Data Exchange and Confidentiality Between CROs and Sponsors

Data exchange is a part of the much broader issue of confidentiality when contracting R&D services.  In reality, regardless of the geographic region to where services are implemented, the moment work is sent outside of the home office, confidentiality is potentially compromised.

DEL BioPharma LLC works with many clients some of whom are tolerant to perceived risk and some of whom are so concerned that they will not outsource to Asia or India.  From a practical point of view and regardless of the geographic region utilized for contract services, CROs and CMOs would not be in business if there were significant violations of confidentiality.  That having been said, sponsor companies should always take steps to minimize any risk to their programs.  Such steps, applied to chemistry research and development, include the following:

• For medicinal chemistry, contract labs used for the preparation of target compounds should be separate and distinct from contract labs used for the assay of target compounds.  The rationale behind this strategy lies in the fact that a CRO generating target compounds does not need to know what the target compounds are used for.  Similarly, contract labs providing assay services do not require the structural identity of compounds under evaluation.
• For API manufacturing, separate contract labs should be used for the regulatory starting materials and for the final drug substance.  The rationale behind this strategy lies in the fact that the manufacturer of the regulatory starting materials does not require knowledge of the final drug substance.  Similarly, the manufacturer of the drug substance does not require knowledge of the process utilized for production of the regulatory starting materials.

In all instances, effective communication of sensitive information (batch records, analytical data/methods, patent applications, regulatory documents, etc.) is required in order to facilitate tech transfer, troubleshooting and overall project advancement.  Aside from the fact that much documentation is so large that email transmission is ineffective, unless encrypted, there is some risk associated with email.  As an alternative, there are many options for encrypted cloud-based data transfer.  Unless an alternate platform is required by a given client, DEL BioPharma LLC uses ShareVault as a secure and encrypted platform for all document transfer between client companies and contracted laboratories.

In summary, there are many effective strategies and platforms for risk reduction associated with data exchange.  The approaches described above are very effective in maintaining security and confidentiality in our current globalized pharmaceutical research and development industry.

How to forge a successful strategic partnership with a CRO company to reach your company’s goals

Today’s globalized pharmaceutical industry presents many opportunities for diversifying risk in manufacturing.  Part of this diversification comes from the ability to spread manufacturing activities across continents.  In order to successfully develop a portfolio of relationships, each CRO or CMO engaged must be viewed as a strategic partner and those contributing to projects must feel that they are contributing to the overall development efforts.  There are many contract labs available that are capable of providing quality services.  However, the best services come from personal relationships and not from a business model of services and transactions.  In order to forge a successful strategic partnership, the following steps are essential:

• Know who you are working with (personal, infrastructure, capabilities/expertise and quality)
• Keep it personal (relationships first, finances/contracts second)
• Keep the CRO/CMO engaged (solicit thoughts/opinions, discuss/debate strategies, work collaboratively)

From a foundation of solid relationships, costs will decrease, quality will increase and significant cooperation in dealing with problems (timeline extensions, change orders, chemistry issues, etc.) will be realized.

GLOBAL STRATEGIES FOR SUCCESS IN DRUG DEVELOPMENT

An evening drug development seminar and wine tasting event.

Daniel Levy will present a seminar on "Outsourcing in the Pharma Industry: Strategies for Successful Projects with Limited Budgets" during."

Realizing successful outcomes following engagement of CRO/CMO resources amid challenges through the adoption of key strategies that will increase efficiencies and maximize chances to attain project goals.

Event includes a panel discussion on Tricks of the Trade for Virtual Drug Development led by Ken Haas, Partner at Abingworth Global Life Sciences Venture Group

Thursday, December 4, 2014 • 5:30–9:00 p.m
EMBASSY SUITES
250 Gateway Blvd., South San Francisco, CA 94080

Cost: $50.00
Please RSVP by November 30 to akaufman@bizdevconnections.com

Strategies for Successful Transition from Full-Time to Project-Based Employment

San Francisco American Chemical Society Meeting
Tuesday, August 12, 2014

DIVISION: SCHB: Division of Small Chemical Businesses
SESSION: True Stories from Entrepreneurs
SESSION START TIME: August 12, 2014, 8:00 am
PRESENTATION START TIME: August 12, 2014, 8:35 am
LOCATION: Moscone Center, South Bldg., Room: Esplanade Ballroom 301 

ABSTRACT:  Many sectors, including the biotechnology and pharmaceutical industries, continue to be challenged by the current economy. With the current and ongoing trend of engaging contract laboratories for chemistry research and manufacturing, the unemployment rate among those engaged in life-sciences companies continues to be disproportionate to the national average. Through development of skills such as managing CRO activities, leveraging services for resources, networking and marketing, motivated contributors can create opportunities leading to the development of successful consulting practices.

