Altasciences invites you to an Exclusive Complimentary Symposium on November 22, from 3 p.m. to 6 p.m. in Volkshaus, Basel, Switzerland.
Over the last two years, our industry has seen its share of challenges when it comes to outsourcing, supply chain, trial management, and overall planning.
This event will be an opportunity to discuss how early drug development has been impacted by the pandemic. Join us to share your experience and gain key insight from industry experts on how to avoid and overcome roadblocks as you plan ahead for your programmes, including regulatory strategies and case studies on the development of NCEs and biologics from the nonclinical phase, to early-stage clinical and CMC.
3:00 p.m. to 3:10 p.m.: Introduction
Dr. Hazel Clay, B.S., PhD, Drug Development Advisor, Altasciences
3:10 p.m. to 3:40 p.m. : The COVID-19 Pandemic’s Impact on Preclinical Toxicology and Safety Assessment
Dr. Rakesh Dixit, PhD, DABT, Cofounder, President and CSO, Bionavigen, LLC. and Regio Biosciences
3:40 p.m. to 4:10 p.m.: Clinical and Manufacturing Outsourcing Strategy: Impact on the Value of Your Biotech
Benoît Collin, Principal, KISCO Pharma Outsourcing Solutions, Neuchâtel, Switzerland
Bruno Jacob, CRO and CDMO Procurement Professional—Biological Manufacturing Category & Key Account Manager
4:10 p.m. to 4:40 p.m.: We are in the Middle of a Revolution in CGT
Dr. Dorothea Ledergerber, PhD, Chief Technical Officer, Tigen Pharma SA
4:40 p.m. to 5:10 p.m.: How to Overcome a Crisis and Not Let It Go to Waste–A Sponsor’s Tale
Inge De Clercq, M.S., Director, Head Clinical Study Leaders Phase I, Galapagos NV, Mechelen, Belgium
Dr. Gaetano Morelli, MD, Chief Medical Officer, Altasciences
5:10 p.m. to 5:30 p.m.: Closing Remarks
Dr. Hazel Clay, B.S., PhD, Drug Development Advisor, Altasciences
5:30 p.m.: Networking Cocktail
This complimentary event is by invitation only and registration is mandatory.
Dr. Rakesh Dixit, PhD, DABT, Cofounder, President and CSO, Bionavigen, LLC. and Regio Biosciences
Abstract: In the last three years, the COVID-19 pandemic has caused substantial human suffering and deaths worldwide, and severely impacted world economies. In developing innovative new treatments, one central area of R&D that has observed a severe impact is the preclinical safety assessment of biologics drugs that are exclusively tested in non-human primates. In the past, China has been the primary supplier of cynomolgus monkeys; however, given the domestic expansion of biologics research in China, outpacing the demands from foreign companies seeking NHPs for their R&D combined has caused a substantial reduction in the supply of NHPs available for conducting nonclinical safety assessments. This reduction is further impacted by the refusal of many world airlines to transport experimental safety assessment monkeys across the globe. Also, during the development of effective vaccines and other biologics against COVID-19, the use of NHPs in R&D has substantially increased, leading to further disruption in the development of new medications for the treatment. Additionally, there is a severe shortage of sexually mature NHPs to evaluate fertility and reproductive and developmental toxicity of biotherapeutic proteins. The increased demand combined with the limited supply of monkeys has resulted in a steep increase in price by NHP suppliers leading to a nearly 3 to 4-fold increase in the price of NHPs. This price increase has a significant impact on the R&D budget of many biotech companies forcing them to limit the development of some key biologics medicines. The availability of other non-rodent species such as dogs has also been impacted by COVID-19, and companies are increasingly interested in running toxicology studies in minipigs. Additionally, the pandemic has impacted the availability of trained and experienced technical staff to conduct NHP-based experimental research. The presentation will discuss the impact of the pandemic on the preclinical safety assessment of biologics drugs and strategies to mitigate challenges.
