The BioTech Pharma Summit

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The BioTech Pharma Summit 29 - 30 NOV 2021, Porto, Portugal

Transcript of The BioTech Pharma Summit

Page 1: The BioTech Pharma Summit

The BioTech Pharma Summit29 - 30 NOV 2021, Porto, Portugal

Page 2: The BioTech Pharma Summit

Antibody Engineering & Therapeutics

The next-generation antobody therapeutic is

majorly driven by the development of

monoclonal antibodies and frowing chronic

diseases prevalence. The increasing

population, urbanization, and changing lifestyle

are favouring the anti-generation antibody

therapeutics market growth. Increasing

government supports through investments

and focus of the pharmaceutical &

biotechnology firms on the development of

antibodies for future usage of chronic disease

are further accelarating the next generation

therapeutic market.

Page 3: The BioTech Pharma Summit

01DAY

08:00 - 08:20Registration & Welcome Coffee

08:20 - 08:30Chairman's Opening Address

08:30 - 09:00 — Nick Hutchinson, Group lead at FUJIFILMAntibody Manufacturing Strategies during a Pandemic

09:00 - 09:30Speed Networking

09:30 - 10:00 — Kathryn Ching, Research Investigator at LigandHeavy Chain Only Antibodies to SARS-CoV-2

10:00 - 10:30 — Monica Berrondo, CEO at MacromoltekTaking antibody candidate generation from the lab to the cloudwith de novo computational design

10:30 - 11:00Morning Coffee & Networking Break

11:00 - 11:30 — César de la Fuente, Assistant Professor at UPennAntibiotic Discovery by Means of Computers

11:30 - 12:00 — Nicolas Camper, Group Leader at AbzenaDesigning and Developing Next-Generation Antibody-Drug Conjugate Medicines

12:00 - 12:30 — Benjamin Doranz, CEO at Integral MolecularLessons in Discovering Antibodies against GPCRs, Ion Channels, and Transporters

12:30 - 13:00 — Hitto Kaufmann, CSO, Senior VP at PierisDeveloping next-generation therapeutic proteins as highly targeted therapies in immuno-oncology and respiratory disease

13:00 - 14:00Lunch Break

14:00 - 14:30 — Marc A. van Dijk, CTO at Agenus Inc.Discovery and engineering of Immuno-oncology antibodies– Effective formats and impactful combinations

14:30 - 15:00 — Ilse Roodink, CSO at ImmunoPrecise AntibodiesTopic to be announced

15:00 - 15:30Afternoon Coffee & Networking Break

15:30 - 16:00 — Sicco H. Popma, President & CEO at IO BiosciencesGEMS-TM system – a plug-and-play system for biomanufacturing

16:00 - 16:30 — Miriam Bujny, CDO at Sapreme TechnologiesAntibody-targeted cytoplasmic delivery of fusion proteins and antibody fragments using Sapreme’s endosomal escape enhancers

16:30 - 17:00 — Heather Schwoebel, SVP at Alloy Therapeutics, Inc.Topic to be announced

17:00 - 17:30 — Oren Beske, Business & Biology at ATUMTopic to be announced

17:30 - 18:00 — Panel DiscussionComputational Modeling of Antibody-Antigen Interactions

20:00 - 22:30 — The BioTech Pharma Summit 2021Gala Dinner

Antibody Engineering & Therapeutics

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02DAY

08:00 - 08:20Registration & Welcome Coffee

08:20 - 08:30Chairman's Opening Address

08:30 - 09:00 — Kevin Heyries, Co-founder at AbCelleraResponding to the COVID-19 Pandemic with Antibodies, Small Molecules Drugs and Vaccines

09:00 - 09:30 — Vu Truong, Founder at Aridis Pharmaceuticals, Inc.Topic to be announced

09:30 - 10:00 — Katharina B.Frey, Head of Protein Eng. at ApogenixTopic to be announced

10:00 - 10:30 — Harald Kolmar, Professor at TU of DarmstadtThe art of making multifunctional antibodies: therapeutic opportunities and technical challenges

10:30 - 11:00Morning Coffee & Networking Break

11:00 - 11:30 — Soraya Hölper, Lab Head at SanofiChallenges in characterization and developability of multispecific antibodies

11:30 - 12:00 — Katherine Harris VP at Teneobio, Inc.Modulating the Immune System with Multi-Specific Antibodiesin Cancer

12:00 - 13:00 — Panel DiscussionAntibody Selection and Screening in Early Discovery

13:00 - 14:00Lunch Break

14:00 - 14:30 — Click here to submit your PosterTOP–5 Poster Presentations (5min. On Stage)

14:30 - 15:00 – Paul W.H.I. Parren, Exec VP at Lava TherapeuticsBispecific γδ-T cell engagers for the treatment of cancer

