Project Manager

Timothy J. Kachmar

Amherst, NH *****

C: 617-***-****

*********@**.***

PROFESSIONAL SUMMARY:

v Pharmaceutical professional with proven Submission Project Management skills

v Proven Leadership and mentoring skills: from pharmaceutical project team to client

service program manager to artillery fire support team

v Regulatory Affairs professional specializing in CMC, Global Clinical Trial Initiation and

Quality

v Global Submission experience: IND, CTA, IMPD, NDA, NDS, MAA

v Excellent verbal and written communication skills

PROFESSIONAL EXPERIENCE

Radius Health, Inc., Cambridge, MA 2/2012 to Present

Senior Director – Regulatory Affairs

v Responsible for managing all regulatory aspects of a pivotal, global Phase 3 clinical trial

in postmenopausal fracture prevention.

v Support the planning and execution of a global Phase 2 clinical trial utilizing a novel

transdermal drug delivery system.

v Acting Head of Quality. Evaluating existing SOPs and creating missing SOPs to bring the

Quality System in line with current GxP standards.

v Lead interactions with the FDA regarding the design of the Phase 3 osteoporosis program.

v Developing a plan for an eCTD submission to the FDA and EMA in 2015.

Mersana Therapeutics, Inc., Cambridge, MA 10/2010 to 1/2012

Senior Director – Regulatory Affairs and Quality Assurance

v Responsible for managing all regulatory aspects of two Phase 1 chemotherapeutic

compounds in MTD studies.

v Head of Quality. Revised and updated QA Systems to meet current GxP standards.

v Clinical Project Manager for Phase 1 MTD clinical study. Manage all aspects of a Phase 1

MTD study from budgets to patient recruitment and dose escalation.

v Direct manufacturing and development teams responsible for clinical product

manufacturing and development at contract manufacturing facilities.

v Update IND CMC section to CTD format.

v Regulatory and Project Management liaison for joint development partnership with Teva

Pharmaceuticals.

AMAG Pharmaceuticals, Inc., Lexington, MA 12/2007 to 10/2010

Director – Global Regulatory Affairs

v Assessed current product dossiers (Modules 2 and 3) for completeness and compliance to

specific Ex-US country requirements, performed a gap analysis, and informed

management of potential issues that may arise during the application review process.

v Rewrote the NDA’s Module 2 and 3 to ensure global submission compliance.

v Completed successful Pre-NDS Meeting and submitted NDS to Health Canada in eCTD

format.

v Completed successful Pre-Submission Scientific Advice Meetings with European Health

Authorities and submitted MAA to EMA (Centralized Procedure) in eCTD format.

v Compiled detailed, comprehensive background packages to support regulatory meetings,

presented at and directed the meetings.

v Responsible for managing all aspects of Ex-US clinical trial applications for Phase 2 and 3

clinical studies in both paper and electronic format.

v Drove QP selection process for both clinical and commercial product supply to Europe.

v Submitted a Pediatric Investigation Plan and successfully negotiated approval with the

PDCO.

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Timothy J. Kachmar

*********@**.***

AMAG Pharmaceuticals continued

v Review Quality SOPs, Analytical and Process Validation Protocols for new Contract

Manufacturing Facilities to ensure GMP compliance. Regulatory representative on Quality

Audit Team and MAA Mock Audit Inspection Team.

v Regulatory lead on project development teams for anemia indications in Chronic Kidney

Disease, and provided Ex-US regulatory support to project development teams for anemia

indications in oncology, women’s health and gastrointestinal diseases.

v Regulatory due diligence representative for both in-license products and out-licensing

activities.

v Primary regulatory contact for China, Europe, and Canada partnerships.

ActivBiotics, Inc., Lexington, MA 11/2005 to 11/2007

Director – Regulatory Affairs and Quality/Compliance

v Responsible for managing all aspects of worldwide regulatory submissions (IND, IMPD,

CTA, CTD) in both paper and electronic format for an antibiotic with a cardiovascular

indication.

v Lead interactions including face-to-face meetings with worldwide Regulatory Authorities

surrounding Phase 2 and 3 clinical trial protocols and clinical development strategies,

manufacturing process changes, and product approval strategies.

v Successfully negotiated a formulation change and the follow-on clinical development

strategy midway through Phase 3 with the FDA, and several European Ministries of

Health. Compiled a detailed, comprehensive background package to support these

meetings, and helped facilitate the decisions.

v Implemented a worldwide marketing application strategy, including the comprehensive

analysis of existing study documentation, identified gaps between existing information

and that which is needed to support an application, created an interdepartmental

project team, created a project plan and timeline, and successfully presented the

resulting NDA plan and filing strategy to the FDA.

v Reviewed, analyzed, and revised corporate SOP and Quality Systems in preparation for

continued Phase 3 development. Updated existing SOPs and created missing SOPs to

bring the system in line with current GxP standards.

v Supervised and managed the creation and submission of Orphan Product applications for

the FDA and EMEA.

v Managed Quality (cGMP) activities for contract manufacturers including batch release,

process validation documentation creation and review, and compliance audit reviews.

Associate Director – Regulatory Affairs (11/2005 – 12/2006)

v Responsible for managing all aspects of worldwide regulatory submissions (IND, IMPD,

CTA) in both paper and electronic format for an antibiotic with a cardiovascular

indication.

v Responsible for drafting and reviewing submissions to ensure compliance with

regulations, guidelines and for appropriate content.

v Assessed current manufacturing processes and pharmaceutical development studies for

potential participation in Quality by Design initiatives.

v Developed and managed regulatory group timelines for multiple tasks; assisted regulatory

and corporate leadership in determining project priorities and timelines.

v Performed regulatory due diligence on two products during the purchase of another

company.

v Responsible for managing all aspects of worldwide regulatory submissions (IND, IMPD,

CTA) in both paper and electronic format.

v Lead Project Teams in the planning, preparation and creation of eCTD submission.

v Primary author on eCTD Quality sections (Module 3 and Module 2 QOS) and product

labeling for autologous protein with oncology indications.

v Lead project teams on Clinical Study Report writing and completion. Managed external

clinical writers and reviewed drafts for guideline compliance and appropriate content.

