Biotech Resources Group's GMP Consulting service works with client companies globally to design, build, start-up, operate, and optimize licensable cGMP facilities for biologics projects. They work with clients throughout the concept-to-commercialization process at both clinical and commercial scales. In 2013, the biotechnology economy remained strong, fueling growth for innovator, biosimilar, and CMO companies. Biotech Resources' main goal is to help clients improve their competitive position by advancing needed medicines through development and to market. They believe in strongly integrating with client teams to bring new medicines to patients.

1. Robert Valdes
Principal / GMP Consultant
www.biotechresources.net
bobv@bobv.net
202.738.3386
Focusing exclusively on biologics-based projects, Biotech Resources Group's GMP Consulting
service arm works with client companies globally to design, build, start-up, operate, and optimize
licensable cGMP facilites. Clients work with us because of our hands-on involvement at each interval
of the Concept-to-Commercialization sequence (below) at both clinical and commercial scales.
In 2013, the biotechnology economy remains strong with local and global drivers fueling fantastic
long-term growth for innovator, biosimilar, and CMO companies. Our main goal is to leverage these
drivers to improve our clients' competitive position by ensuring that needed medicines advance
through the clinic and into the commercial marketplace with momentum.
We firmly believe that project success is predicated upon the strong integration with the client's
core teams. For this reason, we work openly with clients as they lead the charge to bring new
medicaines to market.
CONCEPT TO COMMERCIALIZATION
Project Execution
CAPACITY INCREASE
FACILITY OPTIMIZATION
STOCKPILE / LICENSURE
ENG RUNS / GMP RUN #1
COMM / QUALIFICATION
PROCURE / CONSTRUCT
PRELIM / DETAILED DESIGN
DEFINE BUSINESS DRIVERS
BUSINESS RESOURCES DESIGN RESOURCES START-UP COMMERCIAL OPS FACILITY OPTIMIZATION
Business Rationale User Requirements Master Hiring Plans QSIT Metrics Transition to FULL SPEED
Conceptual Design P&ID, 3-D, PFD's FAT / SAT Execution KPI Dashboarding Gap Analyses / FMEA
Benchmark Studies Flow Drawings Operator Training Finance Metrics Cycle TIme Analysis
Type-C Meeting Prep Spare Parts Approach SOP & Batch Records CMO Due-Diligence Capacity Increase
TIme & Motion Studies Viral Segregation Material Management Insourcing Cross Training

2. PROJECT EXPERIENCE: MONOCLONALS & CYTOKINES
FACILITY SCALE BUSINESS PROCURE & START UPS & VALIDATE &
DESIGN OPERATE STATUS
(LITER) RATIONALE CONSTRUCT COMMISSION ENG RUNS
200 √ √ √ √ √ √ CLINICAL
2,000 √ √ √ √ √ √ CLINICAL
2 X 1,500 √ √ √ √ √ √ LICENSED
____ ____ ____ ____
3 X 3,000 √ √ COMPLETED
____ ____ ____ ____ ____
2 X 5,000 √ IN PROGRESS
2 X 20,000 √ √ √ √ √ √ LICENSED
Robert Valdes (Bob) has over 22 years of experience in the biotech Bob lives in Gaithersburg, MD with his wife ( and co-founder)
sector and currently serves as GMP Consultant for Biotech Susie and enjoys cycling, hockey, and philanthropy. Originally
Resources Group (BRG), a Maryland-based company focused from the northeast, Bob and his wife have resided in Maryland
on biologics manufacturing consulting as well as Clinical / for over 12 years.
Manufacturing staffing services since 2000.
Network Strength: Given the Bob’s 20+ years experience
Prior, Bob was Director, Large-Scale Manufacturing at Human in biotech, BRG’s network is comprised of experts with
Genome Sciences (HGS; now GSK), where he oversaw the strong operational, scientific, engineering, start-up, and
manufacture of HGS’ first commercial product Benlysta®, the commercial experience.
first lupus drug to make it through US regulators in over 50 years.
In Q2 / 2000, Bob was the first manufacturing-engineer hired by Biotech Resoures is not your typical consultant. We have direct
HGS for the Large-Scale Manufacturing effort and was hands-on “hands-on” experience in design, start-up, and 24/7/365 Large-
from Conceptual design to Commercialization (Phase I - Phase IV). Scale Commercial Biologics Manufacturing.
Prior to Bob’s 12-year tenure at HGS, he was employed by Lonza Given the project experience, network strength, and ‘long-haul’
Biologics (Portsmouth, NH and Slough, UK) from 1994-2000 in energy, Biotech Resources Group’s consulting team looks forward
various positions in manufacturing design, start-up, and 24/7 to working with you at each/any step of the Concept-to-Commercial
biologics manufacturing operations. His first job as an under- sequence as you lead the charge to bring new medicines to market.
graduate, Bob worked at Charm Sciences Inc. (Malden, MA)
from 1990-1994 as a pilot-plant microbiologist. Location: Only minutes from Rockville, Maryland (FDA) and a short
drive from the Washington, D.C. metro area.
Since 1995, Mr. Valdes has founded/co-founded 4 companies,
3 are currently operational—One of which is a 501c3 nonprofit
serving the Multiple Sclerosis community in over 25 states. Bob Robert Valdes, MBA
has also served on nonprofit boards and currently serves on the Principal / GMP Consultant
Dean’s Alumni Advisory Board (DAAB) at Johns Hopkins Carey 202-738-3386
Business School in Baltimore, MD. bobv@bobv.net
www.biotechresources.net
Mr. Valdes holds Masters degrees from the University of
Massachusetts and Johns Hopkins and a B.A. in microbiology
2013
from the University of New Hampshire.