15:00 - 15:30Afternoon Coffee & Networking Break

15:30 - 16:00 – Mattias Levin, Sr Scientist at Alligator BioscienceNeo-X’: A bispecific antibody concept targeting CD40 and tumor antigens to enhance neoantigen cross-presentation and T cell priming

16:00 - 16:30 – Stefan Zielonka Associate Director at MerckAffinity maturation of B7-H6 translates into enhanced NK cell-mediated tumor cell lysis and improved proinflammatory cytokine release of bispecific immunoligands via NKp30 engagement

16:30Chairman's closing remarks

20:00 - 22:30 — The BioTech Pharma Summit 2021Gala Dinner

Antibody Engineering & Therapeutics

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Inhalation & Respiratory Drug Delivery

A recent report from PhRMA found America’s

biopharmaceutical companies are developing

about 130 new medicines for the millions of

patients affected by respiratory diseases: chronic

obstructive pulmonary disease (COPD), cystic

fibrosis, pneumonia, and asthma. These medicines

represent critical advancements in respiratory care

and improving quality of life. In addition to the

drugs, devices delivering those products are being

designed to improve the quality of life for an aging

population, children, and those who tend not to

comply to dosing regimens because they don’t

know how to use the device.

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01DAY

10:30 - 11:00Morning Coffee & Networking Break

11:00 - 11:30 — Arkadiusz Kuczaj, Manager at Philip Morris InternationalAccurate dosimetry predictions for evolving liquid aerosol delivery

PART II: Inhalation Formulation Solutions & Technology

11:30 - 12:00 — Beatriz Noriega Fernandes, Scientist at HovioneHigh Dosage DPI – formulation and process development considerations

12:00 - 12:30 — Jeffry Weers, CTO at Respira Therapeutics, Inc.Musings on High Dose Powder Delivery

13:00 - 14:00Lunch Break

14:00 - 14:30 — Sven Stegemann, Professor at TU GrazIncreasing the drug load in capsule based DPI drug delivery systems

14:30 - 15:00 — Martin Wing-King, Director at Quotient Sciences

08:00 - 08:20Registration & Welcome Coffee

08:20 - 08:30Chairman's Opening Address

PART I: The challenges of developing inhalation drugs

08:30 - 09:00 — Jörg Schiewe, Head of Global CMC Experts at Boehringer Ingelheim PharmaScience base and challenges of therapeutic equivalence of respiratory products

09:00 - 09:30Speed Networking

09:30 - 10:00 — Thomas Secher, Research scientist at INSERMThe biological barriers to consider for the development of inhaled biotherapeutics

10:00 - 10:30 — Aernout van Haarst, Director at CelerionEarly Phase Clinical Trials for Inhaled Drugs - Challenges and Opportunities

Formulation Development Challenges and Pitfalls When Developing Dry Powder Inhalers

15:00 - 15:30Afternoon Coffee & Networking Break

PART III: Regulatory pathways for inhaled therapies

15:30 - 16:00 — Dino Farina, Founder and CEO at Proveris ScientificUsing a New Human Realistic Approach to In Vitro Characterization to Better Predict In Vivo Performance of Inhaled Aerosols

16:00 - 16:30 — Marco Laackmann, Director at Harro HöfligerGet it right first time: Inhaler technology and manufacturing

16:30 - 17:30 — Panel DiscussionAsthma inhalers: what next for the drug delivery tech?

20:00 - 22:30 — The BioTech Pharma Summit 2021Gala Dinner

Inhalation & Respiratory Drug Delivery

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02DAY

08:00 - 08:20Registration & Welcome Coffee

08:20 - 08:30Chairman's Opening Address

PART IV: New Approaches to Treating Respiratory Diseases

08:30 - 09:00 — Masahiro Sakagami, Professor at VCU Schoolof PharmacyTopic to be announced

09:00 - 09:30 — Tonya Winders, CEO at Allergy & Asthma NetworkShared Decision Making to Improve Adherence in Severe Asthma

09:30 - 10:00 — Fakhrul Ahsan, Professor at the TTUHSCInhalation therapy for pulmonary arterial hypertension, a pulmonary vascular disease

10:00 - 10:30 — Peter Robbins Professor at University of OxfordOptimising surrogate outcome measures for respiratory trials

10:30 - 11:00Morning Coffee & Networking Break

PART V: New analytical insights into dry powder formulations for inhalation

11:00 - 11:30 — Wayland Rushing, Director at EurofinsTopic to be announced

11:30 - 12:00 — Click here to registerSpeaking Sponsorship Available - Have your talk here

12:00 - 13:00 — Panel DiscussionFuture directions in inhalation and respiratory drug delivery research

13:00 - 14:00Lunch Break

14:00 - 14:30 — Click here to submit your PosterTOP–5 Poster Presentations (5min. On Stage)

