Peter Milligan Email and Phone Number

Pharmetheus offers pharmacometric services supporting drug development of compounds in all phases and in all therapeutic areas. Our overall aim is ultimately to improve patients’ lives. In support of our clients, we leverage on recent enhancements in model informed drug development methodology and tools to facilitate robust, tailored and timely decision making.

Joined in 1994 to implement Pharmacometrics. Established/grew internal capabilities and capacities (analysis ready data set generation, organizational awareness, hiring); external capabilities and capacities (foster academics producing skilled practitioners, contract analysis arrangements).Delivered PMx components for Vfend (voriconazole), Viagra (sildenafil), Relpax (eletriptan), Tikosyn (dofetilide), Prodif (fosfluconazole) and Enablex (darifenacin).From 2007 Global Head of PMx, Vice President, and member of Global CP LT. Responsible for managing, formalizing, coordinating internal and outsourced PMx activities for Global CP across Pfizer enterprise. Responsible for 40 ±5 FTEs located at sites in the US (La Jolla, Cambridge, Groton, Ann Arbor, Collegeville, NYC) EU (Sandwich, Uppsala) and Asia (Shanghai, Singapore). Responsible for a $5M budget supporting outsourcing and academic interactions.PMx contributions to Selzentry (maraviroc), Toviaz (fesoteridine), Xalkori (crizotinib), Inlyta (axitinib), Xeljanz (tofacitinib), Eliquis (apixaban) and Ibrance (palbociclib). Partnered with Piet van der Graaf in 2003 to initiate, develop and formalize discovery based PMx activities and increase awareness of PMx.Created/led/contributed to the development of a number of tools and methodology enhancements for Pfizer enterprise - from 2005 was lead Clinical Pharmacology rep. (working with Statistics, Clinical) on MIDD implementation and practice.Created/led/contributed to external collaborations on behalf of Pfizer e.g. NMLEc and DDMoRe (EFPIA group lead, DDMoRe coordinator and Foundation partner). Supported and maintained academic collaborations (over 40 PhD and/or Postdoc). Organizer of conferences e.g. PAGE, PKUK, Noordwijkerhout.Provided Clinical Pharmacology support for compounds in R&D (A&R, Gastrointestinal, Cardiovascular, Neuroscience, Sexual Health, anti-viral) with frequent compound/product related visits to Health Authorities (FDA, Japan, Netherlands).

Represented DMPK on basic research and pre-evaluation teams covering both pre-clinical and clinical aspects of pharmacokinetics.Contributed to the design, analysis, reporting and presentation of pharmacokinetic, drug metabolism and toxicology studies. Recommended the application of novel approaches to data acquisition in the pre-clinical area.Designed, analysed, reported and presented a wide range of clinical pharmacokinetic studies (safety and efficacy studies using healthy and patient populations, elderly/young, food interaction, bioequivalence etc.).Contributed to the development of Ranolazine (now marketed as Ranexa by Gilead Sciences for the treatment of chronic angina).Member of a global multi-disciplinary Clinical Programme Team for a Phase 3 asset under development for erectile dysfunction. Responsible for the clinical pharmacology aspects of the compound, performing a variety of pharmacokinetic and drug metabolism studies and updating the team of any pharmacokinetic-related issue (both study specific and programme wide).Study Management Team leader for these clinical pharmacology studies ensuring they were completed within the pre-agreed timelines and budget.Provided recommendations for clinical doses and dosing algorithms (including drug interaction advice, advice for concomitant administration with food, special population dosing, etc.) to the clinical programme team and in regulatory documentation. Provided written pharmacokinetic summaries for inclusion into monographs and to support IND/NDA applications.Evaluated and recommended the software packages which became the standards within the pharmacokinetics section at Syntex for both compartmental and non-compartmental analysis (including population pharmacokinetic tools).Supervised graduate level pharmacokineticist.Initiated and co-ordinated a number of intra-departmental initiatives to increase both the level of understanding of pharmacokinetics and communication and presentation skills.