Past Regulatory and CMC Consulting Experience
(after leaving FDA in 2015):
• Principal consultant at Parexel International (USA)
• Long-term consultant for several companies (Beigene, Sunshine Lake, ...)
A Brief Biography
Dr. Donghao (Robert) Lu is a drug development expert and a Regulatory and CMC consultant (President and Chief Consultant, Reg-Strategy Consulting, LLC, USA).
Currently Dr. Lu carries out his consulting work with China and US pharmaceutical companies, for their regulatory and CMC development and submissions (Phase 1-2-3, NDA) on small molecules.
In addition, since left FDA, he provided regulatory consulting at Parexel International Corp. (USA) and for several famous Chinese pharmaceutical companies (including Chinese medicine); and therefore has significant
real-case experience on FDA and CFDA meetings, US/EU and China/APAC regulatory submissions, problem solving strategies, and many other regulatory issues.
He was a Senior CMC Reviewer at US Food and Drug Administration with extensive regulatory knowledge
across the areas of formulation development, product commercialization, drug substance and product manufacturing,
and regulatory control strategy. At FDA, he gained over 10 years of first-hand experiences on regulations,
guidances, procedures and day-to-day operations dealing with the evaluation of regulatory submissions of IND (small molecules and some biologics, e.g. ADC),
NDA, ANDA, DMF, BLA consults and others (including device/drug combinations). He started reviewing FDA botanical IND applications (Chinese medicine) as early as in 2006.
He served as a FDA Liaison to Europe EMA Pediatric Committee Formulation Working Group for 6 years.
Prior to joining FDA, Dr. Lu was a full professor in pharmaceutics at Temple University and an associate professor
at University of Georgia. Over 15 years as a university professor, he served as major professor for 17 graduate
students and several post-docs with successful projects across many drug development disciplines, including design
and synthesis of new therapeutic molecules, development of new formulations and controlled release dosage forms,
pharmaceutical salt selection, pharmacokinetics, animal studies and biomaterials for small and protein molecules.
At academia, he also served as a consultant to pharmaceutical industry for many years and held several patents.
Dr. Lu is a Fellow of the American Association of Pharmaceutical Scientists (AAPS) since 2007. Dr. Lu has published
65 drug development papers and book chapters. He also has given over 90 invited presentations (with conference
abstracts). He is a co-editor of the book entitled “Cellular Drug Delivery: Principles and Practice”. Dr. Lu received
his Ph.D. in Industrial and Physical Pharmacy from Purdue University in 1990.
US FDA Senior CMC Review Chemist (7/2005-9/2015)
- (1) Division of Oncology Drug Products (2011-2015), Office of New Drug Quality Assessment, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, MD 20993
- (2) Office of Generic Drug (ANDA review-OPS Squad Team and ANDA supplement review, 2013-2014), CDER, FDA
- (3) Divisions of Cardiovascular/Psychiatry/Neurology Drug Products (2005-2011), Office of New Drug Quality Assessment, CDER, FDA (* started as a CMC Review Chemist and promoted to Senior CMC Review Chemist in 3/2009)
Responsibilities and Review Areas:
- Reviewing, evaluating, and writing technical reviews of the Chemistry, Manufacturing and Controls sections of New Drug Applications (NDAs) and Investigational New Drug (INDs) as well as Post-approval Chemistry Supplements submitted for FDA approval, including almost all types of dosage forms
- Reviewing, evaluating, and writing technical reviews of the Chemistry, Manufacturing and Controls sections of Abbreviated New Drug Applications (ANDAs) and Post-approval Chemistry Supplements
