COMPANY PROFILE 4-Antibody is a biopharmaceutical company with a powerful fully-human antibody drug-discovery technology platform, which is generating an emerging pipeline of antibody therapeutics.
The proprietary discovery engine is the in-vitro Retrocyte Display® technology, a fast and highly efficient source of antibody drug candidates. Retrocyte Display® generates high quality therapeutic antibody drug candidates quickly using a rapid, high-throughput, flow cytometry approach incorporating full-length IgG format human antibody libraries expressed in mammalian B cells (the cell designed by nature for optimal antibody display). Retrocyte Display® produces antibodies with the fidelity of an in vivo system but with the high throughput of an in vitro approach - thus incorporating all the advantages of both in vitro and in vivo approaches without the disadvantages of either of these approaches. 4-Antibody provides access to its technologies to select pharmaceutical R&D collaborators and is also generating an in-house pipeline of antibody drugs.
In collaboration with the Ludwig Institute of Cancer Research in New York, 4-Antibody is generating novel therapeutic antibodies with potential roles in the activation of immune responses in cancer patients. To allow the Company to focus on its emerging oncology pipeline, 4-Antibody is seeking an out-license partner for a late stage pre-clinical development product - which is an anti-cytomegalovirus antibody drug.
4-Antibody is a private company with strong, commercially-experienced leadership located in Basel, Switzerland and Jena, Germany.
COMPANY PROFILE Adocia is a biotech company specialized in the development of best-in-class drugs from the innovative formulation of certain already-approved therapeutic proteins. Adocia is specialized in insulin therapy and the treatment of the diabetic foot one of the main complications of diabetes Adocia. Through its BioChaperone® state-of-the-art technological platform, Adocia intends to enhance the effectiveness and safety of therapeutic proteins and their ease of use for patients, with the aim of making these medicines accessible to the broadest public. Adocia has extended its activities to the formulation of monoclonal antibodies, which are gold standard molecules for the treatment of numerous chronic pathologies (oncology, inflammation, etc.).
COMPANY PROFILE Aepodia (Spin-out of a top 10 US Pharma Company) is a company specialized in Early Clinical Drug Development. The services may include individual scientific consultancy and/or operational support up to all activities required to reach a compound go/no go decision point (Proof of Concept) based on optimal (content/cost/timelines) study designs.
Aepodia offers tailored solutions and innovative approaches to optimize compound development by, depending on client portfolio and/or strategy:
• Proposing a minimal plan supporting “exit” strategy (e.g. adapted to biotech companies)
• Designing an optimal plan to support not only a compound development decision point but to optimize the related compound platform (so called “translational medicine” approach)
Between those two extremes, a variety of approaches exists. Those approaches depend on the indication, the type of compound and the client company strategy. The ability/agility to adapt and develop solutions matching those specificities requires a significant drug development expertise and experience: this is the very competitive advantage of Aepodia.
Our staff designs and develops early phase clinical plans, biomarker strategy, study protocols which include pharmacodynamic measurements and investigation of mechanism of action (in addition to tolerance and safety evalution) up to Proof of concept trials. As part of this core business, we also perform Due Diligence (scientific review) of compounds for Capital Investors, Pharmaceutical and Biotech Companies; and also consultancy in Strategic Outsourcing.
PRESENTER PROFILE Dr Julian Chick is an experienced corporate executive with over 12 years experience in senior management roles including Chief Operating Office, Chief Executive Officer, Head of Business Development across the biotechnology and healthcare industries. Dr Chick has extensive experience running early and late stage Research & Development projects across a range of therapeutic areas as well as medical devices. In the past six years Dr Chick has raised over $180 million for R&D projects. Prior to the executive roles Julian had five years’ experience as an investment adviser and financial consultant with Prudential-Bache Securities, BNP Paribas and Salomon Smith Barney. He was also the principal analyst with Foursight Associates reviewing healthcare and biotechnology investment opportunities for private equity investors and venture capitalists. Julian has a PhD in Muscle Physiology and is currently the COO at Allied Healthcare Group.
COMPANY PROFILE Allied Healthcare Group is an healthcare company with regional sales of US$7M per annum. Allied also has a regenerative medicine division based around its ADAPT® tissue engineering process which greatly reduces calcification of implanted tissue. Benefits to patients are significant as ADAPT® treated tissue has superior biocompatibility, stimulates tissue regeneration and reduces calcification compared to available commercial products. The company is currently filing its lead product, CardioCel®, ahead of a global launch. The technology is applicable to a number of tissue based products. Allied’s R&D division focuses on the development of DNA vaccines, with the lead program for HSV-2 soon to enter Phase I to clinically prove the platform technologies ability to generate both antibody and T-cell responses for both prophylactic and therapeutic vaccine applications.
PRESENTER PROFILE Jack Elands has been the Chief Executive Officer of Amakem since its inception in 2010. Previous to his role as CEO at Amakem, Jack served as the CBO of Silicos, an informatics platform based biotechnology company. Prior to that, Jack served as the CEO of Vitec, a specialty biochemical company focused on antimicrobial surface chemistries and products and the VP of Business Development at Sidec AB, a Swedish company focused on the discovery and development of protein based drugs. Jack started his pharmaceutical career at Marion Merrell Dow (later HMR, now Sanofi-Aventis). He has published extensively in papers and posters on topics ranging from biomolecular screening to protein tomography to life science informatics and functional genomics and has contributed to several patents. He received his undergraduate in medical biology from University of Utrecht in 1985. Jack was awarded his doctorate in Neuropharmacology from the Rudolf Magnus Institute at University of Utrecht in 1989.
THERAPEUTIC AREA: Ophthalmology - Glaucoma
COMPANY PROFILE Amakem Therapeutics is a kinase platform company with a product pipeline based on its unique 'Localized Drug Action' platform which generates novel kinase inhibitors that minimize systemic exposure with the aim of reducing side effects. Initially focusing in ophthalmology, Amakem’s pipeline also includes assets targeting other indications which benefit from its ‘Localized Drug Action’ approach e.g. COPD, IBD.
Amakem’s lead candidate, AMA0076, is a novel, highly potent Rho Kinase (ROCK) inhibitor for the treatment of glaucoma, a condition which damages the optic nerve resulting in vision loss and ultimately blindness. In a series of in vivo models, AMA0076 has been shown to be highly effective in reducing intraocular pressure (IOP), a major factor in glaucoma, while avoiding hyperemia. Also known as ‘red eye’, hyperemia results from excess blood flow in vessels in the white of the eye. It is a distressing and dose-limiting side effect for patients that has hindered the progress of many otherwise promising glaucoma drugs.
Amakem is applying the ‘Localized Drug Action’ platform to a range of other eye diseases and has also demonstrated in-vivo proof-of-concept with a second ROCK inhibitor, AMA0247 in COPD (Chronic Obstructive Pulmonary Disease) and asthma.
Amakem is based in Belgium and located in the life sciences incubator “BioVille” at the University of Hasselt in Belgium.
PRESENTER PROFILE François J. Roman founded FRconsulting in October 2007. As a consultant, he has been collaborating with several biotech companies and universities in France and Belgium. In October 2009, he cofounded AMYLGEN , a company focusing on CNS and neurodegenerative disorders, and sits in its Scientific Advisory Board.
Previously, François J. Roman served as the VP R&D at Euroscreen, Belgium from 2004. Prior to this position, he was Director of HTS and Assay Development at Pfizer PGRD France, Head of Molecular Pharmacology at Parke-Davis France, Director of Biochemistry Department at Jouveinal Laboratoires, France, and Head of Neurochemistry unit at Laboratoires Servier, where he started his career. For more than 25 years, F.J. Roman has been involved in many Drug Discovery programs and has managed various projects in a broad range of therapeutic areas including metabolic, CNS, gastrointestinal, pulmonary and inflammatory diseases. F.J. Roman holds a Ph.D. in Biochemistry from the University of Paris VI, France and has more than 40 publications and 35 patents.
COMPANY PROFILE Amylgen is a privately owned company (CRO) proposing validated in vivo models of psychiatric and neurodegenerative diseases. Amylgen’s models and technique allow fast-scale screening and pre-clinical validation for the pharmaceutical development of new drug candidates. In particular, Amylgen has developed a unique and proprietary know-how on Alzheimer's disease rodent models based on central injection of amyloid peptide fragments with validated predictive value. The company proposes, on each model, an integrated comprehensive panel of morphological, biochemical analyses and behavioral responses. Experimental protocols vary from basic screening on selected molecular, histological or behavioral outcomes to more comprehensive large-scale studies, according to the contractant’s requests. Control treatments and reference molecules are included. Amylgen services have been proven to facilitate decision-making process at critical phases of drug development. Amylgen’s contracting service and obligations, including quality standards and time sensitive deadlines, are fully provided and satisfaction guaranteed.
COMPANY PROFILE Anergis SA is a Swiss-based biopharmaceutical company specializing in the discovery and development of novel ultra-fast and safe specific immunotherapy (SIT) products for the treatment of allergy, the most prevalent and fastest growing chronic condition in the industrialized world with over 500 million people affected. Current SIT remains underused due to its long duration (3-5 years of treatment), low tolerance and safety risks. Anergis possesses a unique know-how and an exclusive license to the technology of Contiguous Overlapping Peptides (“COPs”) developed jointly by several Scientific Organisations in Switzerland under the leadership of Prof François Spertini, the inventor of COPs and founder of Anergis. The technology of COPs allows the identification and development of uniquely profiled proprietary products intended for ultra-fast and very safe desensitization. In the past years, Anergis has studied proprietary COPs targeting bee venom and birch pollen allergies both in animals and in humans. These studies have established the proof-of-concept of Anergis unique approach to SIT. After a successful Phase II A clinical trial, the birch pollen allergy product is now entering a Phase II B trial in 2012, enrolling 300 patients in six countries of Northern Europe. Other products targeting ragweed pollen, Japanese cedar pollen and house dust mites allergies are under development and could enter clinical phase in 2013.
PRESENTER PROFILE Mr. Lane has international and executive management experience in the pharmaceutical, biotechnology, diagnostic and tech industries. A native of Iowa, his corporate career began in mergers & acquisitions at SmithKline Beecham Clinical Laboratories as Director of Business Development. Recruited by SKB Pharmaceuticals R&D, he managed SKB's business development activities in the drug discovery joint venture with Human Genome Sciences, Inc. Following big pharma, he advanced development stage companies, including: Hyseq, Inc. where he engineered and led the business strategy that produced the highest valuation biotech IPO of that year; Michael Milken’s CaP CURE where he managed prostate cancer projects; and, ViaLogy Corp, a London Stock Exchange AIM listed NASA/JPL Caltech spinout company as President, CEO and Chairman. He formed Experigen Management Company in 2005 to provide executive management and advisory services for high growth potential companies, and recently joined Applied Integrin Sciences, Inc., a University of Southern California spinout company and client, to manage the company and build a team to guide development of its exciting cancer therapeutics. Mr. Lane holds degrees in Psychology, Microbiology and Biochemistry, and a Finance MBA. Twice an All American athlete at USC, he won personal and team NCAA championships and was a finalist for the United States Olympic Track and Field Team. He attributes much of his business philosophy and success to the focus, discipline and competitive strengths he developed through his athletic and his corporate training.
COMPANY PROFILE Applied Integrin Sciences, Inc. is developing its novel cancer therapeutic drugs that treat solid tumors and improve patient survival and quality of life. The company's lead candidate, Vicrostatin (VCN), selectively targets integrin receptors that are overexpressed and dysregulated in solid tumors and metastatic foci. A novel mechanism of action produces substantial reduced tumor growth and progression and anti-metastatic effects - independent of tumor origin and cancer type. The company's investment thesis: - Novel, High Value Assets; - Highly Competitive And Disruptive To Industry; - Multiple 'Shots-On-Goal'; - Industry-Experienced Management Team That Can Execute.
