BCG Bulletin |
Date Issued |
Highlights |
| Issue 39 |
September 8, 2008 |
BCG highlights its BCG Regenerative Medicine Expertise. Understanding and Implementing Good Tissue Practices by Darin Weber, PhD. BCG celebrates its 15 year anniversary of providing regulatory consulting services. |
| Issue 38 |
June 16, 2008 |
BCG Welcomes: Steve Kunder, PhD, DABT, Sr. Consultant. BCG GCP & GLP Consulting Services article by Carl Anderson and Michael Trapani, MS, MBA, BCG Sr. Consultants, BCG Nonclinical Consulting Services article by John Jessop, PhD, Sr. Consultant, Analytical Methods Highlights from BioProcess International. BCG-Japan is open for business. |
| Issue
37 |
May
1, 2008 |
BCG
Welcomes:Ruth
E. Wager, Ph.D. Sr. Consultant,
Gilbert
T. Salud, Sr. Consultant and Susan
M. Bowley, Ph.D., Sr. Consultant, Medical Devices.
BCG Consultants presenting
courses at UCSC May 8-10. BCG-Japan is open for business. Regulation
of Pharmacogenetic In Vitro Diagnostic Tests article
by Ron
Salerno, Ph.D., Sr. Consultant. Trends in FDA Bioresearch
Monitoring Inspections article by Carl
Anderson, Senior Consultant reprinted from Medical
Devices Law & Industry Report, Vol. 2, No. 4, 02/27/2008. |
| Issue
36 |
February
5 , 2008 |
BCG
Welcomes:John
Humphries, M.D. Sr. Clinical Consultant and
Ronald
A. Salerno, Ph.D., Sr. Consultant. Spotlight
on Pharmacogenomics article by Ronald
A. Salerno, Ph.D. Protocol
Adherence and Recordkeeping by Carl
Anderson, Recent
Articles in Clinical Infectious Diseases by Ann
Sutton, Capitalize
on the Competitive Partnering Marketplace by Tara
R. St. Amand, Ph.D., BroadOak Capital Partners |
| Issue
35 |
January
14, 2008 |
BCG
Welcomes: Janice
, Sr. Consultant and
Nebojsa
Djordjevic, Ph.D., Sr. Consultant. Spotlight
on Outsourcing articles by Michael
Trapani, MS, MBA and David
Pepperl, Ph.D. An
Early Look at FDA Regulation of Nanotechnology by Stuart
Portnoy, M.D. |
| Issue
34 |
November
29, 2007 |
BCG
Welcomes:Lourdes
Bermejo, M.S., Sr. Consultant,
Ellen
Raaf, MT, ASCP, Sr. Consultant, and Paula
M. Keith, Ph.D., Sr. Consultant. Spotlight
on FDA Bioresearch Monitoring Program. |
| Issue
33 |
October
15 , 2007 |
BCG
Welcomes: Angela
Blackwell, M.S., Sr. Consultant
Carl
Anderson, Sr. Consultant, Spotlight
on Combination Products, introduction of the Proof-of-Principle
Alliance, new
West Coast office location in San
Mateo |
| Issue
32 |
August
9, 2007 |
Spotlight
on ICH
E15: Terminology in Pharmacogenomics by Dr. Jim Kenimer,
BCG Welcomes: Andrew Zelar, Ph.D., Sr. Consultant,
Stuart
Portnoy, M.D., Sr. Consultant - Medical Devices, New
FDA Guidances for Sponsors of Clinical Studies by
Michael Trapani, Senior
Consultant Position available in our North Carolina office |
| Issue
31 |
June
26, 2007 |
BCG
welcomes Eugene
B. Johnston as head of the NC Office and Nanda
K. Subbarao, Ph.D. as a new Sr. Consultant. Ron
Marchesani has taken over as the Head of West Coast
Operations. Current publications by D.
Pepperl, D.
Weber, and S.
