DELIVERABLE 3 - NANOPILOT...industry-clinician translational research centre. Through CÚRAM he...

This project has received funding from the European Union Framework Programme for research and innovation (HORIZON 2020) under grant agreement no 646142

A Pilot Plant for the Production of Nanopharmaceuticals in Compliance with

GMP

DELIVERABLE 3.7

Deliverable title: 2nd

Workshop in translational

nanomedicine (II)

Responsible: IK4-CIDETEC

Due Date (in months): 33

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2nd

Workshop in translational nanomedicine (II)

DELIVERABLE DATA

Number 3.7

Title Second Workshop in translational nanomedicine (II)

Type (R, DEM, DEC, OTHER)1 OTHER

Dissemination Level (PU, CO, Cl)2 PU

Submission Date 29/09/2017

Institution Responsible IK4-CIDETEC

Editor Name Ana B. Benito and Iraida Loinaz

1 R: Document, Report; DEM: Demonstrator, Pilot, Prototype; DEC: Websites, patent fillings,

videos, etc. 2 PU: Public; CO: Confidential. Only for members of the Consortium (including the Commission

Services); Cl: Classified, as referred to in Commission decision 2001/884/EC

ABSTRACT:

This deliverable is the summary of the 2nd Workshop on Translational Nanomedicine

organized by CIDETEC in the frame of NanoPilot project.

KEY WORDS:

Workshop, Dissemination, Pilot Plant, Regulatory, Translational Nanomedicine

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TABLE OF CONTENT

1 INTRODUCTION ..................................................................................................... 1

2 SUMMARY OF THE EVENT .................................................................................... 2

2.1 Open session Day 1 .......................................................................................... 4

2.2 Open session Day 2 .......................................................................................... 4

2.3 Closing Session Day 2 ...................................................................................... 5

2.4 Sessions 1 & 3: Research in Nanomedicine in early stage of development –

how to be prepared for translational research .............................................................. 5

2.5 Session 2: Microfluidics technology applied to nanoformulation ........................ 6

2.6 Session 4: Advanced characterization techniques ............................................ 7

2.7 Session 5: Nanomedicine and regulatory environment for nano-investigational

medicinal products ....................................................................................................... 8

2.8 Session 6: Pilot Plant ........................................................................................ 9

3 SOME ADITIONAL PHOTOS TAKEN DURING THE WORKSHOP ....................... 10

ANNEX 1: FINAL PROGRAM OF THE II WORKSHOP ON TRANSLATIONAL

NANOMEDICINE .......................................................................................................... 12

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1 INTRODUCTION

The Second Workshop in Translational Nanomedicine (2WTN) was organized in the

central building of the Technological Park of Guipuzcoa, located in San Sebastian close

to CIDETEC’s facilities.

The workshop took place on 18th-19th of September, 2017. It included several sessions

about different aspects of Translational Nanomedicine, and also a visit to the GMP Pilot

Plant that has been built during the course of the NanoPilot project. (See final program in

Annex 1).

As mentioned in D3.3 (1st Workshop on Translational Nanomedicine), during the

development of a nanopharmaceutical from R&D laboratories to the first clinical trial,

several challenges at different stages related with different fields have been identified3,4

(characterization, regulatory science, production…). Together with the goal of

disseminating NanoPilot project, the idea for the first workshop was to give a general

overview of these challenges, while this second workshop has been organized with two

main objectives:

1. Going into further details of all those keys aspects or issues with the help of some

experts in each of the fields involved in the development of a new

nanopharmaceutical.

2. Making nanomedicine scientific community aware of NanoPilot GMP Pilot Plant that

will be operating for third parties in the future at CIDETEC.

To accomplish those goals a total of 24 speakers, currently working in nanomedicine

development at different stages or fields, were invited to present case-studies and/or

share their experience with the nanomedicine scientific community. Additionally, a

website for this 2WTN was created and the event was opened to the public by previous

registration. Key companies and research groups, considered relevant in the field of

nanomedicine, were individually informed about the event, encouraging them to attend.