PRESENTER PROFILE Bassam Damaj Ph.D. has been the President, Chief Executive Officer and a director since December 2009. Dr. Damaj served as Chairman of the Board of Directors from October 2010 to April 2012. He has served as a member of our ad hoc Finance Committee since 2010. He is the co-founder of Celltek Biotechnology and served as a director from 1997 until 2000. He is also the founder of R&D Healthcare. He is a co-founder of Bio-Quant, Inc. and served as the Chief Executive Officer and Chief Scientific Officer and a director of Bio-Quant since its inception in June 2000. He has also served as the Group Leader for the Office of New Target Intelligence and a Group Leader for immunological and inflammatory disease programs at Tanabe Research Laboratories, U.S.A., Inc., as a senior scientist and member of the senior staff board of the drug discovery department at Pharmacopeia Inc., and as a visiting scientist at Genentech Inc., Pfizer Inc. and the National Institutes of Health (NIH). He also served as an independent director for CreAgri, Inc. Dr. Damaj holds a Ph.D. degree in Immunology/Microbiology from Laval University and completed a postdoctoral fellowship in molecular oncology from McGill University.
COMPANY PROFILE Apricus Bio (Nasdaq: APRI) is a pharmaceutical company that develops and markets innovative treatments that help large patient populations across numerous, high-demand therapeutic classes. The Company has four approved products and has developed a strong pipeline of multiple late-stage product opportunities. With commercial operations in both the U.S. and Europe (France), Apricus Bio generates revenues and growth from sales of its commercial products and by out-licensing, in certain territories, its pipeline products and NexACT® technology.
Apricus Bio’s growth strategy is to acquire, develop, and commercialize new products through strategic partnerships. The Company currently has commercial partnerships with multiple large pharmaceutical companies including Novartis, Abbott Laboratories, Takeda, Sandoz, Warner Chilcott and Bracco, and co-promotes multiple products in France.
Apricus Bio is headquartered in San Diego, CA and is publicly traded on the NASDAQ under the ticker symbol APRI.
PRESENTER PROFILE Paul Smith joined Axela in April 2006 as VP Sales & Business Development with more than 25 years of experience in the life science and diagnostic instrumentation field. With a diverse background in sales, marketing and field operations, he brings extensive knowledge in commercializing new technologies through direct sales and collaborative partnerships with academic and pharmaceutical clients.
Mr. Smith was previously Vice- President, Sales Europe and North America for Ciphergen Biosystems Inc., a company focused on translating proteomics-based biomarker discoveries into high value research and clinical diagnostic assays. Earlier achievements with Ciphergen included building a strong international team as Director, European Operations as well as founding their successful business in Canada.
In addition, Mr. Smith was recognized as a top sales performer with Beckman Coulter Inc., where he held a variety of bioresearch positions over 8 years, including market planning management for chromatography products. A further 10 years were spent as Technical Director for one of the world’s largest nutraceutical protein manufacturing companies.
COMPANY PROFILE Axela’s unique portfolio of multiplex assay platforms and technologies are focused on biomarker analysis of proteins, DNA and RNA for clinical research and diagnostic applications. The ease of use, robustness and flexibility of these products provide significant advantages in academic research, pharma, biotech, CRO’s, and clinical laboratories. Products include the dotLab® mX System for real time, multiplex protein measurements, the Ziplex® flow through array System for highly multiplexed gene expression and protein assays and panelPlus universal linkers which facilitate biomarker combinations and/or customized assays for either platform. Axela products are adaptable to broad markets and supported by a strong IP position. The company is open to partnering, licensing, and M&A discussions providing synergies in life science tools or diagnostic markets.
COMPANY PROFILE Founded in 1998, BIA Separations www.biaseparations.com is a European company that manufactures new generation of proprietary separation (purification) columns. The Convective Interaction Media (CIM®) technology enables the purification of Mabs, viruses, viral vaccines and vectors, and other large molecules not possible by other technologies. The company also provide customers with best possible biochromatographic solutions used throughout: drug development, semi-prep and industrial-scale processes.
Dr. Greg Parekh was appointed CEO of Biocartis in November 2011.
Prior to his CEO role in Biocartis, Greg was a founding partner of New Rhein Healthcare LLC, a healthcare investment firm focused on later stage investments in diagnostics, difficult-to-make generics and speciality pharmaceuticals businesses. In this capacity, Greg served as a non-executive director of Novogali, a french opthalmic pharma company, and Biocartis.
Prior to founding New Rhein, Greg lead the Alcon integration preparation activities for Novartis AG. Prior to his integration mandate, Greg ran Mergers and Acquisitions for Novartis and was a member of the Novartis Group Finance Committee for six years. While at Novartis, Greg led the Novartis investments into generics, vaccines, diagnostics and medical devices (eye care) with the execution of over 20 transactions with a total deal value of more than $70 billion. Prior to joining Novartis in 2004, Greg was Managing Director and Head of the European Healthcare Group for Deutsche Bank AG. Greg spent ten years in healthcare investment banking based in NY and London where he advised clients on M&A transactions and financings mostly in pharmaceuticals and biotechnology.
Dr. Parekh received a BA in Economics and Political Science from the University of Rochester and a Ph.D. in Economics from Northwestern University in Chicago.
COMPANY PROFILE Biocartis' mission is to transform the global diagnostics market by making personalized medicine an everyday reality. We intend to become a fully integrated provider of novel, broadly applicable molecular diagnostics and immunodiagnostics solutions with high clinical value assay menus. These solutions are designed to be compatible with deployment in a wide variety of health care settings, providing rapid, high-quality care close to the patient.
Biocartis develops and commercializes novel, broadly applicable molecular diagnostics and immunodiagnostics solutions combined with high-value clinical assay menus. The flagship product is a molecular diagnostics system comprising an instrument and disposable cartridges. Capable of detecting up to twenty-five nucleic acid biomarkers from a wide variety of sample types with truly sample-in result-out functionality, it offers fast and high quality care at the point of need. Biocartis’ unique business model is based on a consortium approach to menu development and platform placements. Its partners include bioMérieux and Janssen Pharmaceutica (J&J) who are developing menus in the areas of microbiology and virology respectively, while Biocartis will focus on oncology applications. Biocartis generally retains the right to develop any assay not being developed by its current partners and intends to add other partners to develop specific additional clinically relevant assays.
Firstly, an integrated Molecular Diagnostics Platform system, comprising an instrument, communication console and single use, disposable cartridges. This system can detect and quantify multiple DNA- or RNA-based biomarkers directly from a wide variety of patient samples with truly minimal user intervention.
Secondly, a high Multiplex Detection Platform with disposable, microfluidic cartridges with digitally encoded micro carriers for the rapid and sensitive detection of a broad range and number of biomarkers (proteins, nucleic acids, small molecules). In addition, Biocartis and its strategic collaboration partners are developing a broad menu of diagnostic tests with high clinical utility and compelling health economic value for these platforms.
PRESENTER PROFILE I gained experience in senior management (including P&L responsibilities) in multinational and SME environments(B to B).
I have built good relationships with international key opinion leaders in the healthcare and biotech market. I strive for excellence and high standards when managing people in order to reach stressed objectives. At present, I have set up my own management consultancy company (MindCapture) and I'm responsible for the overall strategic management of Biogazelle as Chief Operations Officer.
COMPANY PROFILE Looking for the right biomarker to improve your treatment monitoring?
Looking for the right assay to diagnose or type your biomarker during clinical phases? Or are you seeking to make your actual assay validated with the highest international standards (MIQE), allowing it to be analyzed in the clinical field? Then Biogazelle has the right solution for you.
Looking for the right data analysis tools for your qPCR data, then qbasePLUS is your ultimate solution. Looking to upgrade the qPCR knowledge of your research institute, Biogazelle can help you with customized qPCR courses.
Biogazelle is an internationally recognized PCR company (real time and digital) built upon a decade of experience in experiment design, assay development, assay validation and data-analysis. Biogazelle is committed to contribute to scientific progress, accelerating discoveries when it comes to understand diseases, discover new biomarkers, support crop improvement or other developments that make our society a better place to live in. At Biogazelle, we focus on developing PCR solutions to get faster and more accurate results. We strive to address unmet needs through excellence in science and technology. We offer support at every level: from experiment design, monitoring quality and performance, up to interpretation of study results. We are a young and dynamic company, eager to learn from and to teach the PCR research community.
Biogazelle’s expert knowledge and experience forms the basis for its complete solution portfolio and our products and services are designed to accommodate the needs of all academic and industrial qPCR users.
Biogazelle is an experienced assay designer, sets the standard in assay validation and provides all kinds of real-time PCR services in the field of mRNA, miRNA, lncRNA. Biogazelle has access to the newest state-of-the art qPCR instruments and robots. Biogazelle offers extreme flexibility to complete projects, which distinguishes us from other service providers. In addition Biogazelle is your partner for qPCR based product development.
PRESENTER PROFILE: Vincent obtained a diploma of Biotech Engineer in 1998, and a PhD in immunology and proteomic in 2002 at Inserm, France. During his PhD, he worked on the identification of biomarkers in rheumatoid arthritis, by proteomic analysis.
He worked as a researcher in Rhône-Poulenc (North Carolina, USA), Biomedical Diagnostics (Marne-la-Vallée, France), Protneteomix (Nantes, France) and Chiron Vaccines (Siena, Italy). In 2005, he obtained a degree in management and founded his own company, MicroBioChips in 2006. He merged MicroBioChips with Biosystems International in 2010 and developped the business. He is currently Head of Business Development at Biosims.
COMPANY PROFILE BioSIMS is a privately held contract research organization. Most of our staff hold a PhD, and we collaborate with a scientific committee of multi-disciplined academic partners: pharmacists, biologists and clinicians.
BioSIMS has won awards at the French Ministry of Research's 11th and 12th National Innovation Prizes (2009 and 2010) for the development of its new DigiPLEX® Protein Microarrays technology.
Our offices and laboratories are situated on “ROUEN INNOVATION SANTE”: the business Biopark of the Rouen Urban Authority dedicated to health development projects within the environment of the Rouen University Hospital Campus. It is only one hour from Paris-La Défense.
PRESENTER PROFILE Dr Ross McLennan is the CEO of Brains Unlimited – an internationally-focused company, based in Maastricht, The Netherlands; which operates a state-of-the-art imaging centre (whole body MRI scanners of 3T, 7T, and 9.4T), providing research and education services to both academia and industry (www.brains-unlimited.com). Following a Ph.D. in Genetics, Ross has followed a career in managing and facilitating large initiatives at the junction of academia, healthcare and the biotech/ pharma industry. Of note, he was previously Programme Manager of the Translational Medicine Research Collaboration, linking Scottish Medical Schools with Pfizer, and involved in the set up of the Wolfson Molecular Imaging Centre in Manchester, UK.
THERAPEUTIC AREA: CNS, Oncology, cardiology, MSK
COMPANY PROFILE Brains Unlimited B.V. is an internationally-focused imaging centre, providing research and education services to both academia and industry.
Brains Unlimited assists clients to answer their challenges in imaging human anatomy, physiology, cognition, and functionality. Specifically, we support clients to develop new therapeutics, diagnostics and technologies, and to expand their knowledge of the principles and applications of MRI. This is achieved by utilising our in house, state-of-the-art clinical imaging technology and by facilitating access to the expertise of our partner organisations.
Brains Unlimited offers you a unique combination of services and technologies. Access to world-leading Ultra High-Field MRI scanners (3T, 7T, 9.4T), is combined with dedicated customer-focused operational support, and the expertise of our clinical and technical networks. Furthermore, Brains Unlimited facilitates the development of projects, provides a one-stop-shop for contractual issues and brings focus on project delivery. In addition, there is the ability to follow advanced level training in the principles and applications of MRI.
