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DAVID E. McCLURE, Ph.D.
11770 Mira Lago Way • San Diego, CA. 92131
Home Phone: (858)-689-0174
Cell phone: (858)-382-3639
[email protected]
SUMMARY
Pharmaceutical Consultant with broad experience in all aspects of the development process,
including project management, preclinical development, manufacturing of drug substance,
formulation development, clinical supplies manufacturing, clinical development and regulatory
affairs, as well as discovery experience in medicinal chemistry and pharmacology. Corporate
experience at the executive level with the design and execution of developmental plans in
conjunction with the FDA and other regulatory bodies; set corporate strategic and operational
directions of companies through the Executive Committee.
PROFESSIONAL EXPERIENCE
McCLURE CONSULTING
Drug Development and Regulatory Affairs Services
2010-Present
Broad experience in program management of multiple projects simultaneously, including preclinical
development, manufacturing of drug substance, formulation development, clinical supplies
manufacturing, clinical development, and the preparation and submission of regulatory filings.
Provide monitoring of outside manufacturing contractors to obtain drug substance (API) and drug
product (clinical supplies) as necessary to keep programs moving forward. Guidance in the design
and execution of developmental plans is provided in conjunction with Regulatory agencies in order
to achieve successful outcomes.
TARGEGEN, INC.
Vice President, Regulatory Affairs and Drug Development
2003-Present
Formulated corporate development/regulatory strategy and company directions as a member of the
executive committee; established regulatory, drug development, and clinical functions at TargeGen;
directed process chemistry, formulation development, manufacturing, toxicology, clinical, and
regulatory affairs internally and externally through contract research organizations (CROs);
transitioned drug candidates from discovery research into developmental processes.

Responsible for taking the first TargGen preclinical candidate (TG100-115) into clinical trials –
1. partnered with outside CROs on toxicology, safety pharmacology, bulk drug
manufacture, formulation development, clinical trial supplies, etc.
2. collaborated with clinical CRO and investigational sites to develop the clinical protocols
and to execute the clinical study.
DAVID E. McCLURE, Ph.D.
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3. prepared the IND and other regulatory documents to support the clinical program and
obtained fast track designation from the FDA.

Responsible for the preclinical activities, including toxicology, bulk drug manufacturing and
formulation development, and regulatory agency interactions to support the filing of the IND for
TargeGen’s first ocular drug candidate, TG100801, a topically administered drug to treat backof-the-eye diseases (AMD, DME, PDR, etc.) in September 2006.
1. Responsible for the conduct of the chronic toxicology studies necessary to initiate clinical
trials in AMD patients.
2. Submitted the regulatory documents to the FDA to support the initiation of the clinical
trial program in AMD patients.

Participated in the discussions on the selection of candidates for development from discovery for
other ocular, oncology, cardiovascular, myeloproliferative disorder candidates to treat various
disease states of interest to and importance for TargeGen.
1. TargeGen designated TG101348 for development to treat myeloproliferative disorders.
2. Responsible for the preclinical activities, including toxicology, bulk drug manufacturing
and formulation development, and regulatory agency interactions to support the filing of
the IND for TG101348 for myeloproliferative disorders (October 2007).

Participated in various partnering discussions with potential outside collaborators having interest
in TargeGen developmental and discovery programs.
SIGNAL RESEARCH DIVISION of CELGENE CORPORATION
Vice President, Drug Development
2000 – 2002
Formulated corporate development/regulatory strategy and company directions as a member of the
executive committee; established regulatory and clinical functions at Signal; directed pharmacology,
toxicology, ADME/PK, clinical, and regulatory internally and externally through contract research
organizations (CROs); transitioned drug candidates from discovery research at Signal to
development at Celgene.

Responsible for taking the first Signal preclinical candidate into clinical trials –
1. partnered with outside CROs on toxicology, safety pharmacology, bulk drug
manufacture, formulation development, clinical trial capsule manufacture, etc.
2. collaborated with investigational sites to develop the clinical protocols.
3. prepared the IND and other regulatory documents to support the clinical program.

Collaborated with Signal representatives and with Nippon Kayaku on the joint development of a
neuroprotective agent to evaluate efficacy and toxicity of the compound and worked to terminate
the collaboration on mutually beneficial terms.

