Experience

Angelique Freudberg

• United States
• Real Estate
• 1 - 100 Employee

• Director, Business Development

  • Mar 2018 - Present

  Advanced Analytical Testing Laboratories (AATL) is a GMP compliant, FDA regulated contract testing laboratory, founded in 2008. We have passed four (4) FDA inspections with no 483s (EIRs available). Our 25,000 sf facility offers analytical chemistry (GC, HPLC), stability and microbiological (sterility, endotoxin) testing services. Our microbiology lab has a new glass-enclosed Sterility Chamber with airlocks. Services include Environmental Monitoring & Facility Support (air, water, gas), QA/QC Release Testing (raw materials, finished product), Method Development/Validation, Compendial Testing (USP, EP, JP) and Stability (long-term, accelerated).



Coram Clinical Trials

• Greater New York City Area

• Director, Business Development

  • May 2012 - Present

  Coram Clinical Trials: Nationwide In-home management of Clinical Trials, Nursing Services and Central Pharmacy. Coram Clinical Trials (CCT) expands clinical research beyond the investigator site and into the patient’s home. CCT’s services help to remove barriers to subject recruitment, retention, and compliance through our unique product offering. Patients do not need to find transportation, worry about traffic or find a place to park. CCT brings the nurse and investigator’s treatment to them. This convenience has provided our clinical trials with over 90% compliance and extremely low dropout rates. Our Central Pharmacy Service dispenses individual dosages and ships the prepared IP directly to the patient’s home in sealed, cold-chain managed containers. Coram nurses administer medication and record observations for the investigator. Coram’s centralized clinical management team provides training, logistical support and data query services. We have extensive experience with Alzheimer’s, C-V, Diabetes, G-I, Immunology, Infectious disease, medical device, Oncology Pain management, Respiratory and transplant patients.



Ecron Acunova

• Germany
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Director, Business Development

  • Oct 2010 - Jan 2012

  Acunova is a Global, Full Service CRO offering Phase I-IV services. Our 3 Phase I CPUs (150 beds) and Bioanalytical Laboratory (LC/MS/MS) in India are all FDA Inspected. We have over 25 years experience in conducting clinical trials in Europe and India. Our clinical trial expertise includes Oncology, CNS, Cardiovascular, Diabetes, Gastroenterology, Dermatology / Ophthalmology, Pulmonary and Infectious Disease. We have conducted over 140 Clinical Studies in 29,000 patients and have preferred access to Manipal Medical University’s complex of 19 hospitals in India We are a global leader in conducting Diagnostic Imaging trials and the leading CRO in India in conducting Stem Cell studies. Our European headquarters is in Frankfurt, Germany with multiple branch offices in East and West European countries. Our Asian headquarters is in Bangalore, India (Manipal Acunova). Our USA office is in Princeton, NJ.



Technical Resources International

• Consultant, Business Development

  • Oct 2009 - May 2010

  Develop full service, clinical trials business (Phase II-III) with private sector companies in the U.S.A. This company has focused solely on government contracts (NIH, NCI, DAIDS, etc) for 30 years and wants to expand their business into the private sector. They have decided to focus on bio-technology pharmaceutical companies as their initial venture. Initially targeted companies developing products for Infectious Disease and Oncology. Develop full service, clinical trials business (Phase II-III) with private sector companies in the U.S.A. This company has focused solely on government contracts (NIH, NCI, DAIDS, etc) for 30 years and wants to expand their business into the private sector. They have decided to focus on bio-technology pharmaceutical companies as their initial venture. Initially targeted companies developing products for Infectious Disease and Oncology.



bioRASI

• Vice President, Business Development

  • Jan 2009 - Sep 2009

  Develop full service clinical trials business (Phase I-IV) including BA/BE, PK with focus on Clinical Endpoint, 505(b)(2) NDA and Therapeutic Equivalency studies. Primary speciallties were CNS (Alzheimer's, Epilepsy, Parkinson's, Schizephrenia), Cardiovascular, Dermatology, Gastroenterology (Crohn's Disease, Ulcerative Colitis), and Oncology. Patient trials were conducted in Eastern Europe, India and USA. I developed several new key clients and generated over $17 million in proposals in the first 8 months.