PRESENTER PROFILE Valeria Uribe obtained her graduate degree from the University of British Columbia, while conducting research in Dr. Michael Hayden’s laboratory, where she worked on target validation in Huntington Disease. Currently she works as a business development representative for Carnot Laboratorios and other international companies. With a diverse background in scientific research, business development, marketing and strategy, she brings knowledge in commercializing products and technologies in Latin America and worldwide.
COMPANY PROFILE Carnot is a privately owned Latin American Pharmaceutical Group that specializes in feminine health, gastroenterology, respiratory and pediatrics. Carnot has developed a low dose estradiol + progesterone combination for the treatment of menopausal symptoms. Based on a patented, injectable slow-release technology, it allows administering doses of estradiol up to 60 times lower than those delivered by the leading competitors. Given its superior safety profile and improved efficacy, the product has the potential to reach global sales of above USD 1bn. To obtain marketing authorization in the US, Europe and Japan, phase III clinical studies need to be conducted. Carnot is interested in forming partnerships to complete clinical trials and market the product globally. Product Highlights -Low dose estradiol + progesterone -Large, unmet medical need -First in class product -Excellent safety/efficacy profile -Late-stage development - Phase IIb -USD 1bn sales potential
PRESENTER PROFILE Matthew Plunkett, PhD, is Executive Vice President, Corporate Development at Cell Therapeutics, where he leads CTI’s partnering strategy and execution, spanning development collaborations, licensing agreements, strategic alliances and joint ventures. Most recently, Dr. Plunkett was Chief Financial Officer at the California Institute for Regenerative Medicine, the $3 billion fund for California stem cell research. He also served as Vice President & Chief Financial officer at iPierian,a privately-held development-stage biotechnology company. Previously, Dr. Plunkett spent 9 years as a biopharma investment banker at Oppenheimer & Co. and its U.S. predecessor CIBC World Markets, most recently as Managing Director and Head of West Coast Biotechnology. Plunkett advised on over 70 completed transactions for biopharma companies in the U.S., Europe and Australia, including over $4 billion in equity-linked transactions and $1 billion in merger, acquisition and other financial advisory transactions. He began his scientific career at Sunesis Pharmaceuticals and Axys Advanced Techologies. Plunkett received his PhD in Organic Chemistry from UC Berkeley and a B.S. in Chemistry with honors from Harvey Mudd College.
COMPANY PROFILE Cell Therapeutics is focused on developing and commercializing novel agents for hematology and oncology. Licensing opportunities are: Pacritinib, a potent, selective inhibitor of WT and mutant JAK2 with promising activity in two Phase 2 trials in myelofibrosis patients. Pacritinib does not appear to be myelosuppressive and therefore may be used in patients with thrombocytopenia, and without increasing red blood cell transfusion requirements. Beginning US/EU Phase 3 in 2012. Asian or Asian+EU licensing opportunity. SB1578, also a potent and selective JAK2 inhibitor, successfully completed a Phase 1 trial. It is intended for autoimmune indications, including rheumatoid arthritis, psoriasis and ophthalmic indications. WW licensing opportunity.
PRESENTER PROFILE Henrik Rundgren has a history of project management from AstraZeneca as well as Pharmadule. He has worked with capitol investment projects as well as with corporate efficiency projects, such has reducing production cost with 50% and shortening delivery time with 50%. This project meant integration breaking down goals for all the company departments and personnel at different positions, a very interesting project.
About working at Chromafora Henrik says "To work with Chromafora is by the most interesting work that I have had. To be able to create a added value to a manufacture and in the same time do something good for the environment is very interesting as well as satisfying".
Chromafora invention is a paradigm shift that will make pharmaceutical production more environmentally benign. "it is not hard to motivate yourself with the potential that this innovations has".
Looking forward to see you all and to discuss the possibilities.
COMPANY PROFILE Chromafora is a Clean Tech company, enabling eco-friendly chemical production.
Our innovative patented phosphine chemistry
• reduces waste-handling cost • reduces production cost and • improves the environmental profile of our customers
Our unique solid phase chemistry enables regeneration of phosphine waste within API production. It thereby allows for desirable large-scale use of cost efficient phosphine syntheses, syntheses that are daily used in R&D but rarely in production due to difficult separation of the phosphine waste.
70% increase in yield has been demonstrated for a reference product.
COMPANY PROFILE Circassia is a specialty biopharmaceutical company focused on developing a new class of T-cell vaccines designed to treat allergies. The Company’s most advanced allergy T-cell vaccine is entering late-stage development, having successfully completed a number of phase II clinical studies.
COMPANY PROFILE The Clinical Investigations Group provides full services in Clinical trials Phase I to IV in Central and Eastern Europe. Our medical headquarters is located in Budapest. We have branches in Bulgaria and Romania, and representations in the Czech Republic, Slovakia and Poland. In these countries experienced local project managers care for regulatory affairs and the smooth performance of the project. We work only with local monitors, mostly physicians and pharmacists. Because of the ready co-operation from investigators with high scientific standard, large study populations, good patient compliance, and favourable cost/benefit ratio we can provide very high quality for a reasonable price. The Clinical Investigations Group provides the complete clinical operation services for all stages of drug development.
COMPANY PROFILE CLINICOBRU: an innovative clinical research interuniversity platform in Brussels CLINICOBRU involves the three academic hospitals of the Brussels Region namely the Hôpital Erasme (ULB), the Clinique Universitaires Saint-Luc (UCL), and the UZ Brussel (VUB). This represents more than 2.500 beds and speed up an activity already contributing to more than 400 sponsored new clinical studies per year, more 700 active sponsored protocols and more than 300 academic ones thanks to 150 FTE. The objectives of the project include: - Supporting the professionalization and improving the quality of clinical research - Providing shared services for clinical research in the three hospitals - Increasing and speeding patient recruitment - Enhancing the attractiveness of the Brussels Region for the conduct of clinical studies.
COMPANY PROFILE Dafra Pharma International is a privately owned European group of pharmaceutical companies bringing quality medicines within reach of patients in Africa for over 15 years. The foundations of our success have been laid by the development and distribution of malaria treatments based on artemisinin derivatives. Subsequently, Dafra Pharma International has continued to expand its product range, turning the company into a total health care solution provider. At present, the company has a team of more than 150 employees covering over 30 countries in Europe and Africa.
As the research branch of the Dafra group, Dafra Pharma R&D is mainly devoted to the development of new therapeutic options in the fields of infectious diseases (antifungal, antiparasite, antiviral) that provide significant clinical benefit to highly sensitive populations, such as immunocompromised patients and children. Our lead drug combines a broad activity range (aspergillosis, candidiasis, leishmaniasis, Chagas disease) with excellent oral bioavailability. In addition, the drug is devoid of hepatic or renal toxicity and does not affect cardiac function. Both oral and intravenous (liposomal) formulations are available.
PRESENTER PROFILE Complete Contact Details: Surname: Szpirer First name: Cedric Function : CEO and Head of Research and Development Company : DELPHI GENETICS Address : Rue A. de Saint-Exupéry, 5 – B-6041 Gosselies – Belgium Telephone: +32 71 25 10 00 Fax: +32 71 37 60 57 E-mail: cyszpirer@delphigenetics.com
Background: • Specialist in DNA engineering and synthetic biology (PhD in biological engineering in 2000). • Inventor of multiple patents in this field – Some technologies licensed for research and biopharmaceutical production (human vaccines). • Co-founder of Delphi Genetics (November 2001) • Currently in charge of R&D and CEO of the company.
Education: • Engineer in Agronomy from University of Brussels, Belgium (Université Libre de Bruxelles, 1995); • Ph.D.in Agronomic science and biological engineering from University of Brussels (Université Libre de Bruxelles, 2000), laboratory of Prokaryote genetics;
Experience: • Research associate for the Belgian National fund for scientific research at University of Brussels, laboratory of genetic evolution (2000-2003) ; • Co-founder of Delphi Genetics SA (2001) ; • Head of Research and Development at Delphi Genetics SA (2004 – today); • CEO at Delphi Genetics, (2010 - today)
Dr. Cedric Y. Szpirer was involved: • As author in several scientific publications in the field of Microbiology (bacterial conjugation, poison-antidote evolution and applications); • As inventor in more than 10 patents covering different applications in Molecular Biology, some of them were licensed for research and industrial applications • In the development of more than 10 products on the market.
COMPANY PROFILE Background:
The spin-off Delphi Genetics was founded in November 2001 between the Université Libre de Bruxelles (ULB) and three researchers from the IBMM (Institute for Molecular Biology & Medicine). The society is specialized in customized services for enterprises and research centres and in the development of technologies in DNA engineering. Delphi Genetics has an undisputed expertise in the field of molecular cloning solutions.
Technology
StabyExpress technology can be applied to any industrial protein production process that involves bacterial fermentation. Biopharmaceutical production represents a booming market and its share of the overall medication market today is estimated to15%. Moreover, the technology is consistent with the recommendations of the FDA and the EMEA with regard to the elimination of Antibiotic Resistance Genes in protein production processes for both human and veterinary uses. Currently, Antibiotic Resistance Genes are used as selection markers for the design of the majority of the genetic systems enabling protein production.
In June 2009, Delphi Genetics announced a licensing agreement with Sanofi-Pasteur, the human vaccines division of Sanofi-Aventis. That agreement allows Sanofi-Pasteur to implement the StabyExpress technology in its recombinant vaccine production and therefore to be able to produce efficiently without the use of antibiotics.
On the 22nd of September 2010, Delphi Genetics has announced the signature of a licensing agreement with GlaxoSmithKline (GSK) for the use of the patented StabyExpress technology for the production of protein vaccines for human use.
Philippe Gabant PhD, Delphi Genetics Founder and Business Development Director, explained at the press conference: “This is the second licensing agreement that we have announced with one of the major vaccine manufacturers. This demonstrates that our technology gives a competitive edge to our biopharmaceutical production partners and shows the importance of our technology in the bioindustrial world. The non-exclusive nature of this licence enables us to consider similar collaborations with other strategic partners, including partners in other fields than vaccine production”
PRESENTER PROFILE Thibault Helleputte graduated as an Engineer in Computing Science in 2006 from the Université catholique de Louvain (UCL) in Belgium, where he also obtained a PhD in 2010 in Engineering Sciences. He obtained a Master degree in Management Sciences from the Louvain School of Management in 2012. For several years, he has been working on the design of new data mining solutions for high-throughput data analysis, and in particular genomic data. He worked, on behalf of UCL, as a data mining expert for several pharmaceutical companies and clinical laboratories, in the field of cancer, allergies and auto-immune diseases. In 2012, with Professor Pierre Dupont, he co-founded DNAlytics, a UCL spin-off company offering an innovative technology for data analysis enabling personalized medicine strategies for the health care industry.
THERAPEUTIC AREA TRACK RECORD: allergies, oncology, arthritis, lupus, and more
COMPANY PROFILE DTL Biotechnology Ltd was founded in 2010 by Denis Looby, who has 30 years experience in animal cell process Research and Development and biopharmaceutical manufacturing. The founder and managing director of DTL Biotechnology has a successful track record in animal cell biotechnology including · the successful development of two immobilised (3D mammalian cell) bioreactors, i.e. fixed and fluidised bed porous glass bioreactor systems · the successful establishment of a stirred perfusion process for the production of an antibody-cytokine fusion protein from rBHK cells immobilised in Immobasil® (porous silicone carriers) · the development, scale-up, regulatory compliance and management of the commercial manufacture of a rCHO based process for the production of a biosimilar EPO. · the development and scale up of a microcarrier production process for an influenzaviral vaccine.
