LORENZ M. HOFMANN, PH.D.

205 Lake Hogan Farm Road

Chapel Hill, NC 27516
Tel: 919 - 918 - 7707
E-Mail:lh1a667c@westpost.net
Web Site: larryhofmann.com
Qualifications and Experience:
* Clinical Pharmacologist with Ph.D. in cardiovascular-renal pharmacology:
* 25 years of clinical operations (medical monitor) and regulatory affairs
experience
* 1982 - 1995 Associate Director / Director Positions in Clinical Research as
Medical Monitor and/or IND/NDA Team Leader for 15 programs
* 1975 - Member, Amer. Soc. Pharmacology & Therapeutics (ASPET)
* 1980 - Member, Amer. Soc. Clinical Pharmacology & Therapeutics (ASCPT)
* 1985 - Member, Regulatory Affairs Society (RAPS)
* 1985 - Member, Drug Information Society (DIA)
* 1990 - Member, Associates of Clinical Pharmacology (ACRP)
* 1997 - Member, Sexual Medicine Society of North America
* 1997 - Member, American Urological Association (AUA)
Clinical Research Experience: Management Areas
* Set-up and managed the Clinical Research Department at a growing or
virtual pharmaceutical or medical device company
* Managed department and assure company is in compliance with all related
FDA regulations and policies [GCP, GMP, and GLP]
* Assure staff's career growth with successful completion of regulatory filings
* Developed and expand department's SOPs FDA liaison, negotiations, and
Drug [IND/NDA] and Device [IDE/PMA or 510(k)] strategy development
together with input/guidance from Clinical Operations and Marketing Depts.
* Drug or Device Master File preparation, including audit/oversight of
investigational supplies manufacturer and filing of CMC documents to the
IND
* Managed Pre-IND or Pre-IDE activities on to IND/IDE filing; then
maintenance with filing of supplements and annual updates with eventual
NDA or PMA or 510(k) preparation & filing
* Provided input into Marketing Dept's brochures and presented clinical trials
information to sales force at prelaunch meetings.
Clinical Operations Experience: IND Clinical Trials
* Clinical pharmacologist: Ph.D. in Cardiovascular-Renal Pharmacology
* Medical monitor for 12 INDs. Clinical pharmacology background augments
regulatory input into IND clinical plans to assure successful FDA negotiations
and approval of Phase 1 -3 protocols and final reports
* Medical monitor for oncology IND programs: Breast , Head & Neck and Basal
Cell Carcinoma
* Medical monitor for cardiovascular, CNS, urology, inflammatory and anti-
infective IND programs
* Significant FDA regulatory strategic planning & negotiations to obtain FDA
approval of the IND clinical plan(s). Co-developed IND/NDA activity and
timeline; budgets; cost-to-complete analyses and monthly "burn rate" and
oversight of CRO budgets
* Co-written Clinical Research department's SOPs
* Led IND/NDA teams with team members in U.S. and Europe [Schwarz
Pharma] to assure successful completion of clinical trials to support
 multinational NDA/EU dossier filings for two approved drugs
* Negotiated cost effective budgets with investigators; and vendors [regional
CRAs; CMC- clinical supply manufacturers; and pre-clinical Toxicity and
Pharmacology Laboratories
* Audits of pre-clinical/clinical investigators, IRB and CMC vendors for
manufacture of IND clinical supplies
* Managed IND clinical plans to assure that ex-US clinical trials support the
NDA and that IND studies support EU submissions: Phase 1-3 studies,
including Phase I Bioequivalence/PK studies
* Co-wrote more than 30 protocols, more than 20 clinical trial reports and
several Integrated Summary(s) of Efficacy and Safety for NDA submissions
Clinical Research Experiences: Medical Monitor
o Co-writing Phase 1-3 protocols, Investigator Brochures and Case Report
Forms
o Identify and qualify investigators and staff
Negotiate and manage investigator budgets
o Set-up and co-manage investigator meetings
o Oversee and mentor CRAs to ensure effective site monitoring with ongoing
review of all sites enrollment status and conduct site audits as needed
o Review compiled data from case report forms after locking of CRF data
base
o Consult on statistical analysis plan prior to writing of clinical reports
o Ongoing management of Phase 1 -3 clinical trials to assure GCP
compliance including subject enrollment updates and timely reporting of
serious [SAEs] and unexpected adverse events [MedWatch 3500A Reports]
to FDA
o Co-write final Phase 1 - 3 study reports
o Prepare Benefit-to-Risk analysis [REMS] for NDAs
Familiarity with IND/NDA Clinical Development Process:
* Medical monitor for 12 INDs and several IDE clinical programs
* Team leader for 6 IND/NDA programs: Managed multi-discipline IND teams
(25+ staff from 5+ R & D, Clinical and Regulatory Departments) via matrix
reporting
* FDA liaison and strategy development: IND/NDA, IND/BLA, 510(k), and
IDE/PMA
* IND/NDA teams' success led to FDA approval of 8 NDAs and several medical
devices;
* Wrote 30+ study protocols: CV, Urology, Antimicrobials, Arthritis; CNS;
Oncology, and Bioequivalence/Pharmacokinetic studies
* Co-wrote 20+ clinical reports and 5 integrated safety & efficacy summaries
(ISS, ISE) Prepared 6 NDAs and set-up/managed up to 3 FDA meetings per
year
* Detailed 10-page C.V. is available
Regulatory Experience:
* 25 years experience in clinical research, regulatory affairs and IND/NDA
project management for more than 20 INDs and as an IND/NDA team
leader for 8 INDs with teams' success leading to 8 approved NDAs and
several medical devices
* Co-written Regulatory Affairs department's SOPs
* Hands-on management of IND submissions:
(Preparation, filing and maintenance of INDs including Serial Amendments,
MedWatch 3500 Adverse Event Reports and annual IND updates)
* Set-up and managed FDA meetings: Pre-IND filing; End-of-Phase 2; Pre-
 NDA filing
* Set up of a regulatory affairs department; pre-IND activities including
development of FDA regulatory strategy, IND filing and ongoing
management/maintenance of INDs
* Regulatory, pre-clinical and clinical oversight to assure studies/reports
comply with FDA's GLP, GCP and cGMP regulations and ICH guidelines
* Managed the multi-steps involved in the transition from the "Lab to Man",
i.e., pre-IND stage of development leading to FDA negotiations and
preparation and submission of an original IND for pre-clinical/pre-IND
programs.
Understanding and Management of 15 Regulatory Affairs' Activities:

