Meet the Expert Consultancy Services

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1 Meet the Expert Consultancy Services Read the expert profiles and see how they can help you with your business related questions. After registration on the HollandBIO website for the SME Event, please send your prefered 30 minutes one-on-one meetings to Please speficify during which rounds you are available. Round 1 ( ) and/or Round 2 ( ). Consultancy services 3D-PharmXchange Ronald van der Geest, Iris Blom drug development strategy, start-up support, marketing Derks & Derks Jan Derks, Wouter Schepers, human resource, recruitment Pieter van Gelderen, Yvette Kmieciak Gedmore Jeroen Elassaiss-Schaap data analysis / PK-PD modeling & simulation Gunn & Twynmore Hester Tak tech transfer, bd Match2Win Sylvia van Hoof recruiting with focus on college graduates /academics PSR Orphan Experts (and ttopstart) Roger Legtenberg (and Jasper Levink) regulatory, clinical planning & execution, orphan funding Quality by Design Dominiek Rossillion technology transfer engineers, quality assurance Scalable Life Sciences Rob Janssen corporate communications, public affairs, market access Xendo Rene Nanninga, Kirsten Lingbeek Research / production facility design, QA, compliance

2 3D-PharmXchange Ronald van der Geest, partner at 3D-PharmXchange, drug development strategy & start-up support. Ronald is one of the founders of 3D-PharmXchange. Next to his role as general partner, he holds roles as CDO and similar positions at various emerging biotech companies. He is an advisor for various regional and strategic development programs in the life sciences and involved in the establishment of a number of early start-up companies. He recently led the development of Glybera for uniqure, the 1st approved genetherapy product in the western world and holds strategic knowledge in the areas of translational development, orphan drugs, individualized medicines and biomarker-based development. Prior to co-founding 3D- PharmXchange Ronald was COO and CDO at Kinesis Pharma, responsible for business development and multidisciplinary drug development, leading the team project leaders. During this time he held advisory board positions and interim management positions for clients, supporting them in fund raising, drug development and corporate strategy. Prior to that he worked for various companies, including Tibotec where he was, amongst others, Compound Development Leader for Prezista. He is a PhD-level clinical pharmacologist and drug delivery expert by training (Leiden University and UC San Francisco) and started his career in this area at Johnson & Johnson, Belgium. Iris Blom, marketing & business development at 3D-PharmXchange, marketing & communication strategy. As of July 1st 2013, Iris Blom has joined 3D-PharmXchange as consultant marketing and communication. Recent projects involved product development and project management for the introduction of Venodermal, a cosmetic product line focused on varicose veins. Project management, including business development, marketing and communication for Pivot Park FlexLab, a new initiative of the Pivot Park Life Science Community in Oss. In addition, Iris is responsible for the coporate identity and business development of 3D-PharmXchange. Iris completed her Bachelor Business Administration in 2009 at the Hotel Management School in Maastricht. She gained sales experience at the marketing and sales department of Grand Hotel Karel V in Utrecht. To develop in-depth knowledge on marketing she enrolled in a master marketing at the Faculty of Economics and Business Administration at the VU University in Amsterdam. During her masters Iris joined the International Research Project to Vietnam, for which she researched the oil additive market in Vietnam. To conclude, she wrote her MA thesis about Customer Passion, which concerns the passion a company has for its customers. Her thesis was nominated for the Generali AM Innovation Thesis Award D-PharmXchange is a world class Dutch consultancy firm specialized in development of pharmaceuticals and diagnostics. We provide advice and support in order to make expert skills 1

3 available to small and mid-size pharma on a highly flexible need-based way. In addition, we reinspire big pharma teams by insertion into their existing operation. Our team of PhD s covers expertise in the key areas of non-clinical, clinical, CMC and regulatory affairs. Furthermore, we provide support in the field of marketing, communications, business development and interim management. As we integrate all required expertise, we are the one-stop-shop to support your development program. Our role varies from temporary replacement to full development program design (including management positions). Through our long-standing experience we know how to take your development program seamlessly to the next level, which enhances an efficient way of working. 2

4 Derks & Derks Jan Derks, owner, strategic hr related consultancy. Wouter Schepers, manager recruitment & selection, (inter)national recruitment and selection. Pieter van Gelderen, manager recruitment & outsourcing. Yvette Kmieciak, manager assesment & development. Derks & Derks is a well-known, independent recruitment agency for the pharmaceutical, medical, healthcare and food industries. Besides permanent and temporary recruitment, the company s services include psychological assessment centers, (job) coaching and scientific research in cooperation with Dutch universities. 3

5 Gedmore Jeroen Elassaiss-Schaap, consultancy / data analysis / PK-PD modeling & simulation. Senior pharmacometrician and owner. Gedmore offers ground breaking new technology. Pharmacokinetic-pharmacodynamic modeling and simulation (PK-PD) is frequently applied by larger drug companies in the analysis of clinical data to fast-track decisions and improve designs. Traditional PK-PD is however too expensive and slow for BioTech. Gedmore's new automated and templated approach unlocks routine application of animal PK-PD. Using established analysis methods and modern web technology, clients can extrapolate PK- PD properties. Gedmore supports decision making such as compound prioritization and design of follow-up experiments. The cost and speed are dramatically improved compared to traditional approaches and are compatible with lead optimization flow chart support. Gedmore can be used with ease. There is no setup or installation needed, and there is also no license fee involved. You can start now and you pay only for what you use! 4

