Abhishek is working as Principal scientific Manager at Biocon. In Biocon, he leads the Biosimilar recombinant human Insulin program for regulated markets. He also leads the bioanalytical functions related to Pharmacokinetics, Immunogenicity and HCP assessment. With close to 10 years of industry experience in biosimilar and biologics development, he has successfully led research teams working on phage display based antibody libraries, mammalian and bacterial cell line development, bioassays and bioanalytical development.
António Pregueiro, PhD has over 12 years of experience in the pharmaceutical and biotechnology industries combined with a strong research background prior to his business career. Following his graduate training, he spent 5 years working in consulting firms focused in the life-sciences developing expertise in strategy, management and technology across several therapeutic areas. He worked globally, gaining experience in the US, Europe, South America, Russia and the Middle East.
Arnout Ploos van Amstel has over 25 years of business and operations experience in the bio-pharmaceutical business in a wide variety of leadership positions. Currently, Mr Ploos van Amstel leads the Global Business Franchise Immunology & Dermatology (I&D) at Novartis Pharmaceuticals. The I&D Business of $3,2bn includes the recently launched, game changing biologic Cosentyx, the first IL17A inhibitor. Cosentyx addresses significant unmet needs for patients with the skin disease Psoriasis and the rheumatology disorders Psoriatric Arthritis (PsA) and Ankylosing Spondylitis (AS). It is one of the most promising assets of Novartis.
Cecil Nick, Vice President (Technical), at PAREXEL Consulting has been working in regulatory affairs and clinical development for over 30 years; for over 25 years he has focused on biological medicines. Cecil Nick has particular expertise in monoclonals and biosimilars, having worked on over 20 such programs, engaged in over 50 interactions and meetings with regulatory agencies in the EU, US, Canada, Australia, Mexico, Brazil and supported 6 submissions in the EU and US including the first monoclonal biosimilar to be approved in the EU and US
Dr. Dairine Dempsey is the CEO/CMO & a co-founder of Open Orphan DAC, a Dublin-based EU pharmaceutical company specialised in bringing orphan drugs to EU patients.
Dairine has over 15 years experience in the pharmaceutical industry including almost 10 years in the national regulatory authority for medicines (now the Health products Regulatory Authority).
Edward Abrahams, Ph.D., is the president of the Personalized Medicine Coalition (PMC). Representing innovators, scientists, patients, providers and payers, PMC promotes the understanding and adoption of personalized medicine concepts, services and products to benefit patients and the health system. It has grown from its original 18 founding members in 2004 to more than 225 today.
Dr Fiona Greer was a founding Director of M-Scan (Mass Spectrometry Consultants and Analysts), contract analytical laboratories specializing in biopharmaceutical characterization. Following acquisition in 2010, she is now Global Director, Biopharma Services Development, SGS Life Sciences.
Javier Camposano is the Managing Director and Head of the Drug Product Division at Celltrion’s Inc. South Korea. Prior to Celltrion he worked for Baxter for 17 years in a variety of technical and Management positions, including Facility and Equipment Project managing, Leading Aseptic Filling Capital Projects, participating in commercial development projects and Supervising cross functional projects between facilities.
Joanna is a patent attorney who focuses her practice on all aspects of services related to patents in the life sciences. Joanna has experience counseling clients on the Hatch-Waxman Act and is monitoring developments involving biosimilars under the Biologics Price Competition and Innovation Act. Joanna is also an Adjunct Lecturer at the Harvard T.H. Chan School of Public Health and the Editor-in-Chief of the Journal of Commercial Biotechnology.
Dr. Paul H. Song has 23yrs of in-depth biologics drug discovery/development experiences in both innovative biologics and biosimilar drugs targeting immunology and oncology indications.
In his current role as Vice President at Samsung Bioepsis, Paul is leading the Cell Engineering team with responsibilities for generating commercial production cell lines for the 2nd wave biosimilars targeting both oncology and immunology indications, and technology development for advanced production cell line and vector system.
Rodeina Challand B.Sc., Director, Challand Biosimilar Consulting Ltd., Graduate from London University with over 25 years of experience in healthcare, cancer research and pharmaceutical industry across a wide range of roles including developing and implementing clinical development strategies for biosimilars at Hospira Inc. as Director of Clinical Projects and Head of Clinical Operations in the EU.
Dr. Samir Kulkarni is leading the Process Development efforts at Intas Biopharmaceuticals as an Associate Vice President. He holds a PhD in Chemical Engineering in addition to which, his educational background includes a combination of faculties such as Pharmaceutical Sciences, BioProcessing and Business Administration from Reputed institutes such as ICT (Mumbai) and IIM (Bangalore).
Sarah Rickwood has 20 years’ experience as a consultant to the pharmaceutical industry, starting at Accenture’s pharmaceutical strategy practice before joining QuintilesIMS Management Consulting. She has wide-ranging knowledge of international pharmaceutical industry issues, having worked with most of the world’s leading pharmaceutical companies in the US, Europe, Japan, and leading emerging markets.
Shane Maloney is a Transaction Director in AstraZeneca’s business development group, based in Gothenburg, Sweden. He has worked in business development for AstraZeneca since 2001, originally in the UK and now in Sweden; and starting with technology platforms and early-discovery deals, before gradually moving to clinical-stage and on-market deals.
Dr. Steinar Madsen is medical director at the Norwegian Medicines Agency. He has been working with generic substitution since it was introduced in Norway in 2001 and with biosimilars since 2006. He is member and previously chairman of the committee for generic substitution at the Agency. Dr. Madsen is also engaged in the drug information service, with a special interest in the safe and cost-effective use of drugs. He is a specialist in internal medicine and cardiology and works part time as a consultant in cardiology.
His industry expertise lies among life sciences engagements across various therapeutic areas, leveraging relationships with key opinion leaders in sectors such as Global Pharmaceutical & Biologics Contract Outsourcing, API manufacturing in India & China, European Oncology & Diabetes market prognosis & Pharma sales force effectiveness.
Uwe Gudat joined the pharmaceutical industry in 1995 with Eli Lilly and since then has held positions at Hesperion/Actelion, Novartis and Merck Serono. In this time he has led global clinical development teams, served as global medical brand director, led clinical teams for in-licensing due-diligence and managed clinical-trial review, first in man transitions and product safety assessments. Currently he is Head of Safety of the Merck Serono Biosimilars Unit.