immunotherapy europe - the perfect combination of strategy and innovation

1 Phacilitate Immunotherapy Europe 2016, 21st – 22

nd September, Maritim Proarte, Berlin.

Draft Agenda – Strictly Private & Confidential © Clarion Events 2016 For more information, please contact Kim Evans on 02073847993

First draft agenda

DAY 1

Wednesday, September 21st 2016

7.25 Registration & buffet breakfast in the exhibition area

Opening plenary session

Driving increased pharma and VC investment in European

immunotherapy

8.45 Chair’s introduction

Setting the scene: Analysing key successes and failures for European immunotherapy in

2015/16

What have been the key deals and collaborations in Europe over the past 12 months?

Where can we expect the biggest breakthrough stories to come from in immuno-

oncology?

Dr Sam Fazeli, Senior Pharmaceutical Analyst & European Head, Bloomberg Intelligence

9.10 Presentation reserved

9.30 European and US VCs and analysts on the keys to winning the battle for investment in

cancer immunotherapy

Presentations & Panel

Analysing recent European investment trends in the immunotherapy space

o Are current VC investment levels in Europe an indicator that immunotherapy is

finally set to disrupt cancer healthcare on the continent?

Financing insights for Europe’s immunotherapy biotech community: how to successfully

engage VCs from the US, Europe and further afield?

o What specific data do they need to see from the industry in order to invest?

o How to de-risk your business model and R&D portfolio to gain investors’

confidence?

o How can the US investment community stimulate innovation in the European

research environment? Is there a fertile ecosystem for US investors to enter

Europe? Are there any challenges to stop them investing here?




Forecasting developments to the European and global IPO environments for

immunotherapy companies over the short- to mid-terms

Dr Vincent Brichard, Venture Partner, (LSP) Life Sciences Partners

Dr Kristina Kakalacheva, Associate, Nextech Invest Ltd

Dr Joshua Resnick, Partner, SV Life Sciences

Giovanni Mariggi, Principal, Medicxi Ventures

10.15 Big Pharma collaborative strategies in immuno-oncology: How can Europe’s biotech

and academic communities capitalise?

Keynote Presentations & Panel

Analysing recent deals between Big Pharma and biotech – what learning can be taken

away?

o Is the immuno-oncology deal frenzy calming down or is this just the beginning?

o Acquisition strategies: What are they looking for in small to mid-sized biotechs?

How are they looking to work with academia?

How are Big Pharma R&D portfolios set to evolve and where do their specific interests lie

in terms of immunotherapy technology areas and indications?

Panellists:

Dr Roy Baynes, SVP, Global Clinical Development, Merck Sharpe & Dohme

Donnie McGrath, Vice President, Head Search & Evaluation, Business Development,

Bristol-Myers Squibb

Dr. Michael S. Perry, Chief Scientific Officer, Global Business Development & Licensing

(BD&L), Novartis

Niels Emmerich, Senior Director, Global Head Search & Evaluation Oncology, Abbvie,

Inc

11.05 Close of session – morning coffee in the exhibition area

Then

Plenary

Preparing for adoption of novel European pricing and reimbursement

models by the evolving oncology healthcare marketplace

11.45 Chairs introduction

11.50 Payer’s priorities for immunotherapy

Assessment, pricing and reimbursement for immuno-oncology drugs

Are present payment models appropriate or do we need alternatives?

Dr Detlev Parow, Head of Department, Care Management Development, DAK-Gesundheit




12.00 Health Technology Assessment (HTA) and payer views; predicting the future for

immuno-oncology pricing and reimbursement strategies

How will Europe’s HTAs use value-based assessment to decide which drugs should be

brought into society?

o How can value be assessed effectively and efficiently for potentially curative

immunotherapies?

What methodological approaches are being used by European

HTA’s?

Is QALY the appropriate method to use for assessment of these

technologies?

Driving an increased uptake of breakthrough immunotherapies in Europe: how can we

streamline market access across the continent?

o How are HTA and payer bodies planning to create a framework for centralised

decision making?

o How can the industry streamline commercialisation plans across Europe as a whole

considering the differences of P&R policies at a national level?

Analysing cost control opportunities along the length of the development cycle: Where can

efficiencies be achieved?

Assessing the requirement for biomarkers: will they help in justifying the high price tag of

immunotherapies?

o What role will companion diagnostics play in reimbursement of immuno-oncology

agents moving forward?

How will CART and other personalised medicines be evaluated? What reimbursement model

might work for a Euro300,000-a-dose drug?

o What does rational pricing for these products look like?