DTL Biotechnology Ltd is an independent consultancy and new product development company, specialising in process R&D and manufacturing for biopharmaceuticals, viral vaccines, specialised cells and biofuels.
Consultancy - in cell and virus culture, bioreactor technologies, downstream processing, process validation and process scale up.
Project management · the management of biopharmaceutical and vaccine processes from R&D through to regulatory compliant manufacturing processes, and · the set up and management of EU and national government funded research and development projects in biotechnology, biofuels.
· The development of 3D immobilised liver cell-carrier based systems for drug discovery applications, toxicology testing and bioartificial organs. This work is currently being set up by DTL Biotechnology Ltd in conjunction with a number of partner companies and research organisations throughout Europe. · The development of novel upstream process technologies for viral vector and vaccine production. This work is currently being set up by DTL Biotechnology Ltd in conjunction with a number of partner companies and research organisations in Ireland.
PRESENTER PROFILE In 1988 Dr. Lacombe graduated as MD from the University of Marseilles (France). He was granted for a Master Post-doctoral Fellowship at the Roswell Park Cancer Institute, Buffalo, NY, USA for Fundamental and Clinical Pharmacokinetics from 1989-1991. From 1991 to 1993 he worked as Clinical Research Adviser in charge of the development of a new drug in oncology in the pharmaceutical industry. Since September 1993 he is working as Clinical Research Physician at the European Organisation for Research and Treatment of Cancer (EORTC) in Brussels. He is still a Clinical Research Physician for the Brain Tumor Group. Between 1993 and 2006, Dr. Lacombe was in charge of coordinating the Regulatory Affairs Unit ensuring compliance to the regulatory framework. Until 2007, as Assistant Director Medical Affairs, he coordinated the EORTC New Drug Development Team (NDD Team) which supported EORTC clinical groups conducting new drug development studies from protocol development to publication. Amongst his activities, he is responsible for the Early Project Optimization Department (EPOD) dedicated to helping the groups in the development of studies in phase with EORTC’s guidelines and strategy. Since November 2010, he has been appointed as Director Headquarters of the EORTC with main mission to ensure that the functioning of the EORTC be in line with the decisions of the EORTC Board.
COMPANY PROFILE The EORTC is a unique organization – a vibrant example of the fact that science and research know no national boundaries. Established in 1962, the EORTC is a non-profit research organization operating as an international association under Belgian law. The EORTC currently links a network of more than 2.500 pre-clinical scientists and oncologists in more than 300 hospitals in over 30 countries. It encompasses all aspects of cancer research, from translational research and new drug development to large phase III clinical trials and meta-analyses. The 170 members of the EORTC Headquarters staff handle some 6.000 new patients enrolled each year in cancer clinical trials, approximately 30 protocols that are permanently open to patient entry, over 50.000 patients who are in follow-up, and a database of more than 180.000 patients. http://www.eortc.org
COMPANY PROFILE A biopharmaceutical company in the diabetes area with headquarters in Lille, France and its US subsidiary in Cambridge, GENFIT is focused on the diagnosis and treatment of diabetes related complications, including liver and cardiovascular diseases. GFT505, GENFIT's most advanced drug candidate, currently in phase IIb, is well positioned to become a first-in-class therapy for NASH. GENFIT seeks Investors and Pharma partners to fund the late-stage clinical development of GFT505 and support its optimal progress & value. Other GENFIT’s proprietary but early-stage programs provide solutions for diabetes and inflammatory diseases. They are available for partnering.
PRESENTER PROFILE Sigrid Booms has served as Director of Clinical Development at Hermo Pharma Ltd. since August 2011. Prior to this, Mrs Booms has acted as regulatory consultant for Hermo Pharma since August 2010.
Mrs Booms is a licensed pharmacist from the University of Utrecht, the Netherlands. She has more than 17 years experience in global development of pharmaceuticals for human use. She has previous experience in regulatory affairs at Finnish midsize pharmaceutical industry and at a global clinical CRO as regulatory consultant for clinical development. Over the years she has become an expert in regulatory aspects for global drug development, particularly nonclinical and early phase clinical development.
Our therapeutic area of classification: neurology and neuro-ophthalmology.
THERAPEUTIC AREA: Neurology and neuro-ophthalmology
COMPANY PROFILE Hermo Pharma Ltd. aims at developing novel disease-modifying treatments for amblyopia in adults and Parkinson’s disease. Research and development focus is on neurodegenerative diseases and on modulation of neuronal plasticity. Amblyopia in Adults program is at Phase IIa clinical trials and Parkinson´s program is in non-human primate pre-clinical stage. Strategy is to gain research and development partnerships with pharmaceutical company for particular product prior to late clinical development phases and marketing. Company was recently funded by Seed Fund Vera Ltd. and Helsinki University Funds. On top of the venture capital investments, the company has obtained additional public funding to support the company operations from e.g. Michael J.Fox foundation.
Jamal El-Mosleh
Chief Executive Officer M.Sc. Industrial Engineering and Management, Innovation and Entrepreneurship
PRESENTER PROFILE Experience: Jamal El-Mosleh is a graduate from Chalmers University of Technology (Industrial Engineering and Management) and Gothenburg International Bioscience Business School (Innovation and Entrepreneurship) in Sweden and has previously worked as a management consultant and as a project manager for a biotech startup.
THERAPEUTIC AREA OF CLASSIFICATION Therapeutic cancer vaccines - target indication: metastasized renal cell carcinoma.
COMPANY PROFILE Immunicum is a Swedish biopharmaceutical company, formed in 2002, that develops therapeutic cancer vaccines based on allogeneic dendritic cells. The company's lead product INTUVAC is currently in a clinical phase I/II study in metastasized renal cell carcinoma. The largest owners consist of private investors and a business incubator (Chalmers Innovation).
COMPANY PROFILE ImmunID is engaged in advancing personalized medicine through the development of molecular diagnostics products and services.
ImmunID has developed and patented innovative technologies to assess a patient's immunity and immune repertoire diversity, which the company uses as a dynamic biomarker of health status and treatment efficiency. ImmunID’s tools include the Divpenia® test (clinical state of reduced T and/or B lymphocytes immune diversity) and NDL® score (combination of lymphocyte count and diversity). Divpenia® was shown to be correlated with a higher risk of infection & mortality and a reduced treatment efficiency. ImmunID presented a poster on the prognostic and predictive value of Lympho-divpenia in metastatic Breast Cancer at ASCO a few months ago and just published this work in the OncoImmunology journal.
ImmunID provides its services to biopharmaceutical companies and clinical research centers worlwide, for prediction of response to therapies, immunomonitoring and patient stratification in clinical trials, in the areas of Oncology (e.g. solid tumors, hematological malignancies, HSCT, BMT, GvHD) and Infectious Diseases (e.g. HIV, HCV). The company’s tests and services are available for research, preclinical (mouse) and clinical validation, and can be applied to different types of therapies: monoclonal antibodies (e.g. anti-CD19, anti-CD20, T cell checkpoint inhibitors such as anti-CTLA4 or anti-PD1), interleukins (e.g. IL-2, IL-7), chemotherapy and therapeutic vaccines.
PRESENTER PROFILE Dimitri Dimitriou has over 20 years’ experience in the pharmaceutical and biotech industry. He is a founder of ImmuPharma. His past roles include senior director, worldwide business development at GlaxoSmithKline, where his responsibilities included worldwide corporate deals with pharmaceutical and biotech companies. He held a similar role in Europe for Bristol-Myers Squibb. He has a marketing background in Procter & Gamble and Novartis. He is also the founder and chief executive officer of DyoDelta Biosciences, a company specialising in transactions between pharma and biotech companies and was chief executive officer of the London-based drug discovery company, Xcellsyz. He has a degree in biochemistry from Kings College, London and an MSc in pathology and toxicology from the Imperial College Medical School.
COMPANY PROFILE ImmuPharma PLC is a drug discovery and development company headquartered in London and listed on AiM. ImmuPharma has its research operations in France and Switzerland. ImmuPharma is dedicated to the development of novel drugs to treat serious medical conditions characterized by: 1) Blockbuster potential in niche markets; 2) very high pricing and low cost of goods 3) low promotional costs in few specialised physicians and centres and 4) lower risk of drug development and lower development costs.
The company has discovered and is developing 5 lead product candidates to treat 1) Lupus, 2) Cancer, 3) Severe pain such as in cancer and post-operative pain, 4) an antibiotic with a novel mechanism of action for severe resistant hospital acquired infections such as MRSA and 5) Inflammation.
ImmuPharma’s drug candidates all belong to innovative and patented libraries and have novel mechanisms of action discovered by the Company and represent significant sales potential. In addition to these lead candidates, ImmuPharma has its own proprietary discovery engine. The company uses Contract Research Organizations while maintaining "in house" key activities as drug modeling, discovery and screening capabilities, project management, patents and research.
ImmuPharma has ownership of a novel and patented Peptide to Drug Converting Technology (PDCT) designed to allow and improve the oral bioavailability and plasma half-life of peptides that can be applied to numerous small peptides to constitute a potent and promising proprietary small molecule library. ImmuPharma is also co-owner and/or has worldwide exclusive licenses for a series of patents coming from the CNRS (French National Research Council) through its exclusive collaboration with the leading research units of the CNRS in the field. These technologies cover mainly new urea chemistries (heterocyclic ureas with a library of more than 300,000 molecules having a drug likeness of 70%, urea and hybrid oligomers) as well as post translational modifications of peptides to act on auto-immune related pathways. Proof of concept products for each type of technology are currently in preclinical development.
PRESENTER PROFILE Daniel Ducharme’s vast and varied careers have spanned industries from media to sales management. Prior to joining Insigniam in Paris, Daniel was a sales manager for a large home improvement company and worked for 15 years in the media industry. He has a personal commitment to contribute as often as possible to support clients in bringing new drugs faster to the market.
His areas of expertise range from:
• Entrepreneurial experience owning and publishing several newspapers and magazines in the Caribbean Islands of Saint Barts and Saint Martin, Guadeloupe and Martinique • Owning a significant land development operation and real estate agency • Managing a private investment fund focused on media groups and financial services companies, and a branch of France Antilles, a regional paper that is part of the Hersant publishing group.
Education
• Bachelor of Science, University of Montreal • Master’s degree in Geology, University of Paris-Sorbonne
Awards and achievements
Published numerous business articles on topics such as finance, transport, taxes, banking, and luxury goods
COMPANY PROFILE Insigniam is an international consulting firm with a proprietary methodology for enterprise performance transformation and catalyzing breakthrough results. Executives in large and complex organizations around the world utilize our custom-designed services to generate unprecedented measurable results. Our work over the last 25 years ago helped pioneer the field of breakthrough performance and organization transformation.
Clients have documented over 50x ROI in additional measurable business results using our services on their business imperatives, innovation, speed to results and enterprise critical initiatives, and enterprise transformation.
PRESENTER PROFILE Joseph Araujo has over 10 years of executive management and consulting experience in contract research and biotech. Prior to his current role as CEO of InterVivo Solutions, Joseph co-founded CanCog Technologies and played an instrumental role in successfully growing CanCog Technologies into an international service provider for companion animal health; he remains on the CanCog Scientific Advisory Board. Joseph is a co-founder of both Karyopharm Therapeutics, a Boston-based biotech that successfully raised $20M in Series A financing, and Ketogen, a Toronto-based biotech focusing on novel therapeutics for epilepsy and pain.
Joseph has extensive experience in the development and implementation of novel models for CNS disorders with a specialty in aged canine models. He has worked on a variety of preclinical projects and has over 100 combined poster presentations, speaking engagements and peer-reviewed publications. Joseph is currently completing his PhD in Pharmacology at the University of Toronto.