- Reviewing, evaluating, and writing technical reviews of Drug Master Files (DMFs) for APIs and drug products (Type II), packaging materials (Type III), and excipient (Type IV)
- Reviewing, evaluating, and writing technical reviews of the Chemistry, Manufacturing and Controls sections for small molecule INDs and for Biologics License Applications (BLAs) and biologics INDs (for peptides and drug payloads)
- Reviewing, evaluating, and writing technical reviews of the Chemistry, Manufacturing and Controls sections for others centers and units at FDA (CDRH and Botanical drug products)
- Reviewing, evaluating, and writing technical reviews of the Chemistry, Manufacturing and Controls sections for pre-INDs and pre-NDAs meeting packages and participating industry meetings at FDA
- FDA Liaison to Europe EMA Pediatric Committee (PDCO) Formulation Working Group (6 years)
- Served as a member of OPS Squad Team for reviews of ANDA generic drug applications
- As member for various Guidance committees and review technical working groups
Book Editing (Drug Delivery)
Cellular Drug Delivery: Principles and Practice. (Editors: D. Robert Lu, and Svein Øie, ISBN: 1-58829-254-1, Humana Publisher, February, 2004)
Publications (Most Published at Universities)
Publication category: New Drug Approvals and Regulatory Sciences
- (1) FDA Approval: Ibrutinib for Patients with Previously Treated Mantle Cell Lymphoma and Previously Treated Chronic Lymphocytic Leukemia. R. de Claro et al., Clinical Cancer Research, In Press (2015)
- (2) FDA Approval: Ceritinib for the Treatment of Metastatic Anaplastic Lymphoma Kinase–Positive Non–Small Cell Lung Cancer. Sean Khozin et al., Clinical Cancer Research 21(11); 1–4 (2015)
- (3) Nasr, M. M., Lu, D. R., and Chen, C-W.: cGMPs for the 21st Century and ICH Quality Initiatives in " Pharmaceutical Dosage Forms: Tablets, 3rd Edition" (L. Augsburger, S. W Hoag, Eds.) Informa Press, 237-249 (2008)
- (4) Malone, R. A., Lukens, J., Spyrou, S. and Lu, D. R.: A management solution for clinical material inventory and tracking of investigational drug products. Pharmaceutical Engineering May/June Issue, 30-38 (1998)
Publication category: Emulsion, Liposome and Lipoprotein Formulation Development
- (5) Liu, S., Lee, C., Wang, S. and Lu, D. R.: A new pharmaceutical carrier for fluorescent quantum dots-phospholipid nanoemulsion mimicking natural lipoprotein core. Drug Delivery, 13, 159–164 (2006)
- (6) Liu, S., Wang, S. and Lu, D. R.: Lipoproteins as pharmaceutical carriers. in "Nanoparticulates as Drug Carriers" (V. Torchilin, Ed.) Imperial College Press, 173-186 (2006)
- (7) Alanazi, F., Fu, Z. F. and Lu, D. R.: Effective transfection of rabies DNA vaccine in cell culture using an artificial lipoprotein carrier system. Pharmaceutical Research, 21, 676-683 (2004)
- (8) Pan, G., Shawer, M., Øie, S. and Lu, D. R.: In vitro gene transfection to glioma cells using a novel and less cytotoxic artificial lipoprotein delivery system. Pharmaceutical Research, 20, 738-745 (2003)
- (9) Shawer, M., Greenspan, P., Øie, S. and Lu, D. R.: VLDL-resembling phospholipid-submicron emulsion for cholesterol-based drug targeting. Journal of Pharmaceutical Sciences, 91, 1405-1413 (2002)
- (10) Ji, B., Chen, W., Halpern, D. S. and Lu, D. R.: Cell culture and animal studies for intracerebral delivery of borocaptate in liposomal formulation. Drug Delivery, 8 13-17 (2001)
- (11) Mehta, S., Lai, J. C. K. and Lu, D. R.: Liposomal formulations containing sodium mercaptoundecahydrododecaborate (BSH) for boron neutron capture therapy. Journal of Microencapsulation 13 (3) 269-279 (1996)
- (12) Mehta, S., Olson, J. and Lu, D. R.: Brain tissue reaction following intracerebral injection of free or liposomally encapsulated BSH. Drug Delivery 2,175-180 (1995)
- (13) LaHann, T., Bauer, W. F. and Lu, D. R.: Enhanced delivery of paraboronophenylalanine by 2-hydroxyprol-b-cyclodextrin. Polymer Preprints 33 (2), (1992) 69-70.