BioPharma Services Inc.

• Canada
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Vice President, Business Development

  • May 2008 - Jan 2009

  Responsible for developing Phase I-III Clinical Trials business in North American (East & Midwest) and Europe. Primary focus was Bioequivalency / Bioavailability studies for the Generic industry. Also worked for our sister company, ADA Medical, which conducted clinical trials in patients. Provided regulatory assistance and client service support for generic clients. Responsible for developing Phase I-III Clinical Trials business in North American (East & Midwest) and Europe. Primary focus was Bioequivalency / Bioavailability studies for the Generic industry. Also worked for our sister company, ADA Medical, which conducted clinical trials in patients. Provided regulatory assistance and client service support for generic clients.



Veeda Clinical Research Limited

• India
• Research Services
• 700 & Above Employee

• Head of Business Development (USA)

  • May 2006 - May 2008

  Veeda is a Full Service CRO that was founded in April 2005. It is now one of the fastest growing CRO’s in India. It started with two Phase I Clinics in India and UK. As of June 2008, Veeda was to have two Phase I Clinics / Bioanalytical Laboratories in India; two Large Molecule Laboratories and a Phase I Clinic in UK and a Phase I Clinic in Germany. I was the first full-time business development person at Veeda. I spearheaded the introduction of Veeda Clinical Research into North America and Brazil. I developed the U.S. market to the point that I had 5 Business Development Staff in the U.S.A. in 2008. Responsible for developing Phase I-III Clinical and Bioanalytical (Small and Large Molecule) business in North America. Supported three Phase I Clinics (India, 116-Beds; Germany, 40-Beds and UK, 63-Beds) and two Bioanalytical Laboratories in India (LC/MS/MS) and UK (RIA, ELIZA, Biomarkers). Presented capabilities to PhRMA, Generic and Bio-Tech companies in the USA, Canada and Brazil. Negotiate contracts, provide regulatory assistance and client service support to clients and train new sales staff.



BASi

• United States
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Senior Director, Business Development

  • Apr 1999 - May 2006

  BASi acquired PharmaKinetics Laboratories in June 2003. Responsible for developing business for Phase I-IV, Clinical Research Unit, Clinical Trials Management (CTM) Group and Bioanalytical Laboratories (Maryland, Indiana and Oregon Labs). The Baltimore facility has a 120-Bed CRU, a Bioanalytical Laboratory and a CTM group which conducts moderate size (up to 600 patients) Clinical Endpoint studies in patients. Responsibilities included contract negotiation, study design / regulatory guidance (generics) and training Clinical Research capabilities to the BASi Corporate Sales staff.. Focus is on acquiring more PhARMA clients to go with their Generic business. Attendance at FDA / AAPS Sponsored workshops kept me current with regulatory requirements.



PPD

• Director, Business Development

  • Jan 1994 - Apr 1999

  Joined Pharmaco LSR in January 1994 and was responsible for developing business for the Austin Phase I Clinic and the Richmond Bioanalytical Laboratory. During a brief period (1995) responsibilities included assisting Toxicology business development for the East Millstone Toxicology Lab (sold to Huntingdon Research). Provided business development and client service support. Negotiate research contracts for clinical and Bioanalytical services. Attend regulatory meetings to keep abreast of current issues as a service to clients and to assist in protocol development. The September 1996 merger between Pharmaceutical Product Development (PPD) and Pharmaco increased business development responsibilities to include two Phase I clinics and two Bioanalytical laboratories. Responsible for over $7 Million in 1997 sales for the Northeast Territory (including Canada). I also provided sales assistance for the Leicester Clinical Research Centre (UK).



Phoenix International Life Sciences

• Associate Director, Business Development

  • Mar 1991 - Mar 1993

  Provided business development and client service support for this full service contract research organization. Negotiated scientific and business details of research contracts for Clinical, Bioanalytical and Drug Metabolism services. Attended state, national and international regulatory meetings to keep abreast of current issues as a service to clients and to assist in protocol development. Company revenues doubled (increased by over $10 million) during my tenure. Company had their first FDA Inspection during my second year.



