pre-conference workshop day and early registration · clinical trials at the patient’s home : how...

P r e - c o n f e r e n c e W o r k s h o p D a y a n d E a r l y R e g i s t r a t i o n

Monday 20th May 9:00 – 11:00

Trade Compliance Workshop – Navigating the Regulatory and Import/Export LandscapeThe Clinical Trial Supply arena is a highly regulated environment. Navigating these troubled and unpredictable waters is challenging, and requires constant process updates.Just when you thought an international shipment was easy & straightforward, you discover that you or someone else is carrying the responsibility to ensure the content of this shipment leaves the country of departure and enters the destination country with the accurate documentation, mentioning the right description (vs. the Import or Export License e.g.), the right classification (equals right taxes), the correct value (1USD? Really?), the agreed Incoterm, the Importer of Record (IOR)…But do you know who the IOR really is, or are you just putting your local affiliate because you always to it for every trial? Is there a CRO involved, and is the CRO the IOR?What strategy do you put in place to address these responsibilities, discover who the IOR really is, or be sure you have your documents reviewed by the responsible party? This session will provide you with an understanding of Trade Compliance, and the roles & responsibilities needed to safely navigate international Clinical Trial Supplies waters.After the Workshop you should:

L Understand what the Importer of Record (IOR) responsibilities areL Examine how to find out who the IOR isL Assess a few different methods to ensuring a compliant shipping documentL Identify the main Incoterms and how they interrelateL Set-up a Trade Compliance department, if you don’t have one yet…

Bernard Jaucot MSc., MPharm. Clinical Trial Supply enthusiast, enjoying 23 years in Clinical Supplies in both Pharma (Eli Lilly & UCB) and CROs (Covance & PPD), of which the last 10 years with PPD. Touched on all aspects of the business, even Quality (Novartis), and currently heading the support department of PPD’s Global Clinical Supplies (GCS), responsible for import/export, project finance support, developing and managing training and SOPs, implementing large projects, like electronic inventory management systems for PPD’s Clinical Supplies GMP Facilities, Trade Compliance

11:00 – 11:30

Coffee Break

11:30-13:30

Clinical Trials At The Patient’s Home : How To Practically Manage Direct To Patient Models For Patient Centric CTS

In this interactive and hands on workshop, participants are invited to consider the changing nature of clinical trial delivery and patient involvement. The rising use of virtual trial and direct to patient models will be examined and practical takeaways identified for any type of company. Participants will also be taken through a series of real life case studies to clearly define the implementation process and challenges for all types of pharma and CT companies.In this session you will:L Analyse where the industry currently is in adopting in-home and virtual trialsL Understand the practicalities of the regulatory and data privacy situationL Identify technical solutions to enable in-home trialsL Examine a series of real life case studies: Participants will develop clinical supply strategies and solutions for

real in-home clinical trials

Dr. Andrea Zobel, Senior Director, PAREXEL Academy Andrea Zobel initially joined PAREXEL in 2004 as Clinical Logistics Manager - Head of Clinical Trial Supply in the newly-founded PAREXEL Clinical Logistics Services. In her initial years with the company, Andrea significantly contributed to building up the Clinical Trial Supply services, including the expansion of a global depot network. By the time she moved on from PAREXEL, Andrea had reached the position of Director, Clinical Logistics Services Europe (EMEA), leading Clinical Trial Supply, Ancillary Supply and Laboratory Logistics Services. In her subsequent role at Marken Ltd, she went on to hold the position of Vice President, Global Clinical Trial Distribution and was heavily involved in developing clinical distribution services.2018 saw Andrea start the role of the Global Head of the PAREXEL Academy, PAREXEL’s education institute for clinical research.

