”Boston 2018 : 21st Century Trends in Drug Development”
Citoxlab team is pleased to invite you to its 2018 Symposium!
The drug development landscape has witnessed a broadening of targets and indications, the emergence of promising new classes of therapeutics, but also an evolving regulatory framework. This symposium will present current and novel drug safety testing approaches and the underlying regulatory toxicology strategies. The sessions cover the full spectrum from early discovery to late stage investigations and across a wide range of portfolios but all focused on non-clinical drug safety testing. From de-risking panels to regulatory filing and from clinical hold lifting approaches to case studies, this symposium will engage dynamic yet pragmatic discussion on real-life drug safety testing challenges!
When : September 13, 2018
Where : DoubleTree Suites by Hilton Boston Hotel in Cambridge, MA.
Registration: Click on this link top Register . Space are limited!
09:00 am – 09:30 am : Welcome coffee
09:30 am – 09:45 am : Introduction – Citoxlab
09:45 am – 10:30 am : Scott Burian, Ph.D., R.A.C, RHO, INC: ”CMC in Drug Development – Requirements, Challenges, and Lessons Learned”
10:30 am – 11:15 am : Guillaume Ravel, PharmD, PhD, Sanofi Pasteur : ”Nonclinical Safety Considerations for the Development of Anti-infectious Vaccines and Monoclonal antibodies”
11:15 am – 12:00 pm : Monika Chabicovsky, PhD, MC Toxicology Consulting GmbH : ”Toxicity and Safety Testing with CRISPR/Cas-Based Therapeutics”
12:00 pm – 01:15 pm : Lunch
01:15 pm – 02:00 pm : Dana Minnick, PhD, DABT, RAC, RHO, INC : ”Toxicological Assessment of Impurities, Degradants, and Excipients in Drug Substances and Drug Products ”
02:00 pm – 02:45 pm : Denis Roy, PhD, SciLucent, LLC : ”Nonclinical Regulatory Hurdles and Challenges in Developing Cell and Gene Therapies”
02:45 pm – 03:00 pm : Break
03:00 pm – 03:45 pm : David J. Pepperl, PhD, Biologics Consulting : ”Challenges and Strategies in Nonclinical Evaluation of Novel Cancer Immunotherapies”
04:00 pm – 06:30 pm : Cocktails
Please note that this complimentary event is by invitation only, and includes lunch, refreshment breaks and afternoon cocktails.
Monika Chabicovsky, PhD, MC Toxicology Consulting GmbH : ”Toxicity and Safety Testing with CRISPR/Cas-Based Therapeutics”
Dr. Chabicovsky is the founder and managing director of MC Toxicology Consulting (www.toxicology.cc). She
received her education in experimental cancer research and toxicology at the Medical University of Vienna and the University of Innsbruck, and in regulatory affairs at the University of Cardiff. In 2006 Dr. Chabicovsky founded MC Toxicology Consulting. Today the company has 10 employees.
MC Toxicology Consulting is specialized in early stage drug development with a focus on regulatory strategy, toxicology, pharmacology, and pharmacokinetics. We also directly help our clients with high quality, hands-on operational support for the execution of non-clinical development programs for drugs. MC Toxicology Consulting was incorporated in 2006 around its core expertise in non-clinical regulatory and toxicology, with an initial focus on small molecules and biologics. Since then the area of expertise has steadily extended and now encompasses, in particular, advanced therapy medicinal products (ATMPs), including gene and gene-editing therapies.
Clients, including medical device companies, small- and mid-sized biotech as well as large pharma, are mainly based in Europe and North America, but also in the Middle East and South East Asia. MC Toxicology Consulting is proud of having served more than 200 companies since its inception, supporting many of them for years. The company continues to build on its key success factor, i.e. to offer focused, boutique consulting by putting highest quality and tailored services first. In addition, the company has built over the years an easy to access network of highly specialized experts in various fields.
Denis Roy, PhD, SciLucent, LLC : ”Nonclinical Regulatory Hurdles and Challenges in Developing Cell and Gene Therapies”
Denis Roy is a Director of SciLucent who leads the Nonclinical Safety and Development practice, which provides strategic scientific, outsourcing, and regulatory expertise to support international development of a wide variety of healthcare products. In addition to internal management and oversight responsibilities, he provides senior strategic consulting services in nonclinical pharmaceutical development and regulatory toxicology testing strategies for pharmaceuticals, biologics, medical devices, and specialized/combination products for a broad range of therapeutic areas. He has a track record for successfully assisting clients in the development and implementation of integrated international regulatory strategies and addressing issues encountered during product development plans including clinical holds, with both national and international agencies. He has participated in the preparation of numerous pre-meeting packages, INDs, CTAs, and premarketing and marketing submissions in multiple countries. Denis has designed and/or conducted several hundreds of nonclinical safety studies, in a wide variety of laboratory species, using common and specialized routes of administration, including inhalation, intravitreal, intrathecal, and special delivery devices/product combinations. In addition, Denis has direct experience in animal surgeries, clinical pathology, GLP compliance, and GLP laboratory management. His broad technical and scientific expertise enables him to provide real-time and hands-on support for the design, outsourcing, conduct and reporting of a wide variety of nonclinical studies including specialty in developmental and reproductive and inhalation toxicology. He has published book chapters on carcinogenicity testing, nonclinical development of oncology drugs, and biologics development strategies. Denis has a Ph.D. in Physiology-Endocrinology, an M.Sc. in Experimental Medicine, and a B.Sc. in Biology from Laval University, Québec, Canada.