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Timothy J. Kachmar

*********@**.***

Antigenics Inc., Lexington, MA 3/2002 to 11/2005

Associate Director – Regulatory Operations (10/2004 – 11/2005)

v Developed, implemented, coordinated and managed external communications and

promotional review committee.

v Managed and coordinated Clinical Study Report completion effort for Phase 1 and 2 study

reports for several products.

v Responsible for implementing an e-publishing and e-submissions tool. Selected

appropriate vendor, created documentation, and performed validation.

v Performed due diligence on potential in-license product candidates.

Manager – Regulatory Affairs (3/2002 – 10/2004)

v Regulatory Affairs lead on company’s primary investigational product, an autologous

protein with oncology indications

v Responsible for all CMC/Quality regulatory interactions including face-to-face meetings

and facility tour with FDA for new, state-of-the-art autologous tumor vaccine

manufacturing facility.

v Managed and mentored team of up to four Regulatory Professionals.

v Drafted and managed comments to developing FDA regulatory guidelines.

v Lead Project Team and assisted Business Development in development of marketing

strategies; provided regulatory input into product indication language.

v Review Quality SOPs, Analytical and Process Validation Protocols for new Manufacturing

Facility to ensure GMP compliance.

v Developed and managed regulatory group timelines for multiple tasks; assisted regulatory

and corporate leadership in determining project priorities and timelines.

InfoMedics, Inc., Woburn, MA 8/2000 to 2/2002

Program Manager – Client Services

v Designed and managed all program aspects from program development to program

closure for patient centered data collection and reporting surveys for Post Marketing

Studies and Phase 4 Clinical Trials.

v Functioned as the primary source of client contact for large accounts such as Bayer,

Pharmacia, and Pfizer.

v Managed project timelines and budgets.

v Provided Regulatory Advertising and Promotion advice and recommendations on program

aids for all programs.

v Lead the Product Development Team.

v Assisted Sales Group in design and pricing of new programs.

DuPont Pharmaceuticals Corporation, Billerica, MA 6/1994 to 8/2000

Regulatory Affairs Associate (2/97 – 8/00)

v Regulatory project team member on product development teams for medical imaging

products.

v Ensured regulatory compliance for all worldwide Regulatory Filings (NDA, CTX, IND, and

MAA) for radiopharmaceutical and medical imaging products; performed final quality

check on submissions.

v Responsible for Project Management timelines, meetings and agendas, and presentations

to FDA, EMEA, European Health Authorities, and Health Canada for pre-submission

meetings.

v Responsible for in-licensed products; represented company in regulatory issues such as

marketing material review, manufacturing and quality issues, and labeling revisions with

partner companies such as Boehringer-Ingelheim, Cytogen Corp., and Berlex

Pharmaceuticals; interacted with Sr. Management team to ensure compliance and

meeting of timelines.

v Assisted in responding to regulatory action letters for Quadramet, Miraluma and Definity.

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Timothy J. Kachmar

*********@**.***

DuPont Pharmaceuticals Corporation continued

v Facilitated all CMC and Quality related activities for marketed products – Change Control

representative, SOP review, process and facility modifications, regulatory authority

inspections and labeling revisions.

v Promotional Review Board member for marketed products. Cross-trained with sales staff

to better understand sales process.

Product Manufacturing Specialist (6/94 – 2/97)

v Manufacturing Team member in radiopharmaceutical manufacturing (Technetium

generators, Xenon and Thallium and Gallium API).

v Validation tech on new production equipment (Thallium and Gallium line); provided

representation to product validation teams.

v Hot Product Distribution Team member.

Johnson Controls Inc. Merrimack, NH 6/1992 – 6/1994

Quality Assurance Inspector

v Inspected product; entered data into analytical tracing software and performed trend

analysis on results; Assisted manager in making product release decisions.

United States Army 5/1988 to 4/1991

Specialist 4th Class – 2nd Armored Division, 1/3 Field Artillery – Ft. Hood, TX

Operation Desert Storm – Babenhausen, Germany

CONSULTING EXPERIENCE

Smart Biotech Solutions, Foxboro, MA 12/2012 to Present

Regulatory Consultant – CMC Writer

v Support client’s global CMC submissions by creating Module 2 QOS documents.

v Create Module 3 Manufacturing, Analytical Methods and Process Validation sections.

Apovax Inc., Lexington, KY 02/2011 to 06/2011

Regulatory/QA Consultant

v Review manufacturing plans for Phase 1 first in human studies, and advise to IND

readiness.

v Review SOPs and advise/revise to support in-house Phase 1 pilot scale manufacturing.

FoldRx Inc, Cambridge, MA 11/2007 to 12/2007

Regulatory/QA Consultant

v Support corporate SOP revision initiative.

EDUCATION

University of Massachusetts-Lowell Lowell, MA

M.S. in Science, May 1997

Research in Alzheimer’s Disease using Cell Cultures

Courses in Biotechnology Manufacturing, Biologic Drug Development and Regulatory Affairs

University of Massachusetts-Lowell, Lowell, MA

Bachelor of Science in Biology, May 1996

Completed courses in Cell Culture, Recombinant DNA, and Chemistry

The Pennsylvania State University University Park, PA

Completed courses toward a B.S. in Science 1987-88 and 1990-1992

References: Available upon request.

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