work. 4. This is targeted training to address any skills gaps (in addition to standard training) 5. Initial support of sponsor project work is under the supervision of an MMS mentor who also provides management oversight – the level of which is determined by the strength and experience of the candidate. 6. Eventually the candidate transitions to a full and independent member of the team. All of these steps are moved through with collaborative discussion and input between MMS and the sponsor partner.
- #14 So far we’ve covered evolving your FSP partnerships for Maximum return through the ability to scale – both up and down – and also to find innovative and creative ways to develop talent to meet expanding needs. I want to cover one more way to maximize return in your FSP partnerships before handing off to Liz. [Click]
- #15 Some logical cross-functional examples of where efficiencies could be realized by using the same FSP partner for these functions. Some of the Advantages we’ve experienced when working across MMS functional lines is the ease of communication affecting multiple levels. Internal colleagues are more accessible and can be more responsive - communication can be direct and informal (ie, IM, phone call, or in-person pre-COVID). This is very helpful where there are questions about the data, statistical analysis, or how to interpret the statistical results. Time efficient: Any time delays in query/response time are removed or reduced. Error id/resolve: With errors, say for instance, the MW identifies an error, this can be communicated and resolved more quickly when the functional lines are within MMS · We’re also better able to collaborate to achieve deadlines (for example if there are delays or extra time is needed by one of the MMS functional lines) we can negotiate internally and make this seamless without affecting the overall timeline. Additionally if unexpected time off arises, it can be mitigated within the MMS team.
- #16 The expansion across functions does not need to be as broad as the multi function examples in the previous slide in order to reap efficiencies. Here’s an example of benefits seen with just MW to Reg Ops Efficiencies in handoff with the medical writer providing reg ops with source documents for publishing on a rolling basis. Since the medical writer is receiving source docs and uploading to SPO long before the client normally involves reg ops in the process, reg ops can publish in advance, reducing publishing timelines and enhancing quality and resource planning. When Reg Ops has access to MW documents, they can research the ans to their own questions without involving the MW. It is more efficient for reg ops to interact with MMS medical writers on questions about external link targets and missing documents than reach out to client teams to determine the correct POC and schedule time to discuss. Further upstream, MW is able to ask reg ops questions throughout the writing process to determine linking strategies and what source documents need to be provided in order to prevent eventual issues with publishing. Not shown here but there are also efficiencies within a functional area that seem obvious but aren’t always taken advantage of. Within Medical Writing there’s a progression of Protocols ICFs CSRs Submissions Often, FSPs can be contracted for Protocols but not the ICFs. Those go hand in hand and efficiencies can be gained especially as you start to get into amendments. And of course, additional efficiencies can be realized extending support to include CSRs and submissions. This concludes my piece of the webinar, Thank you for your time and attention exploring these opportunities to maximize return on your FSP partnerships. I’m going to hand it over to Liz for a real world example.
- #18 RMPs: steady increase/growth Protocols and ICFs: rapid start, steady increase QC of Documents: steady increase Document Redaction: rapid start and demonstrate flexibility Lay summaries: steady increase/growth Case Management Support: rapid growth to meet short term need Regulatory Information Management: rapid start, steady increase