PART VI: New Approaches to Inhalation Product Development and Production

14:30 - 15:00 — Michael Castagna, CEO at MannKind CorporationTopic to be announced

15:00 - 15:30Afternoon Coffee & Networking Break

15:30 - 16:00 — Mark Milton-Edwards Head of Product & Health Solutions - Digital Health at Teva PharmaceuticalsDevelopment of an Integrated Digital Health Product (DigihalerTM)

16:00Chairman's closing remarks

20:00 - 22:30 — The BioTech Pharma Summit 2021Gala Dinner

Inhalation & Respiratory Drug Delivery

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Pharmacovigilance & Drug Safety

With the augmented incidence of diseases, and

the non-medical use of prescription drugs, the

incidence of drug abuse has increased

enormously in the recent years, which is

apparent with the excess documentation of

adversities and drug toxicities. In this context,

the drug safety and pharmacovigilance has

emerged as a dynamic clinical and scientific

discipline to provide adequate information and

ensure health safety by the joint interaction of

doctors and patients in choosing appropriate

treatment method and drug.

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01DAY

08:00 - 08:20Registration & Welcome Coffee

08:20 - 08:30Chairman's Opening Address

08:30 - 09:00 — Margherita D'Antuono, Director at Italfarmaco GroupPSMF in a global environment: compliance with local requirements

09:00 - 09:30Speed Networking

09:30 - 10:00 — Susana Almeida, Director at Medicines for EuropeHow to achieve 3S pharmacovigilance (smart, strategic, selective): view from the generic sector

10:00 - 10:30 — Salvatore Cicirello, Head of Safety Science at Bristol Myers SquibbAdoption of Artificial Intelligence in Pharmacovigilance: a framework for the development of cognitive services and the role of the Drug Safety Professional

10:30 - 11:00Morning Coffee & Networking Break

11:00 - 11:30 — Valentina Mancini, Director at Shionogi EuropeDigital Media, marketing projects, e-commerce and other business initiatives: opportunities and challenges for PV

11:30 - 12:00 — Andrea Oliva, Head of Pharmacovigilance at MylanHow Pharmacovigilance could support business

12:00 - 12:30 — Julia Appelskog, Head of QPPVs & Safety Consulting Services at TFSHow to define PV strategy and build an effective Regulatory Intelligence function

12:30 - 13:00 — Massoud Toussi, Senior Principal at IQVIAPost authorization safety studies (PASS)

13:00 - 14:00Lunch Break

14:00 - 14:30 — Tjark Reblin, Global Head at Vifor Pharma GroupA framework for Safety evaluation and risk managment

14:30 - 15:00 — Click here to registerSpeaking Sponsorship Available

15:00 - 15:30Afternoon Coffee & Networking Break

15:30 - 16:00 — Marie-Laure Kürzinger, Benefit-Risk Expert at SanofiStructured and Quantitative Benefit-Risk evaluation for medicinal products: how can it make a difference?

16:00 - 16:30 — Calin Lungu, CEO at DDCS S.A.EudraVigilance, XEVMPD, EVDAS, SPOR, EMA unique account news

16:30 - 17:00 — Panel DiscussionTopic to be announced

20:00 - 22:30 — The BioTech Pharma Summit 2021Gala Dinner

Pharmacovigilance & Drug Safety

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02DAY

08:00 - 08:20Registration & Welcome Coffee

08:20 - 08:30Chairman's Opening Address

08:30 - 09:00 — Claudia Nolte, Director at CSL BehringRemote PV Audits and Inspections

09:00 - 09:30 — Uwe Gudat, Head of Medical Affairs & CSPV at Fresenius KabiTopic to be announced

09:30 - 10:00 — Robert Weber, Product Mgmt Director at OracleNew Trends in Signal Detection and Management

10:00 - 10:30 — Dennis Vargo, Vice President and Head of Drug Safety and Pharmacovigilance at AkebiaThe Evolution of the Safety Scientist

10:30 - 11:00Morning Coffee & Networking Break

11:00 - 11:30 — Anupam Agarwal, Vice President at Zogenix, Inc.Cardiovascular safety issues during phase III-IV for non-cardiovascular trials.

11:30 - 12:00 — Mircea Ciuca, Global Therapeutic Area Head - Global Clinical Safety and Pharmacovigilance at CSL BehringTopic to be announced

12:00 - 13:00 — Panel DiscussionTopic to be announced

13:00 - 14:00Lunch Break

14:00 - 14:30 — Click here to submit your PosterTOP–5 Poster Presentations (5min. On Stage)

14:30 - 15:00 — Click here to registerSpeaking Sponsorship Available

15:00 - 15:30Afternoon Coffee & Networking Break

15:30 - 16:00 – Martin Holm-Petersen, CEO at InsifeMultivigilance – re-inventing the vigilance system for drug safety with devices, complaints, counterfeits etc.