6 Gunn & Twynmore Hester Tak, partner. Hester Tak has been engaged in technology transfer for more than 10 years. Her work experiences include working for De Brauw in the patent department as a non-legal biotech specialist but also working for a CRO, actively engaged in clinical trial projects and responsible for the analyses and exports of data. In the last 9 years she has worked for a university tech transfer office. She holds 4 MSc degrees in Biomedical Sciences, Science Based Business, Business Valuation and Finance. She is currently doing a PhD on Evaluating and improving efficiency in the Healthcare valorization chain for various stakeholders. Gunn & Twynmore works in close collaboration with clients to develop new innovations that address global challenges and offer clients growth. Our objective is to help young high-tech ventures develop their ideas and dreams into a strong business as well as helping established businesses that wish to expand their business with new high-tech innovative products. Our role is to help deliver new products that will have a societal and economic impact. We offer a wealth of expertise across a broad range of topics that complement our industry and growth process related consulting services. 5

7 Match2Win Silvia van Hoof, owner and senior consultant. Match2Win is a partner in finding highly qualified personnel for the Healthcare in the middle and senior management. The company has developed standardized procedures relating to recruitment. Validated selection methods lead to continuous improvement of services. Match2Win has experience in recruiting graduates college graduates and academics to positions in the healthcare industry. The company provides in coorporation a complete portfolio for the healthcare. 6

8 PSR Orphan Experts Roger Legtenberg, consulting service (these include: orphan drug possibilities, regulatory & clinical planning & clinical execution) together with colleagues of Ttopstart: advice on Horizon 2020 orphan drug possibilities. Roger has over 13 years of experience in the CRO industry in a variety of positions (including project manager, clinical research manager, business unit manager, business development, of which the last 4 years as Chief Executive Officer of PSR Orphan Experts. Roger has succesfully expanded the specialization of PSR into the Orphan Drug space. Following his bachelor's degree in Biomedical Chemistry (in which he specialized in Biochemistry, Toxicology and Molecular Biology), he obtained a Ph.D. in cardiovascular side-effects of a variety of diabetes treatments. During his clinical research positions in the CRO industry he obtained extensive experience in dermatology, CNS, cardiology, rheumatology, internal medicine and diabetology. PSR is the expert full service orphan drug CRO in the rare disease niche. PSR is specialized in running complex orphan drug clinical development programs (Natural History Studies, Phase I IV studies & Registries) and regulatory projects (e.g. Orphan Drug Designations, Clinical Development Plans, EMA and FDA interactions (Scientific Advice /(pre-)ind/pip) requiring innovative regulatory and clinical approaches. PSR has ran over 190 Orphan Drug projects to date. Besides project solutions, PSR provides staffing solutions, including temporary staffing, permanent placements to interim management as well as training / coaching career programs. 7

9 Quality by Design Dominiek Rossillion, technology transfer. Quality by Design (QbD) offers consulting services to companies in the pharmaceutical, biotech and cosmetics industry. 85 validation experts, technology transfer engineers, quality assurance specialists and trainers listen to your story, and deliver a tailored solution. QbD is well-established in Belgium and the Netherlands, with customers ranging from innovative small firms to influential global enterprises including companies like Alcon, Amcor, Arenco, Domo-Campina, DSM, Genzyme, Heel Belgium, Janssen Pharmaceutica, Labo Wolfs, MSD, Multipharma, Pfizer and Pronails. QbD is dedicated to quality in more than one way. We provide three delivery models in order to respond effectively to your requirements. Training and personal development programs ensure that our consultants have the appropriate knowledge and skills to deliver. We aim for long-term relationships with both clients and business partners. 8

10 Scalable Life Sciences Rob Janssen, consulting service / business development. Scalable Life Sciences is a strategic communications consultancy specializing in life sciences. The company offers consultancy and execution in corporate communications, public affairs, governmental affairs, market access, investor relations and marketing communications. Our expertise, unique experience and extensive network will help you to get your messages across, connect you to the right people and maximize your results. Scalable applies a scalable and effective approach to deliver maximum results for its clients. This effectiveness is based on an optimal reinforcement of your corporate communication and - for example - your investor relations or governmental affairs. The company s list of current and past clients includes organizations like: Alliance for Advanced Therapies, Amsterdam Molecular Therapeutics, Bavarian Nordic, Biotechnology Industry Organization, Carmat, Celgene, Chiesi, Royal DSM, PwC, SkylineDx, Sobi, Syngenta, TI Pharma and Vertex. 9

11 Xendo About the expert Rene Nanninga, Director Engineering & Technical Support Research / production facility design and realization Kirsten Lingbeek, Compliance & Validation, R&D R&D, QA, project management, clinical trial materials About the company XENDO is a leading consultancy and project management organization in the fields of (bio- )pharmaceutical products, medical devices and healthcare. Around 150 experienced and highly educated professionals provide strategic advice, project management and implementation, interim management, auditing, operational support and training. Our services focus on Regulatory Affairs, Product Development, E-compliance & Data Management, Pharmacovigilance, Engineering, Qualification & Validation and Quality Management & Operational Excellence. For over 25 years we have successfully completed thousands of national and international assignments for start-ups as well as for the largest, established multinational companies and organizations. It is our mission to provide optimal solutions for our life science customers during the full life cycle of their products and health care solutions. We enhance processes related to quality and safety of your product and we strive to shorten the time to market. WE PROVIDE SOLUTIONS FOR LIFE SCIENCES