Your partner for successful biopharmaceutical development and approval

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1 Your partner for successful biopharmaceutical development and approval

2 About the Founders Experienced experts with unique agency and industry backgrounds Dr. Gabriele Dallmann + 25 years of experience in regulatory affairs and drug development + Ex-regulator Paul-Ehrlich-Institut and EMA Committees + Headed approval of antibody products at the Paul- Ehrlich-Institut + Co-rapporteur for several biopharmaceuticals + Founder of the European Centre for Regulatory Affairs, Dr. Diane Seimetz + 16 years of managerial, regulatory & drug development experience + Former Executive Vice President & CSO of Fresenius Biotech + Headed Regulatory Affairs, Medical Affairs, Preclinical & Clinical Development and Program Management + Successfully developed the first trifunctional antibody catumaxomab 01

3 Our history: Agency and Industry Biopharma Excellence in Brief We, Dr. Gabriele Dallmann and Dr. Diane Seimetz worked together for the first time in At this time, Gabriele was in charge of antibodies, sera, vaccines and blood products at the Paul- Ehrlich-Institut, the German Federal Agency for Vaccines and Biomedicines. She was also represented in key regulatory Committees at EU level. Diane was responsible for poly- and monoclonal antibodies and cell-based therapeutics at Fresenius. Our interaction embraced the life cycle management of the existing biologics portfolio and the development of first-inclass antibody products. Gabriele: I liked very much the professionalism of Diane and her team to present their unique and demanding projects to the agency. The team was well positioned and their documents including scientific rationale were convincingly prepared. We achieved a mutual understanding of quality, safety and efficacy requirements. Diane: The engaging and clear style of Gabriele und her agency team essentially contributed to our understanding of the regulatory expectations. This allowed us to prepare in a focused way. I was impressed by Gabriele s pragmatic approach to identify solutions with the applicants. I had the impression that the focus was on approval rather than rejection. We have experienced that the understanding of drug projects from an agency AND industry perspective combined with an eye for the essentials is a key ingredient for success. Our customers can significantly benefit from our particular experience. This experience is the foundation of our mission: Together for your success. Our company name, Biopharma Excellence, stands for our commitment to excellence. We, Dr. Gabriele Dallmann and Dr. Diane Seimetz, provide in a unique way the agency AND industry perspective to the development and regulatory projects of our customers. We know biopharmaceuticals in all its facets, we understand the authorities in Europe, the U.S. and the BRIC countries. We are well aware of the interests of industrial partners and investors. We always strive for valid and pragmatic solutions, from product idea to life cycle management. With our experience and an eye for the essentials we develop the strategic development and regulatory plans that fit best for our customers. In Scientific Advice procedures we ensure that our customers ask the right questions and provide convincing positions to the agencies. We prepare the company s team for professional presentation and discussions with the regulators. With our international biopharmaceutical experience, we identify opportunities and risks within licensing deals and acquisitions. With our network of renowned experts, we can answer almost any question professionally. This enables our customers to use their resources wisely and to effectively reach their targets

4 Consulting Services Development Authorization Life Cycle + Strategy and Integrated Development Planning + CMC Development + Non-Clinical and Clinical Development + Scientific Advice and Liaison with Regulatory Authorities + Support for Successful Submissions + Due Diligence & Partnering + Rescue Projects We provide targeted solutions for the development and approval of your products and support your company and people to excel. This is our commitment to excellence. Strategy and Integrated Development Planning Preparing the regulatory and development plan according to your needs will ensure timely and cost effective completion of your projects. Strategic planning and bridging of the various disciplines involved is essential for successful product development. One key element is an integrated development plan which includes pharmaceutical manufacture and control, non-clinical and clinical aspects as well as the intended key claims of the product. Regulatory and development strategies go hand in hand, as every step in the development chain needs to be in line with regulatory requirements to ensure approvability. Apart from the integrated support, we can help you along on individual elements of your regulatory or development pathway. We provide gap analysis of your development plans and dossiers. We make recommendations how to deal with these gaps. Chemistry, Manufacturing and Control (CMC) Development Proper technical development is one of the pillars of biopharmaceutical drug development. Your processes, methods, controls and release methods must be established and working to reliably meet specifications. Our services which are typically required during the development of biopharmaceuticals include: + Development plans for biopharmaceuticals, including recombinant proteins and cell-based products + Product comparability or similarity strategy + Immunogenicity risk assessment + Biopharmaceutical product quality control & characterisation + Validation of analytical & bioanalytical methods + Data requirements during early development for successful clinical trial applications 05