16:00 - 16:30 – Budhesh Dhamija, Senior Manager, Regulatory Intelligence and Policy – Europe at CSL BehringTopic to be announced

16:00Chairman's closing remarks

20:00 - 22:30 — The BioTech Pharma Summit 2021Gala Dinner

Pharmacovigilance & Drug Safety

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Pre-filled Syringes & Injectables

The market driver of the highest stature for the global

prefilled syringes market growth is the increase in

chronic ailments and demand for advanced medical

facilities. The rise in diabetes, cancer, and

cardiovascular disorders is also causing market growth.

Other important market drivers are increasing research

& development (R&D), demand for convenient drug

delivery methods, elimination of dosing errors, need

for more effective methods for unit dose medication,

greater dose precision, suitability for home use, and

initiatives from different governments around the

world to boost healthcare sector.

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01DAY

08:00 - 08:20Registration & Welcome Coffee

08:20 - 08:30Chairman's Opening Address

08:30 - 09:00 — Min Wei, Director at AstraZenecaInnovations in drug delivery and combination devices

09:00 - 09:30Speed Networking

09:30 - 10:00 — Amber Witteman, Founder at EPIWatchNext generation design and materials for PFS

10:00 - 10:30 — Click here to registerSpeaking Sponsorship Available

10:30 - 11:00Morning Coffee & Networking Break

11:00 - 11:30 — Jakob Lange, Account Director at Ypsomed AGUser-driven product development: Focus on self-injection devices

11:30 - 12:00 — Click here to registerSpeaking Sponsorship Available

12:00 - 12:30 — Beate Treffler, Manager at Avient CorporationExtractable metals: potential sources in your Prefilled Syringes, risk management and change control

13:00 - 14:00Lunch Break

14:00 - 14:30 — Clemens Günther, Director at Bayer AGNonclinical safety evaluation of extractables and leachables when developing a pre-filled syringe drug device combination product

14:30 - 15:00 — Click here to registerSpeaking Sponsorship Available

15:00 - 15:30Afternoon Coffee & Networking Break

15:30 - 16:00 — Tudor Arvinte Professor at University of Geneva, Switzerland, CEO of TherapeomicTopic to be announced

16:00 - 16:30 — Click here to registerSpeaking Sponsorship Available

16:30 - 17:00 — Panel DiscussionTopic to be announced

20:00 - 22:30 — The BioTech Pharma Summit 2021Gala Dinner

Pre-filled Syringes & Injectables

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02DAY

08:00 - 08:20Registration & Welcome Coffee

08:20 - 08:30Chairman's Opening Address

08:30 - 09:00 — Aaron Johnson, Vice President of Marketing and Customer Strategy at AccumoldInnovation through Miniaturization and Micro Injection Molding

09:00 - 09:30 — Ashley Reynolds, Pharma Technology Sales and Marketing at Körber Group companyModular Feeding Systems for Parenterals, such as Pre-filled Syringes and Injection Devices

09:30 - 10:00 — René Holm, Head and Scientific Director at The Janssen Pharmaceutical Companies of Johnson & JohnsonDeveloping suspensions as long acting injectables

10:00 - 10:30 — Joël Richard, Chief Development Officer at MedinCellLong-Acting Injectable Formulation Technologies: Challenges and Opportunities for the Delivery of Fragile Molecules

10:30 - 11:00Morning Coffee & Networking Break

11:00 - 11:30 — Andreas Kerschbaumer, Senior Technical Manager at Sandoz GmbHAseptic Production and IPC

11:30 - 12:00 — Click here to registerSpeaking Sponsorship Available

12:00 - 13:00 — Panel DiscussionTopic to be announced

13:00 - 14:00Lunch Break

14:00 - 14:30 — Click here to submit your PosterTOP–5 Poster Presentations (5min. On Stage)

14:30 - 15:00 — Click here to registerSpeaking Sponsorship Available

15:00 - 15:30Afternoon Coffee & Networking Break

15:30 - 16:00 — Benedikt Reichart, Global Business Development Manager at Fresenius Kabi AustriaAseptic competence at Fresenius Kabi

16:00 - 16:30 — Click here to registerSpeaking Sponsorship Available

16:30Chairman's closing remarks

20:00 - 22:30 — The BioTech Pharma Summit 2021Gala Dinner

Pre-filled Syringes & Injectables

Page 14: The BioTech Pharma Summit

Gut-Brain Axis

The Gut-Brain Axis event, brings together leading

scientists, physicians, and senior leaders to

explore the potential insights into the

Microbiota–Gut–Brain Axis, the Human

Microbiome Market that exhibits significant

potential in the near future.

