STEVEN C. KUNDER, PH.D., DABT

Steven Kunder, Ph.D., DABT., has joined BCG as a Senior Consultant. Dr. Kunder is an immunopharmacologist (Ph.D., Medical College of Pennsylvania, Philadelphia, PA) who brings 12 years of experience with the U.S. Food and Drug Administration (FDA) in both the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).

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With the estimated costs of bringing a new biopharmaceutical product to market exceeding $1.2 Billion, it is important that companies ensure the quality and integrity of their research data and that the studies are performed in compliance with good laboratory (GLP) and good clinical practices (GCP).   If you are in the process of planning for submission of a BLA or NDA you should include assessment of GCP/GLP compliance of the studies being submitted in support of the market application.  The time to identify and correct deficiencies is prior to the FDA Pre-approval Inspection (PAI) or Bioresearch Monitoring (BiMo) audit.

Biologics Consulting Group, Inc. (BCG) has a team of consultants with extensive FDA compliance inspection experience and extensive experience in clinical regulatory affairs and quality assurance .  These Senior Consultants have a proven record in helping clients navigate regulatory hurdles potentially affecting product approval.   Compliance services that BCG provide include Mock GLP and GCP inspections, data quality and integrity audits, compliance gap assessments, Sponsor/Monitor audits, clinical data due diligence assessments and Clinical Investigator audits.  A more detail list of GLP and GCP compliance services is listed below:

• Clinical site audits, sponsor audits, including clinical databases, in the context of complex study design or preparation for FDA inspections

• “For-Cause” audits for data integrity and data quality issues.

• Independent audits and assessment for suspected research misconduct

• Vendor qualification including contract research organizations (CROs), clinical laboratories, non-clinical laboratories, institutional review boards (IRBs), and contract manufacturers

• Development of a quality systems program

• Quality presentations at investigator meetings

• GCP training for clinical investigators, study staff, and sponsor staff including FDA preparedness training for regulatory inspections

• GLP regulatory training for laboratory staff and vendors

• Preparation and review of standard operating procedures (SOPs)

• Qualification of clinical sites

BCG provides a full array of nonclinical pharmacology-toxicology consulting services that span the entire biologic/drug development process, from discovery through marketing application and approval.  At the early stages of biologic/drug development, BCG toxicologists review the product information and conduct a gap analysis, evaluating currently completed studies and considering the product class, proposed indication and mechanism of action and providing an appropriate nonclinical plan for development through marketing application.  Biologics and therapeutic biologics, and vaccines in particular, are generally designed to affect the immune system, and BCG offers toxicologists with knowledge of immunology that are especially equipped to understand the nonclinical requirements for this type of development program.  This nonclinical plan can be provided in the form of a Product Development Plan, including a detailed outline of the most effective and efficient nonclinical program for initiation of a Phase I clinical trial, and ultimately for submission of a BLA/NDA. 

BCG toxicologists have visited numerous toxicology CROs throughout the U.S. as well as abroad, and are well-equipped to aid the client with their toxicology outsourcing needs, including recommendations as to the best toxicology CRO for a specific development program, obtaining bids for specific studies, GLP auditing, monitoring ongoing studies and reviewing study reports.  BCG toxicologists have extensive experience in writing pre-IND briefing packages and participating in pre-IND meetings with the FDA.  With previous experience as FDA reviewers in most cases, in addition to previous experience in industry, the BCG toxicologists are in an excellent position to determine the best nonclinical path to first-in-man clinical trials, taking into consideration the FDA regulatory requirements, client resource requirements and the importance of client timelines.  BCG toxicologists also have extensive experience in writing and/or review of IND pharmacology-toxicology sections, in standard as well as CTD format. 

With firm knowledge of toxicological principles, FDA regulatory requirements and immunology, they are well-equipped to provide a clear, concise IND document that will best serve the client.  They also have the expertise to evaluate specific toxicology data in terms of strengths and weaknesses in support of a specific clinical trial. 

In addition to pre-IND meetings, BCG toxicologists also offer expertise in preparation and participation in all formal FDA meetings, including end-of-Phase II meetings and pre-BLA/NDA meetings.  They understand the nonclinical requirements to marketing application, and can provide advice in this area that can ultimately save clients a great deal of time and resources.  BCG toxicologists can also write/review the pharmacology-toxicology sections of marketing applications (BLA/NDA) and have considerable experience in this area.  Other services provided by the BCG toxicologists include review of toxicology study protocols and toxicology study reports, preparation of detailed toxicology study protocols, analysis of pharmacokinetic data, conducting due diligence evaluations for potential product acquisitions, and preparation/evaluation of comparability protocols related to manufacturing changes.  And BCG toxicologists also offer extensive experience and expertise in GLP auditing, study monitoring and toxicology study protocol review and evaluation. 

BCG toxicologists offer product expertise and experience in virtually all of the biologic and therapeutic biologic product classes in addition to development of drugs (small molecules) for many indications.  Those biologic and therapeutic biologic product classes include vaccines, therapeutic proteins, cytokines, monoclonal antibodies, blood products, gene therapy products, cell and tissue products and allergenic products.  BCG toxicologists also have considerable experience in the development of drugs, including drugs for CNS, G.I., anti-inflammatory, antiviral and oncology indications.  Experience also includes nonclinical development of peptides, synthetic peptides and co-polymer products.  Therefore, BCG has all of the bases covered in terms of nonclinical pharmacology-toxicology expertise as relates to the various biologic, therapeutic biologic and drug product classes and indications.

Reproduced with permission from BioProcess International, Copyright ©2008, http://www.bioprocessintl.com

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BCG-Japan is open for business

BCG consultants attend numerous conferences every year during which they are available to provide company information or consulting expertise. Below are some conferences that BCG consultants will be attending in the near future. Please feel free to contact the attending consultant either before, or during the conference for company information or to discuss a business opportunity.

Study Directing: Principles and Practices

"Your "other boss": How an FDA reviewer reads your reports"

“Develop Complex Stability Programs for Biologics”

Health Care Compliance Certification Program

"Advertising & Promotion of Medical Devices"

Jim Kenimer
Ron Marchesani
Ron Salerno
Gil Salud

Nadine Ritter, Ph.D.(speaker)

Asia Antibody Congress

Preconference Masterclass A: Gaining Regulatory Approval for Therapeutic Monoclonal Antibody for the US and EU Markets