Ryan Haynes

**** ******** **.

Baltimore MD *****

Telephone: 410-***-****

Mobile: 443-***-****

Email: abnw9u@r.postjobfree.com

Career Profile:

Experienced in the program management in the Pharmaceutical/Biotech product

development process from discovery through clinical Phase I& II trials. Extensive R&D

management of new drug products including: identifying commercial indications;

management of regulatory and clinical requirements early phase trials as well as CRO

and independent contractor management. Proven track record of keeping projects on

time and within budget. Business development experience in evaluating, negotiating

and contracting with outsourced partners. Demonstrated ability to act as the principle or

sole contact for multiple (ongoing) projects. Program management experience in a

cross functional environment comprised of R&D scientists, manufacturers, clinical

sites, consultants and outsourced partners.

Professional Experience:

Independent Consultant December 2008 – Present

Independent pharmaceutical consultant with a focus on project management, regulatory

affairs, clinical operations and QC/QA. I specialize in helping clients build clinical and

regulatory strategies, outsourcing identification and management, developing internal

compliance systems and project management from preclinical through clinical trials.

CytImmune Sciences, Inc. September 2001 – Present

Rockville, MD USA

CytImmune is a clinical stage biotechnology company focused targeted delivery of

proprietary nanomedicines for use in therapeutic oncology.

Program Manager January 2006 - Present

Regulatory Affairs/ Clinical Operations

Responsibilities and Accomplishments:

Management of the clinical and regulatory processes and resources to develop

company’s lead oncology candidate including regulatory and clinical trial strategy and

outsource management.

Clinical operations responsibilities

o Project Manager for 2 NCI sponsored Phase I clinical trials;

CRO/consultant management, site management and trial documents

management

o Simultaneous management of 3 CROs in the conduct of 7 clinical studies

(1 complete, 1 ongoing, 5 pre-study set up in process)

o Management of process and recommendation on the selection of the

CRO for a $2 M - 100 subject Phase I clinical study. Conducted CRO

screening process that included 6-8 full-service and niche CROs.

o Management of process and recommendation on selection of the CRO

for a $13 M program of 5 Phase Ib/IIa trials. Conducted CRO screening

process that included 20 full-service and niche CROs.

o Review, edit and track protocol amendments for multiple ongoing

clinical studies

o Management of Investigation Medical Product and ancillary supplies to

ensure adequate levels were on hand at clinical site. Initiated reorders

and delivery from the storage and distribution vendor. Combine with one

immediately below and shorten

o Coordinated the shipment, analysis and reviewed reports from central

laboratories conducting PK, PD and biomarker analysis. \

o Conducted selection process for trial sites

o Oversight of study budgets and review invoices for accuracy for all

outsourced partners

o Liaise with senior business development team to determine target

indications and to ensure study endpoints are inline with corporate

commercial development plans

Regulatory affairs responsibilities

o Maintenance of the company’s IND: coordination of edit, completion

and submission of Amendments, Annual Reports and SAE reports to

FDA

o Conduct due diligence (GMP & GCP) (pre-award, mid-study) audits of

CROs, contracts laboratories and specialty vendors (biostatistics and

pharmacovigilance) including on-site documentation review and

compiling post study reports

o Oversee process for compilation of regulatory documents for

CTA/IMPD submissions for ex-US trials (UK/ Netherlands)

o Develop and edit MSDS documents for companies lead compound

o Review and edit Quality Agreements in conjunction with company’s

outside regulatory counsel

o Collaborate with FDA (CBER, OPS) on company presentations for

Nanotechnology Advisory Committee Meetings\

o Manage IRB process (approval and annual updates) for company’s

therapeutic monoclonal antibody program

Additional responsibilities:

o Serve as key contact for collaboration with company’s out-licensed

program in collaboration with a top 20 pharmaceutical company

o Manage GMP manufacturing vendors (raw materials, productions,

testing, labeling) add to “conduct due diligence bullet above

o Management of 3-5 final product testing laboratories.

o Draft RFPs and conduct search process for $1M laboratory testing award

o Organized selection process for new API and final product contract

manufacturing organizations for company’s second oncology product.

o Manage key outside collaboration nonclinical collaborations including

budgets, timelines and publications

o Prepare rolling quarterly forecasts of core manufacturing components to

ensure materials will be available to meet production and clinical needs.