Successful Chemistry Outsourcing for Today's Startup Companies

San Francisco American Chemical Society Meeting
Tuesday, August 12, 2014

DIVISION: SCHB: Division of Small Chemical Businesses
SESSION: Start-Up Chemical Businesses in Drug Discovery
SESSION START TIME: August 12, 2014, 1:00 pm
PRESENTATION START TIME: 4:20 pm
LOCATION: Moscone Center, South Bldg., Room: Esplanade Ballroom 301

ABSTRACT:  Chemistry outsourcing has evolved from a tool to supplement internal activities to a necessary function designed to improve efficiencies and control costs within research and development organizations. This is particularly relevant to start-up pharmaceutical and biotechnology companies. However, realizing successful outcomes following engagement of CRO/CMO resources can be challenging - especially when working across large distances and without the ability to frequently monitor day-to-day activities. Through adoption of key strategies, efficiencies with CRO/CMO resources can be increased thus maximizing chances for successful project outcomes.

Chemistry Skills for Drug Discovery

I recently came across the article summarized below. The full PDF can be downloaded here.

Chemistry skills for drug discovery

11 April 2013

Chemistry expertise is critical to technical success across the spectrum of innovative medicines R&D. 

This position paper describes the changes that have taken place in the drug discovery sector and the challenges this presents in terms of ensuring chemistry, as the key enabling science, continues to deliver the essential translation of biological opportunity into clinical application.

It includes:

• Impact of recent developments on training capacity and mobility
• Key skills and capabilities for drug discovery chemists 

Conclusion

From target selection and compound design through to informing the design of clinical studies, chemistry has a vital role to play in driving the future success of drug discovery and, more broadly, the pharmaceutical sector as a whole.

A major stumbling block for the industry over recent years has been unacceptably high level of Phase 2 attrition resulting from poor target selection. It is essential to embed chemistry at the earliest stages of drug discovery as well as within the clinical setting, to help develop a more thorough molecular understanding of disease pathways and to inform target selection.

Equally important is the need to safeguard the skills, knowledge and expertise that are necessary to translate biological opportunities into safe and effective therapeutic agents. As the capacity within UK-based industry to develop these skills amongst drug discovery chemists diminishes, an alternative model for training must be established if the UK is to maintain its global competitiveness in the sector.

Strategies for Success in Virtual Drug Development - San Diego, CA

Please join us for an interactive seminar and discussion focused on virtual drug development and strategies for success from discovery to clinical trials. 

April 15, 2013 

5:00 – 9:00 pm

Hyatt Regency Mission Bay 

1441 Quivira Road 

San Diego, CA 92109 

Cost: $50.00 in advance, 

$60 after 12:00 p.m. April 12 and at the door. 

Register at http://successdrugdev.eventbrite.com/

Preliminary Agenda

5:00 – 6:00 Registration, Exhibitors, Networking, and Appetizers 

6:00 – 6:15 Welcome and Introduction, William Stevens, Ph.D. of Business Development Connections LLC 

6:15 – 6:35 “Chemistry Outsourcing – Avoiding Problems and Maximizing Benefits” Presented by Daniel Levy, Ph.D. of DEL BioPharma 

“Dr. Levy's presentation will focus on current chemistry outsourcing trends, challenges and strategies for success. The goal is to address issues applicable to both early stage medicinal chemistry efforts as well as scale- up and manufacturing.” 

Dr. Levy is an experienced organic/medicinal chemist having led the design of novel therapeutic agents targeting cardiovascular disease, cancer and inflammatory disorders. He has broad experience in the chemistry of amino acids/peptides, sugars/carbohydrates, heterocycles, polyethylene glycols and lipids as documented in almost 30 peer reviewed publications and over 11 issued/published United States patents. Dr. Levy held positions at Glycomed, COR Therapeutics, Scios and Intradigm Corporation. As a consultant, Dr. Levy provides medicinal chemistry and manufacturing services to companies interested in small molecule drug discovery/development. Set-up and management of chemistry outsourcing is a key service supporting these sectors. In addition, he provides technical due diligence services, facilitates IP development and supports the filing of grant applications. Dr. Levy received his Ph.D. in organic chemistry from the Massachusetts Institute of Technology and his B.S. in chemistry from the University of California - Berkeley. 