Identifying a viable reimbursement plan and pricing structure for combination therapies

o Will Europe’s payers view them as two separate drugs and therefore two separately

priced elements?

What factors play a key role in the approval of a combination immunotherapy from a

reimbursement point of view?

o Are side effects taken into account in cost-value calculations or is it all about

efficacy?

Dr Nick Crabb, Programme Director, Scientific Affairs, National Institute for Health &

Clinical Excellence (NICE) – UK

Dr Detlev Parow, Head of Department, Care Management Development, DAK-Gesundheit

Dr César Hernández-Garcia, Head of Department, Department of Medicines for Human

Use, Spanish Medicine Agency (AEMPS) – Spain

Dr Marc Matar, Partner, Simon-Kucher & Partners




1.25 Buffet lunch in the exhibition area

Followed by your choice of 3 highly interactive

parallel breakout streams:

Stream 1 (Shared with the Cell & Gene Therapy stream)

Piecing together the strategic manufacturing jigsaw to deliver lasting

commercial viability and success: part 1


Dr Anthony Davies, President, Dark Horse Consulting

‘Case study’ perspectives from leading ex vivo gene therapy and cell therapy developers in late-

stage clinical development, covering both large and orphan indications - how are autologous

and allogeneic manufacturing business models for both scale-up and scale-out taking shape in

Europe as technical innovation and the manufacturing services sector continue to evolve?

Dissecting decision-making processes around fundamental questions for commercial supply:

outsource or manufacture in-house? (And if you outsource, when to do so? Examining the pros

and cons of making the outsourcing decision at Phase I/II, pivotal and commercial scales)

How will the supply chain be managed? What does the infrastructure look like?

What are the key regulatory obstacles to consider in terms of designing and validating the

bioprocess and supply chain?

Can we quantify the impact on the costs of development/goods if you need to make changes – for

example, to a formulation in late Phase II or Phase III clinical trials?

2.30 Presentation

Dr Stefan Wildt, Vice President, Global Head Technical Research & Development, Cell &

Gene Therapies, Novartis


3.10 Addressing massive and complex datasets generated by manufacturing of autologous

cell therapy products

Gathering information and performing massive data analysis and statistics throughout an

autologous process: how to be exhaustive and relevant?

Rationalisation of the information and identification of potential root causes

Raising up conclusions based on the analysis results

Dr Arnaud Lacombe, Project Manager, MaSTherCell

12.30 Phacilitate lab session: Addressing the real life challenge of market access for immuno-

oncology drugs

This session is designed for those who want to collaborate ideas with their peers on market access in

order to deliver actionable objectives. Take the opportunity to learn from those who share your

problems and enjoy mapping out new opportunities. Would you or your organisation like to lead this

unique session? Contact Michael Adeniya now on [email protected] or on +44

(0)2073847951

mailto:[email protected]




3.30 Harnessing the state-of-the-art in closed automated systems and disposables to maximise

efficiency and minimise Cost of Goods

Presentations, followed by panel discussion

How to combine the core biology of bioprocess with cutting edge engineering and

devices to deliver the most cost effective, regulatory-efficient/effective manufacturing

solution?

How are standardisation initiatives advancing and with what impact in real terms?

Dr Ohad Karnieli, Founder & CTO, Karnieli Ltd; Chair, Process & Product Development

Committee, ISCT

Dr Lothar Germeroth, Senior Vice President & Managing Director, Juno Therapeutics

GmbH

4.05 Afternoon tea in the exhibition area

Or


Preclinical-clinical translation: minimising timeframes, maximising insight


2.30 Case study

Title to be announced

Jean-Philippe Combal, Chief Operating Officer, GenSight Biologics


Case studies: Innovative designs for exploratory studies in humans

3.00 Case study 1

Dr Luise Weigand, Team leader, Cell Biology/ Research Management, Immunocore Ltd

3.15 Case study 2

Denis Dufrane (MD, MsC,PhD), Chief Scientific Officer & Co-Founder, Novadip

Biosciences

3.30 Panel: What makes an optimal animal model for immunotherapy development from

European academic, industry and regulators’ perspectives?

Reflections on the relevance and acceptability to European regulators of animal model

data in support both of clinical trial applications and of product characterization and

potency data – which models are industry and academic developers using most

frequently? Which are the most clinically relevant? What are the regulators’ preferences

in this regard? What are the key new models to consider? Speakers of the session plus

Dr Christopher Bravery, Director, Advanced Biologicals Ltd





Or

Stream 3

Boosting success rates in immuno-oncology clinical trials through

biomarker-driven patient selection


2.30 Presentation: How are big pharma implementing biomarkers in their cancer

immunotherapy clinical strategy?

