Development Team
Celtic Pharma Development Services
Celtic Pharma Development Services Bermuda Ltd. (“CPDS”) is a Bermuda-based entity owned by Celtic Pharmaceutical Holdings L.P., and is responsible for the global clinical, regulatory and commercial development of all of Celtic’s products. CPDS’s team of senior and very experienced pharmaceutical development executives retain responsibility for strategic decision making, guiding the clinical development and regulatory interactions and the financial management of Celtic’s products. Operational project management is largely outsourced to organizations such as Fulcrum Pharma PLC of the UK, and all clinical trial management and other clinical operations are outsourced to Clinical Research Organizations. Most manufacturing is also outsourced to contract manufacturers.
The Development Team includes:Michael Earl
Michael Earl has more than twenty years of strategic and operational experience in the pharmaceutical/biotech field. He joined Celtic from Chiron BioPharmaceuticals where he was VP, European Operations. There he led the European Management Team to successfully deliver against overall business objectives including both financial and cross-functional project targets. Prior to Chiron he was Commercial Development Director with Celltech Group plc, leading commercial strategy for the entire pipeline of development and research projects as well as being a leading operational manager within the company. He also had responsibility for later-stage business development and international sales. He was a member of the Group Operating Committee, leaving after the successful merger with UCB Group.
Michael’s “Big Pharma” experience gained prior to Celltech included increasingly significant roles with SmithKline Beecham, Abbott Laboratories and AstraZeneca covering the sales & marketing, drug development and business development fields, both for domestic markets and globally from UK and international bases. He has had responsibility for products at all stages of their life-cycle, from lead optimization to patent expiry.
Before entering the Pharma industry he was a business manager for a Grand Metropolitan plc subsidiary. He read Dentistry at the London Hospital Medical College.
Dr. Bill Henry
Bill Henry began his career as a research scholar for British Petroleum and gained a PhD in chemistry from the University of Edinburgh. Bill joined ICI as a development chemist where he gained experience in pharmaceutical drug substance development and production and eventually led multi-functional teams to align production capacity with the needs of ICI / Zeneca Pharmaceuticals.
With an original background in biochemistry, Bill was keen to join Zeneca's emerging Bioproducts business to commission a large mycoprotein manufacturing capability before moving on to become the European Operations director for the veterinary pharmaceutical business that was eventually acquired by Schering Plough.
Bill was then part of a successful management buyout team that developed, through a series of acquisitions, a veterinary pharmaceutical company into a biologics based business which was later acquired by Novartis.
A short, but valuable period of medical device manufacturing preceded Bill's appointment to head Celltech's technical operations group. In this role, Bill was responsible for the management of supply solutions for Celltech's range of antibody and antibody fragment products, and also for the development of product formulations and delivery technologies.
More recently, and after Celltech's acquisition by UCB, Bill joined PowderMed to lead the strategic development of DNA vaccine manufacture. Pfizer's purchase of PowderMed was timed perfectly to present an ideal opportunity for Bill to join Celtic Pharma.
Dr. Bob Milsted
Bob Milsted trained as a physician in the UK and gained accreditation in Medical Oncology and General Medicine before joining ICI (now AstraZeneca) for whom he worked for 23 years in both the clinical and regulatory functions. In the 10 years that he lead the oncology Clinical team he was responsible for bringing a number of oncology products to market including Zoladex, Casodex, Arimidex, Tomudex and Faslodex as well as leading the Phase III program for the novel antipsychotic, Seroquel.
For the last 11 years he was VP for Global Regulatory Affairs for Oncology and Infection and a member of the Therapy Area Leadership team. He managed the Iressa Compassionate Use program and the biotechnology collaboration with Abgenix.
Bob spent three years working in the USA and has managed international teams for the last 15 years. He has led many FDA meetings and interactions at all stages of development and was a member of the joint AACR/NCI/FDA working party on clinical endpoints in breast cancer prevention studies. He was a member of the ICH working party on Clinical Study Reports and has made numerous trips to Japan which have led to a number of successful Japanese registrations, including efficient bridging strategies.
Bob has presented at numerous external meetings including ASCO and DIA and more recently has been on the steering committee of the Biotherapy Development Association. His interests in drug development include designing efficient global development programs, using statistics to aid rational decision-making and “doing drug development backwards”.
Dr. Patrick O'Connor
Patrick O’Connor joined Celtic Pharma with 10 years of practice in internal medicine and 20 years of experience in the global pharmaceutical industry. He has participated in the development and approval of more than 20 compounds in both the US and Europe.