THERAPEUTIC AREA: Models and services that cover a wide area of CNS therapeutic areas, CRO
COMPANY PROFILE InterVivo Solutions is a preclinical in vivo contract research organization with the mission of providing translational animal models for assessing early safety and establishing proof of concept efficacy of drugs targeting human diseases of the central nervous system. InterVivo provides predictive animal models in appropriate species that reduces risk and increases success of transitioning new drugs to the clinic. To meet the growing need for translational models, InterVivo actively develops new animal models both independently and in partnership.
InterVivo was founded in 2010 and brings together scientific expertise in a variety of therapeutic areas to provide state of the art tests and animal model systems. Collectively, InterVivo staff and consultants bring more than 100 years of combined expertise in behavioral neuroscience. Our wide range of experts and services provide our clients with the tools necessary to evaluate early safety and efficacy of their compounds in an efficient manner and each protocol is custom designed with this purpose in mind.
InterVivo has expertise and animal models in the following therapeutic areas: Cognition and dementia including Alzheimer’s disease; Movement disorders including Parkinson’s disease; Pain and epilepsy; Neuropsychiatric diseases; Obesity and eating disorders; and Abuse liability. InterVivo provides a range of services that alone or in combination provide our clients with the data they need, which include: Comparative cognitive and behavioral tests; Serial blood, CSF and tissue collection; In vivo Imaging including MRI, CT, PET, US, XRAY, QMR and DEXA; Histopathology; and New model development.
COMPANY PROFILE KBI Biopharma, Inc. is a contract biopharmaceutical development and manufacturing organization offering a full range of preformulation/formulation development, analytical method development, full process development and clinical manufacturing (for both mammalian and microbial programs).
KBI Biopharma has established a world-class reputation in the following core competencies: Preformulation/Formulation Development: KBI has extensive formulation development capability for both liquid and lyophilized biopharmaceutical drug products (including extensive monoclonal antibody formulation development experience). We utilize advanced statistical design of experiments to evaluate multiple factors such as pH, buffer type, ionic strength, and excipient type in preformulation development, while carefully monitoring protein conformation and thermal stability using advanced biophysical techniques including DSC, DLS, CD, FTIR, and Fluorescence.
Analytical Method Development/Validation: KBI offers a broad range of method development services to assess identity, purity, potency, and quantity of protein therapeutics. We have extensive analytical capabilities including HPLC, CE, ELISA, UV-Vis Spectroscopy, Fluorescence Spectroscopy, Mass Spectrometry, AAA, SDS-PAGE, IEF, and carbohydrate characterization. Biophysical techniques include CD, DSC, DLS, Fluorescence spectroscopy, and FTIR. Bioactivity assays include ELISA, Biacore and cell-based assays. KBI is skilled in method development, qualification, validation and transfer, full cGMP release testing and ICH stability testing.
Process Development and cGMP Clinical Manufacturing: We offer both microbial and cell culture process development and clinical manufacturing for recombinant protein expression. Our team has extensive experience in microbial systems such as Pichia, E. coli, and Saccharomyces, as well as mammalian systems such as CHO, NS0, and hybridomas, including downstream processes (e.g. harvest, homogenization, refold, ultrafiltration, chromatographic capture, purification, and polishing). Our efforts are focused on developing scalable and robust processes which result in stable and active products.
We invite you to call us and discuss our track record of success, or to speak with our extensive list of delighted customers.
PRESENTER PROFILE Karri Venn RD, CDE, CCRC, PMP holds a Bachelor of Science degree in Dietetics, having graduated from the University of Kentucky in 1996. In 1997, she completed her internship through the Edmonton Health Regional Authority. Following her internship, Mrs. Venn continued to develop her role as a Dietitian Consultant for Health Care firms in the Toronto area and joined LMC Diabetes & Endocrinology in 1999. Mrs. Venn has brought experience, knowledge and drive to her position as Registered Dietitian, Certified Diabetes Educator and Director of Research for all LMC Diabetes & Endocrinology sites across Canada. In addition, Mrs. Venn has enhanced her professional standing through her memberships in the Dietitians of Canada, the College of Dietitians of Ontario, CanFit Pro, Canadian Diabetes Education Certification Board, Association of Clinical Research Professionals and Project Management Institute.
COMPANY PROFILE LMC Diabetes & Endocrinology has extensive clinical research expertise in the area of Endocrine, Metabolic & Cardiovascular disorders. With 9 offices across Canada, 30 Endocrinologists and >80,000 patient database, we are recognized as the largest non-Academic Endocrinology practice globally and the largest Diabetes Research facility of its kind in Canada. We provide a comprehensive patient registry with >24,000 active diabetes patients, full scope of SOP’s, efficient start up and consistently exceeds enrollment targets. LMC Diabetes & Endocrinology can meet all your needs for Phase I-III Endocrine clinical trials. Our Toronto office includes a 12 bed, dedicated Clinical Research Unit. The CRU is a fully-equipped research facility, designed to conduct Phase I-IIa “First In Patient" and “Proof Of Concept” clinical trials with special expertise in glucose clamping.
PRESENTER PROFILE Philip G. Ralston, Jr., has spent more than 35 years in the life science industry as a senior executive, inventor, company founder, venture capitalist and business coach. He has represented companies in public, private and non-profit sectors. Ralston holds 18 patents on various medical products, including drug delivery, monitoring and cardiovascular devices. Prior to becoming an entrepreneur in medical related businesses, Ralston served as director of biomedical engineering at Baxter Healthcare where he was part of a corporate level group focused on strategic projects, product development and technology commercialization. A proven team builder, he is known for his “teamthink” approach to developing people and has started several programs to accelerate team-based product commercialization. Since leaving Baxter, Ralston has started five companies, has been the senior operating executive of two mid-size medical device companies, and for the last decade has been a business coach for several Fortune 500, mid-size and start-up clients. He has significant hands-on knowledge and experience in all facets of operations and marketing for pharmaceutical, biotechnology and biomedical products from start-ups to mature manufacturing entities. Highly effective in assessing risk and viability probability for start-up life science companies and products, Ralston successfully operated a new technology accelerator at Houston Advanced Research Center (HARC) and designed the Center for New Enterprise Development in the same community. He frequently speaks on “passing attack” product development, an effective, concurrent engineering process for moving ideas from proof of feasibility to proof of efficacy; and “customer delight”, or how to achieve outstanding customer loyalty. A true team player, Ralston has always placed a high priority on the development of his and his client’s teammates. He is committed to helping an organization’s human capital achieve its highest potential in performance driven cultures. Ralston holds a Master of Business Administration from the Kellogg School of Management at Northwestern University and a Bachelor of Science in Chemistry from Brigham Young University. He is a charter board member of the Medical Device Manufacturers Association. He is an executive committee member of the Center for New Ventures and Entrepreneurship at Texas A&M University. He has taught Small Business Growth and Management at the Mays School of Business at Texas A&M University. Phil formerly served on the advisory board of the Houston Technology Center, and was a Director and Senior Business Adviser with the North Texas Enterprise Center.
THERAPEUTIC AREA: Opthalmology - Dry AMD
COMPANY PROFILE If you are not already aware, Age Related Macular Degeneration is the leading cause of blindness worldwide for people over 50, affecting 30 million people; this number is growing as the population ages. As of now, there is no approved treatment for 90% of these AMD sufferers. This huge, unmet need represents a market potential of greater than $20Billion. MacuCLEAR has a novel, preservative-free, eye drop treatment for this pandemic problem, invented by Dr. George Chiou, who pioneered Timolol, the leading treatment for glaucoma. The Company has 6 issued patents, IND and Fast Track Status, and COMPLETED its Groundbreaking, Phase I/POC human trial. Results show MacuCLEAR’s drug, MC-1101 is safe and well tolerated by study subjects. A key finding of the study was the successful migration of the drug to the back of the eye, which increased choroidal blood flow in the back of the retina. MacuCLEAR’s recognized Best in Class* technology will be used in an FDA-guided Phase 3 efficacy trial starting in Q3, 2012.
COMPANY PROFILE Miami Mice Research Corp is a biotechnology company dedicated to providing low cost and accessible diagnostics for disease. Our focus is on the large unfulfilled need for a lung cancer diagnostic. To meet this need, we have developed a blood-based diagnostic for early detection of lung cancer. Miami Mice was established in 2007 in Toronto, Canada. The company owns several mouse models of disease, including a unique mouse model of lung cancer. We used our mouse lung cancer model to identify protein biomarkers that appear at early stage disease, and validated the markers in human patient blood samples. Miami Mice also has mouse models of leukemia and angiogenesis that are available for drug development and testing.
COMPANY PROFILE NeuroProof is a global leader and preferred partner in the field of microelectrode array (MEA)-based phenotypic screening of primary cultures. Neuroproof offers screening services and state-of-the-art mathematical expertise for the phenotypic analysis of test agents on neuronal network activity. The services comprise the growing of primary neuronal cultures on MEA chips, medium throughput screening of test agents, high quality recording of spontaneous and compound-induced network activity, state-of-the-art mathematical analyses, and sophisticated pattern recognition methods. The unique platform is well suited to identify and characterize effects of test agents on neuronal network activity and brain cell functioning.
COMPANY PROFILE Ovizio, Spin-off of the "Université Libre de Bruxelles” is a start-up company, specializing in quantitative imaging devices based on Digital Holographic Microscopy (DHM). Ovizio’s platform technology is developed around a patent portfolio of the University. The spin-off designs and markets its optical instruments primarily to the Pharmaceutical, Biotechnology and clinical analyses markets. Ovizio’s technology breaks the barriers between 3D microscopy and Flow Cytometry and can be used to observe cell cultures in their existing media (bioreactors, cell factories, flasks, petri dishes, ....). Typical applications are: label-free viable cell counting, online bioreactor monitoring and diagnostics. The technology does not require sample preparation. Ovizio has started clinical trials in diagnostics and is actively looking for partners.
PRESENTER PROFILE Founder and current CEO of Palau Pharma, a biotech company based in Barcelona. Raised 38 M € in a series A financing in 2006 and a further 8 M € in a series B round in 2010.
Prior to that, Director of Business Development and Licensing at GRUPO URIACH in Barcelona.
PhD in biochemistry from Indiana Univeristy and MBA from the Kellogg School of Management, Northwestern University.
COMPANY PROFILE Palau Pharma, S.A. (“Palau”) is a product-driven biopharmaceutical company focused on the research and development of revolutionary and differentiated new medicines that are designed to address the unmet needs of patients suffering from inflammatory and autoimmune diseases.
> A Strategy Designed for Solid Results
Palau’s core business model is based on identifying unmet medical needs in order to develop novel drugs through Phase IIa clinical trials. At that point, decisions are made on a case-by-case basis whether to keep the development in-house or partner the compound for further late stage development and commercialization.
Our R&D strategy is focused on developing “best-in-class” or “first-in-class” drugs that modulate the activity of validated targets with established preclinical or clinical proof-of-concept. Based on a unique and high-quality cost-effective structure, our final objective is to achieve early positive differentiation from our competitor’s molecules by addressing their limitations and designing a clear, focused and fast path to commercial success.
Our primary focus is on inflammatory and autoimmune diseases, however, we consider other therapeutic fields, such as oncology, where there are synergies and commercial opportunities with existing development projects.
> Every Partnership Is a Solid Commitment
At Palau, partnering plays a strong role in both our business model and our development philosophy. We believe that the key to success is establishing successful partnerships that are driven by strong commitment, close collaboration and transparent communication.
We have demonstrated above-average success rates in each project we have pursued and our business model has been strongly validated through partnering agreements with a broad range of companies, including GlaxoSmithKline, Schering-Plough, Affectis Pharmaceuticals, Vétoquinol Veterinary Pharmaceuticals and Iberhospitex, amongst others.