Dr Jeff Evelhoch, Vice President, Translational Biomarkers, Merck, Sharp & Dohme

2.50 Questions & discussion

2.55 Presentation: Imaging Biomarkers- the application of advanced image processing and

analysis to clinical decision making

Reserved


3.20 Panel: Assessing how biomarkers can be used for predicting clinical benefit and adverse

events in cancer immunotherapy

Examining biomarker-driven methods for improving the activity of immunotherapies in

patients

o Can predictive biomarkers be used as a reliable tool to identify responders?

o What can we learn from biomarkers that are already on the market for predicting

outcomes with checkpoint inhibitor antibodies?

o Understanding why certain patients respond: can these patients reveal valuable

biomarkers?

o With those patients unlikely to respond, are there any biological clues to suggest

other clinical pathways?

What role will the understanding of signal pathways play in recognizing the appropriate

patient population to determine the efficacy and safety profile of these immunotherapies?

Tumour resistance: how do we address the redundant pathways that can contribute to the

suppression of an effective immune response?

Which type of biomarker has the most potential for clinical utility?

Speakers of the session plus:

Dr Paul Robbins, Senior Director, Translational Development, Pfizer, Inc

Dr Thomas Hoeger, Chief Executive Officer, Apogenix AG








Piecing together the strategic manufacturing jigsaw to deliver lasting

commercial viability and success: part 2

4.45 Maximizing allogeneic cell therapy starting material through strict donor criteria,

selection, management, and repeat collections

A presentation focused on efficient and effective leukapheresis collection within an FDA-

registered cGMP donor facility for starting material procurement for allogeneic cell

therapies

Discuss why strict donor criteria, selection, management, and repeat collections are

critical for maximizing allogeneic cell therapy production.

Review what increases the chances for high quality starting material: apheresis expertise;

quality of leukapheresis collection; donor center that meets FDA cGMP/cGTP

requirements; process control using stringent SOPs, etc.

Louis Juliano, Senior Vice President, Global Sales & Business Development, HemaCare

Corporation

4.55 Strategies for securing the required capacity for ATMP manufacture at each stage of

development – from preclinical-clinical translation through to commercial scale

Presentations & panel discussion

Pharma/biotech strategic insights: optimising collaborative strategies with CMOs and

other critical stakeholders

Creative approaches to overcoming Europe’s GMP capacity shortfall: how diverse public

and private sector organizations are employing innovative partnering models and

initiatives to meet ATMP manufacturing needs at commercial scale

Speakers/panellists:

Professor Dr Martin Hildebrandt, Director of Manufacturing Facility, Qualified Person,

Technischen Universität München (TUM)

Ajan Reginald, Chief Executive Officer, Cell Therapy Limited

Louis Juliano, Senior Vice President, Global Sales & Business Development, HemaCare

Corporation

Dr Nina Kotsopoulou, Director, Process Development, Autolus

Ulrike Verzetnitsch, Chief Technical Officer, apceth GmbH & Co. KG

5.45 Closing panel: Presenting a vision for the future industrialization of ATMPs in Europe

A panel of enablers covering every stage of the commercial ATMP supply chain – from raw

materials through bioprocessing and product release to logistics and delivery to the patient –

will answer the industry’s key questions on how to deal with remaining obstacles, and how

ongoing collaborative and standardization efforts can help deliver viable end-to-end

solutions for industry

6.25 Close of day 1, followed by a drinks reception




Or

Stream 2

Next generation approaches to Immuno-Oncology: what will the next wave

of investigative therapies, tools and technologies deliver?

How will they overcome the challenge of significantly increasing

efficacy?

Will they unlock novel cancer targets?

4.45 Chairs introduction

4.50 Presentation: The revival of the bispecific antibody field; what do these novel bispecifics

promise to deliver?

Dr Lex Bakker, SVP & Chief Development Officer, Merus




5.40 Presentation

Dr AnnChristine Thastrom, Clinical Scientist, PDO Clinical Development, Genentech, Inc


6.05 Further questions for the speakers and panel discussion

6.25 Close of day 1, followed by a drinks reception

DAY 2

Thursday, September 22nd

2016

7.25 Registration & buffet breakfast in the exhibition area

Opening plenary session

Establishing a commercially viable immuno-oncology combination therapy

model

Success stories and learnings from the most exciting novel targets and technologies in the

European immunotherapy field: where will the next commercial breakthrough come from?





