ManxBioMed Associationmanxbiomed.im/ibweb/res/pdf/pdf/ManxBioMed Associaiton.pdf · • New reactor...

116Bio Business Conference 10th December 2015

ManxBioMed Association


ManxBioMed Association MembersToday’s panel:

• Panel Chairman, John Webster, Manx Technology Group & Manx Business Connection

• Steve Burton, CEO, ProMetic Biosciences• Jan Lewis, Business Development, SEQLimited

• Sian Meeuwsen, Head of International Marketing and Research Bodystat


PROMETIC BIOSCIENCES LTDSteve Burton

CEO, ProMetic Biosciences Ltd


ProMetic Biosciences Ltd• Company formed 1987 on the Isle of Man

• Development and manufacture of innovative purification products for the production of biopharmaceuticals and medical devices (technology originally developed at the Institute of Biotechnology, University of Cambridge, UK)

• Became a wholly owned subsidiary of Canadian corporation ProMetic Life Sciences Inc. January 1999 – a public Canadian corporation (PLI:TSX; HQ Montreal, Quebec)

• Development of small molecule drugs, biopharmaceuticals (plasma proteins) and biopurificationtechnology and 3 therapeutic products in clinical trials (Plasminogen, IVIG, PBI 4050)

• > 300 employees globally• Market Cap approx. $1.5 bn CAD• Facilities in Canada, USA, UK & Isle of Man


ProMetic’s Purification Technology

Affinity Ligand

Support Matrix

Attachment Chemistry

Affinity Adsorbent



• Purification of recombinant proteins

• Purification of plasma proteins

• Impurity removal

• Contaminant removal




Target Markets

• North America• Canada, USA

• Europe• Austria, Belgium, Denmark, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, UK

• Asia• China, India, Japan, Korea, Russia, Taiwan

Biopharmaceutical Manufacturing


ProMetic on the Isle of Man• Production Chemists

• Engineering (chemical, mechanical, electrical)

• Quality control (analysts, microbiologists)

• Quality assurance

• HS&E

• Logistics

• IT

• Warehousing

• Maintenance


Expansion on the Isle of Man

• Construction of new production areas within existing buildings

• New reactor suite with 2 x 2,500L stainless steel reactors

• New ligand synthesis suite

• New warehouse building (leased 2013)

• Project completion Q1 2016

• Headcount increase from 27 to 35 (8 new jobs) during 2015

• Further increase from 35 to 41 (6 new jobs) expected 2016


Why the Isle of Man?• Original company founder based on the Isle of Man

• Availability of high‐quality commercial buildings

• Space for expansion

• Highly educated and skilled local workforce

• Family friendly environment (staff retention)

• Competitive business environment

• Good communication and transportation links

• Access to local government

• EXCELLENT GOVERNMENT SUPPORT (DED)


“Pure Innovation”


SAFETY, EFFICACY, QUALITYJan Lewis

Business Development

129Bio Business Conference 10th December 2015 129Bio Business Conference 10th December 2015

Who We Are & Services Provided:

• SEQ Regulatory Affairs Consultants

• Established in 1984

• Based on the IOM for > 22 years

PharmaceuticalsHuman & Veterinary

Specialist Services:

Medical Expert Opinions Medical Writing

Quality Expert Opinions Pharmacovigilance

Regulatory Affairs

Medical Affairs

In- and Out-Licensing Activities

Cosmetic ProductsHerbal ProductsMedical DevicesNutraceuticals


Specialist Project Management:

Marketing

Post Marketing

InitialConcept


Markets:

• Australia• Canada • North Africa • South Africa• South America• Turkmenistan

• Austria• Belgium• Bulgaria• Czech Republic• Denmark• Finland• France• Germany• Greece• Hungary• Italy• Malta

All EU countries, particularly:• Norway• Poland• Portugal• Republic of Ireland• Romania• Slovak Republic• Slovenia• Spain• Sweden• The Netherlands • The United Kingdom