> We Are Making Solid Progress
Palau has a solid pipeline with a total of 11 projects: 2 in the market, 5 in clinical development and the rest in early discovery. Some of the projects have already been partnered with relevant local and global companies (as below indicated): ACTIVE® and IRIST® Stents – Drug eluting coronary stents coated with paclitaxel (ACTIVE®) or simvastatin (IRIST®), using a polymer containing the antiplatelet agent triflusal. Marketed. Partnered with Iberhospitex (Spain). CIMALGEX® – Selective cycloxygenase-2 inhibitor for the treatment of inflammation and pain conditions in companion animals. Marketed. Partnered with Vétoquinol Veterinary Pharmaceuticals (France). Albaconazole – Oral broad-spectrum antifungal agent. Phase Ib/IIa clinical trials complete for tinea pedis. Phase IIa clinical trials complete for vulvovaginal candidiasis and Phase IIb clinical trials complete for onychomycosis. Cimicoxib – Selective cyclooxygenase-2 inhibitor for the oral treatment of depression. Phase IIa clinical trials complete. Partnered with Affectis Pharmaceuticals (Germany). Dersalazine sodium – New chemical entity indicated for the oral treatment of moderate to severe ulcerative colitis. Phase IIa clinical trials complete. UR-13870 – p38 MAP kinase inhibitor for the treatment of inflammatory and autoimmune diseases such as neuropathic pain and rheumatoid arthritis. Phase Ib clinical trials. UR-63325 – Novel histamine H4 receptor antagonist for the oral treatment of allergic respiratory diseases (asthma and allergic rhinitis). Phase Ib/IIa clinical trials. UR-63325 – Novel histamine H4 receptor antagonist for the oral treatment of allergic respiratory diseases (asthma and allergic rhinitis). Phase Ib/IIa clinical trials. UR-65318 – Novel histamine H4 receptor antagonist for the treatment of dermatological conditions. Preclinical testing. Partnered with a leading US, NYSE-listed pharma company. UR-67767 – Balanced Janus Kinase (Jak) selective inhibitor for the treatment of inflammatory and autoimmune diseases. Preclinical testing. Neogenius Pharma – Drug Discovery program focused on the identification of innovative molecules to treat inflammatory pain. Early discovery stage. Partnered with Draconis Pharma within a consortium with Almirall and Esteve (Spain). Dendria – Drug Discovery program focused on the identification of new molecules to treat neuroinflammatory diseases. Early discovery stage. Partnered with Draconis Pharma within a consortium with Noscira and Faes (Spain), and nine other Spanish biotechnology companies.
PRESENTER PROFILE Dr. Anil Gulati is the founder of Pharmazz, Inc. He is Professor of Pharmaceutical Sciences and Associate Dean for Research at the Midwestern University. He is a United States Fulbright Scholar 2008-2009 and winner of International Ranbaxy Research Award 2007. He did his M.D. in 1982 from King George's Medical College, Lucknow, India and became Diplomate American Board of Clinical Pharmacology (1992). He was awarded Ph.D. in 1996 by Erasmus University Rotterdam, The Netherlands. He is Fellow of American College of Clinical Pharmacology. He has more than 275 peer reviewed research publications and guided researches of more than 75 graduate students and research fellows. Dr. Gulati has 31 patent applications (sixteen issued patents) and has founded three companies. Few medications developed by Dr. Gulati are undergoing clinical trials in the United States and India.
COMPANY PROFILE Pharmazz, Inc. is a privately held pharmaceutical company incorporated in the State of Illinois, USA with fully owned subsidiaries in the United Kingdom and India.
The company is engaged in designing, developing, and commercializing novel products for use in critical care and hospital settings.
Pharmazz is presently developing two compounds: • PMZ-2010 as a resuscitative agent for the treatment of hypovolemic shock with a unique mechanism of action. PMZ-2010 in low doses reduced blood lactate levels, improved blood pressure, cardiac output, survival and proved to be a highly effective resuscitative agent. Worldwide market size is projected at $10 billion. • PMZ-2123 for diabetic ketoacidosis. When used along with insulin, PMZ-2123, produced a rapid reduction of blood ketones levels and reduced the threat of brain edema. Worldwide market size is about $800 million.
PRESENTER PROFILE Sam Possemiers is born on November 13, 1980 in Borgerhout (Belgium). He graduated in 2003 from Ghent University as bioscience engineer, option cell and gene biotechnology.
In 2007 he obtained a PhD degree in the field of intestinal microbiology at Ghent University (LabMET). A part of the work was performed at the French Institut National de la Recherche Agronomique (INRA). In 2006 he was awarded with the Scientific Prize McKinsey & Company of the Fund for Scientific Research (FWO) - Flanders.
In 2007 he started as a post-doctoral researcher at LabMET, Ghent University. His main research interest is the interaction between intestinal bacteria and human health. This includes pro- and prebiotics, microbial metabolism and bioavailability of food compounds and pharmaceuticals and the relation between intestinal bacteria and obesity.
In 2008, he founded ProDigest, a spin-off company from Ghent University, which provides customized services in the field of gastrointestinal transit, bioavailability and metabolism, to the operators in the food and pharmaceutical sector.
COMPANY PROFILE ProDigest is the company that brings to the market the SHIME® (Simulator of Human Intestinal Microbial Ecosystem) and its related technology platform. As a spin-off company from Ghent University (Belgium), ProDigest provides customized solutions related to gastrointestinal research to the operators in the market of food, functional food and pharmaceutical industry. We offer specialized services depending on the client company profile due to the very flexible design of our technology platform.
The SHIME® is a scientifically validated dynamic model to study physicochemical, enzymatic and microbial parameters (also the host-microbiota interaction) in the gastrointestinal tract in a controlled in vitro setting. This is the ideal instrument to simulate repeated ingestions of a given product under long-term representative GIT conditions in order to investigate the activity and stability of probiotics and prebiotics during gastrointestinal transfer, the microbial conversion of bioactive food components (e.g. phytoestrogens), the metabolism of pharmaceutical components, the efficacy of targeted delivery systems and the conversion and biological (in)activation of food and/or ingested environmental contaminants and their bioavailability.
PRESENTER PROFILE Eduardo is Partner and Founder of ProGalénika, a novel Pharmaceutical and Services Company based in México City. Under its Start-Ups division, ProGalénika has developed a unique business model that facilitates multinational pharmaceutical and biotechnology companies land their presence and products in the country in a timely and cost-effective way. Through its Pharmaceutical division it can commercialize and distribute own and licensed products in the market.
Eduardo has 26 years of work experience in the pharmaceutical industry. He had a fifteen year career with the Glaxo organization, joining the company in Mexico in 1986, where he had a fast paced ascending career in the marketing and sales area. He was General Manager of their affiliate in Puerto Rico and after the consolidation of GlaxoSmithKline Eduardo was named Vice President, Marketing Latin America.
In 2001, Eduardo joined Wyeth Pharmaceuticals as Area Vice President, South America and subsequently promoted as President of Latin America, and was part of the Wyeth Operations Committee, the Pharmaceutical Management Team, and the Global Commercial Team boards.
In May 2010 Eduardo decided to become an entrepreneur by founding Electio Consulting LLC, a novel consulting firm specialized in the Latin American Pharmaceutical and Biotechnology Market. In his role as President and Founder, Eduardo has supported a wide range of US and European based pharmaceutical and biotechnology companies with advisory and consulting services. The scope of his work span from helping companies establishing a challenging vision and focused strategic direction, to fully restructure their operations supporting the buildup of totally new architectures, to providing comprehensive advice for the introduction and launch of products in the vaccines, biotechnology and biosimilar markets. In May 2012 Eduardo starts ProGalénika.
Eduardo served as Chairman of the PhRMA Latin America Regional Steering Committee from 2006 to 2008 and was a Board Member from 2001 to 2009 and was Chairman of the Pharmaceutical Industry Association of Puerto Rico. He is currently President of the board of the non for profit organization ACLAMO Family Centers.
COMPANY PROFILE ProGalénika is a young and novel company specialized in the Mexican Life Science Industry. Mexico is the second largest Pharmaceutical market and best port of entry to start business in the Latin American region. Our focus is to support multinational companies to start their presence in the Mexican Pharmaceutical market under our unique business model. ProGalénika can support your company on all developmental stages of a product through our knowledge, operational expertise and strong network of partners and allies. ProGalénika is established as a Pharmaceutical company; thus, it can commercialize and distribute Pharmaceutical and Biotechnology products and Medical Devices. Specialties: Pharmaceutical Start-ups; Commercialization of Pharmaceutical and Biotechnology products; Support Product Development; Other Specialized Services.
PRESENTER PROFILE Director, Business Development & Marketing Claire Untereiner joined PXT in January 2008 as Business Development Manager and moved to the position of Business Development and Marketing Director in January 2011. In the past, Claire held various marketing & project management positions in health and life science sectors. She holds a Master's degree in Biochemistry from the University of Lyon and a Master's degree in Technology & Innovation Management from the EM LYON Business School.
COMPANY PROFILE Development and Production of Recombinant Proteins (research grade) • Gene synthesis and molecular biology (including mutagenesis) • Protein engineering • Optimization of the protein sequence in order to solve specific solubility or refolding issues for instance • Definition of relevant combinations of vectors, signal peptides, strains/host cells to achieve improved expression or secretion yield. • Production protocol transfer from the client and protein batch production • Development and optimization of expression and purification protocols • Development of refolding protocols for insoluble proteins • Cell culture in transient conditions • Development of stable monoclonal mammalian cell lines • Development of fermentation process (batch, fed-batch) and scale up of purification scheme in view of large scale industrial or cGMP manufacturing. • Production of protein batches (from mg to gram scale, research to crystallography grade) • Quality controls
Expression Systems - bacterial (E. coli). Specific know-how for insoluble protein. - yeast (S. cerevisiae, Pichia pastoris) - baculovirus / insect cells - mammalian cell lines (CHO, HEK, COS, etc.)
Development and Production of Monoclonal Antibodies
We differentiate from other service companies by our vocation to propose : 1) original and relevant approaches to address antibody development related issues such as immunization of animals with difficult to express antigens or generation of antibodies directed against rare and weakly antigenic epitopes.
2) strategies for the development humanized antibodies based on a « fee for service » model. Those strategies are essentially based on know-how and not on proprietary technologies in order to lower the level of intellectual property associated to the product and increase its value for the client.
1. Development of Murine Monoclonal Antibodies • Mice immunization protocols adapted to the material available • from DNA if the protein material is not accessible • from peptide and protein • from transfected cells • Substractive immunization strategy for the development of antibodies directed against rare or weakly antigenic epitopes • Example : discrimination of antibodies directed against multimers versus monomers, against a protein variant versus the wild type form, against a human protein versus a murine protein displaying sequence homologies, etc • Fusion with myeloma cells, generation and screening of hybridomas • Development of screening methods : Western-Blot, ELISA, Immunofluorescence, etc. • Cloning and characterization of producing hydridomas • Production and purification of antibody batch (optional) • Other services upon request
2. Development of Humanized Antibodies
We offer 3 different strategies targetting the development of chimeric, humanized or fully human antibodies dedicated to therapeutic applications : A) Molecular engineering strategy : characterization of the reference antibody (murine/rat...) to determine isotype, sequence and affinity, humanization of the antibody (based on IMGT tools), production of several variants at small scale and affinity characterization for each of them. B) Development of humanized mice which allows the production of chimeric antibodies (in collaboration with Genoway). C) Development of human antibodies from human B lymphocytes isolated from seroconverted patients (SEBVI technology)
cGMP Development & Manufacturing of Biotherapeutic Products • Cell banking (Master Cell Bank / Working Cell Bank) • Development and validation of analytical methods • Scale up of production process • Preclinical batch manufacturing • Clinical batch manufacturing and batch release • Coordination of Fill & Finish (through qualified partners) • Regulatory support all along the project
Our Added Value Our specific organization and the mix of R&D and manufacturing competences of our team ensure added value to customers. Our strengths rely on: - a strong scientific expertise associated to the regulatory understanding of biotherapeutic product development - the capability to accompany our clients from early stage research and engineering up to clinical batch manufacturing - the optimization of timelines for the development of therapeutic candidates due to the synergy between research and cGMP manufacturing platforms
Promise Advanced Proteomics In 2010, PX’Therapeutics launched Promise Advanced Proteomics, a new start-up dedicated to the development of an innovative technology for the quantification of proteins in biological samples using mass spectrometry. The technology, called PSAQ™ (Protein Standard for Absolute Quantification) shows very high specificity, accuracy and sensitivity compared to classical ELISA. The technology is particularly interesting for the dosage of biomarkers in biological samples or for the quantification of therapeutic proteins during pharmacology studies.