The ability of gut microbiota to communicate

with the brain is emerging as an exciting concept

in health and disease. Mounting evidence, mostly

from rodent studies, suggests that gut microbes

help shape normal neural development, brain

biochemistry, and behaviour.

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01DAY

08:00 - 08:20Registration & Welcome Coffee

08:20 - 08:30Chairman's Opening Address

08:30 - 09:00 — Pierre Lestage, Chief Executive Officer at NeribiOmGut brain axis and neurological diseases

09:00 - 09:30Speed Networking

09:30 - 10:00 — Click here to registerSpeaking Sponsorship Available

10:00 - 10:30 — Jennifer K. Spinler, Instructor at Texas Children’s Microbiome Center & Baylor College of MedicineDo plant-derived exosomes regulate the gut microbiome?

10:30 - 11:00Morning Coffee & Networking Break

11:00 - 11:30 — Rochellys Diaz Heijtz, Associate Professor and Group Leader in the Department of Neuroscience at Karolinska InstitutetTopic to be announced

11:30 - 12:00 — Shahram Lavasani, Founder / CEO at ImmuneBiotechTargeting the brain-gut-microbiome axis by ImmuneBioticsTM, a new therapeutic avenue for management of multiple sclerosis

12:00 - 12:30 — Javier Ochoa-Repáraz, Assistant Professor at Eastern Washington UniversityThe gut microbiome as a therapeutic venue for inflammatory diseases of the central nervous system (CNS)

12:30 - 13:00 — Satya Prakash, Professor at McGill UniversityNovel Microbiome Approach For Management of Alzheimer Diseases

13:00 - 14:00Lunch Break

14:00 - 14:30 — Click here to registerSpeaking Sponsorship Available

14:30 - 15:00 — Click here to registerSpeaking Sponsorship Available

15:00 - 15:30Afternoon Coffee & Networking Break

15:30 - 16:00 — Wouter de Jonge, Professor of Neurogastroenterology at AMC, CoFounder of Gut ResearchThe gut-brain and brain-gut axes in human disease

16:00 - 16:30 — Click here to registerSpeaking Sponsorship Available

16:30 - 17:00 — Panel DiscussionClinical Trials in the Gut-Brain Axis: Challenges & Opportunities

20:00 - 22:30 — The BioTech Pharma Summit 2021Gala Dinner

Gut-Brain Axis

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02DAY

08:00 - 08:20Registration & Welcome Coffee

08:20 - 08:30Chairman's Opening Address

08:30 - 09:00 — Jane A. Foster, Associate Professor at McMaster Uni.Harnessing the Potential of Microbiota-related Therapies for Brain Health

09:00 - 09:30 — Rohan F. Hastie, President & CEO at MetabolonDeciphering the Gut-Microbiome-Brain Axis Relationship with Metabolomics

09:30 - 10:00 — Christian Roghi, Director at CosmosIDIntestinal microbiome medicinal product (IMMP): establishing a licensed platform to create novel products

10:00 - 10:30 — Martha Carlin, CEO at The BioCollectiveTo be announced

10:30 - 11:00Morning Coffee & Networking Break

11:00 - 11:30 — Sergueï O. Fetissov, Professor of physiology at Rouen University and co-founder of TargEDys.Microbiome Mediated Appetite Regulation - First Experiences with EnteroSatys

11:30 - 12:00 — Click here to registerSpeaking Sponsorship Available

12:00 - 13:00 — Panel DiscussionGut microbiota and its implications for psychiatry: Conclusions and Future Directions for Research

13:00 - 14:00Lunch Break

14:00 - 14:30 — Click here to submit your posterTOP–5 Poster Presentations (5min. On Stage)

14:30 - 15:00 — Marcus Böhme, R&D Specialist at Nestlé ResearchDiet & the Gut-Brain Axis: from concept to product

15:00 - 15:30Afternoon Coffee & Networking Break

15:30 - 16:00 — Georges Rawadi, CEO at LNC TherapeuticsFrom Nutrition to Therapy: Commercialising the Therapeutic Potential of The Microbiome in the Field of Metabolic Diseases

16:00 - 16:30 — Domingo Barber, Director at Universidad San Pablo MadridSystemic barrier damage and biomarkers connected to inflammation and the potential role in dysbiosis

16:30Chairman's closing remarks

20:00 - 22:30 — The BioTech Pharma Summit 2021Gala Dinner

Gut-Brain Axis

Page 17: The BioTech Pharma Summit

Probiotics, Human & Skin Microbiome

Probiotics as a key functional ingredient in targeting

major skin concerns (acne, blemishes, wrinkles etc)

is gaining popularity in research, with increasing

clinical evidence pointing towards their efficacy.