1. Set-up and manage Regulatory Affairs Department

2. Maintain Regulatory Affairs Department files
3. Assemble IND/NDA documents and sections ... Experience in 15+ INDs
and 8 NDAs
4 Develop IND Program Strategy to Support NDA Submission
5. Up to date with FDA IND/NDA related policies and guidance documents and
ICH guidance documents: Interpretation and inclusion into IND/NDA
programs
6. FDA liaison/strategy: Pre-IND, during IND, Pre-NDA and Post-NDA filings
7. Pre-IND activities: Prepare Pre-IND documents: Pre-clinical & pertinent
literature; initial IND protocols; CMC section, Drug Master File (DMF), hol
d
Pre-IND meeting with FDA; develop detailed IND budget and timelines
and submit original IND following FDA input.
8. Pre-clinical toxicology studies: Assessment to assure studies support IND
clinical protocols
9. Develop IND Clinical Plan and negotiate with FDA throughout the IND/NDA
program for approvals of clinical protocols, toxicology studies and DMF
related studies
10. Assure IND clinical products' and proposed marketed product
formulations' CMC studies support the IND/NDA submissions
11. Chemistry, Manufacturing and Controls (CMC) section of INDs and NDAs:
Assemble
12 .Annotated (NDA) Package Insert: For NDA
13. Environmental Assessment (for NDA): Have worked with EPA experts
14. Final Labeling: Negotiate with FDA (DDMAC)
15. Assure Activities: # 6 - 11 Support worldwide registration of drug or
medical device products
Regulatory Experience: FDA Negotiations
Since 1992: Led development of IND Clinical Plans and FDA strategic planning/neg
otiations during pre-IND; post-IND filing, End-of-Phase 2, pre-NDA and pre-NDA
505(b)(2)filing stages with following seven [7] FDA/CDER divisions and senior s
taff:
* Cardio-Renal Drug Products
* Office of Oncology Drug Products
* Neuropharmacological Drug Products
* Reproductive and Urologic Drug Products
* Dermatologic and Dental Drug Products
* Office of Orphan Products Development
* Office of Generic Drugs
Managed Pre-IND Activities to:
* Have led four successful pre-IND development programs for clients leading to t
imely original IND submissions.
* Complete the pre-clinical, including toxicity studies, all Chemistry, Manufact
uring and Controls [CMC] studies of the Active Pharmaceutical Ingredient [API] o
r and the IND clinical formulations
* Set-up and hold pre-IND meeting with the FDA, and (3) finalize the Phase I/II
study protocols and submit the IND
* Presented 2-day workshops to Pharma industry staff on pre-IND stage of develop
ment to IND filing via Pharmaceutical Education Organization, PTI International,
New York, NY.
* Preparation of NDAs:
* Understanding of the format of the Common Technical Document [5 modules] . Sin
ce 1992: Led development of IND Clinical Plans and FDA strategic planning & nego
tiations during pre-IND; post-IND filing, End-of-Phase 2, pre-NDA and pre-NDA 50
5(b)(2) filing negotiations with seven [7] FDA/CDER divisions and senior staff
IND/ NDA Project Management Experience:
* Director, Program Management, ClinTrials, Inc., RTP, NC, a CRO from 1989-1992.
Led team of 3 project managers for clients' IND clinical programs; including m
anagement of angina trials in Europe of Pfizer's major drug Norvasc(R) (amlodipi
ne)
* Management of outsourcing of studies/activities to a CRO as a medical monitor
20 years experience as a clinical operations/regulatory client of Parexel, Covan
ce, Quintiles, etc., especially for co-managing NDA preparations and submissions
.
* Develop IND/NDA activity/budget and quarterly funding/"burn rate" requirements