Pia Schmidt, Client Relationship Director, PAREXEL International Pia Schmidt currently holds the position of a Client Relationship Director at PAREXEL’s Commercial Department. In this role she supports strategic Partnership setup in regards to clinical logistics. She develops and implements strategic portfolio level logistics processes to increase project efficiency, employ cost savings and ensure high quality deliverables for the clients. Having gone through the entire clinical trial supply process herself – from Clinical Logistics Associate taking care of every day clinical trial supply tasks, through managing several clinical logistics projects as Logistics Manager and Leader up to implementing and executing Portfolio level oversight function in the same area, Pia has a profound knowledge of all aspects that clinical logistics is most concerned about.

www.asdevents.com - www.asdevents.com/event.asp?id=20305

P r e - c o n f e r e n c e W o r k s h o p D a y a n d E a r l y R e g i s t r a t i o n

Monday 20th May

13:30 – 14:30

Lunch Break

14:30 – 16:30

Planning For The Future Of Clinical Trial Supply – Politics, Leadership, New Markets and Budget Cuts

In this interactive afternoon seminar attendees will discuss the changing landscape of clinical trial supply and the external influences set to impact our supply chain over the next 12-24 months. With a focus on the impact of Brexit and other political factors, the increasing industry pressure on lean supply chain management, budget cuts, smaller headcount expected to do more with less, as well as the increasingly digital nature of our supply chain management – participants will be tested to identify their biggest challenge of the next 12 months and the questions they need to answer over the next two days to put in place a sustainable roadmap to success to manage the change with their people and stakeholders.

In this session you will understand:

L How the global political climate has altered our clinical trial supply strategy, the challenges that this has presented and the importance of agility, listening, teamwork and innovation

L How to plan for the increasingly digitalised nature (AI and Blockchain) of our supply chains – and how to internally manage the changes that this supply chain transformation requires and the stress it creates

L Where our standard protocols need to be adjusted, our stakeholders influenced, and our sponsor-vendor relationships improved to prepare for the supply landscape of the futureSteve Jacobs, President, Global BioPharm Solutions Mr. Jacobs is a successful trainer, business leader, consultant, executive coach and speaker. He’s been heavily involved in clinical supply chain operations, IMPs, cGMPs, cGCPs, clinical development and quality for pharmaceuticals, and biotech products. He sits on the Board of Directors of the largest professional clinical supplies organisation in the world, the Global Clinical Supplies Group. His expertise also includes success in innovation, global cultural dynamics, organisational development, and high performing teams. He has presented globally on leadership, management, forecasting, planning, creativity, making global teams successful, emotional intelligence, generational differences, human error prevention, clinical supplies logistics, project management, problem solving and contract negotiations.

In the past he has been the CEO and COO of a start up company as well as the president and Global Chief Operating Officer of a multinational contract organization that served companies like Novartis, Eisai, Lilly and others in the pharmaceutical and biotech sector.

16:30

Drinks Reception and Early Registration

PharmaIQ welcomes you to the 2019 Clinical Trial Supply Forum with welcome drinks and a chance to register early to beat the queues next morning! Collect your name badge and all information for the forum for the following days ahead of the rest of the delegation.

Get to know your fellow delegates and start the networking early!


F I N D YO U R S E S S I O N !Look out for the icons below, they'll help you get around the programme, indentify panel sessions, case studies, tracks, networking sessions and more!

Panel Discussion

Roundtable Discussion

Case Study

Keynote Address

Networking Session

Live Polling

c o n f e r e n c e d a y o n eTuesday 21st May

8:30 Registration and Coffee

8:55 PharmaIQ Welcome

9:00 Chairman’s Opening Address

Steve Jacobs, President, Global Clinical Supplies Group

9:10 People Bingo: Interactive Speed NetworkingA highlight of Pharma IQ events, now at CTS 2019! Be ready to meet your peers and share best practices. You will have several 2 minute conversations to enable you to introduce yourself to your peers and add to your contact pool. There is a prize in it for the winner so get networking!Please Share:1. Who you are 3. What you plan to achieve from attending this event2. The scope of your job role 4. Your #1 challenge

9:30 Keynote Address: Blockchain - Buzz Word Or Breakthrough? L Analyse the applicability of blockchain within the clinical supply chain – where should you be looking for implementation? L Examine the path towards implementation - what is the status of adoption? – planning, implementation or testing stages? L Discuss the proposed benefits of blockchain – traceability, accountability, compliance – and compare with Novartis’ experience in

implementationFrancesco Spoto, Master Site Manager, Novartis

10:10 Just In Time Manufacturing (JTM) – Optimising Flexibility And Adaptability In Clinical Trial Supplies L Understand the application of JTM in optimising your clinical trial supply strategy L Identify the key considerations for incorporating a JTM strategy for your company L Examine the benefits of a JTM strategy – including risk mitigation, continuous supply, waste reduction and extending clinical life