6:35 – 6:55 "Regulatory & Quality Challenges of Virtual Drug Development – “Or How to Avoid Getting in Bed With the Devil” Presented by Michael A. Swit, Esq. of Duane Morris, LLP

Virtual drug development, while providing many key advantages, presents major challenges for the drug sponsor in selecting and overseeing the vital work that the sponsor outsources. While some issues can be addressed via contract language, savvy sponsors exercise great care in selecting and overseeing their virtual suppliers/contractors. This session will identify key FDA regulatory and quality concerns involved in virtual drug development and how to tackle those challenges to maximize the potential for success. Michael A. Swit, Esq., is a Special Counsel in the San Diego office of the international law firm, Duane Morris, LLP, where he focuses his practice on solving FDA legal challenges faced by highly-regulated pharmaceutical and medical device companies. Before joining Duane Morris in March 2012, Swit served for seven years as a vice president at The Weinberg Group Inc., a preeminent scientific and regulatory consulting firm in the Life Sciences. His expertise includes product development, compliance and enforcement, recalls and crisis management, submissions and related traditional FDA regulatory activities, labeling and advertising, and clinical research efforts for all types of life sciences companies, with a particular emphasis on drugs, biologics and therapeutic biotech products. Mr. Swit has been addressing vital FDA legal and regulatory issues since 1984, both in private practice with McKenna & Cuneo and Heller Ehrman, and as vice president, general counsel and secretary of Par Pharmaceutical, a top public generic and specialty drug firm. He also was, from 1994 to 1998, CEO of FDANews.com, a premier publisher of regulatory newsletters and other specialty information products for FDA-regulated firms. He has taught and written on many topics relating to FDA regulation and associated commercial activities and is a past member of the Food & Drug Law Journal Editorial Board. He earned his A.B., magna cum laude, with high honors in history, at Bowdoin College, and his law degree at Emory University. 

7:00 - 7:15 Break

7:15 - 7:35 “Personalized Medicine in Clinical Development: Phenotyping, Patient Stratification and Tailored Therapy Based on Drug Pharmacology and metabolism in Target Tissue using Accellerator Mass Spectrometry” – resented by Gary Jones, M.D.; Co-Founder and Director of Clinical Development for C3 Research 

This presentation will propose a rational approach of clinical trial enrollment based on pre-trial study to evaluate drug pharmacology and uptake by target organ or tumor. Patients are administered a tracer dose of treatment drug lightly labeled with 14C to permit detection by accelerator mass spectrometry (AMS). The dose may be reduced to <100 a="" addressing="" affect="" allow="" and="" approach="" are="" as="" assessment="" based="" be="" biology="" by="" complex="" diseases="" drug="" each="" effect="" eliminate="" empirical="" enrollment="" environmental="" especially="" excluded="" from="" gene="" high="" in="" influenced="" kinetics="" larger="" longer="" low="" may="" micrograms="" modulators.="" nbsp="" networks="" of="" on="" ones="" or="" outcome="" p="" pathways="" patient="" patients="" personalized="" pharmaco-phenotyping="" pharmacologic="" pharmacology.="" pharmacology="" phase="" poor="" positive="" range="" responders="" showing="" stratified="" study.="" successful="" systems="" target="" the="" then="" this="" tissue="" to="" tracer="" trial.="" tumor="" uptake.="" uptake="" versus="" wider="" yet="">

As Director of Clinical Development, Gary uses his 20 years of experience and expertise, accumulated through his careers in academia, medical care, and clinical research, to enjoy direct involvement in the clinical development of both medical devices and therapeutics. He received his M.D. at the Oregon Health Sciences University had has had academic appointments at University of North Carolina and OHSU. 

Especially interested in “pushing the boundaries of the box” of clinical development in oncology, he is directly involved in the aspects of both development and running of clinical trials, medical monitoring, interpreting results and moving aspects of data forward in a practical way to bring therapeutics to the market that help people with critical needs in any area of medicine. 

7:35- 8:00 “Technology Transfer – Using a Gated Approach in Early and Late Stage Transfers” Presented by Laura Cribbins, MBA, PHP of the ProPharma Group 

This presentation provides detail on how to plan and conduct a successful Pharmaceutical technology transfer using a stage gate approach to the transfer. Examples of actual international transfers will be used to demonstrate the governance structure and tools used to perform a compliant transfer in a high performance team. 

Laura is Director of Program Management for the ProPharma Groups. Laura is a certified Project Management Professional (PMP). She has spoken on the use of a stage gated approach to Technology Transfer at professional meetings including, DIA Annual Meeting, ISPE, BioPharmaPM, and PMI, and regularly provides training and seminars to clients on the topic of Technology Transfer and Project Management. 

Laura worked as a Validation contractor where she managed a multitude of domestic and international teams. The team’s validation work was frequently reviewed during inspections by the FDA and other international government agencies. 

Prior to ProPharma, she worked as an Analytical Chemist, Laura and was trained in quality and assay development. She then moved into the development and manufacturing arena as a Process Engineer. She held positions in Manufacturing in Pharmaceutical and Medical Device companies prior to her work in direct Marketing Research developing new products for manufacturing and testing materials in a GMP environment. 

8:00-9:00 Exhibitors, Networking, Wine and Cheese