Review of the 2018 Annual ConferenceFifty Shades of Outsourcing: The full spectrum of principles and practices that define today’s outsourcing innovation and leadership.

Date: 6-8 June 2018 Location: Grand Hotel Excelsior, Valletta, Malta

Welcome, introduction and review of the PCMG

Richard Scaife and Gill Roberts (PCMG Chairman and Vice-Chair) opened the conference with a review of seismic shifts in the pharmaceutical outsourcing industry. The innovation space is increasingly dominated by small pharma and biotechs, who require different CRO support and services. Consolidation in the CRO sector continues and the future promises much change with continued innovation and greater efficiencies. PCMG will be at the forefront of this evolution, as reflected in the new PCMG mission statement: “PCMG is the industry’s only organisation dedicated to serving the clinical outsourcing community. Led by members, for members, we develop and share best practice for the procurement and management of outsourced R&D services.”

The Biotech journey from start-up to exit: The importance of outsourcing

Dan O’Connor spoke with passion about data being the life blood for biotech companies and start-ups (“without data you’re toast”). CROs are an essential facilitator for the conversion of investment dollars to product development data and therefore effective outsourcing is the key to value-generation within biotechs.

Dr O’Connor reflected on the CRO – sponsor relationship, which is a critical success factor for CROs and biotechs alike. He challenged CROs

DAY 1 08.30 - 08.55 Welcome Richard Scaife (PCMG Chair) and Gill Roberts (PCGM Vice-Chair)

09.00 - 09.45 The Biotech journey from start-up to exit: The importance of outsourcing Dan O’Connor (CEO, OncoSec Medical)

09.45 - 10.30 Strategic outsourcing applied in a small Biotech Heather DiBenedetto (Head of Therapeutic Operations, Moderna Therapeutics)

11.15 - 12.15 Time, Quality, Cost - The race to faster, better & cheaper? Dermot Kenny (Novartis), Chris Moore and Richard Young (Veeva)

12.15 - 12.45 Achieving operational excellence: Are you competent? Jacqueline North and Martin Robinson (IAOCR), Antje Hindahl (PCMG Director)

14.00 - 14.50 Strategic choices when choosing an outsourcing model Adrain Otte (Independent Consultant; formerly Amgen)

14.50 - 15.30 LIFE v 2.0.18 - Artificial Intelligence: Giving data life Andrew Fried (IBM UK)

16.15 - 17.00 “Do good relationships facilitate project delivery?” The importance of instilling the right behaviours to build effective relationships Facilitator: Carl Emerson Panel: Christian Buhlman (PSI), Adrian Otte (Independent Consultant), Heather DiBenedetto (Moderna Therapeutics), Chris Crucitti (Bracket Global)

17.00 - 17.45 PCMG’s Room 101 Chair: Graham Belgrave Panel: Rob Aticheson (Ono Pharma UK), Chris Moore (Veeva), Mark Bee (Covance)

to consider whether they always made their clients feel like a true partner or just another client? “People don’t remember what you said or did, only how you made them feel”. CROs have to decide that they are actually going to care about their clients and Dr O’Connor gave a number of tips of how this could manifest. He also emphasised the need to come with solutions to every potential problem and “..to respect your clients and they will respect you”. Dr O’Connor suggested that biotechs tended to be less price sensitive as long as the CRO was prepared to truly partner.

This was an inspiring talk to illuminate the way forward for CROs and biotech companies to achieve successful partnerships.

Strategic outsourcing applied in a small biotech

Heather DiBenedetto described the unique strategic outsourcing model adopted by Moderna Therapeutics, a US biotech start up. Moderna has a platform technology, which is the basis for a suite of products in different therapeutic areas and different modalities. Development programs are run in parallel and standardisation of methods, systems and processes across the various projects is a critical success factor. Moderna’s decision to outsource strategically was driven by the need for CRO familiarity with the platform technology, the need to constantly refine and share best practice across the programmes and the need for global capabilities.