8.50 Opening keynote





9.30 Analysing the commercial partnering model in industry and academia for the future

development of immuno-oncology combination therapies

Presentations & Panel

Presentation (5-10 minutes): Dr Hazel Jones

What criteria are big pharma using to choose their different cancer immunotherapy

combinations across the industry?

o Are there any issues with the data that early stage biotechs are showing to the

established checkpoint inhibitor pharma companies?

o Are there any learnings that can be taken from the combination partnering model

BMS works with?

Overcoming the commercial challenges for industry/academia working together and

sharing data

Bringing together specialists from two separate modalities: can we define best practice for

this form of collaboration?

Are both companies involved in the trial sharing the clinical operations management

responsibilities?

How are companies approaching cost management? Are the costs divided equally

between the organisations involved or are there other models they are working to?

Panellists



Dr Hazel Jones, Head of Combination Therapies, Cancer Research UK

Steven King, President & CEO, Peregrine

Frederic Ors, CEO, Immunovaccine

10.20 Close of session

Then

10.25-11.25

Interactive hour




A choice of several highly interactive sessions in varying formats, including small

roundtables, workshops, technology briefings and biotech showcases

11.25 Morning coffee in the exhibition area



Stream 1

Checkpoint inhibitor-based combination therapies- is clinical data

justifying the hype?


12.05 Chairs Introduction

12.10 Case study 1- Title to be announced

Dr Andrea Van Elsas, Chief Scientific Officer, Aduro Biotech Europe

12.25 Questions & Discussion

12.30 Case study 2- Reserved

12.45 Questions & Discussion

12.50 Closing Panel: How will checkpoint combination therapies work in the clinic and

beyond?

Physician perspective: How are we going to make these combinations work in practical

application at the coalface of cancer healthcare?

Analysing optimal approaches with checkpoint inhibitor combination studies

o Is it best to dose sequentially or simultaneously, or should this be decided on a

case-by-case basis?

How are biomarkers being used to rationally design checkpoint inhibitor

combination therapies?

How should a decision be made on the timing between doses?

o Can the immune system be made intelligent enough to correct the pathway in

response to various on-off signals that try to push the cascade off course?

What can be learned from checkpoint inhibitor combinations already in the clinic? Are

there any key challenges that need to be addressed?

What is at the forefront of innovation in combination therapy clinical trial design?

Case studies: How is the latest data from checkpoint inhibitor-based combination studies

shaping the industry’s ongoing R&D and commercial strategies?




o What trial designs are proving optimal for the efficient evaluation of novel

combinations?

Without accurate preclinical models what data should be shown to bring the checkpoint

inhibitor combination study into phase 1?

Which checkpoint combinations are showing the best complementary mechanisms of

action?

Reconfiguring drug development to respond to the needs of a very specific marketplace:

The potential and challenges of Dual-Novel immuno-oncology combinations

o How do we conduct first-in-man novel-novel combination studies?

o What is being done to lower the safety and high risk profiles for these

combinations?

o How to overcome regulatory pathway uncertainty to drive these studies?

Panellists


Dr Tony De Fougerolles, Chief Scientific Officer, Ablynx

Prof Martin Schuler, Director, Cancer Centre, University Hospital Essen


Or


How are the world’s modified T cell immunotherapy leaders gearing up for

market in Europe?

Can we take the best from both autologous and allogeneic approaches to

inform next-generation development?


12.10 Dissecting the latest clinical data and commercial business models for leading European

and US CAR T cell and TCR therapy developers


How is the latest clinical data shaping future trial designs and development pathways?

How are regulatory differences between North America and Europe impacting

approaches on each continent?

o Planning to meet European national regulatory requirements beyond

centralised market approval in Europe (eg. GMO requirements)

What’s the latest progress in alleviating safety concerns?

Examining autologous vs allogeneic approaches: how far advanced is commercial supply

chain development for each? What are the signs that allogeneic approaches can deliver

the same game-changing efficacy? Is there room for both in the marketplace of the

future?

Progress with and priorities for next-generation approaches: how to remain nimble in

your R&D portfolio management/resourcing and supply chain development in such a fast

moving technology area?

Panellists




Andre Choulika, Chairman & CEO, Cellectis

Dr Cedrik Britten, Head Cellular Therapy, Immuno-Oncology, GlaxoSmithKline

James Noble, CEO, Adaptimmune

Shawn Tomasello, Chief Commercial Officer, Kite Pharma

Dr Lothar Germeroth, Senior Vice President & Managing Director, Juno

Therapeutics GmbH

12.55 …and multiple stakeholder panel discussion:

What potential pricing & reimbursement model(s) do we envisage for these products in

Europe?