Participated in partnering and M&A discussions leading to the Signal/Celgene merger and other
potential partnerships.

Responsible for preparing the drug candidate selection document at Signal/Celgene, a new
process for the company, taking Signal’s first JNK inhibitor into development (7/01).
DAVID E. McCLURE, Ph.D.

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Overseeing the preclinical development activities, including toxicology, safety pharmacology,
bulk drug synthesis, and formulation work, on the above JNK inhibitor to position it for clinical
trials in September, 2002, as an iv administered agent.
SIBIA NEUROSCIENCES, INC.
1996 - 1999
Vice President, Clinical Development & Regulatory
Developed corporate regulatory/clinical strategy and company directions as a member of the
executive committee; established regulatory function at SIBIA to allow safe and effective conduct of
clinical trials; directed clinical and regulatory personnel in performing trials and submitting
appropriate regulatory documentation with outside contract research organizations (CROs).

Prepared and submitted the first SIBIA therapeutic IND for SIB-1508Y, a novel antiparkinson
agent, to FDA, to support clinical program.




Designed and executed single and multiple-dose Phase 1 studies through CRO.
Prepared and packaged SIB-1508Y clinical trial formulation through appropriate CROs.
Planned initial Phase 2 patient trial with the Parkinson’s Study Group (PSG) to evaluate
safety, tolerability, and efficacy of SIB-1508Y, modified trial to lower doses, as required,
quickly and efficiently, completed trial, analyzed information, and summarized results.
Designed and executed within 6 months early Phase 2 within patient designed trial for 18
patients. Submitted Canadian IND to HPB to include a site in Canada. Monitored
studies at SIBIA, analyzed information, and summarized results.

Participated in Joint Steering Committee on SIB-1508Y with Meiji Seika Kaisha, Japanese
partner.

Contributed to corporate development including presenting at licensing discussions with
potential partners on clinical and R&D progress.

Prepared and filed regulatory documents covering SIB-1553A, novel Alzheimer’s therapy, to
support the initiation of the early clinical program in South Africa through CRO.



Prepared and packaged clinical trial formulation through appropriate CROs.
Designed and executed single- and multiple-dose Phase 1 studies of SIB-1553A with
CRO.
Conducted early Phase 2 within patient designed trial of SIB-1553A for 15 patients at
South African site through CRO, analyzed data, and summarized the results (10/99).
DAVID E. McCLURE, Ph.D.
MOLECULAR BIOSYSTEMS, INC.
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1992 - 1996
Director, Product Development
Directed group of 30-40 scientists and engineers in the discovery, analytical testing, formulation
development, process engineering, and pilot plant manufacturing of new ultrasound contrast agents
with an annual budget of ~$3-5M. Successfully implemented project planning and management that
established effective working teams to move projects from discovery to approval.

Managed scientific group that discovered and developed a 2nd-generation myocardial and
radiological organ perfusion agent (discovery ~ 1 yr., IND ~ l yr.).

Initiated and led 2nd-generation project team to plan and implement developmental strategy;
IND submission achieved, less than one year after selection; NDA submission achieved less
than two years later, followed by subsequent approval.

Directed identification and selection of oral contrast agent; IND submission achieved about one
year after its selection.
ICI PHARMACEUTICALS GROUP
1988 - 1992
Assistant Director, Oncology Clinical & Medical Affairs (1991-1992)
Led 10-member clinical team as project director for multicenter trials of prostate cancer drugs.

Managed single entity trial for 33 centers; recruited new investigators for, conducted
investigators' meeting to initiate, and managed combination trial for 58 centers.

Represented ICI in conferences at FDA to negotiate protocol designs and the conduct of clinical
trials.
Sr. Project Development Manager, Drug Development Department (1988-1991)
Led U.S. development teams for all ICI cardiovascular projects, up to 10 concurrently.

Directed project team responsible for expansion of post-marketing indications for
TENORMIN, an extremely important ß-adrenergic antagonist for ICI.