Probiotics – products containing live bacteria –

comprise of only a small portion of commercialized

cosmetic products and hold great untapped

potential in the skincare market. However,

implementing live bacteria into mainstream

products is not easy. Bacterial products require

aseptic conditions, a challenge for packaging, and

often have a short shelf life so do not last long.

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01DAY

08:00 - 08:20Registration & Welcome Coffee

08:20 - 08:30Chairman's Opening Address

08:30 - 09:00 — Per Falholt, Director at Novo Nordisk FoundationSkin Care and microbes

09:00 - 09:30Speed Networking

09:30 - 10:00 — Chrysi Sergaki, Microbiome Scientist at National Institute for Biological Standards and ControlDeveloping global standards for the microbiome field

10:00 - 10:30 — Radhika Bongoni, Business Developer at BaseClearPre-pro-postbiotics and role in modulating our microbiome – status & case studies

10:30 - 11:00Morning Coffee & Networking Break

11:00 - 11:30 — Huiying Li, Associate Professor at University of California, Los AngelesDissecting the human skin microbiome in health and disease

11:30 - 12:00 — Alexandre Passioukov, VP Translational Medicineat Pierre FabreIs human skin microbiota a goldmine for personalized diagnostic tests?

12:00 - 12:30 — David Berry, General Partner at Flagship PioneeringIntegrated gut biology

12:30 - 13:00 — Momo Vuyisich, Founder and CSO at ViomePlatform that allows to study the connections among diet, gut microbiome, immune system, human physiology, and health/disease states

13:00 - 14:00Lunch Break

14:00 - 14:30 — Denise Kelly, Investment Advisor at SeventureTranslating the Human Gut Microbiome- Progress through Innovation and Investment

14:30 - 15:00 — Click here to registerSpeaking Sponsorship Available

15:00 - 15:30Afternoon Coffee & Networking Break

15:30 - 16:00 — Fabio Piccini Co-founder at Progetto Microbioma ItalianoKetogenic diet and the gut microbiota

16:00 - 16:30 — Pavlovic Guillaume Head of Unit at PHENOMIN-ICSStudying the variability of intestinal microbiome in mice to better understand the Human microbiome

16:30 - 17:00 — Magnus Sjögren, Associate Professor at Uni. of GothenburgAn abnormal microbiome in Anorexia Nervosa – implications for interventions

17:00 - 17:30 — Panel DiscussionThe development of new therapies in skin microbiome

20:00 - 22:30 — The BioTech Pharma Summit 2021Gala Dinner

Probiotics, Human & Skin Microbiome

Page 19: The BioTech Pharma Summit

02DAY

08:00 - 08:20Registration & Welcome Coffee

08:20 - 08:30Chairman's Opening Address

08:30 - 09:00 — Lionel Breton, Scientific Director at L’OrealConsidering the Microbiome Interorgans Axis (MIA) as a future option in Health & Diseases

09:00 - 09:30 — Veronika Oudova, Co-founder and CEO at S-BiomedicS-Biomedic approach of direct skin microbiome modulation

09:30 - 10:00 — Click here to registerSpeaking Sponsorship Available

10:00 - 10:30 — Elinor McCartney, President for Pen & Tec ConsultingFeeding your brain & skin: will European Regulation let psychobiotics & skinbiotics live up to our expectations?

10:30 - 11:00Morning Coffee & Networking Break

11:00 - 11:30 — Frédéric Moens, Head of R&D at ProDigestThe probiotic potential of SYMPROVE: an in-depth study using the SHIME® technology platform

11:30 - 12:00 — Click here to registerSpeaking Sponsorship Available

12:00 - 13:00 — Panel DiscussionPre and Probiotics: A Shift from Pharmaceuticals to Nutraceuticals

13:00 - 14:00Lunch Break

14:00 - 14:30 — Click here to submit your posterTOP–5 Poster Presentations (5min. On Stage)

14:30 - 15:00 — Click here to registerSpeaking Sponsorship Available

15:00 - 15:30Afternoon Coffee & Networking Break

15:30 - 16:00 — Jean-Pol Warzée, President at European Scientific League for Probiotics – ESLPQuality control of probiotics and internationalisation of the ESLP initiative

16:00 - 16:30 — Adam Baker, Director at Chr. Hansen HoldingTopic to be announced

16:30 - 17:00 — Peter Cartwright Human Microecology SpecialistPre-clinical selection of probiotics strains: Six simple steps

17:00Chairman's closing remarks

20:00 - 22:30 — The BioTech Pharma Summit 2021Gala Dinner

Probiotics, Human & Skin Microbiome

Page 20: The BioTech Pharma Summit

Aseptic Processing Technology

The aseptic processing industry has seen many

changes during its progression towards the

21st century. With advances in innovative

therapeutic manufacturing such as ATMPs,

pragmatic barrier system applications,

adaptability and modularity in fill finish,

robotics and automation, small and agile

product manufacturing, just to name a few. In

2018, the global aseptic processing market was

valued over $56 trillion and is estimated to

increase in net revenue upwards $124 trillion

by 2027, with a CAGR growth of 9.18%.