Professional History
1996 - Present: President, LMH Associates, Inc., Chapel Hill, NC 27516
Managing Director of a network of independent clinical operations/medical monito
r and regulatory consultants for Pharmaceutical, Biotech, and Medical Device com
pany clients' IND/NDA (drug) and IDE/PMA and 510(k) device programs. Set up ne
twork of independent consultants [biostatisticians, toxicologists, regional CRAs
, analytical labs and IND clinical supplies manufacturers to support IND/NDA pro
grams.
[Internet CRO web site: www.larryhofmann.com]
1992 - 1995 Schwarz Pharma, Inc., Milwaukee, WI 53201
Associate Director, Clinical Research
Developed IND clinical plan for male impotence. Clinical monitor and IND/NDA pr
oject team leader for 3 eventual marketed Rxs (Edex(R) for impotence and Univasc
(R) and Uniretic(R) for hypertension).
Led NDA preparation teams and assembled NDA clinical sections of Edex(R) and Un
ivasc(R).
1989 - 1992 ClinTrials Research, Inc., Research Triangle Park, NC 27709
Director, Pharmacology and Therapeutics: Director of Project Management
Managed Phase 2-4 IND multicenter studies in U.S. and in European countries. Cl
inical programs included: hypertension, angina, antibiotics, rheumatology and ep
ilepsy.
1986 - 1989 Kendall Healthcare Products Company, Mansfield, MA 02048
Director, Clinical Affairs
Clinical Research Department Director.Prepared Department Standard Operating Pro
cedures. Managed IDE clinical programs for urological and vascular access devi
ces; topical wound (ulcers and burns) products and limb compression devices for
deep venous insufficiency and prophylaxis against deep vein thrombi formation d
uring and post surgery. Led FDA (CDRH) IDE and 510(k) submission negotiations.
1985 - 1986 Parke-Davis Inc., Ann Arbor, MI 48105
Associate Director, Clinical Research
Medical monitor for Phase 2 and Phase 3 studies in Hypertension (ACE inhibitor)
, Congestive Heart Failure (ACE- and PDE- Type III cardiotonics), Angina (beta b
locker) with extensive surveillance of serious adverse reactions, including deat
hs.
1982 - 1985 Adria Laboratories, Columbus, OH 43216
Associate Director, Clinical Research
Medical monitor of Phase 1 bioavailability and Phase 2 - 4 studies with analgesi
cs, anti-hypertensive and an NSAID for osteoarthritis and rheumatoid arthritis i
ndications. Also assembled pre-clinical and clinical sections of INDs.