COMPANY PROFILE Randox Laboratories has over 30 years experience of diagnostic research and manufacturing. Partnering opportunities include; Biochemistry testing of samples (clinical/veterinary), using routine tests and biochip array technology (BAT). BAT is the simultaneous multi-analyte testing utilising antibody or molecular tests providing multiple tests from small sample volume and a variety of matrices. Other partnering opportunities including, Biomarker Development, Mutation Profiling, SNP Analysis, Assay development capability including recombinant proteins and monoclonal antibody development, large R & D and engineering capabilities (prototype and large scale manufacture) and route to market.
PRESENTER PROFILE Teni Boulikas is the Founder of Regulon and the inventor of breakthrough liposomal drugs such as Lipoplatin (liposomal cisplatin), Lipoxal (liposomal oxaliplatin), LipoVIL12 (a liposomal virus expressing the human IL-12 gene).
Teni holds a B.Sc. degree in Chemistry from the Aristotelian University of Thessaloniki and a Ph.D. in Biochemistry from the Southwestern Medical School in Dallas. Teni worked as an EMBO Fellow at ISREC in Epalinges, CH, as an Assistant Professor of Biochemistry at the University of Sherbrooke in Quebec, at the Linus Pauling Institute in Palo Alto and as a Consultant to SEQUUS Pharmaceuticals in Menlo Park. He has over 80 peer reviewed publications and over 6 patents. Teni is the organizer of 8 International Conferences aiming at bridging the fields of Gene Therapy and Molecular Biology, and Founder of the International Society of Cancer Therapy.
COMPANY PROFILE Regulon is a private biopharmaceutical company founded in Silicon Valley, California, possessing a world-wide patented nano-technology that has been applied to cancer chemotherapy achieving important goals and solving 3 major and outstanding problems in clinical oncology.
PRESENTER PROFILE Koen De Witte, M.Sc., MBA, Managing Director reMYND
Koen is the managing director of reMYND since 2007, director of FlandersBio vzw (the Flemish biotech industry representative with more than 210 members) and member of the general assembly and co-founder of CMI (Centre of Medical Innovation, focussing on translational medicine).
Before joining reMYND, Koen was an Associate Partner at McKinsey & company, where he was part of the Global Leadership of the Pharmaceutical and Healthcare practices. His client work focused primarily on new product introductions and setting up new businesses for his pharmaceutical clients. Koen has a M.Sc from MIT, US, a M.Sc from Ghent University, Belgium, and a MBA from Insead, France.
COMPANY PROFILE reMYND develops disease-modifying therapeutics for treating protein-misfolding disorders, counteracting tau-induced toxicity for Alzheimer's Disease (AD), α-synuclein for Parkinson's Disease (PD), preproinsuline/IAPP for Diabetes as well as other proteins for several orphan diseases.
Our therapeutics aim to decelerate cellular degeneration in patients. As such, reMYND responds to a clear unmet medical need, as all marketed treatments and the majority of the products under development world-wide are aimed to mitigate symptoms in the respective disorders. Our current lead compounds in PD and AD fully inhibit the progression in the relevant animal model through modulation of vesicular trafficking and lysosomal clearance. Our lead diabetes compound appears to even reverse the disease in a standard high-fat animal model, restoring part of the pancreas function. Our PD compound is ready to enter Phase 1.
At the heart of our drug discovery platform are phenotypic screens, recapitulating noxious properties of pathological protein aggregation. Candidate drugs have been extensively characterised in our neuronal cell models and proprietary transgenic mouse models. Mode-of-action studies revealed novel, innovative mechanisms and targets mediating the toxicity inhibition of pathological protein-misfolding.
In addition to our own drug discovery unit which will be the focus of our meetings at BioPartnering FutureEUROPE™, reMYND has a second business activity, entailing contract research services involving proprietary transgenic animals models of Alzheimer’s disease for pharmaceutical and biotech companies world-wide.
Dr. Ken Pritzker is President and CEO, Rna Diagnostics Inc. Dr. Pritzker is a pathologist at Mount Sinai Hospital Toronto and a Professor in the Department of Laboratory Medicine and Pathobiology, and Department of Surgery, University of Toronto.
Dr. Pritzker served as Chief, Pathology and Laboratory Medicine, Mount Sinai Hospital, Toronto from 1986 to 2008 and subsequently as founder of Mount Sinai Services, a laboratory service outreach vehicle for the biomedical research and innovation sector. With over 250 scientific publications, Ken is a recognized leader internationally in the fields of arthritis, cancer diagnostics, biomaterials, genomics and nanotechnology.
Throughout his career, Ken has served in leadership and advisory positions to national and international professional societies, research institutes and healthcare organizations. Ken brings over thirty years experience as consultant in the areas of strategic and operational advice for leading universities, health care institutions, pharmaceutical, diagnostics and biotechnology corporations. Dr. Pritzker is widely recognized as an innovator in clinical laboratory organization and management directed towards advancing patient centered clinical laboratory practice.
Ken is a graduate in Medicine from the University of Toronto from which he also has a Bachelor of Science (Medicine) degree in Pharmacology and received post graduate education in pathology at McGill University. Dr. Pritzker is a fellow of The Royal College of Physicians and Surgeons of Canada in Anatomical Pathology.
THERAPEUTIC AREA: Cancer Diagnostics
COMPANY PROFILE Rna Diagnostics has developed the first real-time cancer chemotherapy guidance tool; the RNA Disruption Assay (RDA™) Less than 25% of breast cancer chemotherapy patients derive survival benefit from chemotherapy. All patients endure toxic effects. Reduction of unnecessary chemotherapy is a top priority for breast cancer specialists. The RNA Disruption Assay (RDA™) is the only diagnostic tool that measures early in treatment how a patient is responding to chemotherapy. Administered during the first 3 cycles, RDA™ measures chemotherapy effectiveness. Effective therapy is confirmed for responding patients while non-responders may be switched from chemotherapy to alternate therapies thereby sparing them toxic side-effects. RDA™ improves patient outcomes while lowering breast cancer treatment costs.
COMPANY PROFILE About Savara Pharmaceuticals Savara Pharmaceuticals is an emerging specialty pharmaceutical company developing innovative pulmonary drugs for the treatment of serious and life-threatening conditions. The company’s lead product, AeroVanc (vancomycin hydrochloride inhalation powder), is a dry powder inhaled antibiotic for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) infection in patients with cystic fibrosis.
About AeroVanc AeroVanc (vancomycin hydrochloride inhalation powder) is a proprietary inhaled dry-powder form of vancomycin in a capsule-based inhaler designed for convenient self-administration. Vancomycin administered by IV is the antibiotic of choice for the treatment of MRSA-related bronchopneumonia, however, IV route of administration and systemic toxicities limit its use in a chronic setting. AeroVanc is being developed for the treatment of MRSA infections in cystic fibrosis patients. By delivering vancomycin directly to the site of infection, AeroVanc is expected to improve clinical efficacy and reduce systemic exposure.
About MRSA and Cystic Fibrosis Cystic fibrosis is a genetic disease characterized by the prevalence of thick, sticky mucus produced in the lung, frequent lung infections and a resultant decline in pulmonary function. As the disease progresses, patients’ lungs are typically colonized with bacteria that are difficult to eradicate. In recent years, infections and colonization by methicillin-resistant Staphylococcus aureus (MRSA) have become increasingly common, with a prevalence of up to 30 percent of all cystic fibrosis patients. MRSA infections have been found to cause a decline in lung function and are associated with a significantly shortened life expectancy. Currently there is no approved inhaled treatment for MRSA infections in cystic fibrosis patients.
COMPANY PROFILE Sernova Corp is a clinical stage company developing medical devices and therapeutic cell products for chronic metabolic, neurological, and haematological diseases. Sernova, has two platform technologies, the Cell Pouch System™, a device providing a natural “organ-like” environment for therapeutic cells such as insulin producing islets for diabetes, and Sertolin™ a cell technology providing an immune-privileged environment, to eliminate the need for anti-rejection drugs. Sernova is focused on the Cell Pouch System™ for insulin-dependent diabetes. A Phase I/II clinical study in diabetic patients is being initiated at the University of Alberta assessing the Cell Pouch™ with donor islets. Sernova also plans to commercialize products for Parkinson’s, spinal cord injury, haemophilia and other debilitating diseases.
COMPANY PROFILE Smartfish is a biotechnology company developing pharmaconutrition. Oral clinical nutrition products for cancer patients and patients with immune disorders are registered in several markets. The company has a broad clinical study program on product candidates targeting early Alzheimer’s Disease, Cancer and Diabetes. Smartfish has developed proprietary technology over 10 years facilitating development of innovative products being rolled out to patients through hospitals and pharmacies. It also has a pipeline of product candidates in different stages of clinical testing. The Oslo based organization focuses on developing, testing, documenting and commercializing product candicates based on the company’s own patent platform. Main shareholders of the privately owned company includes Norwegian state owned investment company Investinor.
PRESENTER PROFILE John Yao, PhD. was trained as a synthetic chemist and received his Ph.D. in chemistry from Wuhan University. Following his post-doctorate at the Southern Methodist University in Dallas, Texas, Dr. Yao undertook post-doctorate studies at University of Manitoba. As an experienced scientist, he has participated in collaboration projects with Pfizer and other biotech companies. John Yao has been the Chief Executive Officer of TC Scientific since 2009. He has put great effort in listening to clients’ needs and continuously strives to provide the best service to his customers. John has assembled an excellent team of chemists in Edmonton and has established great synthetic chemistry labs in their corporate headquarters in the Edmonton Research Park in Edmonton, Alberta, Canada.
COMPANY PROFILE TC Scientific Inc. is a Canada based synthetic chemistry CRO located in Edmonton, Alberta. As a globally specialized CRO, they perform medicinal chemistry services, custom synthesis, process research and development. TC Scientific specializes in high-quality medicinal chemistry contract research and custom synthesis of organic compounds including stable isotope and reference compounds. They have very competitive FTE rates and a reputation for delivering on or ahead of schedule.
Dr. David Bell
Vice President, Drug Development and Chief Scientific Officer
PRESENTER PROFILE Dr. David N. Bell is Chief Scientific Officer and Vice President of Drug Development at Therapure Biopharma Inc. located in Toronto, Canada. Dr. Bell’s prime responsibility at Therapure Biopharma is the management of development stage contracts involving cell production, recombinant protein expression, protein purification and process development. Dr. Bell is a founder of the company and member of the executive team with responsibilities touching on all aspects of the business. Dr. Bell’s role requires a thorough understanding of the economics and technology driving the contract services business in the biopharmaceutical industry, intellectual property, regulatory requirements in multiple jurisdictions, as well as, knowledge of the requirements for the preparation of materials under cGMP for the conduct of human clinical trials from Phase I to Phase III. Dr. Bell also directs the development of a pipeline of new product candidates for the treatment of anemia, cancer and infectious diseases. Current programs include the attachment of therapeutic and diagnostic agents to hemoglobin for delivery to selected tissue as a treatment for liver cancer and viral hepatitis, methods to extend the half-life of therapeutic proteins and the development of an antibody-based therapeutic for the treatment of anemia.