5 Nonclinical and Clinical Development Scientific Advice and Liaison with Regulatory Authorities Due Diligence & Partnering Rescue Projects The safety of human subjects and patients is key. Diligent nonclinical testing and sound clinical trial design will keep the patient safe and generate solid data. Within our network we can design your non-clinical program from feasibility studies, receptor binding, xenograft studies all the way to toxicity studies in rodents or non-rodents. We will also attend to individual elements of your program or review your existing program and documentation. We provide strategic clinical development advice to ensure that regulatory expectations are met. We can assist in the interpretation of your clinical data and their communication to regulatory agencies. Advisory boards with key clinical opinion leader are essential to properly prepare the clinical development program and protocols. Early involvement of key opinion leader and their support is crucial for successful market launch. We have a long standing experience in the set-up and management of advisory boards that we are pleased to share. To prepare for a meeting with authorities, a briefing book with the questions and company s position needs to be prepared in time - often a critical phase for the development team. To get the best possible feedback from the authorities, we help to define the scientific advice strategy, to identify the questions of interest and the company s position. Dr. Gabriele Dallmann had been a member of the Scientific Advice Working Party of the EMA and has held numerous scientific advice meetings at the German Authority (Paul- Ehrlich-Institut) on biopharmaceuticals. Dr. Diane Seimetz looks back on a large number of meetings with EMA, national European agencies, FDA, Health Canada, and TGA as well as other jurisdictions. She has dealt with these regulators during (parallel) scientific advice, presubmission, submission, inspections, and post-authorization phases of her projects. Licensing of new biopharmaceutical candidates requires careful assessment of their potential, IP as well as scientific, development and regulatory issues. We support our clients in assessing business opportunities for biopharmaceutical products, either in the area of acquisitions and mergers, in the licensing of new products or in investment decisions. We identify the potential of a biopharmaceutical or a portfolio, key issues and risks from a drug development, regulatory and scientific point of view. Our results will support the client s decision-making and negotiation processes. From our network we can recruit a tailor made due diligence team for your specific needs. Prevention is better than treatment. This is our understanding at Biopharma Excellence. Our prevention approach comprises appropriate guidance to our customers while considering their special needs. However, should your projects or programs in the course of the development or approval process need a therapeutic intervention for whatever reason, we are at your disposal to identify solutions. Don t hesitate to get in contact with us. The sooner the better. Emergency requests are typically requested e.g. for: + Oral explanation at day 181 of the centralized procedure + To turn negative opinions into approval or conditional approval + Major deviations in the production process + Trouble shooting during development 06 07

6 Coaching Training Biopharma Excellence provides targeted solutions for the development and approval of your products and supports your company and people to excel. This is our commitment to excellence. During our professional career we have learned that true and sustaining success requires two essential elements. On the one hand you need promising products and smart strategies. On the other hand there are the people who work on the products, the strategies and the implementation thereof. Therefore, the team of Biopharma Excellence is committed to the coaching of managers and employees. We offer targeted coaching sessions for you, e.g.: Biopharmaceuticals are special and require special knowledge. We provide in-house training for regulatory affairs and product development professionals on all aspects of biopharmaceutical drug development. Our courses provide insights into the particulars of the development and authorisation of biopharmaceuticals including biosimilars and advanced therapies. We are actively involved in pre- and post-graduate programs such as Eucraf ( We design training sessions according to your specific needs. + Coaching for effective leadership + Coaching to achieve your full potential + Coaching for career success + Coaching for effective teams We can design further coaching sessions according to your specific needs. 09

7 Successful Drug Development & Approval is a Multidisciplinary Approach Virus safety Drug Safety CMC experts Non-clinical expert Exregulators Biopharma Excellence Devices Our Network Statistician PK expert Successful drug development & approval is a multidisciplinary approach. In collaboration with our international expert network we provide unique and focussed support for all aspects related to biopharmaceutical drug development, i.e. from product idea to approval and beyond with effective life cycle management strategies. The network comprises well renowned exregulators and experts for immunogenicity, CMC, viral safety, non-clinical topics and intellectual property. Together with our partners experienced in medical and CMC writing we prepare applications for clinical trials, briefing books and dossiers in the CTD format. IP Specialist Expert Pharma law Immunogenicity expert We work with our international network of renowned experts to provide tailor made solutions for our customers 10 11

8 Wolfgang Berthold Manufacture and facility strategy Denis Bourgarel Patent lawyer (IP and FTO) Paul Chamberlain Biopharmaceutical product development & immunogenicity specialist Simon Day Clinical development strategy and statistics Mairéad Duke CMC Expert Peter H. Kalinka Biosimilars and novel biopharmaceuticals Bernd Müller-Beckmann Pre-Clinical Expert Michael Rinck Medical Devices, IVD Heike Wachenhausen Pharmaceutical Law, Medical Devices Law, Healthcare Compliance, Product Promotion Law Pierrette Zorzi Ex-Regulator (French Agency), ATMPs, Biosimilars, CMC Biotech Products For more information, please visit our website and contact us Contact us by mail: We are pleased to discuss how we can best support you. As well as: Henrik Hansson Gopalan Narayanan Hannelore Willkommen Visit us in person Biopharma Excellence c/o Munich Technology Center Agnes-Pockels-Bogen Munich, Germany Sabine Kistner Phone Freiburg: +49 (0) Phone Munich: +49 (0)

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