Heather described biotechs as “a needy bunch” requiring flexibility and

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Dependent upon establishing harmonised, linear, end-to-end processes, working seamlessly with partners and integrating without reservation.

Dermott Kenny described exponentially rising clinical trial costs and suggested solutions for the future, including standardising processes, creating better connections with key stakeholders (investigators and patients) and looking outside the industry for new technologies and processes to improve performance.

Achieving operational excellence: Are you competent?Martin Robinson (CEO, IAOCR) and Antje Hindahl (PCMG Director)

PCMG has developed the first competency framework for outsourcing professionals in the pharmaceutical industry. Comprising 40 core competencies in 12 cluster areas, it reflects the diverse nature of the role. PCMG has designed the “Essentials of Outsourcing” training course to address each of these core competencies. The course delivers learning outcomes for delegates which are pre-defined against learning objectives. The course was over-subscribed in April 2018 and the next course delivery is planned for October 2018. The PCMG trainers (Antje Hindahl, Sandra Johnston, Julianne Hull, Dorte Pedersen and David Davies) were congratulated on their achievement and presented with the IAOCR accreditation certificate.

Strategic choices when choosing an outsourcing model

Adrian Otte asserted that the three most important considerations in outsourcing are standardisation, flexibility and cost. Standardisation of systems and processes across projects is the hardest to achieve consistently and yet correlates with key success outcomes. He argued that functional outsourcing to a small number of strategic partners who are extensively pre-qualified and in whom the sponsor invests to achieve high quality is the best outsourcing model.

There are downsides to the model. Nevertheless, Adrian concluded that functional outsourcing to a small number of strategic suppliers simplified oversight, improved flexibility and lowered both costs and risk.

LIFE v 2.0.18 – Artificial Intelligence: Giving data life (IBM life sciences industry leader for Europe)

Andrew Fried addressed the impact of artificial intelligence in improving the way we conduct clinical trials in the future. He reflected on a dramatic rise in data measurement, retention and manipulation over the last 10 years, requiring a huge amount of processing capability to collect, store and analyse. The challenge is to collect the right data at the right time, analyse it the right way and apply the knowledge to drive algorithms to achieve outcomes that will satisfy regulators, patients and investigators.

Andrew described the current linear process for the conduct of clinical trials and offered a radical alternative based on transformational change towards a patient-centric structure with data analytics and aggregation at the core. One example was the use of cognitive technology (CT) to optimize patient screening for clinical trials in a community cancer practice. CT reduced patient screening time by 78% and allowed early exclusion of 94% ineligible patients.

“Do good relationships facilitate project delivery?” The importance of instilling the right behaviours to build effective relationships

The panel felt that good relationships did indeed facilitate project delivery, but couldn’t resolve everything. There was strong consensus for up-front investment to encourage good relationships between CRO and pharma and with the investigators. This helped to build trust, which was felt to be an essential element in good relations. CRO/Pharma size was not felt to be as important as a culture of mutual respect and trust from the outset. Transparency and shared goals were valuable tools. Heather also commented that there should be no penalty for mistakes!

versatility from their CROs, with greater transparency to assist in long term planning and resourcing. From the CRO perspective, biotechs can make “superfast” decisions due to a flat hierarchy and a culture that allows informal by-passing of formal escalation processes. Some CROs are not comfortable with these requirements. Moderna has a creative, unit price costing model with agreed caps. They have a streamlined contracting model to facilitate early engagement and they recruit staff who are comfortable with a truly open and trusting outsourcing culture. Moderna are getting excellent value from their CRO spend due to their early commitment to a strategic outsourcing partnership and this presentation included lots of tips for successful outsourcing, whether you are in small, medium or large pharma.

Time, quality, cost – the race to faster, better & cheaper? When the demand to reduce timelines meets the need to increase quality meets the ever-reducing budget, who wins?