Benoît Collin, Principal, KISCO Pharma Outsourcing Solutions, Neuchâtel, Switzerland
Bruno Jacob, CRO and CDMO Procurement Professional—Biological Manufacturing Category & Key Account Manager
Abstract: The pandemic had a huge impact on the overall R&D and commercial supply chain, increasing the focus on drug manufacturing, disrupting established worldwide supply chains, and making contract development manufacturing organizations (CDMOs) an even stronger seller’s market; especially in the fields of cell and gene therapies, advanced therapy medicinal products, and biologics. The world is now changing at a faster pace, introducing new paradigms like sustainability, which will impact the healthcare business in the long run. Biotechs and pharmas are still looking for effective models covering the clinical and commercial CDMO services continuum. Finding the right development partners is even harder for biotechs or startups. These face the risk of having to agree to unfavourable terms over the short and long terms. The presentation will discuss the impact of the outsourcing strategy of the manufacturing and clinical activities on your long-term plan, its risks, and the key aspects to focus on to mitigate the challenges.
Dr. Dorothea Ledergerber, PhD, Chief Technical Officer, Tigen Pharma SA
Abstract: The cell and gene therapies industry is in the middle of a revolution, and the potential therapies getting approval will overstrain the healthcare system, from a supply, cost, and sustainability perspective. With the new ecosystem forming, all stakeholders need to transform to accelerate access to breakthrough therapies. We can’t predict the future, but early signals and successes indicate that new collaboration models, technology development, and data integration will play an important role on that journey.
Inge De Clercq, M.S., Director, Head Clinical Study Leaders Phase 1, Galapagos NV, Mechelen, Belgium
Dr. Gaetano Morelli, MD, Chief Medical Officer, Altasciences
Abstract: Since the start of the coronavirus crisis, the whole world has faced unforeseen and critical challenges. Risk management suddenly became the number one activity in many organizations and businesses. This presentation gives insight–from a sponsor’s point of view and from a CRO perspective–into how the different entities involved in Phase I clinical research have made it possible to safely continue ongoing trials, as well as to start-up new ones. It also tackles lessons learned to keep in mind for potential future crises.
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Dr. Hazel Clay, B.S., PhDDrug Development Advisor, AltasciencesHazel Clay joined the Altasciences team in 2022 with over 30 years’ experience supporting the development of innovator pharmaceutical assets. Prior to joining Altasciences, she held a variety of different positions at Labcorp, from Toxicology Study Director to Head of Study Direction, where responsibilities included Independent Toxicology Reviewer for their UK clinic and Ethics Committee. She was a founder member of Program Management service to accelerate sponsors through to first-in-human studies. Latterly, she was Executive Director, Science and Strategy, for Early Phase Development Solutions, leading a global team of drug development specialists. During this time, she was the industry lead for the nonclinical module at Leeds University Masters Course in Biopharmaceutical development. Hazel is passionate about providing bespoke solutions for biotech companies and supporting their goals through nonclinical development and transitioning to first-in-human studies through to clinical proof of concept. She has extensive experience in navigating the challenges of drug development. |
Dr. Rakesh Dixit, PhD, DABTCofounder, President and CSO, Regio BiosciencesRakesh Dixit is an accomplished executive, inventor, and scientist with over 35 years of success with top biotechnology and pharmaceutical companies, including Merck, Johnson & Johnson, and Medimmune/ AstraZeneca. He is President and CSO of Regio Biosciences and Bionavigen, LLC. He is a Board Member of Regio Biosciences and a key member of multiple scientific advisory boards. Rakesh is also a chief advisor and consultant for more than 20 companies worldwide. His biopharmaceutical peers selected Rakesh as one of the 100 Most Inspiring People in the Pharmaceutical Industry by PharmaVOICE in 2015. Rakesh received the Most Prestigious Award of Long-Standing Contribution to ADCs by World ADC (Hanson-Wade), in 2020. From 2006 to 2019, Rakesh was a Global Vice President, Biologics R&D, at Medimmune/AstraZeneca. Rakesh has unique expertise in biologics (e.g., monoclonal antibodies, bispecific biologics, antibody-drug conjugates, fusion proteins, peptides, gene and cell therapies) and small-molecule biopharmaceutical. His expertise includes discovery, early and late preclinical development, safety assessment, DMPK, and translational sciences. Dr. Dixit conducted extensive graduate and post-graduate training in Pharmacology/Toxicology–Biochemistry with both Indian and U.S.A. institutions (e.g., Case Western Reserve University, Medical College of Ohio, University of Nebraska). and is a Diplomate and Board Certified in Toxicology from the American Board of Toxicology, Inc. since 1992. |