Litwin. Tanya
Scharton-Kersten, Ph.D. serving as chair of the Bioprocessing/Process
Development (BPD) Group. The new China office of BCG is now staffed and open for business
and BCG
China Office Head, Lei Zhang, M.D., Ph.D. will present BioChina
pre-conference masterclass |
| Issue
30 |
May
2, 2007 |
Position
Available - Head of West Coast Operations. BCG welcomes Lei
Zhang, MD, PhD as the head of our new China office.
Jim Kenimer to present the "Biologics
Approval Process" course in China. |
| Issue
29 |
March
2 , 2007 |
Position
Available - Head of North Carolina Office. BCG welcomes Melanie
Hartsough Ph.D., and Liana
Harvath, Ph.D. to the VA office and Ron
Marchesani and Louise
Johnson M.S., to the CA Office. Michael
Trapani's article on FDA
Warning Letters - Good Clinical Practices, Jim Kenimer
to present the "Biologics
Approval Process" course in Singapore Advisory
Committee Preparation Services. |
| Issue
28 |
January
5, 2007 |
Bruno
Gagnon, B.Pharm, M.Sc, Michael
Trapani, MS, MBA and Wilson
Bryan, M.D. join the CA, MA and VA offices. Spotlight
on BCG
Regulatory Compliance Consulting. John
Godshalk's article on FDA
Warning Letters. Jim Kenimer to present the "Biologics
Approval Process" course in Singapore. Advisory
Committee Preparation Services. |
| Issue
27 |
October
6, 2006 |
Loriann
Baranauskas joins the Massachusetts office. "New
Indications for Live Bacteria" by Ann
Sutton. 'Senior
Consultant' and 'Consultant'
positions available in our California office. FDA retiree
Stan Woollen has joined BCG as an affiliate. Visit
BCG's booth #502 at RAPS |
| Issue
26 |
May
22, 2006 |
NEW
Head of West Coast Operations, Dr. Howard Raff joins the
group. California office had a new location. Dr. Tanya
Kersten receives promotion to Senior Consultant. Is your
product ready for approval? |
| Issue
25 |
March
27, 2006 |
Martiza
McIntyre, Ph.D. to join the BCG team in April. RAPS
Session Leaders and Speakers Needed. |
| Issue
24 |
March
4 , 2006 |
"To
GMP or Not to GMP Investigational New Drugs" by John
R. Godshalk and David
Lin, Ph.D."Quality
Systems Assessment" by Thomas
Gerteisen, Ph.D. BCG welcomes William
Winslow and Reginald
Neal to the BCG team! |
| Issue
23 |
November
15, 2005 |
Ellen
Areman, MS, SBB and John
Godshalk, MSE, MBA to join the BCG team in December.
Information regarding the 505(b)(2) New Drug Application. |
| Issue
22 |
July
15, 2005 |
BCG has moved it's corporate
office effective July 15th; Stephen Keith, M.D., MSPH
joins the BCG Team; Emergency
Use Authorization; Accelerated
Approval vs. Fast Track Designation |
| Issue
21 |
June
15, 2005 |
Robert
Darius joins the BCG Team & visit BCG at booth #2315
at BIO 2005 in Philadelphia. |
| Issue
20 |
May
9, 2005 |
Newcomers
to BCG, Peter Patriarca, M.D., Bette Goldman, R.N., M.P.H., Kerin Ablashi, Highlight on
existing consultants and services |
| Issue
19 |
April
4 , 2005 |
The
Extrinsic Quality System, Electronic
Submissions, An Update
on BCG-Europe Activities |
| Issue
18 |
February
4, 2005 |
Expanded
Medical Device and Drug Consulting Services, Electronic
Submissions and new BCG addition, Dan
Offringa, Compliance - Quality System Consulting |
| Issue
17 |
January
4, 2005 |
Enhanced
Clinical Services, Training
Courses Rescheduled, Former CDER Review, Dr.