Market exclusivity and CD19: how to differentiate beyond first-to-market?

Beyond conditional approval, what sort of efficacy data will be needed for modified T

cell therapies?

o Will a randomized clinical trial to demonstrate comparative effectiveness

with the Standard of Care be a requirement? Is there a realistic approach to

doing comparative head-to-head studies with existing products?

Speakers of the session plus:

Dr Maria Cristina Galli, Chair of the ATMP Platform, EATRIS-ERIC, the European

Infrastructure for Translational Medicine; Department of Cell Biology & Neurosciences,

Istituto Superiore di Sanità, Italy


Then

Plenary (Shared with the Cell & Gene Therapy stream)

Assessing the prospects of next-generation cellular immunotherapies

entering the clinic – how will they improve upon the first wave?

CAR 2.0

Second generation TCRs

NK cells


2.30 What improvements can second and third generation CAR- and TCR-based

immunotherapies offer in terms of both safety and persistence of response?


How to improve the safety profile of these technologies?

o Harnessing suicide genes

o Utilising selective memory T cells to control toxicity

What do we now know in terms of which T cells to use for longer lasting effects?

Dr Richard Morgan, VP Immunotherapy, bluebird bio

Dr Kai Pinkernell, Chief Medical Officer, Medigene

3.00 What is the future for NK Cells?





How do they shape up against T cell approaches in terms of safety and efficacy - what are

their pros and cons in comparison?

Will autologous or allogeneic NK cell therapies win the day?

What role will combination approaches play in developing the NK Cell therapy field?

How to overcome fundamental challenges in NK cell therapy development?

o Obtaining sufficient numbers of expanded/corrected NK cells

o How to transfect NK cells efficiently?

o How to ensure they are functional?

o How to enhance cell survival in vivo without increasing risk of toxicity?

Dr Hans Klingemann, Vice President, R&D, NantKwest, Inc

Dr Torsten Tonn, CEO, German Red Cross Blood Donation Service North-East;

Professor Transfusion Medicine, Dresden University of Technology

Dr. Winfried Wels, Professor for Tumor Biology and Deputy Director, Georg-Speyer-

Haus, Institute for Tumor Biology and Experimental Therapy Frankfurt, Germany

Dr Jens-Peter Marschner, CMO, Affimed

3.40 Closing panel discussion

How are gene editing platforms being applied to improve next generation T cell and NK

cell immunotherapies?

o What does the early data suggest in terms of how it will affect safety and

efficacy in clinical application?

Beyond cancer – what impact can T cell and NK cell immunotherapies have on the

antiviral and autoimmune areas?

Panellists

Dr Hans Klingemann, Vice President, R&D, NantKwest, Inc

Dr Miguel Forte, Chief Operating Officer, TxCell SA

Dr Richard Morgan, VP Immunotherapy, bluebird bio

Dr Vincent Brichard, Venture Partner, (LSP) Life Sciences Partners


Plenary (Shared with the Cell & Gene Therapy stream)

Targeting solid tumours: how to enable the next great step in cellular

cancer immunotherapy?


Linda Powers, CEO, Northwest Biotherapeutics

4.30 Beyond CD19: what progress to date in the search for targets that can unlock solid

tumours for CART, TCRs and other cellular immunotherapies?

Case studies & panel discussion

Comparative analysis of existing data for CAR T cell and TCR immunotherapies against

solid tumours – which shows the greatest promise to date?

Can we find good targets in solid tumours that lend themselves to CAR- and TCR-based

immunotherapy and avoid the threat of B cell depletion?




Panellist:

Peter Hoang, SVP, Business Development & Strategy, Bellicum

Dr Madhusudan Peshwa, Chief Scientific Officer, Maxcyte

Dr Helen Tayton-Martin, COO, Adaptimmune

5.05 Presentation

Dr Werner Lubitz, Chief Executive Officer & Chief Scientific Officer, BIRD-C GmbH

5.25 Presentation & panel: What’s the latest thinking and research on breaking the barriers

to solid tumours by:

Targeting galectin-9 for immune restoration in solid tumors : rationale and problems to

be solved

harnessing new understanding of the tumour microenvironment?

utilising combinations (eg. with checkpoint inhibitors)?

making T cells intrinsically more effective and more resistant?

Dr Pierre Busson, Group Leader, Tumor Microenvironment, Exosomes & microRNAs in

Solid Tumors, Gustave Roussy


5.45 Close of Phacilitate Immunotherapy Europe 2016

immunotherapy europe - the perfect combination of strategy and innovation

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