David J. Pepperl, PhD, Biologics Consulting : ”Challenges and Strategies in Nonclinical Evaluation of Novel Cancer Immunotherapies”
Dr. David Pepperl is currently Sr. Consultant and Nonclinical group leader at Biologics Consulting, based in the Washington DC metro area. David has a background in biochemistry and pharmacology/toxicology, with nearly 20 years’ experience in nonclinical development of both small molecules and biologic products. David received his Ph.D. in Pharmacology and Toxicology from the University of Arizona in 1994, and subsequently completed post-doctoral work in the pharmaceutical industry. With a background in both nonclinical development and molecular biology, Dr. Pepperl assists early to mid-stage biopharma companies with product development and regulatory strategy. At Biologics Consulting, David oversees nonclinical development programs for a variety of product types, including cell and gene therapies, vaccines, blood products, monoclonal antibodies and protein therapeutics as well as small molecules. He routinely writes and reviews nonclinical sections of pre-INDs, INDs and CTDs, and assists sponsors with FDA meetings and other regulatory interactions. Dr. Pepperl has also worked closely with sponsors to source and manage both non-GLP and GLP safety studies at contract research organizations (CROs) and routinely performs GLP compliance and study monitoring inspections on behalf of his clients. David is actively involved with both the American College of Toxicology (ACT) and Drug Information Association (DIA), and regularly speaks on safety assessment of biologic products.
Guillaume Ravel, PharmD, PhD, Sanofi Pasteur : ”Nonclinical Safety Considerations for the Development of Anti-infectious Vaccines and Monoclonal antibodies”
After receiving his PharmD and PhD degree in immunotoxicology, Guillaume started his carrier as a Study Director in a Contract Research Organization and developed a particular expertise in immunotoxicology. With 5 years of experience, Guillaume joined Sanofi Pasteur’s Nonclinical Safety Department in 2007 as Toxicology Project Representative in support of Vaccine and Infectious Disease portfolios. In this role, he provides guidance on non-clinical development strategies for new vaccine candidates including adjuvants, or new chemical entities and biological products within the infectious disease field. In 2016, Guillaume moved to Cambridge MA as Toxicology Expert and is now overseeing the preclinical safety strategy for Sanofi Pasteur North American R&D programs within the Nonclinical Safety Department.
Dana Minnick, PhD, DABT, RAC, RHO, INC : ”Toxicological assessment of impurities, degradants, and excipients in drug substances and drug products ”
Dr Dana Minnick, DABT, RAC, is a toxicologist and regulatory affairs professional with 20 years’ experience supporting drug and biologics programs throughout the development lifecycle in both the pharmaceutical and CRO industry. In her role as a regulatory affairs professional, Dana provides regulatory consulting including strategy, preparation for FDA meetings, and regulatory filings. She has led several multidisciplinary project teams through successful NDAs/BLAs to marketing authorization. Dana is particularly experienced in regulatory strategy and development of therapeutics for rare diseases. She has demonstrated capabilities in multidisciplinary product development including identifying gaps and defining drug development strategies to support clinical trials and regulatory filings. In addition to general regulatory knowledge and strategy, she has led drug development programs from concept through marketing authorization and beyond. Her early development phase support has resulted in many successful FDA pre-IND meetings and IND filings. Dana is also board certified toxicologist with specific expertise in nonclinical safety assessment. Prior to joining RHO, Dana was a Drug Development Program Manager at RTI International. In this role, she led the regulatory affairs teams for the NIH NHLBI Science Moving towArds Translation and Therapy (SMARTT) program providing extensive drug development consulting and advice to over 30 investigators, including pre-IND meetings, IND filings, Orphan Drug Designations. Dana was also an integral regulatory and nonclinical team member for the Global Alliance for Tuberculosis where she provided regulatory and nonclinical expertise. Dana has helped many clients prepare for FDA meetings including strategic formulation of questions and content for FDA input, review of preliminary comments and attendance and moderation of meetings. Prior to RTI International, Dana provided nonclinical and regulatory expertise as a consultant at Aclairo Pharmaceutical Development Group, and formerly worked as a toxicologist at Viamet Pharmaceuticals, a Project Manager at Calvert Research, and a research investigator and toxicologist at GlaxoSmithKline. Dana has worked in several therapeutic areas and has particular expertise in metabolic diseases, cardiovascular, hematology, respiratory, oncology and antimicrobials. She earned a doctorate in toxicology from Case Western Reserve University and was a postdoctoral IRTA Fellow at NIEHS. She is a Diplomate of the American College of Toxicology and has maintained certification in Regulatory Affairs (RAPS) since 2008.
Scott Burian, Ph.D., R.A.C RHO, INC: ”CMC in Drug Development – Requirements, Challenges, and Lessons Learned”
Scott Burian, Ph.D., is an experienced regulatory affairs professional specializing in pharmaceutical development, regulatory strategy, and chemistry, manufacturing, and controls (CMC). Dr. Burian has more than 15 years of experience in the pharmaceutical industry and has contributed to the development of a diverse range of small molecule, biologic, and nanoparticle-based products. He has provided input into drug substance and drug product development plans, authored CMC related documentation for regulatory submissions, provided input on regulatory strategies related to CMC.
Click on this link top Register . Spaces are limited!
Registration includes lunch, refreshment breaks and afternoon cocktails.
Please feel free to call us at Citoxlab (450-973-2240 ext 2206) with any questions.