After graduating in medicine, Patrick spent four years in basic physiology/pharmacology research at Manchester University in the UK leading to a Ph.D. and then worked for ten years in the British National Health Service. He is a registered specialist in the UK, with accreditation in internal medicine and clinical pharmacology.
Patrick joined Boots Pharmaceuticals in 1984, serving in a number of positions culminating in his appointment as Vice President Medical Research for Boots Pharmaceuticals in the US.
In 1991 he joined Pharmaco (later PPD) and was appointed Chief Operating Officer for European Clinical Development Services based in Brussels, Belgium. In 1994, he relocated to the US to launch PPD’s consulting services worldwide, and two years later he was appointed Head of Regulatory and Product Development for PPD.
In 2002 he was appointed Head of Global Clinical Development at the Ferring Group of Companies, where outsourcing of clinical development is a key component of just-in-time development.
Dr. Robert Ryan
Robert Ryan joined Celtic Pharma with more than 17 years of pharmaceutical/biotech experience, spanning the development process from preclinical through Phase IV. Robert previously held senior regulatory positions at the two leading CRO's, PPD and Quintiles, where he also served as the Chief Regulatory Officer for the company's very successful PharmaBio program. As Chief Regulatory Officer of Quintiles, Robert led the due diligence that resulted in investment of over $1 billion of the company's own money into the development programs of various biotech/pharmaceutical companies. During his involvement with PharmBio at Quintiles, the track record of successful deals was 100%.
Robert also served as Vice President of Regulatory Affairs and Pharmacovigilance at Atherogenics, and, most recently, he served as the Global Head of Regulatory Affairs for Schwarz Pharma. In both roles, Robert had regulatory responsibility for all global development programs. Robert was also a member of the executive team at Atherogenics involved in the negotiation and subsequent agreement with Astra Zeneca for the commercialization of its lead product, AGI-1067.
Prior to working at the two leading CROs, Robert held various positions covering preclinical and clinical activities with Roche, Bristol-Myers Squibb (BMS), and Pfizer. At BMS, he was responsible for the management of the GLP toxicology programs for all oncology, anti-infective, and dermatology products. Prior to working in the pharmaceutical/biotech industry, Robert conducted research for several years at the National Institutes of Health's environmental division.
Robert is board certified in Toxicology and has a Ph.D. in Toxicology from the University of North Carolina at Chapel Hill and Masters in Genetics and Pharmacokinetics.
Lisa M. Rhoads
Lisa Rhoads is an experienced marketing and business development professional who has spent the past 15 years focused on marketing strategy in the pharmaceutical, financial services and technology sectors. Currently a resident of Bermuda, Lisa has founded two successful companies; Trinity Holdings Ltd., a consulting firm offering strategy and business development services where she launched a UK-Based Global Macro Fund, and Rhoads RE LLC, a US-based Real Estate investment company that seeks value in developed and emerging markets.
Prior to opening Trinity Holdings, Ltd. Lisa was senior director of Consumer Marketing at Bristol Myers Squibb in Princeton, New Jersey. While at Bristol-Myers, she helped develop the strategic framework for a new consumer marketing group within the pharmaceutical division that drove significant revenue increases across the division and initiated and led a cross-divisional e-commerce strategy team that became the first in the division. Also at Bristol Myers-Squibb, she led development of a compliance and persistency model focused in the cardio-vascular area that was implemented as a model for other disease-states.
Lisa has also worked in the consumer marketing group at J&J’s McNeil Consumer Products Company and led a consumer initiative within Zeneca’s US pharmaceutical division. She holds an MBA in Marketing and Finance from The Wharton School of Business and serves on the executive committee of the Bermuda International Film Festival.
Solomon Babani
Solomon Babani joined Celtic Pharma Development Services as Director of Contracts and Vendor Management. In this capacity, he is responsible for implementing and overseeing the entire outsourcing process and strategy for all functions (pre-clinical, clinical, regulatory, manufacturing, etc.) within CPDS. In addition, he will be responsible for continuing to cultivate and build relationships with all of the vendors working with CPDS.
Solomon began his career as a research technician at the Albert Einstein School of Medicine. He made his way into industry when he joined the biotechnology company Regeneron Pharmaceuticals as a research associate. While at Regeneron, he transitioned out of the labs and into clinical research where he became the Manager of Clinical Finance. Solomon joined Pfizer, as Manager, Contracts and Outsourcing, where he supported Phase IIIB and IV clinical trials. Most recently, he worked at Novartis Pharmaceuticals, as Associate Director in the CRO Management group, where he managed the outsourcing of global Phase II – IV clinical studies in a variety of therapeutic areas.
Solomon holds a BA in Biology from Yeshiva University and an MBA in Finance and Management from New York University’s Stern School of Business.