Specialist Staff Technical & Medical:• Competent Regulatory Affairs Specialists

• Primary Degree Level and Higher

• Medical Pharmaceutical Physician

• Pharmaceutical Expert

• Members of Relevant Professional Bodies

• Continual Ongoing Education


Island Attraction/Life:• Active Business Environment

• Proactive Supportive Government ‐ Accommodating, Transparent &

Accessible

• Innovative attitude

• Full Amenities & Relaxed Way of Life

• Tax favourable


MEASURING BODY COMPOSITION & NUTRITIONAL STATUS FOR OVER 25 YEARS

Sian MeeuwsenHead of International Marketing and Research

Bio Business Conference 10th December 2015 135

1) Who we are2) What we do3) Industries4) Global Markets5) The Research5) The Future


• On the IOM since 1990

• Family Business

• Manufacture MedicalDevices for Body Composition


We measure:• Body Fat

• Lean Muscle

• Hydration (intracellular and extracellular fluid)

• Nutritional Status

• Cellular Health


Fitness: sports science, gyms, professional sports teams, Olympian athletes, personal trainers

Nutrition: nutritional status of patients, dietitians, nutritionists

Medical: obesity, diabetes, ICU, dialysis, lymphoedema, paediatrics, oncology, sarcopenia (muscle wasting)


Our Global Markets:

Europe & UKUnited States & South America

AsiaAfricaAustralia & New Zealand


New measurement to analyse Health of Cells

• Nutritional Assessment • Malnutrition• Cancer Cells


Could be a prognostic indicator in breast cancer?

“A prognostic indicator in infiltrating ductal carcinoma breast” International Journal of Health & Allied Sciences • Vol. 3 • Issue 1 • Jan‐Mar 2014

“Phase Angle is a superior prognostic marker and should be considered as a screening tool for the identification of risk patients with impaired nutritional & functional status” Dr K. Norman et al. / Clinical Nutrition 31 (2012) 854e861

“Phase angle relates to markers of function, disease severity and prognosis in patients with COPD” Kings College London, M. Maddocks et al. / Clinical Nutrition xxx (2015) 1e6)

“Phase angle is a global indicator of the condition of an individual cancer patient” Michael Singer, Computational Physiology — Papers from the AAAI 2011 Spring Symposium (SS‐11‐04)

“Phase Angle could be useful as an indicator of survival and nutritional status for patients undergoing Transplants” 2012 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism


The ResearchBioelectrical impedance phase angle as a prognostic indicator in breast cancerDigant Gupta, Carolyn A Lammersfeld, Pankaj G Vashi, Jessica King, Sadie L Dahlk, James F Grutsch and Christopher G Lis*BMC Cancer 2008, 8:249 doi:10.1186/1471‐2407‐8‐249

Bioelectrical Impedance Phase Angle Changes During Hydration and Prognosis in Advanced CancerMellar P. Davis, MD, FCCP, Tugba Yavuzsen, MD, Dilara Khoshknabi, MD, Jordanka Kirkova, MD, Declan Walsh, MSc, FACP, FRCP, Lasheen Wael, MD, Ruth Lagman, MD, MPH, FACP, and Matthew T. Karafa, PhDAM J HOSP PALLIAT CARE OnlineFirst, published on January 30, 2009 as doi:10.1177/1049909108330028

Bioelectric impedance phase angle is associated with hospital mortality of geriatric patientsR. Wirth a,*, D. Volkert b, A. Ro¨ sler c, C.C. Sieber b, J.M. Bauer b a Department of Internal Medicine and Geriatrics, St. Marien‐Hospital Borken, Am Boltenhof 7, D‐46325 Borken, Germany b Friedrich‐Alexander‐University Erlangen‐Nuremberg, Chair of Geriatric Medicine, Department of Internal Medicine II, Nuremberg Hospital, Prof.‐Ernst‐Nathan‐Str. 1, D‐90419 Nuremberg, Germanyc Department of Geriatrics, Albertinen‐Haus, Sellhopsweg 18–22, D‐22459 Hamburg, Germany