Natalie Balanovsky, JIT Manufacturing Solutions Manager, ALMAC

10:40 Coffee and Morning Networking Break

11:10 Open Floor Debate: The Brexit Effect – What Has Happened And Where Are We Now?With your colleagues we will be looking into the industry’s preparation for Brexit and alternative supply routes that could prevent timeline delays and minimise additional costs.In addition, we will review what we now know about the impact and cost of Brexit post March 2019 Facilitator: Steve Jacobs, President, Global BioPharm Solutions

Stream A:Planning And Forecasting Stream

Stream BCommercialisation Stream

11:40 Optimising Your Clinical Trial Supply Forecasting And Demand Planning Through Innovative IT Solutions

L Discuss how innovative IT solutions can reduce the pressure on forecasting accuracy and risk mitigation

L Manage the utilisation of your clinical supply and trial data to generate visibility of your supply chain pressure points

L Build your supply strategy and protocols around software implementation to generate an efficient and robust supply model

Ahn Louise Larsen, Senior Supply Chain Specialist, CMC Clinical Supplies - Supply Chain Optimisation and Solutions, Novo Nordisk

Global Standards For Clinical Trial Kit And Component Identification Across The Supply Chain

L Analyse the industry move towards standardisation and what it means for the efficient supply of clinical trial products

L Discuss global traceability standards within the clinical trial space and how a move to standardisation could benefit regional market compliance

Tania Snioch, Healthcare Director, GS1

12:10 5 minute change over


12:15 Looking Beyond The Basics: Why Forecasting Needs To Be Flexible To Be Accurate

L Identify the critical success factors of inventory planning and forecasting models

L Ensure you are incorporating unexpected supply differentials such as resupply and regional market shipment timelines into your forward planning

L Analyse your supply chain visibility and the importance of monitoring supply across the study

Buz Hillman, Associate Director, Clinical Supply Systems and Strategy, Janssen

Clinical Supply Optimisation Beyond Simulation L Defining ‘Optimisation’ in the CTS reality – why it needs to be

more than just a mathematical model L Examine the key pain points you need to consider for end to

end supply optimisation L Discuss the reality of implementation for leading simulation

and forecasting models L Define your supply KPIs as a means of creating internal and

external alignment around your program control and supply visibility

Philippe Verlaine - Head of Global Clinical Supply Optimization, Global Clinical Trials Supply, UCBPending final confirmation

12:45 Networking Lunch Break

13:45 Live Poll!Use this opportunity to interact with your peers about the key points being discussed so far and share your opinion with everyone in the room! Live feeding through our app and polls will give you a 360˚ insight on what the industry’s opinion is!

14:05 LEAN Transformation in Modern RTSM L Reduce waste in effective collaboration between sponsor and vendor L Apply PDCA (Plan-Do-Check-Act) in RTSM setup and validation L Understand how Process Maps, Value Stream and SIPOC diagram strengthen partnerships and minimize communication

challenges L Discuss the importance of meaningful KPIs to monitor your RTSM

Jan Pieter Kappelle, Vice President, Strategy, 4G Clinical

14:35 Interactive Discussion Groups: 2 RotationsDuring this part of the forum, delegates will be sorted into small working groups to take part in interactive discussions around the topics below. Delegates will get the opportunity to select and pre-register for two topics and will rotate between each 30 minute IDG. Discussion groups are kept small to ensure all delegates get the opportunity to ask their most pressing questions, ensuring a perfectly tailored experience.