Publication category: Microsphere (Controlled Release) Formulation Development
- (14) Chen, W., and Lu, D. R.: Carboplatin-loaded PLGA microspheres for intracerebral injection: formulation and characterization. J. Microencapsulation 16(5) 551-563 (1999)
- (15) Abu-Izza, K. and Lu, D. R.: Effect of gastrointestinal protein adsorption on the in vitro release of AZT from ethylcellulose microspheres. Pharmaceutical Development and Technology 3(4) 495-501 (1998)
- (16) Chen, W., He, J., Olson, J. J. and Lu, D. R.: Direct intracerebral delivery of carboplatin from PLGA microspheres against experimental malignant glioma in rats. Drug Delivery 5(2) 1-10 (1998)
- (17) Chen, W., He, J., Olson, J. J. and Lu, D. R.: Carboplatin-laded PLGA microspheres for intracerebral implantation: In vivo characterization. Drug Delivery 4(4) 301-311 (1997)
- (18) Abu-Izza, K., Tambrallo, L and Lu, D. R.: Absorption profiles of AZT in dogs using a sustained-release microsphere dosage form. Journal of Pharmaceutical Sciences 86 554-559 (1997)
- (19) Saini, P., Greenspan, P. and Lu, D. R.: Adsorption of brain proteins on the surface of poly(D,L-lactide-co-glycolide) (PLGA) microspheres. Drug Delivery 4(2) 129-134 (1997)
- (20) Garcia-Contreras, L., Abu-Izza, K. and Lu, D. R.: Biodegradable cisplatin microspheres for brain implantation: preparation and characterization. Pharmaceutical Development and Technology 2(1) 53-65 (1997)
- (21) Abu-Izza, K., Lucila Garcia-Contreras and Lu, D. R.: Preparation and evaluation of sustained-release AZT-loaded microspheres: optimization of the release characteristics using response surface methodology. Journal Pharmaceutical Sciences 85 (2) 144-149 (1996)
- (22) Abu-Izza, K., Lucila Garcia-Contreras and Lu, D. R.: Preparation and evaluation of Zidovudine-loaded sustained-release microspheres: II. Optimization of multiple response variables. Journal of Pharmaceutical Sciences 85 (6) 572-576 (1996)
- (23) Gutman, R. L., Peacock, G., Lu, D. R.: Targeted Drug Delivery for Brain Cancer Treatment. Journal of Controlled Release, 65 31-41 (2000).
- (24) Chen, W., Ji, B. and Lu, D. R.: Biomaterial implants for the treatment of central nervous system diseases. in Biomaterials Engineering and Devices: Human Applications (Wise, D. L., et. al. Eds.) Humana Press. (2000) 307-334
Publication category: Synthesis and Development of New Therapeutic Molecules
- (25) Pan, G., Øie, S. and Lu, D. R.: Uptake of the carborane derivative of cholesteryl ester by glioma cancer cells is mediated through LDL receptors. Pharmaceutical Research, 21, 1257-1262 (2004)
- (26) Alanazi, F., Halpern, D. S. and Lu, D. R.: Intracerebral diffusion of new cholesterol-based anticancer conjugate in tumor-bearing rat model. Journal of Applied Research, 4(1), 127-134 (2004)
- (27) Peacock, G., Sidwell, R., Pan, G., Øie, S. and Lu, D. R.: In vitro uptake of a new cholesteryl carborane ester compound in human glioma cell lines. Journal of Pharmaceutical Sciences, 93, 13-19 (2004)
- (28) Alanazi, F., Li, H., Halpern, D.S., Øie, S. and Lu, D. R.: Synthesis, preformulation and liposomal formulation of cholesteryl carborane esters with various fatty chains. International Journal of Pharmaceutics, 255, 189-197 (2003)
- (29) Peacock, G., Ji, B., Wang, C. K. and Lu, D. R.: Cell culture studies of a carborane cholesteryl ester with conventional and PEG liposomes. Drug Delivery, 10 29-34 (2003)
- (30) Alanazi, F., Halpern, D. S., and Lu, D. R.: Development of cholesterol-based conjugates for targeted drug delivery. STP Pharmaceutical Sciences, 13, 27-35 (2003)
- (31) Lu, D. R.: Cholesterol-based drug conjugates for targeted delivery to tumor cells, Journal of Controlled Release, 91, 250-253 (2003)
- (32) Ji, B., Peacock, G. and Lu, D. R.: Synthesis of cholesterol-carborane conjugate for targeted drug delivery. Bioorganic & Medicinal Chemistry Letters, 12 2455-2458 (2002)