Bioelectrical impedance phase angle as a prognostic marker in chronic heart failureEloisa Colın‐Ramırez Ph.D. a, Lilia Castillo‐Martınez M.Sc. a,*, Arturo Orea‐Tejeda M.D. a, Marisela Vazquez‐Duran B.Sc. a, Ana E. Rodrıguez B.Sc. a, Candace Keirns‐Davis M.D. ba Heart Failure Clinic, Department of Cardiology, Instituto Nacional de Ciencias Medicas

Standardized phase angle from bioelectrical impedance analysis as prognostic factor for survival in patients with cancerSilvana Iturriet Paiva & Lúcia R. Borges & Denise Halpern‐Silveira & M. Cecília F. Assunção & Aluisio J. D. Barros & M. Cristina GonzalezSupport Care Cancer (2011) 19:187–192 DOI 10.1007/s00520‐009‐0798‐9

and many more…


The Future

Bodystat, in conjunction with the Dutch Nutrition Society, is developing a small portable machine measuring Phase Angle to monitor:

MALNUTRITION CANCER


Thank you!www.bodystat.com



• All natural powder sprays for protection from hay fever, allergy symptoms and airborne germs and viruses

• Specialised automated manufacturing facility on the Island • Major market is Russia ‐ other important markets are China, France, Netherlands, Sweden, Italy, Argentina, Chile, Saudi Arabia, Malaysia, Taiwan, Indonesia, Australia, Poland + many other Eastern European markets

• Boots ‐major customer in UK, manufacture a product for them under their brand name• USA 510k approval ‐ will enter the US market in 2017 with a major partner

“The Isle of Man Government has a quick decision process and has assisted with grants for clinical studies and machinery for the factory.”

“Being part of a cluster of biomed companies has been fantastic for us. At the very first meeting we met another Island based company who was able to organise a clinical study in record time enabling us to achieved USA 510k medical device approval.”


• Established in Isle of Man 2008• Grown from 5 people in 2010 to over 30 in 2015, some based in UK

• Pharmaceutical Support Services• Pharmacovigilance• Regulatory Affairs

• Client base across UK and Europe – includes global pharma companies• Continued expansion and diversification expected

“Device manufacture market expected to be valued globally at around £2.5 billion in 2020. With significant and established relationships in the medical device market the future is looking bright for Panacea”


• Core business revolves around thin film deposition technology and techniques

• Specialised manufacturing plant based in the Islands Freeport• Design and development of thin film deposition machines for a number of leading industries including pharmaceutical, precision optics, aerospace, and military

“One of the things I like about the Island is when you go for a walk and say hello to someone they greet you back ‐ if they haven’t already got in a greeting ahead of you, it’s very friendly. Also, companies here tend to co‐operate for the greater good ‐ even those in competition with one another.”

“The deciding factor for us in setting up on the Island is how helpful the government is ‐ they are so pro manufacturing. I feel totally positive about the Isle of Man and our future here. It has all the right ingredients to build a successful business.”


The technological and scientific strengths of Manx Graphene are cemented in three pillars: • Strong IP which has been created and is being constantly improved and evolved with an innovative methodology for fast and reliable achievements

• Decades of plasma and vacuum experience• Extensive academic and commercial experience in Materials Science and High‐Tech Engineering• A proprietary production process that will facilitate multiple variants of Wide Area Graphene to suit the needs of a wide range of industries

Manx Graphene is aiming to be one of the first truly high volume producers of Wide Area Graphene, which production facility will be established and operated in the Isle of Man.

Prof Brian Cox commented at Manchester’s 2015 Graphene Week “Graphene’s so important when you think that it’s a potentially multibillion or even multitrillion pound industry with almost limitless potential. It’s a gold mine.”

Manx Graphene is a R&D sister company to Highland Scientific primarily focused on developing and commercialising technologies to produce large volumes of high quality Wide Area Graphene.

www.manxgraphene.com


ManxBioMed Association

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