1. Direct To Patient Models For Patient Centric Clinical Supply ModelsDr. Andrea Zobel, Senior Director, PAREXEL Academy

2. Harmonising your CTS Strategy to Effectively Ensure Global Trade ComplianceBernard Jaucot, Director Process & Systems Optimization (PSO), Global Clinical Supplies, PPD

3. End To End Planning Of Clinical Trial SupplyKamal Amin (Ph.D), Senior Clinical Supplies Manager, Fujifilm Kyowa Kirin Biologics Co. Ltd

4. Improving Temperature Controlled Logistics In The Clinical Trial Supply ChainAyelet Weissbach, Clinical Supply Chain Manager, NeuroDerm

5. Incorporating Flexibility To Future Proof Your ForecastingBuz Hillman, Associate Director, Clinical Supply Systems and Strategy, Janssen

6. Managing The Challenge Of Efficient Supply To Increasingly Regionalised Clinical SitesDidier Basseras, Vice-President, Global Head Clinical Supply Chain Operations, Sanofi R&D

7. Mapping The Adoption Of Digitalization Through The Clinical Supply ChainElisaveta Frenkel, Master Production Planner & CMO Supply Manager, F. Hoffmann-La Roche AG

8. Mapping The Import/Export Process in a Global Study SettingLeon Dzivinsky, Vice President & Senior Legal Counsel, PRA Health Sciences

15:45 Afternoon Coffee Break

Stream A:Partnership Stream

Stream B:Data Management Stream

16:15 Incorporating The Unexpected Challenge Of Investigator Initiated Trials

L Understand the parameters of investigator initiated trials – when and how they can occur

L Discuss the realities of implementing investigator trials on the ground

L Identify key factors for trial success from an implementation perspective: what can you do to make our lives easier and get your trial to the front of the line?

Samantha Carmichael, Lead Pharmacist Clinical Trials / R&D, NHS

Optimising The End To End Utilisation Of Your Clinical Supply Data Framework Whilst Maintaining Regulatory Compliance

L Understand the role of third party suppliers in data generation and utilisation

L Identify the key tools available to improve your data evaluation

L Utilise your data to safeguard for global regulatory compliance

Bjoern F. Rath, Supply Chain Management Executive, GS1




16:50 Pluristem's Hip Trial Challenges- How To Solve an Unmet Need Through Efficient Clinical Supply Strategy

L Examine the benefits and risks to current partnership models used across the clinical supply chain

L Evaluate the critical success factors to enhance transparency and ensure alignment from sponsor and vendor

L Identify ways that you can manage partnership relationships across the trial lifecycle to ensure continued process and delivery alignment

Boaz Leshem, Vice President Operations & Manufacturing, Pluristem Therapeutics

Incorporating Clinical Site And Global Patient Feedback Into Your Clinical Supply Program

L Designing our global clinical supply chains continues to be complex process. Flexibility is often the key to efficiency, but what impact could that have on study recruitment and retention and what could you do to mitigate this?

L Appreciate the global study challenges around patient retention and recruitment.

L Identify what challenges clinical sites face when considering IMP’s

L Discuss what patients are saying about their IMPs on a global scale, and compare and contrast results from 4 regional surveys (US, EU, China and Japan)

Esther Sadler-Williams, Managing Director, SIMPLYESW


17:45 Chairman’s Closing Remarks


18:30 Networking Drinks ReceptionRelax and unwind at our famous games themed drinks reception which will give you the opportunity to network with your peers over a few drinks while trying your hand at a range of games with some exciting prizes up for grabs.



8:30 Registration and Coffee

9:00 Chairman’s Recap of Day One


9:15 Incorporating The Patient Perspective On European Trials – Where, When And How? L Discuss the realities of running oncology trials in Europe: market and patient pressure L Examine the current patient registration limitations and study protocol limitations for European trials L Analyse the role of a patient centric approach to trial management as a driver to trial retention and patient engagement

Annick Bessems, Director Global Trial Management and GCDO Program Leader- Oncology, Janssen

9:50 The Case For Orphan Drugs And Their Development In Your Supply Chain L Review the unique challenges of early access programmes within the clinical supply paradigm L Examine the benefits of early access programmes for generating real world clinical data to complement your trial data sets L Discuss the impact of early access program results in generating strong value based pricing and approval applications