Radian Corporation, Pharmaceutical Analysis Laboratory

• Marketing Manager

  • Aug 1989 - Mar 1991

  Provided business development and client service support for this Bioanalytical laboratory. Negotiate research contracts for bioanalytical services. Attend regulatory meetings to keep abreast of current issues as a service to clients and to assist in protocol development. Presented capabilities to potential clients Provided business development and client service support for this Bioanalytical laboratory. Negotiate research contracts for bioanalytical services. Attend regulatory meetings to keep abreast of current issues as a service to clients and to assist in protocol development. Presented capabilities to potential clients



Analytical BioChemistry Laboratories

• Business Development Manager

  • Nov 1987 - Jul 1989

  Provide business development support for their contract bioanalytical services and equipment supplies. Presented capabilities to existing and potential clients Provide business development support for their contract bioanalytical services and equipment supplies. Presented capabilities to existing and potential clients



Clin-Tox Consulting

• President

  • Jan 1987 - Nov 1987

  Provide protocol development, regulatory affairs and quality assurance assistance for Pre-Clinical and Clinical trials. Provide protocol development, regulatory affairs and quality assurance assistance for Pre-Clinical and Clinical trials.



Hazleton Laboratories

• Account Executive, Phase I Clinical & Bioanalytical Services

  • Nov 1984 - Dec 1986

  Provided business development and client services support for the Phase I Clinical Research Unit and Biopharmaceutical Laboratory. Presented capabilities, negotiated contracts and attended scientific and regulatory meetings. Provided business development and client services support for the Phase I Clinical Research Unit and Biopharmaceutical Laboratory. Presented capabilities, negotiated contracts and attended scientific and regulatory meetings.



WIL Research

• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Director of Operations - Cincinnati Laboratory

  • Dec 1982 - Nov 1984

  Managed a staff of 34 at the Cincinnati Pre-Clinical Laboratory. Services included Rodent, Canine and Subhuman Primate Toxicology and Pathology. Responsibilities included protocol development, data evaluation, report writing and overall management of this laboratory. Acute and Sub-chronic Toxicology studies were conducted by my staff. Managed a staff of 34 at the Cincinnati Pre-Clinical Laboratory. Services included Rodent, Canine and Subhuman Primate Toxicology and Pathology. Responsibilities included protocol development, data evaluation, report writing and overall management of this laboratory. Acute and Sub-chronic Toxicology studies were conducted by my staff.



Hazleton Laboratories

• Director, Acute Toxicology and Special Projects

  • Nov 1978 - Dec 1982

  Hazleton Laboratories acquired Raltech Scientific Services in 1980. My Acute Toxicology Department grew from a staff of 8 to a staff of 22 professionals in conducting Acute and Sub-chronic Toxicology studies in Rodents, cats, dogs and Rhesus Monkeys. Responsible for writing protocols, supervising conduct of studies, evaluating data, writing reports and attending Regulatory meetings. Hazleton Laboratories acquired Raltech Scientific Services in 1980. My Acute Toxicology Department grew from a staff of 8 to a staff of 22 professionals in conducting Acute and Sub-chronic Toxicology studies in Rodents, cats, dogs and Rhesus Monkeys. Responsible for writing protocols, supervising conduct of studies, evaluating data, writing reports and attending Regulatory meetings.



International Research & Development Corporation

• Assistant Director, Acute Toxicology & Special Projects

  • Sep 1974 - Nov 1978

  Began toxicology career as a Research Associate in several departments and eventually promoted to Assistant Director, Acute Toxicology. Departmental staff numbered 28 when I left in late 1978. Experience included Histopathology and work with a wide range of animals: Mice, Rats, Hamsters, Rabbits, Dogs, Yorkshire Hogs, Rhesus Monkeys, and Baboons. Special projects included Tumor Transplant studies, sub-chronic intravenous studies, simulated cataract surgery and direct blood pressure monitoring in dogs (surgical cut-down). I trained four Research Associates in Surgical Sterile Technique.