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01DAY

08:00 - 08:20Registration & Welcome Coffee

08:20 - 08:30Chairman's Opening Address

08:30 - 09:00 — Matthias Angelmaier, Global Product Manager Isolator Technology at Syntegon Technology GmbHVaccines for the world - insights into design and execution of a BSL2 fill-finish facility

09:00 - 09:30Speed Networking

09:30 - 10:00 — Susan Cleary, Director at Novatek InternationalLearn How to Trend & Analyze Environmental Monitoring Data

10:00 - 10:30 — Click here to registerSpeaking Sponsorship Available

10:30 - 11:00Morning Coffee & Networking Break

11:00 - 11:30 — Thomas Becker, Director Site Quality at RecipharmInnovative and Agile Approaches in the Aseptic Manufacturingof Lyophilised Vialed Drug Products

11:30 - 12:00 — James L. Drinkwater, Head of GMP compliance & Aseptic process integration at F ZielCombined ATMP Viral vector formulation and filling on an integrated Barrier technology platform

12:00 - 12:30 — Mostafa Nakach, Head of pharmaceutical engineering section within Pharmaceutical sciences department at SanofiDe-risking the fill and finish process of biotech products

12:30 - 13:00 — Click here to registerSpeaking Sponsorship Available

13:00 - 14:00Lunch Break

14:00 - 14:30 — Magnus Gustafsson, Head of Global Business Development at BiovianClosed process for aseptic fill without possibility for sterile filtration

14:30 - 15:00 — Click here to registerSpeaking Sponsorship Available

15:00 - 15:30Afternoon Coffee & Networking Break

15:30 - 16:00 — Sue Behrens, Professor in Bioprocessing and Director, Amgen Bioprocessing Center at Keck Graduate InstituteTopic to be announced

16:00 - 16:30 — Click here to registerSpeaking Sponsorship Available

16:30 - 17:00 — Panel DiscussionTopic to be announced

20:00 - 22:30 — The BioTech Pharma Summit 2021Gala Dinner

Aseptic Processing Technology

Page 22: The BioTech Pharma Summit

02DAY

08:00 - 08:20Registration & Welcome Coffee

08:20 - 08:30Chairman's Opening Address

08:30 - 09:00 — Harald Stahl, Sn. Director Innovation and Strategy at GEAContinuous Processing opening new possibilities

09:00 - 09:30 – Christian Kollecker, Business Unit Leader Pharma Liquid & Aseptic at Harro HöfligerAseptic bag processing: bridging the gap

09:30 - 10:00 — Keith W. Dodson, VP of Business Development at AST Use of Robotics in Flexible Format Aseptic Filling

10:00 - 10:30 — Kate Coleman, Director/Senior Consultant Qualityand Compliance at PharmaLexImplementation of an efficient QRM program

10:30 - 11:00Morning Coffee & Networking Break

11:00 - 11:30 — Walid El Azab, Sn. Manager Technical Service at STERISContamination Control Strategy, an Implementation approach

11:30 - 12:00 — Ken Nagai Director at Airex Co.Decontamination 5.0 -Ultradecon® and Enzyme Indicator

12:00 - 13:00 — Panel DiscussionTopic to be announced

13:00 - 14:00Lunch Break

14:00 - 14:30 — Click here to submit your PosterTOP–5 Poster Presentations (5min. On Stage)

14:30 - 15:00 — Click here to registerSpeaking Sponsorship Available

15:00 - 15:30Afternoon Coffee & Networking Break

15:30 - 16:00 — Richard Denk, Sn. Consultant Aseptic Processing & Containment at SKAN AGContamination and Cross Contamination Control during Aseptic Manufacturing

16:00 - 16:30 — Click here to registerSpeaking Sponsorship Available

16:30Chairman's closing remarks

20:00 - 22:30 — The BioTech Pharma Summit 2021Gala Dinner

Aseptic Processing Technology

Page 23: The BioTech Pharma Summit

CDx / Biomarkers & Biobanking

CDx market is growing due to continuous

advancement in medical technology both for the

diagnosis and the treatment of patients. Rise in the

prevalence of diseases like cancer & HIV is fueling

to the growth of companion diagnostics as it assist

in determining the patient specific dose and drugs.

The Biomarkers Market is expected to register a

CAGR of 10.28% during the assessment period of

2020 to 2027, to reach USD 4,5B by 2027. With an

increasing incidence rate of chronic and

life-threatening diseases, the demand for precise

diagnostic procedures is increasing.