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Benoît CollinPrincipal, KISCO Pharma Outsourcing Solutions, Neuchâtel, SwitzerlandBenoît has more than 20 years of experience in the pharmaceutical industry. He held clinical project management roles at Quest Diagnostics, Parexel, and UCB pharma, then moved to Novartis where he held senior procurement roles, from clinical services to technical research and development including comparators, ancillaries, components sourcing, and outsourced manufacturing for cell therapies.Today, Benoît supports the outsourcing efforts of several biotech companies. His focus is on complex supply chain projects (clinical and commercial), with a keen interest for innovative therapies (ATMPS and Psychedelics) and the development of services to answer the specific requirements of these new therapies. |
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Bruno JacobCRO and CDMO Procurement Professional—Biological Manufacturing Category & Key Account ManagerBruno is a pharmacologist by education and a procurement professional with more than 20 years of expertise across the clinical and technical operation spectrum in large pharma and service providers (CROs). He started his career as CRA and Clinical Lead, followed by business and contract roles, including Head of Proposals and Contracts for a major CRO. Fifteen years ago, Bruno moved to clinical service purchasing, then technical operation procurement (two major Pharma). Today, Bruno is a Global Category Manager for a Top 3 pharma company, looking after biological drug substance manufacturing strategy and managing major biological CDMO accounts. |
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Dr. Dorothea Ledergerber, PhDChief Technical Officer, Tigen Pharma SADorothea is a pharmacist with more than 20 years of experience in research, development, manufacturing, and supply of pharmaceutical products. She received her PhD from the University of the Saarland, Saarbrücken, Germany. In 2020, Dorothea joined Tigen Pharma, a Swiss biotech company in the field of cell therapies to cure cancer, as Chief Technical Officer. Tigen Pharma is a disruptive catalyst, combining a unique culture with a multidisciplinary set of clinical and technical capabilities and a long-term perspective to the benefit of patients and society. Previously, Dorothea was at Novartis for 14 years, where she oversaw Novartis’ manufacturing sites in Switzerland, Germany, and Ireland. In fact, she was responsible for building and launching the operations for Novartis’ first commercial cell and gene manufacturing facility in Europe. Dorothea is a firm believer in cross-cultural and functional teams to go beyond the beaten industry track. |
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Inge De Clercq, M.S.Director, Head Clinical Study Leaders Phase I, Galapagos NV, Mechelen, BelgiumHolding a master’s degree in Industrial Sciences biochemistry, Inge has had a passion for Phase I clinical research since 1991, when she started working at a newly starting clinical pharmacology unit. After 15 years in several roles, having seen the unit grow substantially, Inge decided it was time to take the plunge and experience what it is to manage clinical studies of all phases on the sponsor’s side. This experience was gained at Tibotec and Amgen. For the past five years, driven by her continued passion for Phase I, she has been – together with her enthusiastic team of clinical study leaders – focusing on the efficient and effective management of first-in-human, clinical pharmacology, and Phase Ib trials at Galapagos NV. |
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Dr. Gaetano Morelli, MDChief Medical Officer, AltasciencesDr. Morelli joined Altasciences in 2017 as Medical Advisor/Consultant for complex studies. He quickly transitioned to Clinical Principal Investigator before becoming Chief Medical Officer in 2020. He is a member of the Collège des Médecins du Québec, a Fellow of the Royal College of Physicians of Canada, certified in Internal Medicine and Gastroenterology, and a Fellow of the American College of Gastroenterology. Dr. Morelli has over 30 years of medical-clinical experience and 25 years of experience in clinical research. He is a clinical-academic Gastroenterologist at the McGill University Health Network and an Associate Professor of Medicine at McGill University, involved in medical training of students, residents, and specialty fellows. Previously, Dr. Morelli was the Director of Global Medical Affairs (CMO) at MDS Pharma for 10 years, overseeing five clinical sites in Canada, the United States, and Ireland. |
The event will be held at the Volkshaus Hotel, in Basel, Switzerland.
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Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programmes, to offer an integrated/synchronised approach to CRO and CDMO services.