Three industry experts considered how clinical trial conduct can be improved. Richard Young highlighted persistent trends that undermined faster and more efficient working, in particular time to protocol finalisation and subsequent changes. He recommended streamlined processes connected via cutting-edge communication bridges and managed by teams of integrated, collaborative and engaged people from both sponsor and CRO to provide better outcomes.

Chris Moore described the silo-nature of CROs and pharma and how this compromised quality standards. He recommended quality by design based upon desired outcomes rather than quality by comfort based on perpetuating existing norms of working.

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Heather DiBenedetto addresses the conference

Adrian Otte describes the best outsourcing model

Belgrave, resplendent in a black sequined jacket. Designed by NASA to facilitate re-entry into the earth’s atmosphere (the jacket, not Graham), it will be retained for next years’ event.

Rob Aitchison was duly deemed to have presented the best case and master/servant pomposity was consigned to Room 101. Rob accepted the generous donation of £2,000 for his chosen charity (Ovarian Cancer UK) from Jim Lane of event sponsors Longboat. With thanks to all participants, to Jim Lane and to Mike Ryan drove such a successful and memorable event.

Keynote session: Change survival, management or leadership?

Mergers and acquisitions occur within both pharma and CROs as the industry matures and consolidates. CRO M&A aims to increase return on investment (ROI) through increased net present value or earnings per share. CROs acquire to develop global capabilities, to differentiate their services and/or to broaden their range of services.

It was acknowledged that CROs and pharma are two very different organisations. M&A in CROs happens very quickly with speed an essential requirement whereas Pharma M&A is slower but with greater emphasis on reducing risk. It was felt that sponsors should have risk mitigation plans in place for CRO mergers and that CRO staff and sponsors should embrace the opportunities that CRO M&A brings.

When Freakonomics meets PCMG….tell me something I do not know. What idea will have the most significant impact on our business in 2020?

Three outsourcing luminaries were invited to present an idea that will have the most significant impact on our business in 2020. Dawn outlined the use of Artificial Intelligence to refine computer algorithms on an ongoing basis so that their data processing automatically becomes more relevant and accurate. Dawn also provided the reassuring news that no one would lose their jobs because of AI.

Mary provided an eloquent proposal for wearable devices that would facilitate real time, continuous and remote data collection from subjects enrolled in clinical trials. Such devices would facilitate much greater volumes of data retrieval, with no risks of transcription errors and with none of the time and effort to monitor the data using conventional paper-based systems.

Andy argued that risk-based approaches to conducting trials and product development programmes generally would become more prominent and would be actively encouraged by the regulators to reduce timelines and costs whilst increasing quality of clinical development programs.

There was a split decision as to the winner; the panel voted for Dawn and

DAY 2 09.15 - 10.00 Keynote Session: Change Survival, Management or Leadership? Chairs: Gill Roberts (Bayer), Lewis Cameron (Global Head of Clinical Development, Covance International), James Featherstone (Syneos Health)

10.45 - 11.30 When Freakonomics meets PCMG…Tell me something I do not know? Dawn Anderson (Deloitte), Marie McCarthy (Icon), Andy Lawton (Risk Base Approach Ltd.

11.30 -12.15 How is real world data informing healthcare decision making? Otis Johnson (Icon)

13.15 - 14.00 Change orders: How to minimise the pain of this necessary evil? Andrew Copestake (Chief Business Development Officer, TFS Ltd.), Dave Webber (Clinical Contracts and Finance, Gilead Sciences)

14.00 - 14.45 Keynote Session: External perspective on defining scope and managing budgets to drive transparency and build trust. Applying the lessons learned from complex infrastructure projects Simon Taylor (COO, Th3rd Curve)

14.45 - 15.00 Close David Davies, Sandra Johnson

PCMG Lifetime achievement award 2018

This was a new initiative in 2018; the chance for the PCMG Committee to recognise and reward a person who has made a significant contribution to outsourcing over the years and to the growth and development of PCMG. There was unanimous support for Jean Edwards as the first recipient of the PCMG Lifetime achievement award.

