Making America Healthy Again?

For those of you who know me, I rarely post opinions that may create political discourse.  I value the diversity of perspectives from my friends and colleagues that span the full political spectrum.  With this in mind, I have observed the following policies being either discussed or implemented:

1. Increased reliance on fossil fuels – a move that will increase carbon emissions leading to more airborne pollutants
2. Review of policies to eliminate lead pipes – a move that will slow the removal of lead from drinking water in communities where lead pipes are still prevalent
3. Elimination of supplemental fluoride in water – a move that will result in an increase in childhood cavities and tooth decay
4. Undermining of the public’s confidence in use of childhood vaccines – a move that will continue to result in increased epidemics of preventable diseases such as measles above and beyond those recently reported
5. Elimination of funding for mRNA-based vaccine research and development programs – a move that will deprive the public from proven technologies useful to fight diseases and epidemics that broadly threaten public health 
6. Undermining of confidence in existing mRNA-based vaccines – a move that will result in further public distrust of, and poor participation in, vaccination programs that reduce infection severity and minimize reliance on hospital resources
7. Imposition of up to 250% tariffs on pharmaceuticals manufactured outside of the United States – a move that will dramatically increase the cost of many medications at a time when the cost of pharmaceuticals remains under pressure from both political parties
8. Insistence that all pharmaceuticals are manufactured in the United States – a move that will overload the current manufacturing plant capacity within the United States, force production at more expensive manufacturing facilities and, in all likelihood, result in increased pharmaceutical costs and decreased supply chains
9. Reduction of indirect costs allowable in federally funded research grants – a move that will reduce available funds for the training of our next generation of scientists, reduces the sizes of graduate school research groups and, by extension, reduces the number of qualified scientists able to enter the workforce

There are, of course, many more examples that can be listed here.  The main point is the following question:  HOW ARE THE ABOVE ACTUALLY EXPECTED TO MAKE AMERICA HEALTHY AGAIN???

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.