Page 24: The BioTech Pharma Summit

01DAY

11:30 - 12:00 — Shona Kerr, Project Manager at MRC Human Genetics Unit, EdinburghTopic to be announced

12:00 - 12:30 — Click here to registerSpeaking Sponsorship Available

13:00 - 14:00Lunch Break

PART II: CDx & Biomarkers

14:00 - 14:30 — Yong-Jie Lu MD, Professor in Molecular Oncology at Queen Mary University of LondonCirculating biomarkers for cancer diagnosis and precision medicine

14:30 - 15:00 — Carla Leibowitz, Chief BD Officer at Paige.AIDigital biomarkers and the latest development in the pathology space

15:00 - 15:30Afternoon Coffee & Networking Break

08:00 - 08:20Registration & Welcome Coffee

08:20 - 08:30Chairman's Opening Address

PART I: Biobanking

08:30 - 09:00 — Jim Vaught, EIC at Biopreservation & BiobankingAntibody Manufacturing Strategies during a Pandemic

09:00 - 09:30Speed Networking

09:30 - 10:00 — Andres Metspalu, Professor at University of TartuFrom Biobanking to Personal medicine and Prevention

10:00 - 10:30 — Karine Sargsyan, COO at Biobank GrazTopic to be announced

10:30 - 11:00Morning Coffee & Networking Break

11:00 - 11:30 — Daniel Grölz, Scientific Associate Director R&D at QIAGENNeed for workflow solutions from sample collection to diagnostic assay

15:30 - 16:00 — Lauren C. Leiman, Executive Director at BloodPACBloodPAC Consortium: An Update on Establishing Standards, Accelerating Data Sharing and Analysis

16:00 - 16:30 — Matthew Griffin, Professor of Transplant Biology at National University of Ireland, GalwayBiomarkers in transplantation

16:30 - 17:00 — Sophie Brouard, Director of Research at CNRSImmunological signatures as biomarkers in corneal transplantation

17:00 - 17:30 — Christa Noehammer Senior Scientist at AITEpigenetic biomarkers for Type 2 Diabetes from plasma - and saliva derived extracellular vesicles

17:30 - 18:00 — Jörg Engelbergs, Scientific-Regulatory Expert at Paul-Ehrlich-Institut & European Medicines AgencyRegulatory-scientific challenges for predictive biomarker based personalized medicines

20:00 - 22:30 — The BioTech Pharma Summit 2021Gala Dinner

CDx / Biomarkers & Biobanking

Page 25: The BioTech Pharma Summit

02DAY

08:00 - 08:20Registration & Welcome Coffee

08:20 - 08:30Chairman's Opening Address

PART II: CDx & Biomarkers

08:30 - 09:00 — Jane Wilkinson, Senior Director at Broad InstituteTopic to be announced

09:00 - 09:30 — Marianne Oulhen, Head of Projects at Gustave RoussyTopic to be announced

09:30 - 10:00 — Matt Humphries, Scientific Lead at Queen’s University BelfastMultiplexing for Clinical Diagnostics: The Next Generation of Molecular Pathology

10:00 - 10:30 — Catherine Alix-Panabières, Director LCCRH at the University Medical Center of MontpellierLiquid Biopsy: From Discovery to Clinical Application

10:30 - 11:00Morning Coffee & Networking Break

11:00 - 11:30 — Selina Gaertner, Medical Affairs Manager EMEA at HTG Molecular DiagnosticsOvercoming the challenges of RNASeq with extraction-free, low sample input gene expression profiling by the HTG EdgeSeq WTA

11:30 - 12:00 — Christian Werno, Research group leader at Fraunhofer InstituteClinical applications of liquid biopsies

12:00 - 13:00 — Panel DiscussionTopic to be announced

13:00 - 14:00Lunch Break

PART II: Biobanking

14:00 - 14:30 — Click here to submit your PosterTOP–5 Poster Presentations (5min. On Stage)

14:30 - 15:00 — Pasquale De Blasio, Exec. VP and COO at ISENET BiobankingBiobank - an overview

15:00 - 15:30Afternoon Coffee & Networking Break

15:30 - 16:00 — Brent Schacter, Professor Emeritus at Rady College of Medicine, University of ManitobTopic to be announced

16:00 - 16:30 — Vincent von Walcke-Wulffen, CEO at BioKryoBuilding a GMP Biobanking Network in Europe

16:30 - 17:00 — Peadar Mac Gabhann, MD at Biostór IrelandVISICORT Foundation Biobank

17:00 - 17:30 — Panel DiscussionTopic to be announced

17:30Chairman's closing remarks

20:00 - 22:30 — The BioTech Pharma Summit 2021Gala Dinner

CDx / Biomarkers & Biobanking

Page 26: The BioTech Pharma Summit

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