o Ability and willingness to “fill the holes” in the day to day operations

(laboratory, administrative, finance) of the company to maintain

timelines and keep critical projects on track

CytImmune Sciences, Inc. November 2002 – January 2006

Rockville, MD USA

Regulatory Specialist

Functioned as companies sole regulatory professional responsible for improving

laboratory operations standards and working with CROs/consultants to file the

companies first IND which at the time was one of the few INDs of nanocompounds

being reviewed by CBER/CDER.

o Developed of Good Laboratory Practice initiative in accordance with 21

CFR 58

o SOP development and authoring for laboratory, animal, and equipment

operations

o Design, implement, and monitor QC/QA programs

o Managed the process of pre IND briefing document in accordance with 21

CFR 312. Collaborated with CBER personnel in post meeting questions and

final study (clinical and GLP tox) designs.

o Conducted process and recommendation on the selection for a toxicology

laboratory for a $1 M IND enabling GLP toxicology study. Conducted

screening process that included 4-6 toxicology organizations.

Functioned as project management and key contact during the study

from contracting through delivery of final study report

o Technology transfer of the companies manufacturing process and analytical

methods to 2 CMOs and 3 contract testing laboratories

o Provide regulatory support and guidance to R&D staff for continuing and

new programs in drug development and monoclonal antibody technology

development

CytImmune Sciences, Inc. September 2001 – November 2002

Rockville, MD USA

Research Associate

New Product Development

Responsibilities as Research Associate included leading a team of 1-2 additional

associates in the development of the company’s second nanotechnology based drug

delivery system:

o Colloid and protein binding chemistry for nanotechnology drug development

o Develop manufacturing systems to expand on the companies use of colloidal gold as

a drug delivery system

o Sandwich and competitive ELISA assays for the quantitation of native and serum

cytokine levels

o Biotinylation of cytokines for immunoassay development

o Animal necropsies for biodistribution, PK, safety and efficacy studies

Focus Technologies (Now Eurofins Medinet) June 2000 – September 2001

Herndon, VA USA

Lead Medical Technologist

Microbiology

My responsibility in the clinical microbiology laboratory involved bacterial isolate

identification using chemical assays, and rapid tests such as VITEK for registration and

surveillance studies of new and approved anti-infectives

o Bacterial isolate identification using rapid tests and Vitek. Antimicrobial

susceptibility testing using broth microdilution, Etest, disk diffusion, and agar

dilution.

o Responsible for training and mentoring new laboratory technologists including

weekend and PRN supervisory activities.

o Responsible for client contact for the provision of bacterial isolates and compiling

accompanying data reports/ tables

o Design, implement, and monitor QC/QA programs for data integrity purposes.

Integral laboratory member in CAP and GLP compliance program development

o Develop and monitor safety and environmental health initiatives

______________________________________________________________________

Education:

2000 Bachelor of Science in Medical Technology

Morgan State University, Baltimore, MD

Fall 2002 GLP/GMP for Bioscientists-Certificate Program

Montgomery College Rockville, MD

Additional Training

March 2006 Society of Clinical Research Associates- Seminar on

Ethical issues in clinical research

Baltimore, MD

April, 2006 NCI- Oracle Clinical EDC Training Including Ad Hoc

Reporting Using J-Review

Bethesda, MD

June 2006 DIA Annual Meeting

Philadelphia, PA

RAPS-DC Chapter Seminar- Risk Analysis in 21st

June 2006

Century GMPs

Rockville, MD

April 2007 RAPS-DC Chapter Seminar- First, the Bad News:

Managing Up in RA/QA

Rockville, MD

April 2007 Bio-imaging symposia

Philadelphia, PA

Sept, 2007 CBI Oncology Clinical Trials Summit- Optimize

Efficiency and Improve Patient Recruitment and

Compliance by Implementing Innovative Trial Design

Strategies

Washington, DC

June 2007 DIA Annual Meeting

Atlanta, GA

Oct 2007 Successful Clinical Trial Management: Challenges and

Solutions

Bethesda, Maryland

May 2008 American Society of Clinical Oncology Annual

Meeting

Chicago, IL

June 2008 DIA Annual Meeting

Boston, MA

References:

Available upon request

Summary of Experience and Qualifications:

8 years of pharmaceutical industry experience

7 years of drug/ product development experience

6 years experience in project management – Project teams of 4-6 people (Production,

Operations, Safety/Efficacy and Regulatory Affairs departments)

6 years experience in QA/ regulatory affairs management

6 years of outsource management including CROs, CMOs, Pharmacovigilance groups,

3 years of experience in clinical research/trial management – managing CROs, sites and

specialty vendors

Contact this candidate