COMPANY PROFILE Therapure Biopharma Inc. (Therapure) is a biopharmaceutical Contract Development and Manufacturing Organization (CDMO). Therapure specializes in the development and manufacture of complex biologic products at its 130,000 ft2, cGMP facility located near Toronto, Canada. Therapure’s facility is equipped to provide biomanufacturing and aseptic fill/finish scale-up services at pilot, clinical and commercial scales. Therapure’s internal drug development program consists of a portfolio of new drug candidates focused on liver cancer, hepatitis C and anemia. All of the products are pre-commercial with the lead program in liver cancer (TBI 302) scheduled to begin Phase 1 in the near term. Therapure’s products are protected by an extensive portfolio of issued patents in the fields of protein drug conjugation and hematopoietic stem cells.
PRESENTER PROFILE Fredrik obtained his MD and PhD degree at Karolinska Institute, Sweden, and specialized in internal medicine and endocrinology. He has gained extensive experience as clinical investigator and associate Professor at Karolinska Institute. Subsequently, he has worked in senior clinical leadership roles at SmithKlineBeecham, Biovitrum, Danone and as independent consultant. Over his 15 years in the Life Science industry Fredrik has gained a broad experience in research, clinical development, translational medicine and business development in several therapeutic areas including Central Nervous System (CNS) diseases such as Alzheimer’s disease and epilepsy. Fredrik joined to-BBB in 2011 as Chief Medical Officer.
COMPANY PROFILE to-BBB is a clinical stage biotechnology company, which is focused on selectively enhancing the delivery of drugs across the blood-brain barrier. The company is developing novel treatments for brain disorders such as brain cancer, neurodegenerative diseases and orphan diseases, by combining existing drugs with its proprietary G-Technology®. The G-Technology® safely enhances the CNS uptake of drugs by combining the well-established approach of encapsulating drugs in PEGylated liposomes with the use of the endogenous tripeptide - glutathione as the targeting ligand. Based on this G-Technology® platform, to-BBB has a program in Phase I/II clinical trials (2B3-101) to treat brain cancer (brain metastases of breast cancer and glioblastoma). A second product (2B3-201) for neuroinflammation (MS, neuropathic pain and ALS) is in preclinical development.
PRESENTER PROFILE John Pedersen completed his M.Sc. degree in Biochemistry in 1981 at the University of Copenhagen. John is one of the co-founder of Unizyme Laboratories and serves as CEO and CSO of the company. Unizyme Laboratories is a virtual Danish biotech company which now focuse on design and development of small-molecule inhibitors of dipeptidyl peptidase I (DPPI; also known as cathepsin C) for treatment of inflammatory diseases. John is a innovative and highly experienced Biotech Professional with more than 25 years of leadership and exentsive hands-on laboratory experience with protein chemistry, protein bioprocess R&D and drug discovery. John has more than 25 years of experience with DPPI and more than 10 years of experience in the DPPI inhibitors field.
COMPANY PROFILE Unizyme Laboratories is a virtual Danish biotech company focused on design and development of small-molecule inhibitors of dipeptidyl peptidase I (DPPI; also known as cathepsin C) for treatment of inflammatory diseases. Unizyme is looking for a qualified and dedicated partner or investors to accelerate the further development of its DPPI inhibitor program. Studies in DPPI knockout mice have linked activity of DPPI to a range of inflammatory diseases, including COPD, Asthma, RA, Myocardial Infarction, Diabetic Cardiomyopathy and Sepsis. Unizyme has demonstrated the feasibility of using a proprietary DPPI inhibitor for reducing disease severity in an animal model of an inflammatory disease. Unizyme has more than 20 years of experience with DPPI and more than 10 years of experience in the DPPI inhibitors field. Unizyme has extensive know-how and owns important IP rights.
COMPANY PROFILE Vicore Pharma is a drug discovery and drug development company in Gothenburg, Sweden. The company is developing small molecules acting agonistic on the Angiotensin II type 2 Receptor, "AT2R". Principle research partners are University of Uppsala in Sweden and Charité Universitätsmedizin in Berlin. The company holds a number of proprietary compounds with selective agonistic effects on AT2R. AT2R acts anti-inflammatory, anti-fibrotic and neuro-protective. AT2R is overexpressed in organs and tissues at acute and chronic disease conditions. The leading drug candidate is named C21 and has demonstrated its efficacy for a large number of clinical conditions, e.g. post myocardial infarction, stroke, chronic kidney disease, aortic stiffness, scleroderma, rheumatoid arthritis, multiple sclerosis, spinal cord injury and psoriasis.
PRESENTER PROFILE In the last 20 years, Kai has held a variety of roles in the pharmaceutical industry. Kai has been with Vifor Pharma since 2005. He is physician holding degrees in immunology as well as business administration.
THERAPEUTIC AREA OF CLASSIFICATION Pharmaceuticals – Specialty Care – Anemia – Women’s Health – Supportive Care - Nephrology – Gastroenterology – Cardiology
COMPANY PROFILE Vifor Pharma is an international pharma company which researches, develops, produces and markets its own pharmaceutical products. The company operates four franchises: Iron; Vifor Fresenius Medical Care Renal Pharma; Infectious Diseases/OTX; and Consumer Healthcare Switzerland, with manufacturing sites in Switzerland, the UK, and Portugal. Vifor Pharma is the world’s leader in the development, manufacturing and marketing of pharmaceutical products for the treatment of on iron deficiency with or without anaemia. Vifor Pharma Infectious Diseases/OTX product portfolio includes key brands Aero-OM, Broncho-Vaxom, Dicynone, Doxium, Equazen, Otalgan and Uro-Vaxom. In 2011 Vifor counted ca. 1800 employees and achieved sales of CHF 584 million.
PRESENTER PROFILE Oliver Boucher joined Vivacta in July 2010 to lead the company’s commercial and corporate development activities. Oliver has extensive experience of the life sciences industry internationally through prior postings in North America as well as in four European countries. He has an extensive track record of strategic partnering and acquisition transactions in entrepreneurial start-up companies, including Sigmoid Pharma in Ireland, where he was Chief Business Officer, and Trigen in the UK, where he led the firm’s commercial, business and legal functions. Oliver has also held a series of senior positions over 7 years in the worldwide business development group at GSK where he was instrumental in the successful negotiation and execution of numerous licensing and business development transactions. Oliver earned a Masters degree in Natural Science from the University of Cambridge, UK, qualified as a patent attorney in Canada, obtained a certificate in technology transfer from the University of Strasbourg, France and holds an MBA from INSEAD business school.
COMPANY PROFILE Vivacta is developing a unique monitoring system to measure patient outcomes in real time at the point-of-care. For chronic therapies, regular near-patient monitoring of drug levels and drug response allows faster therapy adjustment and longer periods within therapeutic range, leading to improved clinical and economic outcomes of interest to reimbursement agencies. The system, which uses revolutionary piezofilm technology, puts the precision and performance of lab-based analysers at the disposal of non-expert users including patients themselves. In a world where clinical and economic outcomes increasingly drive reimbursement of new therapies and affect re-appraisal of established treatments, the simple-to-use Vivacta desktop device has the potential to revolutionise the personalisation of pharmaceutical care.
PRESENTER PROFILE Thomas Purkarthofer is Head of Business Development at VTU Technology GmbH, a biotech company providing Pichia pastoris protein expression services. Thomas joined VTU in 2006 managing the start-up of the company´s new Protein Technologies Unit. He is responsible for the commercialization of VTU´s proprietary Pichia pastoris protein expression platform and global customer relations and is a member of VTU´s technology development team. Thomas received his Ph.D. in chemistry from Graz University of Technology and was engaged in and managed several international industrial biotechnology R&D projects and is co-author of several peer-reviewed publications. In 2011, he was appointed as authorized representative of VTU Technology.
THERAPEUTIC AREA: Recombinant protein expression/production for biopharmaceuticals of all therapeutic areas.
COMPANY PROFILE VTU Technology is a leading contract research and development company, providing services for the fast track development of high performance, industrial protein production strains and processes for pharmaceutical companies and other protein manufacturers. VTU´s exclusive Pichia pastoris expression platform facilitates the delivery of unparalleled expression levels often achieving more than 10 g/L secreted protein (20 g/L peak expression level) for a wide range of proteins including serum proteins, cytokines, fusion proteins, Fabs, antibody derived fragments, scaffold proteins and enzymes. Within just few weeks of development time VTU Technology delivers customized expression strains including small scale production and purification processes and purified protein samples accompanied by smooth technology transfer to customers or CMOs.
PRESENTER PROFILE Dr. Giorgio Fassina started his scientific career as Visiting Associate at the National Institute of Arthritis, Diabetes and Digestive Diseases (NIADDK)(1985-1987) and later at the National Cancer Institute (NCI, NIH, Bethesda, MD, USA) (1988-1989) dealing with proteomic approaches to cancer. Later he joined the industrial biomedical sector, planning the establisment of 3 research centers in Italy and managing research projects on the development of biopharmaceuticals in many therapeutic areas, including cancer, autoimmune and viral diseases. Member of the Board of several consulting firms in the biotech sector, he has been Adjunct Professor of Molecular Biology at the University of Bologna (1995-1998). Since 1997 is collaborating as International Advisor for the United Nations Industrial Development Organization (UNIDO) to promote technology transfer in the field of drug discovery by combinatorial technologies in countries under development. Recipient of several awards for his scientific accomplishments, including the Federchimica Prize, Dr. Fassina is author of more than 150 papers in peer reviewed journals, editor of 3 books on combinatorial technologies and main inventor in more than 25 international patent applications on biopharmaceuticals. He is acting as expert evaluator for the European Commission, the Slovak Academy of Sciences, Nanochallenge and BioinItaly. Since 2011 head of one of the international expert groups of ICARST (Bratislava, SK) being involved in the center esthablisment.
Dr. Fassina career evolved from basic research to biotech product development and marketing being finalized to business creation. His work on cancer biomarkers and platforms for biomarker discovery constituted the rationale for the creation of Xeptagen S.p.A., a company targeting unmet needs for diagnostics in oncology he founded in 2001 acting as CEO. Dr. Fassina areas of expertse include: Planning and organization of research centers in the biomedical field, managing budgets and P&L's, handling intellectual property, assessing product market potential, planning marketing strategies, managing clinical trials, attracting and training human resources, evaluating regulatory issues and reimbursement policies, in- and out-licensing IP's, managing collaborative research activities with external institutions and contacts with key opinion leaders. He has been successful in handling relations with venture funds finalizing several rounds of financing, in getting grants from national and European agencies to sustain R&D activities and to take to the market innovative diagnostic (IVD) products for liver, colon-rectal and prostate cancer early detection.
COMPANY PROFILE Xeptagen has fulfilled the unmet need for novel biomarkers by exploiting the natural immune response to early stage cancer and the proprietary platform technology Combinatorial Proteomic®. Xeptagen holds patents related to the discovery that many biomarkers are found associated to IgM to form circulating immunocomplexes, and that determination of such immunecomplexes may provide better sensitivity and specificity for cancer detection. Following this innovative line of research XEPTAGEN has discovered novel tumor markers for liver (SCCA-IgM), prostate (PSA-IgM) and colorectal cancer (CEA-IgM), developed diagnostic devices for their measurements intended for laboratory medicine departments and point of care applications, and verified their diagnostic value through retrospective, prospective and longitudinal clinical studies (see www.xeptagen.com).
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