Drove the project development teams for ZESTRIL and ZESTORETIC beyond the initial
indication for treatment of hypertension to clinical for supplemental NDA indications, such as
therapy for heart failure, renal failure, and diabetes.
MCNEIL PHARMACEUTICAL (J & J)
1983 - 1988
Development Team Chairperson
Section Head, Medicinal Chemistry
Chaired international development team for perindopril that created clinical/regulatory plan resulting
in NDA filing for this ACE inhibitor within four years of McNeil/Servier licensure agreement.
Managed medicinal chemistry section of 18-25 scientists; areas under investigation included
DAVID E. McCLURE, Ph.D.
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metabolic/diabetic therapies, cardiovascular drugs, psychotherapeutic agents, and immunotherapeutic
interventions.

Led team that filed a 45-volume IND to initiate Phase 2 U.S. clinical trials approximately 10
months after the completion of the McNeil/Servier licensure agreement.

Led section that provided six candidates for further toxicological and clinical development:
antihypertensive/antianginal agent, antiarrhythmic candidate, unconventional analgesic,
unconventional antipsychotic, anticonvulsant, and antidiabetic/antiobesity agent.

Planned and executed $2M medicinal chemistry section budget and integrated perindopril
budget across the company that kept the fast-track status of the project on schedule.

Prioritized and monitored patent filings and patent office actions that assured adequate legal
protection for developmental candidates; served as company-wide Quality Education Instructor.
MERCK SHARP & DOHME RESEARCH LABORATORIES
1975 - 1983
Senior Research Fellow; Research Fellow; Senior Research Chemist
Designed and synthesized potential medicinal agents primarily for cardiovascular and central
nervous system disorders.

Directed discovery efforts of four medicinal chemists who contributed to development of two
toxicological candidates, one clinical candidate, and fifteen publications.

Served as R&D liaison to the Chemistry Departments at Stanford University and the University
of California, Berkeley, to recruit talented scientists and to develop faculty relationships as a
member of Merck's “ambassador" program.
EDUCATION
Post Doctoral Research, Columbia University
 Sigma Xi (National Scientific Honorary Society)
Ph.D., Organic Chemistry, Stanford University
 NSF Summer Traineeship, Frederick P. Whitaker Fellowship
BS, Chemistry, Nebraska Wesleyan University
 Phi Kappa Phi, Silver Key of Graduating Class, Who's Who Among American University
Students, Blue Key
DAVID E. McCLURE, Ph.D.
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AFFILIATIONS AND HONORS
American Heart Association Heart Walk Executive Committee, San Diego, CA, 1998 and 1999
Project Management and Finance Subsection, Pharmaceutical Manufacturers Association:
Annual Program Committee for 1990-1991. Organized and chaired sessions at the annual meeting in
May 1991.

