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Robert R. Fenichel |
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Professional Activities ConsultingI have been making my living as a consultant since the time I left FDA (mid-2000) through the end of 2015. During that time, I've been paid for activities directly affecting the interests of Ablative Solutions, Actelion Pharmaceuticals US, Aderis Pharmaceuticals, Affymax, Alexza, Allergan, Almirall Prodesfarma, Amgen, Arête Therapeutics, Arginox, Aryx Therapeutics, Astellas, AstraZeneca Pharmaceuticals LP, Avanir Pharmaceuticals, Aventis Pharmaceuticals, AVEO Pharmaceuticals, Bayer, Baxter, Berlex Laboratories, BioCryst Pharmaceuticals, Boehringer-Ingelheim Pharmaceuticals, Bracco Diagnostics, Bristol-Myers Squibb, Cardiome, Cebix, Centocor, Chelsea Therapeutics, Cogentus, CoLucid, Corgentech, Corthera, Corvas International, CoTherix, CV Therapeutics, Daiichi Sankyo Pharma, Daiichi Sankyo Pharma, Dainippon Sumitomo Pharma, DepoMed, DiObex, Eisai Medical Research, Epix, Essentialis, Eyetech Pharmaceuticals, FDA, Flowmedica, Forest, Laboratoires Fournier, Fujisawa, Galderma, Galenea, GeNO, GlaxoSmithKline, Graceway, GTx, Hoffman-LaRoche, Hope Medical Enterprises, Hyperion, Idun Pharmaceuticals, Ikaria, Indigo Pharmaceuticals, Juventas, KAI Pharmaceuticals, Kaiser Permanente, Karos, King Pharmaceuticals, La Jolla Pharmaceutical, Lifescape BioSciences, Ligand, Eli Lilly & Company, Luitpold Pharmaceuticals, H. Lundbeck A/S, LungRx, Lux Biosciences, MannKind, Mast Therapeutics, MDS Pharma, The Medicines Company, MedImmune, Meditor, Medtronic, MetaPhore Pharmaceuticals, Milestone, Mission Pharmacal, Mylan-Bertek Pharmaceuticals, Myogen, Navitas Pharma, Neurochem, NeuroSearch, NicOx, NIDA, NovaCardia, Novartis, Orion Pharma, Otsuka America Pharma, Ovation Pharmaceuticals, Parexel, Penwest Pharmaceuticals, Pfizer, Pharmacia & Upjohn, Pharmacopeia Drug Discovery, Physiome, Phyxius, The Population Council, Prestwick Pharmaceuticals, Procter & Gamble, Purdue, Dr. Reddy Pharmaceuticals, Reliant Pharmaceuticals, Remedy, Rib-X, Ross, Roxane Laboratories, Sanofi-Aventis, Sarfez, Schering-Plough, Schwarz BioSciences, Scios, Scotia Pharmaceutical, Sepracor, Sequel, Servier Canada, Shire Development, Sigma Tau, Solasia, Solvay, Somerset Pharmaceuticals, Synosia, Synpac, TAP Pharmaceutical Products, Teijin America, Theravance, Thrasos, UCB, United Therapeutics, Upsher-Smith, Vanda Pharmaceuticals, VIA Pharmaceuticals, Watson Pharma, WinPharm Associates, Wyeth-Ayerst, XORTX, Yamanouchi Pharma America, Zengen, Zydus and a few companies that choose to remain anonymous. I probably missed a few. Some companies got on this list not because they had hired me, but because I had been hired by an adversary in litigation. I now consider myself to be semi-retired, but I am still active when interesting projects come along. My threshold is high: too many recent projects have begun well ("Tell us what you think we should do"), but then degenerated ("Tell us what you think we can get away with"). I am honoring existing contracts that require travel to the United States, but in view of recent political developments, I won't enter into new contracts that require such travel. Much of my work entailed the collaborative production of documents, and some notes on that process are here. More specifically, I have tried to help various clients preparing for FDA Advisory-Committee meetings. With my friend, classmate, and occasional co-consultant Tom Garvey, I produced a document with suggestions related to Advisory-Committee briefing books (updated 2015-08-01). A few years ago, I served on the data-safety-monitoring board (DSMB) of a clinical trial. As part of this work, I composed a spreadsheet to facilitate optimum use of the expertise of (a) the DSMB members and (b) the contract employees doing most of the legwork. I expect to modify the spreadsheet for use with other trials, and so may you. At one time, much of my consulting had to do with drug-induced changes in ventricular repolarization. That topic is described here. Too many eventsI used to think that having too many events in a RCT was like being too rich or too thin, but it isn't. FDA-relatedWorking at FDA from 1988 to 2000 was formative for me. Some FDA-related material is here. The CATHEDRAL trialSeveral hard-endpoint trials demonstrated that treatment with HMG-coA-reductase inhibitors ("statins") reduces the incidence of atherosclerotic events in high-risk middle-aged adults. At a meeting organized by the Duke Clinical Research Institute in December of 1999, we discussed the difficulty of extrapolating these results to younger patients. We sketched the outlines of a feasible trial to answer some of the open questions, but the matter was left hanging. I'd love to pull together the logistic and financial support that might be needed for such a trial. The ideas were loosely described in a manifesto, but after a certain amount of trolling I doubt that anyone can be found to support it. Describing PatientsStarting in 2002, I was a volunteer mentor for second-year Georgetown Medical School students during their first experiences of interviewing and examining hospitalized patients. The students wrote up their findings, I annotated their reports, and we discussed the issues that arose. Some of the same problems occurred from year to year, and I started assembling my old annotations into handouts. Georgetown Medical School did not make things easy for an irregular faculty member like me, and I stopped working with their students in 2004. The last version of the collected handouts is here. Page revised: 11/13/2016 12:57 |