- (33) Chen, W., Mehta, S. and Lu, D. R.: Selective boron drug delivery to brain tumors for boron neutron capture therapy. Advanced Drug Delivery Reviews 26 231-247 (1997)
- (34) Mehta, S. and Lu, D. R.: Targeted drug delivery for boron neutron capture therapy. Pharmaceutical Research 13 (5) 344-351 (1996)
Publication category: New Pharmaceutical Salt Selection for Existing Drugs
- (35) Ware, E. C., and Lu, D. R.: An automated approach to salt selection for new unique trazodone salts. Pharmaceutical Research, 21, 177-184 (2004)
Publication category: Drug Delivery Modeling and Pharmacokinetics (Animal)
- (36) Lu, D. R.: Computer dynamics simulation of controlled release. in Controlled Drug Delivery: Challenges and Strategies (Park, K. ed.) ACS Press, D.C. (1997) 559-573
- (37) Lu, D. R., Abuizzah, K. and Mao, F.: Nonlinear data fitting for controlled release devices, an integrated computer program (MSFIT). International Journal of Pharmaceutics 129, 243-251 (1996)
- (38) Lu, D. R., Abu-Izza, K and Chen, W.: Optima: A windows-based program for computer-aided optimization of controlled release dosage forms. Pharmaceutical Development and Technology 1 (4) 405-414 (1996)
- (39) Mehta, S., Boudinot, F. D. and Lu, D. R.: Pharmacokinetic studies of sodium borocaptate in rats. Drug Metabolism and Disposition 23 (12) 1368-1371 (1995)
- (40) Mehta, S. and Lu, D. R.: Interspecies pharmacokinetic scaling of BSH in mice, rats rabbits and humans. Biopharmaceutics and Drug Disposition 16 (1995) 735-744
- (41) LaHann, T., Bauer, W. F. and Lu, D. R.: Pharmacokinetics of boronophenylalanine delivered in HP-ß-cyclodextrin formulation. Polymeric Drugs and Drug Administration, (Ottenbrite, ed.) ACS series 545, Am. Chem. Soc., Washington, DC (1994) 66-78
- (42) Lu, D. R. and Mao, F.: PharmK, An interactive Macintosh program for pharmacokinetical modeling. Journal of Pharmaceutical Sciences 82, (1993) 537-542
- (43) LaHann, T., Lu, D. R., Daniell, G., Sills. C., Craft, S., Gavin, P. and Bauer, W. F.: Bioavailability of intravenous formulations of p-boronophenylalanine in dog and rat. Advances in Neutron Capture Therapy (Barth, R. F. and Soloway, A. H., eds), Plenum Press, N. Y. (1993) 585-589
Publication category: Pharmaceutical Analytical Method Development
- (44) Saini, P., Abuizzah, K. and Lu, D. R.: High performance liquid chromatographic determination of sodium mercaptoundecahydrododecaborate in rat tissues Journal of Chromatography, Biomedical Applications 665 (1995) 155-161
- (45) Abuizzah, K. and Lu, D. R.: High performance liquid chromatographic determination of sodium mercaptoundecahydrododecaborate with precolumn derivatiztion. Journal of Chromatography, Biomedical Applications 660 (2) (1994) 347-352
- (46) Saini, P., Lai, J. and Lu, D. R.: FTIR measurement of mercaptoundecahydro-dodecaborate in human plasma. Journal of Pharmaceutical and Biomedical Analysis 12 (1994) 1091-1095
- (47) Lu, D. R. and Munro C.: Quantitative analysis of mercapto-undecahydrododecaborate by Fourier transform infrared spectroscopy. Pharmaceutical Research 9, (1992) 1199-1202.
Publication category: Protein Molecules (Protein Interaction with Biomaterials)
- (48) Lu, D. R., Kadambi, B. N. and Lai, J. C. K.: Protein and cell interactions with biomaterials, protein conformational considerations. in Encyclopedic Handbook of Biomaterials and Bioengineering (Wise, D. L. et al eds.) Marcel Dekker, New York, N. Y. (1995) 305-328
- (49) Lu, D. R.: Glucagon adsorption on polymer surfaces with a-helix and extended b-strand conformations. Journal of Biomaterials Science, Polymer Edition 4 (4) (1993) 323-335
- (50) Kadambi, B. N., Lai, J. C. K. and Lu, D. R.: A computer simulation of adsorption of α and β conformations of glucagon. Trans. Soc. Biomaterials 19, (1993) 178
- (51) Lu, D. R., Lee, S. J. and Park, K.: Calculation of solvation interaction energies for protein adsorption on polymer surfaces. Journal of Biomaterials Science, Polymer Edition 3 (2), (1991) 127-147.