David Lin joins the group, BCG announces opening
of new Massachusetts
office!!! |
Special
Training Issue |
December
9, 2004 |
January-February
2005 Training Courses |
| Issue
16 |
November
18, 2004 |
BCG
TRAINING COURSES, addition of Senior Consultants Sandra
Holmes, Ph.D., MHA and Julia
Barrett, MD, MPH |
| Issue
15 |
July
28, 2004 |
Addition
of 2 new BCG consultants, Tom
Gerteisen, Ph.D. and Nadine Ritter,
Ph.D. and new BCG Affiliate, Louis Mocca. NEW TRAINING
COURSES offered by BCG. |
| Issue
14 |
May
24, 2004 |
Addition
of 3 new BCG consultants, Rajesh K. Gupta, Ph.D., William
Turner, Douglas Bissonnette and new BCG Affiliate, Hansi
Dean. Update on growth of Asia-Pacific region. Upcoming
conferences and presentations. |
| Issue
13 |
February
18, 2004 |
Spotlights
on Compliance & Product Development Plans, welcoming
new Vice President of Compliance, Mr. Steven Masiello
and new BCG Affiliate, Dr. Nadine Ritter |
| Issue
12 |
January
8, 2004 |
Spotlight
of Cell and Tissue Therapies & Spotlight on Preclinical
Product Development Services, welcoming new senior consultants, Dr. David Pepperl and Dr.
Darin Weber. |
| Issue
11 |
September
28, 2003 |
Spotlight
on Therapeutic Proteins, welcoming new senior consultant, Dr. Steve Litwin and new affiliate
Douglas Bissonnette, and BCG announces opening of 2
new asia-pacific offices!!! |
| Issue
10 |
August
18, 2003 |
Spotlight
on Therapeutic Immunoglobulins and other Blood Product
Services, welcoming new senior consultant, Dr.
Jim McIver, and BCG's Pre-Approval Inspection Team. |
| Issue
9 |
May
28, 2003 |
Spotlight
on Medical Device Consulting and GMP Compliance Consulting.
BCG welcomes Patsy Trisler, JD, RAC and Julia Lukas and
highlights their expertise. Upcoming BCG conference appearances. |
| Issue
8 |
April
28, 2003 |
Spotlight
on Translational Development, PreClinical Pharm/Tox, and
Validation Services. BCG welcomes John H. Parker, Ph.D.
and Caroline Samuels, MD and highlights their expertise.
Upcoming BCG conference appearances. |
| Issue
7 |
February
28, 2003 |
Time
is Running Out...Register for BCG's Process Validation
course today! BCG welcomes John H. Parker, Ph.D. to the
team. |
| Issue
6 |
January
29, 2003 |
BCG
presents course entitled: Process Validation in Biotechnology,
Systems Approach, scheduled for April 10&11, 2003. |
| Issue
5 |
December
18, 2002 |
James
L. Cowell, Ph.D. is BCG's new Head of the North Carolina
Office. BCG also welcomes Michele Keane-Moore, Ph.D.,
and Nancy N. Wisniewski to the team. New course announcements
included. Dr. Zoon retires, moves to NIH. Dr. Goodman
named Director of CBER |
| Issue
4 |
October
24, 2002 |
New
HOT TOPICS WORKSHOPS, BCG welcomes Dr.
Raphael Bartholomeusz and Ken Walsh. |
| Issue
3 |
September
26, 2002 |
West
Coast Office Expansion. BCG welcomes Dr. Joe Eiden, Nancy
Hornbaker, Renee Tate, and Janice Castillo to the team.
Recruiting in NC. Appointment of Dr. Kenimer to the Governor's
Advisory Board for the Virginia Biotechnology Initiative.
Upcoming BCG conference appearances. |
| Issue
2 |
May
2, 2002 |
Extended
Course Offerings |
| Issue
1 |
April
18, 2002 |
New
CA, NC, UK Offices, Course Offerings, Dr. Karin Sewerin
joins the BCG team. |
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