3 “Challenges of clinical translation in nanomedicine: A qualitative study”. Priya Satalkar, Bernice

Simon Elger, Patrick Hunziker, David Shaw. Nanomedicine: Nanotechnology, Biology, and Medicine, Volume 12 (2016) 893–900. 4 “Delivering nanomedicines to patients: A practical guide.”. Mike A.W. Eaton, Laurent Levy,

Olivier M.A. Fontaine. Nanomedicine: Nanotechnology, Biology and Medicine, Volume 11 (2015), Issue 4 , 983 - 992

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2 SUMMARY OF THE EVENT

From 52 people initially registered to attend the workshop, finally a total of 40 people

attended from different universities and companies. Those 40 people, together with the

speakers (24) and some partners of NanoPilot project and CIDETEC personnel (10),

made a total of 74 people taking part in the event.

The event was divided in 5 different sessions, each one focused in one specific aspect

about translational nanomedicine:

Session 1: Research in Nanomedicine in early stage of development: how to be

prepared for translational research

Session 2: Microfluidics technology applied to nanoformulations

Session 3: Research in Nanomedicine in early stage of development (II)

Session 4: Advanced Characterization Techniques

Session 5: Nanomedicine and regulatory environment for nano-investigational

medicinal products.

During each session, the speakers gave a 15 minutes talk followed by questions and

discussions from the audience.

Apart from those general sessions the workshop included four additional talks of 30 min

each:

Opening of the first day, by Prof. Abhay Pandit (National University of Ireland,

Galway)

Opening of the second day, by Patrick Boisseau (Nanomedicine Research in

CEA, France)

Closing the second day, Dr. Simo Schwartz (CIBBIM_Nanomedicine, Spain)

Closing the workshop and giving a start to the Pilot Plant visits, Dr. Iraida Loinaz

(CIDETEC_Nanomedicine, Spain)

Additionally, a demonstration of microfluidics was done during coffee breaks and lunch,

where MICRONIT and CHEMTRIX showed their equipment and capacities.

Finally, at the end of the second day attendees had the opportunity to visit NanoPilot

GMP Pilot Plant in small groups (6-8 people each).

A video summarizing the course of the event has been also uploaded in that website

(accessible also from Nanopilot website) and can be accessed from this link:

http://www.cidetec.es/2wtn/#VIDEO.

http://www.cidetec.es/2wtn/#VIDEO

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All the information related to the 2WTN can be found in the website specially created for it

it (http://www.cidetec.es/2wtn/) (see Image 1Image 1: Main page of the Website of 2WTN (Top:

before the event; bottom: after the event)

).

Image 1: Main page of the Website of 2WTN (Top: before the event; bottom: after the event)

In the website there is information about the workshop (venue, speakers, program…),

and also about the NanoPilot project, GMP Pilot Plant and CIDETEC (see Image 2).

http://www.cidetec.es/2wtn/

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Image 2: Different views of the Website content

In the next sections the content of each session is briefly presented. Those

presentations that have been authorized by the corresponding authors to be published

will be uploaded in the 2WTN website.

2.1 Open session Day 1

Prof. Abhay Pandit, PhD, is an established Professor of Biomaterials at the National

University of Ireland, Galway. He is Director of the Science Foundation Ireland funded

Centre for Research in Medical Devices (CÚRAM), a multi-disciplinary academic-

industry-clinician translational research centre. Through CÚRAM he develops affordable,

innovative and transformative device-based solutions to treat global chronic diseases.

His research supports industry from basic scientific research, through translational

preclinical and clinical development, into regulatory and commercialization readiness.

He gave a talk titled: “Being a Good Guest: The Host Implant Paradigm” where he

pointed out and shared some interesting thoughts about the potential pharmaceutical

effect of the carriers themselves, something that often is not even considered.