Contributed significantly to design of "NDA Game", an IND and NDA educational tool
used to teach PMA and FDA representatives about the advantages of cooperation
between FDA and sponsor companies on drug development, 1990-1991.
22nd Reaction Mechanisms Conference, Organizing Committee, 1986-1988.
Philadelphia Organic Chemists Club, Chairman Elect, 1984-1985. Chairman. 1985-1986.
American Chemical Society (Organic and Medicinal Chemistry Divisions); Sigma Xi; American
Heart Association; Project Management Institute; American Association for the Advancement of
Science; Drug Information Association; Regulatory Affairs Professionals Society; American Society
of Hematology.
SELECTED PRESENTATIONS OR POSTERS
1.
“Cholinergic Receptors in Parkinson’s Disease”, Presentation and Chair of Breakfast
Meeting, XIII International Congress on Parkinson’s Disease, D. E. McClure, July 24-28,
1999, Vancouver, Canada.
2.
“Potential Therapeutic Usefulness of Subtype Selective Neuronal nAChR Agonists for the
Motor, Cognitive and Disease Progression Components of Parkinson’s Disease, IBC’s
Second International Symposium on Nicotinic Acetylcholine Receptors”, G.K. Lloyd and D.
E. McClure, May 13-14, 1999, Annapolis, MD.
3.
“Clinical Pharmacology of SIB-1553A, a Neuronal Nicotinic Acetylcholine Receptor
Agonist”, D. E. McClure, T. Gautille, S. Broome, G. K. Lloyd, J. Willmer, T. Krasowski, K.
Hildebrand, J. Terblanche, V. Knott, American College of Neuropsychopharmacology,
Puerto Rico, December 14, 1998.
4.
“Safety and Pharmacokinetics of SIB-1508Y, a Novel Antiparkinsonian Agent , in Healthy
Volunteers”, D. E. McClure, L. Gilliland, S. Broome, I Weston, N. Wang, G. K. Lloyd,
American College of Neuropsychopharmacology, Hawaii, December 8-12, 1997.
5.
“Safety and Pharmacokinetics of Single Doses of SIB-1508Y, a Novel Antiparkinsonian
Agent, in Normal Male Volunteers (40-70 years Old)”, D. E. McClure, G. K. Lloyd, L.
Gilliland, I. Weston, J. S. Owen, Movement Disorders Day at American Neurological
Association, September 1997.
DAVID E. McCLURE, Ph.D.
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PUBLICATIONS
1.
Stereochemistry of -Phenethyl Radical Dimerization, W. G. Brown and D. E. McClure,
J. Org. Chem., 35, 2036 (1970).
2.
Mechanisms in Phosphite Ozonide Decomposition to Phosphate Esters and Singlet Oxygen,
L. M. Stephenson and D. E. McClure, J Amer. Chem. Soc., 95, 3074 (1973).
3.
The Stereochemistry of Singlet Oxygen Ene Reaction with Olefins, L. M. Stephenson, D. E.
McClure and P. K. Sysak, J. Amer. Chem. Soc., 96, 7888 (1974).
4.
Very Fast Zinc-Catalyzed Hydrolysis of an Anhydride. A Model for the Rate and Mechanism
of Carboxypeptidase A Catalysis, R. Breslow, D. E. McClure, R. S. Brown, and J. Eisenach,
J. Amer. Chem. Soc., 97, 194 (1975).
5.
Cooperative Catalysts of the Cleavage of an Amide by Carboxylate and Phenolic Groups in a
Carboxypeptidase A Model, R. Breslow and D. E. McClure, J. Amer. Chem. Soc., 98, 258
(1976).
6.
The Synthesis of (R)- and (S)-Epichlorohydrin, J. J. Baldwin, A. W. Raab, K. Mensler, B. H.
Arison, and D. E. McClure, J. Org. Chem., 43, 4876 (1978).
7.
Chiral Heteroaryloxymethyloxiranes, D. E. McClure, E. L. Engelhardt, K. Mensler, S. W.
King, W S. Saari, J. R. Huff and J. J. Baldwin, J. Org. Chem., 44, 1826 (1979).
8.
Mode of Nucleophilic Addition to Epichlorohydrin and Related Species: Chiral