- (52) Lu, D. R. and Park, K.: Effect of surface-hydrophobicity on the conformational changes of adsorbed fibrinogen. Journal of Colloid and Interface Science 144, (1991) 271-281.
- (53) Lu, D. R. and Park, K.: Solvation interaction energies for protein adsorption. Transaction Society Biomaterials 17, (1991) 80.
- (54) Lu, D. R. and Park, K.: Protein adsorption on polymer surfaces. Journal of Biomaterials Science, Polymer Edition 1 (4), (1990) 243-260.
- (55) Lu, D. R. and Park, K.: A three dimensional protein graphic program. Computer Physics Communications 60, (1990) 257-263.
- (56) Lu, D. R. and Park, K.: Calculation of protein-polymer surface interactions by computer simulation. Transaction Society Biomaterials 16, (1990) 73.
- (57) Lu, D. R. and Park, K.: Theoretical considerations of protein adsorption on polymer surfaces. Proceeding Cardiovascular Sci Tech. Basic and Applied. 1, (1989) 155-156.
Publication category: Drug Delivery Principles and Practice
- (58) Ware, E. C., Lu, D. R. and Øie, S.: Cellular structure, function and membrane transport. in "Cellular Drug Delivery: Principles and Practice" (D. R. Lu and S. Øie, Eds., ISBN: 1-58829-254-1) Humana Publisher, 7-23 (2004)
- (59) Huang, Y., Pan, G., Øie, S. and Lu, D. R.: Cellular growth, development and defensive responses in "Cellular Drug Delivery: Principles and Practice" (D. R. Lu and S. Øie, Eds., ISBN: 1-58829-254-1) Humana Publisher, 25-41 (2004)
- (60) Pan, G., Øie, S. and Lu, D. R.: Biological protein nanostructures and targeted drug delivery. in "Cellular Drug Delivery: Principles and Practice" (D. R. Lu and S. Øie, Eds., ISBN: 1-58829-254-1) Humana Publisher, 217-233 (2004)
- (61) Adams, T., Alanazi, F. and Lu, D. R.: Safety and utilization of blood components as therapeutic delivery systems. Current Pharmaceutical Biotechnology, 4, 275-282 (2003)
- (62) Sarkar, R., Halpern, D. S., Jacobs, S. K. and Lu, D. R.: LDL-receptor mediated drug targeting to malignant tumors. in Biomedical Aspects of Drug Targeting (V.R. Muzykantov and V.P. Torchilin, Eds.) Kluwer Academic Publisher, 327-345 (2002)
- (63) Lai, J., Liang, B. B., Zhai, S., Jarvi, E. J., and Lu, D. R.: Brain mitochondrial citrate synthase and glutamate dehydrogenase: differential inhibition by fatty acyl coenzyme A derivations. Metabolic Brain Disease 9 (2) (1994) 143-152
- (64) Lai, J., Liang, B. B., Jarvi, E. J., Cooper, A. and Lu, D. R.: Differential effects of fatty acyl coenzyme A derivatives on citrate synthase and glutamate dehydrogenase. Research communications in chemical pathology and pharmacology 82 (3) (1993) 331-338
- (65) Emerick, R. J. and Lu. D.: A possible synergism of dietary phosphate and urine-acidifying salts in preventing silica urolithiasis in a rat model. Journal of Nutrition 117, (1987) 1603-1608.
Oral Presentations and Posters (More Than 90, Not Listed Here)
- (1) Lu, D. R. and Ji, B., U.S. Patent No. 6,392,068, Carborane containing cholesterol, a new type of molecule for targeted boron drug delivery. (Patent issued on May 21, 2002)
- (2) Lu, D. R. and Shawer, M., U.S. Patent Application No. 961,028, Artificial lipoprotein carrier system for pharmaceutical use. (pending prior to FDA career)
- (3) Mao, F. and Lu, D. R., Copyright of a Macintosh computer program, PharmK, for pharmacokinetic modeling. U.S. Copyright Office, No. 480-039 (1991) and No. 621-686 (1993).