Quanren He M.D., Ph.D., D.A.B.T., C.C.C.P.

***** * ******* **

Olathe, KS 66062

913-***-**** (m)

abldxr@r.postjobfree.com

OBJECTIVE

. A challenging position in toxicology where my medical knowledge and

toxicology expertise can be effectively utilized to contribute to the

company growth.

SUMMARY OF QUALIFICATIONS

. Board certified toxicologist with solid medical knowledge and

experience in the pharmaceutical industry, academia, and hospitals.

. Hands-on experience in developing non-clinical and clinical

strategies, and designing, analyzing and interpreting toxicology

studies to support drug development.

. Successful experience in negotiating with regulatory authorities for

toxicology study request to support IND/NDA.

. Experience in business management, involvement in hiring process

(candidate selection, interview, and reference check).

. Proven records in providing scientific opinion and direction to

achieve aggressive goals successfully.

. Strong scientific capabilities demonstrated by peer-reviewed

publications and scientific opinion documents to meet regulatory

requirements for drug development.

PROFESSIONAL EXPERIENCE

Biothera, Eagan, MN 2009

- Present

Director of Toxicology & Clinical Safety

. Designed, managed, and completed a 3-month and 6-month toxicity study

including TK in rats.

. Analyzed data, authored report for a toxicity study with combination

of two biologics in monkeys.

. Authored toxicology section of an Annual Report and Investigator's

Brochure for an IND.

. Analyzed pharmacokinetic studies for one compound in various species,

and solved problems of PK differences under different conditions.

. Oversaw PK analysis and finalized the report for PK in colon cancer

patients.

. Critiqued toxicology and nonclinical studies for a monoclonal antibody

in support of due diligence.

. Evaluated and translated report of a 90-day toxicity study by oral

administration.

. Evaluated and translated report of genotoxicity studies in vitro.

. Oversaw drug safety/clinical trials, adverse events reports (expedited

and annual) of IND.

. Interacted with the regulatory authorities in US FDA, Germany BfArM,

China SFDA.

. Actively involved in clinical development plans.

. Molecules are biologics (immune modulators, monoclonal antibodies).

CyDex Pharmaceuticals, Inc., Lenexa, KS

2005 - 2008

Director of Drug Safety and Medical Affairs (2008)

Manager of Toxicology and Drug Safety (2007 - 2008)

Sr. Scientist, Toxicology and Safety (2005 - 2007)

. Pharmaceutical Toxicology Studies (5 New Chemical Entities, 20

studies)

o Screened and evaluated 5 new chemical entities from discovery to

development.

o Evaluated 13 marketed drugs for additional toxicology/clinical

needs.

o Managed 20 toxicology studies at CROs, including site selection,

contract development, budgeting, protocol generation,

monitoring, and reporting.

o Reviewed over 100 toxicology study reports and finalized

numerous study reports.

o Toxicology studies involved parenteral, oral, ophthalmic and

inhalation administration.

o Therapeutic areas included cardiovascular, CNS, oncology,

respiratory, ophthalmological diseases.

. Interactions with regulatory authorities

o Negotiated and obtained waivers for several toxicology studies

requested by the FDA.

o Successfully developed toxicology and clinical strategies and

plans to support oncology drug development (consistent with the

US FDA recommendation for the specific IND).

o Prepared toxicology/drug safety documents for 5 pre-INDs, 6

INDs/CTAs, 1 NDA, and 2 IBs.

o Presented Captisol toxicology information at the FDA, resulting

in reduction of further toxicology studies related to Captisol

in Captisol-enabled formulations.

. Clinical trials and drug safety

o Selected clinical CROs; developed and implemented 9 clinical

studies.

o Managed drug safety/clinical trials, adverse events reports

(expedited and annual) of IND.

. Management and business related activities

o Persuaded an orphan drug designation application and received

the FDA approval.

o Was one of the 5 members who reported directly to the Chief

Executive Officer.

o Evaluated toxicology issues for due diligence support of

pharmaceutical development programs.

o Involved new employee hiring process including candidate

selection, interview, and reference request, making

recommendations to top management team.

. Basic toxicology research in neurotoxicology with 3 peer-reviewed

publications.

The University of Kansas, Lawrence, KS

2007 - Present

Adjunct Assistant Professor, Toxicology

NIOSH/CDC, Morgantown, WV

2005

Associate Service Fellow

. Initiated a program to study occupational exposure and skin damage.

. Trained and mentored a new laboratory researcher.

The University of Georgia, Athens, GA

1999 - 2005

Research Associate

. Led a group under principal investigator's supervision to study

fumonisin toxicity in different types of genetically modified animals

and in vitro models.

. Studied signal transduction in chemical-induced apoptosis.

. Introduced several novel biochemical/molecular technologies to study

chemical toxicity.

. Trained and mentored 3 PhD candidates and 2 laboratory technicians.

. Published over 30 articles in peer-reviewed toxicology and

pharmacology journals.

Hunan Medical University, Changsha, China

1996 - 1999

Assistant Professor, Toxicology & Pharmacology

. Investigated metal renal toxicity with 4 publications and 1 book

chapter.

. Taught Toxicology and Pharmacology to medical students.

. Supervised master graduates and managed a laboratory.

Second Hospital of Hunan Medical University, Changsha, China

1993 - 1996

Clinical Associate Toxicologist

. Developed and implemented analytical methods to detect drugs in human

body fluids.

. Worked with medical teams in the diagnosis and treatment of

intoxicated patients/adverse drug reactions.

. Authored two publications and two book chapters on poison detection

and diagnosis.

Peer-reviewer

2007

. Reviewed Negi et al. 'Recent advances in plant hepatoprotectives: a

chemical and biological profile of some important leads.' Medicinal

Research Reviews, 2008, 28(5):746-72

EDUCATION

. Ph.D. Toxicology, The University of Georgia, Athens, GA, 2004.

. M.D., Medicine, Hunan Medical University, Changsha, China, 1988.

. M.S., Biomedical sciences, Hunan Medical University, Changsha, China,

1993.

o Degrees from China have been notarized and evaluated by Josef

Silny & Associates, Miami, FL

. Diplomate, American Board of Toxicology (D.A.B.T.), 2006.

. Clinical Compliance Certified Professional (C.C.C.P.), 2008.

CONTINUING EDUCATION

. Good Laboratory Practice/Toxicology (nonclinical drug development,

regulatory compliance).

. Good Clinical Practice/Clinical Drug development (regulatory

compliance).

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