Aryloxymethyloxiranes, D. E. McClure, B. H. Arison, and J. J. Baldwin, J. Amer. Chem,
Soc., 101, 3666 (1979).
9.
Preparative Methods for Ergoline Synthons: Uhle's Ketone and the C-Homo Analogue,
G. S. Ponticello, J. J. Baldwin, P. K. Lumma, and D. E. McClure, J. Org. Chem., 45, 4236
(1980).
10.
Chiral -Aminoketones from the Friedel Crafts Reaction of Protected Amino Acids,
D. E. McClure, B.H. Arison, J. H. Jones, and J. J. Baldwin, J. Org. Chem., 46, 2431 (1981).
11.
A New Class of D-Heteroergolines: Total Synthesis and Resolution of a 9-Oxaergoline,
4,6,6a.8,9,10a-Hexahydro-7-ethyl-7H-indolo[3,4-gh] [1,4]benzoxazine, P. S. Anderson, J. J.
Baldwin, D. E. McClure, G. F. Lundell, and J. H. Jones, J. Org. Chem., 47, 2184 (1982).
12.
Use of (S)-(Trifloxymethyl)oxirane in the Synthesis of a Chiral -Adrenoceptor Antagonist,
(R)-and (S)-9-[[3-tert-Butylamino)-2- hydorxypropyl]oximino]fluorene, J. J. Baldwin, D. E.
McClure, D.M. Gross, and M. Williams, J. Med. Chem., 25, 931 (1982).
DAVID E. McCLURE, Ph.D.
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13.
Synthesis of (7R)-7H-Indolo[3,4-gh][l.4]Benzoxazines, A New Class of D-Heteroegoline
which Possesses Potent Dopamine Agonist Activity, P. S. Anderson, J. J. Baldwin, D. E.
McClure, G.F. Lundell, J. H. Jones, W. C. Randall, G. E. Martin, M. Williams, B. V.
Clineschmidt, P. K. Lumma, J.M. Hirschfield, and D. C. Remy, J. M ed. Chem, 26, 363
(1983).
14.
Antihypertensive -Adrenergic Blocking Agents: N-Aralkyl Analogs of 2-[(3-tertbutylamino)-2-hydroxypropoxy]-3-cyanopyridine, D. E. McClure, J. J. Baldwin, W. C.
Randall, T. F. Lyon, K. Mensler, G. F. Lundell, A. W. Raab, D. Gross, E. A. Risley, C. S.
Sweet, M. Williams, J. Med. Chem., 26, 649 (1983).
15.
1,4-Oxazines via Intramolecular Ring Closure of -Hydroxydiazoacetamides: Phenylalanine
to Tetrahydroindeno[1,2-b]-1,4-oxazine-3-(2H)-ones, D. E. McClure, P. K. Lumma, B. H.
Arison, J. H. Jones, J. J. Baldwin, J. Org. Chem, 48, 2769 (1983).
16.
Interaction of the Component Enantiomers of the Putative Dopamine Autoreceptor Agonist,
TL-99 (6,7-dihydroxy-2-dimethylaminotetralin) with Dopaminergic Systems in Mammalian
Brain and Teleost Retina, M. Williams, G. Martin, D.E. McClure, J. J. Baldwin, K. J.
Watling, Naunyn-Schmiedeberg's Arch. Pharmacol., 324, 275 (1983).
17.
Synthesis of 4,5-Dihydroazepine-3,6-dicarboxylate Derivatives by Stereoselective Ring
Expansion - Nucleophilic Addition to 4-(-chloralkyl)-1,4-dihydropyridine-3,5dicarboxylates, D. A. Claremon, D. E. McClure, J. P. Springer, J. J. Baldwin, J. Org. Chem.,
49, 3871 (1984).
18.
Synthesis of 4-Substituted 2H-Napth [1,2-b]-1,4-oxazines, a New Class Dopamine Agonists,
J. H. Jones, P. S. Anderson, J. J. Baldwin, B. V. Clineschmidt, D. E. McClure, G. F. Lundell,
U. C. Randall, G. E. Martin, M. Williams, J. Hirshfield, G. Smith, P. K. Lumma, J. Med.
Chem., 27, 1607 (1984).
19.
Novel Rigid Calcium-Entry Blockers: Intramolecular Reactions of 1,4-Dihydropyridine
Derivatives, D.A. Claremon, J. Hirshfield, P.K. Lumma, D. E. McClure, J. P. Springer,
Synthesis, 144, (1986).
20.
Determination of Enantiomeric Purity of Tertiary Amines by 1H NMR of -Methoxy-trifluoromethylphenylacetic Acid Complexes, F. J. Villani, Jr., M. J. Costanzo, R. R. lnners,
M. S. Mutter, D. E. McClure, J. Org. Chem., 51, 3715 (1986).
21.
Diethyl 3,6-Dihydro-2-4-dimethyl-2-6-methano-1,3-benzothiazocine-5,11-dicarboxylates as