PCMG Room 101

This traditional, end of day 1, tongue in cheek event turned into a tight-jawed affair with the three protagonists presenting their cases for consignment of pet hates into Room 101. Rob Aitchison gave a stinging condemnation of the master and servant relationship perpetuated by some sponsor companies in their dealings with CROs and which he represented with the cast of Downton Abbey. Rob was determined that such behaviours were out of date, out of touch and out of the question and he found a rich vein of empathy amongst the audience.

Mark Bee described bid defence meetings as ineffective, inefficient, unrepresentative and expensive. However other CRO people apparently love the drama of the bid defence and outsourcing experts in the room also thought the bid defence to be a valuable part of the selection process. Nevertheless a worthy effort delivered with good humour and astute observations. Chris Moore nominated clinical trial nurses to be consigned to Room 101. Initial resistance softened when he explained that nurses were much more valuable caring for the sick. This admirable effort was unfortunately a little too oblique for the audience, but a virtuoso performance all the same. The whole affair was magnificently chaired by the ever-stoic Graham

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Room 101 winner Rob Aitchison receives a donation of £2000 for Ovarian Cancer UK from Jim Lane

Jean Edwards receives Lifetime achievement award from Chairman Richard Scaife

most prevalent reason driving change orders and there was a general consensus that sponsors should attempt to finalise their protocol and scope before agreeing the price. There were also pleas for fixed price contracts that included risk mitigation steps as well as risk sharing. The presenters encouraged sponsors to have a process for dealing with change orders and to share this with CROs from the start.

Keynote session: External perspective on defining scope and managing budgets to drive transparency and build trust. Applying the lessons learned from complex infrastructure projects.

Simon Taylor has managed large construction projects, such as London Cross Rail. He described the lack of trust between sponsor and contract builder, with a focus on tracking, measuring and reporting progress and with a prevalent blame culture. However this was changing.

The construction industry uses risk modelling tools to identify risks and to predict and quantify impacts. They also use software tools to break projects down into clearly defined work structures using integrated terms for consistency and traceability across

work streams. And yet more software tools for benchmarking activities against industry standards. It was very important was that everyone working on the project should be very clear about what the desired outcomes were and how they were to be achieved. Regarding contracts, ST strongly endorsed the use of the New Engineering Contract (NEC), which is increasingly being adopted by the construction industry and contains themes that are applicable to other outsourcing industries.

Wrap up and close

Richard Scaife thanked the speakers, the sponsors, the steering committee, the chairs of the various sessions and finally the audience for their attention and inspired company.

AI whilst the delegates voted for Marie and wearable devices.

How is real world data informing healthcare decision making?

This was a fascinating insight into the challenges of collecting, analysing and drawing conclusions from the increasing volumes of real world data. Otis championed patient-centricity in designing clinical trials and the need to allow patients to share their journey to ensure that protocols are relevant. He also argued that organisations should be prepared to embrace failure as an inevitable requirement if lessons are to be learned and improvements made in the future. Otis gave examples of where real world data had been used to refine clinical trial eligibility criteria and thereby to save large amounts of time and money in helping to reduce the recruitment phase duration. Such interventions are extremely valuable.

Change Orders: Necessary evil or avoidable pain?

These two highly experienced professionals provided an informative overview of change orders from their different perspectives. A pre-conference survey had indicated that 96% of delegates reported change order volumes staying the same or increasing over the last 3 years, whilst only 3% responded that change order volumes had decreased. The importance of setting realistic expectations and agreeing a clear scope of work at the outset were emphasised.

Nearly half of the respondents had strategies in place to reduce the incidence of change orders. Sponsor changes to protocol was cited as the

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Members of the conference steering committee take a bow

The final announcement was that the theme for the 2019 PCMG Conference will be “Navigating the 7 C’s of outsourcing and procurement: Consistency, Continuity, Consolidation, Collaboration, Change, Complexity & Competency”. It will be held on 5-7 June at the Melia Hotel, Sitges, Barcelona.

Put it in your diaries now!