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Directory of Consultants
Bay Area Biomedical Consultants Network (BABCN)
Name and Educational Degree(s) Kugler, Alan, PhD
Business Name Coastal Pharma Group
Certifications ACDRS
Education

University of California, San Francisco (UCSF): American Course on Drug Development and Regulatory Sciences (ACDRS) [Certificate 2009]

University of Michigan (UM) - Ann Arbor: Pharmaceutics [PhD 1993]

University of Michigan (UM) - Ann Arbor: Pharmaceutics [MS 1991]

University of Wisconsin (UW) – Madison: Biochemistry [BS 1985]

University of Wisconsin (UW) – Madison: Molecular Biology [BS 1985]

Business Address 156 Mattison Drive
Concord, MA 01742-4146
USA
Contact information
Telephone:
Mobile Number:
Email address:
Website URL:
+1.978.254.5897 (Landline)
+1.617.955.9535 (Mobile)
ARK.CPG@Gmail.com
http://www.linkedin.com/in/alanrkugler
Specialties
  • Drug Development Plans and Strategy
  • Clinical Pharmacology (ClinPharm)
  • Clinical Development (ClinDev)
  • Pharmacokinetics (PK)
  • Absorption, Distribution, Metabolism, and Elimination/Excretion (ADME) Studies
  • Toxicokinetics (TK) for Toxicology Studies
  • Pharmacokinetics/Pharmacodynamics (PK/PD)
  • Population Pharmacokinetics (PopPK)
  • Bioequivalency Strategy (SAP), Protocol, Statistics/Pharmacometrics, and Report
  • Clinical Trial Simulation
  • Noncompartmental Analyses
  • Compartmental Modeling and Analyses
  • Regulatory Interactions (FDA [USA], EMA/EMEA/CHMP [EU], MHRA//MCA [UK], MHLW [Japan], and HC/TPD [Canada])
  • Regulatory Submissions (IND, NDA, sNDA, aNDA, CTD, and MAA using CTD and CDISC)
  • Orphan Drug Submissions (OOPD/COMP)
  • Pediatric Plans, Waivers, and Deferrals
  • Target Product Profile (TPP) Strategy, Drafting, and Maintenance
  • Contract Research Organizations (CROs) Identification and Management
  • Advisory Board Identification and Management
  • Key Opinion Leader [KOL (academic, industrial, MD, PhD, etc.) Identification and Relations
  • Bioanalytical Strategy (ISR and MIST), Overview, and Review
  • Drug Delivery
  • Pharmaceutics
  • Technical and Medical Writing
  • Medical and Scientific Literature Reviews and Summaries
  • Generics
  • Business Development
  • Due Diligence Strategy and Conduction
  • Biotechnology/Pharmaceutical Patent Strategy and Preparation
  • Software: Phoenix WinNonlin, MONOLIX, NONMEM, Berkeley Madonna, SAS, ADAPT5, SigmaPlot, SigmaStat, FORTRAN, etc.
  • Clinical and Preclinical Drug Development and Registration Strategies for Small Molecules, Antisense Oligonucleotides (ASOs), and Peptides/Proteins in Multiple Therapeutic Areas [CNS (Epilepsy, Alzheimer’s, Parkinson’s, Pain), Oncology, Respiratory/Pulmonary, Infectious Diseases, Cardiovascular, and Endocrine]
  • Novel Drug Delivery Strategies (Formulations and Devices) Including PEGylation, Prodrugs, Supercritical Fluid Processing (SCF), Dry Powders, Immediate/Modified/Controlled/Extended/Sustained Release using Oral (PO), Pulmonary/Inhalation (IH), Intravenous (IV), Subcutaneous (SC), Transmucosal (TM), Transdermal (TD), and Intramuscular (IM) Routes of Administration
  • Consultant and Contractor
Experience

Biography

Alan founded Coastal Pharma Group (a consulting and service provider to the pharmaceutical and biotechnology industries) in 2008. He has over 20 years experience in the pharmaceutical industry including Hazleton (currently Covance Laboratories, Inc.), 14 years at Parke-Davis Pharmaceutical Research / Warner-Lambert, 3 years at Pfizer Global Research and Development-Ann Arbor, and 5 years at Nektar Therapeutics..Alan is currently Vice President and co-leader of Translational Sciences in the Neuroscience Innovative Medicines (iMed) organization, leads the AZD3241/MPO program in mid-stage clinical development for Parkinson’s disease, and is based in Cambridge, MA.

Alan started his career as a pharmacokineticist specializing in Bayesian/population pharmacokinetic analyses but has more recently contributed to and led development programs of late-stage compounds. He has contributed to numerous IND, NDA, CTA, and MAA regulatory filings and/or led the preclinical or clinical development of significant drug products such as Lipitor (atorvastatin), Accupril (quinapril), Accuretic (quinapril + hydrochlorothiazide combination), Neurontin (gabapentin), Cognex (tacrine), Cerebyx (fosphenytoin), and Lyrica (pregabalin). He served as an Advisory Board Member for the National EpiFellows Foundation (NEF), and was/is an active member of American Academy of Neurology (AAN), American Epilepsy Society (AES), and American Association of Pharmaceutical Scientists (AAPS). He is well published with original scientific research published in numerous peer-reviewed journals, book chapters, and drug patents. He has given invited presentations both domestically and internationally.

Dr. Kugler has Bachelor of Science (BS) degrees from the University of Wisconsin Madison (double majors of Biochemistry and Molecular Biology), and Master of Science (MS) and Doctor of Philosophy (PhD) degrees from the University of Michigan-Ann Arbor (Pharmaceutics/Pharmacokinetics). He is a graduate of the inaugural UCSF American Course on Drug Development and Regulatory Sciences (ACDRS) and now serves as a faculty member

Employment History:

  • Coastal Pharma Group (CPG): Founder and Chief Scientific Officer [12/2008-Present]
  • AstraZeneca R&D: Vice President, Translational Sciences, Neuroscience Innovative Medines [03/2102-Present]
  • MBO Partners: MBO Exec [05/2010-Present]
  • Pfizer: Contract Clinician [05/2010-03/2012]
  • BAPKPD (Bay Area Pharmacokinetics/Pharmacodynamics): Chair/President [2010-2012]
  • Nektar Therapeutics: Sr. Director, Clinical Pharmacology [08/2007-12/2008], Oral Drug Development Lead and Nektar-India Liaison [05/2005-07/2007], Program Executive [11/2003-05/2005], Director of Clinical Development [08/2003-10/2003]
  • Pfizer Global Research and Development: Associate Director II and US Clinical Leader [10/2000-07/2003], Senior Clinical Scientist & Drug Manager [06/2000-10/2000]
  • Parke-Davis Pharmaceutical Research, Division of Warner-Lambert Company: Senior Clinical Scientist [07/1999-06/2000], Clinical Scientist [02/1998-06/1999], Research Associate [05/1996-01/1998], Senior Scientist [07/1994-04/1996], Scientist [11/1992-06/1994], Associate Scientist [05/1990-10/1992], Senior Assistant Scientist [09/1987-04/1990], Assistant Scientist [08/1986-08/1987]
  • Hazleton Laboratories America, Inc. (currently Covance Laboratories, Inc.): Laboratory Specialist [10/1985-08/1986]

Professional Affiliations:

Outside Interests:

  • General Aviation (Private Pilot - ASEL Rating with Complex and High Performance Endorsements)
  • Hiking
  • Biking
  • Sailing
  • Fishing
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