2.2 Open session Day 2

Patrick Boisseau is graduated in biological engineering from the French Elite

Schools Institut National Agronomique (1983) and Ecole Nationale du Génie Rural, des

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Eaux et des Forêts (1985). His career is fully dedicated to academic research, research

and development and research management. Patrick Boisseau’s current position is VP

Healthcare responsible for the Strategic Planning in Life Sciences and Healthcare

Technologies, at CEATech, a public non-for-profit Research & Technology Organisation,

based in Grenoble, France. He has acquired a large expertise of coordination of EU

projects like the Network of Excellence Nano2Life (2004-2008), EuroNanoBio, BIBA,

TARGET-PDT, and recently the EU-NCL infrastructure on nanocharacterisation.. He is

elected Chairman of the European Technology Platform on Nanomedicine since

December 2012.

He gave a talk about titled: “The ETPN Nanomedicine Translation Hub” where he

explained the work that ETP Nanomedicine is doing and how it can contribute to

translate innovative nanomedicines into the market.

2.3 Closing Session Day 2

Simo Schwartz is the director of CIBBIM-Nanomedicine and Team leader of the “drug

delivery and targeting group” focused on new biomedical nanotechnology-based

applications. Member of the Science Advisory Board of the Vall d’Hebron Research

Institute (VHIR) and Science Advisor of the European Nanotechnology Characterization

Laboratory (EU-NCL). He has been recently appointed as President of the European

Society of Nanomedicine and Executive Board member of the International Society of

Nanomedicine. He helds 13 patents, most transferred to leading companies of the

biotech and pharma sectors and coauthors more than 80 papers in high impact factor

journals. Dr Schwartz was also Co-founder and Science Advisor of ARGON Pharma SL

and is also member of the editorial Board of the journals Nanomedicine-NBM and the

Eur. J. Nanomedicine

The title of his talk was: “Fighting against cancer stem cells with Nanomedicine”. He

summarized the results obtained by his group during the course of the research in

fighting breast cancer using a specific kind of novel nanoparticles and compare those

results with some of the nanomedicines already approved for cancer treatment such as

paclitaxel or abraxane..

2.4 Sessions 1 & 3: Research in Nanomedicine in early stage of development –

how to be prepared for translational research

From a point of view of technology developers generating their own technology on

nanosystems, the way they address the research & development on nanomedicine was

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shared. Some examples were presented and main challenges during this process were

discussed.

Ana B. Benito (CIDETEC_Nanomedicine) and Covadonga Pañeda (SYLENTIS) were

the chairman of these two sessions (1 & 3) respectively.

Bellow there is a list of the speakers and titles of their corresponding talks:

“Translational Research in Early Development: Pitfalls, gaps and some practical

solutions” by Dr. Maria Pilar Calvo from PharmaMar (Spain)

“Translational aspects of Nanopharmaceuticals for Ocular Delivery” by Dr.

Covadonga Pañeda from SYLENTIS (Spain)

“Application of sophisticated micelles and nanogels in drug delivery: challenges

and opportunities”, by Prof. Rene C.F. van Nostrum from Utrecht University (The

Netherlands)

“Single Chain Nanoparticles towards regulation compliance”, by Dr. Damien

Dupin from CIDETEC Nanomedicine (Spain).

“Challenges in the journey from research to final drug product.” by Gemma

Lahuerta form Reig Jofré (Spain).

“From lab procedures to a pilot plant under GMP. An obstacle race” by Dr. Jose

Crecente from University of Santiago de Compostela (Spain).

“Bridging early academic research & clinical development on polypeptide-based

nanomedicines” by Dr. Vicent J Nebot from Polypeptides (Spain).

“Synthesis and characterization of functional hyaluronic acid conjugates for

biomedical applications” by Dr. Vijaya Krishna from National University of Ireland,

Galway.

2.5 Session 2: Microfluidics technology applied to nanoformulation

Some advances on the use of microreactors for chemical production were presented:

principle behavior of microfluidic systems, advantages of using microfluidics, scalability

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of the processes… On-line and in-line characterization for quality control that can be

included in microfluidics systems was discussed specially in the field of

nanomanufacturing.