Ana-Zeralda Canals DPhil, Preclinical and Supply Chain Manager, Sanifit

10:25 Managing An Efficient Clinical Trial Supply Strategy For Rare Disease Clinical Trails L Discuss the ways that Alexion are approaching the challenge of supplying CTS for rare disease clinical programs L Analyses how to manage risk of IP stock out with limited drug expiry L Examine how to create a lean and efficient product supply strategy for multi country trials with a very small patient enrolment

Rawle Dundas, Associate Director, Global Clinical Supply, Alexion Pharmaceuticals


11:15 Coffee and Morning Networking Break

Stream A:Strategic Stream

Stream B: Operational Stream

11:45

12:15

12:20

Change Management: How to Minimise its Effects L Examine the importance and benefits of team buy in before

implementing organisational change L Analyse common change management strategies and how

they can be adapted to the time sensitive and high pressure nature of the clinical trial supply industry

Steve Jacobs, President, Global BioPharm Solutions

5 minute change over

The Practicalities Of Running Clinical Trials In Emerging Markets: Supply and Enrolment Challenges

L Understand the Patient Reality in Markets Such as India and Africa

L Discuss the similarities and differences in running efficient trials across the African and Asian regions, in comparison to traditional western markets

L Analyse the strategic considerations and challenges that companies need to prepare for before entering into these emerging markets with clinical trials

Nancy Meyerson-Hess,Chief Compliance and Regulatory Officer,

eMQT

Reverse Logistics – Where Product Returns And Destruction Fit Into Your Supply Strategy

L Discuss the importance of considering the end to end lifecycle of your clinical supply when looking to implement a lean supply model

L Minimise unforeseen costs by creating a flexible product return and destruction strategy

L Analyse your trial supply reconciliation requirements to ensure end to end alignment in supply management

Tatjana Vorobjova, Global Manager Investigational Product Supply And Global Logistics, Celgene


c o n f e r e n c e d a y T W OWednesday 22nd May


c o n f e r e n c e d a y T W OWednesday 22nd May

Stream A:Strategic Stream

Stream B: Operational Stream

12:55 Panel Discussion: How To Balance Cost And Efficiency Within The Clinical Trial Supply Chain

L Discuss the importance of ensuring that investment generates equal or greater process efficiency to outweigh cost

L Pin-Point your critical investment opportunities to maximise ROI

L Unpack the importance of securing internal support for investment to maximise implementation success

Kamal Amin (Ph.D), Senior Clinical Supplies Manager, Fujifilm Kyowa Kirin Biologics Co. Ltd

Elisaveta Frenkel, Master Production Planner & CMO Supply Manager, F. Hoffmann-La Roche AG

Janet Japzon-Salugao, Senior Director, Investigational Medicine Supply Chain, Incyte

Nancy Meyerson-Hess, Chief Compliance and Regulatory Officer, eMQT

The Geo And Political Effects On Lean And Effective Comparator Sourcing Models

L Create a global critical trial criteria map to identify sourcing priorities

L Examine the different sourcing models currently being utilised by the CT industry

L Analyse how a mixed-model approach can lead to greater sourcing efficiency than one single model

Niklas Mattsson, Global Lead – Comparator Planning, MSD

13:30 Networking Lunch Break

14:30 Dragon's Lair: The Ideal Just In Time (JIT) Labelling Solution This interactive troubleshooting session targets the key CTS challenge of JIT labelling and packs fun into the bargain too!Delegates and solution providers will split into teams and conceptualise, research and create a brand new concept for a JIT labelling solution that would work for big and small companies alike. Once formed each team’s idea will be presented to our judges, who will vote for the best idea!

15:05 Scenario Round TablesEach roundtable will discuss a different “what if” scenario that mirrors a real clinical trial supply time sensitive challenge or emergency. Develop strategies to overcome these likely scenarios and share past experiences and ideas. You won’t know the scenario until you choose your roundtable so get ready for some on-the-spot problem solving and out of the box thinking with your industry peers!


16:10 Chairman’s Closing Remarks


16:20 Closing Coffee and Networking Break

End of Main Conference


pre-conference workshop day and early registration · clinical trials at the patient’s home : how...

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