Calcium Entry Antagonists: New Conformationally Restrained Analogues of Hantzsch 1,4Dihydropyridines Related to Nitrendipine as Probes for Receptor Site Conformation, J. J.
Baldwin, D. A. Claremon. P. K. Lumma, D. E. McClure, S. A. Rosenthal, R. J. Winquist. E.
P. Faison, G. J. Kaczorowski, M. J. Trumble, G. M. Smith, J. Med. Chem., 30, 690 (1987).
22.
Subtype-Selective nAChR Agonists for the Treatment of Neurological Disorders: SIB-1508Y
and SIB-1553A, F. Menzaghi, D. E. McClure, G. K. Lloyd, Neuronal Nicotinic Receptors
and Therapeutic Opportunities, John Wiley & Sons, Ltd., S. P. Arneric and J. D. Brioni (eds)
(1998), pp. 379-394.
DAVID E. McCLURE, Ph.D.
Page 9
PATENTS
1.
U.S. Patent 4,210,653, July
"Pyridyloxypropanolamines".
1,
2.
U.S. Patent 4,336,261,
"Aryloxypropanolamines".
22,
3.
U.S. Patent 4,346,042, August 24, 1982, D. E. McClure, J. J. Baldwin "Preparation of
Epihalohydrin Enantiomers".
4.
U.S. Patent 4,349,673, September 14, 1982, D. E. McClure, J. J. Baldwin, J. G. Atkinson,
"Benzoxazines".
5.
U.S. Patent 4,358,455, November 9, 1982, D. E. McClure, J. J. Baldwin, J. G. Atkinson,
"Aralkylaminoethanol Heterocyclic Compounds".
6.
U.S. Patent 4,408,063, October 4, 1983, D. E. McClure, J. J. Baldwin, “Preparation of
Epihalohydrin Enantiomers".
7.
U.S. Patent 4,431,647, February 14, 1984, D. E. McClure, "Method of Use of Enantiomers of
trans-Indeno[1,2-b]-1,4-oxazines”.
8.
U.S. Patent 4,442,094, April 10, 1984, D. E. McClure, J. J. Baldwin, J. G. Atkinson,
"(3-Aralkylamino-2-OR-propoxy)heterocyclic Compounds".
9.
U.S. Patent 4,472,427, September 18,1984, D. E. McClure, J. J. Baldwin, (Aralkylamino-2OR-propoxy)-heterocyclic Compounds”.
10.
U.S. Patent 4,486,446, December 4, 1984, D. E. McClure, J. J. Baldwin,
"Aralkylaminoethanol Heterocyclic Compounds".
U.S. Patent 4,533,745, August 6, 1985, D. E. McClure, "Amino Ketones and Their
Preparation”.
11.
June
1980,
1982,
D.
D.
E.
McClure,
J.
J.
Baldwin,
E.
McClure,
J.
J.
Baldwin,
12.
U.S. Patent 4,568,679, February 4, 1986, D. E. McClure, J. J. Baldwin, J. G. Atkinson,
"Aralkylaminoethanol Heterocyclic Compounds”.
13.
U.S. Patent 4,588,824, May 23, 1986, D. E. McClure, J. J. Baldwin, "Preparation of
Epihalohydrin Enantiomers".
14.
U.S. Patent 4,609.494, September 2, 1986, D. E. McClure, J. J. Baldwin, D. A. Claremon,
“5-Acetyl-3,4,5,6-tetrahydro-4-oxo-2,6-methano-2H-1,3,5-benzothiazocine
(-benzodiazocine)11-carboxylates Useful as Calcium-Channel Blockers".
DAVID E. McCLURE, Ph.D.
Page 10
15.
U.S. Patent 4,656,168, April 7,1987, D. E. McClure, J. J. Baldwin, J. G. Atkinson,
“(3-Aralkylamino-2-OR-propoxy)-Heterocyclic compounds in Method of Effecting
Bronchodilation”.
16.
U.S. Patent 4,675,321, June 23, 1987, D. E. McClure, J. J. Baldwin, S. M. Pitzenberger,
"Substituted Pyrimidines Useful As Calcium Channel Blockers".
17.
U.S. Patent 4,677,101, June 30, 1987, D. E. McClure, D. A. Claremon, "Substituted
Dihydroazepines Useful As Calcium Channel Blockers".
18.
U.S. Patent 4,677,102, June 30, 1987, D. E. McClure, J. J. Baldwin, J. G. Atkinson,
"Substituted Diazepines and Derivatives Thereof Useful in the Treatment of Cardiovascular
Disorders”.
19.
U.S. Patent 4,686,222, August 11, 1987, D. E. McClure, J. J. Baldwin, J. G. Atkinson,
"Aralkylaminoethanol Heterocyclic Compounds".
20.
U.S. Patent 4,816,457, March 28, 1989, D. E. McClure, J. J. Baldwin, J. Atkinson,
"Aralkylaminoethanol Heterocyclic Compounds”.