Jose Crecente (University of Santiago de Compostela) was the chairman of this session.

Bellow there is a list of the speakers and titles of their corresponding talks:

“Concept of Microfluidics for Chemical production” by Dr. Thomas R. Dietrich

from IVAM (Germany).

“On-line and in-line quality control for nanomanufacturing” by Alice Kasjanow

from MICRONIT (Germany).

“Continuous Flow Processing: Scalability, Advantages & Challenges for

Manufacturing in the Pharmaceutical Industry” by Dr. Charlotte Wiles from

CHEMTRIX (The Netherlands).

“Development of a Micro-mixing Pilot Line for the Continuous Production of

Glycan Coated Nanoparticles” by Dr. Graham Worrall from CPI (England).

2.6 Session 4: Advanced characterization techniques

From basic research to clinical development (validation, standardization of methods…),

speakers went through different approaches to fulfill characterization requirements (both

physicochemical and biological) to advance in nanopharmaceuticals development

towards the market. An overview of new characterization techniques for nanomedicines

was showed, from the biggest challenges, to some achievements during the last years.

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Marco Marradi (CIDETEC Nanomedicine) was the chairman of this session. Bellow there

is a list of the speakers and titles of their corresponding talks:

“Analytical developments for the characterization of nanomedicine; From raw

materials to nanoformulations” by Dr. Mathieu Menta from UT2A (France).

“Overcoming challenges in biophysical characterization of Nanopharmaceuticals”

by Dr. Markus Epe from MALVERN.

“Radiochemistry and nuclear imaging: application to the in vivo investigation of

nanomaterials” by Dr. Jordi Llop from CIC Biomagune (Spain)

“Physical-Chemical Characterization of Nanomedicines” by Dr. Luigi Calzolai

from the Joint Research Center, ISPRA, (Italy).

“Nanocharacterization: what is still missing to improve translation in

nanomedicine” by Patrick Boisseau from Nanomedicine research in CEA,

(France).

2.7 Session 5: Nanomedicine and regulatory environment for nano-

investigational medicinal products

During this session speakers focused the attention on the regulatory science, and went

through the requirements in terms of regulatory in order to enter Phase I clinical trials.

Some European Regulatory Agencies-led initiatives, such as the European Innovation

Network, for a better interaction between researchers and regulatory authorities were

also presented by the Spanish representative.

Carolina Egea (MEJORAN) was the chairman of this session. Bellow there is a list of the

speakers and titles of their corresponding talks:

“Regulatory Science approaches to improve translational research in

nanomedicine” by Dr. Maria Beatriz Silva from University of Lisbon (Portugal).

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“The EudraLex Rules Governing Medicinal Products in the European Union. The

Annex 13 about Investigational Medicinal Products” by Dr. Francisco Arenal from

MEJORAN, (Spain).

“Regulatory requirements for clinical trials authorization” by Dr. Marcos Maroto

from Instituto Fundación Teófilo Hernando IFTH, (Spain)

“The Spanish Medicines Agency’s Office for support of innovation and knowledge

of medicinal products” by Dr. César Hernández García from the EU Innovation

Network, AEMPS5, (Spain)

2.8 Session 6: Pilot Plant

NanoPilot project, together with the activities and capacities of the new pilot plant was

presented by Iraida Loinaz (CIDETEC Nanomedicne).

Following this presentation the visit to the facilities took place (see Image 3)

Image 3: Iraida Loinaz and Ana B. Benito during the visit showing the pilot plant from different perspectives.

5 AEMPS: Spanish Regulatory Agency for Medicines and medical Devices.

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3 SOME ADITIONAL PHOTOS TAKEN DURING THE WORKSHOP

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ANNEX 1: FINAL PROGRAM OF THE 2nd WORKSHOP ON TRANSLATIONAL

NANOMEDICINE

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